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throughout the following description specific details are set forth in order to provide a more thorough understanding of the invention . however , the invention may be practiced without these particulars . in other instances , well known elements have not been shown or described in detail to avoid unnecessarily obscuring the present invention . accordingly , the specification and drawings are to be regarded in an illustrative , rather than a restrictive , sense . the invention in one embodiment is directed to implantable medical devices with a flexible thin film calcium phosphate bio - compatible and bio - resorbable coating that has the ability to act as a high capacity drug carrier . such cap coatings have no side - effects during coating dissolution into body fluids , and can be designed with a high level of control of coating dissolution rate and microstructure , which also determine the drug retention and release characteristics . of all the types of implantable medical devices that exist , the coronary stents utilized in balloon angioplasty procedures provide a useful model for testing the effectiveness of sol - gel deposited thin flexible cap coatings on such stents due to the fact that such stents are designed to be flexible . the use of such stents in the examples below should not , however , be considered as limiting the application of the cap coatings described only to stents . the invention has broad application to virtually any type of body implantable device . we have determined unexpectedly that the intrinsic brittle behaviour of cap ceases to limit the system strain capability if the strongly bonded coating is sol - gel deposited and is thinner than approximately 0 . 001 mm . experiments involving repeated contraction / expansion of such thin cap sol - gel coated stents reveal that there is no separation of the coating from the stent , nor visible damage to the coating , if the coating is thinner than about 0 . 001 mm and is strongly bonded to the substrate ( the tensile bond strength should be larger than about 40 mpa , as measured in model strength experiments according to astm c - 633 standard ). in addition , we have discovered that if the novel sol - gel process for deposition of calcium phosphates , in particular hydroxyapatite ( ha ) synthesis ( as previously disclosed in our u . s . pat . no . 6 , 426 , 114 b1 , jul . 30 , 2002 , “ sol - gel calcium phosphate ceramic coatings and method of making same ”, by t . troczynski and d . liu ) is used , the resulting thin flexible coating has controlled porosity which may be utilized to retain drugs within the coating , and release the drugs at a controlled rate . the invention pertains to a sol - gel ( sg ) process for synthesis of calcium phosphate , in particular , hydroxyapatite ( ha ), thin film coatings on implantable medical devices . the process allows the ha to be obtained in a controlled crystallized form , at a relatively low temperatures , i . e . starting at ≈ 350 ° c . this is an unexpectedly low crystallization temperature for ha sol - gel synthesis . the process provides excellent chemical and physical homogeneity , and bonding strength of ha coatings to substrates . the low process temperature avoids substrate metal degradation due to thermally - induced phase transformation , microstructure deterioration , or oxidation . disclosed herein is a method wherein uniform films of hydroxyapatite by the electro - phoretic deposition ( epd ) method ( epd - ha ) are deposited on complex stent surface , and there is no need to pursue sintering in excess of 500 ° c . to achieve substantial structural integrity of the film and its high bonding strength to the metallic substrate . in this method , the first step is the well - known epd of the ha film , for example as disclosed in u . s . pat . no . 5 , 258 , 044 , using suspension of sub - micrometer particles of ha in water . this film is dried and then heat treated at 500 ° c . for 10 - 60 minutes to initiate sintering of ha . the film is still too weak and too poorly bonded for practical use as a coating on stent or other medical device or implant , but is sufficiently strong to survive the subsequent processing step comprising impregnation by aero - sol - gel ha droplets . the droplets penetrate porosity of the previously deposited epd - ha , strongly aided by the capillary suction . thus , majority of the pores of the epd - ha film are penetrated by the sol - gel precursor of ha , all the way to the metallic substrate . this composite film can be now dried and sintered at a relatively low temperature or 400 - 500 ° c ., due to the very high activity of the sol - gel component of the film . the sol - gel film bonds the particles of ha deposited by epd , and bonds well to the metallic substrate during the heat treatment thus , both the film uniformity ( due to epd process ) and low - temperature sinterability ( due to sol - gel process ) have been achieved . this novel and inventive hybrid technology for uniform ha coatings on stents has the ability to produce films in thickness range from about 1 micron to above 100 microns , with porosity in the range from about 10 vol % to about 70 vol %. such porous thick ha films are excellent carriers for drugs loaded through impregnation into open porosity of the film . details of such hybrid process , and its several variants , for preparation of ha films on stents , are given in the examples below . problems with drug delivery in vivo are frequently related to the toxicity of the carrier agent , the generally low loading capacity for drugs , and the aim to control drug delivery resulting in self - regulated , timed release . with the exception of colloidal carrier systems , which support relatively high loading capacity for drugs , most organic systems deliver inadequate levels of bioactive drugs . sol - gel films heat - treated at relatively low temperatures closely resemble the properties of colloidal films , in terms of accessible surface area and porosity size . the sol - gel process according to the invention allows the calcium phosphate to be obtained in a crystallized form , at relatively low temperature , i . e . approximately 350 - 500 ° c . variation of the heat treatment temperature and time provides for control of coating crystallinity ( i . e . a more amorphous , more easily resorbable coating can be processed at lower temperatures ) as well as coating porosity ( higher porosity and smaller average pore size at lower temperatures ). variation of ca / p ratio in the sol - gel precursor mix allows one to obtain various calcium phosphate phases , for example , hydroxyapatite , dicalcium phosphate , tricalcium phosphate or tetracalcium phosphate . the invention in one embodiment is directed to a sol - gel process for preparing calcium phosphate , such as hydroxyapatite , which comprises : ( a ) hydrolysing a phosphor precursor in a water or alcohol based medium ; ( b ) adding a calcium salt precursor to the medium after the phosphite has been hydrolysed to obtain a calcium phosphate gel such as a hydroxyapatite gel ; ( c ) depositing the gel on the surface of an implantable medical device ; and ( d ) calcining the calcium phosphate , such as hydroxyapatite , at a suitable elevated temperature and for pre - determined time to achieve desired crystallinity , bonding and porosity characteristics for the coating on the device . the deposition of the gel can be done by any number of methods , such as aero - sol deposition , dip - coating , spin - coating , electrophoretic deposition . in a preferred embodiment , the phosphor precursor can be an alkyl phosphite and the alkyl phosphite can be triethyl phosphite . further the calcium precursor can be a water - soluble calcium salt and the water soluble calcium salt can be calcium nitrate . the crystallized calcium phosphate can be calcined at a temperature of at about 350 ° c . or higher . the metallic implantable medical device can be stainless steel , cobalt alloy , a titanium substrate or other metallic alloy substrate . we have discovered that if certain specific characteristics of the calcium phosphate coatings are maintained , the coatings become highly flexible while maintaining their chemistry , high bio - compatibility , and bio - resorbability . the most important characteristics are ( a ) coating thickness , and ( b ) the strength of the coating bonding to the metallic substrate . we have repeatedly demonstrated ( refer to the examples below ) that if cap coating thickness is maintained below about 0 . 001 mm , and its bonding strength to the metallic substrate is above approximately 40 mpa , the substrate - coating system retains the strain capabilities of the substrate alone , i . e . the system maintains its integrity during deformation . furthermore , we have discovered that thicker cap coatings deposited discontinuously on metallic substrate , i . e . in the form of separate “ islands ” and “ patches ” approximately 1 - 100 μm in diameter , retain high resistance against substrate deformation . our experiments have shown that stents coated with such 1 - 100 μm patches , about 1 - 10 μm thick , can be crimped and then expanded without damage to the patches of ceramic . these patches can be deposited on the substrate through a variety of methods discussed above , such as bm - ha , ecd - ha , cpc - ha ( all at room or near - room temperature ), or epd - ha , sg - ha and combinations thereof ( these two techniques including heat treatment at elevated temperatures ). these coating deposition techniques are illustrated in the following examples . the discontinuous cap film coated medical implant may have some fraction of an area of the metallic substrate exposed to living tissue , which may again lead to the adverse tissue reaction described above . this problem can be avoided by combining discontinuous cap films with a continuous bio - compatible and non - thrombogenic polymer . thus , a composite cap - polymer coating on medical implant is the result . furthermore , a thin (& lt ; 0 . 001 mm ) continuous cap coating can be combined with a thicker discontinuous cap coating . the effects of this process ( described in detail in the examples ) are shown in the representative fig1 and 2 . fig1 a illustrates stainless steel ( 316l ) stent coated with discontinuous asg - ha thin film ; fig1 b is a magnification of the sector of ( a ) indicated by the rectangle . fig2 a illustrates a stainless steel ( 316l ) stent coated with discontinuous asg - ha thin film and crimped , with no damage to the coating . fig2 b is the same stent after expansion , showing no damage to the coating . our discovery of flexible continuous / discontinuous cap films or cap / polymer films opens up a range of new applications of highly biocompatible cap coatings for medical implants , particularly , but not limited to those that require deformation capability such as coronary stents . a sol - gel ( sg ) process provides superior chemical and physical homogeneity of the final ceramic product compared to other routes , such as solid - state synthesis , wet precipitation , or hydrothermal formation . the sg process allows the desired ceramic phase , e . g . thin film cap coating , to be synthesized at temperatures much lower than some of the alternate processes . in the sg coating process substrate metal degradation due to thermally induced phase transformations and microstructure modification or oxidation , is avoided . sg widens green - shaping capability , for example , and it is a very convenient method for deposition of thin ceramic coatings . sol - gel deposition of ha ( sg - ha ) films at elevated temperatures ( 350 - 500 ° c .) was disclosed previously in u . s . pat . no . 6 , 426 , 114 b1 . sol - gel ( sg ) processing of ha allows molecular - level mixing of the calcium and phosphor precursors , which improves the chemical homogeneity of the resulting calcium phosphate . the crystallinity of the calcium phosphate phase can be enhanced by appropriate use of water treatment during processing . variation of ca / p ratio in the sol - gel precursor mix allows one to obtain any of a number of calcium phosphate phases , for example , hydroxyapatite , dicalcium phosphate , tricalcium phosphate or tetracalcium phosphate . the versatility of the sg method provides an opportunity to form thin film coatings , either continuous or discontinuous , in a rather simple process of dip - coating , spin - coating or aero - sol deposition . a high degree of ha crystallinity is frequently required for longer - term bioactive applications , because partially crystalline , or amorphous calcium phosphate , such as ha , coatings are rapidly resorbed by living tissue . for the presently disclosed application of thin ha films on implantable medical devices , control of crystallinity of the ha coating is possible through variation of the time / temperature history during processing . this allows control of the coating resorption rate and thus rate of release of the drugs impregnated into microporosity of the coating . ceramics produced by sol - gel processing can be designed to include high fraction of pores , with well - defined ( narrowly distributed ) pore size . this is a consequence of the chemical route to the final oxide ceramic produced through sg . only a small fraction of the original precursor mass is finally converted to the ceramic oxide , the remaining fraction being released during heat treatment , usually in the form of gas , is usually as a combination of water and carbon dioxide . thus , the released gases leave behind a large fraction of porosity , up to 90 % in some instances , depending on the drying conditions and heat treatment time and temperature . these pores can be as small as several nm in diameter , again depending on the drying conditions and heat treatment time and temperature . effectively , the accessible surface area of such sol - gel derived oxide ceramics can reach several hundred square meters per gram of the oxide , making it an excellent absorbent of gas or liquid substances , or solutions . for example , the average pore size in sol - gel ha treated at relatively low temperature of 400 ° c . is about 5 nm in diameter , with 90 % of pore diameters falling within the range of 1 - 30 nm . this unique porosity characteristic is widely utilized to produce desiccants , filters and membranes of sol - gel derived ceramic . in this respect sol - gel derived ceramic oxides have a great advantage over polymers , which are in general difficult to process to possess high porosity and high accessible surface area . in the present invention , we utilize this unique property of sol - gel derived cap coatings on medical implants , especially stents , possessing high accessible surface area to make it a high - capacity drug carrier . in the text of this application , it is understood that when appropriate , the term “ calcium phosphate ” ( cap ) is used generically and includes minerals such as hydroxyapatite , dicalcium phosphate , tricalcium phosphate , tetracalcium phosphate and amorphous or partially amorphous calcium phosphate . studies on the sol - gel route to thin film calcium phosphate coatings on implantable medical devices , particularly stents , performed by the inventors have led to an unexpected break - through in process development . the method according to the invention has produced cap coatings after heat treatment in air , starting at about 350 ° c . we have unexpectedly discovered that the film is highly flexible if it is thinner than about 0 . 001 mm , thereby allowing damage - free manipulation of a cap coated deformable implantable medical device , for example the contraction and expansion of a cap coated stent . preferably , the coating has a thickness between about 0 . 0001 and 0 . 001 mm . furthermore , in this application , we have discovered that the film can accept drugs into its fine porosity , thereby allowing it to address the adverse phenomena related to common medically implanted devices , i . e . the restenosis that occurs after placement of a coronary stent in a blood vessel . the calcium phosphate coating according to the invention has been deposited on stents and other metallic surfaces using variety of techniques , including dip - coating , spin - coating , aero - sol deposition electrophoretic deposition . the coatings were deposited on stents made of 316l stainless steel and tubes , and on other metallic substrates including cobalt - iron alloy and titanium . to demonstrate the feasibility of the unique processing concepts outlined above , the following examples are described below for stainless steel substrate and coronary stents . the procedures outlined below can be applied to other implantable medical devices . in the first stage of the process , phosphite sol was hydrolysed in a water - ethanol mixture ( a concentration of 3m ) in a sealed beaker until the phosphite was completely hydrolysed ( which is easily recognized by loss of a characteristic phosphite odour ), at ambient environment . a ca salt ( 2m ) was then dissolved in anhydrous ethanol , and the solution was then rapidly added into the hydrolysed phosphite sol . the sol was left at ambient environment for 8 hours , followed by drying in an oven at 60 ° c . as a result of this process , a white gel was obtained . for the sol containing ca / p ratio required to produce ha , the gel showed a pure ( single phase ) apatitic structure with a ca / p ratio of 1 . 666 , identical to stoichiometric ha , after calcining at a temperature as low as 350 ° c . varying the ca / p ratio allows other calcium phosphates , such as dicalcium phosphate ( ca / p = 1 ) or tricalcium phosphate ( ca / p = 1 . 5 ), to be obtained . a coating produced using this process , and applied to 316 ss substrate , showed adhesive strength of about 40 mpa after curing at a temperature & lt ; 450 ° c . the coating was crack - free and porous . in another variant of the process , a pure water - based environment was used . the aqueous - based sols were prepared in the same manner as described above in example 1 for the ethanol - based system . a higher rate of hydrolysis of the phosphite sol was observed . the mixed sol was dried while stirring . after 8 hours aging , a white gel appeared . for the sol containing a ca / p ratio required to produce ha an apatitic structure with ca / p ratio of 1 . 663 , close to stoichiometric ha , resulted after calcining the gel at a temperature of 350 ° c . both the ethanol - based and aqueous - based gels showed essentially the same apatitic structure at relatively low temperatures . this invention provides a method of synthesizing the ha ceramics via an aqueous - based sol - gel process . a cap coating was deposited on the surfaces of a group of electropolished stainless steel stents through aerosol - gel processing . the stents were first treated in 2 . 4 n phosphoric acid solution for 10 minutes at 70 ° c . to clean the surface and produce microroughness for increased bonding of the coating . the treated stents were ultrasonically cleaned and dried . the cap sol was prepared by ( a ) hydrolysing a phosphor precursor ( phosphite ); ( b ) adding a calcium salt precursor to the medium after the phosphite has been hydrolysed to obtain a calcium phosphate sol such as a hydroxyapatite sol . the sol was atomized into ˜ 4 μm large particles using ultrasonically assisted atomizer , and the resulting aerosol fed into a coating chamber . this specific deposition technique is referred to as aero - sol - gels ( asg ) deposition and the resulting hydroxyapatite film as asg - ha . the clean stent was inserted into the coating chamber filled with flowing cap aerosol - gel for a period of 30 seconds , while maintaining the aerosol flow at 0 . 1 liter / min and chamber temperature at 50 ° c . the temperature of the coating chamber affects the deposition mode of the coating , producing a uniform , film like coverage of the surface as evidenced by sem . the coating was dried at 60 ° c . and heat treated at 450 ° c . for 15 min to crystallize cap to form hydroxyapatite thin film . the procedure produces a thin coating covering uniformly the surface of the stent . the thickness of the coating is measured using ellipsometry in the range of 50 - 150 nm . the subsequent sem studies on the crimped and expanded coated stents show no evidence of cracking or delamination of the coating . this proves the reliability of the uniform , thin continuous cap coating during the deployment and implantation of the stent into the coronary artery . cap coating has been deposited on the surface of an electropolished stainless steel stents through aerosol - gel processing ( asg ), as described in example 3 . the chamber temperature was maintained at 25 ° c . the coating was dried at 60 ° c . and heat treated at 450 ° c . for 15 min to crystallize cap to form hydroxyapatite thin film . the procedure explained above produces a coating comprising of isolated island of approximately 2 - 6 μm in size and 0 . 1 - 2 μm in thickness , scattered uniformly on the surface of the stent , and covering about 70 % of the surface of the stent , as shown in fig1 a and 1b . subsequent sem studies on the crimped and expanded coated stents showed no evidence of cracking or delamination of the coating , as shown in fig2 a and 2b . this proves the reliability of the discontinuous cap coating of variable thickness during the deployment and implantation of the stent into the coronary artery . stainless steel metallic substrates ( 316l ) were coated with a 0 . 6 - 0 . 8 μm thin layer of apatite ( asg - ha ) as described in example 3 . one group of samples was annealed at 400 ° c . for 20 min to achieve crystalline sg - ha ( c ) film and another group at 375 ° c . for 60 min to achieve amorphous sg - ha ( a ) film . these films were used as nucleation site for precipitation of bm - ha film . the sg - ha coated samples were immersed into “ simulated body fluid ” ( sbf ) of ionic composition ( in units of mmol / l ) 142 na + , 5 . 0 k + , 2 . 5 c 2 + , 1 . 5 mg 2 + , 103 cl − , 25 hco 3 − , 1 . 4 hpo 4 2 − , and 0 . 5 so 4 2 − . the sbf was buffered at ph 7 . 4 with tris ( hydroxymethyl )- aminomethane and hcl . this in - vitro static deposition ( i . e . the sbf was not renewed during the deposition period ) at ˜ 24 ° c . produced good quality , dense 3 - 5 μm thick bm - ha film deposits on flat sg - ha substrates . the crystalline sg - ha ( c ) film is coated with dense bm - ha , whereas amorphous sg - ha ( a ) film is coated with porous bm - ha . the properties of the underlying sg - ha surface modification film can be used to vary the properties , e . g . porosity , of the nucleated and deposited top bm - ha film for drug encapsulation . stainless steel metallic stents ( 316l ) were coated with − 0 . 1 μm thin cap coatings as described in example 3 . an inorganic colloidal slurry containing calcium phosphate precursor ca ( oh ) 2 and calcium phosphate salt monocalcium phosphate anhydrate , was ball milled in ethanol . the two starting inorganic ingredients had particle size 0 . 3 - 2 μm and 0 . 5 - 4 μm , respectively . the initial ca / p ratio in the slurry was kept at 1 . 5 . as dissolution and precipitation are the principal mechanisms for apatite development in such system , 5 wt % of submicron , crystalline hydroxyapatite powder was used as seeds for heterogeneous nucleation of cpc - ha . the thin cap film surface - modified sample was dip coated in the ethanol suspension of the precursors . after single dip coating , an approximately 10 μm thick layer of porous precursor powder mixture developed on the substrate due to rapid evaporation of ethanol . due to the colloidal nature of the precursors slurry , this film develops sufficient structural integrity ( i . e . strength and hardness ) to accept the next processing step . in this step , the film is exposed to sodium phosphate water - based solution ( 0 . 25 m ), which is allowed to soak into the open pores of the film , and then placed in an incubator at 37 ° c ., 100 % relative humidity , for 24 h . during incubation , the colloidal precursors react with the phosphate liquid and precipitate ha . in order to assess the possibility of using this double - coating route for controlled drug release , amethopterin ( sigma chemicals , usa ) was employed as a model drug , in an amount of 5 % based on solid phase content of cpc - ha precursors . the drug was mixed with the colloidal suspension of the precursors , before dip coating was performed . during incubation period , 20 μm thick cpc - ha coating precipitated encapsulating the drug molecules within the nanopores of the crystallizing ha . after encapsulation , a drug release study was conducted by immersion of the substrates into 20 ml of phosphate buffer saline ( pbs , ph = 7 . 4 ) at constant ratio of ( cpc coating weight )/( volume of pbs ) of 1 mg / ml . a reference sample coated with hydrogel film was also tested for drug release kinetics . the hydrogel film was prepared by dipping the cpc - ha layer containing the drug into a polymer solution containing 3 % polyvinyl alcohol . after drying , the weight gain of the ˜ 20 mg cpc - ha layer due to the additional hydrogel coating was ˜ 0 . 5 mg , corresponding to the content of polymer film in the cpc - ha matrix of about 2 . 5 %. the samples of pbs liquid with released drug were periodically taken out ( i . e . entire liquid was emptied ) and refilled with the same amount of 20 ml of pbs . the drug concentration in the supernatant was determined via an uv - visible spectroscopy . although a burst effect was detected for both coatings over the initial period of about 8 h , a slower release is evident for the sample post - coated with hydrogel . a linear relationship was obtained between the amount of drug released and ( time ) 1 / 2 for the release time greater than 8 h . the stent was submerged into water - based , diluted suspension of sub - micron particles of hydroxyapatite , containing approximately 2 wt % of ha in the suspension . dc voltage of 5v was applied to the stent , for times varying from 5 seconds , to 10 minutes . as the particles of ha naturally attain positive charge in such solution , they are attracted to the stent surface which is also a negative electrode ( cathode ) in this system . the buildup of ha particles attracted to the stent ( cathode ) allows to produce an extremely uniformly coated surface , thickness of the coating varying as a function of time of application of voltage . the film uniformity is the biggest advantage of such electro - phoretic deposition ( epd ) processing , which is difficult to reproduce using other methods such as sol - gel processing . for the short time of 10 sec ., the epd - ha coating thickness is about 1 micrometer . this type of epd - ha coating on 316l stainless steel stent is illustrated in fig3 . for the longer times of several minutes , the coating thickness may exceed 10 micrometers . thus , in this epd process , a controlled thickness , uniform ha film may be produced . the as deposited film constitutes loosely bonded particles of ha , of porosity generally in excess of 50 vol %. in order to increase structural integrity and bonding strength to the substrate of such epd film , heat treatment is necessary at temperatures at least 500 ° c ., for times at least 10 minutes . the heat treatment of epd films proceeds at higher temperatures and longer times than sol - gel films , because ha particles deposited in the epd process are less reactive than those deposited in the sol - gel process . the goal of such heat treatment is to increase interparticle bonding , while providing sufficient residual porosity to maintain low stiffness and flexibility of the film , and to provide room for drug impregnation . the need for higher temperature and longer times heat treatment of epd films is a disadvantage , as the heat treatment process may adversely affect properties of the metallic substrate of the stent . the ha was deposited on a 316l stainless steel stent surface through epd process as described in the example 7 . the uniformly deposited epd film was heat treated at 500 ° c . for 10 minutes to achieve minimal structural integrity of the film , sufficient to survive handling and preventing re - fluxing of the film upon contact with liquid medium . such epd - coated stent was exposed to droplets of sol in the aero - sol - gel process described in example 3 . the sol droplets have penetrated open porosity of the epd film , and , by capillary attraction , located themselves mostly within negative curvature of the necks between epd deposited ha particles . such composite coating was heat treated again at 500 ° c . for 10 minutes . now the active sol - gel component of the coating allowed achieving high structural integrity of the film , while epd component of the coating allowed achieving high uniformity of coverage by the film . a uniform , porous ha film was achieved in this novel combined process . the electrochemical deposition ( ecd ) of hydroxyapatite ha has been conducted in the mixed aqueous solution of ca ( no 3 ) 2 4h 2 o and nh 4 — h 2 po 4 . in this process ha is deposited on the cathodic ( negatively biased ) surface of stent or implant by the following reaction : 10ca 2 + + 6po 4 3 − + 2oh → ca 10 ( po 4 ) 6 ( oh ) 2 ecd was conducted in the mixed aqueous solution of 0 . 02329 m ca ( no 3 ) 2 4h 2 o and 0 . 04347 m nh 4 h 2 po 4 . the stainless steel specimen , i . e . stent , was the cathode , and platinum was used as the anode . the ph was controlled at 4 . 0 with the addition of sodium hydroxide . the environment temperature was controlled at 40 ° c .± 1 ° c . the coating morphology deposited at low current density ( 1 ma / cm 2 ) was a thin uniform porous structure , 1 - 2 micrometers thick for deposition time of 0 . 5 - 1 minute , as illustrated in fig4 . the ha was deposited on a 316l stainless steel stent surface through asg - ha process as described in the example 4 . the discontinuous network of ha patches left some of the stent surface uncoated . 5v dc bias voltage was applied to such pre - coated stent , and the stent submerged into suspension of submicron ha particles . the uncoated metallic surface of the stent preferentially attracted ha particles leading to preferential electrophoretic deposition ( epd ) of ha in these areas , to build the coating about 1 micrometer thick in about 10 seconds . the coated stent was heat treated at 500 c for 10 minutes . the epd - ha coated areas show increased porosity as compared to asg - ha coated areas , suitable for impregnation with drug carrying liquid . such composite engineered ha coating shows unique properties regarding mechanical performance and drug release properties . the ha was deposited on a 316l stainless steel stent surface through asg - ha process as described in the example 3 , followed by the process of ecd - ha deposition as described in example 9 , but on top of the already heat treated asg - ha . such composite engineered coating allowed to achieve substantially higher bonding strength ( as compared to ecd - ha deposited directly on metallic surface ), and capability of drug encapsulation during deposition of ecd - ha on top of asg - ha . the ha was deposited on two 316l stainless steel stents surface through asg - ha process as described in the example 4 . the coated stents were evaluated in the standard thromboresistance test in dogs . minimal thrombosis with a grade of 1 ( defined as thrombus found at one location only ) was observed in one out of two test sites . in the second test site , no thrombosis ( grade 0 ) was observed . the process for coating of calcium phosphate , in particular ha , bioactive ceramics , on implantable medical devices disclosed herein offers the following advantages in comparison to other processes and other coating materials on implantable medical devices : ( 1 ) the coating process , including cap sol synthesis , can be completed in ambient environment ( i . e . air ), in less than 24 hours . ( 2 ) the thin (& lt ; 0 . 001 mm ) adhesive cap coatings exhibit sufficient flexibility to survive substantial strain , e . g . during crimping and expanding of a coated stent , without coating damage or spallation ( 3 ) porous cap coatings can be produced , with controlled amount and size of the pores , which allows design flexibility in choice and absorption / release characteristics for the drug impregnated into the coating ( 4 ) the synthesis requires low temperature (˜ 350 ° c .) and short time (& lt ; 1 hour ) of calcination for formation of high quality , highly adhesive cap coating . low temperature calcination of the novel cap coatings on metals permits thermal treatment in an air environment without the risk of metal oxidation and possible property degradation due to microstructural deterioration or phase transformations . it will be clear for the person skilled in the art of sol - gel processing that coating deposition parameters , such as time , the flow rate of the aerosol , temperature of the coating chamber or the concentration of the sol - gel solution can be customized for different implantable medical device materials and applications producing various degree of coverage on the surface . similar manipulation and optimization of process parameters may be applied to other coating methods disclosed , i . e . dip - and spin - coating and electrophoresis , biomimetic coating , electrochemical deposition coating , calcium phosphate cement coating , electrophoretic deposition coating , as well as coating porosity distribution and ratio of the inorganic phase ( cap ) to organic phase ( biodegradable polymer ). these parameters were optimized for the particular cap coatings on the implantable medical devices described in the foregoing examples . it is well known that crystallinity and microporosity of hydroxyapatite directly affects its dissolution rate in body fluids . different heat treatment regimes and temperatures can be adopted to produce various degrees of crystallinity and microporosity to control the degradation of the coating into the body environment . this advantage is of a great importance where drug delivery capabilities are added to the implantable medical device surface coated with sol - gel derived cap . similar deposition process can be applied to coating other metallic surfaces , such as ti substrates or other alloys , such as cobalt - chromium - nickel - molybdenum - iron . a thin uniform thin ha coating is obtained . the results of this experiment provide basic evidence of the feasibility of the as described coating on implantable medical devices composed of non - metallic materials such as polymers . the nature of the process for cap coatings deposition according to the invention is such that it can be easily incorporated into the current production practice of metallic implantable medical devices . the water - based liquid precursors to cap ceramic coatings , simple deposition technique ( e . g . dipping or spin - coating or aerosol deposition or electrophoretic deposition , and others ) and low - temperature heat treatment in air make the process not unlike simple painting - curing operation which can be commercialized with relatively small effort . as will be apparent to those skilled in the art in the light of the foregoing disclosure , many alterations and modifications are possible in the practice of this invention without departing from the scope thereof . accordingly , the scope of the invention is to be construed in accordance with the substance defined by the following claims .
this invention relates to novel calcium phosphate - coated implantable medical devices and processes of making same . the calcium - phosphate coatings are designed to minimize the immune response to the implant and can be used to store and release a medicinally active agent in a controlled manner . such coatings can be applied to any implantable medical devices and are useful for a number of medical procedures including balloon angioplasty in cardiovascular stenting , ureteral stenting and catheterisation . the calcium phosphate coatings can be applied to a substrate as one or more coatings by a sol - gel deposition process , an aerosol - gel deposition process , a biomimetic deposition process , a calcium phosphate cement deposition process , an electro - phoretic deposition process or an electrochemical deposition process . the coating can contain and elude a drug in an engineered manner .
preferred embodiments of the invention are illustrated and described in connection with a stapler for applying staples to an exterior wound or incision across a layer of skin , although the invention is not limited to such a surgical stapler . the embodiment of the stapler illustrated in fig1 - 9 comprises as depicted in fig1 a rear housing portion 10 and a front housing portion 11 . the front housing portion 11 is mounted to the rear housing position for rotation of the front housing portion about its longitudinal axis . the mechanism 12 for actuating the stapler is contained in the rear housing portion 11 . a slide 13 which advances a driver 15 is guided in the front housing portion 10 for longitudinal displacement but is prevented from rotating . the slide 13 comprises a forwardly projecting flexible tongue 14 which also cooperates with the driver 15 , as described more fully below . the driver 15 comprises an elongated rigid strip of material which is displaceable in its longitudinal direction in a channel or duct 16 . the strip has a central recess 17 ( fig4 ) at the forward end of which is disposed a bent - up section 18 having an enlarged head . a leaf spring 19 extends in the channel 16 substantially parallel to the driver 15 . the leaf spring 19 has an inclined surface 20 ( fig2 ) and is provided with a central slot 21 ( fig4 ) closed on all sides which extends forwardly and rearwardly of the region of the inclined surface 20 . the enlarged head of the bent section 18 of the driver 15 protrudes through the slot 21 and is pressed against the upper side of the leaf spring 19 . the forward end of the leaf spring 19 is bent downwardly to form the anvil surface 22 . the rear end of leaf spring 19 is fixed to the front housing portion 11 . when the driver 15 is in its retracted position , as depicted in fig2 the bent section 18 is positioned at the base of the inclined surface 20 . due to the inherent tension in the front region of the leaf spring 19 , the leaf spring positions itself in the channel 16 as depicted in fig2 . since the height of the channel 16 is greater than the height of the anvil 22 , there is a clearance between the anvil 22 in its retracted position and the lower region 16 &# 39 ; at the front of the channel 16 . a staple magazine 26 ( fig1 and 6 ) extends parallel to the channel 16 in the front housing portion 11 . staples 24 are arranged in the magazine standing upright side by side and extending along the feed passage of the magazine parallel to the channel 16 . a helical spring 25 braced against the housing contacts the rearmost staple and urges the rearmost staple and with it the entire stack of staples forward under constant tension . the forward section 26 &# 39 ; of the staple magazine 26 is curved upwardly at an angle of 90 ° and opens into the channel 16 . the staples are urged into the curved section 26 &# 39 ; of the magazine and extend along the arc of the curve as depicted in fig6 with the forwardmost staple 24 &# 39 ; being disposed lying flat in the channel 16 . the lower region 16 &# 39 ; in the forward portion of the channel 16 in which the leaf spring 19 can move vertically is of greater width than the region above it . the height of the wider , lower channel portion 16 &# 39 ; is only slightly greater than the thickness of the staples 24 so that channel portion 16 &# 39 ; forms a guide channel for the advance of the forwardmost staple 24 &# 39 ; and for the driver 15 . this guide channel is defined by the lower guide face 16a , the two upper guide faces 16b , ( fig6 ), and by the lateral guide faces 16c ( fig4 ). the staples 24 , whose undeformed configuration is depicted in broken lines by the staple 24 &# 39 ; in fig5 have arcuate side portions 24a connected via a straight leg region 24b to a central base or crown portion 24c . the straight leg regions 24b extend obliquely outwardly from the base portion to the side portions 24a . the base portion 24c is semicircular with the circumference of the semicircle facing in the direction of the side portions . the base portion is engaged by the anvil surface 22 during forward motion of the staple . in order to insure centering of the staple 24 , the anvil surface 22 is provided with a vertical slot 22 &# 39 ;. in the arcuate section 26 &# 39 ; of the staple magazine 26 , the side portions 24a of adjacent staples 24 are spaced apart while the straight leg regions 24b are in contact with adjacent leg regions due to the difference in radii of the curves for the upper and lower surfaces of the arcuate section 26 &# 39 ;. thus , the force of the spring 25 can be transmitted through the staples in the arcuate section 26 &# 39 ; to the forwardmost staple 24 &# 39 ;. at the opening 27 ( fig5 ) of the magazine 26 into the channel 16 , the underside of the upper guide face 16b is embossed ( not shown ) to hold the forwardmost staple 24 &# 39 ; in a well - defined position . as the driver 15 is advanced from retracted position shown in fig2 ; its front end abuts the forwardmost staple 24 &# 39 ; and pushes it forward in the channel section 16 &# 39 ;. at the same time , the bent section 18 moves along the inclined surface 20 of the leaf spring 19 so that the anvil surface 22 at the forward end of the leaf spring is brought from its retracted position into the operative position shown in fig3 . the staple designated 24 &# 34 ; in fig3 and 4 is now situated between the forward end of driver 15 and the anvil surface 22 in a position in which the tips of the staple side portions protrude slightly forwardly from the instrument . as the driver 15 is advanced further , the staple side portions emerge from the front end of the instrument , with staple 24 &# 34 ; being deformed and closed to the solid line configuration depicted in fig5 in which the base 24c of the staple has been bent flat on the inner side of the anvil surface 22 . to obtain as long a guide path as possible during deformation of staple 24 &# 34 ;, the guide faces 16a , 16b and 16c extend into projections 28 which define the exit gap of channel 16 out of the housing and which protrude slightly beyond the anvil surface 22 . as soon as the driver 15 has carried the forwardmost staple 24 &# 39 ; away from the opening 27 of the magazine into the channel , the opening 27 is closed by the driver so that the next staple cannot be advanced into the channel 16 . the next staple can only be advanced into the channel after the driver 15 has returned to its retracted position where it is clear of the opening 27 . fig7 - 9 illustrate control of the driver 15 by the slide 13 . slide 13 , which is supported to the front housing portion 11 for longitudinal displacement but is prevented from rotating , comprises at its forward end a forwardly projecting , flexible tongue 14 which is vertically springloaded . a laterally projecting guide wing or cam surface 30 is disposed at the end of the tongue 14 and cooperates with a control cam 31 fixed to the housing portion 11 . when the slide 13 is advanced by the actuating mechanism 12 , its front face strikes driver 15 , pushing it in the direction of the tool tip . a bevel formed on wing 30 causes wing 30 to abut on a rearward bevel of the control cam 31 . the tongue 14 then flexes upwardly and wing 30 slides on the upper cam surface 32 . if the slide 13 is retracted before its forward end position is reached corresponding to the operating position of the driver , the wing 30 slides back on to the upper cam surface 32 , which maintains the slide and correspondingly the driver in the advanced position they assumed . only after the slide 13 reaches the position shown in fig8 and the wing 30 has gone beyond the front end of the control cam 31 is the stamping operating completed and staple 24 &# 34 ; closed . as the slide 13 is thereafter being moved back , the rear surface of the wing 30 , which is inclined , contacts the correspondingly inclined forward surface of the control cam 31 . as a result , the tongue 14 is forced downward , and a projection of the tongue 14 enters into the slot 17 of the driver 15 . as the slide 13 is further retracted , the wing 30 is pulled beneath the control cam 31 , and the driver 15 is drawn rearward . referring to fig7 after the wing 30 has passed along the underside of the control cam 31 , the tongue 14 springs upward , releasing the driver 15 at its starting position . until the driver 15 is pulled back to its starting position , it does not clear the opening 27 of the staple magazine 26 into the channel 16 . fig1 depicts an embodiment in which a counting mechanism 33 is secured to the front housing portion 11 . the counting mechanism is stepped by movement of the tongue 14 of the slide 13 . the counting mechanism 33 comprises a hollow cylinder 34 fixed in the housing portion 11 in which is rotatably mounted a cylinder 35 having ratchet teeth 36 disposed about the periphery of the lower end thereof . a projection 37 disposed at the front end of tongue 14 engages the teeth 36 when the wing 30 is raised by the guide cam 31 during a feed movement . in this manner the cylinder 35 is rotated towards the forward end of the instrument by a predetermined angle with each feed movement of the driver 15 . the top of the cylinder 35 is provided with a mark and the periphery of the hollow cylinder 34 is provided with a scale so that the mark indicates on the scale the number of staples 24 remaining in the magazine 26 . at the rear end of the front housing portion 11 is disposed a cylindrical bushing 40 ( fig1 ) in which slide 13 is coaxially mounted . the cylindrical bushing 40 can be removed from the rear housing portion 10 so that the magazine can be loaded with staples . the rear end of the slide 13 is coupled to a part 39 slidably movable along a track 42 in the interior of the rear housing portion 10 . the sliding part 39 includes a sleeve 43 disposed about a shank 44 of the slide 13 which is bounded on both sides by flanges . the sliding part 39 is provided with a rack 45 having teeth or serrations which are engaged by corresponding serrations on a toothed disc segment 46 . the toothed disc segment 46 forms one lever arm of a two - armed lever which pivots about a pivot pin 47 in the housing portion 10 . the other lever arm 48 is engaged by a pin 49 disposed in a transverse slot 50 of a trigger lever 51 . the trigger 51 is guided in a recess 52 of the handle 53 extending approximately parallel to channel 16 , and is urged outwardly of the handle by a spring 54 . trigger 51 is dimensioned so that it can be actuated with the index finger when the handle 53 is gripped . the trigger , upon being pushed into the handle 53 , causes the lever 46 , 48 to be pivoted about the pivot pin 47 so that the sliding part 39 is advanced forwardly , and with it slide 13 . near the end position of the lever 46 , 48 where it extends almost at right angles with the slide 13 , leverage is the greatest , and corresponds to the stamping action of the driver . thus , for a constant actuating force , the maximum force applied to the driver occurs during stamping . an actuating mechanism 12 &# 39 ; similar to mechanism 12 of fig1 is illustrated in fig1 and 12 . fig1 depicts the retracted position of the slide 13 and fig1 its advanced position . spring 54 urges the trigger 51 out of the handle 53 and at the same time brings the sliding part 39 , and with it the slide 13 , into the retracted position . in the embodiment of fig1 the transverse slot 50 of the trigger 51 has an angular shape , while in the embodiment of fig1 and 12 , the transverse slot 50 is straight . certain changes and modifications of the embodiments of the invention disclosed herein will be readily apparent to those skilled in the art . it is the applicants &# 39 ; intention to cover by their claims all those changes and modifications which could be made to the embodiments of the invention herein chosen for the purpose of disclosure without department from the spirit and scope of the invention .
a stapler , particularly for suturing skin wounds or incisions , is disclosed which comprises a channel in which a driver is advanced by a slide in the direction of an anvil surface . a staple magazine which extends substantially parallel with the driver includes a curved section which opens into the channel to deliver staples into the channel for engagement by the driver . during forward displacement of the driver , a projection on the driver presses a leaf spring to which the anvil surface is connected . the anvil surface at the forward end of the leaf spring is thereby brought into its operating position and is automatically moved back into its retracted position upon release of the spring after the driver is retracted . the curved section in the staple magazine enables the stapler to have a slim profile which does not obscure the working area during a stapling operation . after completion of a stapling operation , the anvil surface is automatically retracted from a closed , implanted staple .
embodiments of the present invention provide ngcs with integrated spiral structured porous sheets decorated with surface channels and electrospun fibers . such ngcs provide superior mechanical strength compared to ngcs in the prior art , along with integrated multiple channels , stable aligned fibrous layers , good inter - cell communication , and high surface / volume ratios within the ngcs . chambers at the distal and proximal ends of the ngc provide additional space for fitting nerve stumps in order to reduce the tension at the suture line between the ngc and the nerve stump . a dense outer fibrous tube on the outside of the spiral structured porous sheet can prevent the infiltration of scar tissue while the regeneration process takes place . one embodiment of the ngc of the present invention comprises a three - dimensional ( 3 - d ) spiral structured porous sheet having two chambers at the ends thereof . the spiral structure includes a highly porous polycaprolactone ( pcl ) sheet , which may be formed as a spiral - wound sheet using known methods and decorated with surface channels on a surface of the spiral wound sheet , coated with a thin layer of aligned electrospun fibers on the surface channels , and a dense randomly - oriented fibrous tube on the outside of the ngc . other bioresorbable materials known for use in the biomedical arts may be used in place of pcl for the sheet and fibers ( e . g ., collagen / pcl blends for the fibers ). other embodiments of the present invention provide a process for fabricating an implantable ngc , such as the embodiment of an ngc described above , which can be used as a medical device for facilitating the repair and regeneration of nerve tissues . several features of ngcs according to embodiments of the present invention are discussed herein below . 1 . three - dimensional ( 3 - d ) integrated spiral structured porous sheet with proximal and distal reserved chambers collagen tubes , which have been approved by the fda , lack sufficient mechanical strength to support nerve regeneration . as for multi - channel ngcs , the major drawback is that cells / axons in each channel do not interact well with those in the other channels , which adversely affects nerve regeneration and would affect nerve function recovery even if the nerve gap were bridged . in comparison , the integrated spiral structure makes the ngc of the present invention superior to those in the prior art in that mechanical properties are greatly improved and favorable for inter - cellular interaction and neural myelination . this is important for nerve regeneration because of the time required for nerve regeneration to bridge large nerve gaps . further , a ngc should have enough mechanical strength to provide structural support to the nerve during regeneration . also , the proximal and distal chambers in the ends of the ngc provide an optimal initial environment for nerve ingrowth . these chambers can prevent stress from accruing when the nerve tissue is sutured with the conduit in an end - to - end fashion . moreover , the increased surface / volume ratio and the highly porous intermediate layers of the pcl sheet are preferred for cell attachment and nutrient transportation during nerve regeneration . 2 . decorated surface channels on the spiral porous sheet with additional electrospun aligned fibers and and an outer fibrous tube electrospinning is an approach for polymer biomaterial processing that provides an opportunity to control morphology , porosity and composition of an ngc using relatively unsophisticated equipment . unlike conventional fiber spinning processes that produce fibers with diameters in the micrometer range , electrospinning is capable of producing fibers in the nanometer diameter range , which are typically deposited in the form of nonwoven fabrics . nanofibers provide a connection between the nanoscale and the macroscale world , since , although their diameters are in the nanometer range , the fibers are very long , sometimes having lengths of the order of kilometers . a major problem of all hollow tubes is misdirection of cellular migration : since transected axons produce axon sprouts proceeding in a distal direction , a neuroma is always formed which consists of minifascicles proceeding in an abnormal manner , proliferating schwann cells ( scs ), fibroblasts and capillaries . if there is a directional factor of any kind ( e . g ., an artificial nerve tube which usually provides no endoneurial structure ), the neuroma proceeds in the desired direction . this phenomenon has been called “ neuromateous neurotization ”. in consequence , only a few dispersed axons are able to enter the right fascicle and endoneurial tube in the distal nerve stump once they have reached the end of the conduit in the interior of the ngc . one successful tissue engineering strategy for nerve repair is to create aligned features on the conduit to provide guidance for cell migration and directional axonal regeneration across the glial scar and lesion site in both central nervous system and peripheral nervous system injuries . such features may include aligned surface channels and electrospun fiber - based conduits for nerve repair , according to embodiments of the present invention . consequently , the construction of a spiral structure conduit with highly aligned surface channels and nano - fibers is very helpful for nerve proliferation and neurite extension . meanwhile , the intricate aligned structure can also influence the growth and distribution of seeded scs , which further directs the longitudinal extension of the neural axons . further , there is a wide range of polymers available that are suitable for deposition on the spiral sheet to meet the individualized specifications for the ngc ( e . g ., collagen / pcl copolymer nanofibers , rather than pure pcl sheets ). fibers spun along the outside of the ngc not only assist in stabilizing the spiral structure , but also inhibit infiltration of scar tissue through the inter - connective pores . by increasing the mechanical strength of the ngc , the risk of structural failure can be minimized , promoting more uniform and natural regeneration of nerve tissue . in order to solve the conflict between optimizing the mechanical properties of the ngc and maximizing its length , many techniques may be used to reinforce the ngc . in a method according to an embodiment of the present invention , a spiral conduit ( e . g ., a spiral structured porous sheet ) is placed onto a rotator and a nanofiber is spun in random orientations along the spiral structure to form an outer fibrous tube . the thickness of the outer fibrous tube can be controlled . this dense layer of randomly - oriented fibers deposited on the outside of the spiral conduit can improve the mechanical properties of the entire structure , and meanwhile provide a stable structural support during nerve regeneration . in a method according to an embodiment of the present invention , depositing the outside layer of fibers on the spiral conduit is the final and separate step of fabricating the ngc , so it is practical to modify the polymers used to form the fibers before the electrospinning step . the outer fibrous tube can be made from polymers that are different from that of the spiral sheet or the aligned fibers . in another aspect , the process of the present invention is tunable in that the sizes of the spiral conduit are controllable , and both the length and the outside diameter are dependent on the size of the spiral - wound sheet . therefore , in order to fabricate a spiral conduit with a particular size , ( e . g ., a length larger than 15 mm , which is the maximum length of nerve regeneration achieved with silicone tubes in rats ), it is only necessary to cut a polymer sheet to the appropriate size . fig1 is a schematic illustration in cutaway view of a nerve guidance conduit ( ngc ) 10 according to an embodiment of the present invention bridging the stumps 12 , 14 of damaged nerve 16 . the stumps 12 , 14 are received in reserved chambers 18 , 20 at the proximal and distal ends 22 , 24 of the ngc 10 , and held in place with sutures 26 , 28 , or by other means known in the art . the reserved chambers 18 , 20 allow the nerve stumps 12 , 14 to be placed in the ngc 10 and sutured without tension by housing the nerve stumps 12 , 14 in place with an optimal grip . fig2 is a schematic cross - sectional view of the ngc 10 showing that the ngc 10 includes an outer fibrous tube 30 surrounding one or more spiral wound sheets 32 the fibrous tube 30 includes a dense structure of randomly oriented polymer fibers ( not shown ). the spiral wound sheets 32 define a lumen 34 inside the ngc 10 . the lumen 34 is bounded by an inner surface 36 of the spiral wound sheets 32 . the ngc 10 further includes an integrated guidance spiral 38 having a plurality of surface channels 40 . the guidance spiral 38 is are composed of multiple layers ( e . g ., layers 42 , 44 ), and together define a spiral guidance channel 46 within the lumen 34 . in some embodiments of the present invention , the surface channels 40 are arranged such that they are substantially parallel to each other and to a longitudinal axis ( not shown ) of the ngc 10 . the layers 42 , 44 may be extensions of the spiral - wound sheets 32 , or may be formed separately therefrom , then integrated with the spiral - wound sheets 32 . the plurality of surface channels 40 increases the surface area of the guidance spiral 38 that is available for cell migration and may reduce the length of time needed for nerve regeneration . additionally , the integrated layers 42 , 44 may reduce the wear and tear that can occur in ngcs known in the art . such wear and tear is often observed with single lumen tubular ngcs . in some embodiments of the present invention , a highly aligned orientation of electrospun nanofibers ( not shown ) are provided as coats on the surface channels 40 , and on both layers 42 , 44 of the spiral sheet 38 , and dense randomly - oriented fibers are provided on an outer surface 48 of the ngc 10 , which greatly improves the mechanical properties of the ngc 10 , as discussed above . in some embodiments , the aligned fibers are substantially parallel to each other . in some embodiments , the aligned fibers are substantially parallel to a longitudinal axis of the ngc 10 . the presence of aligned fibers ensures that all areas of the regenerating axon will come into contact with aligned fibers . the ngc 10 is tunable such that its size can be varied in a controlled fashion depending on how it is to be used . the length and the outer diameter of the ngc 10 are dependent on the size of guidance spiral 38 . an ngc 10 according to the present invention may have any length , thus enabling it to be used to repair long gaps in the axon for the repair or regeneration of peripheral nerves . fig3 and 4 are scanning electromicrograph ( sem ) images a first side and a second side opposite the first side of a portion of a porous polymeric sheet 50 of a type that may be used to fabricate the spiral - wound sheets 32 or guidance spiral 38 of an ngc of the same type as ngc 10 , before the application of electrospun nanofibers . interconnected pores ( e . g ., pores 52 ) are present throughout the polymeric sheet 50 . fig5 is an sem image of a porous polymeric sheet 54 of the same type as polymeric sheet 50 , showing aligned nanofibers 56 that have been deposited on the polymeric sheet 54 by electrospinning . fig6 is an sem image of a porous polymeric sheet 58 of the same type as polymeric sheets 50 , 54 showing randomly - distributed nanofibers 60 that have been deposited on the polymeric sheet 58 by electrospinning . fig7 - 9 are stereomicroscopic images of an ngc 62 according to an embodiment of the present invention . ngc 62 is of the same general type as the ngc 10 discussed with respect to fig1 and 2 . fig7 is an image of the intact ngc 62 showing its outer fibrous tube 64 . fig8 is an image of the interior of the ngc 62 after it has been cut lengthwise , showing an interior surface 66 of the outer fibrous tube 64 , the guidance spiral 66 , and the reserved chambers 68 , 70 . fig9 is an end view of the ngc 62 showing the outer spiral wall 64 , the guidance spiral 66 and the channels 72 of the guidance spiral 66 . fig1 is a sem image of a portion of polymer sheet 74 , which is of a type for making an ngc according to an embodiment of the present invention , showing the substantially parallel alignment of channels 76 , which are separated by ridges 78 . in a method of fabricating an ngc according to an embodiment of the present invention , a polycaprolactone ( pcl ) sheet was fabricated using a combination of the solvent evaporation method and the salt - leaching method . an 8 % ( w / v ) pcl solution was poured onto a glass petri dish , and acupuncture needles having a diameter of 150 μm were placed on top of the pcl solution to form multi - channels having widths of about 180 μm . the dish was moved to a hood to let it air dry . after an hour , the resulting pcl sheet was immersed into deionized water so that the salt was dissolved , producing pores in the pcl sheet . the needles were also removed , having formed multi - channels on the pcl sheet with widths of about 180 μm . after 30 minutes , the pcl sheet was taken out and dried on a paper towel . subsequently , 2 hours later , the fully dried pcl sheet was cut into a rectangular shape having dimensions of about 12 mm by 10 . 5 mm to bridge a 10 mm nerve gap in an animal study . referring to fig1 , in an exemplary embodiment of the method , the cut pcl sheet 80 had opposite longer edges 82 , 84 ( i . e ., the 12 mm edges ), and opposite shorter edges 86 , 88 ( i . e ., the 10 . 5 mm edges ). it may be noted that the channels 90 are substantially parallel to the longer edges 82 , 84 . two rectangular areas 92 , 94 were cut out from the opposite corners 96 , 98 of the edge 82 , such that edge 82 was then shorter than edge 84 . pcl aligned nanofibers were spun on the cut pcl sheet 80 using a conductible rotation disk method known in the art . a 16 % ( w / v ) solution of pcl in 1 , 1 , 1 , 3 , 3 , 3 hexafluoroisopropanol ( hfip ) ( oakwood products , inc ) was prepared for electrospinning . aligned fibers were deposited on the 12 mm × 10 . 5 mm pcl sheet longitudinally on the edge of the rotating disk such that the fibers were substantially parallel to channels 90 . the fibers were deposited such that they would be substantially longer than the cut pcl sheet 80 . the sheet was carefully removed from the disk to ensure the fibers deposited remained aligned . the excess lengths of fiber ( i . e ., the portions of the fibers that extended beyond the edges of the cut pcl sheet 80 were collected and folded onto the back of the cut pcl sheet 80 . turning back to fig1 , the cut pcl sheet 80 with the aligned nanofibers thereon was then wound in a spiral fashion from the edge 82 to the edge 84 , such that the edge 82 was in the interior of the resulting spiral ngc and the channels 90 were substantially parallel to a longitudinal axis of the spiral ngc . in the spiral ngc , the cutaway areas 92 , 94 become reserved chambers ( e . g . reserved chambers 68 , 70 of spiral ngc 64 of fig7 - 9 , or reserved chambers 18 , 20 of spiral ngc 10 of fig1 ). random nanofibers were then spun onto the outside of the spiral ngc to form an outer fibrous tube on the spiral ngc . the thickness of the outer fibrous tube was approximately 150 μm . the outer fibrous tube is intended to secure the entire spiral structure , enhance the mechanical strength , and prevent tissue infiltration during nerve regeneration . the resulting spiral ngc with its outer fibrous tube was 1 . 8 mm in diameter and 12 mm in length , suitable for bridging a 10 mm nerve gap . fig1 is a plot of stress versus strain for several ngcs fabricated according to a method of the present invention : an outer fiber tube comprising a dense layer of randomly - oriented nanofibers ; the outer fiber tube with a spiral sheet therein , and the outer fiber tube with the spiral sheet and aligned nanofibers (“ af ”). the following tensile properties were measured : young &# 39 ; s modulus , percent elongation to failure , and tensile strength of the different ngcs . the young &# 39 ; s modulus , calculated through the stress - strain curve shown fig1 , ranged between 0 . 262 - 0 . 7625 mpa . all three of the ngcs yielded a young &# 39 ; s modulus that can stand force stretching and be applicable for in vivo use . the values reported for the outer fibrous tube and the other ngcs all in a useful range for use in nerve regeneration and repair . high tensile strength will provide a mechanically strong ngc that can be sutured well during coaptation of the nerve stump and ngc , and preserve the suture after surgery . the measured physical properties of the ngcs of fig1 are summarized in table 1 , below . the measured porosity values for the outer fibrous tube ( hereinafter , ngc - t ), outer fibrous tube + spiral ( hereinafter , ngc - t - s ), and outer fibrous tube + spiral + af ( hereinafter , ngc - t - s - af ) were respectively 71 . 98 ± 1 . 22 %, 75 . 01 ± 2 . 69 %, and 78 . 41 ± 3 . 64 %. the differences in porosities for these three types of ngcs are not statistically significant ( p & lt ; 0 . 05 ). schwann cells were adopted as the model for evaluation of cellular response on the fiber - based spiral ngcs . at day 4 , ngc - t - s - af showed significantly greater cell proliferation than ngc - t and ngc - t - s . the cell numbers for each type of ngc are shown in fig1 . the degrees of cell proliferation for the ngc - t and ngc - t - s are significantly lower ( p & lt ; 0 . 05 ) than for the ngc - t - s - af . the ngcs were tested in a 10 mm sprague dawley ( sd ) rat sciatic nerve defect to evaluate the effect of nanofibers on peripheral nerve regeneration through porous spiral ngcs . the sciatic nerve of each rat was cut , then bridged with one of the ngcs . one group received an autograft rather than a ngc . one group received no grafts . all rats were in good condition during the survival weeks . there were no obvious signs of systemic or regional inflammation and surgical complications after implantation the recovery of motor function was assessed based on the walking track evaluation referring to fig1 , normal sciatic functional index ( sfi ) value of − 9 . 4 ± 1 . 4 was measured from all healthy rats ( n = 30 ) before surgery . all experimental animals had decreased sfi of values between − 85 . 6 and − 94 . 5 ( n = 30 ) by week 2 after surgery . during the initial 4 weeks , there was no significant improvement in any of the groups . at 6 weeks after surgery , the overall sfi reached the levels between − 72 . 2 and − 91 . 7 , which was equivalent to an improvement of 2 . 8 - 13 . 4 index points from week 2 . each group &# 39 ; s 6 - week sfi value was recorded as follows : autograft (− 72 . 2 ± 6 . 6 ), t - s - af (− 81 . 5 ± 3 . 2 ), t - s (− 88 . 4 ± 4 . 9 ), and t (− 91 . 7 ± 4 . 2 ). the autograft sfi revealed a significant difference ( p & lt ; 0 . 05 ) as compared to the t - s and t groups . the sfi in the t - s - af group was significantly higher than for the t groups ( p & lt ; 0 . 05 ). functional recovery was further evaluated with electrophysiological assessment to determine whether functional recovery occurred through the ngcs . six weeks post - surgery , compound muscle action potentials ( cmap ) were evoked by stimulation at the surgical limbs and recorded from gastrocnemius muscle following by measurements of amplitude and nerve conduction velocity ( ncv ). signals were absent and no muscle contractions were observed in the non - grafted group . referring to fig1 , for the amplitude measurements , each group &# 39 ; s value was recorded as follows : autograft ( 5 . 25 ± 1 . 51 mv ), t - s - af ( 4 . 96 ± 1 . 58 mv ), t - s ( 3 . 6 ± 1 . 39 mv ), and t ( 2 . 0 ± 0 . 64 my ). significant differences in amplitude were observed in the t group as compared to the autograft and t - s - af groups ( p & lt ; 0 . 05 ). however , the difference between the autograft , t - s - af , and t - s groups ( p & gt ; 0 . 05 ) was not statistically significant . similar results were found in ncv measurement : autograft ( 31 . 57 ± 4 . 13 m / s ), t - s - af ( 26 . 47 ± 6 . 87 m / s ), t - s ( 18 . 28 ± 4 . 16 m / s ), and t ( 13 . 3 ± 5 . 65 m / s ) ( see fig1 ). significant differences in ncv were observed in the autograft group as compared to the t - s and t groups ( p & lt ; 0 . 05 ). the ncv result in the t group also showed a significant difference as compared to autograft and t - s - af groups ( p & lt ; 0 . 05 ). however , there were no significant differences when the ncv values of the autograft group were compared to those of the t - s - af group , which may indicate that nanofibers can accelerate the level of muscle reinnervation as well as autograft . after 6 weeks post - surgery , the distal nerve segment from each group was explored and carefully isolated from the surrounding tissues . a pinch reflex test was performed distally . a reflex movement of the back muscles indicates that the sensory fibers are positively regenerated through the ngcs , while no movement was considered as lack of sensory fibers in the ngcs . the results are presented in table 2 , below . further histological evaluations of nerve regeneration behavior with ngcs were investigated under a light microscope . the results clearly demonstrated the potential of the ngcs of the present invention to house a large number of supportive cells , both with and without nanofibers to enhance the surface area of the channel . the ngcs possessed durable mechanical strength to support the entire regeneration process . low magnifications of micrographs showed that neural tissues , including myelinated axons and myelin sheath , were all successfully presented among the groups . angiogenesis occurred through which new blood vessels were formed during the nerve regeneration process . normal axons were nearly all surrounded by uniform thicknesses of myelin sheaths and presented large fiber diameters . nevertheless , the studied groups presented premature morphologies ( i . e ., diverse nerve fiber sizes and thinner myelin sheaths ). quantitative analysis of the total occupied neural tissue coverage in the ngcs compared to those of normal rat nerves ( 70 . 57 ± 3 . 81 %) further confirmed the above findings . referring to fig1 , each group &# 39 ; s value was recorded as follow : autograft ( 29 . 29 ± 4 . 61 %), t - s - af ( 26 . 52 ± 3 . 77 %), t - s ( 17 . 37 ± 2 . 97 %), and t ( 5 . 88 ± 1 . 43 %). no significant differences were found among autograft and t - s - af groups . however , the area occupied by neural tissue in t - s group showed significantly lower values than the autograft , and t - s - af groups . high significance was observed in the t group as compared to the other groups ( p & lt ; 0 . 01 ). finally , it should be noted that the cross - sectional micrograph of t group was covered with a large white area . that implied the single lumen repair limited the nerve regeneration . when severe nerve injury occurs , the muscle is denervated and the balance of muscle metabolism could be shifted from protein synthesis toward protein degradation . as a consequence , the target muscle presents a decreased muscle cell size , muscle weight loss , hyperplasia of connective tissues , and new blood vessel formation . to evaluate the reinnervation of the gastrocnemius muscle , masson trichrome staining was applied to the section followed by measurements of muscle weight ratio , diameter of muscle fibers , and muscle fiber coverage per cross section . referring to fig1 , for comparisons of muscle weight ratio , each group &# 39 ; s value was recorded as follows : autograft ( 39 . 73 ± 4 . 19 %), t - s - af ( 25 . 64 ± 3 . 01 %), t - s ( 22 . 31 ± 2 . 18 %), and t ( 19 . 2 ± 2 . 03 %). the muscle weight ratio of the autograft group was greater than that of the other groups by a statistically significant amount ( p & lt ; 0 . 05 ). however , there were no significant differences between the t - s - af and t - s groups ( p & gt ; 0 . 05 ). the t group revealed a significant lower ratio than the t - s - af group . referring to fig1 , for comparisons of muscle fiber diameter , each group &# 39 ; s value was recorded as follows : autograft ( 34 . 62 ± 1 . 05 μm ), t - s - af ( 31 . 81 ± 2 . 18 μm ), t - s ( 25 . 5 ± 6 μm ), and t ( 21 . 56 ± 2 . 98 μm ). although the autograft group showed a significant difference from the t - s and t groups , it was not significantly higher than the t - s - af group . also , there were no significant differences between the t - s and t groups ( p & gt ; 0 . 05 ). further findings showed that the value for the t group was significantly lower than that for the autograft , and t - s - af groups . referring to fig2 , for comparisons of muscle fiber coverage , each group &# 39 ; s value was recorded as follows : autograft ( 96 . 84 ± 4 . 1 %), t - s - af ( 93 . 72 ± 4 . 63 %), t - s ( 86 . 99 ± 10 . 31 %), and t ( 58 . 42 ± 4 . 69 %). there were no significant differences between the values for the autograft , t - s - af , and t - s groups ( p & gt ; 0 . 05 ); however , they were all significantly greater than the value for the t group ( p & lt ; 0 . 05 ). from qualitative analyses and histological observations discussed above , spiral ngcs of the present invention , with or without nanofibers , revealed the potential to prevent muscle atrophy as well as the effect of autograft . both the surface channels and the aligned fibers provide good topographical cues for nerve regeneration , and thus allow muscle reinnervation faster than single lumen ngcs , thus suggesting that the surface channels and nanofibers further assisted ngc structures in promoting nerve regeneration . it should be understood that the embodiments described herein are merely exemplary in nature and that a person skilled in the art may make many variations and modifications thereto without departing from the scope of the present invention . all such variations and modifications , including those discussed above , are intended to be included within the scope of the invention , as defined by the appended claims .
a nerve guidance conduit includes a spiral structured porous sheet decorated with channels on its surface and electrospun nanofibers in a parallel alignment with the channels and an outer tubular structure including randomly - oriented nanofibers . such a structure provides augmented surface areas for providing directional guidance and augmented surfaces for enhancing and peripheral nerve regeneration . the structure also has the mechanical and nutrient transport requirements required over long regeneration periods . to prepare a nerve guidance conduit , porous polymer sheet is prepared by a solvent casting method while using a template of thin rods to form parallel channels on a surface of the sheet . aligned nanofibers are deposited on the sheet parallel to the channels . the polymer sheet is then wound to form a spiral structure . a dense layer of randomly - oriented nanofibers may be deposited on the outside of the spiral .
referring now to the drawings , and particularly to fig1 and 2 , a portion of the back end of a furniture seat base is illustrated generally at 10 . the seat base 10 comprises spring band assemblies 15 , only one of which is shown , extending in parallel relationship between the front rail ( not shown ) and back rail 16 of the base frame . each assembly 15 includes a normally arced sinuous spring band 20 of standard loop size ; i . e ., a seven - eighths ( 2 / 3 ) inch interval between linear segments 25 and semi - circular segments 26 of the band . each band 20 is connected to the back frame rail 16 by a first form of rail connector 30 embodying features of the invention . the rail connector 30 is fabricated of eleven ( 11 ) gauge wire , similar to standard helicals . it comprises a section 35 of three coils tightly wound on an axis transverse to that of the band 20 and the axis of expansion and contraction of the connector 30 . extending from the coil section 35 , at their uppermost extremity , tangent to the arc of the coils and in opposite directions , are a rail - attachment leg 38 and a spring - attachment leg 39 . the rail - attachment leg 38 terminates in a transversely disposed anchor section 40 which seats in a conventional &# 34 ; g &# 34 ; clip 41 , while the spring - attachment leg 39 seats on and grips the spring band 20 . the spring attachment leg 39 is inclined slightly upwardly from the horizontal , in contrast to the rail - attachment leg 38 , and includes an upwardly formed shoulder 45 and a terminal hook 46 . the shoulder is formed approximately mid - way between the hook 46 and tangency with the coil 35 , seven - eighths ( 2 / 3 ) inches each way in the case where the band 20 is regular sinuous . as seen best in fig1 the downwardly opening hook 46 is designed to seat over the penultimate linear segment 25b in the spring band 20 , while the ultimate linear segment 25a seats against the shoulder 45 . the result is to lock the end of the band 20 and the connector 30 together . in operation , the attachment - arm 39 reaching up into the band 20 sets up a torsioning effect in the back of the band . the arm 39 is spring loaded upwardly by the strength of the coil section 35 and produces dynamic uplift . at the same time the coil section 35 permits of longitudinal expansion - contraction of the connector 30 . the coil section 35 and rail - attachment leg 38 extending outwardly of the band 20 end amplify the leverage induced torque . in an alternative construction of the first form of the invention , as seen in fig3 the rail connector 130 is attached to the rail 116 through a gang bore 142 . the rail - attachment leg 138 of the connector has a shorter anchor section 140 which can pass through the bore 142 from front to back of the rail 116 and then seats against the back of the rail to lock the connector 130 to the rail . the spring - attachment leg 139 in this form of the connector is much shorter and has an upwardly formed hook 146 at its inner end . the hook 146 is so formed that when it seats upwardly , onto the ultimate linear segment 125a of the spring band 120 , it cannot slip off during seat base operation . the connector 130 provides both dynamic uplift and resilient expansion - contraction at the band end . it does not induce torsion or leverage amplification . the connector 130 can also be connected to the ultimate linear segment 125a of the band 120 by a conventional vle clip , as seen at 150 in fig4 . as such , the single spring attachment leg 139 obtains a wider purchase area on the band 120 end . the effect is to enhance lateral stability of the spring band assembly . turning now to fig5 a modified coil section for a connector otherwise identical to that hereinbefore discussed is illustrated at 235 . as illustrated , the coil section 235 is tightly wound in five ( 5 ) coils on an axis longitudinally aligned with the sinuous spring band span ( not shown ). this form of the connector 130 produces the same salutary effects , the dynamic uplift being produced by a torquing expansion - contraction of the coil section 235 in contrast to the loop compression - expansion of the coil section 35 , however . fig6 and 7 illustrate a portion of a furniture seat base 310 comprising spring band assemblies 315 ( only one shown ) in which a second form of spring band 320 connector is illustrated at 330 . the connector 330 uses a cantilever principle to provide dynamic uplift to the band 320 at the back rail 316 . the rail connector 330 is fabricated of spring steel wire of relatively heavy gauge ; i . e ., eight ( 8 ) gauge or heavier . as best illustrated in fig7 it includes a pair of identical connector arms 331 extending parallel to each other between the rail 316 and the band 320 . as seen once again in fig6 each connector arm 331 includes a generally v - shaped body 335 made up of a rail - attachment leg 338 and a spring - attachment leg 339 . the legs 338 are vertically oriented and preferably four ( 4 ) inches long . the legs 338 are joined at their upper ends by a base leg 340 which seats in a conventional eks clip 341 stapled to the top of the rail 316 . curving upwardly and inwardly from the lower end of each rail - attachment leg 338 is a corresponding spring - attachment leg 339 . the spring - attachment legs 339 are approximately eight ( 8 ) inches long . formed on the free ends of the legs 339 are attachment hooks 346 identical to the hooks 146 hereinbefore discussed . the connector 330 is a variation of the second form of the invention wherein the hooks 346 receive and seat on the ultimate linear segment 325a of the spring band 320 . in operation the legs 338 are braced against the rail 316 with the spring - attachment legs 339 extending inwardly and upwardly therefrom to the hooks 346 . in unloaded position the hooks are disposed approximately one ( 1 ) inch above the level of the eks clip 341 . the connector 330 thus is effective to dynamically urge the spring band 320 end upwardly when a subject is seated . at the same time longitudinal resilient expansion - contraction can and does take place in the connector 330 , enhancing seat base softness . fig8 illustrates a sinuous spring band assembly 415 which incorporates a connector 430 identical to the connector 330 hereinbefore discussed . in the spring band assembly 415 the connector hooks 446 are seated on a linear segment 425f of the band 420 which is sixth from the end of the band ; i . e ., the ultimate linear segment 425a . the linear segment 425a is connected to the rail by a swing anchor connector clip 460 such as illustrated in fig1 of the aforementioned u . s . pat . no . 3 , 790 , 149 . the base of the clip 460 is seated , together with the base leg 440 of the connector 430 , in the conventional eks clip stapled to the top of the rail 416 . the spring band 420 immediately inwardly of its ultimate linear segment 425a , at the penultimate linear segment , is bent upwardly for the length of one semi - circular band segment 426a and then bent back into the normal arc of the band . this creates a torsion inducing moment arm configuration in the end of the band as illustrated at fig1 in the aforementioned u . s . pat . no . 3 , 525 , 514 . in operation of this spring band assembly 415 the connector 430 performs the same functions as previously ascribed to the connector 330 . further , however , its dynamic uplift is effected inwardly of the band end . this uplift , coupled with the torsion inducing band 420 configuration and the articulate connection provided by the clip 460 produces a highly sophisticated and luxurious seat base . fig9 illustrates a sinuous spring band assembly 515 which also incorporates a connector 530 identical to the connector 330 hereinbefore discussed . in the assembly 515 the sinuous band 520 is a de - arced band , however ; i . e ., it has very little inherent upward resilience . in this assembly the connector 530 pre - loads the band 520 upwardly at the fourth linear segment 525d from the ultimate linear segment 525a . the ultimate linear segment 525a is seated in the eks clip 540 on the rail 516 , together with the base leg 540 of the connector 530 . the connector leg 539 thus preloads the band 520 upwardly with the seat base 10 in its relaxed state as a subject is seated and rises , the connector provides a dynamic uplift which would otherwise not be present . all of the connectors hereinbefore discussed are also used to connect other forms of seat base support means to the frame rails . as will readily be understood , wire grids such as manufactured under the trademark perma - mesh by flexolators , inc ., chord - rubber webbing such as manufactured by the pirelli , s . p . a ., of italy , and flat steel bands , for example , do not have stored upward resilience in the sense that arced sinuous spring bands do . when connected to the back frame rail by connectors embodying the inventions disclosed herein , however , they are provided with a dynamic uplift adjacent the back rail . in this sense they are similar to a de - arced sinuous spring band . while several embodiments described herein are at present considered to be preferred , it is understood that various modifications and improvements may be made therein , and it is intended to cover in the appended claims all such modification and improvements as fall within the true spirit and scope of the invention .
a rail connector and improvement in seat base support assembly . the connector takes two basic forms . in the first a pre - stressed , close wound coil , disposed either transversely or longitudinally of the connector , is effective to continuously bias the seat base support means upwardly . in the second a cantilevered , curved spring arm serves the same purpose . the connector may be configured to reach into the body of a sinuous spring band , for example , and define a torque arm in the band , at the back rail . all forms are applicable to wire mesh , chord rubber webbing , flat steel bands and sinuous , both arced and dearced .
exemplary embodiments of the presently disclosed damage resistant anvil assembly will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views . in this description , the term “ proximal ” is used generally to refer to that portion of the stapler that is closer to a clinician , while the term “ distal ” is used generally to refer to that portion of the stapler that is farther from the clinician . in addition , the term “ endoscopic ” is used generally to refer to procedures performed through a small incision or a cannula inserted into a patient &# 39 ; s body including endoscopic , laparoscopic , and arthroscopic procedures . finally , the term clinician is used generally to refer to medical personnel including doctors , nurses , and support personnel . the presently disclosed anvil assembly includes an anvil head assembly , an anvil shaft , and a stabilizing collet . in embodiments , the stabilizing collet may be formed of a substantially rigid material . alternately , other materials of construction that provide support to the anvil shaft are envisioned . the anvil shaft includes a plurality of flexible legs that flex outwardly in response to insertion of a trocar of a surgical stapling device into the anvil shaft to releasably couple the anvil shaft to the trocar . the collet is received within a longitudinal bore defined by the flexible legs of the anvil shaft at a location to support the flexible legs and minimize the likelihood of damage to the anvil shaft caused by engagement of the anvil shaft with a grasper . the collet is also positioned in a location not to interfere with flexing of the legs during coupling of the anvil shaft to the trocar of the stapling device . fig1 illustrates a manually powered surgical stapler 10 including a stapling device 12 supporting an exemplary embodiment of anvil assembly 100 . the stapling device 12 includes a handle assembly 14 , a body portion 16 that extends distally from the handle portion 14 , and a shell assembly 18 that supports a staple cartridge 20 . the staple cartridge 20 supports a plurality of staples ( not shown ) that are arranged in an annular configuration within the shell assembly 18 . the stapling device 12 also includes a trocar 22 that extends from the distal end of the body portion 16 through the shell assembly 18 . the trocar 22 is configured to releasably engage the anvil assembly 100 as described in further detail below . for a more detailed description of a suitable stapling device , see u . s . pat . nos . 7 , 234 , 624 , 7 , 364 , 060 and 7 , 857 , 187 (“ the incorporated patents ”) which are incorporated herein by reference in their entirety . referring also to fig2 - 4 , the anvil assembly 100 includes an anvil head assembly 102 and an anvil shaft 104 . although not specifically described in this application , the anvil head assembly 102 can be pivotally or fixedly attached to the anvil shaft 104 . examples of pivotally attached anvil head assemblies are described in the incorporated patents . the anvil head assembly 102 includes a housing 106 that supports an anvil plate 108 ( fig2 ) and a cut ring assembly 110 . the housing 106 has a smoothly curved distal surface 112 that facilitates atraumatic entry of the anvil assembly 100 into and through a body orifice or lumen . a proximal side of the housing 106 defines a cavity ( not shown ) that is configured to receive the anvil plate 108 and the cut ring assembly 110 . for a more detailed description of the components of the anvil head assembly 102 , see the incorporated patents . the anvil shaft 104 includes a longitudinal body portion 116 that includes a tubular portion 118 and a plurality of flexible legs 120 that extend proximally from the tubular portion 118 . each of the flexible legs 120 has a semi - cylindrical configuration such that the legs 120 cooperate to define a longitudinal bore 122 ( fig3 ) that is dimensioned to receive the trocar 22 of the stapling device 12 ( fig1 ) when the anvil assembly 100 is secured to the stapling device 12 . the bore 122 extends from the proximal end of the flexible legs 120 at least partially into the tubular portion 118 of the anvil shaft 104 . in embodiments , the anvil shaft 104 may include a plurality of splines 126 positioned about the anvil shaft 104 . as is known in the art , the splines 126 mate with recesses ( not shown ) defined within the shell assembly 16 fig2 ) of the surgical stapling device 12 to properly orient the staple cartridge 20 in relation to the anvil plate 108 of the anvil assembly 100 when the anvil assembly 100 and the shell assembly 18 are approximated . the anvil shaft 104 may also include one or more stabilization rings 130 ( only one is shown ) positioned about the anvil shaft 104 at a position to engage the shell assembly 16 when the anvil assembly 100 and the shell assembly 18 are approximated to provide added stability to the anvil assembly 100 . for a more detailed description of an anvil assembly including a stabilization ring , see u . s . pat . no . 8 , 424 , 535 which is incorporated herein by reference in its entirety . although the splines 126 and the stabilization ring 130 are shown to be formed integrally with the anvil shaft 104 , it is contemplated the either or both could be formed separately from the anvil shaft 104 and secured to the anvil shaft 104 using any known fastening technique including welding , crimping gluing or the like . referring to fig4 and 5 , each of the flexible legs 120 of the anvil shaft 104 defines a longitudinal channel 134 with an adjacent leg 120 . each longitudinal channel 134 includes an enlarged cutout or hole 136 formed at the distal end of the longitudinal channel 134 . the holes 136 are configured to secure a collet 150 within the longitudinal bore 122 of the anvil shaft 104 . in embodiments , the hole 136 is substantially circular although other configurations are envisioned . one or more of the flexible legs 120 may also include a bore 140 which is configured to receive a suture or the like ( not shown ). the suture can be used to allow a clinician to retrieve or position the anvil assembly 100 from or within a surgical site . the proximal end of each of the flexible legs 120 has an inner surface that defines a recess 160 ( fig7 ) such that the recesses 160 collectively define an annular recess 160 a ( fig9 ). the annular recess 160 a facilitates releasable engagement of the anvil assembly 100 to the stapling device 12 . referring also to fig6 , the collet 150 may be substantially rigid and is positioned within the longitudinal bore 122 defined by the anvil shaft 104 . the collet 150 is substantially cylindrical and defines a longitudinal bore 152 ( fig7 ) that is dimensioned to receive the trocar 22 ( fig1 ). a distal portion 154 of the collet 150 includes a plurality of cantilevered fingers 156 . each of the fingers 156 includes a protrusion 158 that is dimensioned and configured to be received in a respective one of the holes 136 ( fig5 ) formed in the anvil shaft 104 as described in further detail below . referring to fig7 - 9 , in order to assemble the collet 150 within the anvil shaft 104 , the distal end of the collet 150 is inserted into the proximal end of the longitudinal bore 122 of the anvil shaft 104 and slid distally in the direction indicated by arrow “ a ” in fig7 and 8 . the collet 150 is positioned to align the protrusions 158 with the longitudinal channels 134 positioned between the flexible legs 120 . when the protrusions 158 engage an inner wall of the flexible legs 120 , the fingers 156 are deflected inwardly in the direction indicated by arrow “ b ” in fig8 to facilitate passage of the collet 150 through the longitudinal bore 122 . when the protrusions 158 are moved into alignment with the holes 136 , the fingers 156 spring outwardly in the direction indicated by arrow “ c ” in fig9 to move the protrusions 158 into the holes 136 to secure the collet 150 within the longitudinal bore 122 . referring to fig1 , the trocar 22 includes a pointed distal end 30 and an enlarged proximal portion 32 that defines a shoulder 32 a . as known in the art , the proximal end of the trocar 22 is secured to an approximation mechanism ( not shown ) of the stapling device 12 ( fig1 ) to facilitate movement of the trocar 22 between retracted and advanced positions . when the trocar 22 is inserted into the longitudinal bore 122 of the anvil shaft 104 and the longitudinal bore 152 of the collet 150 in the direction indicated by arrow “ d ” in fig1 , the enlarged proximal portion 32 of the trocar 22 engages a proximal end of the flexible legs 120 of the anvil shaft 104 to urge the flexible legs 120 outwardly in the direction indicated by arrows “ e ”. when the enlarged proximal portion 32 of the trocar 22 is moved distally in the direction indicated by arrow “ d ” into alignment with the recess 160 defined at the proximal end of the flexible legs 120 , the flexible legs 120 return to their undeformed configuration to receive the enlarged proximal portion 32 of the trocar 22 . when the enlarged proximal portion 32 is received within the recess 160 , the shoulder 32 a on the enlarged proximal portion 32 of the trocar 32 engages a proximal wall 161 defining the recess 160 to secure the anvil shaft 104 to the trocar 22 . during an endoscopic surgical procedure , the anvil assembly 100 is grasped with a grasper ( not shown ) that is inserted through a small incision in the skin to position the trocar 22 within the longitudinal bore 122 of the anvil shaft 104 and secure the anvil assembly 100 to the trocar 22 of the surgical stapling device 12 . the collet 150 is positioned within the longitudinal bore 122 of the anvil shaft 104 and extends from a distal end of the flexible legs 120 towards the proximal end of the flexible legs 120 to support the flexible legs 120 and inhibit radial compression or other deformation of the flexible legs 120 that may result from pressure applied to the flexible legs 120 by a manipulating instrument ( not shown ). collet 150 may be formed from any suitable , medical grade material having a stiffness to perform the functions described herein . suitable materials include , for example , stainless steel or nylon . the collet 150 is secured within the longitudinal bore 122 of the anvil shaft 104 in a position that does not interfere with outward flexing of the flexible legs 120 and , thus , allows the anvil assembly 100 to be readily connected to the trocar 22 . persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non - limiting exemplary embodiments . it is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure . as well , one skilled in the art will appreciate further features and advantages of the disclosure based on the above - described embodiments . accordingly , the disclosure is not to be limited by what has been particularly shown and described , except as indicated by the appended claims .
an anvil assembly is disclosed that includes an anvil shaft including a proximal portion and a distal portion and defining a first longitudinal bore . the proximal portion includes a plurality of flexible legs that define the first longitudinal bore dimensioned to receive a trocar of a stapling device . an anvil head assembly is secured to the distal portion of the anvil shaft and supports an annular anvil plate that a plurality of staple deforming pockets . the anvil assembly also includes a rigid collet defining a second longitudinal bore that is configured to receive the trocar of the stapling device . the rigid collet is supported within the first longitudinal bore and is positioned to prevent crushing of the plurality of flexible legs when the anvil assembly is manipulated with a grasper .
fig1 illustrates an optical ablation system 15 according to the present invention including an ablation instrument 10 and an electro - optic generator 11 . in fig1 optical energy in the form of light is supplied to ablation instrument 10 by electro - optical generator 11 . as used herein , the term &# 34 ; optical &# 34 ; is intended to include that portion of the electromagnetic spectrum including radiation in the ultraviolet , visible and infrared wavelengths . electro - optical generator 11 includes an optical energy source 12 , one or more energy coupling devices 14 , one or more optical filters 16 , one or more variable attenuators 18 which may also comprise a variable neutral density filter , one or more fiber optic bundles 20 , one or more thermocouple inputs 24 and control circuitry 22 . optical energy source 12 may be , for example , a laser , a halogen lamp , a conventional incandescent lamp or other optical energy source . optical energy source 12 may be a single source which provides light which is white or spectrally pure at a specific wavelength . alternatively , optical energy source 12 may include a plurality of light sources having any combination of wavelengths and power levels . optical energy source 12 is coupled to fiber optic bundle 20 by energy coupling lens 14 , optical filter 16 and variable attenuator 18 . energy coupling lens 14 focuses optical energy from optical energy source 12 through optical filter 16 and variable attenuator 18 onto the proximal end of fiber optic bundle 20 . the intensity and / or wavelength of optical energy source 12 may be controlled by , for example , signals from control circuit 22 transmitted through control line 72 . optical filter 16 may be a single frequency filter adapted to filter out all but one of the wavelengths generated by optical energy source 12 . alternatively , optical filter 16 may be a plurality of selectable filters from which a filter effective at one or more wavelengths may be chosen to selectively filter optical energy generated by optical energy source 12 . optical filter 16 may also be a spectral filter adapted to pass energy within a band of wavelengths . optical filter 16 may also be a filter wheel which contains a number of band pass filters . the wavelength of light filtered by optical filter 16 may be controlled by , for example , signals from control circuit 22 transmitted through control line ( s ) 70 . after passing through optical filter 16 , energy from optical energy source 12 passes through variable attenuator 18 . variable attenuator 18 may also be referred to as a variable neutral density filter . variable attenuator 18 is adapted to control the energy level of the light which is focused on to the proximal end of fiber optic bundle 20 . the setting of variable attenuator 18 may be controlled by , for example , signals from control circuit 22 transmitted through control line ( s ) 74 . the energy passed by variable attenuator 18 may be controlled by signals from control circuit 22 to ensure that the appropriate energy level is input to the proximal end of fiber optic bundle 20 . energy coupling lens 14 may include a plurality of energy coupling lenses , for example the three energy coupling lenses 14a , 14b and 14c illustrated in fig1 . optical filter 16 may include a plurality of optical filters , for example , the three optical filters 16a , 16b and 16c illustrated in fig1 . variable attenuator 18 may include a plurality of variable attenuators , for example , the three variable attenuators 18a , 18b and 18c illustrated in fig1 . in addition , fiber optic bundle 20 may include a plurality of fiber optic bundles , for example , the three fiber optic bundles illustrated in fig1 . the number of energy coupling lenses , optical filters , variable attenuators and fiber optic bundles will depend upon the design of the ablation system 15 , however , the number of coupling lenses , optical filters , variable attenuators and fiber optic bundles will generally correspond to the number of regions the ablation instrument is designed to separately heat within the body cavity being treated . electro - optic generator 22 includes temperature signal wires 24 which are adapted to relay signals representative of the temperature at selected points at the distal end of ablation instrument 10 to control circuit 22 . the number of temperature signal wires 24 will depend upon the design of ablation system 15 , however , the number of thermocouple inputs will generally correspond to a multiple of the number of regions the ablation instrument is designed to separately heat . in the embodiment of the ablation instrument illustrated in fig1 the electro - optic generator includes three temperature signal wires 24a , 24b and 24c . in one embodiment of the present invention , temperature signal wires 24 comprise a pair of wires which are connected through ablation instrument 10 to a thermocouple at a distal end of the ablation instrument . fiber optic bundles 20 and temperature signal wires 24 terminate at generator connector 19 which is adapted to mate with instrument connector 26 . in fig1 instrument connector 26 is shown in cutaway view to show fiber optic bundles 21a , 21b and 21c and to show thermocouple inputs 25a , 25b and 25c which are positioned within instrument connector 26 and flexible sleeve 27 . fiber optic bundles 20 exit electro - optic generator 11 at generator connector 19 where each fiber optic bundle 20a , 20b and 20c is butt - coupled to a corresponding fiber optic bundle 21a , 21b and 21c such that optical energy is transmitted from fiber optic bundles 20a , 20b and 20c to fiber optic bundles 21a , 21b and 21c , respectively . temperature signal wires 24 also exit electro - optic generator 11 at generator connector 19 where temperature signal wires 24a , 24b and 24c are connected to temperature signal wires 25a , 25b and 25c , respectively . fiber optic bundles 21 and temperature signal wires 25 pass through flexible sleeve 27 to instrument handle 28 and through instrument handle 28 to rigid sleeve 34 . instrument handle 28 includes connector 35 , fluid source connector 29 , sleeve retractor 32 , sleeve retractor stop 33 and fluid line 36 . flexible sleeve 27 , terminates at connector 35 while fiber optic bundles 21 and temperature signal wires 25 pass through connector support 27 and the central portion of instrument handle 28 to the central annulus of rigid sleeve 34 . fluid source connector 29 , which is adapted to receive a fluid source such as , for example , syringe 30 , is connected to fluid line 36 . in the embodiment of fig1 syringe 30 includes plunger 31 which is adapted to force fluid , for example air , through fluid line 36 . fluid line 36 extends from fluid source connector 29 to the annulus of rigid sleeve 34 . in instrument handle 28 as illustrated in fig1 sleeve retractor 32 is connected to sleeve collar 37 which is connected to rigid sleeve 34 such that rigid sleeve 34 may be retracted in the proximal direction by moving sleeve retractor 32 in the proximal direction . the travel of sleeve retractor 32 is limited by sleeve retractor stop 33 , thus limiting the proximal travel of rigid sleeve 34 . as rigid sleeve 34 is retracted , expandable sleeve tip 40 at the distal end of rigid sleeve 34 opens , releasing the balloon or other device positioned in the central annulus of rigid sleeve 34 at the distal end of sleeve 34 . fig2 is a cross sectional view of the ablation instrument illustrated in fig1 along view line 2 -- 2 . in fig2 fluid line 36 is surrounded by fiber optic bundles 21a , 21b and 21c and by temperature signal wires 25a , 25b and 25c . as illustrated in fig2 fiber optic bundles 21a , 21b and 21c each include one or more fiber optic fibers 38 which are adapted to transmit optical energy . temperature signal wires 25 are adapted to transmit signals representative of temperature . fluid line 36 is adapted to transmit fluid such as , for example , air . fig3 illustrates an optical ablation system according to the present invention including an ablation instrument and an alternative embodiment of an electro - optic generator . in the embodiment of electro - optic generator 11 illustrated in fig3 optical energy source 12 of fig1 is divided into a plurality of controllable optical energy sources 12a , 12b and 12c . in one embodiment of the present invention , the intensity of optical energy sources 12 is controllable and the energy from optical energy sources 12a , 12b and 12c is controlled by energy control signals from control circuit 22 which are transmitted through , for example , control lines 72 . each of energy sources 12a , 12b and 12c pass optical energy through energy coupling lenses 14a , 14b and 14c respectively . energy coupling lenses 14a , 14b and 14c focus optical energy on fiber optic bundles 20a , 20b and 20c through optical filters 16a , 16b and 16c respectively . in one embodiment of the present invention , optical filters 16 may include a plurality of selectable optical filters which may be selected by filter selection signals from control circuit 22 which are transmitted through , for example , control lines 70 . the number of energy coupling lenses , optical filters and fiber optic bundles will depend upon the design of ablation system 15 , however , the number of coupling lenses , optical filters and fiber optic bundles will generally correspond to the number of regions the ablation instrument is designed to separately heat within the body cavity being treated . in all other respects , the ablation system 15 illustrated in fig3 is substantially identical to the ablation system 15 illustrated in fig1 . fig4 is a cutaway view of a cross section of an expandable diffusing web 46 according to the present invention . in fig3 expandable defusing web 46 includes reflective coating 42 , balloon 44 , optical fiber mesh 47 and an adhesive layer 50 for attaching the fiber optic mesh to the balloon . reflective coating 42 may be , for example , a coating of silver or other reflective material which covers the outer surface of balloon 44 . balloon 44 may be constructed of , for example , mylar or other expandable balloon material . optical fiber mesh 47 may include optical fibers 48 , reflective fiber terminator 52 and fill threads 49 . fill threads 49 may be solid as illustrated in fig4 . alternatively , fill threads 49 may be made of an optically conductive material . optical fiber mesh 47 may be , for example , a light emitting woven light emitting panel which is manufactured by ploy - optic or by lumitex . reflective fiber terminator 52 is located at the end of optical fiber 48 to reflect any optical energy which reaches the end of optical fiber 48 without being diffused . fig5 is a cutaway side view of the distal end of ablation instrument 10 according to the present invention prior to deployment of expandable diffusing web 46 . in fig5 the distal end of rigid sleeve 34 , including expandable diffusing web 46 is disposed within uterus 56 . expandable diffusing web 46 is folded to fit within rigid sleeve 34 . the interior of uterus 56 is covered by an endometrial layer 58 . as rigid sleeve 34 is withdrawn , by , for example moving sleeve retractor 32 , expandable diffusing web 46 forces expandable sleeve tip 40 open , exposing expandable diffusing web 46 . fluid line 36 is connected to the proximal end of expandable diffusing web 46 such that a fluid , such as air , supplied at fluid source connector 29 fills the interior of expandable diffusing web 46 , forcing expandable diffusing web 46 to expand . fig6 is a cutaway side view if the distal end of ablation instrument 10 according to the present invention after deployment of expandable diffusing web 46 . in fig6 rigid sleeve 34 has been retracted , exposing expandable diffusing web 46 . expandable diffusing web 46 , which includes balloon 44 and optical fiber mesh 47 is expanded to fit against endometrial lining 58 of uterus 56 by filling balloon interior 60 with a fluid such as air . fluid line 46 connects balloon interior 60 to fluid source connector 29 . fig7 is a side view of a balloon 44 for use in the present invention . it will be recognized that balloon 44 may be shaped to fit within any body cavity , however , in the embodiment of the invention described herein , expandable diffusing web 46 is designed to be used within the uterus to destroy the endometrial lining . thus , balloon 44 illustrated in fig7 is shaped to fit within the uterus and to hold the optical fiber mesh firmly against at least a substantial portion of the endometrial lining . nor is it necessary that the invention be limited to the use of a balloon as an expandable element since any means of expanding expandable diffusing web 46 to position optical fiber mesh near or adjacent the interior lining ( e . g . the endometrium ) of the body cavity to be treated is within the scope of the present invention . in fig7 balloon 44 has been expand ed by filling interior 60 with an appropriate fluid , such as air , and the expanded balloon 44 takes on the shape of the interior of a uterus . fig8 is a side view of the distal end of ablation instrument 10 according to the present invention illustrating a portion of expandable diffusing web 46 which includes a first optical fiber mesh 47a . the embodiment of the invention illustrated in fig8 further includes a first thermocouple 62a . in fig8 optical fiber mesh 47a is disposed on the distal end of balloon 44 . in fig8 optical fiber mesh 47a includes optical fibers 48a which are interwoven with fill threads 49a . at their proximal end , optical fibers 48a of optical fiber mesh 47a are connected to the distal end of one of fiber optic bundles 21 which extend through rigid sleeve 34 , alternatively , optical fibers 48a of optical fiber mesh 47a may be a continuation of one of the optic fiber bundles 21 . for example , the proximal ends of fiber optics 48a may be gathered together to form an optical fiber bundle 51a which is connected to , for example , the distal end of fiber optic bundle 21a using , for example a butt - connector such as the one used to connect fiber optic bundle 20a with fiber optic bundle 21a , alternatively , fiber bundle 51a may be a continuation of the distal end of fiber optic bundle 21a . fiber optic bundle 21a is joined to or disperses to form optical fibers 48a such that optical energy is passed from fiber optic bundle 21a to optical fibers 48a , thus optical energy generated at optical energy source 12 may be transmitted through fiber optic bundle 20a to fiber optic bundle 21a and through fiber optic bundle 21a to optical fibers 48a of optical fiber mesh 47a . thermocouple 62a is positioned to detect the temperature of tissue adjacent optical fiber mesh 47a . temperature signal wires 25a , being connected to thermocouple 62a , relay a signal representative of the temperature at thermocouple 62a to temperature signal wires 24a which , in turn relay the signal to control circuit 22 . optical fiber mesh 47a , being positioned on balloon 44 , is held in place against the tissue to be treated by the expansion of balloon 44 as a result of the fluid supplied through fluid line 36 . fig9 is a side view of the distal end of ablation instrument 10 according to the present invention illustrating a portion of expandable diffusing web 46 which includes a first optical fiber mesh 47a and a second optical fiber mesh 47b . the embodiment of the invention illustrated in fig9 further includes a first thermocouple 62a and a second thermocouple 62b . in fig9 a second optical fiber mesh 47b has been wrapped around the distal end of the balloon illustrated in fig8 to increase the surface area of balloon 44 covered by optical fiber mesh 47 . thus , the previous description of the instrument with respect to fig8 is applicable with respect to like elements of fig9 . in addition to the elements described with respect to fig8 fig9 illustrates optical fiber mesh 47b which includes optical fibers 48b which are interwoven with fill threads 49b . at their proximal end , optical fibers 48b of optical fiber mesh 47b are connected to the distal end of one of fiber optic bundles 21 which extend through rigid sleeve 34 . for example , the proximal ends of fiber optics 48b may be gathered together to form an optical fiber bundle 51b which is connected to , for example , the distal end of fiber optic bundle 21b using , for example , a butt - connector such as the one used to connect fiber optic bundle 20b with fiber optic bundle 21b , alternatively , fiber bundle 51b may be a continuation of the distal end of fiber optic bundle 21b . fiber optic bundle 21b is joined to optical fibers 48b such that optical energy is passed from fiber optic bundle 21b to optical fibers 48b , thus optical energy generated at optical energy source 12 may be transmitted through fiber optic bundle 20b to fiber optic bundle 21b and through fiber optic bundle 21b to optical fibers 48b of optical fiber mesh 47b . thermocouple 62b is positioned on balloon 44 to detect the temperature of tissue adjacent optical fiber mesh 47b . temperature signal wires 25b , being connected to thermocouple 62b , relay a signal representative of the temperature at thermocouple 62b to temperature signal wires 24b which , in turn , relay the signal to control circuit 22 . optical fiber mesh 47b , being positioned on balloon 44 , is held in place against the tissue to be treated by the expansion of balloon 44 as a result of the fluid supplied through fluid line 36 . fig1 is a side view of the distal end of ablation instrument 10 according to the present invention illustrating a portion of expandable diffusing web 46 which includes a first and optical fiber mesh 47a , a second optical fiber mesh 47b and a third optical fiber mesh 47c . the embodiment of the invention illustrated in fig1 further includes a first thermocouple 62a , a second thermocouple 62b and a third thermocouple 62c . in fig1 , a third optical fiber mesh 47c has been wrapped around the distal end of the balloon illustrated in fig8 and fig9 to increase the surface area of balloon 44 covered by optical fiber mesh 47 . thus , the previous description of the instrument with respect to fig8 and fig9 is applicable with respect to like elements of fig1 . in addition to the elements described with respect to fig8 and fig9 fig1 illustrates an optical fiber mesh 47c which includes optical fibers 48c which are interwoven with fill threads 49c . at their proximal end , optical fibers 48c of optical fiber mesh 47c are connected to the distal end of one of fiber optic bundles 21 which extend through rigid sleeve 34 . for example , the proximal ends of fiber optics 48c may be gathered together to form an optical fiber bundle 51c which is connected to , for example , the distal end of fiber optic bundle 21c using , for example , a butt - connector such as the one used to connect fiber optic bundle 20c with fiber optic bundle 21c , alternatively fiber bundle 51c may be a continuation of the distal end of fiber optic bundle 21c . fiber optic bundle 21c is joined to optical fibers 48c such that optical energy is passed from fiber optic bundle 21c to optical fibers 48c , thus optical energy generated at optical energy source 12 may be transmitted through fiber optic bundle 20c to fiber optic bundle 21c and through fiber optic bundle 21c to optical fibers 48c of optical fiber mesh 47c . thermocouple 62c is positioned on balloon 44 to detect the temperature of tissue adjacent optical fiber mesh 47c . temperature signal wires 25c , being connected to thermocouple 62c , relay a signal representative of the temperature at thermocouple 62c to temperature signal wires 24c which , in turn , relay the signal to control circuit 22 . optical fiber mesh 47c , being positioned on balloon 44 , is held in place against the tissue to be treated by the expansion of balloon 44 as a result of the fluid supplied through fluid line 36 . the embodiment of the invention illustrated in fig1 is adapted to controllably heat three separate regions within the uterus of a human patient to selectively destroy the endometrial layer within those regions . the energy and depth of penetration of the optical energy may be controlled by controlling the energy level and wavelength of the energy transmitted to the proximal end of each fiber optic bundle 20a , 20b and 20c . longer wavelengths penetrate deeper into tissue . shorter wavelengths , for example , blues and greens , may be used to achieve surface heating . thus , depending on the effect that is desired , different wavelength of optical energy may be selected . optical energy is transmitted through optical bundles 20 to optical bundles 21 and optical bundles 51 . optical energy which passes through optical bundles 51 is diffused by optical fiber mesh 47 of expandable diffusing web 46 . reflective coating 42 acts to reflect optical energy away from balloon 44 and into tissue surrounding expandable diffusing web 46 . the depth of penetration of the optical energy into surrounding tissue will be a function of a number of factors , including the wavelength of the optical energy radiated by expandable diffusion web 46 and the distance from the expandable diffusion web 46 to the tissue to be treated . the rate at which the tissue is heated will also depend upon a number of factors , including the output energy generated by optical energy source 12 , the losses in electro - optic generator 11 and ablation instrument 10 , the distance from the expandable diffusion web 46 to the tissue to be treated and the wavelength of the optical energy . however , by monitoring the tissue as it is treated using , for example , thermocouples 62 , the surgeon may control the temperature of the tissue being treated with relative accuracy . in use a surgeon will introduce the distal end of ablation instrument 10 into the body cavity of a patient such that expandable sleeve tip 40 is positioned at a predetermined depth within the body cavity . for the purposes of this discussion , the body cavity to be treated will be the uterus of a female human being . it will be recognized that , with slight modification , the present invention may be used to treat other body cavities . once sleeve tip 40 is inserted into the uterus 56 as illustrated in fig5 sleeve retractor 32 may be used to slide rigid sleeve 34 back away from expandable diffusing web 46 . as rigid sleeve 34 is retracted , expandable diffusing web 46 forces expandable sleeve tip 40 open . once sleeve retractor 32 reaches its proximal most travel point it is stopped by sleeve retractor stop 33 which prevents rigid sleeve 34 from retracting further . once rigid sleeve 34 is retracted , expandable diffusing web 34 may be expanded to contact the interior of the uterus by , for example inflating balloon 44 by injecting an appropriate fluid , such as , for example air into balloon interior 60 . fluid is introduced into balloon 44 through fluid line 36 which is connected to fluid source connector 29 which , in the embodiment illustrated in fig1 is connected to a syringe and plunger which may be used to inflate or deflate balloon 44 . expandable diffusing web 46 , being shaped to fit the body cavity , e . g . the uterus , being treated , is designed to force optical fiber mesh 47 against a substantial portion of the interior surface of the body cavity . thus , when expandable diffusing web 46 is fully expanded , optical fiber mesh 47 is positioned directly adjacent or in direct contact with endometrium 58 of uterus 56 . once expandable diffusing web 46 is positioned within uterus 56 , optical energy may be supplied to optical fiber mesh 47 by turning on optical energy source 12 . once optical energy source 12 is turned on , the light radiated by optical energy source 12 is focused on the proximal end of optical fiber bundle 20 by energy coupling lens 14 . as optical energy passes through optical filter 16 , it is filtered to remove unwanted wavelengths . as optical energy passes through variable attenuator 18 the energy level is attenuated . therefore , the optical energy focused upon fiber optic bundle 20 is filtered and attenuated such that it is optical energy of a selected wavelength and energy level . optical energy focused upon the proximal end of fiber optic bundle 20 is transmitted through fiber optic bundle 20 to fiber optic bundle 21 and from fiber optic bundle 21 to expandable diffusing web 46 where it is radiated into the endometrial layer from optical fiber mesh 47 . where different optical energy levels or wavelengths are to be transmitted to different regions of the endometrium , a plurality of energy coupling lenses 14a - 14c , optical filters 16a - 16c and variable attenuators 18a - 18c may be used to focus filtered optical energy onto a plurality of fiber optic bundles 20a - 20c as illustrated in fig1 . alternatively , where different optical energy levels or wavelengths are to be transmitted to different regions of the endometrium , a plurality of optical energy sources 12a - 12c , energy coupling lenses 14a - 14c and optical filters 16a - 16c may be used to focus filtered optical energy onto a plurality of fiber optic bundles 20a - 20c as illustrated in fig2 . the optical energy focused on optical bundles 20a - 20c may then be transmitted through optical fiber bundles 21a - 21c to each optical fiber mesh 47a - 47c . once the optical energy reaches expandable diffusing web 46 , it is radiated by optical fibers 48 which are woven with fill threads 49 to form optical fiber mesh 47 . radiation from optical fibers 48 which is not directed into the tissue adjacent optical fiber mesh 47 is reflected by reflective coating 42 as illustrated in fig4 . thus , both the energy radiated toward the tissue and the reflected energy is absorbed by the tissue adjacent to fiber optic mesh 47 . further , since the energy is transmitted optically , it is not necessary for the tissue to be directly adjacent fiber optic mesh 47 as the radiated energy will be absorbed by any tissue illuminated by the energy from the mesh . this arrangement provides for uniform escape or emission of energy focused on the fiber optic bundles 20 in fiber optic generator 11 . further , in an arrangement according to the present invention , energy is evenly radiated from the outside of the expandable diffusing web , and is , therefore absorbed by the endometrial lining of the uterus causing temperature of the tissue to rise . the control sequence for control circuit 22 of the electro - optic generator illustrated in fig1 is illustrated in fig1 . once expandable diffusing web 46 has been positioned and inflated as described previously , optical energy may be supplied to expandable web 46 to heat endometrial lining 58 . the first step in supplying optical energy to endometrial lining 58 is to select an appropriate wavelength . in particular , red and near infrared wavelengths would be selected for heating deep ( e . g . 0 - 10 millimeters ) into uterine tissue . ultraviolet , blue or green wavelengths would be used for heating uterine tissue to a depth of , for example , ( 0 - 3 millimeters ). once the appropriate optical energy wavelength has been selected by , for example , adjustment of optical filter 16 or by appropriate selection of optical energy source 12 , optical energy may be supplied to expandable web 46 . the energy level or intensity of the optical energy supplied to expandable web 46 may be controlled by controlling the attenuation of variable attenuators 18 or by controlling the intensity of optical energy source 12 . temperature feedback from thermocouple 62 may be used to adjust the energy level supplied to fiber optic bundles 20 . thus , the temperature of the body lining being treated is controlled by controlling the energy level supplied to expandable web 18 while the depth of penetration of the energy supplied to expandable web 46 is controlled by controlling the wavelength of the optical energy supplied to fiber optic bundles 20 . the flow diagram of fig1 illustrates the control sequence for the electro - optic generator illustrated in fig1 . the temperature of endometrial lining 58 is sensed by , for example , thermocouple 62 which provides a signal to control circuit 22 through temperature signal wires 24 and 25 . as illustrated in fig1 , control circuit 22 , in step 67 , senses the temperature at thermocouple 62 and produces a signal 100 which is representative of the temperature measured at thermocouple 62 . in step 68 , signal 100 is compared to a predetermined set point temperature such as , for example , any temperature between 42 ° c . and 100 ° c . for a time sufficient to destroy the inner lining of the organ in question . if the temperature represented by signal 100 is lower than the set point temperature , control circuit 22 generates a signal 103 . in step 71 , signal 103 causes control circuit 22 to decrease the attenuation of the optical energy focused on optical fiber bundle 20 , thus increasing the optical energy supplied to expandable web 46 . once the attenuation has been reduced , control circuit 22 generates a signal 105 which causes control circuit 22 to return to step 67 where the temperature is measured again and a new signal 100 is generated . once the temperature represented by signal 100 reaches the set point temperature control circuit 22 , in step 69 , generates a signal 106 which is representative of the time the endometrium has been at the desired temperature . the time represented by signal 106 is compared , in step 72 to a predetermined set time and if the time represented by signal 106 is less than the predetermined set time , control circuit 22 generates signal 107 which returns control circuit 22 to step 67 . if during the control cycle , the signal 100 rises above the set point temperature , then signal 102 is generated , causing control circuit 22 to increase attenuation at variable attenuators 18 , thus decreasing the optical energy delivered to expandable diffusing web 46 . once the actual time at the desired temperature , represented by signal 106 , reaches the predetermined set time in step 72 , signal 108 is generated indicating , in step 73 , that the procedure is complete and generating signal 109 which turns off optical energy source 12 in step 74 . the flow diagram of fig1 illustrates the control sequence for the electro - optic generator illustrated in fig2 . the temperature of endometrial lining 58 is sensed by , for example , thermocouple 62 which provides a signal to control circuit 22 through temperature signal wires 24 and 25 . as illustrated in fig1 , control circuit 22 , in step 80 , senses the temperature at thermocouple 62 and produces a signal 200 which is representative of the temperature measured at thermocouple 62 . in step 81 , signal 200 is compared to a predetermined set point temperature . if the temperature represented by signal 200 is lower than the set point temperature , control circuit 22 generates a signal 203 . in step 84 , signal 203 causes control circuit 22 to increase the optical energy from optical energy source 12 which increases the intensity of the optical energy focused on optical fiber bundle 20 , thus increasing the optical energy supplied to expandable web 46 . once optical energy has been increased , control circuit 22 generates a signal 205 which causes control circuit 22 to return to step 80 where the temperature is measured again and a new signal 200 is generated . once the temperature represented by signal 200 reaches the set point , temperature control circuit 22 , in step 82 , generates a signal 206 which is representative of the time the endometrium has been at the desired temperature . the time represented by signal 206 is compared , in step 85 to a predetermined set time and , if the time represented by signal 206 is less than the predetermined set time , control circuit 22 generates signal 207 which returns control circuit 22 to step 80 . if during the control cycle , the signal 200 rises above the set point temperature , then signal 202 is generated , causing control circuit 22 to decrease the optical energy from optical energy source 12 , which decreases the intensity of the optical energy focused on optical fiber 20 , decreasing the energy delivered to expandable diffusing web 46 . once the actual time at the desired temperature , represented by signal 206 , reaches the predetermined set time in step 85 , signal 208 is generated indicating , in step 86 , that the procedure is complete and generating signal 209 which turns off optical energy source 12 in step 87 . in operation , ablation instrument 10 would be connected to electro - optic generator 11 and the distal end of instrument 10 would be inserted into the appropriate body organ , for example , into the uterus 56 . rigid sleeve 34 would then be retracted using sleeve retractor 32 , thereby exposing expandable diffusing web 46 which includes balloon 44 . balloon 44 is inflated using , for example , balloon inflator syringe 30 which includes plunger 30 . once balloon 44 is inflated forcing expandable diffusing web 46 to conform to the interior of uterus 56 , electro - optic generator 11 is activated , thus delivering optical energy to optical fibers 48 of optical fiber mesh 47 on expandable diffusing web 46 . control circuit 22 is then used to monitor the heating of endometrial layer 58 of uterus 56 through thermocouple ( s ) 62 . control circuit 22 acts to bring endometrial layer 58 up to a desired temperature , hold endometrial layer 58 at that temperature for a predetermined length of time and then turn off optical energy to the endometrial layer . expandable diffusing web 46 may then be collapsed by deflating balloon 44 using , for example syringe 30 . once expandable diffusing web 46 is deflated , it may be retracted from uterus 56 . use of an ablation instrument according to the present invention may be advantageous , when compared to electrosurgical or other apparatus for use in endometrial ablation , for example : light energy may be less likely to interfere with the operation of the thermocouples ; a light diffusing fiber - optic web may be more adaptable to expansion than rf electrodes ; contact with the uterine wall is not required as it may be in an rf device ; it is possible to control the depth of heating by controlling the wavelength of the optical energy applied to the endometrial lining . according to one embodiment of the present invention , light energy from optical energy source 12 , which may be , for example , common projection lamps , may be used to uniformly heat the endometrium 58 ° to 70 ° c . and thereby ablate the endometrium . the array of fiber - optic mesh or webs 47 are connected individually to an array of high intensity lamps 12 via fiber - optic cables 20 and 21 . fiber optic mesh 47 may heating of the endometrium 58 is achieved through absorption of the optical radiation transmitted through fiber optic cables 20 and 21 . the temperature of each fiber optic web , for example fiber optic webs 47a - 47c , is monitored by a thermocouple , for example 62a - 62c , which , through a feedback loop including temperature signal wires 24 and 25 which are connected to control circuitry 22 , controls the intensity of its associated lamp 12 . in this embodiment , fiber - optic mesh 47 and thermocouples 62 cover the outside of an inflatable silvered mylar pouch or balloon 44 . balloon 44 is inserted into the uterus and then inflated . inflation brings fiber - optic webs 47 and thermocouples 62 into contact with the endometrium or endometrial layer 58 . lamps 12 are then turned on and the temperature of the endometrium is monitored intensity of the optical energy supplied to fiber optic webs 47 is controlled by monitoring feedback from thermocouples 62 until therapy is complete . the silvered surface of mylar balloon 44 directs all the optical radiation into the endometrium for heating . while preferred embodiments of the present invention have been shown and described herein , it will be obvious to those skilled in the art that such embodiments are provided by way of example only . numerous variations , changes , and substitutions will now occur to those skilled in the art without departing from the invention . accordingly , it is intended that the invention be limited only by the spirit and scope of the appended claims .
a method of performing endometrial ablation comprising heating entire surface of the endometrium to a temperature of between 45 ° c . and 70 ° c . to destroy the cells of the endometrial lining while maintaining the average temperature of the myometrium at a temperature below approximately 42 ° c . an apparatus for performing an endometrial ablation comprising an expandable membrane such as a balloon adapted to fit within the uterus and contact the endometrial lining when expanded . a web of light diffusing fiber - optic cables arranged on the outer surface the balloon such that the web contacts the endometrial lining of the uterus when the balloon is expanded . the fiber - optic web is connected to an array of high intensity lamps via a series of fiber - optic cables . the temperature of the endometrium is monitored by a of a series of temperature sensors arranged upon the surface of the balloon .
1 indicates the tank containing the mixture of vegetable and / or animal natural products , each one in a clean and fragmented state , containing one or more primary mineral elements in addition to those in smaller quantities , combined with organic substances to be eliminated ; 2 indicates the heated cell , normally at a temperature included between 200 ° and 900 ° c ., in which the mixture coming from container 1 is mineralised , therefore the organic portion is normally separated in vapours and fumes . the mineralised complex in container 3 is a mineral complex characterised by a qualitative and quantitative composition of the chosen primary mineral elements , each one combined with a plurality of mineral elements already present , sometimes in minimum measures , on the vegetal and / or animal products from which they are originally produced and contained . the product coming out from group 3 is in one case conveyed directly to chamber 6 , and in the other case conveyed to mixer 4 in which it is mixed with other active principles coming from container 5 in order to originate in chamber 6 the mixture that is to be transformed into capsules or tablets , then to be packed and after distributed on the market . in the general formulation the production process of a mineral complex first foresees the quantitative determination of the metals that one wishes to integrate , hence a selection of the vegetal and / or animal raw materials that present a particularly high content of the above - mentioned metals . after having accomplished the choice of the organic raw materials to be used , the process through which the wanted mineral complex is obtained , can be described in a detailed way as follows : the chosen raw materials are analysed to make sure that the element is to be integrated is constant in them . the selected raw materials are dried , then individually cut and sieved until obtaining a uniform granulometry that is adapted for being mineralised . the previously processed raw materials as described above , are eventually mixed between them in the right proportion in order to obtain in the final complex the content of principal elements as wanted in the ratio . the aforesaid mixture is distributed on trays of stainless steel until reaching a layer of 5 cm . for each tray . the trays are stacked in a muffle one on top of the others , with some space between them for combustion fumes to escape . the normally methane operating muffle is programmed in such a way to reach within it a temperature of approximately 200 - 400 ° c . for 1 - 3 hours , then it is raised to a temperature of about 500 - 900 ° c . for 3 - 5 more hours , or anyway until the complete removal of the organic portion from the mixture of drugs introduced . the first period of time , at a temperature of 200 - 400 ° c ., is essential in order to obtain a perfect light coloured mineralised product , without any carbonised organic products . the mineralised product obtained from the muffle is subjected to a quantitative analysis for being titrated , at least in its main elements , and to a control in order to verify the absence of elements recognised as toxic . it can be conveyed in the packaging division , or first mixed with additional chosen active principles , and hence sent to the packaging . however , the invention is illustrated here as follows with reference to two applications for the production of different highly concentrated mineralised natural complexes . the proportion for the mixing has been chosen according to the content of iron in the single drugs above - indicated , in particular : the selected vegetal drugs have been cut until reaching a uniform granulometry that is adequate to be mineralised . the optimal granulomethy is the following : the aforesaid fragmented mixture has been distributed on the stainless steel trays until reaching a layer of about 5 cm . of drug for each tray . the trays are stacked one on top of the other , with some space between them for the combustion fumes to escape . the methane operating muffle is programmed to reach within it a temperature of approximately 300 ° c . for a time of 2 hours at first , then it is raised and kept at a temperature of approximately 700 ° c . for 4 more hours . the first step at 300 ° c . is essential in order to obtain a perfect white coloured final product completely inorganic . the mineralised product is encapsulated in gelatine capsules with a final weight of about 500 mg . in this process the obtained mineralised complex contains all the mineral substances originally contained in the raw materials in form of oxides and other salts . the composition of the mineralised complex is the following : ______________________________________element concentration in the complex in mg / g______________________________________iron 7 . 73 calcium 109 . 8 zinc 0 . 19 magnesium 21 . 75 potassium 85 . 0 sodium 9 . 3 copper 0 . 03 manganese 0 . 49______________________________________ due to the high concentration of iron and the relatively high specific weight of the mineralised complex , only four capsules a day are sufficient to obtain a good daily integration of such element ( the daily recommended ration of iron is 14 mg . according to the italian law ). as a matter of fact , the solubility , and therefore the bio - availability with a ph : 1 , is extremely high : in fact 2 g . of product are 93 . 05 % soluble in one litre of hydrochloric acid with a ph : 1 at 37 ° c . ( liquid simulating gastric juice ). the proportions for the mixing have been chosen according to the calcium content in the single above - mentioned drugs , in particular : the selected vegetable drugs have been cut until reaching a uniform granulometiy , adequate for being mineralised . the optimal granulometry for each drug is the following : after having mixed the drugs , separately chopped up by following the above - mentioned granulometry , the mixture is distributed on steel trays until reaching a layer of 5 cm . of drug for each tray . the trays are stacked one on top of each other , with some space between them for the combustion fumes to escape . the muffle , normally heated with methane , is programmed in such a way to reach within it a temperature of approximately 300 ° c . for 2 hours , then it is raised and kept at a temperature of about 700 ° c . for 4 more hours . the first step at 300 ° c . is essential in order to obtain a perfect white coloured final product and completely inorganic . the mineralised product is encapsulated in gelatine capsules with a final weight of about 500 mg . in this process the obtained mineralised complex contains all the mineral substances originally contained in the raw materials in form of oxides and other salts . the composition of the obtained mineralised complex is the following : ______________________________________element concentration in the complex in mg / g . ______________________________________iron 1 . 9 calcium 299 . 5 zinc 0 . 46 magnesium 33 . 74 potassium 94 . 6 sodium 8 . 5 copper 2 . 5 manganese 4 . 08______________________________________ due to the high concentration of calcium and the relatively high specific weight of the mineralised complex , only five capsules per day are sufficient to obtain a good daily integration of calcium ( in italy the recommended daily ration of calcium is of 800 mg .). in fact , the solubility , and so the bio - availability with a ph : 1 , is extremely high : 2 g . of product are 77 . 15 % soluble in a little of hydrochloric acid with a ph : 1 at 37 ° c . ( liquid simulating gastric juice ). the process is repeated for any other individually chosen vegetal and / or animal product , or in combination with other organic products characterised by a high content of metal or metals , through which the integration of mineral oligoelements in humans , animals or plants is intended to be operated .
the invention concerns a highly concentrated mineralised natural complex , characterised by at least one main mineral element quantified with nutritional and / or dietetic integrator properties and by other mineral elements obtained in the complex from the mineralization of vegetal and / or animal products . moreover , it concerns the method for its production consisting in using vegetal and / or animal organic substances , having a high content of oligominerals , in carrying out their fragmentation , their mixing and the mineralization until the inorganic part is completely separated from the organic part , and then in transforming the aforesaid inorganic part in forms of easy commercialization .
illustrated in fig1 and 3 is the exterior box or container 10 for the curtain puller . the box 10 may be constructed of metal or plastic halves that merely snap together or are fastened together with mechanical fasteners . adjacent to the top of the box is a separate cover piece 12 open at the top and affixed to the front of the box 10 . within the cover 12 is a drive pulley 14 mounted on a motor drive shaft extending from a small electric motor 16 within the box 10 . the pulley 14 engages the drapery or curtain cord 18 in turn extending downwardly about the pulley 14 and upwardly to the curtain rod ( not shown ). thus , the electric motor 16 drives the curtain cord 18 to open or close the curtains or drapes . in other words , the motor 16 moves the object or curtains from an open first position to a closed second position or vice versa . below the box is a bracket 20 that may be attached to the wall of a house adjacent a window with mechanical fasteners through the holes 22 in the bracket . within the bracket 20 is a transverse rod 24 to which a pair of springs 26 are attached at their lower end . the upper ends of the springs 26 are attached to a second transverse rod 28 in turn affixed to the inside of the back of the box 10 . the springs 26 provide suitable tensioning for the curtain cord 18 . atop the box 10 is a small shield 30 which may be manually rotated about a vertical axis . the shield 30 has an opening 32 to permit light to enter therein . inside the shield is a photocell connected to the internal circuitry of the curtain puller . a 110 volt ac power supply cord as indicated at 34 extends into the box 10 and is attached to a rectifier and motor power circuit indicated at 36 . also inside the box 10 is a printed circuit board 38 to which are attached the electric elements comprising the control circuit for the curtain puller . as shown the box 10 encloses the entire electric control and power supply for the curtain puller . the box 10 is not substantially larger than a conventional spring tensioner for a curtain cord loop . fig4 a , 4b , and 4c illustrate the control and power circuitry for the curtain puller . with the exception of the 110 volt ac power supply cord 34 and plug for the electrical power to the curtain puller , the control and power circuitry is entirely contained within the box 10 . referring in particular to fig4 c , a fuse f1 and transformer t1 in the 110 volt ac supply provide power to a regulator circuit comprising a diode bridge 40 and an integrated circuit regulator reg - 1 . the regulator circuit provides 12 volts dc power to the control circuit illustrated in fig4 a and 4b and to the isolator circuit including opto - isolators ic1 and ic2 shown in fig4 c . the transformer t1 also provides ac power at reduced voltage to the pulley drive motor 16 through the triacs q1 and q2 . triacs q1 and q2 are in turn triggered by signals respectively from opto - isolators ic1 and ic2 . in other words , the transformer and regulator circuit act as a power supply means for supplying power from the 110 ac power source to the control circuit and motor . a suitable motor 16 is a reversible 24 volt 60 cycle ac motor . a reversible dc motor might be substituted for motor 16 with suitable changes in the power supply to provide dc current and solid state switching means in substitution for triacs q1 and q2 . the opto - isolators or optical couplers ic1 and ic2 provide electrical isolation between the ac power for the motor 16 and the low voltage substantially dc control signals in the control circuit shown in fig4 a and 4b . the signal through the opto - isolators ic1 and ic2 is provided by a 12 volt dc signal in turn controlled by a pair of transistors q3 and q4 . the pair of optically isolated connection circuits is between transistor q4 and triac q1 and between transistor q3 and triac q2 . thus , the control of rotational direction of the motor 16 is determined by a signal from opto - isolator ic1 to triac q1 , or for the other direction , by the signal from opto - isolator ic2 to triac q2 . the control circuit identified by the reference 38 to a printed circuit board within the box 10 comprises in fig4 a and 4b a photo - electric cell q5 which is contained within the hooded cover 30 at the top of the box 10 . in response to a sufficient increase or decrease in light the photo cell q5 provides an input to an integrated circuit ic3 which in turn provides an output at pin 7 of a sudden up or down voltage change as indicated by arrows 42 and 44 . in other words , the photoelectric cell q5 is a light sensing means for detecting changes in levels of light , i . e ., presence or absence of light in the daytime and nighttime , respectively . the sudden change in voltage up 42 or down 44 is provided as an input to pin 4 of integrated circuit ic4 which in turn massages the signal to provide through integrated circuit ic7 a reset and start signal illustrated by the &# 34 ; one shot &# 34 ; 46 at pin 4 of integrated circuit ic7 . the reset and start &# 34 ; one shot &# 34 ; 46 in turn is provided to pin 6 of a dual timer integrated circuit ic5 . a suitable integrated circuit ic4 is a motorola monostable multivibrator mc14538b or equivalent . integrated circuit ic5 is a national semiconductor dual timer lm556 or equivalent . the reset and start &# 34 ; one shot &# 34 ; 46 is also provided through integrated circuit ic8 from pin 3 to the base of transistor q6 , which with the associated circuitry and dual timer ic5 provides a ramp function timing signal that increases in voltage continuously from the moment that the &# 34 ; one shot &# 34 ; reset and start signal is received . typically , this ramp function , as indicated schematically by arrow 48 on the xy plot adjacent transistor q6 , constantly increases the charge on capacitor c6 until a prespecified voltage is reached . each time the signal from the photocell q5 passes a threshold of increasing light or decreasing light an up or down voltage change is generated by integrated circuit ic3 and sensed at the base of transistor q6 to reset the ramp function output 48 by discharging capacitor c6 . typically the ramp function circuit elements connected between transistor q6 and pins 1 , 2 and 3 of integrated circuit ic5 are specified to provide about a 15 minute time period from start or reset until a specified voltage is reached . thus , short term changes in light level sensed by the photo electric cell q5 do not result in actuation of the control circuit beyond resetting the ramp function output 48 . once the specified ramp function voltage is reached , the second timer of integrated circuit ic5 is actuated by the output 1 at pin 5 to t2 pin 8 . the second timer includes the circuit elements connected to pins 7 , 11 , 12 and 13 of integrated circuit ic5 . the potentiometer p1 provides adjustable means for setting the length of time the motor 16 operates by setting the specified ramp function maximum voltage for the second timer . with actuation of the second timer an output 2 signal at pin 9 is provided to pin 3 of integrated circuit ic6 which acts as a flip - flop or latch to determine the current state or position of the motor 16 and thereby determine the current position of the curtain . a suitable integrated circuit ic6 is motorola dual flip - flop mc14013b or equivalent . the flip - flop integrated circuit ic6 thereby permits or does not permit the motor to operate depending upon the direction of operation of the motor the previous time the motor was actuated to move the curtain . in other words , the flip - flop or latch acts as a latching means for determining the current position of the motor in either of the first and second positions and for actuating the motor to move the object or curtain to the position opposite the current position of the object or curtain . the status of the integrated circuit ic6 can be easily determined by the light emitting diode d8 which is connected to pin 9 of integrated circuit ic6 and illuminated when the curtain is in the closed position . a by - pass or a manual switch s2 is also provided so that the curtain can be conveniently opened or closed as desired during the night or during the day . the manual closure or opening of the curtain is sensed through the connection to pins 2 and 5 of integrated circuit ic6 . the output from integrated circuit ic6 pins 1 and 2 respectively provide one - half of the control to the base of transistor q4 or the base of transistor q3 thereby determining the direction of rotation . the other half of the control is provided by the output at pin 9 of the dual timer ic5 . once actuated by the output at pin 9 of integrated circuit ic5 the motor operates for a period of time necessary to move the curtain as set by the exterior circuitry and potentiometer p1 of the second timer of dual timer ic5 . the second timer circuit is also actuated by engaging the manual switch s2 to also start the motor running with the second timer . in either case the motor runs for a set period of time sufficient to open or close the curtain . in summary , the flip - flop circuitry only permits the motor to operate when either the signal from integrated circuit ic3 or from the manual switch s2 , if thrown , provides for movement of the curtain opposite to that of the previous movement of the curtain .
an automatic electro - mechanical device for opening and closing a curtain or drapery in response to changed light striking a photoelectric cell on the device . the device comprises a miniature high torque reversible electric motor and control packaged in a container of substantially the same size as a conventional cord tensioner of curtains or draperies . to close the drapes at sun - down and open the drapes at sun - up automatically without actuation if the lighting changes for short periods of time , the device comprises a dual timer circuit with individual ramping circuits . one timer circuit monitors the sustained presence or absence of light for a predetermined amount of time . the other timer regulates the motor drive run time . a flip flop circuit signals the current state of the curtains or drapes by providing memory of the last directional movement of the motor .
as shown in fig3 , the present invention is a container includes a cup ( 1 ), a rigid lining ( 2 ) mounted inside the cup ( 1 ). the lining ( 2 ) is a prefabricated component combined to the cup ( 1 ) by injection molding . in other words , the lining ( 2 ) is first placed in the mode and then a transparent or translucent acrylic cup ( 1 ) is formed to wrap over the circumference of the lining ( 2 ) integrally as a whole by injection molding ; finally , they are never detached from each other . lining ( 2 ) is shaped as a half - mask , that is , the lining ( 2 ) only shields the lower half portion of the cup ( 1 ) but the upper half portion of the cup ( 1 ) is not shielded by the lining ( 2 ). users can see vegetable or fruit cubes are whipped or thrashed in the cup ( 1 ). if the lining ( 2 ) is shaped as a whole - mask ( as shown in fig1 ), the upper and lower half portions of the cup are shielded by the lining ( 2 ). users only look down on the vegetable or fruit cubes whipped or thrashed in the cup ( 1 ). lining ( 2 ) is combined to the inner wall of the cup ( 1 ) to form a shield screen characterized in that a number of teeth ( 21 ) projected from the inner wall of the lining ( 2 ) applied to grate fibers of vegetable and fruit . teeth ( 21 ) can be arranged in parallel with one another , but they are all arrayed in alignment with each other finally to form a crossed or columned shape of teeth array . rather , the lining ( 2 ) can be made of metal , glass , alloy , or non - alloy material , which is with a hardness rather rigid than the acrylic cup ( 1 ). lining ( 2 ) is an annular member formed integrally as a whole one , but which is preferred in the shape of polygon . a lining base ( 21 ) can be added to the bottom of the cap ( 1 ) as a shield screen thereof . the top end of the lining ( 2 ) has an l type wall ( 25 a ) bended outward and upward , the bottom end of the lining ( 2 ) has an l type wall ( 25 b ) bended inward and downward respectively . both l type walls ( 25 a , 25 b ) are embedded into the inner wall of the cup ( 1 ) to eliminate the permeation of liquid through a chink on the wall . cup ( 1 ) has a handle ( 12 ) and a spout ( 13 ). several vertical ribs ( 11 ) are protruded from the inner wall of the cup ( 1 ); several vertical stopper members ( 22 ) corresponding to the ribs ( 11 ) are also formed on the obverse side of the wall of the lining ( 2 ), hollowed troughs opposed to the stopper members ( 22 ) are formed on the reverse side of the wall of the lining ( 2 ), the hollowed troughs are suitable for matching up and receiving the vertical rib ( 11 ). as shown in fig6 , look down on the cup ( 1 ), and the lining ( 2 ), a facet ( 111 ) of the rib ( 11 ) and a facet ( 221 ) of the stopper members ( 22 ) can be formed as perpendicular spoilers which dampen vibration of the vegetable and fruit fibers ( as shown in fig7 ) but sweep them in the whirlpool ( 4 ) as much as possible to the center thereof ; and then to the lower half portion of the cup ( 1 ) being crumbled by the straight blades . but only a few rough and long fibers ( 41 ) are forced into the center of the whirlpool , most of them still left outside the inner circle of the whirlpool ( 4 ). as shown in fig7 , when the straight blades ( not shown ) is rotated in high speed , rough and long fibers ( 41 ) in the whirlpool ( 4 ) remained in the teeth ( 21 ) on the surrounding inner wall of the lining ( 2 ) will soon be grated and chopped into pieces . possibility of the rough and long fibers being grated is greatly improved . though the fibers all are not easily forced into the whirlpool center at once , they can be chopped into pieces by the teeth ( 21 ) as well . therefore , the duration for the blender stirring the chopped fibers is reduced ; meanwhile , possibility of oxidization of the stirred juice is also reduced . rather , the top end of the stopper members ( 22 ) has a number of teeth ( 21 ′) projected up thereof , by means of the projected teeth ( 21 ′), the fibers of vegetable and fruit can be further grated and chopped into pieces . the teeth ( 21 ′) projected up from the top end of the stopper members ( 22 ) are advantageous to the grinding . as shown in fig8 , the container of the blender includes a cup ( 1 ), and a rigid lining ( 2 ) mounted inside the cup ( 1 ). first , each of the cup ( 1 ) and lining ( 2 ) are prefabricated components , and then the lining ( 2 ) is mounted inside the cup ( 1 ) and combined to the cup ( 1 ) integrally as a whole . after combination , the assembled view of the container is illustrated as shown in fig9 . the lining ( 2 ) is shaped as a half - mask . but several prop stands ( 23 ) extended from the top rim of the hood ( 2 ) to a height adjacent to the top rim of the cup ( 1 ), a horizontal ring ( 24 ) is connected to the top ends of the prop stands ( 23 ). the horizontal ring ( 24 ) is convenient for the users to hold , and when the lining ( 2 ) is mounted inside the cup ( 1 ), the horizontal ring ( 24 ) placed on the l - shape ( i . e . like a top step of a ladder ) top rim of the container which is suitable for a lid ( not shown ) capped over the container , then the horizontal ring ( 24 ) is sandwiched between the container and the lid . therefore the lining ( 2 ) can be mounted inside the container without any movements . as shown in fig1 , the container of the blender includes a cup ( 1 ), and a rigid lining ( 2 ) mounted inside the cup ( 1 ). the cup ( 1 ) and the lining ( 2 ) are prefabricated separately , and then the lining ( 2 ) is embedded into the cup ( 1 ) and combined to the cup ( 1 ) integrally as a whole . after combination , the assembled view is illustrated as shown in fig1 . the lining ( 2 ) is shaped as a half mask , which is composed of a number of lining pieces ( 2 a ). a stopper member ( 22 ) is formed on the obverse side of the lining piece ( 2 a ) as well as the teeth ( 21 ) are arrayed on the same side . the first facet of the stopper member ( 22 ) is bended inward to form a buckled piece ( 222 ). a groove ( 113 ) is defined on the first facet of the rib ( 11 ) of the cup ( 1 ), the buckled piece ( 222 ) can be led into the groove ( 113 ) in place and then the rib ( 11 ) enclosed inside the hollowed trough formed on the reverse side of the stopper member ( 22 ). the second facet of the lining pieces ( 22 ) is a flat facet directly leads into a trench ( 112 ) defined on the second facet of the rib ( 11 ) of the cup ( 1 ). a number of teeth ( 21 ′) can also be arranged on the top end of stopper member ( 22 ). rather , the lip ( 26 ) is extended radially outwardly from the top rim of the lining pieces ( 2 a ) is convenient for the user to hold when the lining pieces ( 2 a ) are assembled or disassembled with each other . as shown in fig1 , the container of the blender includes a cup ( 1 ), and a rigid lining ( 2 ) mounted inside the cup ( 1 ). the cup ( 1 ) and the lining ( 2 ) are prefabricated components . the lining ( 2 ) is embedded into the cup ( 1 ) and then combined to the cup ( 1 ) integrally as a whole . after combination , the assembled view is illustrated as shown in fig1 . the lining ( 2 ) is shaped as a whole mask . the lining ( 2 ) is composed of a number of lining pieces ( 2 b ), but the top rim of the lining ( 2 ) is bended outward to form a horizontal ring ( 27 ). the horizontal ring ( 27 ) is not only convenient for the user to hold to assemble or disassemble the lining pieces ( 2 b ), but the horizontal ring ( 27 ) can be placed on the top step of the ladder like top rim of the container so as the horizontal ring ( 27 ) can be sandwiched between the cup ( 1 ) and the lid ( not shown ) without any movements .
the present invention is aimed to provide a container of the blender . it can prevent the inner wall of the container from abrasions and blemishes . further , the time - consuming for fibers of the fruit and vegetable being grated and chopped can be reduced . the container of the blender includes a cup , a lining mounted inside the cup characterized in that the lining as a shield screen on the inner wall of the cup , the inner wall of the lining has a number of teeth projected thereof for grating the fibers of the vegetable and fruit .
the catheter comprises a calibrator oval 10 , a flexible shaft 12 , a manifold 14 which serves for the connection of a syringe 16 to the instrument , a balloon 18 which is longitudinally extensible from the oval 10 under the fluid pressure applied by syringe 16 and thereafter laterally expansible under increased fluid pressure , and a guide wire 20 to be pulled to re - invert the balloon 18 within the oval 10 . a blood vessel 22 partially occluded by occlusion 24 is provided with an incision 26 for the introduction into the vessel of the catheter . the catheter is moved along the vessel until the oval 10 bears against the end of occlusion 24 , as shown in fig1 . the syringe 16 is then attached to manifold 14 and actuated to evert the balloon 18 and extend it into the restricted lumen of occlusion 24 . the fluid pressure is then increased to radially expand the balloon and compress the occlusion . the fluid pressure is then reduced by reverse operation of the syringe and the syringe is removed from manifold 14 . wire 20 is then manually pulled to re - invert the balloon within the oval . the oval is then moved within the compressed occlusion 24 . ready movability of the oval through the occlusion indicates that the occlusion has been adequately compressed . if the oval is not readily movable through the occlusion the instrument is used to further compress the occlusion . once the occlusion has been suitably compressed the instrument may be moved further along the vessel 22 , as indicated in fig4 if there is a further occlusion to be treated . the details of construction of the instrument are shown in fig5 - 6 . the oval 10 and shaft 12 are formed by a tightly wound helical spring 28 which provides the catheter with sufficient flexibility to enable its movement through tortuous arteries . the oval and shaft are provided with an overcoating 30 of silicone , heat - shrink tubing , teflon , or the like . the balloon element 18 is made of an elastomeric material such as latex . one end of the balloon is attached to the end of the oval 10 and the other end of the balloon is attached with suture 32 to guide wire 20 . the wire 20 is small in diameter relative to the internal diameter of spring 28 to provide an annular fluid passage between the syringe 16 and balloon 18 . expansion of the balloon element out of the end of the catheter takes place in anisotropic fashion , with the balloon element first everting out of the catheter in advance of substantial lateral expansion , and then , after eversion , laterally expanding in response to the continued exertion of fluid pressure internally of the catheter . optimal dimensional data for the catheter and the balloon element are set forth in my co - pending application ser . no . 060 , 408 . while the invert - evert form of balloon is preferred , other types and forms of balloons may be used as long as they do not impede the movability of the catheters through the arteries and as long as they do not interfere with the use of the calibrator ovals to measure or calibrate the inside diameters of the arterial lumens .
a catheter is provided with an inflatable - deflatable balloon element to radially enlarge a partially occluded artery lumen and the catheter is provided with a calibrator oval to internally gauge the enlarged lumen .
turning now to the drawings wherein several preferred embodiments of the invention are shown , in fig1 , a conventional , well known agricultural cutting machine , which is a combine 20 , is shown including a header 22 . header 22 is shown supported in the conventional , well - known manner on a forward end 24 of combine 20 , and is operable for cutting or severing crops such as , but not limited to , small grains such as wheat and soybeans , and inducting the severed crops into a feeder 26 for conveyance into combine 20 for threshing and cleaning , in the well known manner , as combine 20 moves forwardly over a field , as denoted by arrow f . referring also to fig2 , which is a side view of header 22 , header 22 includes a pan or floor 28 which is supported in desired proximity to the surface of the field during the harvesting operation , and an elongate , sidewardly extending sickle 30 along a forward edge portion 32 of floor 28 , sickle 30 being operable for severing the crop for induction into header 22 , as will be explained . header 22 additionally includes an elongate , sidewardly extending reel 34 ( shown in outline form in fig1 ) disposed above sickle 30 and rotatable in a direction for facilitating induction of the severed crops into header 22 . an elongate , rotatable auger 36 ( also shown in outline form in fig1 ) that extends in close proximity to a top surface 38 of floor 28 and has helical flights therearound is operable in cooperation with reel 34 for conveying the severed crops toward an inlet opening of feeder 26 for induction into combine 20 , in the well - known manner . referring more particularly to fig1 , sickle 30 extends in a sideward direction along the width of floor 28 , between a first side edge portion 40 of the floor , and an opposite second side edge portion 42 . sickle 30 includes an elongate , sidewardly extending cutter bar assembly 44 supported in substantially longitudinally aligned relation adjacent to forward edge portion 32 of floor 28 , along the length thereof . referring also to fig3 , 4 and 5 , cutter bar assembly 44 includes a plurality of forwardly extending , elongate guards 46 arranged in a sidewardly extending , spaced apart array , along the forward edge portion of header 22 . each guard 46 is preferably of cast metal and includes a rearwardly located base 48 , which is suitably attached , here by a bolt 50 and a nut 52 , to a fixed bar 54 or other fixed structure of assembly 44 . here , it can be observed that guards 46 are provided in pairs connected together by a crossmember , although it should be understood that , alternatively , they could be provided individually , or connected together in a greater number , with equal utility for the purposes of the present invention . each guard 46 additionally includes a forwardly extending finger 56 attached to base 54 , finger 56 having a forwardly located forward tip 58 . each finger 56 includes oppositely facing side surfaces 60 and 62 which extend forwardly from adjacent base 48 to tip 58 , and which taper convergingly as they approach tip 58 . each finger 56 also includes an upwardly facing surface 64 which extends from base 48 to tip 58 . each finger 56 includes a slot 66 extending therethrough between side surfaces 60 and 62 , intermediate base 48 and tip 58 , slots 66 of the respective fingers 56 being aligned along the length of sickle 30 . referring more particularly to fig2 and 5 , cutter bar assembly 44 supports an elongate sickle knife 68 for reciprocating longitudinal movement within slots 66 , knife 68 including a row of knife sections 70 including oppositely facing , angularly related knife edges 72 which , in conjunction with site surface 60 or 62 of adjacent guards 50 , respectively , effect a shearing or cutting action which severs plant stems and stalks or other material captured between the knives and the guards as the knife sections are reciprocatingly moved sidewardly , as denoted by arrow a in fig5 . guards 46 will typically extend beyond sickle knife 68 by no more than 12 inches , as it may be desired under some conditions to have a capability to point the guards downwardly at a small acute angle to the ground , for instance , with the sickle close to the ground , for harvesting downed crops , without the guard tips entering the ground . it is also desirable for the guards to have a smooth streamlined shape , which is relatively narrow , so as to smoothly guide the crops into the spaces therebetween , for cutting . as noted above under the background art heading , as combine 20 is moved forwardly over a field containing crops , sickle knife 68 will be moved reciprocatingly sidewardly relative to guards 46 , to sever the crops which enter the spaces between guards 46 . knife edges 72 will capture and cut the stems or stalks of the crop plants against the side surface 60 or 62 of the adjacent guard , in an area denoted as a cutting zone 74 illustrated in relation to the leftmost guard 46 in fig5 . as a result of the cutting action , and particularly if the crop is dry and / or knife edges 72 are dull , and / or the side edge of the slot is worn and rounded , and also as a result of being batted by reel 34 , grain can be loosened from the crop plants , e . g ., pods shattered , such that the loose grain will fall onto sickle 30 , and onto any plant material thereon , so as to be in danger of falling to the ground and being lost . grain can also be shaken loose if the guards are large , or are not sufficiently streamlined for smooth crop flow therepast , or have obstructions that extend into the crop flow path , so as to shake or jar the crops as they are inducted into the sickle . this can be particularly problematic in drilled crops which lack defined rows and thus increase the possibility of guards 46 being propelled directly into plants during the cutting operation . referring more particularly to fig2 , loose soybeans 76 are depicted in the area above sickle 30 , as would be typically present during the harvesting of crops such as soybeans or other legumes , as well as other small grains . if not captured , at least some of loose grains 76 would typically be lost , for instance by falling through the spaces between knife sections 70 and guards 46 , or by falling forwardly over the front edge of the sickle . to avoid or reduce the occurrence of grain loss in the above described manner , an air discharge system 78 is incorporated into some and preferably all of guards 46 of sickle 30 , according to the present invention . air discharge system 78 includes at least one rearwardly facing air discharge nozzle 80 incorporated into upwardly facing surface 64 of each finger 56 , and an air flow passage 82 extending internally through each finger 56 from an air inlet 84 located adjacent to base 48 , to nozzle 80 , for delivering a flow of pressurized air thereto . the pressurized air is provided by a suitable source thereof , such as , but not limited to , an air pump or air compressor 86 disposed at a suitable location , such as on header 22 , and which is suitably powered , for instance , by a fluid motor , belt , shaft , chain , or the like , in the well - known manner . compressor 86 is connected to air inlets 84 , for delivering pressurized air thereto , via an air distribution system which will preferably include a main air manifold 88 extending sidewardly beneath floor 28 of header 22 , and including a plurality of nipples or small air distribution tubes 90 emanating therefrom at appropriately spaced locations therealong corresponding to the locations of air inlets 84 . smaller air distribution tubes 90 are shown extending from manifold 88 individually to air inlets 84 . alternatively , it should be recognized that a variety of different air distribution system configurations can be utilized according to the present invention . the configuration and location of air discharge nozzles 80 on surfaces 64 of respective fingers 56 can be varied according to the preferences and / or requirements for a particular application . generally , it will be an objective of the invention for nozzles 80 to be minimally if at all obstructive to crop and plant flow over and passed fingers 56 , such that little or no resultant additional jarring or disturbing of the plants passing over the nozzle occurs so as to result in additional loosening of grain from the plants . additionally according to the invention , an objective will be to generate rearwardly directed pressurized air flows that will be effective in blowing and directing loose grain on to floor 28 to capture the loose grain and prevent loss thereof . further according to the invention , it will be an objective to minimize susceptibility of plugging of nozzles 80 by plant material and the like . still further , it will be an objective when incorporating nozzles 80 and air flow passages 82 into fingers 56 , to maintain and not significantly degrade the structural integrity of the fingers , or to materially change the operability thereof . in accordance with the above objectives , several embodiments of nozzle configurations of the invention are illustrated in fig2 through 9 . referring more particularly to fig2 , 4 , 5 , and 7 through 9 , nozzles 80 are illustrated as rearwardly directed and recessed into upwardly facing surface 64 of fingers 56 . of these , nozzles 80 of fig2 , 4 , 5 and 8 are circular shaped , and nozzles 80 of fig8 and 9 are diamond shaped . this represents a range of acceptable nozzles and is thus not intended to be limiting . each nozzle 80 is also illustrated disposed at a forward end of a rearwardly extending recessed channel 92 , which , in cooperation with the nozzle configuration , facilitates and guides the pressurized air flow in a desired pattern , without significantly disrupting crop flow over upwardly facing surface 64 of the finger . however , it should be noted that other locations , including a more forward location , can be utilized according to the invention . referring more particularly to fig2 , the pressurized air flow , denoted by arrows 94 , is illustrated as flowing along a relatively low , rearwardly directed trajectory over sickle 30 and forward edge portion 32 of floor 28 . referring in particular also to fig5 , fig5 and 6 , air flow 94 is also illustrated from the side in fig8 . here , it should be recognized that the configuration , including , but not limited to , size , shape , and angular orientation , of nozzles 80 can be determined for a particular application , as can the configuration , e . g ., size , shape and angular orientation of the channel 92 if used . fig5 illustrates possible air flow patterns that can be achieved with the nozzles of the invention , including a narrower pattern that generally extends over the base region of the guard in which the nozzle is located , as defined by lines 96 emanating from the respective nozzles , and a wider fan shape pattern that extends over a greater portion of the sickle knives also , as defined generally be lines 98 . referring in particular to fig3 , a nozzle 80 which is substantially flush with surface 64 is shown , the nozzle having a generally oval or tear drop sectional shape when viewed from above . again , this illustrates the variety of nozzle configurations that can be used according to the invention . referring more particularly to fig6 , still another nozzle configuration is illustrated , which is a multiple nozzle arrangement including an array of three nozzles 80 disposed in surface 64 , facing in slightly offset directions , and configured to discharge streams of pressurized air in a wide ranging fan pattern , illustrated again by lines 98 emanating from each of the nozzles . here , it should be noted that the number of nozzles , positions , and orientations , on a finger can be varied , as desired or required for a particular application . in the fore and aft direction , nozzles 80 are preferably disposed so as to most advantageously direct the pressurized air for recovering or protecting from the loss of loose grain , without degrading the integrity and strength of the fingers . in the embodiments shown , nozzles 80 are generally located above a forward region of slot 66 through which the sickle knife reciprocates . to achieve this location , air flow passage 82 has a generally v shape , including a lower portion 100 which is routed forwardly through the finger below slot 66 , and an upper portion 102 which connects with lower portion 100 and extends rearwardly therefrom to the nozzle , or nozzles , as variously shown in the figs . air flow passage 82 can be cast in place in the finger . essentially , the fore and aft location selected here has been found to be advantageous as it places the nozzles close to the cutting zone where the largest portion of the loose grain has been typically found to be present , such that the air will be at its greatest pressure where the grain is found , and will be less likely to be dissipated by intervening plant material such as leaves , stems and the like which will be passing through the cutting zone also . it will be understood that changes in the details , materials , steps , and arrangements of parts which have been described and illustrated to explain the nature of the invention will occur to and may be made by those skilled in the art upon a reading of this disclosure within the principles and scope of the invention . the foregoing description illustrates the preferred embodiment of the invention ; however , concepts , as based upon the description , may be employed in other embodiments without departing from the scope of the invention . accordingly , the following claims are intended to protect the invention broadly as well as in the specific form shown .
a guard for a sickle of an agricultural plant cutting machine includes a forwardly extending finger including a longitudinally extending , upwardly facing surface extending over the sickle , which includes a rearwardly facing air discharge nozzle therein located above and / or forwardly of the sickle , and the finger includes an air flow passage extending internally therethrough from an air inlet adjacent to a base of the finger to the nozzle , for delivering a flow of pressurized air thereto , the nozzle being at least mostly flush with or recessed into the upwardly facing surface . as a result , the nozzle is operable for discharging the flow of air rearwardly over the finger without obstructing plant material flow thereover , the air flow being sufficient to blow at least a substantial amount of loose grain and other plant material located forwardly of the front edge of a header floor of the machine , onto the floor for collection by a conveyor of the header for processing .
referring now to the drawings , and particularly to fig1 a two - level storage and display rack , adapted for mounting on a store counter , is shown generally at 10 . the storage rack shown in fig1 has only two tiers , but more tiers may be provided using vertical spacers , as shown in fig3 and 5 , to space the additional tiers apart . each shelf , or tier , of the two - tiered display rack example of fig1 may be provided of a size , to have supported thereon , the goods - containing portion of a box of counter goods , such as chocolate bars , chewing gum , or other goods that the store keeper may be offering for sale . a five - tiered rack , using structural elements as disclosed hereinafter , has been constructed and has been demonstrated to be of stable construction . the horizontally elongated shelf of the lowermost tier of display rack 10 is generally indicated by numeral 12 , with an upper , second , horizontally elongated tier shelf 14 spaced above said lowermost tier shelf 12 . each of the tier shelves 12 and 14 has associated , elongated , edge rails that are similarly constructed , so that a detailed description of the edge rail elements , and other features of construction of the lower tier shelf 12 will operate to provide a description of similar elements shown associated with the second tier shelf 14 . some elements , such as the specific vertical , columnar , side spacers 16 , that are positioned to extend between side rails associated with the two shelves 12 and 14 are shown assembled only in fig1 - 3 , in position on vertically aligned side rails to serve as a spacer and a support . the exploded view of fig5 illustrates how these vertical spacers may be used either above or below a tier that includes one horizontal tier shelf for supporting another tier shelf , and these spacers may , for example , be used below the tier shelf 12 shown in fig5 or between a pair of tier shelves 12 and 14 , to serve to either support the lowermost tier above a counter , or to space a next higher tier above a next lower tier . in the specific illustrations in the figures , the lower tier includes a flat , planar , horizontal support shelf member 12 . the forwardmost end of shelf member 12 is provided with a transverse abutment wall 20 that lies in a plane transverse to the plane of shelf member 12 , and is secured to shelf member 18 by any means , such as by being glued or melded thereto . the portion of the transverse , forward abutment wall 20 that extends above the upper surface of shelf 12 , is positioned to serve as an abutment against which a wall of a body , or box , that is supported on shelf 12 may abut . the rear end of the storage and display rack 10 , that is opposite forward wall 20 , is open , so that an attendant may easily withdraw an empty box supported on the shelf 12 , and insert onto the shelf 12 , from rearwardly of the rack 10 , a fresh , or replacement , box with goods therein . the lower tier shelf 12 is provided , along each of its longitudinal edges , with associated , elongated , upper and lower rail members , respectively 22 and 24 , whose assembled structural portions are best seen in fig1 - 4 , and whose overall shape may be seen in perspective in fig5 . an upper rail member 22 , located adjacent to the left edge of shelf member 12 , as viewed in fig1 and 3 , includes an elongated , upper side rail , or body , that is provided with an elongated upwardly - opening groove means 25 in the upper edge of rail member 22 that is bounded by spaced , upright , inner and outer , longitudinal side walls , 28 and 30 , that are spaced by transverse end walls 32 and 33 . the upper side rail along the right hand longitudinal edge of shelf 12 is of similar construction and is designated 22 &# 39 ;, and with the parts thereof using the same identifying numeral with a prime (&# 39 ;) mark . as seen in fig3 when a shelf , such as shelf 12 , and its side rails are assembled , only a portion of the total height of upper rails 22 and 22 &# 39 ; extend above the upper surface of shelf 12 . the lower rails 24 and 24 &# 39 ; each are of mirror image construction relative to its adjacent upper side rails 22 and 22 &# 39 ;. but while upper rails 22 and 22 &# 39 ; have only portions thereof located vertically above the plane of adjacent shelf 12 , the lower edge rails 24 and 24 &# 39 ; have all portions thereof located below the plane of shelf 12 . the lower edge rails 24 and 24 &# 39 ; each also include a downwardly opening elongated recess or groove 27 that is located in a mirror - image relation to the similar structures provided in upper rails 22 and 22 &# 39 ;, but as seen in fig3 all portions of lower side rails 24 and 24 &# 39 ; are located below the plane in which shelf 18 is located . one purpose of having a pair of laterally spaced upper rails 22 located adjacent the two longitudinal edges of shelf 12 is to provide a pair of longitudinal elements that may be moved toward or away from each other to engage , or accommodate , the width of the box that rests on shelf 12 , where the box is at least as wide as , or or wider than , the shelf 12 . if the width of a rectangular box on shelf 12 is less than the width of shelf 12 , then , at most , only one side wall of the box might be engaged by the innermost side of one of the two upper rails 22 or 22 &# 39 ;. since each of the two upper rails 22 and 22 &# 39 ; are mirror images of each other , the similar elements on rail 22 &# 39 ; carry the same identifying numeral as appears on rail 22 , but with a prime mark (&# 39 ;) added . it will now be seen , from fig1 and 5 together , that the upper and lower rail members adjacent the side edges of shelf 12 have an exterior shape that is essentially the same . it will be understood that , if desired or necessary , the rail members themselves may be provided with selected interior shapes and walls for receiving and cooperating with spacer members of different size as may be necessary , or desired . however , for purposes of the description herein , it is to be understood that all rail members will be fundamentally of the same shape and size , except as may be needed to provide a modification . fig1 and 3 illustrate how a pair of upper , side rail members , 22 and 22 &# 39 ;, are each assembled alongside the two longitudinal edges of both lower shelf 12 and upper shelf 14 . the underside of each shelf , 12 and 14 , includes the same structure as shown on the underside of shelf 22 in the exploded perspective view of fig5 . thus , the underside of each tier shelf , 12 and 14 , is provided with two pairs of spaced angle sections 26a and 26b that are secured , or otherwise adhered to , or melded with , the undersurface of said shelves to make an integral structure adjacent each of the two lateral edges of the shelf . also , and so that shelf 12 will not tilt , or slope , from front to back , the rear end of shelf 12 is provided with a rail 20 &# 39 ;, seen in exploded fig5 which extends below shelf 12 the same distance that the lower portion 20a , of transverse abutment wall 20 , extends below shelf 12 . as best seen in fig5 a shelf , such as either the planar support shelf 12 or 14 , has affixed to the underside thereof , such as by gluing , or melding , two sets of socket angle sections , 26a and 26b , that lie respectively adjacent the lateral shelf edges 12a and 12b . although aligned sets of separated socket angle sections 26a and 26b are shown , elongated angle - shaped sections , of the cross - section seen in fig4 could be used instead , and then the end portions of said elongated sections would be the equivalent of the structures shown . the said socket angle sections , together with the underside of the shelf 12 to which the socket angle sections attach , provide generally socket - like , or generally rectangular , tubular - like , sockets , or tongue - holding means , indicated at 26c , for slidably receiving thereinto , or therethrough , lateral extensions , or tongues , 22a and 22b , that extend from an upper rail 22 . the same sockets , or tongue - holding means , also receive lateral extensions 24a and 24b that extend from a lower rail 24 , as is seen in fig3 . as best seen in fig3 when a shelf 12 or 14 has its rails 22 or 24 assembled thereon , the socket angle sections 26a and 26b are of a size and spacing from the underside of the associated shelf 12 , so that the two adjacent tongues , 22a and 24a , or 22 &# 39 ; a and 24 &# 39 ; a , of the two rails 22 and 24 are held by the tongue - holding means against the undersurface of a planar support , such as 12 or 14 , in each socket space 26c provided between spaced , angled , flange sections 26a and 26b . the cross - sectional view of fig3 shows the upper rails 22 and 22 &# 39 ;, when moved to their closest spacing , which is controlled or dictated , by the fact that upper rails 22 and 22 &# 39 ;, as seen in fig1 and 3 , abut opposite lateral edges of shelf 12 , with rail 22 abutting shelf edge 12a while rail 22 &# 39 ; abuts an opposite shelf edge 12b , as seen in fig3 . the lower rails 24 and 24 &# 39 ; are not so constrained , but lower rails 24 and 24 &# 39 ;, are preferably to be selectively moved into a position of vertical alignment with a set of upper rails 22 and 22 &# 39 ;, as best seen in fig1 . alternatively , lower rails 24 and 24 &# 39 ;, may be selectively moved laterally inwardly until said rails abut the edges of angle flange sections 26a and 26b , or may be moved laterally outwardly of the position shown in fig3 provided that some portion of tongues 24a and 24 &# 39 ; a are not moved outwardly to a position where all portions of tongues 24a and 24 &# 39 ; a escape the tongue holding means provided by socket angle sections 26a and / or 26b . considering the structure shown in fig3 the lower rails , 24 and 24 &# 39 ;, could be moved inwardly toward each other until an innermost portion of those rails abut an edge of the socket angle sections 26a and 26b . referring now to the manner of effecting selective vertical spacing between the support shelves 12 and 14 , or between shelf 12 and the top of a counter upon which the tiered display of fig1 is supported , or between upper shelf 14 and a third shelf thereabove , the means for effecting such spacing utilizes the fact that each rail member 22 , 24 , 22 &# 39 ; and 24 &# 39 ; is provided with an interior groove means , such as the upwardly opening groove means 26 of rail 22 , that is bounded longitudinally , such as by side walls 28 and 30 as described above , and as seen in fig1 - 3 and 5 . more specifically , the groove means 26 does not provide a continuous slot along the length of its rail . instead , each rail , such as rail 22 seen in fig2 and 4 , and rail 24 as seen in fig3 and 5 , includes , in the groove means for the rail , one or more transverse ribs such as 40 and 42 , that are clearly shown in fig2 . to cooperate with such groove means and its transverse ribs 40 and / or 42 , there are provided vertical spacers , or columnar spacer means , in the form of planar , spacer plates 16 , referred to earlier above . these planar spacer plates 16 are of a thickness to slidably fit into the longitundinal space between spaced side walls 28 and 30 of a rail member 22 or 24 . within the longitundinal space between the spaced side walls 28 and 30 of the rail member , there are provided one or more transverse ribs 40 and 42 as seen in fig2 . the shape of spacer plates 16 are most clearly seen in fig1 and 5 . spacer plates 16 are rectangular in elevation as seen in fig5 with their length edges 46 being greater than their height edges 48 . as will appear from the following description , the rectangular spacer plates provide for two alternative spacings between shelves 12 and 14 . a pair of opposed notches , 44 , extending from the length edges of spacer plate 16 , are provided in alignment with each other and extend toward each other from the long edges 46 of the rectangular plate 16 . the length of the short edges 48 and 48 &# 39 ; of plate 16 provides an effective measure of one spacing between an aligned upper rail 22 , associated with lower shelf 12 , and a lower rail 24 , associated with upper shelf 14 , spaced thereabove as seen in fig1 . the notches 44 are of a size and shape to permit a spacer plate 16 to fit over a transverse rib 40 or 42 , here shown , in fig2 to be rectangular in cross section . the spacing of notch 44 from the distal short edge 48 &# 39 ; is selected so that when a notch 44 receives therein a rib 40 , as seen in fig2 the distal short edge 48 &# 39 ; of plate 16 will slide against , and engage the closest edge 42 &# 39 ; of rib 42 , as shown in fig2 . similar ribs provided in an opposite rail member , such as rail members 24 or 24 &# 39 ; ( seen in fig5 ) permits the spacer plate to provide for firm engagement and interconnection between a pair of oppositely facing rail members , such as between one lower rail 22 and an opposed upper rail 24 , as seen in fig1 . if a greater spacing is desired between a pair of shelves 12 and 14 , the spacer plates 16 are to be rotated ninety degrees ( 90 °) from their length position seen in fig1 to a width position where edges 48 and 48 &# 39 ; take the positions shown for long edges 46 as seen in fig5 . the length of edges 48 and 48 &# 39 ; are selected so that long edges 46 of a spacer plate 16 will slidingly fit between ribs 40 and 42 . in this latter arrangement , since a shorter edge of spacer plate 16 is captured in a groove , the spacing between a pair of spaced shelves 12 and 14 will be greater . the spacer plates may also be used as a pair of free legs to support lower rail members 24 and 24 &# 39 ; upon the surface of a flat counter , as suggested by the lower truncated spacer plates shown extending downwardly in fig3 . by inclining , or beveling the lower edges , of a pair of laterally spaced support legs extending downwardly from lower rail members 24 and 24 &# 39 ;, the tiered display stand may be converted to a stand wherein the goods supported thereon are displayed at an inclined attitude , with the goods on a shelf , such as shelf 12 , engaging the upper front flange 20 located at the forward end of a support shelf plate 12 or 14 . the material used in making the various parts shown in the figures of the drawings are a transparent plastic , thereby creating a tiered display stand that is eye - catching and attractive , while at the same time providing the rigidity and strength needed to serve the purpose as a display stand . the nature of the plastic material permits ease in forming and assembly , yet provides for inexpensiveness of construction and strength for the intended purposes . while a particular embodiment of this invention has been shown and described , it will be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the spirit and scope of the invention and , therefore , it is intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention .
a variable width tiered display stand , which may be supplied in knocked - down condition , and which may be readily assembled at the site of use , is disclosed . the stand provides multiple tiers , each adapted for support of a box of boxed goods thereon , to provide an attractive means for display , and offer , of goods to prospective customers , while permitting the shopkeeper to easily withdraw empty boxes of goods from the tiers and to insert fresh boxed goods on the tiers as may be required or desired . the stands are preferably made of transparent plastic parts which may be easily fit together , and which do not require additional fastener means for keeping the tiered display stand assembled .
as shown in the drawing fig1 - 70 , the present invention is directed to a mission - adaptable set of components forming a convertible cart / utility table . for example , the present invention may include foldable cart 1 , having a load support for carrying a load , such as a boat , such as a canoe , which can also function as a game cart or a wagon for carrying gear in outdoor field applications . fig1 shows cart 1 in a disassembled storage position with a pair of horizontal load support members 10 laid parallel adjacent to each other , supporting wheels 30 thereon . wheels 30 are secured in place by a transverse connecting rod 31 through wheel hubs 30 a and by one or more load securing straps 50 . disassembled storage cart 1 is inserted within carry bag 120 , which includes ledge 121 and fabric loops 122 for holding bracket members 60 , 70 and handle 80 outside of carry bag 120 . to transport portable cart 1 by hand carry straps 124 are attached to carry bag 120 . conversely as shown in fig2 , to transport portable cart 1 upon the back of a user , carry straps 124 are attached to carry bag 120 , which supports portable cart 1 in a weight bearing manner , or else horizontal support members 10 are inverted to support portable cart 1 in a weight bearing manner , and carry bag 120 covers portable cart 1 in a non - weight bearing manner . to be disassembled in a carry position , u - shaped bracket rails 60 , 70 , wheels 30 and axle members 32 are inversely attached to horizontal load supports 10 to comprise a folded manually transportable cart . as shown in the exploded view of fig3 , in the storage position , in a preferred embodiment , cart 1 includes a pair of parallel , spaced apart inverted horizontal load support members 10 . support members 10 each have a front - end 10 a and a rear end 10 b . the front and rear ends 10 a , 10 b each have at least one axially placed receptacle aperture 12 extending longitudinally within each load support member 10 , for holding structural components therethrough in a storage position , such as axle members 32 for wheels 30 . in this storage position , axle members 32 are also inserted within aperture of 33 of axle connector 34 . fig3 also shows horizontal load support members 10 having preferably a generally upside down u - shaped configuration when viewed in cross - section , wherein a generally flat member 10 c has downwardly extending flanges 10 d , 10 e including one or more linearly extending slots 10 f for insertion of holding straps 50 therein . although apertures 12 are shown in the drawings , it is contemplated that other configurations may be applicable to horizontal load support members 10 , so long as other members , such as rails 60 , 70 and so forth , may be attached thereto by fasteners , preferably in an axis parallel to the axis of horizontal support members 10 . while size may vary , support member 10 is preferably sixteen ( 16 ) inches long and two and a quarter ( 2 . 25 ) inches wide . each flange 10 d , 10 e extends down about one ( 1 ) inch from flat member 10 c . slots 10 f are preferably 2 . 125 inches wide and 0 . 1875 inches high , to accommodate straps 50 , such as , for example , standard 2 - inch wide fabric straps . fig3 also shows vertical struts 20 optionally having at least one small hole 22 , such as kickstand receptacle aperture 22 , for insertion of optional kickstand 40 therein . fig3 also shows horizontal load support members 10 being respectively demountably attached to a pair of vertical struts 20 , having apertures 21 and 22 . in one embodiment , horizontal load support members 10 can be demountably attached to vertical struts 20 , but in an alternate embodiment they can be permanently affixed to each other , such as in the alternate embodiments shown in fig3 a and 3b . moreover , while preferably horizontal struts are u - shaped , as in fig3 , in alternate embodiments other configurations can be used , as long as vertical strut 20 can be attached to horizontal support member 10 . for example , in fig3 a vertical strut 20 ′ is in a unified t - shaped member with horizontal support member 10 ′. in fig3 b , vertical struts 20 ′ and horizontal support members 10 ′ are attached by weldment 20 ″. in fig3 c , vertical strut 20 ′ is inserted in hole 10 ″ of horizontal support member 10 ′, and attached by fastener 10 ′″, such as a screw or other fastener . in these alternate embodiments shown in fig3 a , 3 b or 3 c , horizontal load support members 10 ′ may be solid in cross sectional configuration . one such configuration shown in fig3 a , 3 b and 3 c is that of a parallelepiped , namely a solid form , all of whose sides are parallelograms , such as rectangles , and whose opposite sides are parallel to one another . in another embodiment vertical strut 20 may be adjustable in length with a sleeve containing a telescopic shaft ( not shown ) and with a spring urging the shaft in and out of the sleeve , with a lock provided . kickstand 40 is secured in place by a fastener , such as nylon set screw 37 . setscrews 37 also hold axle members 32 in the storage position through vertical struts 20 . vertical struts 20 are preferably made from 1½ × 2 - inch solid bar stock anodized aluminum , or stainless steel . vertical struts 20 are preferably about 10 . 25 inches long , 2 inches wide and 1½ inches in depth . also shown in fig3 , the plurality of optional larger holes 21 , such as holes , which are 0 . 765 or 1 . 625 inches in diameter , are located on a front side of vertical strut 20 . smaller hole 22 on the bottom accommodates kickstand 40 , which is preferably a hollow aluminum tube of 0 . 75 - inch diameter and 16 inches in length . optional larger holes 21 within vertical strut 20 are provided for weight reduction of portable cart 1 . on a side 23 transverse to the front 24 of each vertical strut 20 , at a lower portion 20 a thereof , is provided a further hole 25 of about 1 - inch in diameter for insertion of each axle member 32 therethrough . hole 25 has a permanently affixed , bushing 26 therein , such as a pvc ( polyvinyl chloride ) bushing , to prevent wear and tear of each aluminum axle member 32 by the aluminum surface of hole 25 . as also shown in fig3 , 4 and 6 , each wheel 30 is demountably attached at an end , respectively , to a pair of axle members 32 , with axle members 32 extending inwardly from and demountably attached to lower portion 20 a of the respective vertical struts 20 , wherein axle members 32 are in a transverse relationship to horizontal load support members 10 . fasteners , 36 , such as cotter pins , hold each wheel 30 upon each axle 32 . each axle member 32 is received within each hole 25 , of each lower portion 20 a of each vertical strut 20 . a compression groove 27 exists from the underside of vertical strut 20 to hole 25 and continues to further through hole 27 a , providing for compression of lower portion 20 a of vertical strut 20 . to accommodate narrow or wider cargo , such as watercraft of varying widths , the distance between vertical struts 20 can be varied along the axle length by loosening and tightening the tightening member 28 and moving vertical struts 20 laterally apart or towards each other along axle members 32 . although optionally a one - piece axle may be used ( not shown ), preferably the pair of axle members 32 are held in opposite axial orientation by straight rigid axle connector 34 . axle connector 34 has tightening member 35 , and a pair of receptacles 33 at the respective two ends of axle connector 34 , so that axle members 32 respectively extend outwardly from , and are demountably attached within , the axle connector receptacle bore 33 . while the axle may be optionally a one - piece axle , such as shown as reference numeral 606 in fig3 herein , preferably the pair of connected oppositely extending axle members 32 form together an axle for wheels 30 . each axle member 32 is made of solid round stock of anodized aluminum or stainless steel , approximately 0 . 75 inches in diameter . at the wheel - supporting end 32 a , the diameter is about 0 . 59 inches in diameter with shoulders 32 b of about 0 . 08 inches in height , transverse to the axis of axle member 32 . these shoulders 32 b provide a resting surface to prevent axial movement of wheel 30 upon axle member 32 . as shown in fig7 , each wheel 30 rotates about press fit bearings 32 b , while each wheel 30 is positioned upon each respective axle member 32 of fig8 . as shown in fig6 , at the opposite end of one axle member 32 , there is provided a hollow , threaded recess 32 c of about 0 . 75 inches deep , to accommodate a connecting threaded member 32 d of other axle member 32 , to axially connect both axle members 32 together within axle connector 34 , with a wheel 30 at each end . fig8 and 9 show how axle connector 34 is compensated along groove 38 , thereby locking axle members 32 within bushing 39 , which is within receptacle bore 33 of axle connector 34 , by tightening of tightening bolt 35 a of tightening member 35 . preferably bushing 39 is a pvc ( polyvinyl chloride ) bushing . groove 38 is preferably 1 / 16 to ⅛ inch , in width , which allows for the compression of axle connector 34 around axle members 32 . tightening bolt 35 a is inserted within a conventional receptacle which is a through hole at the proximal end and which is tapped with threaded grooves at the distal end , to allow for compression of axle connector 34 . fig4 and 6 also show at least one kickstand 40 , preferably a pair , respectively extending horizontally rearward from each lower portion of vertical struts 20 . each kickstand member 40 extends rearwardly from the at least one kickstand receptacle aperture 22 of respective vertical struts 20 and each kickstand 40 is demountably attached within each respective kickstand receptacle aperture 22 . each kickstand member 40 is preferably contoured so as to contact the ground to stabilize portable cart 1 is a parked position of rest . as shown in fig5 , to hold a canoe , game or cargo in place upon cart 1 , one or more adjustable load - securing straps 50 are slidably attached to both respective horizontal load supports 10 in a transverse relationship to load supports 10 . straps 50 are preferably reinforced flexible canvas straps of about 2 inches in width . to complete portable cart 1 as a canoe or boat cart , fig4 shows support cushions 13 mounted upon respective horizontal load supports 10 . support cushions 13 are flexible , such as of rubber or foam , to support the weight of boat 2 thereon . fig1 and 11 show the precision balancing of boat 2 upon cart 1 , wherein the placement of boat 2 upon cart 1 causes cart 1 to rotate from a position of rest in fig1 to a horizontal load position of fig1 , in the direction of the arrow . fig1 - 17 show another embodiment that converts portable cart 1 into a game cart . alternatively , fig1 - 20 show how to convert cart 1 into a cargo wagon with a hollow well . first , in either situation , carry frame 55 is secured to horizontal load supports 10 . although a one piece , generally rectangular frame ( not shown ) may be used , preferably frame 55 includes a pair of u - shaped brackets 60 , 70 joinable together to form frame 55 . various fasteners may be provided to horizontal load supports 10 to carry objects , such as carriers , thereon . alternatively , for example , a clamp maybe provided to horizontal load supports 10 to carry a frame of a discrete transportable carrier directly thereon , as disclosed hereinafter with respect to fig2 - 24 . in that case , instead of the frame being integrally part of the portable chart , as in fig1 - 17 , in fig2 - 24 , the frame is clamped to the horizontal load supports 10 of portable cart 1 . other fasteners may include longitudinally extending channel slots , such as in fig3 - 39 described further below . meanwhile , further with respect to fig1 - 17 , u - shaped front bracket 60 extends horizontally forward from front - end receptacle apertures 12 of horizontal load supports 10 , wherein front bracket 60 is demountably attached within front - end receptacle apertures 12 at one end of horizontal load supports 10 . u - shaped rear bracket 70 extends horizontally rearward from oppositely positioned rear end receptacle apertures 12 of horizontal load supports 10 and rear bracket 70 is demountably attached within each oppositely positioned rear end receptacle aperture 12 of horizontal load supports 10 . fig1 shows how frame 55 is secured to cart 1 . each distal end of u - shaped front bracket 60 is inserted through apertures in respective ends 10 b of horizontal supports 10 until each distal end engages a corresponding hole in each vertical support 20 , where they are held in place by pins 29 . pins 29 engage lateral holes 18 in horizontal supports 10 and corresponding through holes 19 in distal ends of u shaped brackets 60 . likewise , each distal end of u - shaped rear bracket 70 is inserted through apertures in respective ends 10 a of horizontal supports 10 until each distal end engages a corresponding hole in each vertical support 20 , where it is also held in place by a pin 29 . pins 29 engage lateral holes 18 in horizontal supports 10 and corresponding through holes 19 in distal ends of u shaped brackets 60 , 70 of frame 55 . u - shaped brackets 60 , 70 are preferably of hollow , anodized aluminum tubing of about 0 . 75 inches in diameter . the length of each distally extending side member thereof is about 23 . 50 inches and the width of the cross bar connecting the distal side members is about 21 . 63 inches . about 0 . 75 inches from each distal end is a scoring , to accommodate a clamp thereon , to form frame 55 . as shown in fig1 and 15 for pulling or pushing game or cargo upon portable cart 1 , handle 80 extends rearwardly at an upward angle from joints 71 of either u - shaped rear bracket 70 for pushing portable cart 1 , or from front u - shaped bracket 60 for pulling portable cart 1 ( not shown ). furthermore , handle 80 may be permanently attached to either u - shaped bracket 60 or 70 , or handle 80 may be removable and demountably attached to either front u - shaped bracket 60 or rear u - shaped bracket 70 . handle 80 has preferably two aluminum tubing connecting members about 22 . 5 inches in length , connected by a hand accommodating transverse bar of solid aluminum , and is 17 . 5 inches in width . handle 80 includes connectors 81 , having distal sleeves , such as pvc ( polyvinyl chloride ) sleeves 82 , permanently affixed thereto , which are insertable within joints 71 by locking member 72 , having threaded member 72 a which passes through bore 71 a of joint 71 and bore 81 a of handle 80 . compression groove 73 exists in joint 71 , providing compression of joint 71 . handle 80 may optionally have an auxiliary extension member and clamp ( not shown ), so that it can be attached to the rear frame of a bicycle ( not shown ), to pull portable cart 1 . to carry game 3 , as shown in fig1 , or to carry an injured person in a rescue operation , fig1 shows portable cart 1 having fabric stretcher 100 stretched tautly between horizontal load members 10 and preferably mounted over and around front and rear u - shaped brackets 60 and 70 of frame 55 , by threading brackets 60 , 70 through fasteners such as sewn - in loops 102 of fabric stretcher 100 , which may alternatively be made of plastic or other taut load bearing material . other types of fasteners can be used . for example , fig1 shows that loop 102 a is openable , and closed by fastener , such as zipper fastener 102 b . as also shown in fig1 , handle 80 may include a pair of posts extending obliquely off of a horizontal axis of portable cart 1 , wherein a head rest cushion 85 extends between the posts to support the head and neck of an injured person being transported upon stretcher 100 . fig1 - 20 show that to carry cargo , hollow fabric cargo well 110 is attached in the same manner to frame 55 . hollow cargo well 110 may also alternatively be made of plastic or other taut load bearing material , and covered by cover 112 . fig1 and 19 also show wider wheels 130 for use on sand or granular terrain . the various embodiments of the mission adaptable multiple - purpose portable cart / utility table can be quickly and easily assembled and disassembled . for example , for making a canoe cart from the disassembled portable cart 1 , wheel - retaining members , such as cotter pins 36 , are taken out of axle members 32 in their stored position , and wheels 30 come out . axle members 32 are then removed from between vertical struts 20 . the axle members 32 are then clamped in a horizontal use position into receptacles 33 of rigid axle connector 34 . axle members are inserted between vertical struts 20 and locked in place . wheels 30 are placed upon axle members 32 and secured by cotter pins 36 . kickstand 40 is loosened from its rest position and placed in place in receptacles within vertical struts 20 . canoe supporting cushions 13 are installed upon horizontal load supports 10 to support a canoe or boat thereupon . straps 50 hold the canoe or boat installed upon cushions 13 in a secure transportable position . to convert portable cart 1 into a game cart as in fig1 or a rescue cart as in fig1 , kickstands 40 are removed and fabric stretcher 100 is installed on u - shaped frame members 60 , 70 of frame 55 frames by fasteners such as sewn loops 102 thereof . u - shaped frame members 60 , 70 are placed on horizontal load supports 10 , and kickstand members 40 are installed as braces for fabric stretcher 100 . straps 50 are then installed to securely hold game or an injured party upon stretcher 100 . then handle 80 is installed upon u - shaped bracket 60 or 70 of frame 55 to pull or push portable cart 1 . to convert portable cart 1 into a wagon to haul cargo , as in fig1 and 19 , fabric stretcher 100 is removed and hollow well 110 is installed over u - shaped members 60 , 70 of frame 55 . to make the portable chart 1 portable again , the components are disassembled in reverse into bag 120 . strap or straps 50 are used as a carry handle or for backpack shoulder loops . while the rescue stretcher shown in fig1 has its own customized stretcher 100 , in another embodiment shown in fig2 - 24 , to convert portable cart 1 to a retrofit disabled person - bearing transportable carrier cart for search and rescue operations , using conventional railed stretcher 230 , support cushions 13 are removable from horizontal load supports 10 and replaced by clamping assembly 200 . clamping assembly 200 includes lower jaw 202 , and upper jaw 204 . while different jaw configurations can be used , the embodiment shown in fig2 - 24 shows each having longitudinally extending recesses 206 and 208 therein to grip perimeter frame rails of a load supporting transportable carrier , such as conventional railed stretcher 230 therebetween , as shown in fig2 . lower jaw 202 of clamping assembly 200 includes an engaging surface 210 with threaded studs 212 which are inserted into through - holes 214 of load supports 10 , and permanently locked with nuts 216 . upper jaw 204 is provided with a pair of oblong through - slots , 218 , to allow upper jaw 204 to slide on upper surface of lower jaw 202 , when threaded t - handles 220 are loosened . as shown by the arrows in fig2 this sliding action allows for quick removal of any stretcher frame rail secured between jaw assembly 200 . fig2 and 24 are perspective views of a typical stretcher 230 , and a stokes - type rescue basket 240 , securely clamped to portable cart 1 utilizing the previously described clamping assembly 200 . as shown in fig2 in this embodiment , instead of being permanently attached to each horizontal load support 10 , removable support cushion 13 is permanently attached to removable plate 302 with an adhesive 304 . this cushion assembly is removably attachable by nuts 316 and threaded studs 312 , to each horizontal load support 10 . fig2 illustrates portable cart 1 , outfitted with a plurality of racking assemblies 400 , each comprising a rail clamp 410 , an upstanding post 424 , and a hanger clamp 430 . rack assembly 400 , when used in conjunction with additional rack assemblies 400 , allows for transportation and quick removal of essential hunting gear such as a chair stand 440 , archery equipment 441 , and rifle 442 . other related items such as knapsacks and bedrolls may be supported by rack assembly 400 , as well . rack assembly 400 is easily disassembled from cart 1 upon reaching a chosen destination , and the components are conveniently transported within cart 1 &# 39 ; s storage backpack , such as carry bag 120 shown in fig1 . also illustrated in fig2 are stabilizing assemblies 450 and 460 . assembly 450 makes use of post 420 , which is friction - fit into an inverted rail clamp 410 . assembly 460 comprises an inverted tubular sleeve 462 , optionally permanently welded to the handle assembly crosspiece . sleeve 462 accepts kickstand post 424 in a similar fashion to rail clamp 410 . these assemblies 450 460 serve to brace the cart 1 when it is parked . moreover , kickstand post 424 may be used with any embodiment having a handle , such as handle 80 of fig1 and 17 - 19 , or handle 81 of fig3 and 33 . turning to fig2 , which is highlighted in fig2 , an exploded perspective close - up detail view of rail clamp 410 is presented . clamping block 411 is provided with a bore 412 to receive post 424 , an attachment face 413 including a semi bore 414 , and notch 415 , and threaded bore 416 . plate 417 includes semi bore 418 , through hole 419 , and protruding rib 420 . as shown in fig2 , when threaded knob 422 is inserted into hole 419 of plate 417 and tightened into threaded bore 416 of block 411 , clamping is achieved against frame member 60 . rib 420 is secured within notch 415 by a camming action in the direction of arrow “ a ”. fig2 shows cantilevered hanger clamp 430 , poised to slide down upstanding post 424 . hanger clamp 430 is provided with a bore 431 , which is notched in a similar manner to clamping receptacles 71 of the handle assembly . the notch separates the body of hanger clamp 430 into two walls . threaded knob 422 will compress the walls surrounding the notch , thereby tightening bore 431 around post 424 . l - shaped region 432 is integrally formed with the body of the hanger clamp , and provides a strong and durable support for transporting hunting or other gear . fig3 is a perspective view of an anti - tipping linkage 500 , which couples cart 1 to a bicycle . linkage 500 counteracts cart rollover caused by centrifugal force as the bicycle negotiates turns . fig3 illustrates the components of linkage 500 . bicycle seat - stem compression clamp 510 is formed of a body portion 511 , and plate 512 , fastened by screws 513 . bore 514 is angled so that clamp 510 remains perpendicular when installed on a typical bicycle seat - stem . clamp 510 is provided with a bore 515 on rear face 516 , which accepts a shaft 520 . pin 517 passes through clamp and fixes shaft 520 via a through - bore . shaft 520 includes through - bore 522 at its distal end . another through - bore 523 is provided slightly proximal of aperture 522 . when shaft 520 is inserted into coil spring 530 , hooked leg 531 of the spring will fit into bore 522 . a sliding collar 524 will then extend over leg 531 to prevent pull - out , and a pin 526 will be fitted into collar hole 525 , and into bore 523 of the shaft 520 , thereby securing the collar to the shaft and preventing removal of the coil spring . a shaft 540 is provided for the opposite end of coil spring 530 . hooked leg 532 fits into bore 542 of the shaft , and collar 544 slides over and is fixed by pin 546 , fitted into collar hole 535 and shaft bore 543 . support rails 550 and 551 are fixed to handle clamps 71 of cart 1 . the rails are bent into an inverted v configuration , and permanently affixed to block 552 . block 552 is provided with bore 553 , into which the free end of shaft 540 is fitted . pin 555 is inserted into through bore 554 of block 552 , and passes through bore 547 of shaft 540 , creating the continuous , secure anti - tipping linkage 500 between cart 1 and a bicycle . it is understood that during maneuvers of the bicycle , there will be no problems associated with a typical universal or pivot joint ; the coil spring will absorb and disperse any rotational stresses , and will react as a 360 ° “ living hinge ”. fig3 a - 32g , 33 and 33 a show an alternate embodiment 600 of the portable cart using four wheels 30 in an overlapped configuration . a hard molded cover 601 is illustrated although any cover or no cover can be used as well . cover 601 covers bin 602 with lower overlapping edge cap 601 a fitting over peripheral shoulder 602 a of bin 602 . bin 602 also has longitudinally extending concave channels 603 , which rest upon rails 604 of cart 600 of fig3 . downward pressure of the weight of bin 602 and its contents helps stabilize bin 602 upon rails 604 , which may be optionally covered with rubber or other resilient linearly extending cushions . although fig3 illustrates portable cart 600 with covered bin 602 , portable cart 600 can be used with other embodiments , such as , for example , boat cushions 13 shown in fig4 , framed rail stretchers 100 as in fig1 , the game cart of fig1 , the cargo cart of fig1 , the conventional rescue carriers of fig2 and 24 or the gear rack of fig2 , among others . fig3 h shows an exploded inverted view of an alternate embodiment for a ruggedized handle assembly , including handle 630 and handle shaft 626 with spring pin 628 lined up to enter the end of stanchion truss weldment 620 . stanchion truss weldment 620 has two downward extending struts 632 , which accommodate axles 624 therethrough , which axles 624 , in - turn , attach to wheels 622 . central bushing receptacle 634 accepts the end of handle shaft 626 . receptacle 634 also has a lower pushpin aperture and a pair of opposite holes for a through pin to hold handle shaft in place . fig3 h also shows kickstand 640 stowable within handle shaft 626 . fig3 i shows a close - up inverted view of receptacle 634 , showing handle shaft 626 located within truss weldment 620 , and held in place by spring pin 628 of handle shaft 626 and / or through pin 629 . fig3 j shows a four wheel cargo hauling cart with kickstand 640 attached to kickstand attachment bracket 638 , which is part of handle 630 . also shown are stacked cargo bin shell containers 634 held securely by straps 636 . in the sequence of fig3 k , 32 m , and 32 n , straps 636 have been detached from bin shell containers 634 , and the sequence of removal of top bin 634 is shown ending with a vertically oriented bin drawer cabinet 635 with a cover panel 639 removed , thereby exposing slidably openable drawers 642 on its front surface . fig3 n shows drawers 642 behind drawer retaining panel 639 in a cutaway view . lower bin 634 optionally contains related medical supplies for a field hospital , such as power packs , oxygen tanks , and other necessary medical supplies . fig3 o is an optional hitch assembly 644 , which replaces the handle assembly . hitch legs 646 are received into handle 630 . spring pins 651 also participate in this coupling . connector 646 , with hitch tongue 652 , form a structure engagable with receiver clevis 653 attached to all terrain vehicle 656 . fig3 p shows hitch 644 being used to pull cart 632 by all - terrain vehicle 656 . fig3 shows a perspective view of the frame of cart 600 . long axle 606 attaches front wheels 30 while short axle 605 attaches rear wheels 30 through respective vertical support pairs 20 . the use of four wheels doubles the carrying capacity of the cart of this invention while the overlapped positioning of the wheels maintains a short wheelbase for compactness and for maneuverability such as turning with fixed axles and the ability to easily climb ledges . for durability , the rails 604 may be a double pair of parallel rails . double axled cart 600 has increased maneuverability , since user pushing upon an optional handle 81 enables user to lift the farther away , distal pair of wheels 30 off the ground , and the user pulling upward of handle 81 raises the nearer proximal wheels 30 off the ground . fig3 through 39 are concerned with an alternate embodiment of the horizontal load support member 10 . the alternate embodiment 610 has an integral t - slot channel 611 in its top surface to facilitate easy installation and removal of a variety of attachments , such as cushions 615 shown in fig3 - 36 , clamps 620 , 630 , 640 , shown in fig3 - 39 , or platform 1450 shown in fig5 . load member 610 can be conveniently extruded of aluminum or magnesium ; it can be used either with the two - wheel cart 1 or the four - wheeled embodiment 600 . fig3 shows a resilient cushion 615 installed in the t - slot 611 of support member 610 . this cushion 615 can be extruded of a variety of rubber or thermoplastic elastomers and serves the same purpose as cushion member 13 described above . a perspective view of fig3 shows cushions 615 installed on a four - wheel cart 600 . as described above , clamp assembly 200 is used to convert portable cart 1 to a disabled person - bearing transportable carrier cart . three separate alternate embodiments of clamp assembly 200 are presented ; all are compatible with the use of horizontal support member 610 . fig3 shows a one - piece clamp 620 with full width top section 622 and short end pieces 621 , which mate with , and slip into the t - slot 611 of horizontal support member 610 . fig3 shows clamp 630 with a full width bottom member 631 which mates with and slides into t - slot 611 of horizontal support 610 . fig3 shows another alternate embodiment consisting of two short identical clamp members 640 , which are inserted into the t - slots 611 of member 610 at the two extreme ends . in all cases , the short clamping sections can be sized to offer spring - like gripping action on the tubular members , or fasteners , such as thumbscrews or ball plungers ( not shown ) can be used for retention . fig4 - 50 show alternate embodiments for converting a conventional hand carried , railed medical rescue stretcher to a lightweight wheeled version . for example , fig4 - 42 show shortened horizontal support members 710 with tightening members 711 . rails 713 are held either by clamps , such as shown in fig3 - 39 , or alternatively through apertures in horizontal support members 710 , as shown in fig1 . horizontal support members 710 are demountably attached to vertical struts 720 having extending therethrough transverse axles 732 supporting wheels 730 . optional pivotable kickstand 740 is attached to rails 713 by clamp 800 . as also shown in fig4 - 50 , clamp 800 includes two jaws 801 , 802 having aperture recess 803 for insertion of rails 713 therethrough . clamp 800 is closed and tightened by fastener 804 operated by rotatable knob 805 . internal spring pins 806 , as shown in fig4 , cooperate with fastener 804 and knob 805 to tighten clamp 800 about rail 713 . internal grooves 807 , 808 accommodate kickstand 740 in the respective positions of support and rest , as shown in fig4 and fig4 respectively . fig4 shows an alternate embodiment for a military or emergency rescue carrier cart 900 with a profile set low to the ground , including shortened horizontal members 910 with tightening fasteners 911 . rails 913 are also held by clamps as in fig3 - 39 , or alternately through apertures in horizontal support members 910 , as in fig1 . horizontal support members 910 are demountably attached to shortened vertical struts 920 to keep stretcher rails 913 close to the ground . optional bent handle 945 is connected by clamps 800 disclosed in fig4 - 50 , as discussed above . fig4 - 46 show how the stretcher version shown in fig4 - 42 can be converted to a stationary medical gurney 1000 . rails 1013 are supported by horizontal support members 1010 , which hare demountably attached to vertical struts 1020 , having axles 1032 supporting wheels 1030 . to stabilize gurney 1000 , horizontally extending tie rods 1036 , 1037 are joined by threaded clamp 1038 or other fastening means . the major structural components of an alternate embodiment low profile rescue carrier are shown in fig4 a . latch clamps 1800 of stretcher bearing tube assemblies 950 support stretcher 1730 and also engage handles 630 at each end . handles 630 may be rotated into an upward locking position or downward . tube assemblies 950 include lateral spring pins 962 and upper spring pins 963 for proper placement of wheel assemblies comprising struts 920 having rail bearing clamps 910 operable by latch handles 911 . fig4 b shows an exploded view of handles 630 engagable with stretcher bearing tube assemblies 950 of fig4 a . handles 630 are attached to short handle shafts 956 with spring pins 958 ( as in detail callout fig4 c ) within . similarly , a coupling section detailed in fig4 c has spring pins 958 installed as shown . spring pins 958 include bent leaf spring section 960 which tail end impinges on the inside of tube 956 or tube 952 while the other end is attached to spring pin button 962 which protrudes through a hole in the side of tube 956 or 952 . buttons 962 couple with a tube mid sections 954 via holes near the ends of these tubes . buttons 963 function as wheel set locators and fit into wheel set clamps for proper fixturing , as shown in fig4 a . the low profile rescue carrier is also shown in the side elevational view of fig4 d , which illustrates the feature of the handles 630 rotated to the downward position and functioning as kickstands . as shown in fig4 e , the low profile rescue carrier is easily converted into a low profile transport rotating handles 630 from the kickstand support position to an upright handle position which is easily grasped by medical personnel . short handle shafts 956 are shown in the optionally extended position in fig4 e , to allow for clearance between the medic and the stretcher . the medic may drag the stretcher 1730 upon stretcher bearing assembly 950 as shown , or alternatively , push or pull the stretcher or other carrier bearing assembly 950 forward by reversing his orientation . fig5 - 53 show a further embodiment for portable cart 1101 which folds down to a disassembled storage position as in fig5 and which unfolds to an assembled position of use as in fig5 . cart 1101 includes a pair of horizontal load support members 1110 laid parallel to each other , which rotate axially to move perpendicularly extending vertical struts 1120 outward from a position within a storage bag 1101 a , where vertical struts 1120 face each other &# 39 ; s distal ends , to a position of use 90 degrees perpendicular to the storage position , where vertical struts 1120 extend in the same plane but outward from horizontal load support members 1110 . in this embodiment shown in fig5 - 53 , the resilient rails 1178 are engaged to horizontal supports 1110 such that when in a position of storage the rails 1178 are biased to return to their normal position of use , when released from the storage position , thus causing vertical struts 1120 attached to horizontal supports 1110 to pivot upward and bow , thus increasing the strength of the cart . the same is true with other embodiments of the present invention . for example , placing a boat 2 upon cart 1 causes horizontal support members 10 and wheel axles 31 to bow , giving it the strength of an uncollapsible roman arch . the same is true with respect to stretcher or cargo hauling embodiments shown in fig1 , 17 - 19 , 40 - 45 and 58 - 66 , for example , wherein putting weight makes the carrier portion taut and bows the frame members into a position of strength . also the multiple floating overlapping rails as in fig1 , for example , bow the rails and strengthen the cart with a load supported thereon . moreover , vertical struts 1120 can be further strengthened in place to horizontal supports 1110 by connecting braces , such as v - shaped braces 1121 . wheels 1130 are held by axle 1131 , which in a storage position is placed within the storage bag 1101 a . to lengthen cart 1101 , rails 1178 move away from each other within holes 1112 within horizontal supports 1110 , and are stopped from further movement by spring stop buttons 1171 . fig5 - 55 show portable cart 1201 which can be converted from a cargo hauling wagon configuration with cargo well 1290 attached to frame 1255 , to a rescue stretcher with taut rescue canvas or other stretcher 1292 when stretcher 1292 , which sits loosely above hollow well 1290 during the cargo hauling configuration , but which becomes taut when peripheral fasteners , such as zippers 1296 , snaps or the like tighten stretcher 1292 in place about frame 1255 . optional kickstand 1240 or handle 1280 may be attached to cart 1201 by joints 1271 . a further accessory arm bag 1201 b may be draped down from handle 1280 for further storage . an optional hard floor member 1294 may be provided below stretcher layer 1292 within cargo well 1290 for cargo hauling strength . fig5 shows optional ski attachments 1330 for cart 1301 , wherein ski portions 1331 are attached by braces 1332 to vertical struts 1320 . the length of braces 1332 is equal to the radius of wheels 30 in previous embodiments . fig5 shows optional platform base 1450 for supporting object such as camera tripods , cooking devices , ordnance , etc . upon cart 1401 . platform base 1450 slides within channels 1411 and is secured in place by fasteners such as recessed hex nuts . fig5 shows a portable cart frame of this invention configured as a cargo hauler or as a multi - victim stretcher . the cart includes two outer longitudinal horizontal parallel rigid load support frame members 1501 , which are preferably tubular . the cart also may include an optional center frame member 1502 , also preferably tubular , as well as optional transverse frame members 1503 , overhead tube frame 1505 , two vehicle actuators , such as wheels 30 and axle 32 . it is contemplated that in snow conditions the vehicle actuators can alternatively be skis , such as shown in fig5 herein . also as shown in fig5 , fasteners , such as cotter pins 1504 are used to attach horizontal support members 1501 and 1502 within holes , such as circular holes for tubular shaped horizontal support members in transverse members 1503 . also as in fig5 , vertical struts having the wheel subassembly with wheel 30 are attached to outer horizontal support members 1501 , such as tubes , with mechanisms 1506 which permit quick attachment and detachment . attachment clamps 1507 secure overhead handle 1505 to outer ends of horizontal support members 1501 . although not shown in the drawings , any of the embodiments herein shown in all the drawing fig1 - 70 may have vertical length adjustment means ( not shown ), such as a sleeve containing a telescoping shaft , the sleeve having a spring means for urging the shaft in a selectably extendable manner out of the sleeve and a lock for locking the telescoping shaft into a selected extended position . fig5 shows a single cargo or person hauling fabric top surface sheet 1512 , which can be made of canvas or similar material . sheet 1512 preferably has sewn longitudinal pockets at the outer edges to accept horizontal support members 1501 and a central pocket 1513 to accommodate optional central frame member 1502 when inserted in direction 1514 as shown . optional apron sections 1513 can be flipped over the side edges . fig6 shows the frame of this cargo hauling or multi - victim cart readjusted to foreshorten the distance between transverse members 1503 by securing cotter pins 1504 in holes in horizontal support members 1501 and 1502 which are located farther in from the ends . as shown in fig6 , this adjustment can be used to accommodate separate stretchers 1525 with locating extensions 1526 and handles 1527 . fig6 and 63 show end views of the quick disconnect / connect mechanisms 1506 ( in viewing direction “ 62 - 62 ” in fig5 ) with horizontal support member 1501 shown optional as tubular in cross section . top clamping member 1532 has slot 1531 which permits it to slide from the locking position shown in fig6 to the unlocked position of fig6 thereby releasing side horizontal support member 1501 from the wheel 32 subassembly which continues below lower clamp jaw 1533 . in fig6 , spring 1534 is compressed since the locking shaft concentric with it has been threaded downward by turning handle 1530 in a clockwise direction . in fig6 , handle 1530 has been turned about 180 degrees counter - clockwise thereby permitting spring 1534 to push up on top member 1532 releasing horizontal support member 1501 . fig6 is a partial end cross section ( in plane “ 64 - 64 ” of fig5 ) of clamp 1507 . the split 1544 in clamp body 1540 permits selective grasping of horizontal support member 1501 as per the clamping force from screw 1542 as applied through knob 1541 . stainless steel insert 1543 prevents collapse of the end of tube 1505 of the overhead assembly . fig6 shows yet another embodiment of the cart of this invention as a frame for a portable operating room table or a gurney . this portable operating room table / gurney includes side horizontal support members 1550 , such as , for example , frame tubes , auxiliary side bars 1551 , transverse frame members 1552 , vertical struts 1553 , overhead support frames 1554 , overhead rails 1555 , trolley 1556 , and attachment clamps 1557 . the portable operating room table / gurney rides on four wheels 30 with axles 32 . the fully configured gurney is shown in fig6 . additional features shown include flexible fluid capture collection sling 1562 , fluid collection tube 1563 , fluid collection tank 1564 , adjustable side clamp 1560 , side rest or surgical instrument table 1561 , wheel brakes 1558 , and overhead accessory 1569 for attaching lights or other surgical accessories . fig6 and 68 show the construction and operation of wheel brake assembly 1558 . brake frame 1570 is rigidly attached to vertical strut 1553 . upper pivot frame 1572 works in conjunction with handle / link 1574 , curved spring link 1573 , and plunger shaft 1575 to form an “ over - center ” mechanism with two stable states , clamped or unclamped . in fig6 , handle 1574 is pushed down into a snap - locked position pushing tip 1576 into contact with wheel 32 tire 1571 thereby contacting the top surface and deforming it to prevent wheel 32 from rotating . fig6 shows the “ brake - off ” position which is obtained by lifting handle 1574 past the center position thereby lifting tip 1576 out of contact with tire 1571 . fig6 is an end view of adjustable side clamp 1560 with side tube 1550 and auxiliary rod 1551 in cross section ( see plane “ 69 - 69 ” in fig6 ). instrument table 1561 attached to clamp body 1580 can be moved longitudinally along tube 1561 and locked in place as desired by turning knob 1581 which impinges the end of screw 1582 against horizontal support member 1550 . fig7 shows an exploded view of attachment clamp 1557 used in a variety of locations on overhead frames 1554 . it includes main body 1590 with groove 1591 , outer clamp member 1593 with lip 1593 and screw 1596 with knob 1595 . in operation , lip 1593 pivots within groove 1591 ; tube 1554 is grasped by the concave surfaces of body 1590 and outer member 1593 as tightened by screw 1596 . a tube end 1594 which can represent a tube 1555 or an accessory 1568 is inserted in the hole in the end of body 1590 and locked . fig7 is a flow chart showing the use of the convertible cart / utility table of the present invention in a medical emergency response triage environment . for example , in disaster medical care , triage is the medical screening of patients to determine their relative priority for treatment . three groups are defined , the first is those casualties not expected to survive even with treatment , second is the group who will recover without treatment , and third the highest priority group who need treatment in order to survive . fig7 illustrates how the convertible cart / utility table ( ccut ) of this invention can be utilized in this environment . for example , as in fig7 , incoming casualties 1650 arrive at triage center 1652 by ambulance , helicopter or otherwise . here they are screened into the three categories , labeled “ type 1 ”, “ type 2 ” and “ type 3 ” and those who can be treated are then transported via exit path 1654 to field hospital unit 1656 by using a wheeled version of the convertible cart / utility table ( ccut ). after prep at a pre - operative station , the patient is wheeled via path 1658 to the operating room ( or ) where a table version of the convertible cart / utility table ( ccut ) is used in a utility table mode as an operating platform . patient is then wheeled upon convertible cart / utility table ( ccut ) via path 1660 to the post - operative / post recovery station for monitoring , which may be done , on either a wheeled or table version of convertible cart / utility table ( ccut ). the patient may need further surgery , which would require transporting wheeled on convertible cart / utility table ( ccut ) back via path 1666 to the pre - operative station . if patient is sufficiently recovered , he or she is transported via path 1662 upon wheeled convertible cart / utility table ( ccut ) back to triage center 1652 vicinity for further transportation merging with others from triage in the outgoing exit queue path 1664 . fig7 shows an exploded view of the major components of convertible cart / utility table ( ccut ) 1700 for supporting stretcher 1730 thereon . these include axle support struts 1712 with rail clamps 1716 at the top ends and wheels 1718 located by axle 1715 . kick stands 1704 , used with heavy duty rail clamps 1714 , convert convertible cart / utility table ( ccut ) to the stationary utility table configuration . adjustable feet 1710 provide a high friction surface and terrain adjustability . macro adjustment of leveling or height is via multiple holes 1706 , in kickstand like 1704 , which accept spring pin 1713 attached near the end of foot extension 1708 . side rails 1702 complete the basic structure . fig7 shows side rails 1702 , which are mounted to kickstands 1704 by clamps 1714 , which engage tubing rails 1702 . tubing rails 1702 have middle connecting tube 1723 and side tubes 1722 , connected by connectors , such as , for example , spring pins and holes . fig7 shows convertible cart / utility table ( ccut ) 1700 configured as a utility table with auxiliary power pack 1732 and stretcher 1730 . fig7 shows the feature , which tilts the table top by adjusting the height of kickstands 1704 on different ends at different heights . fig7 also shows an optional body fluid capture collector 1760 such as a concave sling connected to a medical waste collector 1762 . fig7 shows details of kickstand foot 1710 . threshold shaft 1752 is screwed into nut 1754 and into foot extension 1713 thereby providing a micro adjustment of height up to about one inch . high friction pad 1756 and tilt adjustment ball and socket joint 1754 complete foot 1710 . fig7 shows reversible clamp 1800 , as in fig4 a , which is used with convertible cart / utility table ( ccut ) 1700 . it includes housing block 1802 , with rail aperture 1812 , which clamps onto tubing 1722 via lever screw 1814 . groove 1816 receives tubing rail 1730 , such as that from a stretcher , which rail 1730 is locked in place via over - center clamp 1804 with jaw 1808 , operable by actuator lever 1810 . the opposite grooves 1818 , 1820 and 1822 are spaced laterally to accommodate stretchers of different widths . these can be optionally locked via a clamp 1806 having a jaw similar to jaw 1808 , which is moved to the desired groove 1818 , 1820 or 1822 . fig7 shows reversible clamp 1800 inverted to use the multiple width grooves 1818 , 1820 or 1822 . fig7 and 80 show details of heavy duty clamp 1900 , which has upper block 1902 with groove 1904 to receive a stretcher side tube 1730 . over - center latch 1906 locks stretcher tube via jaw 1910 and actuator lever 1908 . lower block 1912 has side rail groove 1920 , holding rail 1722 , which groove 1920 is lockable via latch 1914 with jaw 1918 and lever 1916 . lower extension 1922 accommodates either stretcher tube or fluid drape in groove 1924 . the end view of clamp 1900 in fig8 shows that upper retaining latch block 1932 can pivot to permit stretcher tube 1930 to tilt relative to side rail 1722 . in the more complete perspective view of fig8 , it can be seen that the lower ( foot ) end of stretcher rail 1731 of stretcher 1730 is then supported by recess or groove 1924 in the lower extension 1922 of the second clamp 1900 . fig8 depicts auxiliary pivotable medical support platform assembly 2000 including base 2001 , clamp insert 2002 and platform 2003 . this versatile mechanism clamps onto a side rail of the convertible cart / utility table ( ccut ). body limb member support 2004 holds a limb . assembly 2000 has movable hinge section can swivel relative to clamp base 2016 . fig8 shows medical support platform assembly 2000 with pole 2022 used to support intravenous ( iv ) bag 2026 with infusion line 2028 . extension rod 2024 provides more height for proper infusion gravity head . tray 2030 is similarly supported . fig8 shows medical support assembly 2000 used to support gooseneck examination / surgical lamp 2040 attached to flexible neck conduit 2042 held in and movable arm support 2046 . fig8 shows another use of medical support assembled 2000 to support multiple instrument trays 2050 . it is further noted that other modifications may be made to the present invention , without departing from the scope of the invention .
a mission adaptable multi - purpose , collapsible portable cart / utility table , for use in emergency response and disaster situations , camping , hunting and other outdoors activities , which carries medical rescue carts , canoes , small boats , game , or hauled cargo by hand . it transports one or more cargo bins over long , rough terrain and each bin can include one or more cabinet drawers therein , wherein upon tilting of a cargo bin from a horizontal transport position to a substantially vertical position the cargo bin serves as a supply cabinet . each bin is openable to expose the supply drawers for use .
it is presumed that patients perceive tinnitus because neurons within the central auditory system ( auditory cortex and / or medial geniculate nucleus ( mgn ) of the thalamus ) are firing abnormally . by using sophisticated medical imaging and neurosurgical techniques discussed in u . s . pat . no . 5 , 496 , 369 , the contents of which are incorporated herein by reference , specific regions in the brain can be targeted and the abnormal electrical activity blocked or masked with stimulating electrodes or with drugs delivered through precisely placed brain catheters . the primary auditory region of the human brain is buried deep within the sylvian fissure . it is not visible from the brain surface and its exact location varies slightly from one person to the next . mri and ct scanners were not invented at the time of dr . dobelle &# 39 ; s experiments so the anatomy of the patient &# 39 ; s auditory cortex could not be studied prior to surgery , and this region could only be visualized with difficulty in the operating room after the sylvian fissure was surgically dissected . once the buried auditory cortex was exposed , surface stimulating electrodes were placed by hand over the area thought to be the auditory cortex and the brain was stimulated in a fashion similar to that used to generate visual phosphenes . reproducible sound sensations were generated in the experimental subjects . though these preliminary findings were encouraging , a range of limitations precluded further work by this group . among the more daunting problems the utah group faced were recruiting suitable patients for the experimental study and obtaining good stimulation characteristics from the experimental surface electrodes . the minimal stimulation threshold for eliciting sound sensations was found to be 6 milliamperes , which is too high to be tolerated chronically and is thousands of times greater than currents found subsequently to be required to generate phosphenes in visual cortex using penetrating electrodes . recent advances in mri and computer technology now allow detailed preoperative imaging of human auditory cortex . an important aspect of the cochlear implant technology , which is now highly refined , involves transducing sound into complex electrical stimulation sequences . this large body of technical knowledge developed over the last twenty years will be directly applicable to the treatment of tinnitus via the auditory cortex prosthetic device . mechanisms of human hearing are reviewed briefly to provide a framework for discussion of the tinnitus masking system . the auditory system is composed of many structural components that are connected extensively by bundles of nerve fibers . the system &# 39 ; s overall function is to enable humans to extract usable information from sounds in the environment . by transducing acoustic signals into electrical signals that can then be processed in the brain , humans are able to discriminate amongst a wide range of sounds with great precision . fig1 a and 1b show a side and front view of areas involved in the hearing process . in particular , the normal transduction of sound waves into electrical signals occurs in cochlea 110 , a part of the inner ear located within temporal bone ( not shown ). cochlea 110 is tonotopically organized , meaning different parts of cochlea 110 respond optimally to different tones ; one end of cochlea 110 responds best to high frequency tones , while the other end responds best to low frequency tones . cochlea 110 converts the tones to electrical signals which are then received by cochlear nucleus 116 . this converted information is passed from cochlea 110 into brain stem 114 by way of electrical signals carried along the acoustic nerve and in particular , cranial nerve viii ( not shown ). the next important auditory structure encountered is cochlear nucleus 116 in brain stem 114 . as the acoustic nerve leaves the temporal bone and enters skull cavity 122 , it penetrates brain stem 114 and relays coded signals to cochlear nucleus 116 , which is also tonotopically organized . through many fiber - tract interconnections and relays ( not shown ), sound signals are analyzed at sites throughout brain stem 114 and thalamus 126 . the final signal analysis site is auditory cortex 150 situated in temporal lobe 156 . the mechanisms of function of these various structures has also been extensively studied . the function of cochlea 110 is the most well - understood and the function of auditory cortex 150 is the least understood . for example , removal of the cochlea 110 results in complete deafness in ear 160 , whereas removal of auditory cortex 150 from one side produces minimal deficits . despite extensive neural connections with other components of the auditory system , auditory cortex 150 does not appear to be necessary for many auditory functions . advanced imaging combined with an intraoperative stereotactic system now enable placement of penetrating electrodes into auditory cortex during routine epilepsy surgery without dissection of the sylvian fissure . primary auditory cortex 150 in fig1 a and 1b is tonotopically organized , meaning stimulation in different areas is likely to cause the patient to perceive different tones . these tones form the building blocks of complex sound phenomena such as speech . tonotopic organization is a fundamental characteristic of the cochlea and cochlear nucleus as well , as discussed above . auditory cortex 150 , however , has its tonotopic map stretched across a larger volume of tissue ( greater that twice the volume of cochlear nucleus 116 ). greater tissue volume enables placement of a greater number of electrical contacts for a given tonotopic zone . this results in increased signal resolution and improved clarity of auditory sensation . finally , because of anatomical differences , auditory cortex 150 can accommodate penetrating electrode arrays . fig2 a shows a multi - contact recording / stimulating electrode system 100 for blocking and / or masking the abnormal electrical activity present in tinnitus patients according to one embodiment of the invention . in particular , system 100 includes a multi - contact stimulating / recording electrode 104 connected to cables 108 via connector 112 . cables 108 enter skull 116 at burr hole opening 120 of skull 116 and are connected to a stimulation device 410 positioned in subcutaneous tissue of axial skeleton ( thorax or abdomen ). fig2 b shows a closer view of multi - contact stimulating / recording electrode 104 of electrode system 100 . electrode 104 has a first end 206a and a second end 206b which is blunt or smoothly curved . electrode 104 has electrical contacts 220 along a longitudinal support 226 . support 226 can be anywhere from several millimeters long to several centimeters long . electrical contacts 220 are small metal pads which can be separately electrically charged via respective wires 232a available at first end 206a . wires 232a are coupled to stimulation device 410 ( see fig2 a and 4 ). electrical contacts 220 are spaced approximately 10 micrometers to several millimeters apart and preferably approximately 50 to 150 micrometers apart . application of a voltage to contacts 220 near first end 206a results in stimulating low ( or high -- to be determined by questioning the patient ) tones in auditory cortex 150 ( see fig1 a and 1b ), whereas application of a voltage to contacts 220 near second end 206b results in stimulation of high ( or low ) tones in auditory cortex 150 . electrode 104 is stereotaxically placed into the primary auditory cortex of the patient with tinnitus . this can be done using a standard stereotaxic head frame under local anesthesia . that is , the above discussed three dimensional computerized mri reconstruction method of fig3 a - 3c is used to stereotaxically place electrode 104 within the targeted region of auditory cortex 150 . correct placement is confirmed by presenting a series of tones to the patient and mapping the tonotopic responses of the neurons along electrode 104 . in deaf patients , this mapping procedure is not possible , but mapping can still be carried out using microstimulation currents delivered to various contacts along electrode 104 . the deaf patient describes the relative pitch of the sounds he or she perceives following stimulation , whereby the electrically stimulated location and parameters which most closely match the patient &# 39 ; s tinnitus are determined . this approach could be used in the thalamus ( mgn ) as well , but the preferred embodiment involves implantation in the cortex . regardless of whether or not stimulating electrode 104 is placed into the correct region of the cortex or into the correct region of the mgn , electrode 104 is coupled to stimulation device 410 via cables 108 and in particular , wires 232a . longitudinal support 226 can be a rigid support or a flexible wire with a rigid introducer which enables the physician to introduce electrode 104 into a patient &# 39 ; s brain and then subsequently remove the rigid introducer thereby exposing electrical contacts 220 to auditory cortex 150 . support 226 can be one of the probes shown in fig3 - 5 in &# 34 ; possible multichannel recording and stimulating electrode arrays : a catalog of available designs &# 34 ; by the center for integrated sensors and circuits , university of michigan ann arbor , mich ., the contents of which are incorporated herein by reference . alternative electrodes such as depthalon depth electrodes and interconnection cables from pmt corporation 1500 park road , chanhassen , minn ., 55317 could also be used as support 226 and electrical couplers between contacts 220 and a speech processor ( 410 in fig4 ). electrical contacts 220 can operate as high impedance ( megohms ) contacts or low impedance ( a few ohms to several thousand ohms ) contacts . this enables the contacts to output a small ( a few microamperes as opposed to a few milliamperes ) current . high impedance contacts localize the potentials applied to the patient &# 39 ; s primary auditory cortex to approximately a few hundred micrometers . the localization of applied electric charges corresponds to the tonotopic spacing of nerve cell pairs . electrode 104 is arranged along a longitudinal direction of auditory cortex 150 . however , auditory cortex 150 is located in the transverse temporal gyrus and is buried deep within the sylvian fissure . consequently , its location cannot be determined simply by looking at an exposed surface of the brain . therefore , mri imaging techniques must be employed to reveal the exact orientation of auditory cortex 150 . a single coronal image of an individual &# 39 ; s brain cannot reveal the exact orientation of auditory cortex 150 . however , for treatment of tinnitus , a standard coronal mri provides a fairly good estimate as to the location of the target region , whether or not the target region is the auditory cortex or the thalamus . however , if more precise targeting is desired , a series of two dimensional images must be obtained and a resulting 3 - d mri image constructed . once such an image is constructed , the digital data making up that image can be transformed to provide a view of the sylvian fissure . this in turn exposes auditory cortex 150 as a mole - like mound . that is , tissue on top of the digital image can be &# 34 ; peeled off &# 34 ; to expose the sylvian fissure and consequently auditory cortex 150 &# 34 ; pops out &# 34 ; of the image . this process is described in &# 34 ; three - dimensional in vivo mapping of brain lesions in humans &# 34 ;, by hanna damasio , md , randall frank , the contents of which are incorporated herein by reference . fig3 a shows a side view of a plane a which intersects a coronal section 310 as well as a view of coronal section 310 with sylvian fissure 316 exposed . fig3 b and 3c show coronal section 310 before and after tissue is digitally &# 34 ; peeled off &# 34 ; to expose auditory cortex 150 . one or more resulting mounds 320 is revealed in fig3 c and this mound corresponds to auditory cortex 150 of fig1 b . mound 320 does not appear until after tissue on the underside of sylvian fissure 316 is reconstructed to provide the 3 - d image . once the exact location and orientation of mound 320 and consequently auditory cortex 150 have been determined using these 3 - d mri image processing techniques , electrode 104 can be accurately inserted into auditory cortex 150 . fig4 shows electrode 200 just prior to insertion into auditory cortex 150 . in addition , fig4 shows stimulation device 410 coupled to wires 238 via cable 414 . stimulation device 410 is a chronic electrical stimulation device . this stimulator device is well tested and widely available . examples include chronic epidural stimulators made by medtronics used for chronic back and leg pain and deep brain stimulators , as well as nearly all types of cochlear implants . the above electrical implantation technique for tinnitus is quick and safe , e . g ., over 100 auditory cortex region electrode implantations have been performed in patients being evaluated for medically intractable seizures as reported by a french epilepsy surgery group . in addition , since electrode 104 is placed in the exact site of presumed abnormal neuronal electrical activity , it is much more effective in disrupting or altering abnormal neuronal electrical activity , thereby eliminating tinnitus . moreover , preliminary testing has shown that placement of electrode 104 within the central auditory system causes patients to perceive sounds , and this will likely be the case even in patients who are deaf from causes refractory to cochlear implantation . also , stimulation in the auditory cortex does not impair hearing in tinnitus patients who do have good hearing . fig5 shows an electrode 510 which includes two longitudinal supports 226a and 226b according to another embodiment of the invention . although two supports are shown , three or more such supports could be used . longitudinal support 226a is connected to cable 108a containing wires 232a via connector 112a and longitudinal support 226b is connected to cable 108b containing wires 232b via connector 112b . cables 108a and 108b are again connected to stimulation device 410 as in fig4 . fig6 shows an electrode 610 according to yet another embodiment of the invention . in particular , fig6 shows longitudinal support rod 226 with first end 606a and second end 606b . end 606a is arranged in the region of auditory cortex 150 with low tones ( or high tones as previously discussed ) and second end 606b is arranged in the region of auditory cortex 150 with high ( or low ) tones in a manner similar to first end 206a and second end 206b of fig2 b . here , however , longitudinal support 226 has a sphere 616 which is stopped by a stopping piece 614 . this enables the physician to insert longitudinal support 226 at a wide range of angles and yet secure electrode 610 once longitudinal support 226 has been inserted . fig7 a shows electrode 610 of fig6 as looking down on the patient &# 39 ; s brain surface 704 . fig7 b shows a closer view of stopping piece 614 with a cup 708 and a lid 714 with a notch 716 for passing leads 232 . fig7 c corresponds to fig7 a with support 226 inserted into surface 704 and sphere 616 resting in cup 708 &# 34 ;( fig7 b )&# 34 ;. fig7 c also shows lid 714 covering sphere 616 with leads 232 extending out of notch 716 . fig8 shows another embodiment of the invention involving drug - infusion into regionally targeted locations within the brain . the alternative drug - infusion treatment strategy relies on the same principal of regionally targeted treatment within the brain , but employs a different effector to eliminate the abnormal neural activity causing tinnitus . namely , a small drug infusion catheter 801 is stereotaxically placed into either the auditory cortex or thalamus ( mgn ) and microinfusions of various drugs that block abnormal neural activity are infused into the targeted locations . referring in more detail to fig8 a drug infusion catheter - recording device 800 is connected to an injectable ( rechargeable ) drug reservoir - pump 804 via connector 803 which is secured with sutures widely used in neurosurgery . pump 804 is secured to the patient &# 39 ; s skull 808 under the scalp and is not exposed to the external environment . pump 804 has a valve 824 which can be accessed externally so that additional drugs can be injected via a syringe ( not shown ) without reopening the patient &# 39 ; s scalp . catheter 801 has multiple ports 814 from which the drugs are microinfused into the targeted brain regions . fig9 shows a closer view of catheter 801 with ports or openings 814 . catheter 801 can be made , for example , of silastic such as the catheters sold by radionics , codman , and medtronics . catheter 801 need not have a circular cross - section 817 and instead can be flat , elliptical or any other shape which facilitates broader diffusion of the drug . catheter 801 can include a small embedded recording - stimulating electrode 819 which can be connected to stimulation device 410 so that cathether 801 can be properly positioned . electrophysiologic recording data from this special catheter electrode will provide physiologic confirmation of proper catheter position in auditory cortex . the diameters of ports ( or openings ) 814 can be approximately between 10 micrometers and several millimeters and preferably between approximately 40 micrometers and 1 millimeter . the centers of ports 814 can also be tens of micrometers apart to millimeters apart and the spacing need not be uniform . pumps manufactured by medtronics and alzet can serve as injectable drug reservoir - pump 804 . examples of drugs that could be infused include anticonvulsants such as dilantin and inhibitory neurotransmitters such as gaba and local anesthetics such as lidocaine . in high enough concentrations , these compounds should block abnormal neuronal discharges . by delivering the drugs to the specific central nervous system target , significantly higher concentrations of the drug reach their target without exposing non - targeted surrounding tissue , as compared to the concentrations which could be delivered by simply systemically administering the same drug orally or intravenously . consequently , this strategy should result in marked improvement in efficacy while avoiding toxic side effects . the precise amount of drug infusion depends on the type of drug but can be determined at the outset of implantation . in particular , catheter 801 is initially inserted into the targeted location in the manner described above . the patient is then asked if there is any noticeable reduction in ringing due to the tinnitus as the amount of drug infusion is manually adjusted . the amount of infusion is that amount which is required to eliminate the ringing . once the amount is determined , the appropriate chronic infusion pump 804 is connected to catheter 801 and all incisions are closed . post - operative modifications of infusion rates can be carried out using percutaneous radio control techniques , e . g ., medtronics . as mentioned above , the alternative drug - infusion treatment strategy relies on the same electrode placement principals as described above with respect to fig3 a - 3c . namely , a series of images must again be obtained and a resulting 3 - d mri image constructed . once the image is constructed , the digital data making up that image can be transformed to provide a view of the sylvian fissure . this in turn exposes auditory cortex 150 as a mole - like mound . again , tissue on top of the digital image can be &# 34 ; peeled off &# 34 ; to expose the sylvian fissure and consequently auditory cortex 150 &# 34 ; pops out &# 34 ; of the image . numerous additional modifications and variations of the present invention are possible in light of the above teachings . it is therefore understood that the invention may be practiced otherwise than as specifically claimed .
a neural prosthetic device for reducing or eliminating the effects of tinnitus is inserted into a tinnitus patient &# 39 ; s primary auditory cortex . the prosthetic device includes a stimulation device for outputting processed electrical signals and an electrode arranged in the primary auditory cortex having a plurality of electrical contacts . each of the plurality of electrical contacts independently outputs electrical discharges in accordance with the electrical signals . in another embodiment , a catheter is inserted into the tinnitus patient &# 39 ; s primary auditory cortex or thalamus . the catheter microinfuses drugs which suppress or eliminate abnormal neural activity into disperse geometric locations in the cortex or thalamus , thereby reducing or eliminating the effects of the patient &# 39 ; s tinnitus .
conventional cocktail garnish picks are typically thin , straight , cylindrical pieces of wood , metal or plastic , with a sharpened end . while the typical garnish pick is formed by a single straight shaft to skewer and hold a garnish , such a design allows the entire pick to occasionally slide below the line of the liquid , potentially submerging the garnish pick . this is inconvenient for people that prefer to eat the garnish while drinking the cocktail , because it may require the person to dip his or her fingers into the cocktail to retrieve the pick and garnish , and which may be perceived as unsanitary and unappealing . in addition , when more than one garnish is skewered and stacked onto a single shaft , it may be difficult for a person to remove each garnish from the garnish pick without using his or her fingers . if , for example , three olives are stacked on a single shaft , the olive next to the sharp end of the shaft can be easily pulled off by a person using their teeth , while removing a second or third olive may require the person to use his or her fingers to remove the second or third olives because of the increased distance of the second and third olives from the sharp end of shaft . referring now to fig1 , an example garnish pick 100 is shown according to one embodiment in an example usage environment of a martini glass 114 . specifically , fig1 shows how an appendage 110 of the garnish pick may exit a main shaft 112 angling toward the skewering end of the garnish pick , and hook or otherwise secure the pick to the rim of a glass , preventing the garnish pick from sliding into the cocktail glass , or completely or further submerging the garnish pick into a beverage . in this embodiment , the main shaft 112 also serves as a skewering shaft for holding a garnish . fig2 shows a garnish pick 200 in an example usage environment of a martini glass 216 . in this example embodiment , garnish pick 200 includes three appendages , wherein a first appendage 210 may serve as a hook , and a second appendage 212 and a third appendage 214 may serve as skewering shafts . fig2 also shows how garnishes , e . g ., in this case olives , can be held on the garnish pick , for example , by appendages 212 and 214 . fig3 shows a single embodiment of a garnish pick depicted at different angles rotated 45 degrees relative to each other . fig3 shows how multiple appendages can exit the primary shaft , one serving as a hook for the rim of the glass , while the others serve as skewers . in further detail , still referring to fig1 , fig2 and fig3 , the garnish pick may be of a total length that is approximately equal to the distance from the rim of a martini glass to the center of the bottom of the glass . however , other suitable lengths may be used . because martini glasses come in a variety of shapes and sizes , this distance may vary . in at least one non - limiting example , a total length of the garish pick does not exceed five inches and is not less than two inches in length . fig9 further shows how an appendage for serving as a hook may be omitted from the garnish pick in at least some embodiments . in at least some embodiments , a total diameter or width of the garnish pick may be at its largest is 15 cm or less , with the diameter or width diminishing toward the sharp end of the skewering shafts . the portions of the garnish pick that are adapted to hold a garnish may have a diameter sufficiently small such that a garnish ( e . g ., an olive or other suitable garnish item ) can slide onto that portion of the garnish pick without undue difficulty and / or without splitting or damaging the garnish . in at least some embodiments , the main shaft and / or appendages may curve , have abrupt bends , or be curved along at least a portion of its axis . the main shaft and / or appendages may have bumps , ridges , craters , or be otherwise unsmooth or rough ( e . g ., as shown by the non - limiting examples of fig1 and 11 ). the main shaft and / or appendages may have circular cross - sections , convolute cross - sections , ovular cross - sections , non - circular cross - sections , square or rectangular cross - sections , pentagonal cross - sections , hexagonal cross - sections , or irregularly shaped cross - sections , among other shapes . the main shaft and / or appendages may have twists and / or cork screws that may be expanding or narrowing ( e . g ., at a radius of curvature ) along a longitudinal axis of the main shaft or appendage ( e . g ., non - regular corkscrew or twist ). such twists and / or corkscrews may be less than a full rotation , between one full rotation and two full rotations , greater than two full rotations , or comprise an even greater number of rotations . in at least some embodiments , one or more of the appendage may have smaller appendages ( e . g ., sub - appendages ) that branch from them . the construction details of the garnish picks disclosed herein may be that such garnish picks may be made of wood or of any other sufficiently rigid , flexible , and / or strong material such as plastic , rubber , metal , glass , ceramic , and the like depending on implementation . further , the various components of the garnish pick can be made of different materials . for example , a garnish pick may comprise two or more materials . for example , the garnish pick may comprise a first material ( e . g ., metal or plastic ) having an outer coating comprising a second material ( e . g ., rubber , plastic or paint ). the advantages of the disclosed embodiments may include , without limitation , that the garnish pick can be hooked to the side of a glass , preventing the pick from becoming completely or further submerged in a beverage , and can provide additional shafts ( e . g ., appendages ) on which to hold garnishes . such embodiments may also eliminate the need to retrieve the pick out of the beverage or beverage container ( e . g ., with fingers ) and may make it easier to eat garnishes off of the pick ( e . g ., without using fingers to touch the garnishes ). as previously described , a garnish pick is provided that may be used to hold garnishes with one or more appendages emerging from a main shaft , angled toward a sharp end of the main shaft , that are used either to hook the pick to the rim of the glass or to skewer garnishes , or both . in embodiments where the garnish pick comprises a plurality of appendages , such appendages may project from a main shaft of the garnish pick at the same or different angles relative to each other along a longitudinal axis and / or an orthogonal axis of the main shaft . for example , a first appendage may project from the main shaft at a greater angle relative to a longitudinal axis of the main shaft than a second appendage and / or a third appendage . accordingly , the garnish pick may comprise two , three , four , five , or more appendages that each project from a main shaft or other base appendage ( e . g ., where such appendages comprise sub - appendages ) at different angles relative to each other as measured relative to a longitudinal axis of the main shaft or other base appendage . as another example , a first appendage may project from the main shaft or other base appendage ( e . g ., for sub - appendages ) at a 2 o &# 39 ; clock position when viewed in a plane that is orthogonal to the longitudinal axis of the main shaft or base appendage , while a second appendage may project from the main shaft at a 6 o &# 39 ; clock position , and / or a third appendage may project from the main shaft at an 8 o &# 39 ; clock position . such examples are provided for descriptive purposes and should not be considered limiting . fig1 shows another example garnish pick 1200 according to one embodiment . fig1 shows the example garnish pick 1200 of fig1 in an example use environment of a beverage container . garnish pick 1200 includes a pick body 1210 . the pick body may include a first elongate body portion 1212 having a first end 1214 forming a first tapered skewer 1216 and having a second end 1218 forming a hook 1220 . the pick body may include a second elongate body portion 1230 branching outward from the first elongate body portion at an intermediate location 1232 between first end 1214 and second end 1218 . the second elongate body portion may have a distal end 1232 forming a second tapered skewer 1234 . in at least some embodiments , first elongate body portion 1212 may taper from second end 1218 toward first end 1214 , and second elongate body portion 1230 may taper from a base end 1236 toward distal end 1232 of the second elongate body portion . in at least some embodiments , a cross - sectional area of the second elongate body portion at the base end is smaller than a cross - sectional area of the first elongate body portion at the intermediate location where the second elongate body portion branches outward from the first elongate body portion . in at least some embodiments , the first elongate body portion may be curved along a length of the first elongate body portion between the first end and the second end . the curvature of the first elongate body portion may vary along at least a portion of the length of the first elongate body portion between the first end and the second end . in at least some embodiments , the first elongate body portion may be curved in one , two , or more orthogonal planes along at least a portion of the length of the first elongate body portion between the first end and the second end . the second elongate body portion may be curved in one , two , or more orthogonal planes along at least a portion of a length of the second elongate body portion between a base end and the distal end . the first and second elongate body portions may each have a different curvature . a length of the second elongate body portion may be less than , greater than , or equal to a length of the first elongate body portion between the intermediate location and the first end of the first elongate body portion . in at least some embodiments , the pick body may further include a third elongate body portion branching outward from the first elongate body portion at another intermediate location between the first end of the first elongate body portion and the intermediate location where the second elongate body branches outward from the first elongate body . the third elongate body portion may have a distal end forming a third tapered skewer . the third elongate body portion may be curved in one , two , or more orthogonal planes along at least a portion of the length of the third elongate body portion between a base end and a distal end of the third elongate body portion . the first , second , and third elongate body portions may each have different curvature a , and may each have similar or different lengths of one or more other elongate body portions of the garnish pick . in at least some embodiments , hook 1220 formed at second end 1218 of first elongate body portion 1212 may branch outward from first elongate body portion 1212 at a location that is offset 1240 from second end 1218 of first elongate body portion 1212 . the hook may taper along its length toward a distal end 1221 of the hook . the hook formed at the second end of the first elongate body portion may be adapted to receive a rim of a beverage container 1300 ( e . g ., as depicted in fig1 ). in at least some embodiments , a remainder of the pick body including at least the first and second elongate portions may be sized to fit substantially within a beverage container when or if the rim of the beverage container is received by the hook as depicted in fig1 , for example . fig1 shows garnish pick 1200 with example garnish 1310 . in at least some embodiments , the pick body may be asymmetric about any plane ( e . g ., any or all reference planes ) passing through the garnish pick . the pick body may comprise a core formed from a first material and an outer coating substantially surrounding the core , the outer coating formed from a second material that is different from the first material . as yet another alternative description of an example garnish pick , a pick body of the garnish pick may include a stem portion ( e . g ., the portion of pick body 1212 between 1218 and 1232 ), a first elongate body portion ( e . g ., the portion of pick body 1212 between 1214 and 1232 ) branching from the stem portion , and a second elongate body portion ( e . g ., elongate body portion 1230 branching from the stem portion or the first elongate body portion . the first elongate body portion may taper from a base end toward a distal end of the first elongate body portion to form a first tapered skewer , and the second elongate body portion may taper from a base end toward a distal end of the second elongate body portion to form a second tapered skewer . the stem portion may form a hook as previously described . while the foregoing written description enables one of ordinary skill to make and use what is considered presently to be the best mode thereof , those of ordinary skill will understand and appreciate the existence of variations , combinations , and equivalents of the specific embodiments , methods , and examples disclosed herein . such disclosure and / or claimed subject matter should therefore not be limited by the above described embodiments , methods , and examples .
a garnish pick for food and / or beverages is disclosed . in at least some embodiments , the garnish pick includes a plurality of appendages that form skewering shafts for skewering garnishes . in at least some embodiments , at least one appendage of the garnish pick forms a hook for securing the garnish pick to a food or beverage container . in at least some embodiments , the garnish pick and its associated appendages may be shaped to simulate the appearance of organisms or portions thereof . as one example , the garnish pick may simulate the appearance of a branch of a tree or an antler of an animal .
the present invention employs a sensor to monitor cardiac electrical activity and cardiac demand in a skeletal muscle - powered cardiac assist system ( hereinafter referred to as &# 34 ; cas &# 34 ;). a basic cas may be configured in a variety of ways as described in the aforementioned patent to khalafalla . one specific configuration is discussed herein simply as an illustration . the present invention , however , may be used in any system concerning cardiac augmentation using skeletal muscle , such as aortic counterpulsation or a skeletal muscle ventricle . thus it should be understood the particular configuration illustrated is not intended to limit the present invention . fig1 illustrates an example of a system 1 for performing long - term stimulation of skeletal muscles for cardiac assistance using systolic augmentation as well as direct electrical stimulation of a heart 2 . as seen , skeletal muscle graft 3 is positioned about the heart 2 . in the preferred embodiment the latissimus dorsi muscle is used for the skeletal muscle graft , as is well known in the art . the longitudinal fibers of the muscle graft 3 are oriented generally perpendicular to the longitudinal axes of the right ventricle 4 , left ventricle 5 and interventricular septum 10 of the heart . muscle graft 3 is positioned in this manner so that when it is stimulated , muscle graft 3 compresses ventricles 4 , 5 and particularly left ventricle 5 , to thereby improve the force of right and left ventricular contraction . in such a manner the overall hemodynamic output of heart 2 is increased . in a preferred configuration , muscle graft 3 is wrapped around the heart 2 and fixedly attached to itself to form a cup - shaped &# 34 ; sling ,&# 34 ; using running sutures 12 . alternatively , muscle graft 3 may be attached to heart 2 using running sutures 13 as illustrated . as seen , electrical stimulation and sensing of heart 2 is accomplished through lead 15 . in particular , lead 15 electrically couples pulse generator 6 to heart 2 . lead 15 provides cardiac pacing as well as defibrillation therapies . in the preferred embodiment lead 15 is the model 6936 tri - polar transvene lead from medtronic inc ., minneapolis , minn . as seen , lead 15 is implanted in right ventricle 4 such that bipolar pacing electrode assembly 16 is in the right ventricular apex and defibrillation coil 17 is within the right ventricle 4 . although in the preferred embodiment a single lead is provided for pacing as well as defibrillation therapies , other types of lead configurations , such as multiple transvenous or subcutaneous or any combination thereof , may be used . muscle graft 3 is electrically stimulated through a pair of leads 21 , 22 . in particular leads 21 , 22 couple pulse generator 6 to skeletal muscle graft 3 . in the preferred embodiment leads 21 , 22 are the model 4750 intramuscular lead from medtronic , inc ., minneapolis , minn . as seen , each lead 21 , 22 extends from pulse generator 6 to latissimus dorsi muscle graft 3 . the electrodes ( not shown ) of each lead 21 , 22 are placed to cause muscle graft 3 to contract when electrically stimulated , as is well known in the art . other types of leads or electrodes , however , may be used , such as epimysial or neuromuscular leads or nerve cuff electrodes . fig2 is a functional block diagram of a pulse generator 6 in which the present invention may usefully be practiced . this diagram should only be taken , however , as exemplary of the type of device in which the invention may be embodied and not as limiting . it is believed the invention may usefully be practiced in a wide variety of device implementations . for example , the invention is also believed practicable in conjunction with the implantable muscle stimulator - pacemaker - cardioverters - defibrillators disclosed in u . s . pat . no . 5 , 251 , 621 issued to collins entitled &# 34 ; arrhythmia control pacer using skeletal muscle cardiac graft stimulation .&# 34 ; the device is illustrated as being provided with six electrodes , 500 , 502 , 504 , 506 , 508 , 572 and 574 . electrodes 500 and 502 may be a pair of electrodes located in the ventricle and mounted to a lead 15 as discussed above . electrode 504 may correspond to a remote , indifferent electrode located on the housing of pulse generator 6 . electrodes 506 and 508 may correspond to large surface area defibrillation electrodes located within the right ventricle , coronary sinus , superior vena cava or may also be located subcutaneous , located on or part of the device housing or to the epicardium . electrodes 572 and 574 are muscle stimulation electrodes coupled to the skeletal muscle wrap 3 , as discussed above . electrodes 500 and 502 are switchable through switch matrix 512 to the r - wave detector circuit , comprising band - pass filter circuit 514 , auto threshold circuit 516 for providing an adjustable sensing threshold as a function of the measured r - wave amplitude and comparator 518 . a signal is generated on r - out line 564 whenever the signal sensed between electrodes 500 and 502 exceeds the present sensing threshold defined by the auto threshold circuit 516 . as illustrated , the gain on the band pass amplifier 514 is also adjustable by means of a signal from the pacer timing and control circuitry 520 on gain adj line 566 . the operation of this r - wave detection circuitry may correspond to that disclosed in commonly assigned u . s . pat . no . 5 , 118 , 824 , issued to keimel and incorporated herein by reference . however , alternative r - wave detection circuitry such as that illustrated in u . s . pat . no . 4 , 819 , 643 , issued to menken and u . s . pat . no . 4 , 880 , 004 , issued to baker et al ., both incorporated herein by reference , may also be employed . the threshold adjustment circuit 516 sets a threshold corresponding to a predetermined percentage of the amplitude of a sensed r - wave , which threshold decays to a minimum threshold level over a period of less than three seconds thereafter , similar to the automatic sensing threshold circuitry illustrated in the article &# 34 ; reliable r - wave detection from ambulatory subjects &# 34 ;, by thakor et al ., published in biomedical science instrumentation , vol . 4 , pp . 67 - 72 , 1978 . it is preferable that the threshold level not be adjusted in response to paced r - waves , but instead should continue to approach the minimum threshold level following paced r - waves to enhance sensing of low level spontaneous r - waves associated with tachyarrhythmias . the time constant of the threshold circuit is also preferably sufficiently short so that minimum sensing threshold may be reached within 1 - 3 seconds following adjustment of the sensing threshold equal to 70 - 80 % of the amplitude of a detected spontaneous r - wave . the invention may also be practiced in conjunction with more traditional r - wave sensors of the type comprising a band pass amplifier and a comparator circuit to determine when the band - passed signal exceeds a predetermined , fixed sensing threshold . switch matrix 512 is used to select which of the available electrodes are coupled to band pass amplifier 534 . under control of microprocessor 524 , switch matrix directs delivery of electrical stimulation pulses to cardiac tissue and the skeletal muscle wrap . selection of the switch matrix settings is controlled by the microprocessor 524 via data / address bus 540 . signals from the selected electrodes are passed through band - pass amplifier 534 and into multiplexer 532 , where they are convened to multi - bit digital signals by a / d converter 530 , for storage in random access memory 526 under control of direct memory address circuit 528 . multiplexer 532 further receives voltage from battery 537 via vbatt 536 . amplifier 534 may be a broad band pass amplifier , having a band pass extending for approximately 0 . 5 to 200 hertz . the filtered egm signals from amplifier 534 are passed through multiplexer 532 , and digitized in a - d converter circuitry 530 . the digitized data may be stored in random access memory 526 under control of direct memory address circuitry 528 . the occurrence of an r - wave detect signal on line 564 is communicated to microprocessor 524 via data / address bus 540 , and microprocessor 524 notes the time of its occurrence . the remainder of the circuitry is dedicated to the provision of muscle stimulation , cardiac pacing , cardioversion and defibrillation therapies . the pacer timing / control circuitry 520 includes programmable digital counters which control the basic time intervals associated with cardiac pacing and muscle stimulation . the durations of these intervals are determined by microprocessor 524 , and are communicated to the pacing circuitry 520 via address / data bus 540 . pacer timing / control circuitry also determines the amplitude of the muscle stimulation and cardiac pacing pulses and the gain of band - pass amplifier , under control of microprocessor 524 . during cardiac pacing or muscle stimulation , the escape interval counter within pacer timing / control circuitry 520 is reset upon sensing of an r - wave as indicated by a signal on line 564 , and on timeout triggers generation of a pacing pulse by pacer output circuitry 522 , which is coupled to electrodes 500 and 502 or electrodes 572 and 574 . the escape interval counter is also reset on generation of a cardiac pacing pulse , and thereby controls the basic timing of cardiac pacing functions , including anti - tachycardia pacing and subsequent muscle stimulation . the duration of the interval deemed by the escape interval timer is determined by microprocessor 524 , via data / address bus 540 . the value of the count present in the escape interval counter when reset by sensed r - waves may be used to measure the duration of r - r intervals , to detect the presence of tachycardia and change muscle stimulation parameters . microprocessor 524 operates as an interrupt driven device , and responds to interrupts from pacer timing / control circuitry 520 corresponding to the occurrence of sensed r - waves and corresponding to the generation of cardiac pacing and muscle stimulation pulses . these interrupts are provided via data / address bus 540 . any necessary mathematical calculations to be performed by microprocessor 524 and any updating of the values or intervals controlled by pacer timing / control circuitry 520 and switch matrix 512 take place following such interrupts . in the event that a tachyarrhythmia is detected , and an antitachyarrhythmia pacing regimen is desired , appropriate timing intervals for controlling generation of anti - tachycardia pacing therapies are loaded from microprocessor 524 into the pacer timing / control circuitry 520 and switch matrix 512 . similarly , in the event that generation of a cardioversion or defibrillation pulse is required , microprocessor 524 employs the counters in timing and control circuitry 520 to control timing of such cardioversion and defibrillation pulses , as well as timing of associated refractory periods during which sensed r - waves are ineffective to reset the timing circuitry . further , in the event the onset of a tachyarrhythmia is detected , but not yet confirmed , the filtered and digitized egm available at a / d 530 will be compared by microprocessor 524 with a value from ram 526 . measured values above set will continue detection . values below set confirm the arrhythmia if more than 50 % of the x out of y have been detected . in the preferred embodiment x and y are programmable counts corresponding to the vfnid and the fibrillation event buffer memory ( located in the ram 526 ) respectively , both of which are discussed in more detail below with regards to the vf counting mode state 34 seen in fig4 . microprocessor 524 will then initiate a therapy if programmed to do so . in response to the detection of fibrillation or a tachycardia requiring a cardioversion pulse , microprocessor 524 activates cardioversion / defibrillation control circuitry 554 , which initiates charging of the high voltage capacitors 556 , 558 , 560 and 562 via charging circuit 550 , under control of high voltage charging line 552 . during charging , microprocessor 524 enables pacer / timing control 520 to pace out 522 and switch matrix 512 to deliver muscle stimulation pulses until the high voltage capacitors 556 are sufficiently charged . the voltage on the high voltage capacitors is monitored via vcap line 538 , which is passed through multiplexer 532 , and , in response to reaching a predetermined value set by microprocessor 524 , results in generation of a logic signal on cap full line 542 , terminating charging . the cap full line 542 signal is sent over data / address 540 to the pace timer / control 520 , which then inhibits delivery of the muscle stimulation pulses . thereafter , delivery of the timing of the defibrillation or cardioversion pulse is controlled by pacer timing / control circuitry 520 . one embodiment of an appropriate system for delivery and synchronization of cardioversion and defibrillation pulses , and controlling the timing functions related to them is disclosed in more detail in the commonly assigned u . s . pat . no . 5 , 188 , 105 by keimel , method and apparatus for detecting and treating a tachyarrhythmia , incorporated herein by reference . any known cardioversion or defibrillation pulse generation circuitry , however , is believed usable in conjunction with the present invention . for example , circuitry controlling the timing and generation of cardioversion and defibrillation pulses as disclosed in u . s . pat . no . 4 , 384 , 585 , issued to zipes , in u . s . pat . no . 4 , 949 , 719 issued to pless et al ., cited above , and in u . s . pat . no . 4 , 375 , 817 , issued to engle et el ., all incorporated herein by reference may also be employed . similarly , known circuitry for controlling the timing and generation of anti - tachycardia pacing pulses as described in u . s . pat . no . 4 , 577 , 633 , issued to berkovits et el ., u . s . pat . no . 4 , 880 , 005 , issued to pless et el ., u . s . pat . no . 7 , 726 , 380 , issued to vollmann et el . and u . s . pat . no . 4 , 587 , 970 , issued to holley et el ., all of which are incorporated herein by reference may also be used . in modern cardiac pulse generators , the particular anti - tachycardia and defibrillation therapies are programmed into the device ahead of time by the physician , and a menu of therapies is typically provided . for example , on initial detection of tachycardia , an anti - tachycardia pacing therapy may be selected . on re - detection of tachycardia , a more aggressive anti - tachycardia pacing therapy may be scheduled . if repeated attempts at anti - tachycardia pacing therapies fail , a higher level cardioversion pulse therapy may be selected thereafter . prior art patents illustrating such pre - set therapy menus of antitachyarrhythmia therapies include the above - cited u . s . pat . no . 4 , 830 , 006 , issued to haluska , et al ., u . s . pat . no . 4 , 727 , 380 , issued to vollmann et al . and u . s . pat . no . 4 , 587 , 970 , issued to holley et al . the present invention is believed practicable in conjunction with any of the known anti - tachycardia pacing and cardioversion therapies , and it is believed most likely that the invention of the present application will be practiced in conjunction with a device in which the choice and order of delivered therapies is programmable by the physician , as in current cardiac pulse generators . in addition to varying the therapy delivered following a failed attempt to terminate a tachyarrhythmia , it is also known that adjustment of detection criteria may be appropriate . for example , adjustment may comprise reducing the number of intervals required to detect a tachyarrhythmia to allow a more rapid redetection or by changing the interval ranges to bias detection towards detection of ventricular fibrillation , for example as disclosed in u . s . pat . no . 4 , 971 , 058 , issued to pless et al and incorporated herein by reference . in the present invention , selection of the particular electrode configuration for delivery of the cardioversion or defibrillation pulses is controlled via output circuit 548 , under control of cardioversion / defibrillation control circuitry 554 via control bus 546 . output circuit 548 switches the high voltage electrodes 506 and 508 for delivery of the defibrillation or cardioversion pulse regimen , and may also be used to specify a multi - electrode , simultaneous pulse regimen or a multi - electrode sequential pulse regimen . monophasic or biphasic pulses may be generated . one example of circuitry which may be used to perform this function is set forth in u . s . pat . no . 5 , 163 , 427 , issued to keimel , incorporated herein by reference . however , output control circuitry as disclosed in u . s . pat . no . 4 , 953 , 551 , issued to mehra et al . or u . s . pat . no . 4 , 800 , 883 , issued to winstrom both incorporated herein by reference , may also be used in the context of the present invention . alternatively single monophasic pulse regimens employing only a single electrode pair according to any of the above cited references which disclose implantable cardioverters or defibrillators may also be used . fig3 is an illustration of detection interval ranges which may be employed in a preferred embodiment of the present &# 39 ; invention . the specific detection interval ranges are selected and programmed by the physician . as seen , events which occur less than 120 milliseconds ( hereafter &# 34 ; ms &# 34 ;) apart are not detected due to blanking . this is a fixed interval and its length is not programmable by the physician . the range of intervals between detected events taken as indicative of fibrillation are greater than 120 ms and less than 300 ms . that is the fibrillation detection interval ( hereafter &# 34 ; fdi &# 34 ;) extends to 300 ms . this range is programmed and is selected by the physician to suit the particular patient . the range of intervals between detected events taken as indicative of tachyarrhythmia are greater than 300 ms and less than 450 ms . that is the tachyarrhythmia detection interval ( hereafter &# 34 ; tdi &# 34 ;) extends to 450 ms . this range is also programmed and is selected by the physician to suit the particular patient . events having intervals between 450 ms to 923 ms , in the preferred embodiment , are taken as indicative of normal sinus rhythm . that is the brady escape interval ( hereafter &# 34 ; bei &# 34 ;) extends to 923 ms . this range is also programmed and is selected by the physician to suit the particular patient . events which occur at intervals which would be greater than the bei are taken as indicative of bradycardia . for example , if a first event is sensed and a second event is sensed 200 ms later , ventricular fibrillation is provisionally detected . as a second example , if a first event is sensed and second event occurs 100 ms later and a third event occurs 210 ms after the second event , then a ventricular tachycardia ( hereafter &# 34 ; vt &# 34 ;) is provisionally detected . this is so because the second event occurred during blanking and thus was not sensed ; the third event was thereafter sensed a sum of 320 ms after the first , well within the vt zone . it should be noted that the specific times for intervals is for the preferred embodiment and thus is only illustrative of the present invention . other interval lengths may also be used within the scope of the present invention . fig4 is an arrhythmia detection / therapy muscle state diagram of the present invention . as discussed above the present invention features skeletal muscle graft stimulation as well as cardiac stimulation . one of the important requirements of such a system , however , is to accurately detect cardiac arrhythmias and respond with the appropriate therapy . as discussed above , concurrent skeletal muscle graft stimulation may interfere with the detection and diagnosis of arrhythmias . thus , one important feature of the present invention is the manner in which it provides for skeletal muscle graft stimulation as well as cardiac stimulation while also managing the prompt detection and diagnosis of arrhythmias . in particular , the present invention temporarily stops or inhibits skeletal muscle stimulation once the onset of an arrhythmia is sensed . as seen , during normal sinus rhythm the system remains at normal sinus rhythm state 30 . in state 30 device provides both skeletal muscle graft stimulation and any bradycardia stimulation required . bradycardia stimulation may take the form of any suitable electrical stimulation therapy , and preferably is given in the form of vvi pacing , although other types of pacing therapy may be delivered , such as voo , ovo and wt . bradycardia stimulation is delivered , in the preferred embodiment , upon the detection of a sequence of cardiac events in which the range of intervals between detected events greater than bei . if , however , a sequence of cardiac events is detected in which the range of intervals between detected events is less than the tdi , then the skeletal muscle stimulation is inhibited ( as represented by line 31 ) and vt counting mode state 32 is reached . in the preferred embodiment , if only one tdi is detected , then the skeletal muscle stimulation is inhibited and vt counting mode state 32 is reached . while in the vt counting mode state 32 , the skeletal muscle stimulation is re - enabled and the device returns to normal sinus rhythm state 30 if one interval greater than the tdi is detected . in addition , when a sequence of cardiac events is detected in which the range of intervals between detected events is less than the fdi , then the skeletal muscle stimulation is inhibited ( as represented by line 31 ) and vf counting mode state 34 is reached . in the preferred embodiment , if only one fdi is detected , then the skeletal muscle stimulation is inhibited and vf counting mode state 34 is reached . while in the vf counting mode state 34 , if vt detection is programmed on , the skeletal muscle stimulation is re - enabled and the device returns to normal sinus rhythm state 30 upon the detection of consecutive events with intervals greater than tdi equal to one - third of the number of intervals to detect vf ( hereafter &# 34 ; vfnid &# 34 ;). if , however , vt detection is programmed off , the skeletal muscle stimulation is re - enabled and the device returns to normal sinus rhythm state 30 upon the detection of consecutive intervals greater than fdi equal to one - third of vfnid . of course , if vt detection is programmed off , deliver vt therapy state 36 may still be reached through combined count state 38 , discussed below . it should be noted because fdi is smaller than tdi , then when vf counting mode state 34 is reached , this necessarily implies vt counting mode state 32 is also reached . from an electronic circuit design perspective , however , the counting bins for each state are simultaneously active , although both not necessarily registering events at the exact same time . while in vt counting mode state 32 the device counts the number of events which meets the tdi criterion . when the cumulative vt event counter is equal to the number of intervals to detect vt , also called vtnid , then vt detection is fulfilled , deliver vt therapy state 36 is reached and vt therapy is delivered . in the preferred embodiment vtnid is programmable . as discussed in more detail below , vt detection and deliver vt therapy state 36 may also be reached through combined count state 38 . while in the vf counting mode state 34 the device counts the number of events which meet the fdi criterion . when the cumulative event counter is equal to vfnid , then vf detection is fulfilled , deliver vf therapy state 40 is reached and vf therapy is delivered . in the preferred embodiment vfnid is programmable . as discussed above , vfnid essentially is the number of past events that must satisfy the fdi criteria to be detected as fibrillation . the count uses past events that have been stored in the fibrillation event buffer memory ( located in the ram 526 of fig2 ) which include both paced and sensed events . for example , if vfnid is set to 18 and fibrillation event buffer is set to 24 ; then to detect vf 18 of the last 24 events must satisfy the fdi criteria . as seen , deliver vf therapy state 40 may also be reached combined count state 38 . combined count state 38 is provided to avoid excessive detection times during competing vt and vf counters . thus combined count state 38 is reached , in the preferred embodiment , when the vf event counter reaches five and the vt event counter plus the vf event counter is greater than or equal to the combined number of intervals to detect parameter ( hereafter &# 34 ; cnid &# 34 ;). in the preferred embodiment cnid is not directly programmable , but rather is equal to seven sixths of vfnid . once the combined count state 38 is reached , then the second look criterion is applied . second look criterion is used only after combined count state 38 is reached . second look criterion is applied to determine whether vt or vf therapy should be delivered . in the preferred embodiment second look criterion is as follows : if all of the previous 8 intervals are greater than or equal to fdi , then the vt detected path should be followed and deliver vt therapy state 36 is reached , but if one of the previous 8 intervals is less than fdi , then the vf detected path will be followed and deliver vf therapy state 40 is reached . once deliver vf therapy state 40 is reached , vf therapy is completed or aborted and vt / vf termination detection state 42 is reached . similarly once deliver vt therapy state 36 is reached , vt therapy is completed or aborted and vt / vf termination detection state 42 is reached . while in vt / vf termination detection state 42 , the device determines whether vt or vf is re - detected . if either vt or vf is detected , then the device returns to the relevant therapy state . if neither vt nor vf is re - detected , the device returns to normal sinus state 30 . vt / vf termination detection is accomplished as follows : if vt detection is programmed &# 34 ; off &# 34 ; and eight consecutive events having intervals greater than fdi are sensed , then vf termination is detected and the device returns to normal sinus state 30 . if vt detection is programmed &# 34 ; on &# 34 ; and eight consecutive events having intervals greater than tdi ( which by definition is greater than fdi ) are sensed , then vt termination is detected and the device returns to normal sinus state 30 . as discussed above the present invention also features skeletal muscle stimulation while charging for defibrillation . essentially this feature provides muscle stimulation pulses to the grafted skeletal muscle while the device is charging a capacitor to deliver a defibrillation pulse . as mentioned above , because the muscle continues to contract and causes cardiac perfusion to be maintained . this cardiac perfusion , in turn , limits the increase in the overall defibrillation threshold . because the increase in these thresholds is minimized , this permits the device to feature smaller capacitors or lower voltages or both . fig5 is a timing diagram showing the relationship between muscle stimulation , cardiac events and a defibrillation charge cycle . as seen , during normal sinus rhythm , represented here by normal qrs complex 202 the device is in normal sinus state 30 . as such , muscle stimulation burst 201 is delivered to stimulate the skeletal muscle graft and thereby provide cardiac assistance , as described above . at first occurrence of a vf event 204 device enters detection state 206 . as explained in fig4 during detection state 206 device is in vf counting mode state 34 and vt counting mode state 32 . as also explained in fig4 once a vf event 204 is detected all muscle stimulation is inhibited , as may be seen in the lack of any muscle bursts in the region of detection state 206 . once vf is confirmed the device then enters deliver vf therapy state 40 . while in deliver vf therapy state 40 , device performs several operations , including charging of the output capacitors , depicted as line 208 . in addition , skeletal muscle stimulation is re - initiated and a series of asynchronous muscle stimulation bursts 210 , 212 are delivered . in the preferred embodiment asynchronous bursts 210 , 212 have a greater amplitude than muscle stimulation burst 201 , on the order of one and a half times as large . once charging of the output capacitors is completed , a sequence to synchronize the defibrillation discharge to a sensed r - wave is undertaken . in particular , device begins a synchronization sequence during synchronization time 216 . synchronization sequence is undertaken to synchronize defibrillation discharge to a sensed cardiac event as well as to re - confirm the presence of the arrhythmia . if the synchronization sequence is successful , then defibrillation discharge 214 is delivered synchronized to a sensed cardiac event . if the synchronization sequence is unsuccessful , then defibrillation discharge 214 is delivered at the timing out of synchronization time 216 . in addition during synchronization time 216 , device re - inhibits skeletal muscle stimulation in order to permit reliable sensing of any intrinsic cardiac events . fig6 is a timing diagram showing the relationship between muscle stimulation and cardiac events of an alternate embodiment . in particular , in an alternate embodiment , if synchronization is unsuccessful , then the device delivers an asynchronous muscle stimulation burst 322 immediately prior to defibrillation discharge 214 , as best seen in fig6 . muscle stimulation burst 322 is intended to cause the heart to be squeezed by the skeletal muscle graft and achieve roughly a systolic position when defibrillation discharge 214 is delivered . because the volume of the heart in such a position is decreased the defibrillation threshold is likewise decreased . turning again to fig5 once defibrillation discharge 214 is delivered , then device enters into vt / vf termination detection state 42 to thereby confirm heart has returned to normal sinus rhythm . fig7 depicts an alternate muscle stimulation burst which may be used with the present system . these muscle stimulation bursts may be used at any suitable time within the present system , and are not limited to only use prior to delivery of the defibrillation therapy . as seen muscle stimulation burst 300 occurs after qrs 303 in the amount of a synchronization delay 305 . in the preferred embodiment synchronization delay 305 is programmable and is undertaken in order to synchronize the muscle stimulation burst 300 with the ventricular contraction . muscle stimulation burst 300 has essentially two sections , first section 301 and second section 302 , often referred to as &# 34 ; muscle catch &# 34 ; and &# 34 ; muscle pulse train &# 34 ; respectively . as seen , first section 301 has a smaller interpulse interval 304 within the burst , i . e . a higher frequency . in comparison second section 302 has a relatively larger interpulse interval 304 within the burst , i . e . a relatively smaller frequency . the higher frequency first section 301 increases the velocity and force of the skeletal muscle graft contraction . in the preferred embodiment interpulse interval 304 and number of pulses in the catch may be selected by the physician . the pulse waveform , amplitude 308 and width of the muscle catch are the same for the remainder of the burst . fig8 depicts an alternate embodiment of the muscle catch stimulation which may be used with the present system . as seen all parameters of the muscle stimulation burst 300 are the same as that described above with respect to fig7 but for the amplitude of second section 302 . fig9 depicts an alternate embodiment of the muscle catch stimulation which may be used with the present system . as seen all parameters of the muscle stimulation burst 300 are the same as that described above with respect to fig7 but for the amplitude of second section 302 . in particular amplitude of each burst within second section 302 decreases . the rate of decrease of pulse amplitude within each burst decreases as a function of rate , i . e . the faster the rate of muscle stimulation , the greater the decrease of pulse amplitude within the pulse train . as discussed above , the mechanically induced cardiac output augmentation of the present invention during vf ( which is associated with loss of cardiac output ) leads to maintaining defibrillation thresholds during prolonged episodes of fibrillation , thus resulting in longer battery life or smaller device size or both . it also permits a longer charging interval without the concern of a dangerously low or temporarily lost cardiac output . while the present invention has been described in detail with particular reference to a preferred embodiment , it will be understood variations and modifications can be effected within the scope of the following claims . such modifications may include substituting elements or components which perform substantially the same function in substantially the same way to achieve substantially the same result for those described herein .
a device and algorithm for a combined cardiomyostimulator and a cardiac pacer - cardioverter - defibrillator . in particular the present device operates , in a first embodiment , to deliver stimulation to a skeletal muscle grafted about a heart ; sense depolarizations of a patient &# 39 ; s heart ; measure the intervals separating successive depolarizations of the patient &# 39 ; s heart ; define first and second interval ranges ; determine the number of the measured intervals falling within the first and second interval ranges ; inhibit the delivery of stimulation to a skeletal muscle grafted about a heart upon the sensing of a depolarization within the first or second interval range ; detect the occurrence of a first type of arrhythmia when the number of the measured intervals falling within the first interval range equals a first predetermined value ; detect the occurrence of a second type of an arrhythmia when the number of the intervals falling within the second interval range equals a second predetermined value ; deliver a first type of arrhythmia therapy in response to the detection of the first arrhythmia ; and deliver a second type of arrhythmia therapy in response to the detection of the second arrhythmia , the second type of arrhythmia therapy having a cardiac stimulation component and a skeletal muscle component .
specific , non - limiting embodiments of the present invention will now be described with reference to the drawings . it should be understood that such embodiments are by way of example and are merely illustrative of but a small number of embodiments within the scope of the present invention . various changes and modifications obvious to one skilled in the art to which the present invention pertains are deemed to be within the spirit , scope and contemplation of the present invention as further defined in the appended claims . fig1 a - 1b depicts a basic structure of an embodiment of the accommodating intraocular lens ( iol ) 100 . the iol 100 is depicted as comprising an elastically deformable lens chamber 110 , a base lens 150 , and a lens periphery 170 coupling the lens chamber 110 and the base lens 150 . the elastically deformable lens chamber 110 provides most , if not all , of the accommodative power by deforming or changing in curvature in response to the radially compressive forces that are exerted onto the iol 100 during accommodation . the base lens 150 provides most , if not all , of the corrective refractive power that is required by a particular patient and is not required to deform or change in shape or curvature . thus , the lens chamber 110 and the base lens 150 cooperate to restore both a patient &# 39 ; s vision and natural range of accommodation . the lens chamber 110 is made of an elastically deformable material and comprises opposing sides 112 and 114 that are joined together at the periphery of the lens chamber 110 to define a bi - convex exterior shape and an internal enclosed cavity 120 . each of the opposing sides 112 and 114 comprise a central region 112 a , 114 a and a peripheral region 112 b , 114 b and a gradient of thickness that increases radially from the peripheral region 112 b , 114 b to the central region 112 a , 114 a . this thickness profile is intended to encourage deformation of the opposing sides 112 , 114 away from one another and to permit the opposing sides to bulge and increase its curvature in opposing directions along an optical axis a - a without causing the membrane to buckle about the central region 112 a , 114 a . thus , while the conventional wisdom suggests that a greater degree of deformation and outward bulging would be achieved with the opposite thickness profile ( e . g ., a thickness profile that decreases radially from the peripheral region 112 b , 114 b to the central region 112 a , 114 a ), such a thickness profile is more likely to cause the lens chamber 110 to buckle or collapse inwardly about the central region 112 a , 114 a upon the application of a radially compressive force once implanted in a patient &# 39 ; s eye . during accommodation , the application of radially compressive forces may cause an internal vacuum to develop inside the lens chamber 110 , thereby causing the opposing sides 112 , 114 to buckle inwardly . thus , in a particularly preferred embodiment , the opposing sides have a gradually increasing thickness from the peripheral regions 112 b , 114 b , to the central region 112 a , 114 a . in a preferred embodiment , the central region 112 a , 114 a , as measured along the optical axis a - a , has a thickness that is two times or more , preferably three times or more , and most preferably four times or more than the thickness of the peripheral region 112 b , 114 b , as measured just adjacent to the area where the opposing sides 112 , 114 join at the peripheral region . in another preferred embodiment , the point of greatest thickness in the central region 112 a , 114 a and the point of least thickness in the peripheral regions 112 b , 114 b is characterized as having a thickness ratio of 2 : 1 or greater , preferably 3 : 1 or greater , and most preferably 4 : 1 or greater . in one embodiment , the central region 112 a , 114 a , as measured along the optical axis a - a , comprises an area of thickness that is about 100 microns , preferably about 200 microns , and the peripheral region 112 b , 114 b comprises an area of thickness that is about 50 microns as measured just adjacent to the area where the opposing sides 112 , 114 join at the peripheral region . while the thickness profile is described in relation to fig1 a - 1b , it is understood that the same or a substantially similar thickness profile may be provided for all of the iol devices depicted and described herein . the base lens 150 is coupled to the lens chamber 110 via a lens periphery 170 . the base lens 150 may be a positive lens that provides convergent power , such as a bi - convex , plano - convex or a positive meniscus lens . alternatively , the base lens 150 may be a negative lens that provides divergent power , such as a bi - concave , plano - concave or a negative meniscus lens . the base lens 150 depicted in fig1 a - 1b is a positive meniscus lens . the base lens 150 is preferably more rigid than the opposing sides 112 , 114 of the lens chamber 110 . the greater rigidity may be imparted by providing a base lens 150 having a thickness that is significantly greater than the thicknesses of the opposing sides 112 , 114 of the lens chamber 110 . alternatively or in addition to providing a greater thickness , the base lens 150 may be made of a different or stiffer material having a higher elastic young &# 39 ; s modulus as compared to the lens chamber 110 . the base lens 150 preferably does not substantially change its shape and curvature in response to the radially - compressive accommodative force applied onto the peripheral edge 180 of the lens periphery 170 . instead , the radially compressive accommodative forces are transferred onto the lens chamber 110 to cause the desired deforming changes . in a preferred embodiment , the base lens 150 is substantially thicker than one of the opposing sides 112 , 114 of the lens chamber 110 , as measured along the optical axis a - a . in a preferred embodiment , the thickness of each one of the opposing sides 112 , 114 of the lens chamber 110 , as along the optical axis a - a depicted in fig1 a - 1b and 9 , is less than ½ , preferably less than ⅓ , preferably less than ¼ , and most preferably less than ⅕ of the thickness of the base lens 150 at the central optical axis a - a . because the base lens 150 is substantially thicker than either one of the opposing sides 112 , 114 of the lens chamber 110 , the base lens 150 has an effective young &# 39 ; s modulus that is substantially greater than either one of the opposing sides 112 , 114 of the lens chamber 110 . while fig1 a - 1b and 9 depict the relative thickness of the opposing sides 112 , 114 of the lens chamber 110 and the base lens 150 for iol 100 , it is understood that all of the iol devices disclosed herein may have the same or similar thickness profile with respect to the lens chamber 110 and the base lens 150 . the lens chamber 110 and the base lens 150 are coupled together by a lens periphery 170 . the lens periphery 170 comprises a circumferential edge 180 configured to engage a circumferential region of the capsular bag of the eye . as depicted in fig1 a - 11c , the circumferential region 52 is where the capsular bag 40 is coupled to the zonules 50 , generally at a location where the density of the zonules 50 is the greatest . the zonules 50 , in turn , couple the capsular bag 40 to the ciliary muscles 60 which contract and relax to provide a range of accommodation . while fig1 b and 11c depict a particularly preferred embodiment in which an iol 100 is implanted with the lens chamber 110 being oriented anteriorly within the lens capsule 40 of the eye , it is understood that the iol 100 may also be implanted with the lens chamber 110 being oriented posteriorly within the lens capsule 40 of the eye . the lens periphery 170 comprises a radial portion 172 and a circumferential hinge 174 that cooperate together to transmit a significant portion , if not most , of the radially compressive forces exerted onto the circumferential edge 180 onto the lens chamber 110 and away from the base lens 150 . referring back to fig1 a - 1b , the radial portion 172 extends radially inwardly from the lens periphery 170 to the lens chamber 110 and the hinge 174 is disposed between the lens periphery 170 and the base lens 150 . both the radial portion 172 and the hinge 174 cooperate to maximize the extent to which the radially - compressive accommodative forces applied to the peripheral edge 180 are transmitted to the lens chamber 110 . the greater the force transmitted to the lens chamber 110 , the greater the deformation and change of curvature of the opposing sides 112 , 114 of the lens chamber 110 . the lens periphery 170 may be solid and thickened as compared to the base lens 150 , as depicted in fig1 a - 1b and 9 . alternatively , the lens periphery 170 may comprise a hollow space or a circumferential channel to reduce the delivery profile of the iol , as depicted in fig2 a , 3b , 4 , 6 , 7 , and 8 . because the iol 100 is implanted into a relatively small incision size , it must be rolled up to assume a delivery profile that is at least as small as the incision size . the circumferential hinge 174 is provided as a thinned or grooved area disposed in the lens periphery 170 and surrounding the base lens 150 . the circumferential hinge 174 permits the lens periphery 170 to pivot radially inwardly towards the lens chamber 110 such that the radially compressive forces applied to the circumferential edge 180 are directed substantially along the radial portion 172 and applied to the lens chamber 110 , as opposed to being applied to the base lens 150 , which is configured to generally resist deformation ( see fig1 c ). thus , the radial portion 172 is itself preferably sufficiently rigid in order to substantially transmit the radial compressive force onto the lens chamber 110 . in a preferred embodiment , the hinge 174 is provided both peripherally and circumferentially around the base lens 150 as a thinned area or as a groove . fig1 b and 11c depicts the configuration of the iol 100 in the absence of a radial compressive force applied to the circumferential peripheral edge 180 ( fig1 b , an unaccommodated eye ) and in the presence of a radial compressive force applied to the circumferential peripheral edge 180 ( fig1 c , an accommodated eye ) in which the peripheral edge 180 tilts in the direction c about the hinge 174 , transmitting the radial compressive forces onto the lens chamber 110 , and thereby causing the opposing sides 112 , 114 of the lens chamber 110 to be displaced apart from one another and increase in curvature . the features described herein which are intended to maximize the extent to which the radially compressive forces are transmitted to a lens chamber 110 and thus provide a large range of accommodation . the iols described herein may further be made of a material that does not resist deformation or is characterized as having a low young &# 39 ; s modulus . the iols may be made of a single material or , alternatively , different portions of the iol may be made of different materials having differing young &# 39 ; s modulus ( see fig1 a - 10b ). in one preferred embodiment , at least the opposing sides 112 , 114 of the lens chamber 110 is made of a material of sufficient mechanical strength to withstand physical manipulation during implantation , but is of sufficiently low young &# 39 ; s modulus so as to minimize its resistance to deformation . in a preferred embodiment , the opposing sides 112 , 114 of the lens chamber 110 is made of a polymer having a young &# 39 ; s modulus of 100 psi or less , preferably 75 psi or less , and most preferably 50 psi or less . in one preferred embodiment , the remaining portions of the iol 100 ( e . g ., the base lens 150 , the peripheral portion 170 ) has a young &# 39 ; s modulus that is greater than the young &# 39 ; s modulus of the walls 112 , 114 , of the lens chamber 110 . the walls 112 , 114 of the lens chamber 110 may be a polymer , preferably a silicone polymer and , more preferably a phenyl siloxane , such as a vinyl - terminated phenyl siloxane or a vinyl - terminated diphenyl siloxane . in order to impart sufficient mechanical strength , the polymer may be crosslinked , reinforced with fillers , or both . the fillers may be a resin or silica that have been functionalized to react with the polymer . the opposing sides 112 , 114 of the lens chamber 110 defines an enclosed cavity 120 that is filled with a fluid or gel having specific physical and chemical characteristics to enhance the range of refractive power provided by the iol during accommodation . the fluid or gel is selected such that it cooperates with the walls 112 , 114 of the lens chamber 110 in providing a sufficient range of accommodation of up to at least 3 diopters , preferably up to at least 5 diopters , preferably up to at least 10 diopters and most preferably up to at least 15 diopters . in a preferred embodiment , the enclosed cavity 120 is filled with the fluid or gel before implantation of the iol 100 into the capsular bag 40 of the eye and , in a more preferred embodiment , the cavity 120 is filled with the fluid or gel in the manufacture of the iol 100 . in one preferred embodiment the enclosed cavity 120 is filled with a fluid , such as a gas or a liquid , having low viscosity at room temperature and a high refractive index . in a preferred embodiment , the fluid is a liquid having a viscosity of 1 , 000 cp or less at 23 ° c . and a refractive index of at least 1 . 46 , 1 . 47 , 1 . 48 , or 1 . 49 . the fluid may be a polymer , preferably a silicone polymer , and more preferably a phenyl siloxane polymer , such as a vinyl - terminated phenyl siloxane polymer or a vinyl - terminated diphenyl siloxane polymer . preferably , in embodiments where the fluid is made of a polymer , the polymer is preferably not crosslinked and that the polymer may be linear or branched . where the fluid is a vinyl - terminated phenyl siloxane polymer or diphenyl siloxane polymer , the vinyl groups may be reacted to form other moieties that do not form crosslinkages . in accordance with one embodiment , fluid may be a polyphenyl ether (“ ppe ”), as described in u . s . pat . no . 7 , 256 , 943 , entitled “ variable focus liquid - filled lens using polyphenyl ethers ” to teledyne licensing , llc , the entire contents of which are incorporated herein by reference as if set forth fully herein . in accordance with another embodiment , the fluid may be a fluorinated polyphenyl ether (“ fppe ”). fppe has the unique advantage of providing tunability of the refractive index while being a chemically inert , biocompatible fluid with low permeability in many polymers . the tunability is provided by the increasing or decreasing the phenyl and fluoro content of the polymer . increasing the phenyl content will effectively increase the refractive index of the fppe , whereas increasing the fluoro content will decrease the refractive index of the fppe while decreasing the permeability of the fppe fluid through the walls 112 , 114 of the lens chamber 110 . in another preferred embodiment , the enclosed cavity 120 is filled with a gel . the gel preferably has a refractive index of at least 1 . 46 , 1 . 47 , 1 . 48 , or 1 . 49 . the gel may also preferably have a young &# 39 ; s modulus of 20 psi or less , 10 psi or less , 4 psi or less , 1 psi or less , 0 . 5 psi or less , 0 . 25 psi or less and 0 . 01 psi or less . in a preferred embodiment , the gel is a crosslinked polymer , preferably a crosslinked silicone polymer , and more preferably a crosslinked phenyl siloxane polymer , such a crosslinked vinyl - terminated phenyl siloxane polymer or a vinyl - terminated diphenylsiloxane polymer . other optically clear polymer liquids or gels , in addition to siloxane polymers , may be used to fill the cavity 120 and such polymers may be branched , unbranched , crosslinked or uncrosslinked or any combination of the foregoing . a gel has the advantages of being extended in molecular weight from being crosslinked , more self - adherent and also adherent to the walls or opposing sides or walls 112 , 114 of the lens chamber 110 than most liquids . this makes a gel less likely to leak through the walls 112 , 114 of the lens chamber 110 . in order to obtain the combination of accommodative power with relatively small deformations in the curvature of the walls 112 , 114 of the lens chamber 110 , the gel is selected so as to have a high refractive index while being made of an optically clear material that is characterized as having a low young &# 39 ; s modulus . thus , in a preferred embodiment , the gel has a refractive index of 1 . 46 or greater , preferably 1 . 47 or greater , 1 . 48 or greater and most preferably 1 . 49 or greater . at the same time , the gel preferably has a young &# 39 ; s modulus of 10 psi or less , preferably 5 psi or less , and more preferably 1 psi or less . in a particularly preferred embodiment , the gel has a young &# 39 ; s modulus of 0 . 5 psi or less , preferably 0 . 25 psi or less , and most preferably 0 . 01 psi or less . it is understood that at lower young &# 39 ; s modulus , the gel will present less resistance to deformation and thus the greater the deformation of the walls 112 , 114 of the lens chamber 110 for a given unit of applied force . in particularly preferred embodiment , the gel is a vinyl - terminated phenyl siloxane that is produced based on one of the four formulas provided as follows : 100 parts 20 - 25 mole % vinyl terminated diphenylsiloxane - dimethylsiloxane copolymer ( gelest pdv 2335 ). 3 ppm platinum complex catalyst 0 . 35 pph of phenyl siloxane hydride crosslinker ( nusil xl - 106 ) young &# 39 ; s modulus of elasticity = 0 . 0033 psi 100 parts 20 - 25 mole % vinyl terminated diphenylsiloxane - dimethylsiloxane copolymer ( gelest pdv 2335 ). 3 ppm platinum complex catalyst 0 . 4 pph of phenyl siloxane hydride crosslinker ( nusil xl - 106 ) young &# 39 ; s modulus of elasticity = 0 . 0086 psi 100 parts 20 - 25 mole % vinyl terminated diphenylsiloxane - dimethylsiloxane copolymer ( gelest pdv 2335 ). 3 ppm platinum complex catalyst 0 . 5 pph of phenyl siloxane hydride crosslinker ( nusil xl - 106 ) young &# 39 ; s modulus of elasticity = 0 . 0840 psi 100 parts 20 - 25 mole % vinyl terminated diphenylsiloxane - dimethylsiloxane copolymer ( gelest pdv 2335 ). 3 ppm platinum complex catalyst 0 . 6 pph of phenyl siloxane hydride crosslinker ( nusil xl - 106 ) young &# 39 ; s modulus of elasticity = 2 . 6 psi the walls 112 , 114 of the lens chamber 110 and the fluid or gel contained within the lens cavity 120 are preferably selected so as to prevent or reduce the likelihood of the fluid or gel migrating outside of the walls 112 , 114 of the lens chamber 110 . thus , in a preferred embodiment , one or both of the walls 112 , 114 of the lens chamber 110 and the fluid or gel is / are selected from biocompatible materials that optimize the resistance to permeability of the fluid or gel across the walls 112 , 114 of the lens chamber 110 . one method of decreasing the permeability of the gel contained inside the cavity 120 across the walls 112 , 114 of the lens chamber 110 is to provide a gel that is cross - linked . the degree of cross - linking , however , must be selected and controlled such that , on the one hand , the walls 112 , 114 of the lens chamber 110 and the gel have a sufficiently low young &# 39 ; s modulus to minimize the resistance of the walls 112 , 114 of the lens chamber 110 to deformation and , on the other hand , to minimize the permeation of the gel across the walls 112 , 114 of the lens chamber 110 . thus , in a preferred embodiment , longer chain polymers that are lightly cross - linked , such as those used for silicone gels , starting with monomers having molecular weights that are greater than 35 , 000 daltons , preferably greater than 50 , 000 daltons and , most preferably , at least 70 , 000 daltons are desired . in another preferred embodiment , a gel is used having low permeability extractables . such gels may be formulated by using long chain polymers that are branched . in a preferred embodiment , one or both of the lens chamber walls 112 , 114 and the gel is made of homo - or co - polymers of phenyl - substituted silicones . for the lens chamber walls 112 , 114 , the crosslinked homo - or co - polymers preferably have a diphenyl content of 5 - 25 mol %, preferably 10 - 20 mol % and more preferably 15 - 18 mol %. alternatively , for the lens chamber walls 112 , 114 , the homo - or co - polymers preferably have a phenyl content of 10 - 50 mol %, preferably 20 - 40 mol %, and more preferably 30 - 36 mol %. for the gel , the homo - or co - polymers preferably have a diphenyl content of 10 - 35 mol %, preferably 15 - 30 mol % and more preferably 20 - 25 mol %. alternatively , for the gel , the homo - or co - polymers preferably have a phenyl content of 20 - 70 mol %, preferably 30 - 60 mol % and more preferably 40 - 50 mol %. in a particularly preferred embodiment , the lens chamber walls 112 , 114 are made of a crosslinked phenyl siloxane having a diphenyl content of about 15 - 18 mol % or a phenyl content of about 30 - 36 mol % and the gel is made of a phenyl siloxane having a diphenyl content of about 20 - 25 mol % or a phenyl content of about 40 - 50 mol %. the lens chamber walls 112 , 114 are understood to be more crosslinked than the gel . in a particularly preferred embodiment , the lens chamber walls 112 , 114 are made of a vinyl - terminated phenyl siloxane , most preferably a crosslinked vinyl - terminated phenyl siloxane . reinforcing agents , such as silica , may also be included in a range 10 - 70 mol %, preferably 20 - 60 mol % and most preferably 30 - 50 mol %. the walls 112 , 114 of the lens chamber 110 and the fluid or gel contained within the lens cavity 120 are also preferably selected so as to increase the range of accommodative power that is provided by the lens chamber 110 . in one preferred embodiment , the walls 112 , 114 of the lens chamber 110 are made of a material having a lower refractive index than the fluid or gel contained in the enclosed cavity . in one preferred embodiment , the refractive index of the lens walls 112 , 114 of the chamber 110 is 1 . 38 and the refractive index of the gel or fluid is 1 . 49 . the differential refractive indices provided by the lens chamber walls 112 , 114 and the gel or liquid contained within the chamber 120 may be provided by the differences in the materials or the composition of the materials used for the lens chamber walls 112 , 114 and the gel or liquid . in one embodiment , both the lens chamber walls 112 , 114 and the gel or liquid is made of a phenyl siloxane having different diphenyl or phenyl content . in a preferred embodiment , the lens chamber walls 112 , 114 has a diphenyl or phenyl content that is less than that for the gel or liquid . in another preferred embodiment , the walls 112 , 114 of the lens chamber 110 may be made of a cross - linked vinyl - terminated phenyl siloxane having a diphenyl content of 15 - 18 mol % or a phenyl content of 30 - 36 mol % and the gel contained within the walls 112 , 114 of the lens chamber 110 may be made of a vinyl - terminated phenyl - siloxane having a diphenyl content of 20 - 25 mol % or a phenyl content of 30 - 36 mol %. in another embodiment , the differential refractive indices may be provided by providing a dimethyl siloxane for the lens chamber walls 112 , 114 and the gel may be a phenyl siloxane having a high diphenyl or phenyl content . in a preferred embodiment , the diphenyl content is at least 20 mol %, at least 25 mol %, at least 30 mol %, at least 35 mol %, and at least 40 mol %. alternatively , the phenyl content is at least 40 mol %, at least 50 mol %, at least 60 mol %, at least 70 mol %, and at least 80 mol %. in a further embodiment , the differential refractive indices may be provided by a crosslinked fluoro siloxane , such as a 3 , 3 , 3 - trifluoropropylmethyl siloxane and the gel may be a phenyl siloxane having a high diphenyl or phenyl content . in a preferred embodiment , the diphenyl content is at least 20 mol %, at least 25 mol %, at least 30 mol %, at least 35 mol %, and at least 40 mol %. alternatively , the phenyl content is at least 40 mol %, at least 50 mol %, at least 60 mol %, at least 70 mol %, and at least 80 mol %. now turning back to fig1 a - 1b , a main cavity 130 is defined between the lens chamber 110 , the base lens 150 and the lens periphery 170 . the main cavity 130 is preferably filled with a fluid or gel . the fluid or gel in the main cavity 130 may be the same as the fluid or gel contained in the enclosed cavity 120 . in a preferred embodiment , the fluid is a saline solution and the main cavity 130 is filled with the saline solution after implantation of the iol in the capsular bag of the eye . filling the main cavity 130 after implantation of the iol into the capsular bag will permit the iol to take on a significantly smaller delivery profile such that the iol may be rolled up and inserted through a relatively small incision . in a preferred embodiment , the incision size is less than 6 mm , preferably less than 5 mm , most preferably less than 4 mm and even most preferably less than 3 mm . in embodiments where the main cavity 130 is filled with a fluid or gel after implantation , a valve ( not shown ) is preferably disposed on the iol to permit injection of the fluid or gel into the main cavity 130 after implantation . the valve may be a one - way valve that permits injection of fluid or gel into the main cavity 130 but prevents the fluid or gel from exiting the main cavity 130 . the valve is preferably disposed on the surface of the iol that is facing in the anterior direction after it has been implanted in the eye . it is understood that the valve , however , is preferably not disposed on either one of the opposing sides 112 , 114 so as to avoid disrupting the integrity of the lens chamber 110 which may house the same of different fluid or gel . in a preferred embodiment , the fluids or gels in the respective enclosed cavity 120 and the main cavity 130 are completely segregated from one another . in one preferred embodiment , the enclosed cavity 120 and the main cavity 130 may have a different fluid and / or gel . in another preferred embodiment , one of the enclosed cavity 120 and the main cavity 130 may comprise one of a fluid or gel and the other one of the enclosed cavity 120 and the main cavity 130 may comprise the other one of a fluid or gel . in a preferred embodiment , there is no fluid exchanged between the enclosed cavity 120 and the main cavity 130 . the iol 100 is intended to be implanted in a capsular bag 40 of the eye and centered about an optical axis a - a ( see fig1 a - 11c ). the lens chamber 110 and the base lens 150 are dimensioned to extend to or beyond the effective optical zone b - b as defined about the optical axis a - a of a patient &# 39 ; s eye . the effective optical zone b - b is generally the largest possible opening through which light can enter the eye and thus is controlled by the largest effective diameter of the pupil 30 when completely dilated . this diameter is typically about 4 - 9 mm . therefore , in a preferred embodiment , the diameters of the lens chamber 110 and the base lens 150 is preferably at least 4 mm , at least 5 mm , at least 6 mm , at least 7 mm , at least 8 mm and at least 9 mm . as previously indicated , either one or both of the enclosed cavity 120 of the lens chamber 110 and / or the main cavity 130 is / are filled with a fluid or gel . the fluid may be a gas , a liquid . the fluid or gel preferably is characterized as having a sufficiently high refractive index such that the lens chamber 110 provides a range of accommodation in response to small changes in the curvature of the opposing sides 112 , 114 . because the iol 100 is resiliently biased such that the opposing sides 112 , 114 of the lens chamber 110 are substantially flat or have minimal curvature , small changes in the curvature of the opposing sides 112 , 114 will lead to proportionately greater changes in the refractive power of the lens . thus , the lens chamber 110 , in combination with the base lens 150 , can provide a change in the optical power of up to at least 3 diopters , preferably up to at least 5 diopters , preferably up to at least 10 diopters and most preferably up to 15 diopters in response to the accommodative forces ( e . g ., radially compressive forces ) exerted on the implanted iol . fig2 depicts another embodiment of the iol 200 . the iol 200 is similar in many respects with the iol 100 of fig1 a - 1b in that it comprises a lens chamber 210 , a base lens 250 and a lens periphery 270 joining the lens chamber 210 and the base lens 250 . the lens periphery 270 further comprises a circumferential edge 280 . the iol 200 differs from iol 100 in that iol 200 comprises a plurality of holes 202 disposed circumferentially along the top surface of the iol 200 and externally around the lens chamber 210 and a circumferential channel 240 disposed within the lens periphery 270 . the holes 202 are intended to provide a fluid exchange channel between the circumferential channel 240 , the main cavity 230 and the exterior of the iol 200 . the accommodative forces of the eye &# 39 ; s capsular bag will cause the iol 200 to radially expand and compress which , in turn , will cause the aqueous fluid to enter and exit the main cavity 230 through the holes 202 . in a preferred embodiment , the holes 202 are disposed symmetrically about the top surface of the iol 200 . fig3 a - 3b depict another embodiment of the iol 300 which comprises a plurality of through - holes 302 around the circumferential periphery of the iol 300 . the through - holes 302 differ from the holes 202 in fig2 in that the through - holes are provided through both sides of the iol 300 and the iol 300 does not comprise a circumferential channel , whereas the holes 202 of the iol 200 of fig2 are only provided on the top surface of the iol 200 . the provision of through - holes 302 increase the efficiency with which the aqueous fluid fills and exits the main cavity 330 . moreover , the through - holes 302 are dimensioned to be as large as can fit between the space between the circumferential edge 380 and the lens chamber 310 . one advantage in the provision of numerous large through - holes 302 about the circumferential periphery is that it reduces the material bulk of the iol 300 and permits it to take on a smaller delivery profile when it is folded and inserted into the capsular bag of the eye during implantation surgery . thus , the iol 300 will require a smaller incision for implantation into the capsular bag of the eye . it is understood , however , that the spacing 301 between the through - holes 302 must be sufficient to permit the transfer of force applied to the circumferential edge 380 onto the lens chamber 310 . in a preferred embodiment , the spacing 301 is no more than ¼ , preferably no more than ½ , and most preferably no more than ¾ of the diameter of the through - holes 302 . fig4 depicts another embodiment of the iol 400 also comprising through - holes 402 , except that the through - holes 402 do not provide a fluid exchange between the main cavity 430 and the exterior of the iol 400 . the iol 400 is thus similar to the iol 100 of fig1 a - 1b in that a valve is required such that the main cavity 430 of the iol 400 may be filled after implantation into the capsular bag of the eye . the main function of the through - holes 402 in this embodiment is to reduce the bulk of the iol 400 so as to provide a smaller delivery profile . thus , once implanted , the fluid or gel in the lens cavity 420 and the main cavity 430 remain contained and the iol 400 does not permit for fluid exchange between the fluid in the exterior of the iol 400 and the fluid or gel in the main cavity 430 . fig4 differs from the iols depicted in the preceding figures ( fig1 - 3 ) in that it depicts the shape of the iol 400 when a radial force is applied to the peripheral edge so as to cause a the opposing sides of the cavity 420 to bulge apart from one another . it is noted that the iol 400 must be dimensioned such that the lower wall of the lens cavity 420 does not contact the base lens 450 within a range of the radial force that would be expected during the accommodation of the eye . fig5 a - 5b depict yet a further embodiment of the iol 500 which comprises a plurality of arc - shaped cutouts 502 . the arc - shaped cutouts 502 are configured to function to provide a fluid exchange between the main cavity 530 and the exterior of the iol 500 . the iol 500 comprises radial arms 504 between the arc - shaped cutouts 502 to couple and support the base lens 550 to the lens periphery 570 . in a preferred embodiment , the radial arms 504 comprise a hinge between the peripheral portion 570 and the base lens 550 that permits the radial arms 504 to bend or rock inwardly upon application of a force upon the circumferential edge 580 so that the force is transferred to radially compressing the lens chamber 510 . the hinge may simply be a groove or an area of reduced material thickness that is disposed either on the internal , external or both internal and external surfaces of the radial arms 504 . as with the other iols described herein , the iol 500 returns to a radially - expanded state in the absence of a force applied upon the circumferential edge 580 . the iol 500 is resiliently biased to a flatter configuration as shown in fig5 a in the absence of radially - compressive forces being exerted on the circumferential edge 580 , as when the eye is unaccommodated . the iol 500 is radially compressible to reduce the overall diameter of the lens chamber 110 and thus cause opposing sides 512 , 514 of the lens chamber 510 to increase its curvature upon the application of a radially compressing force onto the circumferential edge 580 , as when the eye is accommodated . see , e . g ., fig4 . fig6 a - 6b depicts yet a further embodiment of the iol 600 which comprises an internal circumferential channel 640 in addition to the enclosed cavity 620 and the main cavity 630 . the circumferential through - holes 602 permit aqueous fluid flow into and out of the circumferential channel 640 and the arc - shaped cutouts 604 permit aqueous fluid flow into and out of the main cavity 630 . radial arms 606 couple the base lens 650 to the peripheral portion 670 and a hinge is disposed on the radial arm between the base lens 650 and the peripheral portion 670 . again , the presence of the internal circumferential channel 640 is intended to reduce the material bulk and thus to permit insertion of the iol 600 through relatively smaller incisions . the iols described herein are intended for implantation in a capsular bag of a patient &# 39 ; s eye following performance of a capsulorhexis , in which a circular portion is removed from the anterior portion of the capsular bag . fig1 a depicts the eye 10 following performance of a capsulhorexis and before implantation of an iol . the eye 10 is depicted as comprising a cornea 20 through which the surgical incision is made to access the capsular bag 40 . the diameter of the circular portion b - b removed from the capsular bag 40 depends upon each person &# 39 ; s individual anatomy is typically in the range of from about 4 mm to about 9 mm . here , the diameter 32 of the circular portion b - b removed from the capsular bag 40 corresponds roughly to the diameter of the pupil 30 . preferably , as much of the capsular bag 40 and its zonular connections 50 are maintained as possible . the zonules 50 couple the capsular bag 40 with the ciliary muscle 60 and transmit the accommodative forces to effectuate the curvature or shape changes of the capsular bag 40 . once the crystalline lens material is removed from the capsular bag 40 , the iol may be inserted and implanted such that the circumferential edge substantially engages the zonules 50 attached to the capsular bag 40 . additionally , the iol is substantially centered along the optical axis a - a and engagement of the iol with the zonules 50 is preferred to reduce the likelihood of decentration . in embodiments of the iol comprising holes and through - holes , it is preferable that the holes and through - holes be located outside of the optical zone b - b . moreover , the holes and through - holes should have rounded edges so as to prevent the perception of glare by the recipient . fig7 a - 7b and 8a - 8b depict an iol 700 which is configured with raised protrusions 790 or troughs 795 adjacent to the through - holes 702 to create a space between the capsular bag and the through - holes 702 and to thereby ensure the free flow of the aqueous fluid in and out of the main cavity 730 and the circumferential channel 740 . the iol 700 comprises three enclosed chambers : an enclosed lens chamber 720 , a main cavity 730 and an internal circumferential channel 740 . a plurality of circumferentially disposed through - holes 702 are sized to provide fluid exchange between both the main cavity 730 and the internal circumferential channel 740 , on the one hand , and the exterior of the iol 700 , on the other hand . the fluid or gel in the lens chamber 720 remains contained within the lens chamber 720 . the iol 700 further comprises arc - shaped cut - outs 704 and radial arms 706 disposed to couple the base lens 750 to the peripheral portion 770 , in the same manner as depicted in fig6 a - 6b . the significant feature of iol 700 is the presence of raised protrusions 790 ( fig7 a - 7b ) or troughs 795 ( fig8 a - 8b ) adjacent the through - holes 702 . the raised protrusions 790 or troughs 795 are configured to ensure that the capsular bag does not form a seal over the through - holes 702 so as to impede or prevent the aqueous fluid from flowing freely in and out of the main cavity 730 and the circumferential channel 740 . as discussed above , the iols described herein are configured to transmit most , if not all , of the radially compressive forces exerted on the circumferential edge onto the lens chamber . in contrast to the elastically deformable lens chamber , the base lens is not configured to deform or change its curvature in response to the radially compressive forces exerted on the circumferential edge . the transfer of the radially compressive forces onto the lens chamber may be accomplished by incorporating one or more of the following features in the iol : ( 1 ) the opposing sides of the lens chamber having a reduced thickness as compared to the base lens , ( 2 ) a hinge disposed between the base lens and the peripheral portion , ( 3 ) utilizing materials having different elastic moduli for the lens chamber and the base lens ; and ( 4 ) the variation of refractive indices provided for the opposing sides of the lens chamber and the fluid or gel contained therein . fig1 a and 10b depict an iol 800 which is constructed of at least two different elastomeric materials having different young &# 39 ; s modulus of elasticity , with at least the base lens 850 being made of a material having a higher young &# 39 ; s modulus than the lens chamber 810 . fig1 a depicts the iol 800 as being constructed by assembling at least five ( 5 ) separately molded pieces , 801 a , 802 a , 803 a , 804 a , and 850 . thus , in addition to the two halves 801 a , 803 a of the lens chamber 810 , the peripheral portion of the iol 800 is provided in two ring portions 802 a , 804 a . the first ring portion 802 a surrounding the lens chamber 810 has a higher elastic young &# 39 ; s modulus than the second ring portion 804 a surrounding the base lens 850 . in a preferred embodiment , the two halves 801 a , 803 a of the lens chamber 810 and the second ring portion 803 a has a young &# 39 ; s modulus of 100 psi or less , preferably 75 psi or less , and most preferably 50 psi or less and the base lens 850 and the first ring portion 802 has a young &# 39 ; s modulus of more than 100 psi , preferably more than 250 psi , and most preferably more than 350 psi . in a particularly preferred embodiment , the young &# 39 ; s modulus of the first ring portion 802 a may be up to 500 psi . fig1 b depicts the iol 800 as being constructed by assembling at least three ( 3 ) separately molded pieces 801 b , 802 b and 803 b . the first lens chamber 810 and the surrounding peripheral portion is provided by assembling 801 b and 802 b and the base lens portion 850 and the surrounding peripheral portion is provided by assembling 803 b to the underside of 802 b . the assembled first lens chamber 810 and surrounding peripheral portion ( 801 b , 802 b ) has a lower elastic young &# 39 ; s modulus than the base lens portion 850 and the surrounding peripheral portion ( 803 b ). in a preferred embodiment , portions 801 b , 802 b has a young &# 39 ; s modulus of 100 psi or less , preferably 75 psi or less , and most preferably 50 psi or less and the base lens portion 803 b has a young &# 39 ; s modulus of more than 100 psi , preferably more than 250 psi and , most preferably , more than 350 psi . in a particularly preferred embodiment , the young &# 39 ; s modulus of the base lens portion 803 b may be up to 500 psi . the invention described and claimed herein is not to be limited in scope by the specific preferred embodiments disclosed herein , as these embodiments are intended as illustrations of several aspects of the invention . indeed , various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description . such modifications are also intended to fall within the scope of the appended claims .
an intraocular lens device comprising a first lens , a second lens and a circumferential haptic . the first lens comprises a pair of opposing and deformable surfaces and a cavity defined therebetween . the first lens has a first lens diameter . the second lens has a second lens diameter . the circumferential haptic has an outer peripheral edge and couples the first lens and the second lens . a main iol cavity is defined by the circumferential haptic , the first lens and the second lens . the iol device is resiliently biased to an unaccommodated state , characterized by the iol device having a first diameter d 1 in the absence of radial compressive forces exerted on the outer peripheral edge . the iol device actuates to an accommodated state being characterized by a second diameter d 2 in response to radial compressive forces exerted on the outer peripheral edge , wherein d 1 & gt ; d 2 .
the present invention relates to an edible composition having a salty taste which consists essentially of an admixture selected from the group consisting of ( 1 ) lysine monohydrochloride and potassium chloride , and ( 2 ) the lysine monohydrochloride , the potassium chloride and succinic acid each of which are food grade , wherein the weight ratio of the lysine monohydrochloride to potassium chloride is between about 1 to 9 and 3 to 2 and wherein the ratio of lysine monohydrochloride to succinic acid is between about 3 to 1 and 13 to 1 and the composition has a ph between about 5 . 5 and 6 . 3 . the present invention also relates to a method for imparting a salty taste to a food which comprises providing an edible composition in the food which consists essentially of an admixture selected from the group consisting of ( 1 ) lysine monohydrochloride and potassium chloride , and ( 2 ) the lysine monohydrochloride , the potassium chloride and succinic acid which are food grade , wherein the ratio of the lysine monohydrochloride to potassium chloride is between about 1 to 9 and 3 to 2 and wherein the ratio of lysine monohydrochloride to succinic acid is between about 3 to 1 and 13 to 1 and the composition has a ph between about 5 . 5 and 6 . 3 . the composition is easily prepared by simple mixing of the ingredients . in order to mask the bitter aftertaste of the potassium chloride there must be between 10 % to 60 % of the lysine monohydrochloride . when crystals of lysine monohydrochloride are physically mixed with crystals of potassium chloride , the resulting mixture has the appearance of , and taste intensity of , table salt , without the characteristic taste of the potassium ion . lysine monohydrochloride can also be co - crystallized with potassium chloride from a solution in which they are soluble ( such as water ) to produce a salty crystalline mixture . the succinic acid produces a more salty taste in amounts between about 0 . 1 and 10 percent by weight in the composition . in the most preferred compositions the weight ratio of lysine monohydrochloride to potassium chloride is between 2 and 3 to 7 . when succinic acid is present , the weight ratio of lysine monohydrochloride to potassium chloride is 2 and 2 . 99 to 7 and the succinic acid is included in an amount between 0 . 1 and 10 percent by weight of the composition . lysine is an essential amino acid and thus is a dietary supplement . potassium chloride is commonly used as a salt substitute to avoid sodium intake . succinic acid is a common food acid . thus , the composition fulfills dietary as well as taste needs . table 1 shows the results of taste tests by a taste panel of 3 people of various compositions incorporating lysine monohydrochloride ( lysmhc ) lysine monohydrate ( lysmh ) potassium chloride ( kcl ) and an acid ( hcl ) or base ( koh ). table 1______________________________________salt molar ratio ofname lys / cl / k solution comp . sol . ph taste______________________________________1 2 : 4 : 2 lysmhc + kcl 5 . 55 salty +++ 2 2 : 3 : 1 lysmhc + kcl 5 . 66 salty - acid3 2 : 2 : 1 lysmhc + lysmh + kcl 9 . 34 salty4 4 : 3 : 1 lysmhc + lysmh + kcl 9 . 48 salty - sweet5 2 : 2 : 1 lysmhc + koh 9 . 50 salty - metallic6 2 : 6 : 2 lysmhc + kcl + hcl 1 . 00 acidic______________________________________ * the salt + tastes saltier than salty and salty - tastes less saltier than salty . ** the water used was double distilled water . a crystallized dry salt product composed of lysmhc and kcl ( 1 ) with a molar ratio of 2 : 4 was found to possess the desired salty taste . table 2 shows the results of taste tests by a taste panel of 3 people for various mixtures of lysine monohydrochloride ( lysmhc ) and kcl mixtures as dry salts and in solution . table 2______________________________________weight % sol ./ 2 glysmhc / kcl dry mixture water ph______________________________________0 / 100 ( 25 %) irritates irritates 7 . 6210 / 90 salty ++++* salty ++++ 6 . 2320 / 80 salty +++ salty ++++ 6 . 2130 / 70 salty ++ salty +++ 6 . 1240 / 60 salty ++ salty +++ 6 . 0150 / 50 salty + salty + 5 . 9960 / 40 salty salty 5 . 9770 / 30 salty - salty + 5 . 8780 / 20 salty -- salty + 5 . 8390 / 10 salty --- salty -- 5 . 71100 / 0 ( 33 %) salty - sweet salty - sweet 5 . 75100 % dd ** water -- -- 5 . 70______________________________________ * the salt + tastes saltier than salty and salty - tastes less saltier than salty . ** double distilled water . as can be seen from table 2 mixtures including 10 to 60 % of the lysine monohydrochloride with potassium hydrochloride had the desired taste both in dry form and in solution . these mixtures also had an acid ph between about 5 . 5 and 6 . 3 depending upon the amount of lysine monohydrochloride . table 3 shows different concentrations of a thirty weight percent ( 30 %) lysine monohydrochloride to potassium chloride mixture ( dry ) mixed which is then dissolved in water used in taste tests by a taste panel of 3 people . as can be seen , the mixture can be used in an amount up to about 30 % by weight in water to produce the desired salty taste . table 3______________________________________30 wt % lys / kclcont . in water ph taste comment______________________________________10 6 . 04 salty clear sol . 20 6 . 02 salty + clear sol . 30 6 . 02 salty ++ clear sol . 40 5 . 90 irritates saturated25 % ( 100 % kcl ) 7 . 62 irritates clear sol . 25 % ( 100 % 7 . 11 standard blurrednacl ) sol . ______________________________________ no other amino acid tested ( including glutamic acid , glutamic acid monohydrochloride , glycine , glycine monohydrochloride , and lysine monohydrate ) provided the masking of the potassium taste . the optimal concentration of lysine monohydrochloride in the mixture was about thirty percent ( 30 %) by weight in example 3 based upon taste tests . a preference test was conducted in which 38 panelists participated and tasted four dry samples in random order . the samples were : 1 . 70 / 30 wt % potassium chloride / crystalline lysine monohydrochloride , which is the subject of the current application . 2 . commercially available morton salt substitute ( containing potassium chloride , fumaric acid , tri - and mono - calcium phosphate ). 3 . example 1 of u . s . pat . no . 2 , 829 , 056 ( containing lysine dihydrochloride , mono - potassium glutamate , potassium chloride and tricalcium phosphate ). the results of this test indicated the composition no . 1 of the invention was preferred to no . 2 and no . 3 . the ranking of samples no . 1 , no . 2 and no . 3 were 61 , 75 , and 86 , respectively , with the lowest number being preferred . the ranking was determined as follows : there was statistically difference at the 95 % level between no . 1 and no . 3 ( u . s . pat . no . 2 , 829 , 056 ), but the difference between no . 1 and no . 2 was not statistically significant . taste trials were performed to assess the intensity of the composition no . 1 of the invention in aqueous solution . in these trials a fifth sample was added to those of example 4 . a 4 % solution was prepared of each sample and the rank scores were 16 , 49 , 50 , 55 , and 55 for samples no . 4 , no . 5 , no . 2 , no . 3 and no . 1 , respectively . this test indicates that the samples no . 1 and no . 5 were about 50 % the intensity of regular table salt . succinic acid ( sa ) was added to physical mixtures of potassium chloride ( kcl ) and lysine monohydrochloride ( lysmhc ). the results are shown in the following table 4 . table 4______________________________________wt % kcl / lysmhc / sa dry mixture taste 4 % solution taste______________________________________70 / 30 / 00 salty very mild salty70 / 15 / 15 very acidic , irritates very acidic , irritates70 / 20 / 10 very acidic acidic70 / 25 / 05 salty acidic salty acidic70 / 27 . 5 / 2 . 5 very good salty mild salty45 / 45 / 10 salty acidic very little saltiness______________________________________ these data indicate that there is a taste improvement by addition of a small amount of succinic acid . the ratio of lysine monohydrochloride to succinic acid that gives this advantage is 10 : 1 as in application ser . no . 08 / 376 , 395 , filed jan . 23 , 1995 . preferably between about 2 . 5 and 2 . 9 percent of the composition is succinic acid and the remainder is potassium chloride . it is intended that the foregoing description be only illustrative of the present invention and that the present invention be limited only by the hereinafter appended claims .
a physical mixture which consists essentially of compositions of lysine monohydrochloride and potassium chloride alone or admixed with small amounts of succinic acid , in particular weight ratios , and which has a salty taste comparable to table salt . the mixture masks the bitter aftertaste of the potassium chloride and can provide dietary lysine which is an essential amino acid .
in fig1 the torso and head of a patient are shown along with the patient &# 39 ; s heart h , esophagus e and stomach s . the stomach is located posterior and spaced from the ventricle v . the esophageal - stomach displacement electrode shown extends through the patient &# 39 ; s mouth , through the esophagus and into the stomach with its distal end located relatively close to the ventricle v . the present invention enables the distal end of the esophageal - stomach displacement electrode to displace angularly within the stomach and subsequently be pulled slightly back out of the esophagus , or alternatively , further angularly displaced , upwardly into pressurized contact with the stomach wall to position the wall closer than normal to the heart ( see fig4 ) and thereby place the stomach displacement electrode in closer proximity to it . this is illustrated in fig2 and 3 and 4 . the electrode includes a semi rigid plastic tube 10 made of nylon or other suitable material which may be approximately 20 inches long and approximately 3 / 16 inch in diameter . the tube should be semi rigid , much like a gastric tube , and be relatively torque free . the distal end 12 of the tube carries an electrode 14 , preferably spherical in shape and having a stem 16 that fits within the distal end of the tube . the electrode may be pressed in place or suitably fastened by other means . in the preferred form , the electrode 14 is 1 / 4 inch in diameter , which just exceeds the diameter of the tube 10 so that the ball will make positive contact with the stomach wall when the distal end 12 of the tube 10 is displaced . the distal end 12 may be then further displaced or the complete electrode pulled back out of the esophagus to cause a bulge 50 ( fig4 ) in the stomach wall to place the wall and the electrode 14 closer to heart ventricle v . at this point , the electrode is prevented from further displacement by resistance of the stomach wall . the tube 10 is carried by a control mechanism 20 shown in fig4 which is connected to a displacement mechanism 22 disposed in the tube . the control mechanism is located at the proximal end of the tube outside the mouth when the esophageal - stomach displacement electrode is placed in the stomach as shown in fig1 . the tube 10 is crimped as suggested at 26 in fig2 and 4 so as to form a hinge 27 in the tube , which enables it to bend readily at that point . in the wall 25 of the tube 10 , ports 28 and 30 are formed on opposite sides of the hinge 27 , each spaced approximately an inch therefrom . while in the embodiment shown , each of the two ports is approximately one inch from the crimp 26 , that dimension as well as others given may be varied to suit the particular application , as is more fully described below . a rigid pin 32 is disposed in the tube 10 and extends generally parallel to the tube axis . the pin may be made of metal , rigid plastic , or any other material having sufficient rigidity to prevent the tube 10 from bending at the crimped area 26 when the pin spans the hinge . a pair of cords 34 and 36 are connected to the proximal and distal ends 38 and 40 , respectively , of pin 32 and extend proximally in the tube 10 out its proximal end 42 and into the control mechanism 20 . cord 34 extends directly from the proximal end of the pin 32 within the tube 10 to the control mechanism 20 , while cord 36 extends from the distal end 40 of the pin , out the tube 10 through port 28 and from that point it extends proximally externally of the tube , spanning the crimped portion 26 to the port 30 where the cord reenters the tube 10 and extends in the tube to the control mechanism 20 . as is evident from fig2 and 4 , the location of the pin 32 may readily be changed by pulling one or the other of the cords 34 or 36 in a proximal direction . pin 32 is somewhat shorter than the distance between the crimped portion 26 of the tube and the lower port 28 . travel of the pin 32 in the tube 10 in a distal direction is limited by the location of port 28 . the size of pin 32 is such that it cannot be drawn through port 28 and , therefore , when the pin 32 reaches its lowermost point and a continued pull is exerted on cord 36 , the distal portion of the tube 10 is caused to deflect ( in this example approximately 135 °) from the position shown in fig2 to that shown in fig3 . at this point the tube must still be further deflected or pulled back out of the stomach to place it into pressurized contact with the stomach wall to cause a bulge 50 as shown in fig4 . while the tube 10 is displaced or bent about the hinge 27 by pulling on cord 36 when pin 32 has reached its lowermost position , merely by releasing tension on the cord 36 , the natural bias of the tube 10 to the configuration of fig1 and 2 will cause it to return to the shape shown therein . the control mechanism 20 shown in fig5 is connected to the distal ends of the cords 34 and 36 to operate the displacement mechanism 22 by taking up one cord and playing out the other . the control mechanism 20 includes a sleeve 50 , rectangular in cross section in the embodiment shown , and containing a slide 52 . a bracket 54 is secured to the bottom wall 56 of sleeve 50 and retains the proximal end 42 of tube 10 in place . the bracket 54 includes a bar 62 and clamping plate 58 that sandwich the tube end , and the plate 58 is secured to the bar 62 by screws 60 . the cords 34 and 36 enter the sleeve 50 through a port 64 in bottom wall 56 , aligned with the proximal end 42 of the tube 10 when the tube is secured to the bracket 54 . the proximal ends 66 and 68 of the cords are respectively connected to flanges 70 and 72 carried by the slide 52 . in fig5 slide 52 is shown in the position that places the pin 32 in the tube in the position shown in fig2 . when the slide is moved to the right as viewed in fig5 the pin 32 moves to its lowermost position in tube 10 and the tube is deflected , as shown in fig3 . because the slide 52 is generally u shaped with an opening 74 in its bottom wall 76 that rests upon the bottom wall 56 of sleeve 50 , movement of the slide 52 in the sleeve 50 does not in any way interfere with the movement of the cords 34 and 36 in response to displacement of the slide . the electrode typically may be used in the following manner . assume that the electrode is part of a pacing mechanism as shown in u . s . pat . no . 4 , 735 , 206 , supra . the tube 10 is inserted into the esophagus either through the mouth or the nasal passage to a depth wherein the electrode 14 is disposed out the lower end of the esophagus into the stomach at a depth sufficient to enable displacement of the tube &# 39 ; s distal end 12 to approximately 135 degrees from its straighten or insertion position as shown in fig3 . the external electrode also forming part of the pacer is mounted on the chest of the patient and the controls , etc . are properly set . in order to reduce the amount of electrical energy required to effect pacing , the operator moves the slide 52 to the right as shown in fig5 which will cause the pin 32 to move downwardly in the tube 10 so that its distal end 40 is immediately adjacent the port 28 . further movement of the slide 52 in that direction will cause the distal portion of the tube 10 to deflect and place the electrode 14 in proximity to the upper stomach wall near the heart ventricle v ., as shown in fig3 . further deflecting the distal end 12 or pulling back the tube 10 at its proximal portion then places the electrode 14 in pressurized displacable contact with the upper stomach wall causing a bulge that places the electrode closer to the ventricle v ( fig4 ). with the electrode in the displaced position of fig4 the pacing pulses are imposed across the electrodes . when the procedure is completed , the operator may move the slide 52 back to the position of fig5 which will relieve the tension on the cord 36 and allow the tube 10 to return to the position of fig2 . thereafter the tube 10 may be withdrawn . from the foregoing description , those skilled in the art will appreciate that the present invention provides a very convenient means of enabling an operator to place the esophageal stomach displacement electrode very close to the heart or other organ by means of a noninvasive procedure and thereby reduce the energy required to carry out the particular procedure such as pacing or defibrillation upon the patient . it will also be appreciated that while a specific embodiment is shown in the drawings , modifications may be made thereof without departing from this invention . for example , while a pin is shown as applying the bending force to the interior of the tube , other configurations for the device may be employed . any structure which will not pass through the lower port 28 and will not interfere with the action of the hinge 27 will cause the tube 10 to deflect when the cord attached to it and exiting the tube through the port 28 is tensioned . it should , if necessary , also stiffen the hinge portion of the tube when it is being inserted in the esophagus and stomach . the member which applies the bending force must be capable of moving freely in the tube under the operation of the control 20 so as to be readily movable in response to actuation of the control . the tube 10 could , of course , carry more than one electrode . for example , in the earlier patents , supra , a number of spaced contact rings are shown carried by the tube . because modifications may be made of the invention without departing from its spirit , it is not intended that the scope of this invention be limited to the specific embodiment illustrated and described . rather , the scope of this invention is to be determined by the appended claims and their equivalents .
an esophageal - stomach displacement electrode comprises a flexible tubular member designed to be inserted through the esophagus into the stomach . an electrode is carried by the tube in the region of its distal end . the tube is hinged near the distal end which enables that end of the tube to displace angularly in the stomach and displace the stomach wall . the stomach wall displacement may occur by angularly displacing the distal end or by otherwise pulling the tube partially out of the esophagus after its distal end partially displaced toward the stomach wall . a displacement mechanism is disposed in the tube in the region of the hinge and is controlled from a point externally of the body for causing the distal end of the tube to displace angularly , and to be positioned to engage and displace the stomach .
the present invention is a board game intended to simulate the life at a lake . much of the interest in the game lies in experiencing the ups and downs of life on , at , adjacent , or near a lake , and includes the acts of acquiring , selling , mortgaging and improving properties , such as lake areas , dams and boat dealerships associated with lakes . while the preferred embodiment set forth below involves particular properties , such as lake areas , boat dealerships on , adjacent , or relating to various lakes , those skilled in the art will understand that the invention is not limited to only lake areas , boat dealerships and dams . other types of lake - related properties are within the scope of the invention . as best illustrated in fig1 a , the game includes a generally square - shaped game board 10 including a total of eight portions b , c , d , e , f , g , h , i positioned about a periphery of the board . each of the portions b , c , d , e , f , g , h , i includes five delineated , sequential spaces . as seen in fig1 a , each of portions b , c , d , e , f , g , h , i are contiguous with two other portions b , c , d , e , f , g , h , i , thus forming a continuous path of delineated spaces adjacent a periphery of board 10 . as best illustrated in fig2 a through 2c , tokens 20 represent the identities of the players . tokens 20 are moved across the path according to a throw of dice by the token &# 39 ; s owner . for example , if a total of seven results from the owner &# 39 ; s dice throw , that player moves his or her token seven spaces along the path . while only three exemplary tokens 20 are depicted , those skilled in the art will appreciate that the invention is not limited to such examples . other examples of configurations include those in the shape of a captain &# 39 ; s wheel , a life preserver , a boat trailer , a cigarette boat , a cabin cruiser , a drag boat , a cruise liner , a jet ski , a ski boat , a fishing boat , an open bow boat , a day cruiser , and a sailboat . moreover , the number of players is not limited to three . while any reasonable number of players may play , a preferred number of players is four to nine . portion b includes a go space 100 , which serves as a starting point for the players on the board &# 39 ; s continuous path . portion b further includes two spaces corresponding to lake areas , namely bear lake 110 and jump off joe lake 130 . sunken chest space 120 , and waterfront taxes due space 140 make up the remainder of portion b . lake areas in the game are organized into groups . each of the lake areas in a given group has a common color that identifies their association as a group . for example , a purple bar on each of bear lake 110 and jump off joe lake 130 may be used to identify them as belonging to one group of lake areas . portion c includes three lake areas , namely , medical lake 160 , clear lake 180 , and waitts lake 190 . a bluish - green bar may be used to identify these areas as making up another associated group of lake areas . portion c further includes sun runner boat dealership space 160 and makin a wake space 170 . portion d includes an in jail / just visiting space 200 , which has a in jail portion 204 and a just visiting portion 205 . portion d also includes three spaces corresponding to another group of associated lake areas , namely , liberty lake 210 , marshal lake 230 , and rock lake 240 . orangish - red bars are preferably included on lake areas 210 , 230 , 240 to indicate their association . spokane falls dam space 220 completes the amount of spaces in portion d . portion e includes three spaces corresponding to yet another group of associated lake areas , namely , deer lake 260 , silver lake 280 and loon lake 290 . bars colored orange may be used to indicate their association as a group . searay dealership space 250 and sunken chest space 270 complete the number of spaces in portion d . portion f includes a free boat launch space 300 and three spaces corresponding to yet another group of associated lake areas , badger lake 310 , sprague lake 330 , and thomson lake 340 , each of which preferably has a red bar thereon to indicate their group association . makin a wake space 320 completes portion f . portion g includes three spaces to form yet another group of associated lake areas , namely , lake cocolala 360 , spirit lake 370 , and long lake 390 . they preferably have yellow bars indicating their association . a bayliner space 350 and a grand coulee dam space 380 complete portion g . portion h includes go to jail space 400 . lake sachine 410 , priest lake 420 , lake roosevelt 440 make up still another group of associated lake areas . they preferably have colored bars , in this case green , to indicate their association . sunken chest space 430 completes portion h . finally , portion i includes two spaces corresponding to a last group of associated lake areas , namely , lake pend oreille 470 and lake couer d &# 39 ; alene 490 . an association between them as a group is preferably indicated by dark blue bars thereon . portion i is completed by donzi dealership space 450 , makin a wake space 460 and boat tab renewal space 480 . the game is played with scrip money , preferably in denominations of $ 1 , $ 5 , $ 10 , $ 20 , $ 50 , $ 100 , and $ 500 . at the beginning of the game , the players should be given equal amounts of scrip , which in a preferred embodiment of the game is $ 1 , 500 . if the number of players exceeds the amount of preferred $ 1 , 500 multiples of scrip in the bank , then each share of scrip may be accordingly decreased and a credit against the decreased amount be maintained for the player against the bank . the game also utilizes a plurality of makin a wake cards 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 , as individually shown in fig3 a through 3d , that are stacked face down and piled at space 30 , as illustrated in fig1 a . similarly , a plurality of sunken chest cards 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 , individually illustrated in fig3 e through 3i , are stacked face down and piled at space 40 , again as shown in fig1 a . the game also includes a predetermined amount of lake cabins 50 and marinas 60 , as shown in fig2 d and 2e , respectively , for placement upon lake areas . the game may be played by two or more players , one of whom serves as banker . the banker handles all receipt and payment of scrip on behalf of the bank . the bank is the original owner of all of the lake areas , boat dealerships , and dams , as described above . play of the game is organized into turns for each player . on each player &# 39 ; s turn , he or she operates one or more elements for randomly determining movement of the tokens over the path . preferably , two such elements are dice . based upon the amount shown on the element ( s ), such as dice , the player moves his or her token the indicated number of spaces along the continuous path in a clockwise direction . those skilled in the art will appreciate that the invention is not limited to the use of dice , but that any chance - determining element may be used . for example , a spinner may be used to determine the number of spaces advanced by a player &# 39 ; s token during his or her turn . if , as a result of a player &# 39 ; s throw of the dice , his or her token lands upon one of the lake areas , boat dealerships , or dams , he or she may purchase it from the bank if it is not already owned . the price for the lake area , boat dealership or dam in question is preferably displayed on the associated space . exemplary prices for the lake areas may be found in table i , while exemplary prices for each of boat dealerships and dams may be found in table ii . as seen in tables i and ii , prices for the lake areas vary greatly , just as they do around lakes in reality . table i preferred prices for lake areas lake area price ($) bear lake 110 60 jump off joe lake 130 60 medical lake 160 100 clear lake 180 100 waitts lake 190 120 liberty lake 210 140 marshal lake 230 140 rock lake 240 160 deer lake 260 180 silver lake 280 180 loon lake 290 200 badger lake 310 220 sprague lake 330 220 thomson lake 340 240 lake cocolala 360 260 spirit lake 370 260 long lake 390 280 lake sachine 410 300 priest lake 420 300 lake roosevelt 440 320 lake pend oreille 470 350 lake couer d &# 39 ; alene 490 400 [ 0065 ] table ii preferred prices for boat dealerships and dams boat dealership or dam price ($) sun runner dealership , 150 200 spokane falls dam , 220 150 searay dealership , 250 200 bayliner dealership , 350 200 grand coulee dam , 380 150 donzi dealership , 450 200 as best shown in fig4 a through 4n , one title deed card 113 , 133 , 163 , 183 , 193 , 213 , 233 , 243 , 263 , 283 , 293 , 313 , 333 , 343 , 363 , 373 , 393 , 413 , 423 , 443 , 473 , 493 is associated with each one lake area . similarly , a title deed card 153 , 253 , 353 , 453 , 223 , 383 , is associated with each individual boat dealership 150 , 250 , 350 , 450 and each individual dam 220 , 380 , respectively . after payment of scrip money to the bank , the player purchasing a property receives the associated title deed card as proof of ownership . preferably , each of the title deed cards associated with a lake area has a colored bar displayed thereon to match the corresponding lake area on board 10 . if the player landing upon an unowned property does not wish to purchase it , the banker , upon preagreed rules , may auction off the property to the highest bidder among the remaining players . the winning bidder receives the associated title deed card after receipt of payment to the bank . once a property has been sold , the associated title deed card is displayed face side up by that player in order to indicate that it is not mortgaged . preferably , each of the boat dealership spaces 150 , 250 , 350 , 450 , and title deed cards 153 , 253 , 353 , 453 associated therewith includes a picture 154 , 254 , 354 , 454 , respectively , that is illustrative of life at a lake . for example , each of pictures 154 , 254 , 354 , 454 can be an ornamental design for a boat , such as one commonly used on a lake . similarly , each of the dam spaces 220 , 380 , and title deed cards 223 , 383 , includes a picture 224 , 384 illustrative of life at a lake . for example , each of pictures 224 , 384 can be an ornamental design of a waterfall plunging over a dam at the edge of a lake . if the property landed upon is already owned by another player , the player landing , or “ trespassing ”, upon the property must pay a rental fee to the owner if the owner demands the same in a timely manner such as , for example , before the next player rolls the dice . in the case of boat dealerships or dams , the rental fee will depend upon how many boat dealerships or dams are owned by the owner of the landed upon space at the time of the trespass . if the player &# 39 ; s token is trespassing upon a dam space , the player must throw the dice and pay a multiple of the dice throw in scrip to the owner of the dam as a rental payment . the multiple used depends upon how many dams are owned by the player owning the dam in question , and is indicated on the title deed to the dam . for example , in a preferred embodiment the player whose token lands upon a dam must pay four times the amount resulting from the dice throw if only one dam is owned , and ten times the amount if two dams are owned . similarly , if a player &# 39 ; s token lands upon a boat dealership that is owned by another player , the player trespassing must also pay the owner a rental fee based upon the number of boat dealerships owned by the player whose boat dealership was landed upon . however , the rental fee is not dependent upon a throw of the dice , but is instead displayed on the associated title deed card . in a preferred embodiment , the trespasser must pay $ 25 if the owner owns only a single boat dealership , $ 50 if the owner owns two dealerships , $ 100 if the owner owns three dealerships and $ 200 if the other player owns all the dealerships . if a player &# 39 ; s token lands upon a lake area that is already owned by another player , the rental fee due will depend upon whether all the lake areas in the group are commonly owned and whether the lake area landed upon has been improved , i . e ., whether lake cabin ( s ) and / or a marina have been erected upon the lake area landed upon . the particular rental fee may be read from the information displayed on the associated title deed card . if one player owns all the lake areas in a given group , the rental payment is twice the amount displayed on the associated title deed card if the lake area is not improved , i . e ., no lake cabins or marinas have been erected thereon . for example , the rental payment for trespassing upon the thomson lake area 340 ( and the other lake areas 310 , 330 in the group are not commonly owned ) in an unimproved condition is only $ 20 , as best shown in fig4 i . the rental payment for trespassing on an unimproved thomson lake area 340 increases to $ 40 if the owner also happens to own both the other lake areas 310 , 330 associated therewith . the rent for trespassing increases with the number of lake cabins and marinas built upon the trespassed upon lake area . for example , with reference to fig4 i , rent for one lake cabin on the thomson lake area 340 costs $ 100 , rent for three lake cabins costs $ 750 , and rent for one marina costs $ 1 , 100 . as described above , the lake areas are organized into groups . if a player acquires all the lake areas within an associated group , the player is allowed to improve one or more of his or her lake areas in the associated group on his or her turn by erecting lake cabins and / or marinas . the player may erect up to four lake cabins on each lake area in the group . once four lake cabins have been erected on each lake area in the group , the player may then erect up to one marina each on one or more of the lake areas in the associated group . when a marina is erected , the lake cabins must be returned to the bank . thus , the rental payment for trespassing on a lake area with a marina does not include any additional rent for the four lake cabins previously , i . e ., the rental payment is not cumulative for all improvements . the costs for erecting lake cabins and marinas is displayed on the title deed card associated with the lake area that is being improved . for example , with reference to fig4 i , the erection of each lake cabin on lake thomson 340 costs $ 150 , while the marina costs an additional $ 150 . as in purchases of lake areas from the bank , the costs for improving a lake area are payable to the bank . because the number of lake cabins and marinas is limited , they may not be available from the bank at the time a player wishes to buy them . if so , that player must wait until another player sells or returns one or more of them back to the bank , a subject that is described in greater detail below . a player improving his or her lake areas in an associated group must do so in an even manner upon the lake areas within that group . for example , while a player may erect one house at a time upon any one of the lake areas in an associated group , he or she may not erect , for example , two houses on one lake area and no houses on another lake area within the same group , or for example , three houses on one lake area and one or no houses on another lake area within the same group . the board includes several other lake - related spaces , spaces which do not have corresponding title deed cards and which may not be owned . these spaces include waterfront taxes due space 140 , in jail / just visiting space 200 , free boat launch 300 , boat tab renewal space 480 , and go space 100 . waterfront taxes due space 140 represents the relatively higher amount of taxes paid by a person owning a lot adjacent a lake shore . if a player &# 39 ; s token lands upon waterfront taxes due space 140 , that player must pay the bank his or her choice of 10 % of his or her scrip on hand , or $ 200 . boat tab renewal space 480 represents a boat owner &# 39 ; s requirement to renew his or her boat trailer &# 39 ; s registration , a process evidenced by a new tab . if a player &# 39 ; s token lands upon boat tab renewal space 480 , that player must pay the bank $ 75 in scrip . preferably , waterfront taxes due space 140 includes a picture 144 illustrative of home on a lakefront that is subject to , of course , waterfront taxes . desirably , boat tab renewal space 480 includes a picture 484 illustrative of a boat trailer and money . free boat launch 300 space represents a boat launch open to the public without any fees . free boat launch space 300 indicates that no rental is due for any player landing his or her token upon the space . similarly , free boat launch space 300 also includes a picture 340 , which in this case , is preferably illustrative of a boat launch site . if a player &# 39 ; s token lands upon go to jail space 400 , that player must place his or her token in an in jail portion 204 of in jail / just visiting space 200 . a player whose token is in the in jail portion 204 must remain in that space until a dice throw on his or her next turn ( or his third turn ) is a “ double ”. if no such double is thrown by the player &# 39 ; s third consecutive turn , he or she must pay a $ 50 fine to the bank to be freed . a “ double ” is a dice throw in which each die results in the same number . for example , one type of “ double ” includes the situation when a “ 3 ” is displayed by each of two dice . once freed from the in jail portion 204 , the player moves his or her token to the just visiting portion 205 of the space 200 . when a player lands upon the in jail / just visiting space 200 in the ordinary course of play , the player places his or her token in a just visiting portion 205 of the in jail / just visiting space 200 to indicate that he or she is “ just visiting ”, and is not subject to imprisonment as described above . a player &# 39 ; s token is also placed in the in jail portion 204 if he or she rolls doubles thrice in succession during a turn or draws a “ go to jail ”- type sunken chest or makin a wake card , each of which is described in greater detail below . at the beginning of the game , players start moving their tokens from go space 100 . as the continuous path wraps around and reaches go space 100 , players will inevitably either land upon , or pass over , go space 100 , thus completing a full circuit of the path . because the path is continuous , there is no point along the board at which play terminates or a player wins . instead , the termination of play is determined by other facets of the game , the details of which are discussed below . if a player &# 39 ; s token lands upon , or passes over , go space 100 , that player collects $ 200 from the bank . the makin a wake spaces 170 , 320 , 460 and sunken chest spaces 120 , 270 , 430 represent some of the ups and downs of life on a lake . metaphorically speaking , a wake from a boat may sometimes tip a boat over , while at other times lift a boat high up in the air . similarly , a chest found at the bottom of a lake may hold a surprise or two for a person opening it up . if a player &# 39 ; s token lands upon one of the makin a wake spaces 170 , 320 , 460 or sunken chest spaces 120 , 270 , 430 , he or she must draw a card from the appropriate one of two piles stacked face down at the respective spaces 30 , 40 , as illustrated in fig1 a . as best illustrated in fig3 a through 3d , each of the makin a wake cards 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 has indicia thereon announcing one of a benefit , a penalty and an instruction to move the drawing player &# 39 ; s token 20 to a particular space on the board 10 . similarly , as best shown in fig3 e through 3i , each sunken chest card 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 has indicia thereon announcing one of a benefit , a penalty and an instruction to move the drawing player &# 39 ; s token 20 to a particular space on the board 10 . preferably , a plurality of the makin a wake cards 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 and / or sunken chest cards 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 have lake - related indicia associated with a penalty , benefit or instruction . after following the instructions indicated by the indicia printed thereon , the drawing player returns the card face down to a bottom of the appropriate pile at the respective space 30 , 40 . as best illustrated in fig1 b , 1c , 1 e , 1 f , 1 h and 1 i , in a preferred embodiment , each of the makin a wake spaces 170 , 320 , 460 , and sunken chest spaces 120 , 270 , 430 includes a picture 174 , 324 , 464 and 124 , 274 , 434 , respectively , illustrative of life at a lake . for example , the sunken chest picture 124 , 274 , 434 can be an ornamental illustration of a treasure chest , and the makin a wake picture 174 , 324 , 464 can be a scene of a boat traveling fast enough to create a wake in the water . moreover , as best illustrated in fig3 a through 3i , each makin a wake card 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 and sunken chest card 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 will either grant a particular benefit , assign a particular penalty , or instruct the drawing player to move his or her token to a particular space , and a picture 501 , 506 , 511 , 516 , 521 , 526 , 531 , 536 , 541 , 546 , 551 , 556 , 561 , 566 , 571 , 576 , 601 , 606 , 611 , 616 , 621 , 626 , 631 , 636 , 641 , 646 , 651 , 656 , 661 , 666 , 671 , 676 illustrative of the benefit , penalty or instruction is also born thereon . more preferably , they are illustrative of the associated benefit , penalty or instruction . more preferably , they are illustrative of a benefit or penalty associated with life at a lake . descriptions for preferred pictures 501 , 506 , 511 , 516 , 521 , 526 , 531 , 536 , 541 , 546 , 551 , 556 , 561 , 566 , 571 , 576 , 601 , 606 , 611 , 616 , 621 , 626 , 631 , 636 , 641 , 646 , 651 , 656 , 661 , 666 , 671 , 676 may be found in tables iii through vi . obviously , the invention scope includes any and all illustrations , pictures , designs , schematics , etc . that represent life on a lake . table iii makin a wake cards description of benefit or penalty description of picture “ skier down : go back illustration of a ski boat three spaces .” speeding away from a water skier flailing in the water , 501 . “ ticket for no life illustration of a judge preserver : pay $ 15 .” holding a gavel while sitting at a desk between two flags , 506 . “ set sail to liberty lake . illustration of a sailboat if you pass go , collect $ 200 .” sailing on a lake , 511 . “ take a walk on the lakeshore : illustration of a boardwalk advance token to beautiful lake extending around a marina , couer d &# 39 ; alene .” 516 . “ skier down : go back three illustration of a ski boat spaces .” speeding away from a water skier flailing in the water , 521 . “ you overpay interest on your illustration of a first hand boat loan : bank pays you $ 50 .” handing over paper money to a second hand , 531 . “ water ski to thomson lake . if illustration of a person you pass go , collect $ 200 .” water skiing on a lake , 526 . “ pull up anchor and race to go : illustration of a boat collect $ 200 .” speeding across a lake , 536 . “ go to jail . do not pass go . illustration of a coast guard do not collect $ 200 .” boat with a flasher towing a smaller boat , 541 . “ make a wake to sun runner ™ illustration of a sun runner dealership .” boat , 551 . “ get out of jail freel !“ illustration of birds peacefully flying across a sunlit sky , 546 . “ if dealership is unowned , you illustration of a boat on a may buy it from the bank .” lake , 556 . [ 0081 ] table iv additional makin a wake cards description of benefit or penalty description of picture “ win fishing derby : collect illustration of a person on a $ 150 .” lakeshore holding up a fish larger than himself , 561 . “ set sail to the nearest dam . illustration of a dam , 571 . if unowned , you may buy it from the bank . if owned , throw the dice and pay the owner ten times the amount shown .” “ set sail to the nearest illustration of a boat , 566 . dealership and pay the owner twice the rental to which he or she is entitled .” “ set sail for the nearest illustration of a boat , 576 dealership and pay the owner twice what he or she is entitled .” [ 0082 ] table v sunken chest cards benefit or penalty description of picture “ sell vintage cris craft ™, illustration of one hand collect $ 200 .” handing paper money to another hand , 606 . “ your boat broke its prop : pay illustration of a boat on a $ 40 .” lake that has just lost its prop to the bottom of the lake , 601 . “ you have won second place at illustration of a boat lake pend oreille poker run : speeding across a lake , 611 . collect $ 100 .” “ buy new camping gear for illustration of campsite , weekend at lake roosevelt : pay volleyball court and $ 150 .” treeline adjacent a lakeshore , 616 . [ 0083 ] table vi additional sunken chest cards benefit or penalty description of picture “ complete boating safety course illustration of a person and enjoy insurance discount : wearing a graduation - style collect $ 20 .” cap and gown in front of a boat on a trailer , 626 . “ restored ski boat wins 1 st illustration of a first prize in boat show : collect $ 50 place ribbon and a boat , from each player .” 631 . “ you won the long lake poker illustration of a boat run : collect $ 25 from every speeding across a lake , 636 . player .” “ take a cruise to go : collect illustration of a cruise $ 200 .” ship sailing on a lake , 641 . “ boat needs repairs : pay $ 200 .” illustration of a outboard boat motor and a pipe wrench , 651 . “ go to jail . do not pass go . illustration of a coast do not collect $ 200 .” guard boat with a flasher towing a smaller boat , 656 . “ overcharged for boat repair : illustration of a person collect $ 25 .” smiling and receiving paper money from another person , 661 . “ win fishing bet by catching illustration of a person on prize steelhead in lewiston : a lakeshore holding a fish collect $ 100 from the player on larger than himself and of a your right .” hand handing over paper money , 671 . “ sell old boat trailer : collect illustration of a boat $ 45 .” trailer attached to a truck , 676 . a roll of doubles allows a player , after completing any actions associated with the space their token is moved to , to roll the dice again without having to wait for a next turn . in this fashion , a player may roll doubles twice or thrice during a single turn . if , however , a player rolls doubles three times in succession during a turn , they must to jail and place their token in the in jail portion 204 of the in jail / just visiting space 200 . the object of the game is to force all the other players to quit the game because of their inability to meet their financial obligations that develop as the game proceeds . because each player &# 39 ; s token will from time to time land upon a lake area , boat dealership or dams owned by another player , the trespassing player will incur rental charges . moreover , a player &# 39 ; s token will inevitably land upon other spaces exacting some sort of financial penalty . if unable to pay his or her obligations in scrip on hand , the player must dispose of his or her property , i . e ., lake areas , boat dealerships , dams , lake cabins , and marinas . lake areas , boat dealerships and dams may be given to the creditor in satisfaction of the rental payment , sold to any other player , auctioned to the highest bidder , or mortgaged to the bank in order to raise enough scrip to satisfy the rental payment . lake cabins and marinas may not be sold to other players , but may be sold back to the bank at half the purchase price listed on the associated title deed card . as mentioned above , lake areas , boat dealerships and dams may be mortgaged to the bank for a mortgage amount listed on the associated title deed card . once one of the above is mortgaged , the mortgaging player must turn the title deed card face down to indicate that it is mortgaged . if the player wishes to later pay off the mortgage , he must pay back to the bank the amount of the mortgage principal , plus , according to preferred rules of the game , ten percent interest . if a mortgaged property is transferred to another player without first lifting the mortgage , the new owner must pay ten percent interest immediately upon transfer . in order to lift the mortgage , the receiving player must pay the mortgage principal and an additional ten percent interest . according to preferred rules , no player may mortgage a lake area without first selling back to the bank all of his or her lake cabins and marinas erected upon that lake area . as a result of mortgaging a property , no rental payment may be demanded for it if another player trespasses upon that property . if the trespassing player is unable to meet his or her obligations by selling , transferring or mortgaging lake areas , boat dealerships , dams , lake cabins and marinas , he or she is declared bankrupt and must quit the game . all of the bankrupt player &# 39 ; s scrip must be given to his or her creditor . all of the bankrupt player &# 39 ; s lake cabins and marinas must be sold back to the bank at half price and the scrip given to his or her creditor . all of the bankrupt player &# 39 ; s remaining lake areas , boat dealerships and dams must then be sold by the bank to the highest bidder ( s ), or if no bid on a property is made , given to his or her creditor . the scrip resultant from the sale goes to the creditor . if the creditor receives a mortgaged property , the creditor must immediately pay a ten percent interest charge on the mortgage to the bank as described above , and may optionally pay off the mortgage principal at that time . if the principal is not paid at that time , an additional ten percent interest will be due at the time the principal is actually paid . play of the game continues until all but one of the players is bankrupt . thus , the remaining player is declared the winner . it is to be understood that the present invention is not limited to the embodiment described above , but encompasses any and all embodiments within the scope of the following claims .
a game includes : a playing board ; a plurality of tokens representing identities of players playing the game ; a plurality of title deed cards ; a plurality of game pieces ; a source of scrip ; a plurality of cards each one of which bears indicia related to one of a penalty , an award and a direction ; and at least two elements operable by the players in turn for randomly determining movement of the tokens upon the board . the playing board includes a plurality of successive , contiguous spaces defining a continuous path about a periphery of the board . first second and third sets of the spaces identify properties , such as lake areas , dams and boat dealerships , that may be purchased with scrip by a player landing upon the respective space . title deeds bear indicia indicating a rental payment .
fig1 shows one embodiment of the apparatus according to the invention . the dressing is sealed to the wounded tissue by means of a pliable polymer sheet . treatment fluid contained in a pliable bag reservoir is connected to the supply port of the dressing by way of flexible tubing , while a suction pump is connected by tube to a drainage port . fluid bag and horizontal level meter are placed on a rest which is movable along a pole in a vertical direction , and can be fixed in a position which is level with the wound . the pole is fixed on a base which holds a suction pump with canister . more specifically , patient 1 is being treated with an open polymer dressing pad 2 sealed to the wounded tissue by means of a pliable polymer sheet 3 . the means for accomplishing fluid flow comprises a pliable bag filled with treatment fluid 4 which is placed on rest 5 . this bag connects by its outlet 6 to a drip chamber 7 which is followed by a flexible supply tube 8 comprising a fluid rate controlling device 9 and injection port 10 before connecting with the supply port 11 of the dressing 2 . a rest 5 which is sloping in the area of the fluid bag is shown . the bag 4 is positioned on rest 5 with outlet 6 dependently , facilitating complete drainage and displacing eventual contained air upwards . the rest 5 can maintain fluid bag 4 in a flat or inclined plane in a range between 0 ° and 30 °, allowing full fluid evacuation without , or with minimal , height difference between full and empty bag . a dressing drainage port 12 is connected by tube 13 to suction pump 14 . suction pump 14 and / or its fluid canister 15 may be connected to the line of suction anywhere — including on rest 5 — where it may effectively drain fluid and prevent build - up of significant hydrostatic pressure within said tube 13 . canister 15 may be fitted with a scale 16 to allow determination of fluid volumes . the suction pump 14 may be fixed to the base 17 , pole 18 or rest 5 by means of a screw , clamp or elastic strap . rest 5 is movable in vertical directions along pole 18 and fixed by means of a clamp 19 in a position where the fluid surface in bag 4 and the supply port 11 of the dressing are level , i . e . the hydrostatic pressure at port 11 is at or near zero . this adjustment may be accomplished using a height indicator means 20 which may be connected with said rest 5 . the means 20 may constitute for instance a horizontal level meter fixed either to a rewindable cord or to the proximal end of tube 8 , or alternatively a telescopic pole or low energy red laser pointer connected with rest 5 . the base 17 may be fitted with wheels 21 . the rest 5 , pole 18 , and base 17 can for instance be made of aluminium , stainless steel or polycarbonate . rest 5 can be moved along pole 18 manually , and locked at a suitable level by said clamp 19 , or the pole may be height adjustable , constituted for instance of telescoping tubular sections which can be locked by screws at required length . the disclosed base 17 with pole 18 and rest 5 may be adapted for self - assembly . fig2 shows an embodiment of an apparatus according to the invention , which rids the rest 5 and its pole 18 of contact with the floor . in this device the footboard 22 of the bed is used as base . the construction minimizes the area of working - space occupied by the treatment devices and tubing . rest 5 with u - shaped pole 18 is fastened to the footboard 22 by means of a hook - like structure 23 which may comprising elastic polymer or metal . the u - shape of pole 18 may allow positioning of rest 5 within a vertical range corresponding to the combined length of the two parallel vertical parts of pole 18 , allowing the total length of pole 18 to be minimized . immobilization of pole 18 is achieved by means of clamps 19 and 24 . the fluid bag 4 , placed on rest 5 with its outlet 6 dependent , is kept in place by vertical bars 25 . an ultrasound distance sensor 26 is fixed to hook 23 — for instance by means of an elastic or rewindable cord 27 — and used for determining the horizontal level by measuring distances from wound and fluid bag to the roof . the device according to fig2 may also be adapted for self - assembly . the straight pole 18 shown in fig1 may fit in clamp 24 shown in fig2 and used as an alternative to the u - shaped pole . fig3 shows an embodiment of an apparatus according to the invention , which may allow automatic movement and fixation of a horizontal rest 5 at a height along said pole 18 corresponding to the level of the wounded tissue at the press of a button . this may be accomplished by means of a unit comprising a computer 28 connected electronically with ultrasound sensors 26 and 29 and an electrical motor 30 . the said motor 30 operates a cog - wheel 31 which meshes with another toothed part 32 extending along pole 18 . wire - based or hydraulic mechanisms may also be used . once the said computer 28 receives for instance telemetric input on the distance from the wounded tissue to the roof from sensor 26 after activation by the therapist , computer 28 activates sensor 29 and moves rest 5 vertically to the same level . the said rest 5 may maximally be moved vertically in a range from 10 cm to 200 cm above floor level , which corresponds approximately to that of a lower leg wound on a sitting or standing patient and a wound on the head of a standing patient . the range of movement may also be restricted to fit patients lying or sitting in bed , with a range from 30 cm to 150 cm above floor level . fig4 shows an embodiment of an apparatus used according to the invention for administering treatment fluid from a fluid bag in a sloping or horizontal position . it comprises a transparent drip chamber 7 with an angulated entry channel 33 between the spike 34 and chamber 7 . said angulated entry channel 33 may be rigid or elastic , bendable to a chosen angle , and preferably made of polymer material . the chamber 7 is made of rigid polymer material . tube 8 is made of pliable polymer material whose walls may be luer format . the tube is fitted either with a roller clamp 9 or other mechanically or electronically operated device for controlling the flow rate — accomplished either by external compression of tube 8 or another known means of lumen reduction — and finally includes a connector 35 to the dressing supply port 11 . the angulated entry channel 33 permits the chamber 7 to be approximately vertically positioned with the connected fluid bag placed on sloping or horizontal rest 5 . this allows drops to fall freely in the chamber , permitting secure reading of the drip rate . drip chambers of interest allow 40 - 80 drops per ml when exposed to negative pressures as high as 150 mmhg . standard luer format of tube 8 , roller clamp 9 and connector 35 may be used but not obligatorily . the connector 35 to be fitted on the dressing port tube may alternatively constitute an elastic tube . fig5 shows a further embodiment of apparatus according to the invention to administer treatment fluid from a fluid bag . it differs from that described in fig4 by including a horizontal level meter 36 and a tubular injection port connector 37 . the latter may include tap 38 for directional control . the tubular connector 37 may be substituted by an elastic injection membrane . said level meter 36 , comprising for example a small gas bubble enclosed in a transparent glass tube filled with liquid fluid , is connected with the tube 8 for instance by arms 39 embracing tube 8 . the level meter 36 should preferably be positioned near the drip chamber 7 to allow the meter 36 to be read while adjusting the height of the fluid bag 4 on rest 5 to match that of dressing 2 . connector 37 may be used for adding a drug dose to pad 2 during ongoing continuous supply and suctioning . to achieve optimal drip rate readability in chamber 7 of the embodiments shown in fig4 and 5 , the combined angle of entry channel 33 and rest 5 for the fluid bag should be 90 °. both the supply tube 8 and suction tube 13 may be thick - walled and / or corrugated at the inside to withstand kinking and compression , with inner diameter of approximately 3 mm . the suction tube 13 and canister 15 may be manufactured in pliable polymer materials . the sensor which measures fluid supply rate is suitably connected with an alarm . in special situations , in particular associated with low - flow tissue culturing applications using pressure pumps , monitoring of volume rates of fluid supply and drainage may be included , as may pump head pressure and inadvertent gravity free flow . the propulsing force or head of the pressure pump should be just sufficient to achieve fluid flow . the pump should suitably be connected with a pressure sensor in the tube 8 or pad 2 to allow detection and adaption to a pump - related pressure disturbance . computerized alarms concerning start / stop , occlusion , overflow and air - leak conditions may be applied . known pressure and / or ultrasonic transducers or optical sensors may be used . a drip - sensing device may be attached to drip chamber 7 . a timer - activated clamp may allow the fluid supply tube of a drip set to open and close at user - defined intervals , and a timer may control the start - stop function of the suction pump . fig6 shows an example of an open pore dressing with its pad 2 placed on the wound 40 and covered by a pliable , adhesive film or sheet 3 , which is adhered to the adjacent skin 41 . one supply port 11 and one drainage port 12 are adhered to the sheet 3 at a distance from each other . each port is fitted with a tubular member , which allows the port to be connected to known supply or drainage tubes . corresponding to these ports , apertures through the said sheet 3 allow access to pad 2 for fluid supply and suction drainage respectively . flexible tubes are connected airtightly with the said ports 11 and 12 , for instance by means of luer lock or elastic tube being forced over a conical rigid and tubular end - piece . the said sheet 3 , ports 11 , 12 and tubing 8 , 13 provide a seal which allows the negative pressure within pad 2 and on the surface of wound 40 to be contained at a predefined level at least during operation of the suction pump . pad 2 may comprise cell material with open pores or spatia like polyurethane or polyester foam or polyester fibers , and the latter may be matted . pad 2 may include layers in which the pores and / or spatia have different dimensions . a thin dressing layer sandwiched between pad 2 and the wound surface may comprise knit or woven biofiber like cotton , wool or silk containing capillary functioning pores . this layer may be cut to fit sensitive areas of the wound where blood vessels and nerves are superficial or exposed . the sheet 3 may be fluid - or air - impermeable and is typically produced in polymer material ( minnesota mining and manufacturing , st . paul , minn . 55144 ). pad , ports and tubes may be assembled either during fabrication , or bedside by the user . in a method according to the invention intended for treatment of wounds by means of the dressing shown in fig6 , the pressure at the supply port of the dressing is typically 0 mmhg , including correction for tube friction . this level of pressure is combined with suctioning at the drainage port ranging between − 20 mmhg and − 200 mmhg . this treatment may be applied intermittently or continuously for variable periods of time . the maximal suction applied under these circumstances is − 760 mmhg . fluid is supplied according to the invention at rates which may vary between 100 ml / 24 h and 2 , 000 ml / 24 h and loading doses for filling the dressing with drug solution may vary between 1 ml and 500 ml . this treatment may be undertaken on a continuous or intermittent basis . an injection port device can be used for adminstering treatment fluid intermittently to the complete wound surface underneath dressing pad 2 . this administration is always accomplished during ongoing suctioning through the drainage port 12 . this apparatus , shown in fig7 , comprises an elastic membrane 42 which must have qualities which allow maintainment of occlusion after being perforated repeatedly by a needle . membrane 42 may be connected adhesively to sheet 3 , and the construction may or may not include a hole in said sheet 3 corresponding to the center of membrane 42 . in connection with injection by needle through said membrane 42 , the elastic qualities of membrane 42 should prevent formation of needle holes which could result in elimination of the vacuum in dressing pad 2 . the membrane device may also be available as a separate unit with an adhesive rim at its circumference , the latter covered by removable protective paper , whereby said device can be applied adhesively around a hole in a dressing sheet 3 in a known manner . finally , an adhesive , reusable and pliable lid may be placed on membrane 42 to maintain sterility between injections . fig8 shows an injection port apparatus according to fig7 which is integrated in a pre - fabricated dressing sheet 3 intended for self - assembly , such that the dressing becomes complete by inclusion of dressing pad 2 and drainage port 12 . fig9 exemplifies another embodiment of the said injection port apparatus , and comprising a rigid frame 43 which may be circular , and which is adhesively connected with the edges of a hole made in flexible sheet 3 covering the pad 2 . the frame is likewise airtightly connected with elastic membrane 42 . frame 43 may be fitted with a lid 44 , a handle 45 , a joint 46 and a flange 47 . when the device is not in use , lid 44 is closed over membrane 42 . in this process , flange 47 enters a slit 48 in frame 43 to maintain secure occlusion . the membrane may optionally be protected by an adhesive tape patch 49 when not in use . underneath the said membrane 42 is a rigid impermeable plate 50 which is connected by side walls 51 to said frame 43 , and said walls 51 are fitted with apertures 52 . the plate 50 may prevent the needle from inadvertently entering the wounded tissue in situations where the pad is thin . the membrane of the device according to fig9 can suitably be manufactured in natural or synthetic rubber or elastic polymer including silicone . the frame , lid and plate structures may be manufactured in , for example , known , rigid polymer materials , and plate 50 may contain metal to prevent needle penetration . in operation during ongoing suctioning the lid 44 is opened by its handle 45 , the piece of tape 49 is removed . a needle connected with a fluid - filled syringe is advanced through said membrane 42 while the membrane 42 is stabilized by holding lid 44 . the fluid is slowly injected , allowing it to become distributed throughout the dressing by suction and capillary force . the supply of fluid may be terminated once fluid appears in the drainage tube . after injection the needle is removed and tape 49 and lid 44 are repositioned . fig1 shows an embodiment of an apparatus according to the invention comprising a drainage port which facilitates drainage of debris through a capillary - active dressing pad . it comprises a drainage port tube 53 with flange 54 sealed to pad 2 by means of an adhesive sheet 3 . an open grid 55 adhered to the flange covers the entry to the opening 56 in the flange in order to avoid obstruction of dressing material against the edges of said opening 56 . the grid is preferably manufactured of semi - flexible or rigid cells with open pores or spatia made of polymer materials , for instance polyester , polyurethane or steel wool , all typically less compressible to suction than dressing pad 2 . fig1 shows an apparatus and method according to the invention comprising an open polymer pad 2 overlying a tissue culturing scaffold 57 used for regenerating skin tissue in a wound 40 . the adhesive cover sheet 3 , the supply port 11 and suction drainage port 12 are indicated . depending on which type of tissue is to be regenerated , the scaffold may comprise biological and / or non - biological material . a biological scaffold may comprise collagen or dermis , hyaluronic acid or fibrin . when regenerating bone the scaffold may comprise bioactive ceramics or glass . non - biological polymer fiber scaffolds may be biodegradable and comprise , for example , poly - glycolic acid polyester ( pga ) or related substances . the optimal pore size of the scaffold may vary with the phase in the growth process . passage by diffusion of all relevant nutrients and growth substances is obligatory throughout the regenerative process , and cell and vascular structures will have to be accommodated as they develop . the scaffold may thus include a range of more narrow pores which allow passage of molecules including peptides and proteins , as well as a range of wider pores allowing passage of cells , and this pore ratio may vary with the degree of tissue development . antibacterial substances , analgesics , enzymes , growth factors , growth media and cells , including stem cells , fetal cells and genes , may be supplied . in a method for accomplishing tissue regeneration in vivo or in vitro , see fig1 , the positive and negative pressures applied to pad 2 should be minimized in order to leave diffusional and cellular processes in the growth zone of the underlying tissue scaffold undisturbed . the forces governing the passage of fluid through the scaffold should be determined mainly by diffusion and minimal suction . this is accomplished in a controlled way by combining zero hydrostatic pressure or minimal pump head pressure in the dressing with at most weak suction at the drainage port . the hydrostatic pressure in the dressing can be 0 mmhg including compensation both for tube and open pore and / or tissue scaffold resistance . the suction pressures can range , for example , from − 0 mmhg to − 30 mmhg . the fluid supply rates may typically vary between 20 ml / 24 h and 400 ml / 24 h and loading doses for filling the dressing with drug solution may vary between 1 ml and 100 ml . this treatment may be undertaken on a continuous or intermittent basis . the pad 2 may be substituted for a tissue scaffold when the porosity of the scaffold allows passage of treatment fluid under flow and pressure conditions as defined above . fig1 shows an apparatus according to an embodiment of the invention for detecting bleeding from the wound during ongoing suctioning by a simple weighing technique . canister 15 is immobilized in a tight - fitting receptacle 58 placed over load sensor 59 , which in turn is connected to computer 60 , display and control - panel 61 , loudspeaker 62 and telemetric unit 63 , all constructed according to the state of the art , and being part of the basal part 64 of the said apparatus . elastical force or movement in suction tube 13 , or movement in the pump 14 in operation , is prevented from being propagated to canister 15 by means of tubular buffer organs 64 and 65 , each comprising a rigid and a pliable part . the rigid part constitutes in this example two closely fitting openings in the rigid receptacle wall 66 . the pliable tubular part 67 is designed to further minimize movement and elastic force . the rigid part of each buffer organ may comprise polymer or metal . the pliable tubular part can be made of elastic polymer fitted with an inner discontinuous “ skeleton ” of rigid material to prevent collapse and occlusion . the pump 14 is additionally isolated with regard to vibration by means of elastic layer 68 placed between the base of the pump 14 and the basal part of the apparatus containing the computer and control means . this part of the apparatus can be made of metal to avoid vibration and increase stability . the scale 59 may be operated by a load cell according to the state of the art . the computer 61 measures the weight of fluid in the canister 15 at pre - set intervals , and stores and displays the data using simple state of the art technology . the computer 61 first determines the baseline rate and variability of the therapeutic fluid formation over time based on measurements for instance at 2 - 5 min intervals . the smallest rate of fluid formed in addition to the therapeutic rate , which is to be considered as sign of a bleeding , is decided by the user and fed into the computer 61 . the computer 61 then subtracts incoming rates from baseline serially and gives an audible , visual and possibly telemetric alarm once bleeding is detected . a bleeding in the wound may manifest itself 1 ) as a stepwise increase in liquid fluid weight 2 ) as a linear increase or 3 ) as an exponential increase . in a more advanced design , such patterns may also be identified and used by the computer as additional signs of bleeding . the computer can also warn of overflow of fluid in canister 15 . fluid flow rates in the dressing were studied in vitro as a function of the negative pressure applied at the suction port . the flow resistance was unchanged throughout . table i . rate - limited fluid flow vs suction pressure in occlusively applied open polymer dressing with supply and drainage ports , studied in vitro . the dressing comprising polyester fibers ( 11 × 13 cm ) covered occlusively by polymer film and fitted with supply and drainage ports at opposing ends . the dressing was positioned horizontally . the hydrostatic pressure at the supply port was 0 mmhg and the flow resistance in the supply was unchanged during the experiments . fluid flow at the entry to the dressing and pump pressure were measured according to the state of the art . in this situation with unchanged resistance to entry of fluid into the porous dressing , fluid flow rate and suction pressure were close to linearly related . the negative pressure and degree of hydration in the dressing were studied in vitro as functions of the negative pressure at the drainage port . table 2 . in vitro assessment of pore gas pressure and fluid saturation during treatment according to the invention . the dressing comprising polyester fibers ( 11 × 13 cm ) covered occlusively by polymer film and fitted with supply and drainage ports at opposing ends . the dressing was positioned horizontally . the hydrostatic pressure at the supply port was zero . fluid flow was unchanged throughout the experiment . pressure was measured in the drainage port and on the surface of the dressing pad . dressing fluid saturation was measured by weighing , and calculated as percentage of the total saturable volume under influence of negative pressure as indicated . suction pressures at the drainage port and within the pad were correlated over a pressure range of therapeutic interest . the dressing pad was partially saturated with fluid ( mean : 44 percent , range : 35 - 52 percent ). clinically , a wound would thus be exposed dynamically to a combination of wetting and suction . the drainage capacity of a dressing exposed to fluid loading was studied in vitro . in vitro assessment of the drainage capacity of a dressing exposed to fluid loading . the dressing comprising polyurethane foam ( 10 × 7 . 5 cm ) covered occlusively by polymer film and fitted with supply and drainage ports at opposing ends . the dressing was positioned horizontally . fluid supply was increased from 20 drops / min to 100 drops / min in steps of 20 drops . the hydrostatic pressure at the supply port was zero . the suction pressure applied at the drainage port was − 50 mm hg . the thickness of the dressing was used as a measure of its compressed volume , and measured at each step . dressing fluid saturation was assessed in the last step of the experiment , and determined as the percentage between the fluid contained in the dressing ( assessed by weighing ) and the total saturable volume assessed volumetrically during maximal suctioning . the height of the dressing at each step of the experiment was compressed to approximately 7 mm . the dressing fluid saturation at 100 drops / min ( equal to 7 , 200 ml / 24 h ) was 50 / 63 ml , and the maximal saturation thus 80 %. this small format dressing remains partially saturated even when fluid is supplied at a rate as high as 7 , 200 ml / 24 h . the results indicate that drainage capacity and hence a local suctioning effect is functional in a wide volume range at a pressure of − 50 mmhg . in one embodiment , an apparatus for treating and regenerating tissues , covering a wound , combining liquid fluid supply and suction , comprises a pole , a rest , said rest being movable in vertical directions along said pole and having a clamp for securing said rest at a height corresponding to the height of the tissue , at least one fluid reservoir placed on said rest , connected to the tissue , and means for controlling the fluid supply and suction . the rest can form an angle , for example , in the range 0 - 30 ° to the horizontal . the rest can be hinged , and immobilized in any angle from horizontal to vertical . the range of vertical movement of the rest can be , for example , approximately 10 - 200 cm , including for example 30 - 150 cm . a horizontal level meter can used for securing said rest at a height corresponding to the height of the tissue . the level meter such as a telescopic pointer , laser pointer or ultrasound sensor , can be connected with said rest directly or by means of a cord . the fluid reservoir can comprise a pliable and flexible bag filled with treatment fluid . the fluid supply can be connected with the tissue by means of a tube . the controlling means can include a drip chamber and a roller clamp connected with said tube . the controlling means include a drip chamber with an angulated spike connected with said tube . the controlling means can include a level meter connected with said tube . the controlling means can include an injection port connected with said tube . the means controlling the fluid supply can comprise an electronically operated valve . the means controlling the fluid supply can comprise a kink - resistant supply tube . the apparatus can further comprise at least a drop - sensitive sensor for assessing the flow rate . the suction means can comprise a suction pump placed on the platform and connected to the tissue by means of a tube . the inner wall of said tube can be corrugated . the suction pump can be connected to a canister whose liquid fluid content can be determined by means of a scale or by weighing . the suction means can comprise a suction pump is placed on the floor . the suction means can comprise a pump is fixed to the pole by means of a clamp . the pole is , for example , u - shaped and fixed by means of a clamp to a hook which can be fastened to the footboard of a bed . the pole can be straight and fixed to a base . the pole can comprise telescoping parts which can be locked in position by means of screws , clamps or by a hydraulic mechanism . the apparatus can farther comprise a motor which moves said rest in a vertical direction and which is operable by means of a computer . the apparatus can also comprise ultrasound level meters , one fixed and one movable , and both connected to said computer . the apparatus can further comprise a pump used for administering the fluid supply . the pressure head of the said pump can be monitored by means of a sensor in the supply tube . the fluid flow can be controlled by means of timer activated clamps . in one embodiment , apparatus for treating and regenerating tissues allowing administration of a restricted amount of fluid to the supply port of an occlusively applied porous dressing pad during exposure of said pad to continuous suctioning through a separate drainage port , comprising a restricting means preventing free fluid flow , a means to prevent ingress of air through said supply port in connection with said fluid administration , and a drainage port . the supply port can comprise of an injection membrane airtightly connected with a polymer sheet . the supply port can comprise a plate at the side of the dressing pad which can prevent a needle used for injecting treatment fluid through said membrane from penetrating into the dressing and to the wound . the apparatus can further comprise a roller clamp that provides additional restricting means . the friction between piston and syringe wall can provide additional restriction means . in another embodiment , a method for treating and regenerating tissues allowing administration of a restricted amount of saline or drug solution to the supply port of an occlusively applied porous dressing pad during exposure of said pad to continuous suctioning , comprises : applying continuous suction to the drainage port in the range between 30 and 200 mmhg ; applying an injection needle airtightly to a syringe or fluid bag filled with saline or drug solution ; avoiding a fluid bag hydrostatic load ; perforating said supply port elastic injection membrane with the needle during ongoing suction at the drainage port of said dressing pad ; injecting the content of the syringe into the dressing pad in 1 - 5 minutes during ongoing suctioning at said drainage port ; stopping the injection once injected fluid becomes visible through the suction tube wall as it exits the drainage port of the dressing pad ; and withdrawing the said needle from the elastic membrane . in yet another embodiment , a method for non - regenerative tissue treatment by means of combined fluid supply and suction drainage to a porous dressing , comprises : eliminating hydrostatic pressure in the fluid supply port by positioning the fluid bag at the level required for neutralizing supply tube flow resistance ; maintaining the tissue hydrostatic pressure at the supply port at 0 mmhg ; maintaining the fluid flow in a range between 100 ml / 24 / h and 2 , 400 ml / 24 h ; providing a seal which allows negative pressure to be distributed over the tissue and to be maintained at a predetermined level at least during operation of the suction ; maintaining the suction normally in a range between − 20 mmhg and − 200 mmhg , maximally − 760 mmhg ; utilizing loading doses in the range between 1 ml and 500 ml ; and applying steps a - f continuously or intermittently . in yet another embodiment , a method for regenerative treatment by means of combined fluid supply and suction drainage to a tissue scaffold , comprises : eliminating hydrostatic pressure by positioning the fluid bag at a level just sufficient to overcome both supply tube and / or open pore scaffold flow resistance ; maintaining the fluid flow in the range between 20 ml / 24 / h and 400 ml / 24 h ; providing a seal which allows negative pressure to be distributed over the tissue and to be maintained at a predetermined level at least during operation of the suction ; maintaining the suction in the range between − 0 mmhg and − 30 mmhg ; utilizing loading doses in the range between 1 ml and 100 ml ; and applying steps a - e continuously or intermittently . in yet another embodiment , a method for regenerative treatment allowing artificial circulation to a tissue scaffold , comprises : eliminating hydrostatic pressure by positioning the fluid bag at a level just sufficient to overcome supply tube , porous pad and / or scaffold flow resistance ; controlling fluid supply rate by interposing a pump in the supply line ; monitoring the pressure head in the supply port ; monitoring the pressure in the porous pad or scaffold ; maintaining the tissue hydrostatic pressure at the supply port at 0 mmhg ; maintaining the fluid flow in the range between 20 ml / 24 / h and 400 ml / 24 h ; providing a seal which allows negative pressure to be distributed over the tissue and to be maintained at a predetermined level at least during operation of the suction ; maintaining the suction in the range between − 0 mmhg and − 30 mmhg ; utilizing loading doses in the range between 1 ml and 100 ml ; and applying steps a - i continuously or intermittently . in another embodiment , an apparatus for treating and regenerating tissues by means of an occlusively applied dressing pad , comprises a drainage port with means to counteract occlusion of the underlying open pores of the pad when said pad is exposed to continuous suction . the drainage port means can comprise an open grid consisting of interconnected or separate units which form a pattern covering the whole underside of the port abutting the dressing pad . the grid can include the opening in the flange . in another embodiment , an apparatus for detecting bleeding from a wound during continuous suctioning treatment comprises a receptacle , a scale , a canister , movement buffer organs , a computer , visual display , audible alarm and telemetry . in another embodiments , a method for detecting bleeding from a wound during continuous suctioning treatment , comprises : determining the baseline rate and variability of therapeutic fluid formation over time based on measurements of net weights of fluid in the canister at 2 - 5 min intervals ; determining of the minimal rate of fluid formed in addition to said baseline rate which is to be considered as a sign of bleeding , and feeding this information to the computer ; making the computer subtract incoming rates of fluid formation from baseline serially , and giving an audible , visual and telemetric alarm once bleeding is detected .
hydrostatic pressure of aqueous solutions — supplied from reservoir under rate control through tube to port of airtightly applied open pore dressing pad — is eliminated by levelling reservoir placed on rest with pad . dressing pad may overlie a tissue culturing scaffold . a drip chamber with angulated channel permits drops to fall freely and be counted . injection port elastic membrane prevents air inlet to pad while suction is applied at port , permitting fluid given under rate control through membrane to distribute evenly in pad . a drainage port flange , wholly covered by an open grid , is described . acute wound bleeding is detected by computer - controlled serial weighing of a movement - stabilized drainage fluid canister with warning of abnormal flow rate increase .
referring now to the figures , set forth is the corpectomy device 10 in a compressed position with the pivoting endplate 12 angled forward . the corpectomy implant device 10 is defined by a base member 14 telescopingly received into an expansion member 16 . the base member 14 is formed from a housing having a lower end 15 with a first 17 and second 19 side walls extending from said lower end 15 . said base member include end walls 21 and 23 positioned between said first and second side walls 17 , 19 each having a centrally disposed u - shaped slot 18 formed therein extending from the lower end along a length of the end walls with a first edge 20 of said slot 18 non - engaging and a second edge 22 lined with an engaging edge , preferably directional ratchet teeth 22 . lower endplate 12 can be inserted into the open end of the base member 14 , the lower endplate having a surface 11 for use in bone engagement . the expansion member 16 is formed from housing having first and second side walls 25 and 27 and first and second end walls 29 and 31 , the four walls constructed and arranged to encompass said base member walls . side wall 25 includes an aperture 24 sized to permit insertion of pinion tool 30 having a shoulder 32 that allows ease of rotation by bearing upon the side wall 25 with a pinion for engagement of the ratchet teeth 22 . rotation of the pinion tool 30 provides extension of the expansion member 16 from the base member 14 as the pinion tool is limited in movement with the expansion member 16 by the size of the aperture 24 . positioned with the base member is a spring loaded biasing ratchet assembly 36 having a pair of engagement prongs 38 and 40 that engage the ratchet teeth 22 . the biasing ratchet assembly 36 includes having a biasing member 41 that engages an inner surface of the base member 14 expanding the engagement prongs 38 and 40 against the ratchet teeth 22 wherein the spacing of the extension member from the base member is unidirectional to prohibit compression of the structure once positioned . the expansion member 16 permits the device to expand relative to the base member 14 and overall longitudinal dimension of the device . upper endplate 42 can be inserted into the open end of the expansion member 16 , the upper endplate having a surface 44 for use in bone engagement . the endplates 12 and 42 may be interchangeably connected or permanently attached , such as laser welded , to the corpectomy device . these endplates may be of any desired shape , size or thickness . for example , the endplate 42 of fig1 is substantially flat with engagement teeth 44 forming a pattern allowing bone growth material to pass through . in fig1 - 3 the endplate 12 can be moved at an angle that will allow the implant to restore the normal curvature of the spine after the corpectomy device is installed . moreover , the shape may or may not correspond to the cross - sectional shape and size ( foot - print ) of the base . in those instances where the patient presents unusual physiology , such as curvature of the spine ( lordosis or kyphosis ), additional physiology compensating members may be interposed with the respective endplates . these compensating members allow the corpectomy implant device 10 to take on a more arcuate shape thereby conforming more closely with the existing spinal configuration . fig2 is a side view of the corpectomy implant device 10 in a compressed position having expansion member 16 placed over the insert of base member 14 with the pivoting endplate 12 angled backward . fig3 is a side view of the corpectomy implant device 10 in a raised position with the pivoting endplate 12 centered . fig4 is the opposite side view of fig3 depicting the pinion driver 30 inserted into aperture 24 . fig5 is the reverse perspective view illustrating the biasing ratchet mechanism 36 for use in locking the base member 14 and the expansion member 16 in a raised position . fig6 - 8 and 13 are pictorial views depicting the corpectomy implant device 10 between vertebra 100 and 102 in a compressed position . fig9 - 11 depict the device in an expanded state with the pinion driver 30 used to raise the expansion member 16 over the base member 14 . accordingly , in preferred embodiments , a corpectomy device comprises a base member , an expansion member , an upper or lower endplate . in another preferred embodiment , the base member comprises a slot having a first side wall and a second side wall , wherein the first side wall is smooth and the second side wall comprises one or more teeth , spikes or jagged edges . in another preferred embodiment , the expansion member comprises an aperture for receiving a pinion tool having a first shoulder wherein the first shoulder is smooth , and a second shoulder for engagement of the base member . in yet another preferred embodiment , the corpectomy device comprises a ratchet , the ratchet comprising at least one engagement prong , a biasing member or combinations thereof . in yet another preferred embodiment , the upper and lower endplates are interchangeable and comprise patterns , dimensions , shapes , smooth surfaces , grooved surfaces , rough surfaces , or mobility for engaging a vertebra . embodiments of the invention are also directed to methods for manipulating the distance between vertebrae in a patient in need thereof . accordingly , in a preferred embodiment , a method of manipulating the distance between adjacent vertebrae in a patient , comprising surgically inserting an expandable corpectomy device into an intervertebral cavity , the corpectomy device comprising an upper endplate , a lower endplate , a base member wherein the base member is telescopingly receivable into an expansion member ; the base member comprising a slot having a first side wall that is smooth and a second side wall lined with teeth ; the expansion member having an aperture for receiving a pinion tool for increasing longitudinal distances of the expansion member relative to the base member . in some preferred embodiments , the distances between the teeth in the second side wall of the base member aperture are sized so that the expansion can occur by desired increments . in another preferred embodiment , the corpectomy device comprises a spring loaded biasing ratchet having a pair of engagement prongs for engaging the second side wall of the aperture of the base member and a biasing member for engaging an inner surface of the base member . in other preferred embodiments , the upper endplate is insertable into an open end of the expansion member , the upper endplate having a surface for bone engagement . preferably , the upper and lower endplates are interchangeable and comprise patterns , dimensions , shapes , smooth surfaces , grooved surfaces , rough surfaces , or mobility for engaging a vertebra . unless otherwise defined , all terms ( including technical and scientific terms ) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs . it will be further understood that terms , such as those defined in commonly used dictionaries , should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein . as used herein , the singular forms “ a ”, “ an ” and “ the ” are intended to include the plural forms as well , unless the context clearly indicates otherwise . furthermore , to the extent that the terms “ including ”, “ includes ”, “ having ”, “ has ”, “ with ”, or variants thereof are used in either the detailed description and / or the claims , such terms are intended to be inclusive in a manner similar to the term “ comprising .” it is to be understood that while a certain form of the invention is illustrated , it is not to be limited to the specific form or arrangement herein described and shown . it will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings / figures included herein . one skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned , as well as those inherent therein . the embodiments , methods , procedures and techniques described herein are presently representative of the preferred embodiments , are intended to be exemplary and are not intended as limitations on the scope . changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims . although the invention has been described in connection with specific preferred embodiments , it should be understood that the invention as claimed should not be unduly limited to such specific embodiments . indeed , various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims .
the instant invention is a longitudinally adjustable corpectomy device which fits within the intervertebral distracted channel . a ratchet mechanism allows for an extendable member to adjust to a longer length to accommodate a distracted channel . the ratchet type mechanism allows the members to move in a unidirectional movement to prevent the two members from contracting once expanded .
referring now to the drawings wherein the showings are for the purpose of illustrating the preferred embodiments of the invention only , and not for purpose of limiting same , fig2 - 4 show a wound shield 30 including a hollow tubular inflatable dam 32 , and a clear plastic window 34 attached to the dam 32 . dam 32 is formed of an inner peripheral surface or wall 42 which defines and surrounds a central opening 50 . dam 32 also includes an outer peripheral surface or a wall 44 connected to inner peripheral surface 42 by a rear or bottom body - engaging surface 48 and a front or top surface 46 . dam 32 is provided with an irrigation aperture 52 extending from outer peripheral surface 44 through inner peripheral surface 42 . aperture 52 is adapted to receive or otherwise couple with an irrigation tube for providing communication between an irrigation system and central opening 50 . typically , the irrigation system provides an irrigation solution with medicinal characteristics for continuous or frequent cleansing of the wound . a drying aperture 54 is provided , which is adapted to receive or otherwise couple with a drying tube connected to an associated air supply . drying aperture 54 provides communication between the air supply and central opening 50 for continuous or selective intermittent drying of the wound after irrigation . the drying aperture is also useful for connection to an associated source of vacuum ( not shown ) for use with vac devices to apply a vacuum to the wound . a drainage aperture 56 is provided , preferably on a side of the dam opposite from the irrigation and drying apertures as shown . the drainage aperture is adapted to receive or otherwise couple with a drainage tube . the drainage tube could be connected to a pump , a collecting device , or a like device , to facilitate the removal of the irrigation solution , and dead skin and blood discharged from the wound . both apertures 52 and 56 extend through the dam 32 from outer peripheral surface 44 through inner peripheral surface 42 . these apertures can be plugged using suitable stoppers or the like when used as a vac , when the patient is ambulatory , or as desired . it is to be appreciated that any of the apertures can be adapted for connection with an associated source of vacuum . dam 32 is preferably manufactured using a rotational casting or a rotational molding such as slush molding . the mold is typically made of aluminum but could be made of a variety of other metals . dam 32 is formed from a soft liquid plastic , preferably vinyl , and the apertures are formed by extending a core pin through the mold , and removing the core pin after the liquid plastic cures . dam 32 further includes a soft self - sealing plug 40 preferably molded into the outer wall 44 . self - sealing plug 40 is adapted to receive a hypodermic needle used to inflate the dam 32 with air . the needle is inserted through the self - sealing plug 40 and the bulb is compressed to force air into the dam until the desired firmness of the dam 32 is obtained . the needle can be withdrawn at any time from the self - sealing plug 40 without any leakage of the air after removal . the self - sealing plug also allows for addition or removal of air at any time . self - sealing plug 40 is preferably made of nitriale rubber . window 34 is made of a semi - hard clear plastic vinyl and has a generally flat planar bottom surface 33 and a generally flat top planar surface 35 . in the embodiment illustrated , the window has an overall generally rectangular shape . preferably , bottom planar surface 33 is attached to front surface 46 of the dam 32 using ultra - violet curable adhesive . however , various other types of adhesives could be used . window 34 completely encloses central opening 50 of the dam 32 so that central opening 50 can remain airtight when the wound shield 30 is placed on the body of the patient , except for apertures 52 , 54 , and 56 . it is preferred that window 34 encompass outer peripheral surface 44 of the dam 32 to increase the rigidity of the wound shield 30 . a pair of spaced apart connector assemblies 64 are disposed on top planar surface 35 of window 34 at opposite sides of the window . connector assemblies 64 include a set of spaced apart co - axial tubes 66 holding a rod 68 that is connected to a set of eyelets 70 . tubes 66 are preferably made of plastic and could be bonded to top planar surface 35 of the window 34 or could be formed during the molding of window . rods 68 and eyelets 70 are placed in tubes 66 prior to bonding or molding . rod 68 and eyelet 70 are pivotable about an axis parallel to top planar surface 35 , so that movement or twisting of the patient does not cause wound shield 30 to move from its position on the body of the patient . further , connector assemblies are placed at a location outside central opening 50 to ensure that even pressure is applied to the entire perimeter of dam 32 when wound shield 30 is on the body of a patient . rods 60 and eyelets 70 are preferably made of metal , but could be made of plastic or the like . the rods 68 extend completely across the face of the would shield 30 and in that way help prevent the shield from buckling in the middle during use such as along the line defined by section a — a in fig2 . a pair of belts 36 and 38 are provided for holding wound shield 30 at a fixed location on the patient , so that central area 50 surrounds the wound . belts 36 and 38 are preferably made of an elastic material , such as latex or neoprene foam , and are preferably non - absorbent and easy to clean . each belt includes a first and a second connecting end 58 . each connecting end 58 includes a connecting portion 60 attached to the belt , and a hook portion 62 adapted to engage eyelet 70 . it should be appreciated that in some circumstances , the wound shield may only need one belt because of the size or location of the wound . further , the belt could be fixed at one end to a fixed connector on the wound shield , and be pivotable at the other end . it also should be appreciated that the releasable engagement of the belt and the connector assembly could employ connector types other than the preferred eye and hook arrangement . with particular reference now to fig3 , dam 32 includes a ridge 72 extending angularly from inner peripheral surface 42 beyond and away from the bottom body - engaging surface 48 . dam 32 also includes a ridge 74 extending angularly from outer peripheral surface 44 beyond and away from the bottom body - engaging surface 48 . ridges 72 and 74 cooperate in holding wound shield 30 in a fixed position on the patient &# 39 ; s body , even during movement and twisting of the patient . further , ridges 72 and 74 seal central opening 50 and prevent any fluids or vacuum from escaping , and prevent contaminants from entering central area 50 . ridges 72 and 74 also alleviate the need to apply skin adhesives to the skin of the patient prior to applying the front body - engaging surface of the wound shield , while adding substantially to the cross - sectional rigidity of the dam 32 . with continued reference to fig3 , dam 32 preferably also includes a ridge 76 extending angularly from inner peripheral surface 42 beyond and away from top surface 46 and a ridge 78 extending angularly from outer peripheral surface 44 beyond and away from top surface 46 . ridges 76 and 78 aid in the adhesion process of front surface 46 to the back surface 33 of window 34 . additionally , ridges 76 and 78 increase the cross - sectional rigidity characteristic of dam 32 , which helps prevent the center of the wound shield 30 from buckling after securing wound shield 30 on the body of a patient . it should be appreciated that in some cases , such as in stubborn wounds , more pressure is necessary for irrigation of the wound . it also should be appreciated that it is not always necessary to place irrigation aperture , drying aperture , and drainage aperture through the dam . for example , fig5 shows a wound shield 77 having a dam 79 attached to a window 81 . a first hole 75 is cut out of window 81 and covered over by a piece of adhesive tape 80 or plug . a second hole 82 is cut out of window 81 and covered by a piece of adhesive tape 84 or plug . the holes 75 , 82 are adapted to receive the tip of an asepto syringe . adhesive tape 80 or plug can be removed and irrigation solution can be communicated to the wound through hole 75 via large syringe , or the like . further , an air source could be used to communicate air to the wound through hole 75 for drying the wound . adhesive tape 84 or plug can be removed to provide drainage of irrigation solution , dead skin , and blood from central area 50 . after cleansing , drying , and drainage , tape 80 and 84 or plug can be placed back over holes 75 and 82 , respectively , protecting the wound from outside dirt or bacteria . it should be noted that the shape of the wound shield could take on many forms , and the connector assemblies could be disposed on the window in a variety of different orientations . for example , fig6 shows a wound shield 30 ′ having an overall smaller size than the shield 30 shown in fig2 - 4 . only a single belt 36 ′ is needed to receive the shield 30 ′ to a patient . this type of wound shield could be useful for a wound near the groin area of an individual , such as one that would occur in a hernia operation or catheterization procedure . the wound shield 30 ′ is formed and functions substantially identical to the shield 30 described above . like parts are indicated in fig6 with a primed (′) suffix . the foregoing descriptions are specific embodiments of the present invention . it should be appreciated that these embodiments are described for purposes of illustration only , and that numerous alterations and modifications may be practiced by those skilled in the art without departing from the spirit and scope of the invention . it is intended that all such modifications and alterations be included insofar as they come within the scope of the invention as claimed or the equivalents thereof .
an irrigation dressing is provided including a hollow inflatable tubulardam with a central opening adapted to surround the wound of the individual . a semi - hard resilient clear plastic window is attached to the dam , such that the central opening is completely enclosed on a front surface of the dam . the dressing includes an inner peripheral ridge and an outer peripheral ridge extending beyond a bottom or back body - engaging surface of the dam which facilitates drawing a vacuum . a plurality of connectors are attached to a front planar face surface of the clear plastic window . at least one connector is pivotable about an axis parallel to the front planar surface of the window . a self - sealing plug is disposed inside the dam so that the dam can be inflated to selected pressures using an associated hypodermic needle or the like .
alopecia ( baldness ) a deficiency of either normal or abnormal hair , is primarily a cosmetic problem in humans . it is a deficiency of terminal hair , the broad diameter , colored hair that is readily seen . however , in the so - called bald person although there is a noticeable absence of terminal hair , the skin does contain vellus hair which is a fine colorless hair which may require microscopic examination to determine its presence . this vellus hair is a precursor to terminal hair . in accordance with the invention as described herein , compounds represented by wherein r 1 , r 2 , a , b , z and x are defined above , can be used to stimulate , such as stimulating the conversion of vellus hair to growth as terminal hair as well as increasing the rate of growth of terminal hair . in the course of treating patients having glaucoma , treatment may only be appropriate in one eye . within the course of daily practice it was discovered that a patient who been treated with bimatoprost has lashes that were longer , thicker and fuller in the treated eye than in the non - treated eye . on examination the difference was found to be very striking . the lashes were longer and had a more full dense appearance in the treated eye . the lash appearance on the lids of the treated eye would have appeared quite attractive if it represented a bilateral phenomenon . because of its asymmetric nature , the long lashes on one side could be construed as disturbing from a cosmetic standpoint . because of the very unusual appearance a systematic examination of other patients who were taking bimatoprost in only one eye was made . it soon became apparent that this altered appearance was not an isolated finding . comparison of the lids of patients who were taking bimatoprost in only one eye revealed subtle changes in the lashes and adjacent hairs of the bimatoprost - treated side in several patients . definite differences could be identified to varying degrees in the lashes and adjacent hairs of all patients who were taking the drug on a unilateral basis for longer than 6 months . these findings were totally unexpected and surprising . minoxidil is thought to stimulate hair growth by its ability to cause vasodilation suggesting that agents with such a capability may be uniquely effective in stimulating hair growth . the finding that bimatoprost , which , as explained below , is not a prostaglandin derivative , such as latanoprost stimulates hair growth is especially surprising and unexpected . the changes in the lashes were apparent on gross inspection in several patients once attention was focused on the issue . in those with light colored hair and lashes , the differences were only seen easily with the aid of the high magnification and lighting capabilities of the slit lamp biomicroscope . in the course of a glaucoma follow up examination , attention is generally immediately focused on the eye itself . because of the high power magnification needed only one eye is seen at a time and the eye is seen at a high enough power that the lashes are not in focus . at these higher powers , any lash asymmetry between the two eyes is not likely to be noticed except by careful systematic comparison of the lashes and adjacent hairs of the eyelids of the two eyes . observed parameters leading to the conclusion that more robust hair growth occurred in the treated area following administration of bimatoprost were multiple . they included increased length of lashes , increased numbers of lashes along the normal lash line , increased thickness and luster of lashes , increased auxiliary lash - like terminal hair in transitional areas adjacent to areas of normal lash growth , increased lash - like terminal hairs at the medial and lateral canthal area , increased pigmentation of the lashes , increased numbers , increased length , as well as increased luster , and thickness of fine hair on the skin of the adjacent lid , and finally increased perpendicular angulation of lashes and lash - like terminal hairs . the conclusion that hair growth is stimulated by bimatoprost is thus supported not by evidence of a difference in a single parameter but is based on multiple parameters of hair appearance in treated vs . control areas in many subjects . this finding is entirely unexpected and represents a previously unrecognized effect of bimatoprost on stimulation of hair follicles . the modified hairs of the lashes normally turn over slowly and are in their resting phase longer than hair on , for example , the scalp . the ability to cause differences in appearance of lashes , the ability to stimulate conversion of vellus or intermediate hair to terminal hairs in transitional areas and the ability to stimulate growth of vellus hair on the skin indicates that bimatoprost is a diversely effective and efficacious agent for the stimulation of hair growth . thus , the present invention provides a treatment by bimatoprost of hair of the scalp , eyebrows , beard and other areas that contain hair that results in increased hair growth in the corresponding areas . patients that are treated in or around the eye with compounds of the invention , such as bimatoprost , regularly develop hypertrichosis including altered differentiation , numbers , length , thickness , curvature and pigmentation in the region of treatment . some examples of representative compounds useful in the practice of the present invention include the compounds shown in table 1 : one presently preferred compound for use in the practice of the present invention is cyclopentane n - ethyl heptanamide - 5 - cis - 2 -( 3α - hydroxy - 5 - phenyl - 1 - trans - pentenyl )- 3 , 5 - dihydroxy , [ 1 α , 2 β , 3 α , 5 α ], also known as bimatoprost and sold under the name of lumigan ® by allergan , inc ., calif ., usa . this compound has the following structure : the synthesis of the above compounds described above has been disclosed in u . s . pat . no . 5 , 607 , 978 . this patent also shows , particularly in examples 1 , 2 , 5 and 7 that these compounds are not prostaglandins , in that they do not behave as prostaglandins in art - recognized assays for prostaglandin activity . the invention thus relates to the use of the above compounds , or prodrugs of the active compounds , for treatment for the stimulation of hair growth . as used herein , hair growth includes hair associated with the scalp , eyebrows , eyelids , beard , and other areas of the skin of animals . in accordance with one aspect of the invention , the compound is mixed with a dermatologically compatible vehicle or carrier . the vehicle which may be employed for preparing compositions of this invention may comprise , for example , aqueous solutions such as e . g ., physiological salines , oil solutions or ointments . the vehicle furthermore may contain dermatologically compatible preservatives such as e . g ., benzalkonium chloride , surfactants like e . g ., polysorbate 80 , liposomes or polymers , for example , methyl cellulose , polyvinyl alcohol , polyvinyl pyrrolidone and hyaluronic acid ; these may be used for increasing the viscosity . furthermore , it is also possible to use soluble or insoluble drug inserts when the drug is to be administered . the invention is also related to dermatological compositions for topical treatment for the stimulation of hair growth which comprise an effective hair growth stimulating amount of one or more compounds as defined above and a dermatologically compatible carrier . effective amounts of the active compounds may be determined by one of ordinary skill in the art but will vary depending on the compound employed , frequency of application and desired result , and the compound will generally range from about 0 . 0000001 to about 50 %, by weight , of the dermatological composition , preferably from about 0 . 001 to about 50 %, by weight , of total dermatological composition , more preferably from about 0 . 1 to about 30 %, by weight of the composition . the present invention finds application in all mammalian species , including both humans and animals . in humans , the compounds of the subject invention can be applied for example , to the scalp , face , beard , head , pubic area , upper lip , eyebrows , and eyelids . in animals raised for their pelts , e . g ., mink , the compounds can be applied over the entire surface of the body to improve the overall pelt for commercial reasons . the process can also be used for cosmetic reasons in animals , e . g ., applied to the skin of dogs and cats having bald patches due to mange or other diseases causing a degree of alopecia . the pharmaceutical compositions contemplated by this invention include pharmaceutical compositions suited for topical and local action . the term “ topical ” as employed herein relates to the use of a compound , as described herein , incorporated in a suitable pharmaceutical carrier , and applied at the site of thinning hair or baldness for exertion of local action . accordingly , such topical compositions include those pharmaceutical forms in which the compound is applied externally by direct contact with the skin surface to be treated . conventional pharmaceutical forms for this purpose include ointments , liniments , creams , shampoos , lotions , pastes , jellies , sprays , aerosols , and the like , and may be applied in patches or impregnated dressings depending on the part of the body to be treated . the term “ ointment ” embraces formulations ( including creams ) having oleaginous , water - soluble and emulsion - type bases , e . g ., petrolatum , lanolin , polyethylene glycols , as well as mixtures of these . typically , the compounds are applied repeatedly for a sustained period of time topically on the part of the body to be treated , for example , the eyelids , eyebrows , skin or scalp . the preferred dosage regimen will generally involve regular , such as daily , administration for a period of treatment of at least one month , more preferably at least three months , and most preferably at least six months . for topical use on the eyelids or eyebrows , the active compounds can be formulated in aqueous solutions , creams , ointments or oils exhibiting physiologically acceptable osmolarity by addition of pharmacologically acceptable buffers and salts . such formulations may or may not , depending on the dispenser , contain preservatives such as benzalkonium chloride , chlorhexidine , chlorobutanol , parahydroxybenzoic acids and phenylmercuric salts such as nitrate , chloride , acetate , and borate , or antioxidants , as well as additives like edta , sorbitol , boric acid etc . as additives . furthermore , particularly aqueous solutions may contain viscosity increasing agents such as polysaccharides , e . g ., methylcellulose , mucopolysaccharides , e . g ., hyaluronic acid and chondroitin sulfate , or polyalcohol , e . g ., polyvinylalcohol . various slow releasing gels and matrices may also be employed as well as soluble and insoluble ocular inserts , for instance , based on substances forming in - situ gels . depending on the actual formulation and compound to be used , various amounts of the drug and different dose regimens may be employed . typically , the daily amount of compound for treatment of the eyelid may be about 0 . 1 ng to about 100 mg per eyelid . for topical use on the skin and the scalp , the compound can be advantageously formulated using ointments , creams , liniments or patches as a carrier of the active ingredient . also , these formulations may or may not contain preservatives , depending on the dispenser and nature of use . such preservatives include those mentioned above , and methyl -, propyl -, or butyl - parahydroxybenzoic acid , betaine , chlorhexidine , benzalkonium chloride , and the like . various matrices for slow release delivery may also be used . typically , the dose to be applied on the scalp is in the range of about 0 . 1 ng to about 100 mg per day , more preferably about 1 ng to about 10 mg per day , and most preferably about 10 ng to about 1 mg per day depending on the compound and the formulation . to achieve the daily amount of medication depending on the formulation , the compound may be administered once or several times daily with or without antioxidants . a study is initiated to systematically evaluate the appearance of lashes and hair around the eyes of patients who are administering bimatoprost in only one eye . the study involves 10 subjects , 5 male , 5 female , average age 70 years , ( ranging from 50 - 94 years ). all patients have glaucoma . each subject is treated daily by the topical application of one drop of bimatoprost at a dosage of 1 . 5 . mu . g / ml / eye / day ( 0 . 03 %, by weight , ophthalmic solution , sold under the name lumigan ® by allergan , irvine , calif ., u . s . a .) to the region of one eye by instilling the drop onto the surface of the eye . the region of the fellow control eye is not treated with bimatoprost and served as a control . in the course of treatment with eye drops , there is typically spontaneous tearing , and excess fluid from the drops and associated tears gathers at the lid margins . in the course of wiping the drug containing fluid from the lid margins and adjacent lid , a thin film of the fluid is routinely spread to contact the adjacent skin of the lid area . this widespread exposure of the skin around the lid to the effect of drops is regularly demonstrated in patients who develop a contact dermatitis . typically the entire area of the upper and lower lid are involved with induration , erythema and edema demonstrating the regular extensive exposure of the ocular adnexa to the influence of topically applied drugs . the study is limited to subjects who have administered bimatoprost to one eye for more than 3 months . the mean duration of exposure to bimatoprost prior to assessing the parameter of lash growth between the control and study eye is 129 days ( range 90 - 254 days ). observations are made under high magnification at the slit lamp biomicroscope . documentation of differences between the control and treatment areas is accomplished using a camera specially adapted for use with the slit lamp biomicroscope . length of lashes : increased length of eyelashes is regularly observed on the side treated with bimatoprost . the difference in length varies from approximately 10 % to as much as 30 %. number of lashes : increased numbers of lashes are observed in the treated eye of each patient . in areas where there are a large number of lashes in the control eye , the increased number of lashes in the bimatoprost - treated eye gave the lashes on the treated side a more thickly matted overall appearance . auxiliary lash - like hair growth : several patients have an apparent increase in lash - like hair in transitional areas adjacent to areas of normal lash distribution . these prominent robust appear lash - like hairs appeared to be of comparable length to the actual lashes . these long , thick lash - like hairs were present in the central portion of the lids of several patients in a linear arrangement just above the lash line . hairs are present at similar locations in the control eyes but are by contrast thinner or more fine in appearance , have less luster and pigment and are more flat against the skin of the lid typical of vellus or intermediate hairs . in several patients , lash - like terminal hairs grow luxuriantly in the medial canthal area in the treated eye . in the corresponding control eye , vellus hairs are seen at the same location . lash - like hairs are also present in the lateral canthal area of the treated eye but not the control eye in several subjects . large lashes are not normally present at the lateral canthus and the area is generally free of all but a few occasional very fine lashes or vellus hairs . increased growth of vellus hair on lids : fine microscopic vellus hair is present on the skin of the lids and is easily seen with the slit lamp biomicroscope . this vellus hair is typically denser adjacent to and below the lateral portion of the lower lids . while remaining microscopic , vellus hairs are increased in number , appear more robust and are much longer and thicker in treated than in control eyes in the areas below and lateral to the lower lid . perpendicular angulation of hairs : in areas where there are lash - like hairs above the lash line and in the medial and lateral canthal areas , the hairs are much longer , thicker and heavier . they also leave the surface of the skin at a more acute angle , as though they are stiffer or held in a more erect position by more robust follicles . this greater incline , pitch , rise or perpendicular angulation from the skin surface gives the appearance of greater density of the hairs . the foregoing observations clearly establish that bimatoprost can be used to increase the growth of hair in man . this conclusion is based on the regular and consistent finding of manifestations of increased hair growth in treated vs . control areas in human subjects . the conclusion that the drug bimatoprost is capable of inducing increased robust growth of hair is based not on a single parameter , i . e ., length , but is based on multiple lines of evidence as described in the results . detailed examination and description of multiple parameters of differences in hair is greatly facilitated by the ability to examine the hairs at high magnification under stable conditions of fixed focal length and subject position utilizing the capabilities of the slit lamp biomicroscope . the figure shows the actual results on the eyelashes of a patient treated for glaucoma with lumigan ® bimatoprost for 6 months . a topical cream is prepared as follows : tegacid and spermaceti are melted together at a temperature of 70 - 80 ° c . methylparaben is dissolved in about 500 gm of water and propylene glycol , polysorbate 80 , and bimatoprost are added in turn , maintaining a temperature of 75 - 80 ° c . the methylparaben mixture is added slowly to the tegacid and spermaceti melt , with constant stirring . the addition is continued for at least 30 minutes with additional stirring until the temperature has dropped to 40 - 45 ° c . finally , sufficient water is added to bring the final weight to 1000 gm and the preparation stirred to maintain homogeneity until cooled and congealed . a topical cream is prepared as follows : tegacid and spermaceti are melted together at a temperature of 70 - 80 ° c . methylparaben is dissolved in water and propylene glycol , polysorbate 80 , and bimatoprost are added in turn , maintaining a temperature of 75 - 80 ° c . the methylparaben mixture is added slowly to the tegacid and spermaceti melt , with constant stirring . the addition is continued for at least 30 minutes with additional stirring until the temperature has dropped to 40 - 45 ° c . finally , sufficient water is added to bring the final weight to 1000 gm and the preparation stirred to maintain homogeneity until cooled and congealed . the composition is applied to bald human scalp once daily to stimulate the growth of hair . an ointment containing 2 % by weight bimatoprost is prepared as follows : white petrolatum and wool fat are melted , strained and liquid petrolatum is added thereto . the bimatoprost , zinc oxide , and calamine are added to the remaining liquid petrolatum and the mixture milled until the powders are finely divided and uniformly dispersed . the mixture is stirred into the white petrolatum , melted and cooled with stirring until the ointment congeals . the foregoing ointment can be applied topically to mammalian skin for increased rate of hair growth , and can be prepared by omitting the zinc oxide and calamine . a dermatological ophthalmic ointment containing 10 % by weight bimatoprost is prepared by adding the active compound to light liquid petrolatum . white petrolatum is melted together with wool fat , strained , and the temperature adjusted to 45 - 50 ° c . the liquid petrolatum slurry is added and the ointment stirred until congealed . suitably the ointment is packaged in 30 gm tubes . the foregoing ointment can be applied to the eyelid to enhance the growth of eyelashes . similarly the composition can be applied to the brow for eyebrow growth . an aqueous solution containing 5 %, by weight , bimatoprost is prepared as follows . bimatoprost is dissolved in water and the resulting solution is sterilized by filtration . the solution is aseptically filled into sterile containers . the composition so prepared can be used in the topical treatment of baldness by application to the scalp daily . a sample of bimatoprost is dissolved in the vehicle of n - methyl pyrrolidone and propylene glycol . the composition can be used for application to dogs or cats having hair loss due to mange or alopecia of other causes . an aerosol containing approximately 0 . 1 % by weight bimatoprost is prepared by dissolving the bimatoprost in absolute alcohol . the resulting solution filtered to remove particles and lint . this solution is chilled to about minus 30 ° c . to the solution is added a chilled mixture of dichlorodifluoromethane and dichlorotetrafluoroethane . thirteen ml plastic - coated amber bottles are cold filled with 11 . 5 gm each of the resulting solution and capped . the composition can be sprayed on the scalp daily to stimulate the growth of hair . a powder of the compound bimatoprost is prepared by mixing in dry form with talcum powder at a weight / weight ratio of 1 : 10 . the powdered mixture is dusted on the fur of minks or other commercially valuable fur bearing animals and show animals for increased rate of hair growth . following the procedure of the preceding examples , compositions are similarly prepared substituting an equimolar amount of a compound of table 1 for the bimatoprost disclosed in the preceding examples . similar results are obtained . while the preferred embodiment of the invention has been illustrated and described , it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention . the embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows :
methods and compositions for stimulating the growth of hair are disclosed wherein said compositions include a cyclopentane heptanoic acid , 2 - cycloalkyl or arylalkyl compound represented by the formula i wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration , a , b , z , x , r 1 and r 2 are as defined in the specification . such compositions are used in treating the skin or scalp of a human or non - human animal . bimatoprost is preferred for this treatment .
the following is a description of the preferred embodiment of the invention . it is clear that there may be variations in the size and the shape of the gravity driven wheeled vehicle , in the materials used in the construction and in the orientation of the components . most importantly , the teaching of the wheeled version of the gravity driven vehicle is applicable to the version having skis or pans mounted in place of some or all of the wheels and which is used as a gravity driven vehicle on snow or ice covered downhill terrain . the stability in the absorbing of shock from uneven surface conditions and the stability and performance while making turns while going downhill derives from the combination of the steering and suspension geometry and the inherent shape of the skis mounted in place of the wheels and tires . in order to most simply and clearly characterize the essential features of the invention reference is made to drawing fig1 a , 1 b , 2 , 3 , 6 and 10 in which the essential elements of the invention are identified by numerals ( not in a circle ). fig4 , 7 , 8 and 9 are details of various elements which are well known to the ordinary skilled artisan . it is also important to note that the instant vehicle invention may have one wheel in front and one wheel in the rear . it is also possible to have three wheels with the single wheel either in the front or in the rear of the vehicle . steering may be effected by using either the front wheel ( s ) or the rear wheel ( s ) or both . braking combinations are likewise possible — front wheel , rear wheel or both . with reference now to particularly fig1 , 3 , 6 , 10 , 14 a , 14 b , 15 a and 15 b there is illustrated a four wheeled gravity driven steerable wheeled vehicle 10 . there is a chassis 12 having chassis front portion 12 a , chassis rear portion 12 b , chassis underside 12 c and chassis top side 12 d . a rider riding surface 14 is on chassis top side 12 d and is configured to cause a rider on rider riding surface 14 to be oriented in a prone , face down , face forward position . there is provided a means for attaching , 16 , a rear axle assembly 16 a substantially at chassis rear portion 12 b . there is also means for mounting , 18 , a front axle assembly 18 a substantially at chassis front portion 12 a . provided also is a means for steering , 20 , gravity driven steerable wheeled vehicle 10 or three - wheeled vehicle 40 by the rider when the rider is positioned on rider riding surface 14 . there are rear wheel hub and spindle assemblies 22 integral with rear axle assembly 16 a . wheels and tires 23 are normally mounted to the wheel hub . front wheel hub and spindle assemblies 24 are integral with front axle assembly 18 a . a braking system or means for causing deceleration and halting of motion 26 of vehicle 10 when vehicle 10 ( or 40 ) has motion is provided . braking system 26 may be hydraulic , mechanical or a combination of the two and braking may be of all wheels or some of the wheels . in order to help the rider stay on vehicle 10 or 40 , there is a means for harnessing 28 the rider onto and into rider riding surface 14 when the rider is positioned on the vehicle . to provide additional comfort for the rider and to improve the stability of the vehicle while moving , there may be provided means for absorbing shock 20 exerted on each of the front wheels and tires 23 attached to each of the two front wheel hub and spindle assemblies 24 thereby damping shock caused by vehicle 10 passing over rough terrain , between front wheels and tires 23 and front axle assembly 18 a . there may also be means for absorbing shock 32 exerted on each of the rear wheels and tires 23 attached to each of the two rear wheel hub and spindle assemblies 22 thereby further damping shock . in order to get wheeled vehicle 10 or 40 or ski equipped vehicle 10 a or 40 a up a ski slope for example , there is provided a combination rear roll bar and transport bail 34 . when the rider is on the vehicle , bar 34 is in the lowered position providing the rider with a roll bar and an object against which pressure may be applied when the rider is in a sharp turn . bar 34 is placed in a second position which permits attachment to a lift such as a ski lift . in order to discuss some of the engineering features , reference is again made to the drawings including fig4 - 19 . the drawings show simply the preferred embodiments of the wheeled and the ski equipped vehicle which have the following preferred specifications : fig1 shows a top , side , and front plan view of the vehicle , illustrating the body curvatures , the rider inclined riding surface / bed including the 11 ″ diameter high speed pneumatic , tubeless tires in the preferred embodiment of the vehicle , which are designed for motor vehicle racing at speeds in excess of 100 mph and which provide excellent traction and a soft but firm ride . advanced four wheel “ a ” arm air spring , oil damped suspension — independent four wheel suspension with air / oil shocks or with coil / oil shocks is provided and yields a smooth , stable ride over surfaces with irregularities ranging from wash board to large bumps . however , not all four wheels need have suspension , possibly only the front wheels might have suspension . also , the vehicle could be made in either a four - wheeled or three wheeled embodiment . in either embodiment , the suspension is not essential . fig3 illustrates a three ( 3 ) wheeled embodiment of the vehicle . fig4 shows a detail view of the assembly axle with an air / oil shock used in the wheel suspension , and fig5 shows a detail view of the assembly axle with a coil / oil shock used in the wheel suspension . independent hydraulic braking is provided from dual , real wheel , hydraulic disk brakes , designed for motor vehicle racing at speeds to 150 mph and operated with a single hand lever . these brakes give smooth , uniform and powerful braking capability whether with a four or three - wheeled embodiment . the braking system could be modified for a three - wheeled embodiment . fig6 is a detail view of the hydraulic rear wheel brake system . for the detail of the braking system used with the ski equipped version of the vehicles 10 a or 40 a , reference is made to fig1 - 19 . particularly , fig1 a and 16b illustrates in the partial top plan view in shadow front skis 70 a assembled to the front a - arm 32 a and also illustrating in shadow the steering linkage , the front brake system 80 including brake return system 88 and the front suspension system 30 and particularly in fig1 b is illustrated the “ canting ” of the skis 70 a ; fig1 shows the attachment of a rear ski assembly 70 a i . e , the ski assembly having ski brake assembly 80 as a part of ski assembly 70 and also shows , in shadow , the “ unloaded ” attitude of ski assembly 70 a and the relative positions of the suspension components and the fully loaded shock absorber 32 b compressed attitude of the ski and the relative positions of the suspension components , i . e ., a - arm 32 a and the piston of absorber 32 b ; fig1 shows a left rear ski 70 a attached to means for absorbing shock 32 which is attached to the rear axle 31 , the manner of the a - arm 32 a attachment to the ski post 72 , the a - arm pivot point 32 a 3 on the axle 31 , the connection of the a - arm shock attachment end 32 a 2 to the shock absorber end 32 b 1 which shock absorber is attached to the axle at the shock absorber pivot location 32 b 2 and also showing the brake blade 84 , brake arm 82 , and the brake cylinder 81 . fig1 is a view of the ski assembly 70 a of the invention , which shows , in shadow , the change in position of the brake components of the braking assembly 80 . fig1 a is a top view of section aa which illustrates the detail of the brake return spring assembly 88 along with return springs 88 a . there is provided a combination rear roll bar and transport bail . this bar is hinged so that locked in the folded down position , it tends to confine the legs of the rider and further resists overturning of the vehicle . when this bar is in the unfolded or up position it is useful as a tow or lift bar which may be attachable to a ski lift as an example of use . however , it is possible to have an embodiment of the vehicle without this feature . fig1 illustrates detail of the tow - bar assembly which also is a part of the rider restraint system . the prone ( lying down ) low center of gravity design provides control and good visibility . it is also possible that this low position may add to the level of safety for the rider . the extremely low center of gravity provides a relatively stable and safe ride — overturning is nearly impossible . there is provided a safety harness which enhances control , stability and rider safety , and which is shown illustrated in fig2 and 3 . the shoulder harness provides rider stability and contributes to rider safety by keeping the rider in place on the vehicle . there is also an automatic brake which actuates upon release of the hand grips for operation and parking safety . this feature is not essential to the basic embodiment of the invention , however this is an important additional feature . with this safety braking mechanism , the vehicle will be stopped if the rider were to fall off of the vehicle at some point during the operation of the vehicle . additional to the automatic brake system there may also be a means for causing the vehicle to go into a constant tight turn mode of operation if the rider loses control or if the rider fall from the vehicle while in motion . the surface of the vehicle on which the rider lays is comprised of a closed cell body pad for rider comfort . there is an elevated chest rest and thick foam mat which provide additional rider comfort and visibility . in the preferred embodiment , the body and chassis of the vehicle is made from light weight foam core fiberglass reinforced construction . the strong , rigid , impact resistant foam filled fiberglass body with aluminum inserts provides a single framework for attachment of all components . fiberglass body , plated steel parts , and extensive use of aluminum provide optimum protection from the elements , and from impact damage . the steering and braking mechanism is a ball bearing bicycle style steering and braking assembly which is positive , responsive and familiar to all to control , thus making learning to ride , and riding the vehicle easier and more comfortable . fig7 and 15a provide , in combination a detail view showing the prone steering linkage . substantially the same steering system as shown is fig7 and 15a is also used in the ski equipped vehicles as shown in fig1 a , 12 a , 13 a and 16 a . there are provided precision bearings on all four axles in one embodiment . independent rear axles provide maximum maneuverability in a four wheeled embodiment . the vehicle may be provided with precision wheel hubs , with pre - lubricated ball bearings , which are maintenance free . in a preferred embodiment the suspension and steering spindle bearings are formed of woven teflon or nomex and are designed to withstand high impact forces and hostile environments , and provide long life with no maintenance . fig2 shows a top , side , and front plan view of the vehicle showing , in shadow , the axle , steering , and wheel spindles . also , fig8 and 9 show a detail view showing the right rear wheel spindle and a detail view showing the right front wheel spindle . the preferred steering post ball bearings and linkage ball rod ends provide maintenance free , smooth , zero back lash response . each vehicle may be provided with elastomer bumper strips in the front and the rear which provide impact protection for the vehicle and rider . the preferred steering post , wheel , and front and rear axle assemblies can be removed intact should maintenance be required , thus reducing time and cost of any necessary maintenance . in a preferred embodiment , the vehicle chassis has a ramp - shaped underbody and detachable covers which offer protection for axles , steering linkage , and suspension from road obstacles . each vehicle in the preferred embodiments has strong , impact resistant fiberglass fenders which protect the rider from track dirt and contact with the wheels or skis when riding . following is a general description of the many technical features and the advantages achieved by the presently disclosed invention . it is material provided to further enhance the level of disclosure and present all of the presently known advantages achieved because of the technical features of the invention . a . the gravity driven vehicle with skis or combination of skis and wheels or slide pan while much of the following description is presented as a description of a wheeled vehicle similar to the vehicle of the present invention as described above but which has been retrofitted or specially constructed to result in the vehicle for use on snow covered terrain . it is important to note that the vehicle basically as described above but modified for use on snow may be custom made rather than created from a wheeled version by means for retrofitting the wheeled version . all of the disclosure above is applicable to the disclosure of the ski version of the vehicle except of course that portion which relates to the specifics of the braking system and some aspects of the steering systems . the retrofit kit is used in conjunction with the gravity driven wheeled vehicle of the present invention or other like products to make the product easily adaptable for use in snow covered conditions . the details of the systems described below apply as a retrofit package or basically describe the components and the function when applied to a gravity driven vehicle custom designed and dedicated for use only on snow . i . e ., a wheeled vehicle may be retrofitted with the combination of skis or slide pans or custom designed and built in the same manner . fig1 - 13 and 16 illustrate the vehicle with skis in the front and wheels to the rear , skis both front and rear , and skis in front and a slide pan with braking to the rear respectively . it should further be noted that the use of skis and slide pan or slide pans is interchangeable in that they both provide the sliding surface upon which the vehicle rides when in descent on a snow covered surface . a slide pan or ski may be used in any combination in the front in the rear or both front and rear locations of the vehicle . a unique discovery during the course of the development efforts to create the winter or snow covered terrain version of the gravity driven vehicle occurred in the integration of the skis onto the existing single swing arm suspension design of the wheeled product . as a consequence of the advanced four wheel “ a ” arm air spring , oil damped suspension — independent four wheel suspension with air / oil shocks or with coil / oil shocks as illustrated in at least fig4 , and the multiple views of fig1 - 16 there achieved a smooth , stable ride over surfaces with irregularities ranging from wash board to large bumps . with the mounting of skiis to the a - arm or the wishbone portion of the suspension system , the position or attitude of the outer edge of all skis due to the single arm geometry when there is no rider on the sled and the shocks are operating properly , causes the outer edge of all skis to be constantly engaged with the ground or snow surface . when the sled is being ridden the loading of the shocks , depending on how they are set , causes the skis to change to a more flat or level attitude relative to the snow or to the ground surface . this attitude only reaches a substantially flat attitude if there is extreme loading on the sled body and does so to absorb shock to the sled and rider . after such levels of loading and impulse types of shocks to the sled , the sled always returns to the outer edge engagement posture . substantially because of this characteristic of ski attitude or the inward canting of the skis when the sled is being ridden , on a modest downhill terrain put in particular when travelling on steeper downhill and upon initiation of turns , the lower or downhill ski becomes more heavily loaded tending to increase the flatness orientation relative to the snow surface yet still resulting in the outer edge carving into the snow . i . e ., the outer edge of the ski carves into the snow and as it becomes increasingly loaded the suspension slightly counters the digging or carving action but continues to engage the snow surface . the upper ski or uphill ski , particularly the outer edge , with the lesser loading while in the turn it is still partially canted inwardly , carves as well and even more aggressively because of this canted attitude of the uphill ski in the turn . alternatively described , the uphill ski acts somewhat as an anchor as this engagement becomes more unloaded in an aggressive turn , the a - arm extends its full travel maintains constant engagement with the snow due to the fact the lower or downhill ski is flattening allowing the attitude of the uphill ski to remain in constant contact with the snow . this unexpected performance characteristic or functionality provides benefits such as for example : the carving action of both skis constantly counterbalancing each other provides tremendous control and maneuverability in virtually every snow condition ; and under conditions of heavy loading of the downhill ski , the digging and tipping tendency of the sled is reduced dramatically . to provide further control and maneuverability a keel component may be added to the ski bottoms . a . the front ski retrofit is attached to the existing front a - arm ( wishbone ) assembly of the wheeled version with either a double or the single arm / linkage geometry by utilizing the existing fastening system . when fixed to the suspension linkage the ski has the ability to pivot from an axis perpendicular to the axle allowing the tip and heal to pivot in opposition to one another , upwards and downwards and is limited in its pivot by a stop mechanisms mounted to either the ski or the mounting system . the width and length of the selected skis and the forward or rearward positioning of the pivot point is established based upon the terrain and the specific performance requirements desired . the steering geometry has been designed to create a carving action when the skis are turned by the steering linkage . i . e ., upon causing a turn using the steering mechanism both ski tips rise slightly , the tails sink slightly and the inner edge of the ski opposite of the direction of the turn and the outer edge of the ski in the direction of the turn tilt slightly downwards into the snow or ice surfaces . these edges can also be described as the ski edges on the inner radius of the turn . b . the independently or simultaneously actuated right and left , rear , front or rear and front , or independent rear and front combined brakes or single brake actuation unit whether one or divided mechanism is integrated in to the front ski and trailing or sliding pan or ski assemblies that are part of the vehicle / mountain sled retrofit package . the actuation of the mountain sled brake is either mechanical , hydraulic , servo - mechanical , pneumatic or a combination of these technologies . when this solution is used as a retrofit it is intended , whenever and wherever possible , that the existing actuation system or systems be utilized . c . the rear brake system or systems is / are integrated into an under body pan covering a portion or all of the sled under body from approximately the middle of the sled length and some distance forward of the rear axle location mounting surfaces and is attached or nearly meets the sled underside and extends sufficiently across the width of the sled in the front in a fixed or in a limited manner with a hinge or slide like interface allowing the pan from the hinge point rearwards to move up and down or to slide or flatten out across the under face of the sled a distance equal to the translated stroke distance of an internally mounted shock system . the pan will be a complete cover with a downward sloping straight or radiused lead edge , running from the mounted or hinged or meeting leading edge and transitioning to a gliding surface that runs almost parallel to the underside of the body or sled frame . the rear pan or ski assemblies will be covering a single or double shock absorption mechanism able to operate independent of or together with each other and the braking mechanism that will be substantially a swing arm or linearly actuated arm or blade that will when actuated protrude out from the pan or ski below their running surfaces and into the snow or ice surface at a positive , negative or right angle to the pan or running surface and will be depth adjustable equal to the geometry and stroke of the actuation . this pan or ski ( if chosen ) as seen from behind is profiled to provide maximum lateral grip and stability when either turning or gliding . the geometries are optimized to address snow condition and terrain . d . commercial : the winter retrofit package allows an owner of a summer mountain sled the simplified and flexible solution of utilizing at a minimum a sled body with an integral frame or a sled body with a separate frame . additionally , depending upon the components of the winter retrofit package , many more of the basic of summer mountain sled components can be used in retrofitting the summer sled for winter recreation such as the axle , suspension , steering and braking systems . e . technical : the retrofitted summer sled steering , braking , and rear tracking and control systems provide in the sled retrofitted for winter use all of the already known benefits of summer / wheeled sled including superior control and stability for a snow sledding experience . the condition of downhill ice packed or ice covered roadways , trails , paths , etc . presents a braking , steering and control challenge for both a conventional summer mountain sled and a winter mountain sled of any form or configuration . the operational challenge is to provide a sled with a steering and braking solution that handles these conditions . the following embodiment of the invention and declared benefits address this challenge . a mountain sled equipped with four wheel or three wheel independent or simultaneous braking systems will have its standard tires replaced with slick or profiled tires that have been retrofitted or produced to order with studs , nails , screws , etc . fixed to , inserted into or imbedded in the rolling surface of the tire and protruding from the rolling face of the tire sufficiently to provide contact and grip in the existing ice or ice packed condition on the running surface . the selection of each tire profile and cleat material , cleat geometry and cleat placement and number of cleats is dependent solely on the application surface and can be changed and optimized accordingly to best suit the exact requirements of each downhill surface . this solution has the distinct benefit of providing exceptional control on most every downhill ice covered or ice packed roadway , trail , path , etc . running surface . i . due to the fact that only the tires used for summer sport are replaced with tires having studs or nails ( or the like ) mounted to the tread portion of the tire to provide improved friction interface between the sled and the running surface . all other subsystems , steering , suspension and braking remain the same for the studded tire version as for the summer tire version . the resulting sled has substantially all of the performance advantages of the summer wheeled vehicle . the challenge of providing superior handling and control of a gravity driven mountain sled is to offer the best technology to achieve differing optimized operating results to meet the demands of the conditions and requirements of various terrains . the integration of certain solutions in a mountain sled with tires or with winter attachments such as in various presented solutions is primarily possible due to the combination of certain existing technologies , materials and compact componentry and by integrating them into various suspension geometries . the advent of small components coming from the mountain bike industry , has permitted mountain sledding to move from being basically unsophisticated toys to sophisticated sports equipment . integrated into the mountain sled is a suspension system that displays when viewed from the side ( from sled rear to front or front to rear ) a suspension geometry that is trapezoidal in form ( parallelogram ) with all four joints forming pivots and the two sled side , upper and lower fastening points / pivots are fixed in some manner firmly to the sled frame or uni - body or axle system or combination thereof and the spindle or the ski assembly or ski pan assembly is fixed somewhere on the fixed member connecting the outboard pivot points of the trapezoid . as part of this design and resisting loading of the trapezoidal design is an arm that extends at an angle away from one of the inboard trapezoid pivot locations and is an integral mechanical arm to which a shock absorber is attached to the end of arm and to a fixed point on the body , frame or axle system and both ends of the shock absorber can pivot . this geometry allows the upright mounting face for the spindle or ski or pan to move the spindle or ski or snow pan assembly upward and downward when the sled is pointed straight forward and when the sled itself has certain load exerted and released such that the tire , ski or pan maintains complete contact of its lower running surface with the operating surface , the running surface remains parallel with itself as it is loaded and unloaded . the longitudinal motion of the entire assembly is limited by the stroke of the shock absorber and the operating envelope of the related mechanics . this design permits minimal axial motion of the contact running surface as it is loaded and unloaded called scrubbing . this scrubbing action is considerably less than that witnessed by the solution already presented in the claim from tsi with a single arm solution . ii . maintaining constant and maximum contact of the entire running face of the tire , ski , and pan solutions with the running surface . iii . reduces scrubbing and non - uniform wear of the running surfaces of the tires , skis and pans . iv . simplifies steering geometry compound angles allowing maximization of ski contact and carving benefits . this system is highly recommended for applications utilizing skis and sliding pan systems . the body design and construction for the instant vehicle represents the latest form of taking the idea of monocoque or body integral frames and eliminating the need for conventional frames and separate bodies for use in mountain sled , sleds and sled product applications . this idea utilizes the fiberglass upper and lower body components known as or halves and sandwiches them together and imbeds inserts to add strength , to bond the halves , to stiffen the body and to take maximum advantage of the collective strength of each system . this solution accommodates and allows the fiberglass to be a connecting structure through the use of adhesives and epoxies that are part of the normal fiber - glassing process of dissimilar materials . this permits the combination of a variety of materials that would not otherwise be combined in a conventional fame / body construction . the imbedded materials then are optimized for their ability to retain fasteners , to choose material that accommodates extreme variations in temperature , adequately spread load across the fiberglass surface and eliminating extra material where it is unnecessary . i . provides singular body and frame system , simplifying assembly , inventory and repair . ii . makes maximum use of the strength and stiffness of each system . iii . allow adaptability and design modifications when new materials come available without requiring the whole design be changed . there are additional subsystems which may be incorporated into the gravity driven vehicle of each of the embodiments described such as for example : complete braking system i . e ., one system for the front and one for the rear which may use two ( 2 ) independent master cylinders and brake circuits . detail relative to the suspension system , the ski assembly and the braking system suspension geometry action and performance contribution to tracking and steering control : the existing , previously disclosed single a - arm suspension geometry provides the ability to present the outer edge of four skis , when mounted to a two opposing arm axle assemblies , to the snow at an angle to the running surface which delivers significant unique , maneuvering and steering control performance in most all snow conditions . this performance results from the fact that a carving geometry of the skis to the snow occurs . this engagement with the running surface is equally as consistent improves as the sled is underway and is caused to turn through the steering linkage . in a turn or as one is traversing a downhill slope the outboard or downhill ski receives increased load and the ski engages more with the snow / ice running surface until such time that the load on this ski begins to overcome the resisting force of the shock attached to the shock anchor point on the a - arm and the axle . as the resisting force ( ajustable ) is gradually overcome the a - arm begins to pivot at the a - arm pivot and ski assembly begins to move toward a flatter orientation with the snow . this action helps to avoid over powering the engagement of the downhill ski downhill edge and helping to avoid overturning . simultaneously , the uphill ski is less loaded but still has its outer edge engaged in the snow and creates a scrapping action on the adjacent downhill snow / ice as well as packing what ever loose snow is present under the underside of the ski . this uphill ski performance improves as the downhill ski continues to flatten in respect to the running surface and loading . additionally , the underside of any and all skis can be equipped with various geometry keels to assist in linear or turn tracking of all skis as they , under suspension applied compressive loads , present more ski surface and the keels to the running surface . there are always limits to this performance resulting from excessive speed and surface conditions , etc . the ski foot and post pivot allows any ski when traveling over uneven surfaces to follow the terrain contour more closely . the swing motion allowed by this feature is limited by the presence of bumpers mounted on the ski foot which contact ski post extensions when pivot travel limits are reached . this function delivers another benefit because of the ability to allow the ski to follow the terrain more closely that being it causes the brake mounted on the attached ski assembly to achieve more consistent contact with running surface . the brake assembly developed by the applicants provides superior braking action in various snow and ice conditions . the brake assembly has a hydraulic piston actuated lever equipped with a brake blade . this brake is actuated through the introduction of hydraulic pressure into the input port , the pressure causes the piston shaft to extend from the cylinder in the direction of the rear of the ski , the shaft is attached to the brake lever which begins to pivot at the brake lever pivot and rotates the lever with the attached blade toward the running surface until such point that the full stroke piston and the lever has been reached . the developed solution looked to achieve maximum force , with limited space by using a short stroke cylinder and applying multiple ratio motion at the brake tip . currently , the solution developed provides practically two inches of travel at the brake tip . the solution utilizes external extension springs to assist the brake return when no longer under hydraulic pressure . the solution is further supported by the presence of an expansion tank mounted to and on the non - pressure side of the brake actuation cylinder . the expansion cylinder is partially filled with the same fluid used to actuate the piston and then securely plugged . this expansion tank provides three benefits , closed system that does not allow air to enter the non - pressurized side of the system and contaminate the pressurized side of the system if air were to get by the piston seals , this non - pressurized side of the system could be used to introduce opposing pressure by filling it with more fluid and when compared with an open ended system where an air vent is present to relieve pressure this solution eliminates the likelihood of drawing contaminants such as water into the cylinder or by the piston seals into the pressurized fluid side of the system . the brake assembly developed by the applicants provides superior braking action in various snow and ice conditions . the brake assembly depicted in print number ( s ) ______ shows a hydraulic piston actuated lever equipped with a brake blade . this brake is actuated through the introduction of hydraulic pressure into the input port , the pressure causes the piston shaft to retract extend from the fully extended position away from the rear end of the ski , the shaft is attached to the brake lever which begins to pivot at the brake lever pivot and rotates the lever with the attached blade upwards away from and out of the running surface until such point that the full stroke piston and the lever has been fully retracted . the developed solution looked to achieve maximum force , with limited space by using a short stroke cylinder and applying multiple ratio motion at the brake tip . currently , the solution developed provides practically two inches of travel at the brake tip . the solution utilizes external extension springs to assist the brake return when no longer under hydraulic pressure . the solution is further supported by the presence of an expansion tank mounted to and on the non - pressure side of the brake actuation cylinder . the expansion cylinder is partially filled with the same fluid used to actuate the piston and then securely plugged . this expansion tank provides three benefits , closed system that does not allow air to enter the non - pressurized side of the system and contaminate the pressurized side of the system if air were to get by the piston seals , this non - pressurized side of the system could be used to introduce opposing pressure by filling it with more fluid and when compared with an open ended system where an air vent is present to relieve pressure this solution eliminates the likelihood of drawing contaminants such as water into the cylinder or by the piston seals into the pressurized fluid side of the system . the gap between the rear end of the ski and the brake blade is critical . the development of this ski brake determined that when braking , the disturbed running surface , snow , ice , etc . needs to find a place to release the braking loads and if this release location is readily available between the blade and the ski it will escape at that point , evidenced through the plume , rooster tail that gets larger the larger the gap and the higher the speed . conversely , when the gap is reduced to a minimum the loads , forces , energy is then captured under the ski and greatly increases brake drag and brake performance . while these additional subsystems are not being described in detail herein , it is certainly within the skill of the ordinary artisan in the field of mechanics and mechanical design to understand and implement many types of mechanisms or systems addressing the incorporation of any or all of the above subsystems into any one of the vehicles as described as the instant invention . it is thought that the present gravity driven steerable vehicle , for use in riding or racing primarily down hill over varied terrain , and many of its attendant advantages is understood from the foregoing description and it will be apparent that various changes may be made in the form , construction and arrangement of the parts thereof without departing from the spirit and scope of the invention or sacrificing all of its material advantages , the form hereinbefore described being merely a preferred or exemplary embodiment thereof . 14 a rider riding surface on said chassis top side 12 d configured to cause a rider to said ride riding surface 14 to be oriented in a prone , face down , face forward position ; 16 means for attaching a rear axle assembly 16 a substantially at said chassis rear portion 12 b ; 18 means for mounting a front axle assembly 18 a substantially at said chassis front portion 12 a ; 20 means for steering said gravity driven steerable wheeled vehicle 10 by said rider when said rider is positioned on said rider riding surface 14 ; 22 rear wheel hub and spindle assemblies integral with said rear axle assembly 16 a ; 24 front wheel hub and spindle assemblies integral with said front axle assembly 18 a . 26 braking system or means for causing deceleration and haulting of motion of said vehicle 10 when said vehicle has motion . 28 means for harnessing the rider onto and into said rider riding surface 14 when said rider is positioned on said vehicle 10 30 means for absorbing shock exerted on each said front wheels and tires 23 attached to each said two front wheel hub and spindle assemblies 24 thereby damping shock caused by said vehicle 10 passing over rough terrain , between said front wheels and tires 23 and said front axle assembly 18 a ; 32 means for absorbing shock exerted on each said rear wheels and tires 23 attached to each said two rear wheel hub and spindle assemblies 22 thereby damping shock caused by said vehicle 10 passing over rough terrain , between said rear wheels and tires 23 and said rear axle assembly 16 a ; 40 a a gravity driven steeable vehicle with two skis in front and two wheels in the rear
a gravity driven steerable vehicle having wheels , or skis or a combination of wheels and skis for recreational use , most particularly on surfaces such as pavement , artificial hard - pack turf , mountain slopes , dirt roads , grass and hard - packed or non - packed snow . the vehicle has at least three but preferably four wheels , or skis or a combination of wheels and skis which may or may not be on independent axles one from the other and which may or may not be each independently shock suspended . there is also a steering mechanism for steering the vehicle and a driver compartment portion for containing a driver of the vehicle in a prone face - down and face - forward position . the vehicle is steerable by the driver from the prone face - down and face - forward position . the mechanism for suspension of the wheels and / or skis is configured to provide precise control in turns especially the carving of turns , by the skis , while descending on snow covered terrain . the attitude of the skis relative to the snow surface changes upon initiation of a turn and while in the turn to increase the edgeing of the skis thereby enhancing the turning characteristics of the vehicle . the vehicle may further have a braking system for slowing or stopping the vehicle and a harness apparatus for harnessing the driver onto and into the vehicle .
referring now to the following detailed information , and to incorporated materials ; a detailed description of the invention , including specific embodiments , is presented . unless otherwise indicated , numbers expressing quantities of ingredients , constituents , reaction conditions and so forth used in the specification and claims are to be understood as being modified by the term “ about .” accordingly , unless indicated to the contrary , the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the subject matter presented herein . at the very least , and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims , each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques . notwithstanding that the numerical ranges and parameters setting forth the broad scope of the subject matter presented herein are approximations , the numerical values set forth in the specific examples are reported as precisely as possible . any numerical value , however , inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements . the present invention employs inverse wave techniques to reconstruct images of a medium surrounding a physical probe in a plane perpendicular to an axis of rotation in a radial reflection configuration , i . e ., in a multimonostatic or a multistatic arrangement disclosed infra , wherein one or more transmitting and receiving elements , more often at least about 15 of such elements , e . g ., transducer ( s ), are at a fixed radius and designed to collect scattered fields , e . g ., reflected and diffracted fields . such a radial reflection diffraction tomography ( rrdt ) technique is based upon a linearized scattering model to form images given the disclosed physical transmitter and receiver configurations and the mathematical method , i . e ., a hilbert - based wave algorithm , utilized to invert the scattering collected fields . as example embodiments , the multimonostatic and multistatic probes can be mounted at the end of a flexible substrate , such as a catheter or snaking tube that can be inserted into a part with an existing access hole or a medium ( e . g ., an artery ) with the purpose of forming images of the plane perpendicular to the axis of rotation . by applying the hilbert space inverse wave ( hsiw ) algorithm of the present invention to the collected data of such multimonostatic and multistatic probes , radial reflected diffraction tomographic images are readily obtained . fig1 ( a ) shows a basic multimonostatic conceptual arrangement of the present invention , wherein a single energy source element 1 , such as a transducer , can operate as both source and receiver ( as denoted by t / r , to indicate transmitter and receiver ) at multiple spatial locations . at each angular location along the illustrated dashed circumference , as denoted by the directional arrow , energy source element 1 can launch a primary field wave ( not shown ) and receive a reflected scattered field wave ( not shown ). such an arrangement often requires a spectrally wide band frequency diverse source capable of producing frequencies from about 1 khz to about 3 thz ( electromagnetic frequencies ), often from about 100 hz to about 10 ghz ( acoustic frequencies ), more often between about 20 mhz and about 60 mhz ( acoustic frequencies ), to provide spatial diversity so as to form images of a surrounding medium . fig1 ( b ) shows an example conceptual multistatic mode embodiment , wherein a plurality of fixed energy source elements 2 , e . g ., transducers , are arranged as an annular array , generally designated by the reference numeral 20 . in succession , along for example , the illustrated directional arrow , each energy source element ( for example , the element denoted by the letter t to indicate a transmitter ) is capable of launching a primary field wave ( not shown ) and a backscattered field wave ( not shown ) is measured on all the remaining elements ( as denoted by the letter r , indicating the remaining fixed elements are operating as receivers ). fig1 ( c ) illustrates a beneficial multistatic conceptual arrangement that includes a plurality of energy source elements 4 configured in a rotating sub - aperture 6 , as denoted by the bi - directional arrow , formed by a single transmitter , as denoted by the letter t to indicate a transmitter , and surrounded by multiple receivers , as denoted by the letter r . at each angular location , as denoted by the single directional arrow along the illustrated dashed circumference , transmitter t can launch a primary field ( not shown ) and a backscattered field ( not shown ) is measured on all receivers r . when operating in a reflection mode as disclosed herein , the mathematics applied to the collected data operate beneficially to image objects because the range resolution of the reconstructed image is proportional to the number of frequencies used in the reconstruction . under the hilbert space inverse wave algorithm , increasing the number of frequencies and transducers , increases the complexity of the reconstruction , the size of the intermediary data files , reconstruction time , and computer memory requirement . thus , the trade - off between computer resources and resolution is a consideration . nonetheless , the techniques employed in the present invention are beneficial even at acoustic frequencies from as low as about 100 hz to as high as about 10 ghz . such lower frequencies allow the disclosed embodiments to additionally be employed in borehole type of applications , such as , but not limited to , characterizing underground contamination plumes or waste in contamination barrels . for either the multimonostatic or multistatic example embodiments , the planar reconstruction of the imaged object ( s ) requires that the one or more collected measurements map a pair of spatial variables ( i . e ., angular location and incident source frequency ) of a physical object into the angular location and frequency parameters of the measured field . an exemplary application of the present invention is in the characterization of vulnerable atherosclerotic plaque . arthrosclerosis is a condition where the arteries are obstructed by the buildup of deposits , “ intravascular plaque ” ( ivp ), on the inside of arterial walls and such a buildup of deposits can lead to what is known to those of ordinary skill in the art as cerebrovascular disease , which is the third leading cause of death and the leading cause of major disability among adults . plaque grows as a fibrous tissue encapsulating a lipid pool and as the plaque grow it may incorporate calcium . of particular concern is vulnerable or unstable plaque because of the possibility of such plaque becoming inflamed and unexpectedly rupturing . stable or non - vulnerable plaque , typically includes a thick layer of fibrous tissue of about 800 microns but is not life threatening and can be treated slowly . a thin fibrous cap of typically up to about 300 microns covering a pool of a soft lipid core typically characterizes vulnerable plaque . when such a cap is disrupted , the thin cap is compromised and the lipid deposited into the artery can produce adverse effects , such as thrombus formation , strokes and death . fig2 shows a conventional catheter , generally designated as reference numeral 200 , for intravascular tissue characterization , such as atherosclerotic vulnerable plaque . such a catheter 200 , typically has an elongated flexible substrate 202 with an axially extending lumen 204 through which a guide wire 206 , and / or various other devices or other instruments can be delivered to a region of interest . an ultrasonic transducer assembly 208 is provided at the distal end 210 of the catheter , with a connector 214 located at the proximal end of the catheter for transducer manipulation and processing received transducer signals . transducer assembly 208 can comprise a plurality of transducer elements 216 arranged in a cylindrical array centered about a longitudinal axis 218 of the catheter for transmitting and receiving ultrasonic energy . adhesive ( not shown ) and or an end - cap ( not shown ) can be applied to transducer assembly 208 , and lumen 204 to protect such elements from the surrounding environment . transducer assembly &# 39 ; s 208 individual elements ( not shown ) and conductive acoustical backing ( not shown ) are often mounted on the inner wall of elongated flexible body 202 operating as the flexible substrate . fig3 a illustrates a typical ivus method using such a catheter 200 , as shown in fig2 a . in such a conventional application , catheter 200 , having a transducer assembly 208 that can launch an energy wave as a primary field ( as denoted by the letter f ) is inserted typically non - centered into a nominally circular diseased artery 302 . around a wall 304 of artery 302 is a fibrous collagen plaque 306 . a lipid pool 308 can reside inside such a fibrous structure , wherein when a fibrous cap 310 of plaque 306 separating lipid pool 302 from the blood ( not shown ) within artery 302 is more than about 800 μm thick , plaque 306 is characterized as stable . however , in cases where cap 310 is less than about 300 μm thick , such a plaque is characterized as vulnerable , and is more likely to rupture and / or thrombosis . the present invention utilizes the disclosed rrdt approach for improved intravascular applications such as characterizing plaque as discussed above , and incorporates various aspects of the method of utilizing a probe , such as , but not limited to , the catheter as shown in fig3 a . however , such catheters 200 and similar probes known to those of ordinary skill in the art typically show angular overlap for beam processing , which results in loss of valuable image information of one or more objects of interest within a surrounding medium . the present invention overcomes such processing by incorporating novel improvements of the transmitters and receivers , by utilizing frequencies between about 20 mhz ( acoustic ) and about 60 mhz ( acoustic ), and by utilizing rrdt techniques of the present invention as discussed herein . such novel embodiments accounts for phase , amplitude , and beam diffraction , to recover not only such loss of valuable image information information but to further enhance the imaging capabilities of the invention by providing images with improved lateral resolution of the acoustic absorption and sound speed . fig3 b shows the geometry incorporated by the rrdt method of the present invention . fig3 b shows a cross - sectional view of a catheter 200 , having an outer diameter between about 0 . 25 mm and about 5 mm , being inserted into an artery 302 , having a surrounding plaque 306 that includes a cap 310 and a lipid pool 308 . inserted into artery 302 is a non - centered catheter 200 , which includes a transducer assembly ( not shown ) that can be disposed about the distal end of catheter 200 , as disclosed in the present invention , with a radial location specified by r o ≡ r o ( cos θ o , sin θ o ), where r o is the catheter 200 probe radius , a constant . at each angular location , θ o , transducer assembly 208 , as shown in fig3 a , launches a primary field f radially outward ( as denoted by the letter r ) into a medium , such as the blood ( not shown ) and surrounding tissue in this example , and the transducer arrangement , as disclosed in the present invention , can measure a reflected scattered field ( not shown ) having , for example , at least up to about 90 degrees of angular content from one or more objects , such as the linings of cap 310 that overlies lipid pool 308 . as another example embodiment , the rrdt method and apparatus of the present invention can be combined with elastography to gain further insight into a surrounding medium &# 39 ; s elastic properties and provide further information in the determination of characterizing plaque as vulnerable or stable . generally , the contrast in elastic properties between a lipid pool and a fibrous cap is evident . by utilizing elastography , the elastic properties of a vessel wall can be obtained by observing a deformation of the vessel due to an external pressure , such as the pressure produced by a heart . such a change in the arterial pressure due to the pumping action of the heart produces a measurable deformation of the tissue surrounding the vessel . such a deformation can be measured by tracking a motion of patterns in successive intravascular scans as disclosed by the present invention . by knowing the arterial pressure and the measured deformation , the present invention can recover elastic properties of the surrounding tissue . from such elastic properties , one can further characterize the surrounding tissue to predict plaque composition . fig4 illustrates a further beneficial embodiment , wherein the present invention can be utilized for non - destructive characterization ( i . e ., rrdt imaging ) in applications other than for intravascular rrdt imaging . as shown by the example cross - sectional underground view of a borehole 404 in fig4 , a flexible substrate 400 or snake - like tube having a transducer assembly 402 similarly configured like the intravascular rrdt application discussed above , can be lowered into bore hole 404 so as to image a site using rrdt techniques . such an arrangement can launch a primary field ( denoted by the letter f ) and receive diffracted energy waves having frequencies often between about 100 hz and about 300 hz , to determine the state of buried wastes , such as waste within a radioactive waste drum barrel 410 or a biohazardous container , and / or to track a plume 412 of underground contaminants . in a similar manner , disclosed probes herein , can be inserted into waste drum barrels 410 , or weapons ( not shown ) or any part having an existing access hole , such as , but not limited to , an automobile engine , and determine the state of the part or material . hilbert spaces are spaces constructed using vectors . specifically they define vector spaces where sets of vectors in the space “ add up ” to another vector , an analog to euclidean space where measurements can be added to result in another valid measurement . hilbert spaces are particularly useful when studying the fourier expansion of a particular function . in the fourier transform , a complex function describing a waveform is re - expressed ( transformed ) into the sum of many simpler wave functions . a hilbert space describes the “ universe of possible solutions ” given one particular such function . the hilbert space inverse wave ( hsiw ) algorithm of the present invention enables an inverse for any multistatic or multimonostatic geometry with any combination of sources , receivers , and frequencies . in a radial reflection device of the present invention , such as an intravascular ultrasound probe having an outer diameter between about 0 . 25 mm and about 5 mm , or a probe configured to non - destructively characterize buried wastes ( e . g ., tracking plumes of underground contaminants of materials ), evaluating the state of materials residing in waste drum barrels or weapons , or to non - destructively evaluate parts with existing access holes ( e . g ., automobile parts ), acquired data are collected at discrete angular locations . such angular locations are denoted by : r n t ≡ r 0 ( cos θ n , sin θ n ) ( 1 ) for transmitter locations , where θ n = nδθ src for n = 0 , 1 . . . , n src − 1 , where n src 2π / δθ , and δθ src is the source angular increment . r m r ≡ r o ( cos θ m , sin θ m ) ( 2 ) where θ m = mδθ rcv for m = 0 , 1 . . . , n src − 1 , where n rcv 2π / δθ rcv , and δθ rcv is the receiver angular increment . for each source , configured receiver ( s ) can record a backscattered field as a time series that can be digitized for processing . discrete fourier transforming the time series data result in the spectrum of one or more measured wave forms at discrete frequencies . the forward scattering equation under the born approximation with both spatial and frequency diversity is given by : ψ b scat ( r m r , r n t , ω l )= p ( ω l ) k o 2 ( ω l )∫ dr ′ g ( r m r , r ′ , ω l ) o ( r ′ ) g ( r ′ , r n t , ω l ), ( 3 ) where ω l , l = 0 , 1 . . . , n f − 1 are the discrete frequencies and n f is the number of frequencies in the pulse band width . the hsiw as disclosed herein interprets equation ( 3 ) as a mapping from a continuous object space to a discrete measurement space . the object space is the physical ( x , y ) space of the object function . the measurement space includes discrete angles and temporal frequencies at which the scattered data are collected . the scattering operator projects the object onto the measurement space . the forward propagation or projection kernel is defined as : π *( r )≡ p ( ω l ) k o 2 ( ω l ) g ( r m r , r , ω l ) g ( r , r n t , ω l ), ( 4 ) where π ( r ) is a j ≡( n src × n rcv × n f ) element column vector , and p ( ω l ) is the incident pulse spectrum . mathematically , the projection is represented as an inner product between the object function and the kernel via : where d is a j element column vector , and where each element represents a particular source , receiver , and frequency combination . symbolically , the forward scattering operator , k , is defined as : the hsiw method of the present invention is employed to derive an inverse of the operator as shown in equation ( 6 ). the singular value decomposition ( svd ) of k is given as : where the columns of u form an orthonormal set of column vectors , u j , which span a measured data space , and the components of v form an orthonormal set of vectors , v j ( r ), which span an object space . s is a diagonal matrix of singular values , σ j . it is emphasized that the u j are complex column vectors where as the v j ( r ) are complex functions of r . the set of normal equations for such a singular system are : kk † u j = σ j kv j ( r )= σ j 2 u j , ( 10 ) k † kv j ( r )= σ j k † u j ( r )= σ j 2 v j ( r ), ( 11 ) the inversion method of the present invention estimates the object function of equation ( 5 ) given measured data in d . such an inversion incorporates expanding the object function in terms of v j ( r ): o ^ ⁡ ( r ) = ∑ j = 0 j - 1 ⁢ α j ⁢ v j ⁡ ( r ) , ( 12 ) where the α j are constant coefficients to be determined . substituting the object expansion into equation ( 5 ) results in : applying the definition of the k operator in equation ( 6 ) to equation ( 8 ) yields an expression for the integral of equation ( 13 ), kv j =∫ dr π *( r ) v j ( r )= σ j u j , ( 14 ) using the orthogonality of the u j vectors , the unknown α j is solved as follows : u i † ⁢ d = ∑ j = 0 j - 1 ⁢ α j ⁢ σ j ⁢ u i † ⁢ u j = ∑ j = 0 j - 1 ⁢ α j ⁢ σ j ⁢ δ ij = α i ⁢ σ i , ( 16 ) the adjoint of the forward scattering operator , k † and the singular values and singular vectors , σ j , u j , and v j ( r ) are now required . first , the following inner product equation defines the adjoint , using the definition of the forward scattering operator from equation ( 16 ) results in : u † ∫ dr π *( r ) v ( r )=∫ dr ( u † π *( r )) v ( r ), ( 19 ) by comparing the right hand sides of equations ( 18 ) and ( 19 ), the following definition of the adjoint of the forward scattering operator is obtained : the σ j and u j are determined by solving the eigenvalue equation of equation ( 10 ) formed by the outer product of the forward scattering operator with its adjoint . explicitly , the outer product is represented by : (∫ dr π *( r ) π t ( r )) u j = σ j 2 u j , ( 21 ) which is a j × j eigenvalue equation of the form ax = λx . the π ( r ) vectors are known analytically and can be evaluated numerically . it follows that the elements of the outer product matrix can be computed numerically and the resulting system solved numerically for the σ j 2 and u j . given these and using equation ( 19 ) to solve for v j ( r ) results in : substituting equations ( 17 ) and ( 22 ) into equation ( 12 ) yields the final expression for the reconstruction : as described above , the π ( r ) vectors of equation ( 4 ), and outer products and eigenvalues of equation ( 21 ) are computed numerically . the measurement system of the analytically described invention only measures part of the scattered field due to the aperture and the loss of the evanescent field information and accordingly , some of the eigenvalues , σ j 2 , are close to zero . those eigenvalues and their corresponding eigenvectors determine the rank of the outer product matrix , and they must not be used in the reconstruction of equation ( 23 ). thus , in the method of the present invention , a best rank n approximation is used to select the number of singular values / vectors . a ratio is computed as follows : r ⁡ ( n ) = ∑ j = 0 n - 1 ⁢ σ j 2 ∑ j = 0 j - 1 ⁢ σ j 2 , ( 24 ) where the singular values are assumedly arranged from smallest to largest : σ 0 2 ≦ σ 1 2 ≦ σ j − 1 2 . plotting r ( n ), the point at which the function starts to rise rapidly is graphically identified . the index of the singular value at which this occurs is labeled as j 0 . with this value determined , a final reconstruction is as follows : the hsiw as disclosed herein is flexible in that it allows any transducer configurations of the present invention and any number of frequencies to be used in forming such a final reconstruction . changes and modifications in the specifically described embodiments can be carried out without departing from the scope of the invention , which is intended to be limited only by the scope of the claims .
a wave - based tomographic imaging method and apparatus based upon one or more rotating radially outward oriented transmitting and receiving elements have been developed for non - destructive evaluation . at successive angular locations at a fixed radius , a predetermined transmitting element can launch a primary field and one or more predetermined receiving elements can collect the backscattered field in a “ pitch / catch ” operation . a hilbert space inverse wave algorithm can construct images of the received scattered energy waves using operating modes chosen for a particular application . applications include , improved intravascular imaging , bore hole tomography , and non - destructive evaluation of parts having existing access holes .
referring now in general to the drawings and in particular to fig1 - 3 , a chicken coop 10 is shown for transporting chickens from a poultry house to a processing plant . the chicken coop is formed of an assembly of cages 11 , here fifteen in number , arranged in rows and columns with three cages in a row and five cages in a column . the cages are integrally joined to form a rectangular enclosure having a roof 12 , five floors 13 , a front wall 14 , rear wall 15 and four side walls 16 . the side walls 16 and rear wall 15 are formed of an open framework to confine the chickens while providing ventilation . the two interior side walls 16 form a common wall for adjacent cages . a pair of spaced tubular , rectangular beams 17 are joined to the underside of bottom floor 13 to receive a fork lift to move the coop . each cage 11 of the coop has a frame opening 18 which collectively form the front wall 14 . each frame opening comprises a top frame member 19 , a bottom frame member 20 and two side frame members 21 . the frame members can be fabricated from lengths of square tubing common to multiple frame openings . referring now to fig3 a door 22 is pivotally mounted on the bottom frame member 20 to move from an open position shown in the top cage of fig3 to a closed position shown in the lower cage in fig3 . the pivotal mounting of door 22 includes a limiting pivot position where the door remains at rest in an open position with its inside surface substantially flush with the cage floor as shown in the top cage in fig3 . in its closed position shown in the bottom cage in fig3 the door is rotated until it engages a stop 23 where it remains until manually moved to an open position . a handle 24 is mounted on the outside surface of the door to facilitate manual opening and closing . the prior art shows numerous mechanisms for opening and closing a cage door . a simple hand latch is disclosed in u . s . pat . no . 4 , 285 , 299 mentioned above while an over center spring mechanism 25 is employed here to hold the door closed when it is manually lifted from its at rest open position . the mechanism for opening and closing the cage door is conventional and is not part of the disclosed invention . a vision obstructing flexible curtain 26 is mounted across the opening 18 forward of the door to obstruct the opening when the door is in its open position . applicant has discovered that when caged chickens cannot see an unobstructed escape path they will not attempt an escape . the curtain 26 in fig3 is in the form of a black sheet of plastic having a hem 27 . as seen in fig4 the curtain is hung from the inside of the top member 19 by means of a clamping strip 28 and a number of screws 29 . fig4 and 5 are part schematic views explaining the mode of operation of the vision obstructing curtain . fig4 is a view of the inside of the curtain as seen by chickens confined by the remaining five sides of the cage . the inventor has discovered that chickens will not attempt flight when an open escape path is not visible to them . in this manner , the invention solves the problem of chicken escape when door 22 is in the open position during the cage loading operation . as an optional feature , a wood dowel or steel pin 34 can be inserted in hem 27 for ballast . fig5 diagrammatically explains the operation of the curtain . fig5 also discloses an alternative mounting for the curtain . instead of a clamping strip and screws as shown in fig4 fig5 discloses a series of open hooks 30 spaced along top member 19 which supports the curtain on a matching series of grommets 31 . as seen in fig5 when door 22 is in the open position , chickens are pushed through the curtain , causing it to rotate in a counterclockwise direction as shown by the arrows 32 around pivots 30 , 31 . after the chickens are loaded , the curtain rotates back to its vertical rest position , darkening the opening . when the cage is full , door 22 is moved to a closed position . to unload all of the cages in a coop , a fork lift engages the rectangular beams 17 , and rotates the coop about a quarter turn in a counterclockwise direction . the weight of the birds sliding down the floors forces the doors to open and the curtains to swing to an open position as shown by the arrows 33 . after the chickens are unloaded , the coop is rotated back to a rest position and the doors are closed . fig6 shows a modified curtain construction which is suspended from top frame member 19 in a manner similar to fig4 . however , instead of a single layer curtain , two layers 34 and 35 are employed . the front layer 34 is split at cuts shown with a solid line while the rear layer 35 is split at cuts shown with a dashed line . this construction provides for greater flexibility while still obstructing the line of sight . fig7 shows a modified curtain suspended from top member 19 in the manner shown at 28 and 29 in fig4 or by means of hooks and grommets as shown in fig5 . the curtain 35 is formed of a closely woven fabric which allows for a certain degree of ventilation while obstructing the line of sight . it is not intended to limit the present invention to the details of illustration or terms of description of the preferred embodiments shown above . it will be appreciated by those skilled in the art that various modifications and alterations therein may be made within the scope of the present invention .
method and apparatus for loading a poultry coop . each compartment in the coop has a rectangular frame opening which is blocked or unblocked by a pivoted door . a flexible vision blocking curtain is hung across the opening to prevent the escape of any poultry during the loading procedure .
in the description of the present invention below the terms biological oil composition , copepod oil , copepod oil composition , oil composition are used interchangeable . epa and dha are predominant fatty acids present in marine fish , whale , seal and crustaceans . also , the oil present in the marine copepod calanus finmarchicus is a rich source of epa and dha , but this oil differs from other marine oils in a number of other chemical characteristics . compared to other marine oils , the copepod oil of the present invention is very rich in the c18 : 4n - 3 pufa ( stearidonic acid , sda ). unlike other common marine food oils , the pufas present in the copepod oil exist predominantly as monoesters with long chain monounsaturated alcohols i . e . wax esters . compared to other common dietary marine oils , the copepod oil of the present invention contains a relatively high proportion of free fatty acids , low amounts of triglycerides , and high levels of astaxanthin and cholesterol . based on the common understanding that epa and dha are the key factors responsible for the beneficial effects of marine oils in prevention and treatment of coronary artery disease , the biomedical effects of these two fatty acids have been compared with those of the copepod oil composition , as described in the present invention . the effects of the copepod oil according to the present invention have been compared with that of a concentrated epa / dha - preparation on atherosclerotic plaque formation and on total cholesterol level in mice , adjusted so that copepod oil provided the same total amount of epa and dha as the total amount of epa and dha in the reference preparation . in these studies , experimental animals ( apolipoprotein e ( apoe ) deficient mice ) feeding on an atherogenic high fat ( 21 % w / w ) diet containing 0 . 2 % ( w / w ) cholesterol were used . although there are differences in chemical composition between the copepod oil composition of the present invention and other dietary marine oils , the remarkable difference in biological activities , as described in the present invention , could not at all be predicted by anyone working on the effects of marine pufas on coronary heart disease . most striking is the highly unexpected finding that the biological oil composition of the present invention , as opposed to concentrated epa / dha , has a statistically significant ability to inhibit formation of atherosclerotic plaques . it also differs from epa and dha in the way it affects the pattern of lipid deposition in the body of the experimental animals . the copepod oil described in the present invention is in itself a novel anti - atherosclerotic composition . the biological oil composition according to the present invention also shows a significant effect on blood cholesterol level . total blood cholesterol levels are significantly lower in animals fed with a diet comprising the biological oil composition according to the present invention as compared with the levels in animals fed a diet comprising concentrated epa / dha the biological oil composition according to the present invention is derived from a marine copepod , preferably a copepod of the genus calanus , such as calanus finmarchicus , using freshly harvested , frozen / thawed or dehydrated raw material . oil compositions according to the invention may be obtained by any method known to the person skilled in the art such as , but not limited to , conventional fish oil production technology , biotechnological methods , organic solvents or supercritical fluid extraction , or cold pressing . independent of the procedure of obtaining the oil and the yield of oil , the typical gross composition will be as shown in table 1 . to illustrate the uniqueness of the biological oil composition according to the present invention , the corresponding compositions of conventional fish oil ( cod liver oil ) and krill oil are shown for comparison . it is evident from this gross chemical analysis that these oils are highly different , in particular regarding their contents of triglycerides , phospholipids , monoesters ( wax esters ), and of astaxanthin . it should be noted that wax esters constitute the major lipid component in the copepod oil of the present invention , unlike both cod liver oil and krill oil . besides the notable difference in gross chemical composition ( table 1 ), the three marine oils used here for illustration purposes , are highly different also in their content of individual fatty acids ( table 2 ). in the oil composition of the present invention , sda , epa and dha exist to a large extent as esters with long chain alcohols . a typical composition of wax esters and long chain alcohols in the copepod oil of the present invention is shown in table 3 . in conclusion , the copepod oil of the present invention differs markedly from typical fish oil and krill oil in both gross chemical composition and fatty acid content . however , like other marine oils it comprises epa and dha . in spite of its high wax - ester content , the oil composition of the present invention is a low - viscous and completely free - flowing liquid at room - temperature . one of the reasons for this is that the alcohols of the wax esters are predominated by medium - length monounsaturated alcohols , typically 80 % or more ( mainly c20 : 1 and c22 : 1 ). depending on the analytical methods used , the typical content of wax - ester of the oil composition of the present invention is 70 - 90 %, whereas it contains 10 - 20 % of other components such as free fatty acids , triacylglycerols , sterols and pigments . in certain applications , it may be advantageous or even desirable to remove free fatty acids and other components by suitable methods known to those skilled in the art . thus , in one embodiment of the preset invention the oil composition may contain up to 100 % wax ester . it has been found that the copepod oil according to the present invention has markedly different biological effects than a concentrated preparation of epa and dha used in the same concentration as in the copepod oil . particularly the composition according to the present invention prevents the formation of atherosclerotic plaque and thus is useful in the prevention and treatment of cardiovascular disease . the composition according to the present invention is also found to have an effect on the total blood cholesterol level and is useful in the prevention and treatment of hypercholesterolaemia and elevated blood cholesterol levels . the biological oil composition according to the present invention comprises from 20 %, 25 %, 30 %, 35 %, 40 %, 45 %, 50 %, 55 %, 60 %, 65 %, 70 %, by weight up to 75 %, 80 %, 85 %, 86 %, 87 %, 88 %, 89 % 90 %, 91 %, 92 %, 93 %, 94 %, 95 %, 96 %, 97 %, 98 %, 99 %, 100 % by weight of wax esters . preferably the biological oil composition comprises from 80 %, 81 %, 82 %, 83 %, 84 %, 85 %, 86 %, 87 % 88 %, 89 % by weight up to 90 %, 91 %, 92 %, 93 %, 94 %, 95 %, 96 %, 97 %, 98 %, 99 %, 99 . 5 %, 100 % by weight of wax esters . further the biological oil composition of the present invention comprises from 5 %, 6 %, 7 %, 8 %, 9 %, 10 % by weight up to 11 %, 12 %, 13 %, 14 %, 15 %, 16 %, 17 %, 18 %, 19 %, 20 % by weight of sda . the content of epa in the biological oil composition may be 3 %, 4 %, 5 %, 6 %, 7 %, by weight up to 8 %, 9 %, 10 %, 11 %, 12 %, 13 %, 14 %, 15 % by weight . the composition may comprise 2 %, 3 %, 4 %, 5 % by weight up to 6 %, 7 %, 8 %, 9 %, 10 % by weight of dha . in one embodiment , the present invention provides a biological oil composition wherein the composition comprises 20 - 100 % by weight of wax esters , preferably 50 - 100 % by weight of wax esters , more preferred 70 - 100 % by weight of wax esters for use as a medicament for the prevention and treatment of cardiovascular disease . the oil composition may be isolated from a marine copepod , preferably one of the genus calanus , and more preferably said copepod is of the species calanus finmarchicus . in other embodiments of the invention the present invention provides a biological oil composition for the use as a medicament in the prevention and treatment of atherosclerosis , hypercholesterolaemia and elevated blood cholesterol levels . in another embodiment the present invention provides an oil composition that further comprises 5 - 20 % by weight of sda . in yet another embodiment the present invention provides an oil composition comprising 3 - 15 % by weight of epa and 2 - 10 % by weight of dha . in a further embodiment of the present invention an oil composition comprising 20 - 100 % by weight of wax esters , preferably 70 - 100 % by weight of wax esters , 5 - 20 % by weight of sda , 3 - 15 % by weight of epa and 2 - 10 % by weight of dha is provided . in another embodiment of the present invention an oil composition comprising fatty alcohols and sda , dha and epa as monoester with fatty alcohols is provided . in a further embodiment the present invention provides an oil composition comprising 1000 - 4000 ppm of astaxanthin , mainly in esterified form . a dietary supplement formulation comprising an oil composition as described above is also provided by the present invention . a functional food formulation comprising an oil composition as described above is also encompassed by the present invention . in yet another embodiment of the present invention a pharmaceutical formulation comprising an oil composition as described above is provided . the formulation according to the invention comprising an oil composition as described above may be provided in capsules , tablets , emulsions or tonics and may comprise one or more pharmaceutically acceptable additive selected from the group consisting of adjuvans , antioxidants , emulsifiers , surfactants and carriers . the present invention further provides the use of an oil composition as described above for the manufacturing of a product for the prevention or treatment of a cardiovascular disease , particularly atherosclerosis , hypercholesterolaemia and elevated blood cholesterol levels . the present invention also provides a method for the prophylaxis or treatment of cardiovascular disease , particularly atherosclerosis , hypercholesterolaemia and elevated blood cholesterol levels wherein the individual in need of such prophylactic or curative treatment is orally administered with a pharmaceutical composition comprising a biological oil composition wherein the composition comprises 20 - 100 % by weight of wax esters , preferably 50 - 100 % by weight of wax esters , more preferred 70 - 100 % by weight of wax esters , and wherein a daily dosage level in the range of 4 - 100 mg / kg body weight . in another embodiment the present invention provides a method wherein the administered pharmaceutical composition further comprises 5 - 20 % by weight of sda . in yet another embodiment the present invention provides a method wherein the pharmaceutical composition comprising 3 - 15 % by weight of epa and 2 - 10 % by weight of dha . in a further embodiment of the present invention a method wherein the administered pharmaceutical composition comprises 20 - 100 % by weight of wax esters , preferably 70 - 100 % by weight of wax esters , 5 - 20 % by weight of sda , 3 - 15 % by weight of epa and 2 - 10 % by weight of dha is provided . in another embodiment of the present invention a method wherein the administered pharmaceutical composition comprising fatty alcohols and sda , dha and epa as monoester with fatty alcohols is provided . in a further embodiment the present invention provides a method wherein the administered pharmaceutical composition comprises 1000 - 4000 ppm of astaxanthin , mainly in esterified form . the following non - limiting experimental part and examples illustrate and document the present invention . when studying the preventive efficacy of any drug candidate or dietary ingredient on coronary heart disease , the most reliable end - point analyses are the actual disease manifestations , such as , for instance , formation of atherosclerotic plaques . effects on blood parameters considered to be indicative of the risk of disease development are of course important for evaluation of mode of action of new anti - atherogenic drug candidates , but it is preferable to relate such blood analyses to efficacy data on the disease manifestation itself . this has been the philosophy in the studies constituting the foundation of the present invention . the biological effects of the copepod oil of this invention were recorded in mice deficient in apolipoprotein e ( apoe ). mice of this strain are routinely used to determine effects of dietary components on development of vascular inflammation and atherosclerotic plaques , since they develop atherosclerotic lesions according to a pattern very similar to that of humans , and they are useful model animals for studies of biochemical and cellular processes involved in initiation , progression and regression of atherotrombotic disease . the studies were carried out at the faculty of medicine at the university of tromsø ( norway ). three groups of ten female mice were installed at an age of 7 weeks and fed 3 different diet treatments ( see below ) for 13 weeks . the mice were fed ad libitum with an experimental high fat ( 21 % w / w ) and cholesterol ( 0 . 2 % w / w ) diet , rich in bioavailable carbohydrates ( sugar / dextrin ) and with a high proportion of saturated fat ( sniff spezialdiaten gmbh , sniff ef clinton / cybulsky ( ii ) mod .). the composition of this diet promotes development of obesity and of atherosclerotic lesions . the diet was added either 1 % ( w / w ) of the copepod oil of the present invention ( diet 1 ) or 0 . 1223 % ( w / w ) of an epa / dha - concentrate ( diet 2 ), producing two experimental feeds with equal contents of epa and dha . the cholesterol content of these two diets and of the control diet ( diet 3 ) without added oil was adjusted to 0 . 20 % by adding cholesterol , taking into account the cholesterol present in the feed ingredients and in the copepod - oil itself . the composition of the experimental diets is shown in table 4 . the copepod oil preparation was an experimental product provided by calanus as , tromsø , norway ( www . calanus . no ). the epa / dha concentrate used as reference test substance was the lipid lowering drug omacor ( pronova biopharma asa , p . o . box 420 , no - 1327 lysaker , norway ). according to the manufacturer ( www . pronova . com ) this product contains 90 % omega - 3 - acid ethyl esters of epa ( 460 mg / g ) and dha ( 380 mg / g ) and is manufactured using fish oil as a starting material . the experimental mice were monitored daily , and weighed at regular intervals . samples of blood serum were taken at different points for later analysis of various blood parameters including lipids and fatty acids . the mice were sacrificed at the end of the experiment , and all relevant organs were dissected out following standard procedures . following dissection of the sacrificed mice , the aortas were isolated , cleaned and cut open longitudinally , pinned to a white cardboard and fixed in 10 % formalin for at least 24 hours . the aortas were stained with oil red o ( sigma ) before analysis . after rinsing , the aortas were mounted on microscopic slides , and images ( 2 , 700 dpi ) were acquired using a sprintscan 35 scanner ( polaroid , cambridge , mass ., usa ) equipped with geoscan enabler ( meyer instruments , houston , tex ., usa ). the images were analyzed for positive areas , adopting the state - of - the art calibration and image analyses methodology . the total lesion area was quantified in each group by computer - assisted quantitative morphometry as described by n . v . guevara et al . ( the absence of p53 accelerates atherosclerosis by increasing cell proliferation in vivo . nature medicine 1999 ; 5 : 335 - 339 ). it has been found that the copepod oil of the present invention has markedly different biological effects than a concentrated preparation of epa and dha used in the same concentration as in the copepod oil . this was a highly unexpected finding , considering the overwhelming consensus among the skilled in the art , that the positive health effects of marine oils are associated with their content of epa and dha , exclusively . the results are shown in table 5 and in fig1 - 3 . the effect of the copepod oil of the present invention and of epa / dha - concentrate on atherosclerotic plaque formation in the aortas of female mice is shown in table 5 . the copepod oil preparation had a striking and statistically highly significant effect on reduction of plaque formation both in the aortic arch ( p = 0 . 002 ) and the total aorta ( p = 0 . 001 ) compared to control . also the epa / dha - concentrate reduced plaque formation compared to control , but the effect did not meet the requirements of statistical significance . 1 the figures represent the average lesion area in percent of total area of each target region at time of sacrifice . see fig1 for the subdivision of target regions ( a - d ) of the aorta . growth of the mice is shown in fig2 . although the mice grew fastest on feed enriched with copepod oil , and thrived well on that diet , this apparent difference does not meet the requirements for statistical significance . there was no difference between the groups in feed intake and no negative effects could be observed on animals fed the experimental diets . weight of different organs is shown in fig3 . although there was a higher level of fat deposited in the white adipose tissue ( wat ) in mice fed the copepod oil , the difference was not statistically significant . however , it is a noteworthy observation indeed that the copepod oil of the present invention reduces plaque formation while more lipids are deposited in lipid storage tissues . the copepod oil has a notably more pronounced anti - atherosclerotic effect than purified epa and dha at same concentration as in this oil . the mechanisms involved in this effect of the copepod oil may accordingly be additive to the epa - and dha - effects or be entirely different . the results shown in table 6 illustrate that calanus oil differs from epa and dha also regarding the effect on blood cholesterol level in the experimental animals . whereas the cholesterol level in blood of animals fed the epa / dha - diet was the same as in control animals after 13 weeks of feeding , the cholesterol level in blood of the calanus oil group was notably lower . both treatment groups seem to have a slight , and similar , triglyceride lowering effect compared to control .
this invention relates to a biological oil composition , preferably obtained from a copepod , most preferably the copepod calanus finmarchicus and the use thereof to prevent or treat formation of atherosclerotic plaques and hence development of coronary heart disease . the composition comprises the same marine n - 3 polyunsaturated fatty acids generally regarded as being responsible for the anti - atherosclerotic effect of marine oils , namely epa and dha . however , quite unexpectedly , it has been found that the oil composition of the present invention has a remarkably higher ability to prevent formation of atherosclerotic plaques than what can be attributed to epa and dha alone , and moreover , unlike epa and dha alone it has a notable blood cholesterol lowering effect .
the partners employed for the complex formation are preferably biocompatible , biodegradable polyacids and polybases which are naturally occurring or composed of natural subunits . in this case , &# 34 ; poly &# 34 ; means that the compound carries more than one charge of the same polarity , preferably a large number of such charges . the particular counterions can be composed either of low molecular weight ions or likewise of a polyionic species . either one or both ionic partners can be either inorganic or organic in nature . in the case of organic polyions , hydrophobic substituted derivatives prove suitable and preferable . preferred materials for the preparation of biocompatible polyelectrolyte complex / active substance combinations are , as polyacids : xylan polysulfate , partially hydrophobically esterified xylan polysulfate , polysulfates of other polysaccharides such as , for example , starch hydrolysates , inulin , hydroxyethylstarch , dextrans and the partially hydrophobically substituted derivatives thereof in each case , and poly ( amino acids ) such as polyaspartic acid or polyglutamic acid and the hydrophobically substituted derivatives thereof in each case . as polybases : poly - l - lysine of various defined molecular weight ranges , poly - α , β -( 2 - dimethylaminoethyl )- d , l - aspartamide ( pdaa ), copolymers of pdaa and hydrophobically esterified poly - α , β -( 2 - hydroxyethyl )- d , l - aspartamide ( phea ), chitosan , lysine octadecyl ester , aminated dextrans , aminated cyolodextrins , aminated cellulose ethers , aminated pectins and the partially hydrophobically substituted derivatives thereof in each case . in one preferred embodiment , the polyelectrolyte complex contains a polyacid which is selected from : xylan polysulfates , dextran sulfates , poly ( amino acids ) such as polyaspartic acid or polyglutamic acid , polysaccharide polysulfates such as sulfates of starch hydrolysates , inulin , hydroxyethylstarches , polysaccharide polysulfonates , polysaccharide polyphosphates , polyphosphates , and , more preferably , the polyelectrolyte complex contains a polyacid which is selected from : in each case partially hydrophobized ( for example etherified , esterified ) derivatives of xylan polysulfate , polysulfates of other polysaccharides such as , for example , starch hydrolysates , inulin , hydroxyethylstarches , dextrans ; of poly ( amino acids ) such as polyaspartic acid or polyglutamic acid , and of polysaccharide polysulfonates , polysaccharide polyphosphonates , polyphosphates . in another preferred embodiment , the polyelectrolyte complex contains a polybase which is selected from : poly - l - lysine , poly - α , β -( 2 - dimethylaminoethyl )- d , l - aspartamide , chitosan , lysine octadecyl ester , aminated dextrans , aminated cyclodextrine , aminated cellulose ethers , aminated pectins , and , more preferably , the polyelectrolyte complex contains a polybase which is selected from : in each case ( for example by partial or complete esterification and / or etherification ) hydrophobized derivates of : poly - l - lysine of various molecular weight ranges , poly - α , β -( 2 - dimethylaminoethyl )- d , l - aspartamide , chitosan , aminated dextrans , aminated cyclodextrins , aminated cellulose ethers , aminated pectins and copolymers of poly - α , β -( 2 - dimethylaminoethyl )- d , l - aspartamide and hydrophobically esterified poly - α , β -( 2 - hydroxyethyl )- d , l - aspartamide . microparticles composed of polyelectrolyte complexes can , depending on the requirements , be prepared in average particle sizes from a few nm up to a few hundred μm . it is also possible by definition for the microparticles to be in the form of emulsions . the breadth of the size distribution can be adjusted , for example by the stirring speed on mixing the polyelectrolytes , the drop rate , the nozzle diameter , the ph and by suitable choice of the polyelectrolyte partners . it is particularly advantageous to carry out the formation of the complexes with addition of auxiliaries such as amphiphilic molecules ( for example ® pluronic ) or colloidal substances ( for example adjuvants ) with high incorporation capacity . these parameters can be determined in simple routine tests and adjusted to the required particle size and particle size distribution . particles below 5 μm in diameter are suitable for intravenous injection . particles with a diameter & lt ; 15 μm , preferably & lt ; 10 μm can be employed as s . c . or i . m . injectable depot forms and as a vehicle to increase the enteral absorption . the incorporation of an active substance in the polyelectrolyte complex particles / colloids can be carried out in at least 4 ways : a ) incorporation by &# 34 ; entrapment &# 34 ; of the active substance , which is present in solution , on precipitation of the complex , b ) incorporation by absorption of the active substance from a solution with which the already prepared polyelectrolyte complexes come into contact ( especially in the case of porous materials or gels with &# 34 ; sponge &# 34 ; properties ), c ) precipitation of the polyelectrolyte complex , in which case the active substance is chemically bound to at least one complex partner and , d ) incorporation by employing the active substance as partner in the formation of the polyelectrolyte complex . this usually requires at least one charge or polarizable group on the active substance . the invention therefore also relates to a process for preparing pharmaceutical compositions containing polyelectrolyte complexes and active substances , where a solution of an acidic and a solution of a basic substance , where at least one of these substances must be polymeric , are mixed and where a ) either one of the partners is an active substance or contains the latter in chemically bound form , or b ) the active substance is contained in one of the solutions , and subsequently the resulting polyelectrolyte complex is precipitated in microparticulate form or , where appropriate , converted into a microparticulate form . polyelectrolyte complex / active substance formulations show , because the consistency properties can be widely varied on the one hand and can be very specifically adjusted on the other hand , property profiles as required for diverse pharmaceutical applications . thus , it has emerged that the cytostatic daunorubicin and the polyacid xylan polysulfate produce macroparticles which contain daunorubicin and release the latter in buffer solution or in biological systems uniformly over a lengthy period , during which they are broken down . if polybases are also added and / or the polyacid is changed , especially by replacing xylan polysulfate by xylan polysulfate which is partially substituted with palmitoyl ester groups , it is possible to reduce the particle size to & lt ;& lt ; 5 μm and the result is an i . v . injectable system with the release properties described above . the therapeutic index of the cytostatic can be drastically increased with a slow - release form of this type . the activity properties of other low molecular weight active substances such as antibiotics ( for example tetracycline ) or other cytostatics can also be distinctly improved in this way . if proteins are incorporated in polyelectrolyte complex microparticles , it is possible in this way both to protect them from hydrolytic attack and to achieve controlled release profiles . thus , for example , vaccine preparations can be produced using vital proteins or similar substances suitable for vaccination and can , depending on the particle size , be injected i . m . or even administered orally , in which case there is absorption in the gastrointestinal tract of particles & lt ; 5 μm , and subsequent antigen expression / immunization occurs . it is possible , with such antigen - containing polyelectrolyte complexes according to the invention , to achieve release profiles which allow a large dose of the vaccine to be delivered shortly after administration and after a period of , for example , 4 weeks ( booster ). the substances particularly suitable for forming polyelectrolyte complexes in this case are described in example 3 . it is also possible to convert peptide - based active substances by means of polyelectrolyte complex preparations into suitable long - term systems . these formulations are in some cases superior to the known polymeric depot systems for lhrh analogs , for example , both because the degradability is better and because the release profiles are defined . polyelectrolyte complexes are likewise suitable for preparing wound ointment preparations which contain , for example , antibiotics or proteins as regeneration promoters . the polyelectrolyte complex microparticles according to the invention are also outstandingly suitable as air - containing echogenic contrast agents for ultrasonic diagnosis . polyelectrolyte complex particles composed of hydrophobically esterified dextran sulfate and of a copolymer of pdaa and hydrophobically esterified phea ( for abbreviations , see page 4 ) have proven particularly suitable for ultrasonic diagnosis . the invention is explained in more detail hereinafter by means of examples . the particle size has been determined by microscopic methods or by filtration through filters of defined pore size and , in some cases , by coulter counter ( from coulter electronics ) or flow cytometer . a 0 . 1 % aqueous solution of each of xylan polysulfate sodium salt ( from bene - chemie ) and of poly - l - lysine of average molecular weight 3800 ( from sigma ) is made up . sufficient hcl is added to the poly - l - lysine solution for the ph to be 3 . the xylan polysulfate solution is likewise adjusted to ph 3 ( hcl ) and added dropwise via a metering pipette . the polyelectrolyte complex precipitates and is separated off by centrifugation and membrane filtration . after washing with h 2 o , the microparticulate product can be freeze - dried . the particle size can be controlled by the vessel size , the stirring speed , the diameter of the dropwise addition nozzle and the dropping rate and can be adjusted from the region around 20 nm to 100 μm . complex of palmitoylxylan polysulfate with 20 % palmitic acid residues and chitosan 0 . 1 % solutions are prepared as in example 1 . the procedure corresponds to that employed in example 1 , only that no ph control is carried out in this case , and polylysine is replaced by chitosan ( from protan ). the palmitoylxylan polysulfate can be prepared , for example , by the process described in german patent application p 3921761 . 2 . chitosan 143 is used . the resulting particles are large agglomerates ( 100 μm and larger ) and can be reduced to a size of 1 - 4 μm by grinding in a mortar . polyelectrolyte complex particles composed of palmitoylxylan polysulfate with 20 % palmitic acid and chitosan with incorporation of human serum albumin as model protein for vaccines . the procedure is carried out as described in example 2 , only that 0 . 2 % human serum albumin ( from sigma ), dissolved in water , is added to the palmitoylxylan polysulfate solution before the dropwise addition . particles in the range 2 - 5 μm can be obtained after grinding . see example 10 for the determination of the albumin release . particles in the & lt ; 5 μm range can be obtained with two different preparations : 50 mg of polyacid are dissolved in 5 ml of a 0 . 1 % strength solution of rabies vaccine from behringwerke ( the solution is aqueous and contains 40 % sucrose ), the ph is 6 . 3 . 50 mg of polybase are added to 5 ml of a 0 . 5 % strength solution of ® pluronic f68 in water . the polyacid / vaccine solution is added dropwise to the stirred polybase solution ( which has ph 5 . 8 ). after centrifugation ( 10 min , 2000 rpm ), the clear supernatant is separated off , and the residue is made into a paste with h 2 o and freeze - dried . yield 779 . 7 mg of particles . the amount of the employed vaccine incorporated can be found by resuspension and analysis of the supernatant ( in h 2 o ) to be 90 %. once again , two solutions are made up , each containing 50 mg of polyacid / base . the polyacid solution is identical to that in i . the polybase solution is identical to that in i except that it contains no ® pluronic . both solutions are adjusted to ph 7 and , as in i , centrifuged and the residue is made into a paste and freeze - dried . the incorporation efficiency corresponds to that in i . yield : 76 . 5 mg . vaccination of mice against human serum albumin with polyelectrolyte complex microparticles sample i : xylan sulfate esterified with about 15 % palmitic acid / lysine octadecyl ester + 7 % pluronic ® 68 , 5 - 30 μm sample ii : xylan sulfate esterified with about 15 % palmitic acid / lysine octadecyl ester , ≦ 10 μm sample iii : xylan sulfate esterified with about 15 % palmitic acid / poly - l - lysine 4 kda + 7 % pluronic ® f68 , 2 - 50 μm all the samples contained about 7 % by weight human serum albumin ( behringwerke ). these complexes were resuspended in concentrations of 66 . 67 μg / ml , 6 . 67 μg / ml and 0 . 67 μg / ml in pbs ( phosphate - buffered saline ). 0 . 3 ml of each vaccine was administered s . c . to , in each case , 10 nmri mice weighing about 20 g . 14 weeks after the vaccination , the experimental animals were revaccinated with the same dose . the antibodies directed against human serum albumin in the serum of the experimental animals were quantified in an elisa . used as comparison was aluminum hydroxide al ( oh ) 3 which is known as a good adjuvant and is contained in various vaccines . elisa titer after inoculation with 6 . 67 μg of formulation / ml ( average dose ), 2 , 4 , 8 , 14 ( revaccination ), 16 and 21 weeks after the first vaccination : ______________________________________sample day 0 day 2 day 4 day 8 day 14______________________________________i & lt ; 1 : 300 & lt ; 1 : 300 1 : 300 1 : 900 1 : 900ii & lt ; 1 : 300 & lt ; 1 : 300 1 : 300 & lt ; 1 : 300 & lt ; 1 : 300iii & lt ; 1 : 300 1 : 300 1 : 900 1 : 2700 1 : 8100iv & lt ; 1 : 300 & lt ; 1 : 300 & lt ; 1 : 300 1 : 2700 1 : 8100v & lt ; 1 : 300 1 : 900 1 : 2700 1 : 8100 1 : 24300al ( oh ). sub . 3 & lt ; 1 : 300 1 : 900 1 : 900 1 : 900 1 : 900______________________________________sample day 16 day 21______________________________________i 1 : 72900 1 : 72900ii 1 : 24300 1 : 24300iii 1 : 72900 1 : 24300iv 1 : 72900 1 : 72900v 1 : 72900 1 : 72900al ( oh ). sub . 3 1 : 8100 1 : 24300______________________________________ administration of the same vaccine to guinea pigs likewise resulted in distinct seroconversion . polyelectrolyte complex particles composed of polyaspartic acid and poly - α , β -( 2 - dimethylaminoethyl )- d , l - aspartamide ( pdaa ) with incorporation of tetracycline as example of a low molecular weight active substance . the procedure is as described in example 3 , except that a 0 . 2 % solution of tetracycline in water is employed in place of human serum albumin . see example 11 for the tetracyctine release . 10 mg of xylan polysulfate are dissolved in 0 . 5 ml of h 2 o . 100 μl of a 10 % daunorubicin solution ( daunorubicin from sigma ) are diluted to 0 . 4 ml with water . the daunorubicin solution is added dropwise to the xylan polysulfate solution . the resulting suspension contains particles whose diameter is in the 5 μm range . see example 12 for the daunorubicin release . polyelectrolyte complex particles composed of palmitoylxylan polysulfate with 20 % palmitic acid , daunorubicin and lysine octadecyl ester . 1 ml of a solution which contains 1 % each of daunorubicin and lysine octadecyl ester is adjusted to ph 4 . a 1 % solution of palmitoylxylan polysulfate , likewise 1 ml , likewise adjusted to ph 4 , is added dropwise . the resulting suspension can no longer be fractionated by filtration . the particles can be adjusted by altering the concentration , the stirring speed , the dropping rate and the nozzle diameter in the range from 100 nm to 1 μm ( see table 1 ). table 1______________________________________particle concen - stirring dropping nozzlesize tration speed rate diameter______________________________________ 1 μm 0 . 1 % 300 min . sup .- 1 100 min . sup .- 1 0 . 5 mm 10 μm 0 . 5 % 300 min . sup .- 1 100 min . sup .- 1 0 . 5 mm 20 μm 1 % 300 min . sup .- 1 100 min . sup .- 1 0 . 5 mm100 nm 0 . 1 % 1000 min . sup .- 1 100 min . sup .- 1 0 . 5 mm 20 nm 0 . 1 % 1000 min . sup .- 1 100 min . sup .- 1 0 . 2 mm 80 μm 1 % 100 min . sup .- 1 100 min . sup .- 1 0 . 5 mm100 μm 1 % 100 min . sup .- 1 200 min . sup .- 1 0 . 5 mm______________________________________ in each case a 1 % strength aqueous solution at ph 7 is made up from dextran sulfate ( m = 6000 ) in which about 20 % of the dextran oh groups have been esterified with caproic acid and the remaining oh groups have been sulfated (&# 34 ; hydrophobically esterified dextran sulfate &# 34 ;, &# 34 ; polyacid &# 34 ;) and from a copolymer of poly - α , β -( 2 - dimethylaminoethyl )- d , n - aspartamide ( 60 %) and poly - α , β -( 2 - palmitoyloxyethyl )- d , l - aspartamide ( 40 %) (&# 34 ; polybase &# 34 ;). the polyacid solution is added dropwise to the polybase solution and stirred at room temperature for 10 minutes , the complex is removed by centrifugation , the solution is decanted off , and the solid is made into a paste with and freeze - dried . freeze - dried and resuspended microparticles with a size of the order of 1 - 3 μm are investigated in a phantom which represents a model of the heart and extremely small capillary vessels ( lung model ) for the ultrasonic contrast brought about by incorporated air . the particles pass through the capillaries unhindered . a microparticle suspension in phosphate buffer is shaken continuously . after 1 , 4 , 7 , 13 , 21 add 28 days , the supernatant is removed and then the albumin content is determined by electrophoresis known from the literature . the result is a profile with 2 release maxima as is required for various vaccines : ______________________________________release on day 1 4 7 13 21 28albumin released 50 20 & lt ; 5 & lt ; 5 10 & lt ; 5______________________________________ particles are no longer present after somewhat more than one month . the breakdown test is carried out as test 10 . the active substance is determined by a uv spectroscopic method known from the literature . ______________________________________release on day 1 4 7 13tetracycline released 30 10 10 & lt ; 5______________________________________ the particle suspension is placed in a soxhlet extractor and extracted with h 2 o for several days . daunorubicin in the extract is determined by a fluorometric method known from the literature ( at 472 / 555 nm ). it emerges that the release , based on the total amount of daunorubicin weighed in , is as follows : ______________________________________after 3 . 5 h 11 h 20 h 29 h the releasewas : 8 . 5 % 10 . 5 % 15 . 0 % 26 . 2 % of the amount______________________________________
the invention relates to a pharmacological composition comprising a polyelectrolyte complex , in particular a polyacid with an average particle size of less than 15 μm and an active agent , among which are active peptides , proteins , enzymes , enzyme inhibitors , antigens , cytostatics , antiinflamatory agents , antibiotics and vaccines . the said composition ensures that the active agent is converted in a non - deleterious manner into a form which can be administered . in addition , the biodistribution , bioavailability and absorption of the pharmaceutical are beneficially affected .
referring now to the drawings , wherein like or corresponding reference numerals are used for like or corresponding parts throughout are used , there is shown in fig1 a container generally designated 10 and comprising a first part 12 which is generally in the form of the end portion of a poultry egg , extending to a large diameter circumference of such poultry egg . the part 12 encompasses an unobstructed space 14 extending inwardly from an edge 16 thereof . the second part 18 comprises a generally cylindrical wall 20 and a bottom 22 joined to it , the wall 20 having at its upper end , as shown in fig1 a , a shoulder 24 and , interiorly thereof , an upstanding peripherally extending ridge 26 . on the shoulder 24 is a body of adhesive 30 , the adhesive 30 extending entirely about the part 18 , and is continuous and unbroken . the adhesive body 30 is provided with a protective covering 32 of paper , or the like , which may be readily removed from the adhesive body 30 , but which protects it from engagement with another object , such as the part 12 , until it is removed . the part 18 provides an open space 28 in it , which is unobstructed , and which may readily receive a part of a sanitary napkin or other absorbent body . there is shown in fig1 within the container 10 , occupying the spaces 14 and 34 , an absorbent body 34 , i . e ., a bandage which is unused , i . e . aseptic . the absorbent body 34 may have a disposable cover ( not shown ) and is specifically a new , ready - for - use sanitary napkin . alternatively , the bandage 34 may be a tampon , or other product of material , shape and size to absorb body fluids . when assembled , the body 34 may be placed in the part 18 , and with the covering 32 in place , the part 12 is associated with the part 18 , guidance for such association being provided by the upstanding ridge 26 . thus , there will be provided a container 10 with an unused aseptic , and ready - for - use absorbent body 34 . the part 12 will not be bonded to the part 18 , since the adhesive 30 will not be in engagement with the part 12 . the container 10 with the unused and aseptic absorbent body 34 therein may be placed at convenient locations , such as in rest rooms , or medical facilities , and may be carried by a person . the container 10 with the body 34 therein is therefore readily available for use , since there will be no impediment to the disassociation of part 12 from part 18 , thereby providing ready access to the sanitary body 34 . after the container 10 has been separated and the new sanitary absorbent body 34 has been removed , the parts 12 and 18 are retained for re - use , to receive a used , septic and possibly infectious absorbent body , which may or may not be the absorbent body which was removed from the container 10 . when a used absorbent body is to be disposed of , it is placed within one or another of the parts 12 and 18 , the protective cover 32 is removed , and the parts 12 and 18 are associated together so that the adhesive 30 is in contact with both of the parts 12 and 18 . the adhesive 30 provides a substantially permanent bond between these parts and is of sufficient strength to prevent the manual separation of the parts 12 and 14 . the adhesive 30 also provides a hermetic seal between the container parts 12 and 42 . among the adhesives which are suitable is adhesive 4693 of 3m company , st . paul , minnesota . container 10 , and each of the containers herein disclosed , is made of material which is readily combustible , so that the container and the used and possibly infectious absorbent body within it may be disposed of by burning , in accordance with established procedures and regulations . the material of which the container is made includes combustible plastic , as well as other materials such as those which are paper - based . in fig2 there is shown an egg - shaped container 40 comprising an upper part 12 , and a lower part 42 having the shape of a part of a poultry egg . the part 42 will be seen to have a shoulder 24 and a ridge 26 , with an adhesive body 30 on the shoulder 24 . the lower portion of the part 12 engages the adhesive 30 , and the adhesive 30 thereby serves to bond the parts 12 and 42 . the space within the container 40 is unobstructed , so that the space readily contains a used absorbent body 44 , such as a used sanitary napkin , tampon or bandage which may contain body fluids . since such body fluids may be infectious , and therefore the body 44 may be infectious , the container 40 , including the adhesive 30 , seals the used absorbent body 44 therewithin and is not hazardous . in fig3 there is shown another embodiment of a container in accordance with the present invention . the container 50 comprises a first part 52 having a top 54 of square configuration , and depending walls 56 , the walls terminating in a peripherally extending edge 58 located at the bottoms thereof , and surrounding an opening into the unobstructed space 60 within the part 52 . a similarly shaped second or bottom part 62 has a bottom 64 which is congruent with the top 54 , and has walls 66 extending upwardly therefrom and which are in alignment with the walls 56 . on the upper edge 68 of the walls 66 is a body of adhesive 30 , shown partly covered with a protective strip 32 . the total height of the container 50 is substantially equal to the height of a used septic absorbent body , such as a sanitary napkin ( not shown ). as will be understood , the protective strip 32 will have been removed , to expose the adhesive 30 , so that the parts 52 and 62 , with their substantially unobstructed spaces , may be joined at their edges to provide a butt joint . there is provided a disposable container 50 with the septic body therein , and which is both hermetically sealed and incapable of being separated by manual force . there is shown in fig4 a further embodiment of the present invention , there being provided a container 70 having a first part 72 having a top 74 in the form of a flat disc , which may be provided with a depending annular flange 76 . there is also provided a second part 78 shaped generally like the part 42 of fig2 and having an upper edge 80 on which there is an adhesive body 30 which bonds to the underside of the top 74 . within the body 78 there is a used , septic absorbent body 44 , which may be a sanitary napkin . fig5 is a perspective view of a container 80 which is of generally elongate parallelepiped shape and size so as to closely encompass a sanitary napkin 84 . container 80 comprises a tray - like bottom part 82 having a length and width substantially equal to the length and width of the sanitary napkin 84 and having a height provided by the walls 86 which is somewhat less than the thickness of the sanitary napkin 84 . the walls 86 include a shoulder 88 and an upstanding ridge 90 ; a body of adhesive 30 is on the shoulder 88 . the top part 92 is of substantially the same length and width as the bottom part 82 and has depending walls 94 which have internal dimensions slightly greater than the ridge 90 , so as to be guided thereby . the bottom edges of the walls 94 engage the adhesive 30 , so that the container with the used septic sanitary napkin 84 is hermetically sealed , and the container 80 may not be opened by manual force . in fig6 there is a generally elongate parallelepiped container 100 , having a first , bottom part 102 of the same shape and size as the bottom part 82 , but having a height of the walls 106 thereof substantially equal to the thickness of a used septic sanitary napkin 84 . the top edge of the walls 86 is provided with a body of adhesive 30 , and the second or top part 108 of the container 100 has a rectangular top 110 , the bottom surface of which engages the adhesive 30 , and the depending walls 112 of which telescope over a portion of the walls 106 of the first or bottom part 102 . fig7 discloses a container 120 in accordance with the present invention comprising a first part 122 and a second part 124 , each of which has a width substantially equal to the width of a sanitary napkin 84 and a depth substantially equal to the thickness of the sanitary napkin 84 . the total height of the container 120 , comprised of the parts 122 and 124 , is substantially equal to the length of the sanitary napkin 84 ; each of the parts 122 and 124 has a height which is less than the length of sanitary napkin 84 . the part 124 will be seen to have a shoulder 126 with adhesive 30 thereon , and an upstanding ridge 128 . ridge 128 has an exterior size and shape slightly smaller than the interior size and shape of the part 122 , and thereby serves to guide the part 122 into engagement with the adhesive 30 on the shoulder 126 . there has been provided a container which may be readily used for the disposal of septic , potentially infectious bodies , such as absorbent bodies that may have body fluids in them . such absorbent bodies or bandages include sanitary napkins , tampons , and bandages . the container herein provided has a substantially unobstructed space for receiving the septic body and is made of separable parts which are bonded together by an adhesive which provides both a hermetic seal and a bonding of such strength as to prevent manual disassembly . the insertion of a septic body , such as a used sanitary napkin , may be readily accomplished , requiring no complicated manipulation . when put in the container or container part , and after removal of the protective cover from the adhesive , a hermetically sealed container , incapable of being manually opened , results . the sealed container may be disposed of in an ecologically acceptable manner , such as by incineration , due to the fact that the container is made of combustible material . the herein disclosed container may be used to ship and / or store an aseptic , unused sanitary napkin or other absorbent body . such an aseptic body , which can be properly packaged to maintain its aseptic condition , may be placed in the container with the parts of the container joined , but one part being separated from contact with the adhesive by a protective layer on the adhesive , so that the parts of the container are readily separable . the herein disclosed container is readily usable , both to extract a body from the container and to place a body within a container , and to provide a hermetic sealing of the container with the aseptic within it . the claims and specification describe the invention presented , and the terms that are employed in the claims draw their meaning from the use of such terms in the specification . some terms employed in the prior art may be broader in meaning than specifically employed herein . whenever there is a question between the broader definition of such term as used in the prior art and the more specific use of the term herein , the more specific meaning is meant .
a container of combustible material is provided for disposal , in an ecologically satisfactory manner , of septic bodies , such as a used sanitary napkin , tampon or bandage . the container comprises two parts , with at least one part providing an open , obstructed space for the reception of the septic body . one of the parts of the container has an adhesive body which completely encircles it . the adhesive body is initially protected by a removable cover . when the parts are assembled , so that both parts are in contact with the adhesive , the adhesive provides a continuous bonding of the parts of the container to hermetically seal the container . the adhesive is sufficiently strong to prevent manual separation of the parts . the container may be used to ship and store an aseptic body , prior to use , and then be used for the reception , sealing and disposal of the same or a similar body which has become septic .
the first compound of this invention is a growth hormone secretagogue ( ghs ). any ghs may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . a representative first class of growth hormone secretagogues within those compounds of formula i as described hereinabove is set forth in pct application publication no . wo97 / 24369 , which is incorporated herein by reference , as compounds having the structural formula : wherein the various substituents are as defined in wo97 / 24369 . said compounds are prepared as disclosed therein . are both within the scope of the disclosure of international pat . application publication no . wo97 / 24369 . those compounds of formula i which are not within the disclosure of international pat . application publication no . wo97 / 24369 may be prepared as disclosed in international pat . application publication no . wo98 / 58947 , which is incorporated herein by reference . is within the scope of the disclosure of international pat . application publication no . wo98 / 58947 . other ghs compounds which may be used in the compositions , methods and kits of this invention include the following : wherein the various substituents are defined , and the compounds are prepared , as disclosed in u . s . pat . no . 5 , 206 , 235 , which is incorporated herein by reference ; wherein the various substituents are defined , and the compounds are prepared , as disclosed in u . s . pat . no . 5 , 283 , 241 , which is incorporated herein by reference ; wherein the various substituents are defined , and the compounds are prepared , as disclosed in international pat . application publication no . wo97 / 41879 , which is incorporated herein by reference ; and wherein the various substituents are defined , and the compounds are prepared , as disclosed in u . s . pat . no . 5 , 492 , 916 , which is incorporated herein by reference . the most preferred compounds within ( 1 ) above have the following structures : the most preferred compound within ( 3 ) above has the following structure : still other compounds which may be used within the compositions , methods and kits of this invention include : ( 5 ) ghrp - 6 , which is the prototype gh - releasing peptide h - his - d - trp - ala - trp - d - phe - lys - nh 2 , ( also called his 1 , lys 6 )- ghrp ), is sold commercially by bachem , catalog number h - 9990 and peninsula labs , catalog number 8071 and is disclosed in u . s . pat . no . 4 , 411 , 890 , which is incorporated herein by reference , and in bowers et al ., endocrinology , 114 : 1537 , 1984 ; ( 6 ) ghrp - 1 , also known as kp101 , which is the second generation gh - releasing peptide ala - his - d - βnai - ala - trp - d - phe - lys - nh 2 and is disclosed in akman , endocrinology , 132 : 1286 , 1993 ; ( 7 ) ghrp - 2 , also known as kp - 102 ( kaken ) and gpa - 748 ( wyeth - ayerst ), which is the gh - releasing peptide d - ala - d - βnai - ala - trp - d - phe - lys - nh 2 and is disclosed in bowers et al ., endocrinology , 114 : 1537 , 1984 and in bowers in : molecular and clinical advances in pituitary disorders , pp . 153 - 157 , 1993 , edited by s . melmed , endocrine research and education , inc ., los angeles , calif ., usa ; and ( 8 ) hexarelin , which is his - d - 2 - methyl - trp - ala - trp - d - phe - lys - nh 2 , is sold commercially by peninsula labs , catalog number 8083 , was synthesized by europeptides , argenteuil , france and is disclosed in guillaume et al ., endocrinology , 135 , 1073 , 1994 . any antidepressant may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . the term antidepressant means an agent used to treat affective or mood disorders and related conditions . affective mood disorders are characterized by changes in mood as the primary clinical manifestation . either extreme of mood may be associated with psychosis , manifested as disordered or delusional thinking and perceptions which are often incongruent with the predominant mood . affective disorders include major depression and mania , including bipolar manic - depressive illness . preferred classes of antidepressants include norepinephrine reuptake inhibitors ( neris ), including secondary and tertiary amine tricyclics ; selective sertraline reuptake inhibitors ; combined neri / ssris ; monoamine oxidase ( mao ) inhibitors ; and atypical antidepressants . any norepinephrine reuptake inhibitor ( neri ) may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . the term norepinephrine reuptake inhibitor means agents which potentiate the actions of biogenic amines by blocking their major means of physiological inactivation , which involves transport or reuptake into nerve terminals , and specifically , agents which block the reuptake of norepinephrine into said nerve terminals . preferred tertiary amine tricyclic norepinephrine reuptake inhibitors which may be used in accordance with this invention include , but are not limited to , amitriptyline , which may be prepared as described in u . s . pat . no . 3 , 205 , 264 ; chlomipramine , which may be prepared as described in u . s . pat . no . 3 , 467 , 650 ; doxepin , which may be prepared as described in u . s . pat . no . 3 , 420 , 851 ; imipramine , which may be prepared as described in u . s . pat . no . 2 , 554 , 736 ; and trimipramine , which may be prepared as described in jacob and messer , compt . rend . 252 , 2117 ( 1961 ). preferred secondary amine tricyclic norepinephrine reuptake inhibitors which may be used in accordance with this invention include , but are not limited to , amoxapine , which may be prepared as described in u . s . pat . no . 3 , 663 , 696 ; desipramine , which may be prepared as described in u . s . pat . no . 3 , 454 , 554 ; maprotiline , which may be prepared as described in u . s . pat . no . 3 , 999 , 201 ; nortriptyline , which may be prepared as described in u . s . pat . no . 3 , 442 , 949 ; and protriptyline , which may be prepared as described in u . s . pat . no . 3 , 244 , 748 . any selective serotonin reuptake inhibitor ( ssri ) may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . the term selective serotonin reuptake inhibitor refers to a compound which inhibits the reuptake of serotonin by afferent neurons . such inhibition is readily determined by those skilled in the art according to standard assays such as those disclosed in u . s . pat . no . 4 , 536 , 518 and other u . s . patents recited in the next paragraph . preferred selective serotonin reuptake inhibitors ( ssri ) which may be used in accordance with this invention include , but are not limited to : citalopram , which may be prepared as described in u . s . pat . no . 4 , 136 , 193 ; femoxetine , which may be prepared as described in u . s . pat . no . 3 , 912 , 743 ; fluoxetine , which may be prepared as described in u . s . pat . no . 4 , 314 , 081 ; fluvoxamine , which may be prepared as described in u . s . pat . no . 4 , 085 , 225 ; indalpine , which may be prepared as described in u . s . pat . no . 4 , 064 , 255 ; indeloxazine , which may be prepared as described in u . s . pat . no . 4 , 109 , 088 ; milnacipran , which may be prepared as described in u . s . pat . no . 4 , 478 , 836 ; paroxetine , which may be prepared as described in u . s . pat . no . 3 , 912 , 743 or u . s . pat . no . 4 , 007 , 196 ; sertraline and the hydrochloride salt of sertraline , which may be prepared as described in u . s . pat . no . 4 , 536 , 518 ; sibutramine , which may be prepared as described in u . s . pat . no . 4 , 929 , 629 ; and zimeldine , which may be prepared as described in u . s . pat . no . 3 , 928 , 369 . fluoxetine is also known as prozac ®. sertraline hydrochloride is also known as zoloft ®. sibutramine is also known as meridia ®. any combined neri / ssri may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . the term combined neri / ssri refers to a compound which blocks the reuptake of both serotonin and norepinephrine by afferent neurons . a preferred combined neri / ssri which may be used in accordance with this invention is venlafaxine , which may be prepared as described in u . s . pat . no . 4 , 535 , 186 . any monoamine oxidase ( mao ) inhibitor may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . the term monoamine oxidase inhibitor refers to a compound which inhibits monoamine oxidase , for example by blocking the metabolic deamination of a variety of monoamines by mitochondrial monoamine oxidase . preferred monoamine oxidase inhibitors which may be used in accordance with this invention include , but are not limited to , phenelzine , which may be prepared as described in u . s . pat . no . 3 , 000 , 903 ; tranylcypromine , which may be prepared as described in u . s . pat . no . 2 , 997 , 422 ; and selegiline , which may be prepared as described in u . s . pat . no . 4 , 564 , 706 . any atypical antidepressant may be used in the combinations , pharmaceutical compositions , methods and kits of this invention . the term atypical antidepressant refers to any antidepressant not within any of the aforesaid classes of antidepressants . preferred atypical antidepressants which may be used in accordance with this invention include , but are not limited to , bupropion , which may be prepared as described in u . s . pat . no . 3 , 885 , 046 ; nefazodone , which may be prepared as described in u . s . pat . no . 4 , 338 , 317 ; and trazodone , which may be prepared as described in u . s . pat . no . 3 , 381 , 009 . the disclosures of each of the patents and published patent applications cited within this description are incorporated herein by reference . the expression “ pharmaceutically acceptable salts ” includes both pharmaceutically acceptable acid addition salts and pharmaceutically acceptable cationic salts , where appropriate . the expression “ pharmaceutically - acceptable cationic salts ” is intended to define but is not limited to such salts as the alkali metal salts , ( e . g ., sodium and potassium ), alkaline earth metal salts ( e . g ., calcium and magnesium ), aluminum salts , ammonium salts , and salts with organic amines such as benzathine ( n , n ′- dibenzylethylenediamine ), choline , diethanolamine , ethylenediamine , meglumine ( n - methylglucamine ), benethamine ( n - benzylphenethylamine ), diethylamine , piperazine , tromethamine ( 2 - amino - 2 - hydroxymethyl - 1 , 3 - propanediol ) and procaine . the expression “ pharmaceutically - acceptable acid addition salts ” is intended to define but is not limited to such salts as the hydrochloride , hydrobromide , sulfate , hydrogen sulfate , phosphate , hydrogen phosphate , dihydrogenphosphate , acetate , succinate , d - tartrate , i - tartrate , citrate , methanesulfonate ( mesylate ) and p - toluenesulfonate ( tosylate ) salts . pharmaceutically acceptable cationic salts of the compounds used in this invention may be readily prepared , where appropriate , by reacting the free acid form of said compound with an appropriate base , usually one equivalent , in a co - solvent . typical bases are sodium hydroxide , sodium methoxide , sodium ethoxide , sodium hydride , potassium methoxide , magnesium hydroxide , calcium hydroxide , benzathine , choline , diethanolamine , piperazine and tromethamine . the salt is isolated by concentration to dryness or by addition of a non - solvent . in many cases , salts are preferably prepared by mixing a solution of the acid with a solution of a different salt of the cation ( sodium or potassium ethylhexanoate , magnesium oleate ), and employing a solvent ( e . g ., ethyl acetate ) from which the desired cationic salt precipitates , or can be otherwise isolated by concentration and / or addition of a non - solvent . the acid addition salts of the compounds used in this invention may be readily prepared by reacting the free base form of said compound with the appropriate acid . when the salt is of a monobasic acid ( e . g ., the hydrochloride , the hydrobromide , the p - toluenesulfonate , the acetate ), the hydrogen form of a dibasic acid ( e . g ., the hydrogen sulfate , the succinate ) or the dihydrogen form of a tribasic acid ( e . g ., the dihydrogen phosphate , the citrate ), at least one molar equivalent and usually a molar excess of the acid is employed . however when such salts as the sulfate , the hemisuccinate , the hydrogen phosphate or the phosphate are desired , the appropriate and exact chemical equivalents of acid will generally be used . the free base and the acid are usually combined in a co - solvent from which the desired salt precipitates , or can be otherwise isolated by concentration and / or addition of a non - solvent . in addition , the growth hormone secretagogues and antidepressants which may be used in accordance with this invention , prodrugs thereof and pharmaceutically acceptable salts thereof or of said prodrugs , may occur as hydrates or solvates . said hydrates and solvates are also within the scope of the invention . the utility of the combinations , pharmaceutical compositions , kits and methods of the present invention as medical agents in the treatment of musculoskeletal frailty ( e . g ., conditions which present with low bone mass or low muscle mass including osteoporosis ) in mammals ( e . g . humans ) is demonstrated by the activity of the compounds of this invention in conventional assays as set forth in u . s . pat . no . 5 , 552 , 412 and international pat . application publication no . wo97 / 24369 . such assays also provide a means whereby the activities of the compositions of this invention can be compared between themselves and with the activities of other known compounds and / or compositions . the results of these comparisons are useful for determining dosage levels in mammals , including humans , for the treatment of such diseases . administration of the compounds used in this invention can be via any method which delivers the compounds or the combination of this invention systemically and / or locally . these methods include oral , parenteral , intraduodenal routes , etc . generally , the compounds used in this invention are administered orally , but parenteral administration ( e . g ., intravenous , intramuscular , transcutaneous , subcutaneous or intramedullary ) may be utilized , for example , where oral administration is inappropriate for the instant target or where the patient is unable to ingest the drug . the two different compounds used in this invention can be co - administered simultaneously or sequentially in any order , or a single pharmaceutical composition comprising a first compound as described above and a second compound as described above in a pharmaceutically acceptable carrier can be administered . in any event the amount and timing of compounds administered will , of course , be dependent on the subject being treated , on the severity of the affliction , on the manner of administration and on the judgment of the prescribing physician . thus , because of patient to patient variability , the dosages given below are a guideline and the physician may titrate doses of the drug to achieve the activity ( e . g ., muscle mass improvement , mental state improvement and / or metabolism improvement ) that the physician considers appropriate for the individual patient . in considering the degree of activity desired , the physician must balance a variety of factors such as muscle mass starting level , cardiac output , age of the patient , presence of preexisting disease , other ongoing or planned medical treatments or procedures , as well as the presence of other diseases . the following paragraphs provide preferred dosage ranges for the various components of this invention . this invention relates both to methods of treating the physical and mental condition of a patient and / or to improve the cardiac function , metabolism and muscle condition of a patient in which the ghs and antidepressant are administered together , as part of the same pharmaceutical composition , and to methods in which these two agents are administered separately , as part of an appropriate dosage regimen designed to obtain the benefits of the combination therapy . the appropriate dosage regimen , the amount of each dose administered and the intervals between doses of the active agents will depend upon the ghs and the antidepressant being used , the type of pharmaceutical formulations being used , the characteristics of the subject being treated and the severity of the complications . generally , in carrying out the methods of this invention , an effective dosage for the ghs compounds of this invention is in the range of 0 . 0002 to 2 mg / kg / day , preferably 0 . 01 to 1 mg / kg / day in single or divided doses . it is preferred that the dosage amount of said ghs is about 1 mg to about 50 mg per day for an average subject , depending upon the ghs and the route of administration . the ghs compound and the antidepressant will be administered in single or divided doses . the preferred dosage ranges for the antidepressants used in this invention will vary depending upon the particular antidepressant used . the preferred dosage amounts of the antidepressants are well known to those skilled in the art or can be found in the physicians desk references ( pdr ®), 54 th edition , 2000 , medical economics company , inc ., montvale , n . j ., 07645 or in goodman and gilman &# 39 ; s the pharmacological basis of therapeutics , hardman , limbird , molinoff , ruddon and gilman , eds ., 9 th edition , 1996 , mcgraw - hill , new york , pp . 433 - 435 . for example , ssris will generally be administered in amounts ranging from about 0 . 05 mg / kg / day to about 10 mg / kg / day in single or divided doses , preferably 5 mg to about 500 mg per day for an average subject , depending upon the ssri and the route of administration . however , some variation in dosage will necessarily occur depending on the condition of the subject being treated . the prescribing physician will , in any event , determine the appropriate dose for the individual subject . pharmaceutical compositions comprising a growth hormone secretagogue , a prodrug thereof or a pharmaceutically acceptable salt of said growth hormone secretagogue or said prodrug and an antidepressant , a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug are hereinafter referred to , collectively , as “ the active compositions of this invention .” where the tartrate salt , hydrochloride salt or other pharmaceutically acceptable salt of any of the above compounds is used in this invention , the skilled person will be able to calculate effective dosage amounts by calculating the molecular weight of the salt form and performing simple stoichiometric ratios . the compounds , prodrugs and pharmaceutically acceptable salts used in the combinations of the present invention are generally administered in the form of a pharmaceutical composition comprising at least one of the compounds or pharmaceutically acceptable salts thereof of this invention together with a pharmaceutically acceptable vehicle or diluent . thus , the compounds , prodrugs and pharmaceutically acceptable salts thereof of this invention can be administered separately or together in any conventional oral , parenteral or transdermal dosage form . when administered separately , the administration of the other compound or a pharmaceutically acceptable salt thereof of the invention follows . for oral administration a compound or pharmaceutical composition can take the form of solutions , suspensions , tablets , pills , capsules , powders , and the like . tablets containing various excipients such as sodium citrate , calcium carbonate and calcium phosphate are employed along with various disintegrants such as starch and preferably potato or tapioca starch and certain complex silicates , together with binding agents such as polyvinylpyrrolidone , sucrose , gelatin and acacia . additionally , lubricating agents such as magnesium stearate , sodium lauryl sulfate and talc are often useful for tableting purposes . solid compositions of a similar type are also employed as fillers in soft and hard - filled gelatin capsules ; preferred materials in this connection also include lactose or milk sugar as well as high molecular weight polyethylene glycols . when aqueous suspensions and / or elixirs are desired for oral administration , the compounds or pharmaceutically aceptable salts thereof of this invention can be combined with various sweetening agents , flavoring agents , coloring agents , emulsifying agents and / or suspending agents , as well as such diluents as water , ethanol , propylene glycol , glycerin and various like combinations thereof . for purposes of parenteral administration , solutions in sesame or peanut oil or in aqueous propylene glycol can be employed , as well as sterile aqueous solutions of the corresponding water - soluble salts . such aqueous solutions may be suitably buffered , if necessary , and the liquid diluent first rendered isotonic with sufficient saline or glucose . these aqueous solutions are especially suitable for intravenous , intramuscular , subcutaneous and intraperitoneal injection purposes . in this connection , the sterile aqueous media employed are all readily obtainable by standard techniques well - known to those skilled in the art . for purposes of transdermal ( e . g ., topical ) administration , dilute sterile , aqueous or partially aqueous solutions ( usually in about 0 . 1 % to 5 % concentration ), otherwise similar to the above parenteral solutions , are prepared . methods of preparing various pharmaceutical compositions with a certain amount of each active ingredient are known , or will be apparent in light of this disclosure , to those skilled in this art . for examples , see remington &# 39 ; s pharmaceutical sciences , mack publishing company , easton , pa ., 19th edition ( 1995 ). pharmaceutical compositions according to the invention may contain 0 . 1 %- 95 % of a combination of the compounds , prodrugs or pharmaceutically acceptable salts thereof used in this invention , preferably 1 %- 70 %. in any event , the composition or formulation to be administered will contain a quantity of a combination of the compounds , prodrugs or pharmaceutically acceptable salts thereof used in the invention in an amount effective to treat the disease / condition of the subject being treated . since the present invention relates to treatment with a combination of the two active ingredients which may be administered separately , the invention also relates to combining separate pharmaceutical compositions in kit form . the kit includes two separate pharmaceutical compositions : a ghs , a prodrug thereof or a pharmaceutically acceptable salt thereof or of said prodrug and an antidepressant , a prodrug thereof or a pharmaceutically acceptable salt thereof or of said prodrug . the kit includes a container for containing the separate compositions such as a divided bottle or a divided foil packet , however , the separate compositions may also be contained within a single , undivided container . typically the kit includes directions for the administration of the separate components . the kit form is particularly advantageous when the separate components are preferably administered in different dosage forms ( e . g ., oral and parenteral ), are administered at different dosage intervals , or when titration of the individual components of the combination is desired by the prescribing physician . an example of such a kit is a so - called blister pack . blister packs are well known in the packaging industry and are being widely used for the packaging of pharmaceutical unit dosage forms ( tablets , capsules , and the like ). blister packs generally consist of a sheet of relatively stiff material covered with a foil of a preferably transparent plastic material . during the packaging process recesses are formed in the plastic foil . the recesses have the size and shape of the tablets or capsules to be packed . next , the tablets or capsules are placed in the recesses and the sheet of relatively stiff material is sealed against the plastic foil at the face of the foil which is opposite from the direction in which the recesses were formed . as a result , the tablets or capsules are sealed in the recesses between the plastic foil and the sheet . preferably the strength of the sheet is such that the tablets or capsules can be removed from the blister pack by manually applying pressure on the recesses whereby an opening is formed in the sheet at the place of the recess . the tablet or capsule can then be removed via said opening . it is desirable to provide a memory aid on a card insert , e . g ., in the form of numbers next to the tablets or capsules whereby the numbers correspond with the days of the regimen which the tablets or capsules so specified should be ingested . another example of such a memory aid is a calendar printed on the card e . g ., as follows “ first week , monday , tuesday , . . . etc . . . second week , monday , tuesday , . . . ” etc . other variations of memory aids will be readily apparent . a “ daily dose ” can be a single tablet or capsule or several pills or capsules to be taken on a given day . also a daily dose of antidepressant can consist of one tablet or capsule while a daily dose of a ghs can consist of several tablets or capsules and vice versa . the memory aid should reflect this . in another specific embodiment of the invention a dispenser designed to dispense the daily doses one at a time in the order of their intended use is provided . preferably , the dispenser is equipped with a memory - aid , so as to further facilitate compliance with the regimen . an example of such a memory - aid is a mechanical counter which indicates the number of daily doses that has been dispensed . another example of such a memory - aid is a battery - powered micro - chip memory coupled with a liquid crystal readout , or audible reminder signal which , for example , reads out the date that the last daily dose has been taken and / or reminds one when the next dose is to be taken . it should be understood that the invention is not limited to the particular embodiments described herein , but that various changes and modifications may be made without departing from the spirit and scope of this invention as defined by the following claims .
this invention is directed to combinations comprising a growth hormone secretagogue , a prodrug thereof or a pharmaceutically acceptable salt of said growth hormone secretagogue or said prodrug and an antidepressant , a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug and to pharmaceutical compositions and kits comprising such combinations . antidepressants within the scope of this invention include norepinephrine reuptake inhibitors , selective sertraline reuptake inhibitors , agents which are combined norepinephrine / sertraline reuptake inhibitors , monoamine oxidase inhibitors and atypical antidepressants . this invention is also directed to methods of improving the physical and / or psychological condition of a patient undergoing a medical procedure , to methods of treating musculoskeletal frailty , to methods of treating congestive heart failure and to methods of attenuating protein catabolic response after a major operation comprising administering such a combination . in particular , this invention relates to such compositions and kits that improve the cardiac function , metabolism , muscle tone and / or mental state of patients undergoing a medical procedure . the compositions and kits of this invention are also useful in treating central nervous system disorders of patients undergoing a medical procedure .
the present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims . the drawings described are only schematic and are non - limiting . in the drawings , the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes . the dimensions and the relative dimensions do not correspond to actual reductions to practice of the invention . furthermore , the terms first , second , third and the like in the description and in the claims , are used for distinguishing between similar elements and not necessarily for describing a sequence , either temporally , spatially , in ranking or in any other manner . it is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein . moreover , the terms top , bottom , over , under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions . it is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein . it is to be noticed that the term “ comprising ”, used in the claims , should not be interpreted as being restricted to the means listed thereafter ; it does not exclude other elements or steps . it is thus to be interpreted as specifying the presence of the stated features , integers , steps or components as referred to , but does not preclude the presence or addition of one or more other features , integers , steps or components , or groups thereof . thus , the scope of the expression “ a device comprising means a and b ” should not be limited to devices consisting only of components a and b . it means that with respect to the present invention , the only relevant components of the device are a and b . reference throughout this specification to “ one embodiment ” or “ an embodiment ” means that a particular feature , structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention . thus , appearances of the phrases “ in one embodiment ” or “ in an embodiment ” in various places throughout this specification are not necessarily all referring to the same embodiment , but may refer to different embodiments . furthermore , the particular features , structures or characteristics may be combined in any suitable manner , as would be apparent to one of ordinary skill in the art from this disclosure , in one or more embodiments . similarly it should be appreciated that in the description of exemplary embodiments of the invention , various features of the invention are sometimes grouped together in a single embodiment , figure , or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects . this method of disclosure , however , is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim . rather , as the following claims reflect , inventive aspects lie in less than all features of a single foregoing disclosed embodiment . thus , the claims following the detailed description are hereby expressly incorporated into this detailed description , with each claim standing on its own as a separate embodiment of this invention . furthermore , while some embodiments described herein include some but not other features included in other embodiments , combinations of features of different embodiments are meant to be within the scope of the invention , and form different embodiments , as would be understood by those skilled in the art . for example , in the following claims , any of the claimed embodiments can be used in any combination . in the description provided herein , numerous specific details are set forth . however , it is understood that embodiments of the invention may be practised without these specific details . in other instances , well - known methods , structures and techniques have not been shown in detail in order not to obscure an understanding of this description . the invention will now be described by a detailed description of several embodiments of the invention . it is clear that other embodiments of the invention can from the true spirit or technical teaching of the invention , the invention being limited only by the terms of the appended claims . in fig1 , the assembled and erected apparatus 10 comprises a base 20 . this base 20 comprises two feet 30 , one at the lower end of each leg 40 . each foot comprises a rectilinear length of box - section section . each foot 30 comprises a rear 34 and a front 36 member . the front member 36 has a smaller cross - section than the rear member 34 such that it may be moved telescopically into and out of the larger rear member 34 . this allows the length of the feet 30 to be adjusted as required and allows the apparatus to be packed into a small volume as may be seen in fig3 . the position of the two members 34 , 36 of each foot 30 relative to one another may be adjustably fixed by means of a pin ( not shown ), attached to the rear member 34 by means of a chain 93 , passing through a hole in each member 34 , 36 , the hole selected from a plurality of holes for the appropriate length as required . other means of adjustably maintaining the relative positions of the two feet members 34 , 36 are contemplated such as the pull - pins discussed above . each leg 40 comprises two members 44 , 46 of generally tubular shape . the lower leg 44 has a larger cross - section than the upper leg 46 such that the upper leg 46 may be moved telescopically into and out of the larger lower leg 44 . this allows the length of the legs 40 to be individually adjusted to cater for uneven ground and for adjustment of the height of the upper gripping member 50 relative to the base 20 . it also allows the apparatus to be packed into a small volume as may be seen in fig3 . the upper 46 and lower 44 leg members are retained in position relative to one another by means of bolts 49 a provided at the upper end of the lower leg members 44 . corresponding holes 49 b are provided in the upper leg members 46 at various positions along their lengths to allow positive locking of the bolts 49 a therein . other means of adjustably maintaining the relative positions of the upper 46 and lower 44 leg members are contemplated such as the pull - pins discussed above . each leg 40 may be releasably attached to each foot 30 . alternatively , or additionally , each leg 40 may be pivotable connected to each foot 30 . slots 91 , 92 are provided on each lower leg member 44 . these will be described in more detail in conjunction with the discussion regard fig3 below . the upper gripping member 50 is provided at the upper end of the legs 40 . it comprises a first portion 52 which is substantially rectilinear and horizontally positioned . the first portion includes downwardly depending portions which fit inside the upper end of each upper leg member 46 . the position of these downwardly depending portions are indicated by reference numeral “ 54 ”. these portions 54 may be locked to the upper leg members 46 by use of bolts similar to the ones describe above and referenced “ 49 a ”. however , other means of releasably maintaining the upper gripping means 50 to the upper leg members 46 are contemplated such as the pull - pins discussed above . from the upper end of each downwardly depending portion 54 a portion 53 extends substantially horizontally . it is to these horizontal sections 53 that the first portion 52 is attached . the first portion 52 extends over the top of both legs 40 and projects beyond the area defined by the base 20 . two second portions 55 are connected to the middle of the length of the first portion and each extends towards a leg 40 such that they extend in different directions to one another . each second portion 55 extends to the same side of the first portion 52 . each second portion 55 lies in the same plane as the first portion 52 , but not parallel to it . each second portion 55 makes a “ v ” shape arrangement with the first portion 52 . a third portion 58 extends from the end of each horizontal portion 53 in the same direction thereas . each third portion 58 connects the end of each second portion 55 , opposite from the end which is connected to the first portion 52 , to the first portion 52 , to form a triangular shape therebetween . each third portion 58 extends beyond the end of each second portion 55 to provide another position for gripping by the user in use . an additional second portion 56 is also provided substantially above each leg 40 . these additional second portions 56 connect to each end of the first portion 52 at one end and to each of the third portions 58 at their other end in the vicinity where the second portions 55 connect to each third portions 58 . this arrangement provides a triangular shape therebetween . the additional second portions 56 also lie in the same plane as the first 52 and second 55 portions . a fourth portion 59 is also provided at each end of the first portion 52 . these fourth portions are not in the same plane as the first , second and third portions . rather , they depend downwardly . the arrangement of various portions allows a user to grip the upper gripping member 50 in numerous ways . a handle 80 is included at one point along the length of the first portion 52 as will be described in more detail below . the various portions may be integral with one another in that they may be manufactured from one piece . alternatively , one or more various portions may be attached or connected together , such as by welding . the apparatus 10 may comprise steel and / or aluminium , although other materials are contemplated . to provide greater stability to the apparatus 10 a brace 70 is provided between the legs 40 . this brace 70 comprises two struts 72 , 74 which are each connected at one end to each of the lower leg members 44 . the two struts 72 , 74 lie substantially horizontally , in this assembled state shown , and meet in the middle between the two legs 40 . the two struts are hinged or pivoted together . a locking means 76 in the form of a channel is located at this mid - point to prevent the two struts 72 , 74 from moving relative to one another . the locking means 76 may be moved to allow the struts 72 , 74 to pivot relative to one another during disassembly . fig2 shows the apparatus 10 with the upper leg members 46 retracted fully inside the lower leg members 44 . a handle 80 is shown attached to the upper gripping member 50 for use as a carrying handle when the apparatus is disassembled and packed as shown in fig3 . all other referenced elements are the same as described with reference to fig1 . fig3 demonstrates how the apparatus 10 may be packed into a relatively small volume for ease of storage and or portability . the upper gripping member 50 is attached to the lower leg members 44 , which have the upper leg members 46 substantially fully retracted inside . the lower leg members 44 are , in turn , attached to the rear feet members 34 , which have the forward members 36 fully retracted inside them . the legs 40 have been brought together and the feet 30 have been rotated relative to the legs ( by means of pivoting means 90 ) such that the longitudinal axes of the feet 30 , legs 40 and first portion 52 of the upper gripping member 50 are substantially parallel and adjacent with one another . the legs 40 may be releasably fixed in this position , relative to the feet 30 , by use of a locking means , such as one or more pins 99 passing through appropriate holes in the pivoting means 90 . the upper gripping member 50 is attached to the lower leg members 44 by means of the slots 91 , 92 provided on the surface of the lower leg members 44 . the two third portions 58 each fit inside the slots 91 , 92 and are retained therein by means of a releasable pin 94 .
a free - standing exercise apparatus is provided which comprises a base , at least one leg extending , in use , upwardly from the base , and a substantially horizontal bar attached to the at least one leg at an end substantially opposite to the base , wherein the bar has a substantially rectilinear first portion and at least one second portion arranged substantially in the same plane as , but substantially non - perpendicularly to , the first portion .
this invention relates to the therapeutic use of nap and adnf polypeptides in the treatment of diseases and disorders including anxiety and depression , and disorders related thereto . the invention is based on the finding set out in example 1 that treatment of mice with nap peptide significantly reduces anxiety - like behavior in a widely used and accepted industry standard model of anxiety , the elevated plus - maze ( see rodgers & amp ; dalvi , neurosci . biobehav . rev . 21 ( 6 ) 801 - 810 ( 1997 )). the invention further discloses that while providing anxiolytic effects , nap does not inhibit cognitive functions . in another embodiment , this invention further discloses nap mechanism of action and identifies tubulin as the molecular target for nap &# 39 ; s activity offering a novel target platform for anxiolytic drug discovery ( see example 2 ). the discovery of nap &# 39 ; s mechanism of action provides drug assays for compounds that also can be used to treat anxiety and depression . in such assays , compounds that modulate the interaction between nap and tubulin are identified . in one embodiment , the adnf polypeptides of the present invention comprise the following amino acid sequence : ( r 1 ) x - asn - ala - pro - val - ser - ile - pro - gln -( r 2 ) y ( seq id no : 13 ) and conservatively modified variations thereof . in this designation , r 1 denotes the orientation of the amino terminal ( nh 2 or n - terminal ) end and r 2 represents the orientation of the carboxyl terminal ( cooh or c - terminal ) end . in the above formula , r 1 is an amino acid sequence comprising from 1 to about 40 amino acids , wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs . the term “ independently selected ” is used herein to indicate that the amino acids making up the amino acid sequence r 1 may be identical or different ( e . g ., all of the amino acids in the amino acid sequence may be threonine , etc .). moreover , as previously explained , the amino acids making up the amino acid sequence r 1 may be either naturally occurring amino acids , or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids ( i . e ., amino acid mimetics and analogs ). suitable amino acids that can be used to form the amino acid sequence r 1 include , but are not limited to , those listed in table i , infra . the indexes “ x ” and “ y ” are independently selected and can be equal to one or zero . as with r 1 , r 2 , in the above formula , is an amino acid sequence comprising from 1 to about 40 amino acids , wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs . moreover , as with r 1 , the amino acids making up the amino acid sequence r 2 may be identical or different , and may be either naturally occurring amino acids , or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids ( i . e ., amino acid mimetics and analogs ). suitable amino acids that can be used to form r 2 include , but are not limited to , those listed in table i , infra . as used herein , “ nap ” or “ nap peptide ” refers to the formula above where x and y both equal 0 . “ nap related peptide ” refers to any of the other variants of nap which are described the formula . r 1 and r 2 are independently selected . if r 1 r 2 are the same , they are identical in terms of both chain length and amino acid composition . for example , both r 1 and r 2 may be val - leu - gly - gly - gly ( seq id no : 14 ). if r 1 and r 2 are different , they can differ from one another in terms of chain length and / or amino acid composition and / or order of amino acids in the amino acids sequences . for example , r 1 may be val - leu - gly - gly - gly ( seq id no : 15 ), whereas r 2 may be val - leu - gly - gly ( seq id no : 16 ). alternatively , r 1 may be val - leu - gly - gly - gly ( seq id no : 17 ), whereas r 2 may be val - leu - gly - gly - val ( seq id no : 18 ). alternatives , r 1 may be val - leu - gly - gly - gly ( seq id no : 19 ), whereas r 2 may be gly - val - leu - gly - gly ( seq id no : 20 ). within the scope of the above formula , certain nap and nap related polypeptides are preferred , namely those in which x and y are both zero ( i . e . nap ). equally preferred are nap and nap related polypeptides in which x is one ; r 1 gly - gly ; and y is zero ( seq id no : 21 ). also equally preferred are nap and nap related polypeptides in which is one ; r 1 is leu - gly - gly ; y is one ; and r 2 is - gln - ser ( seq id no : 22 ). also equally preferred are nap and nap related polypeptides in which x is one ; r 1 is leu - gly - leu - gly - gly - ( seq id no : 23 ); y is one ; and r 2 is - gln - ser ( seq id no : 24 ). also equally preferred are nap and nap related polypeptides in which x is one ; r 1 is ser - val - arg - leu - gly - leu - gly - gly -( seq id no : 25 ); y is one ; and r 2 is - gln - ser ( seq id no : 26 ). additional amino acids can be added to both the n - terminus and the c - terminus of the active peptide without loss of biological activity . in another aspect , the present invention provides pharmaceutical compositions comprising one of the previously described nap and nap related polypeptides in an amount sufficient to exhibit anxiolytic ( e . g . anxiety reducing ) or anti - depressant activity , in a pharmaceutically acceptable diluent , carrier or excipient . in one embodiment , the nap or nap related peptide has an amino acid sequence selected from the group consisting of seq id no : 2 , and 9 - 12 , and conservatively modified variations thereof . in another embodiment , the adnf polypeptide comprises the following amino acid sequence : ( r 1 ) x - ser - ala - leu - leu - arg - ser - ile - pro - ala -( r 2 ) y ( seq id no : 27 ) and conservatively modified variations thereof . in this designation , r 1 denotes the orientation of the amino terminal ( nh 2 or n - terminal ) end and r 2 represents the orientation of the carboxyl terminal ( cooh or c - terminal ) end . in the above formula , r 1 is an amino acid sequence comprising from 1 to about 40 amino acids , wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs . the term “ independently selected ” is used herein to indicate that the amino acids making up the amino acid sequence r 1 may be identical or different ( e . g ., all of the amino acids in the amino acid sequence may be threonine , etc .). moreover , as previously explained , the amino acids making up the amino acid sequence r 1 may be either naturally occurring amino acids , or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids ( i . e ., amino acid mimetics and analogs ). suitable amino acids that can be used to form the amino acid sequence r 1 include , but are not limited to , those listed in table i , infra . the indexes “ x ” and “ y ” are independently selected and can be equal to one or zero . as with r ′, r 2 , in the above formula , is an amino acid sequence comprising from 1 to about 40 amino acids , wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs . moreover , as with r 1 , the amino acids making up the amino acid sequence r 2 may be identical or different , and may be either naturally occurring amino acids , or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids ( i . e ., amino acid mimetics and analogs ). suitable amino acids that can be used to form r 2 include , but are not limited to , those listed in table i , infra . as used herein , “ sal ” or “ sal peptide ” refers to the formula above where x and y both equal 0 . “ sal related peptide ” refers to any of the other variants of sal which are described the formula . r 1 and r 2 are independently selected . if r 1 r 2 are the same , they are identical in terms of both chain length and amino acid composition . additional amino acids can be added to both the n - terminus and the c - terminus of the active peptide without loss of biological activity . in another aspect , the present invention provides pharmaceutical compositions comprising one of the previously described sal and sal - related polypeptides in an amount sufficient to exhibit anxiolytic ( e . g . anxiety reducing ) or anti - depressant activity , in a pharmaceutically acceptable diluent , carrier or excipient . in one embodiment , the sal or sal related peptide has an amino acid sequence selected from the group consisting of seq id no : 1 and 3 - 8 , and conservatively modified variations thereof . polypeptides and peptides comprising the core napvsipq or sallrsipa active site can be easily made , e . g ., by systematically adding one amino acid at a time and screening the resulting peptide for biological activity , as described herein . in addition , the contributions made by the side chains of various amino acid residues in such peptides can be probed via a systematic scan with a specified amino acid , e . g ., ala . one of skill will recognize many ways of generating alterations in a given nucleic acid sequence . such well - known methods include site - directed mutagenesis , pcr amplification using degenerate oligonucleotides , exposure of cells containing the nucleic acid to mutagenic agents or radiation , chemical synthesis of a desired oligonucleotide ( e . g ., in conjunction with ligation and / or cloning to generate large nucleic acids ) and other well - known techniques ( see giliman & amp ; smith , gene 8 : 81 - 97 ( 1979 ); roberts et al ., nature 328 : 731 - 734 ( 1987 )). most commonly , polypeptide sequences are altered by changing the corresponding nucleic acid sequence and expressing the polypeptide . however , polypeptide sequences are also optionally generated synthetically using commercially available peptide synthesizers to produce any desired polypeptide ( see merrifield , am . chem . soc . 85 : 2149 - 2154 ( 1963 ); stewart & amp ; young , solid phase peptide synthesis ( 2nd ed . 1984 )). one of skill can select a desired nucleic acid or polypeptide of the invention based upon the sequences provided and upon knowledge in the art regarding proteins generally . knowledge regarding the nature of proteins and nucleic acids allows one of skill to select appropriate sequences with activity similar or equivalent to the nucleic acids and polypeptides disclosed herein . the definitions section , supra , describes exemplar conservative amino acid substitutions . modifications to the nap and adnf polypeptides are evaluated by routine screening techniques in suitable assays for the desired characteristic . for instance , changes in the immunological character of a polypeptide can be detected by an appropriate immunological assay . modifications of other properties such as nucleic acid hybridization to a target nucleic acid , redox or thermal stability of a protein , hydrophobicity , susceptibility to proteolysis , or the tendency to aggregate are all assayed according to standard techniques . more particularly , it will be readily apparent to those of ordinary skill in the art that the small peptides of the present invention can readily be screened for anxiolytic and anti - depressant activity by employing suitable assays and animal models known to those skilled in the art . among the animal models employed to evaluate the anxiolytic or anxiogenic effects of drugs , the elevated plus - maze is probably the most popular . ( see rodgers and dalvi , supra ). for factors controlling measures of anxiety and responses to novelty in the mouse , see file , behav . brain res . 125 : 151 - 157 ( 2001 ). for a review of the validity and variability of the elevated plus - maze as an animal model of anxiety , see hogg , pharmacol . biochem . behav . 54 : 21 - 30 ( 1996 ); and lister , psychopharmacology ( berlin ) 92 : 180 - 185 ( 1987 ). the elevated plus - maze model is described in some detail in example 1 . still , those skilled in the art are aware of a wide range of alternative models which are also available to measure the anxiolytic effect of therapeutic agents . such models may require measurement of physiological or endocrine functions ( e . g ., hyperthermic or corticosterone responses to stress ) while others analyze behavior . broadly speaking , suitable behavioral models for testing anxiolytic effects of a test compound involve exposure of animals to stimuli ( exteroceptive or interoceptive ) that appear capable of causing anxiety in humans . the animals are then treated with the test compound to determine if it generates an anxiolytic effect . the models may also be grouped into two general categories involving either conditioned ( e . g . geller - seifter conflict , potentiated startle ) or unconditioned ( social interaction and light / dark exploration tests ) responses . those in the art are aware that any of these standard behavioral models may be used to test nap or adnf polypeptides to identify or confirm anxiolytic activity of test peptides . using these assays and models , one of ordinary skill in the art can readily prepare a large number of nap and adnf polypeptides in accordance with the teachings of the present invention and , in turn , screen them using the foregoing animal models to find adnf polypeptides , in addition to those set forth herein , which possess the desired activity . for instance , using the nap peptide ( i . e ., asn - ala - pro - val - ser - ile - pro - gln ( seq id no : 2 )) or sal peptide ser - ala - leu - leu - arg - ser - ile - pro - ala ( seq id no : 1 ) as a starting point , one can systematically add , for example , gly -, gly - gly -, leu - gly - gly - to the n - terminus of the peptide and , in turn , screen each of these nap or adnf polypeptides in the foregoing assay to determine whether they possess anxiolytic or anti - depressant activity . in doing so , it will be found that additional amino acids can be added to both the n - terminus and the c - terminus of the active site , i . e ., asn - ala - pro - val - ser - ile - pro - gln ( seq id no : 2 ) or ser - ala - leu - leu - arg - ser - ile - pro - ala ( seq id no : 1 ), without loss of biological activity . the peptides of the invention may be prepared via a wide variety of well - known techniques . peptides of relatively short size are typically synthesized on a solid support or in solution in accordance with conventional techniques ( see , e . g ., merrifield , am . chem . soc . 85 : 2149 - 2154 ( 1963 )). various automatic synthesizers and sequencers are commercially available and can be used in accordance with known protocols ( see , e . g ., stewart & amp ; young , solid phase peptide synthesis ( 2nd ed . 1984 )). solid phase synthesis in which the c - terminal amino acid of the sequence is attached to an insoluble support followed by sequential addition of the remaining amino acids in the sequence is the preferred method for the chemical synthesis of the peptides of this invention . techniques for solid phase synthesis are described by barany & amp ; merrifield , solid - phase peptide synthesis ; pp . 3 - 284 in the peptides analysis , synthesis , biology . vol . 2 : special methods in peptide synthesis , part a . ; merrifield et al 1963 ; stewart et al . 1984 ). nap and related peptides are synthesized using standard fmoc protocols ( wellings & amp ; atherton , methods enzymol . 289 : 44 - 67 ( 1997 )). in addition to the foregoing techniques , the peptides for use in the invention may be prepared by recombinant dna methodology . generally , this involves creating a nucleic acid sequence that encodes the protein , placing the nucleic acid in an expression cassette under the control of a particular promoter , and expressing the protein in a host cell . recombinantly engineered cells known to those of skill in the art include , but are not limited to , bacteria , yeast , plant , filamentous fungi , insect ( especially employing baculoviral vectors ) and mammalian cells . the recombinant nucleic acids are operably linked to appropriate control sequences for expression in the selected host . for e . coli , example control sequences include the t7 , trp , or lambda promoters , a ribosome binding site and , preferably , a transcription termination signal . for eukaryotic cells , the control sequences typically include a promoter and , preferably , an enhancer derived from immunoglobulin genes , sv40 , cytomegalovirus , etc ., and a polyadenylation sequence , and may include splice donor and acceptor sequences . the plasmids of the invention can be transferred into the chosen host cell by well - known methods . such methods include , for example , the calcium chloride transformation method for e . coli and the calcium phosphate treatment or electroporation methods for mammalian cells . cells transformed by the plasmids can be selected by resistance to antibiotics conferred by genes contained on the plasmids , such as the amp , gpt , neo , and hyg genes . once expressed , the recombinant peptides can be purified according to standard procedures of the art , including ammonium sulfate precipitation , affinity columns , column chromatography , gel electrophoresis and the like ( see , e . g ., scopes , polypeptide purification ( 1982 ); deutscher , methods in enzymology vol . 182 : guide to polypeptide purification ( 1990 )). once purified , partially or to homogeneity as desired , the nap and adnf polypeptides may then be used , e . g ., to prevent neuronal cell death or as immunogens for antibody production . optional additional steps include isolating the expressed protein to a higher degree , and , if required , cleaving or otherwise modifying the peptide , including optionally renaturing the protein . after chemical synthesis , biological expression or purification , the peptide ( s ) may possess a conformation substantially different than the native conformations of the constituent peptides . in this case , it is helpful to denature and reduce the peptide and then to cause the peptide to re - fold into the preferred conformation . methods of reducing and denaturing peptides and inducing re - folding are well known to those of skill in the art ( see debinski et al ., j . biol . chem . 268 : 14065 - 14070 ( 1993 ); kreitman & amp ; pastan , bioconjug . chem . 4 : 581 - 585 ( 1993 ); and buchner et al ., anal . biochem . 205 : 263 - 270 ( 1992 )). debinski et al ., for example , describe the denaturation and reduction of inclusion body peptides in guanidine - dte . the peptide is then refolded in a redox buffer containing oxidized glutathione and l - arginine . one of skill will recognize that modifications can be made to the peptides without diminishing their biological activity . some modifications may be made to facilitate the cloning , expression , or incorporation of the targeting molecule into a fusion peptide . such modifications are well known to those of skill in the art and include , for example , a methionine added at the amino terminus to provide an initiation site , or additional amino acids ( e . g ., poly his ) placed on either terminus to create conveniently located restriction sites or termination codons or purification sequences . use of nap and adnf polypeptides for treating anxiety and / or depression , including other mood disorders and anxiety disorders this invention discloses for the first time the surprising finding that nap and adnf polypeptides that were shown before to be neuroprotective and providing cognitive enhancement can be used in the treatment and / or prevention of a broad range of human clinical disorders such as anxiety and depression and a broad range of related disorders . as current medications used for treatment of anxiety disorders may adversely affect alertness , this surprising discovery offers an obvious advantage . furthermore , anxiety is common in the elderly and can present as a primary anxiety disorder or as a symptom of another disorder . generalized anxiety disorder ( gad ), in particular , is a common syndrome in late life . anxiety symptoms are also common features of late - life depression and dementia . treatment of anxiety in elderly persons has typically involved the use of benzodiazepines , which are often effective but problematic because they are associated with increased risk of cognitive impairment , falls , and fractures ( lenze et al ., cns spectr . 12 suppl 3 : 6 - 13 ( 2003 )). benzodiazepines interact with the gamma - aminobutyric acid ( gaba ) receptor . previously , gephyrin , a tubulin - binding protein , was found as the core of inhibitory postsynaptic scaffolds stabilizing glycine receptors ( glyrs ) and / or gaba ( a ) receptors ( hanus et al ., j neurosci . 24 ( 5 ): 1119 - 28 ( 2004 )). here , a mechanism for nap is disclosed and the molecular target — tubulin , the subunit protein of microtubules is identified as the nap binding protein . the direct interaction of nap with tubulin may circumvent the adverse side effects associated with benzodiazepines treatments and further offers a target platform for novel drug discovery . anxiety is a cardinal symptom of many psychiatric disorders as well as a disease in itself . symptoms of anxiety commonly are associated with depression and especially with dysthymic disorder ( chronic depression of moderate severity ), panic disorder , agoraphobia and other specific phobias , obsessive - compulsive disorder , eating disorders and many personality disorders . anxiety in human includes those further divisions set out in the diagnostic and statistical manual of mental disorders ( american psychiatric association , dsm - iv , 4th ed . 1994 ). anxiety disorders are serious medical illnesses that affect approximately 19 million american adults . ( narrow et al ., nimh epidemiology note : prevalence of anxiety disorders . one - year prevalence best estimates calculated from eca and ncs data . population estimates based on u . s . census estimated residential population age 18 to 54 on jul . 1 , 1998 . unpublished ). these disorders fill people &# 39 ; s lives with overwhelming anxiety and fear . anxiety disorders are acute attacks or are chronic , relentless , and can grow progressively worse if not treated . examples include : panic disorder , obsessive - compulsive disorder , attention deficit disorder and attention deficit hyperactivity disorder , post - traumatic stress disorder , social phobia ( or social anxiety disorder ), specific phobias , and generalized anxiety disorder . major depression is characterized by clinically significant depressions of mood and impairment of functioning as its primary clinical manifestations . its clinical manifestations and current treatment overlap the anxiety disorders including panic - agorophobia syndrome , sever phobias , generalized anxiety disorder , social anxiety disorder , post - traumatic stress disorders and obsessive - compulsive disorder . extremes of mood may be associated with psychosis , manifested as disordered or delusional thinking and perceptions , often congruent with the predominant mood . in any given 1 - year period , 9 . 5 percent of the population , or about 18 . 8 million american adults , suffer from a depressive illness ( robins & amp ; regier ( eds ). psychiatric disorders in america , the epidemiologic catchment area study , 1990 ; new york : the free press ). depression often accompanies anxiety disorders ( regier et al ., british journal of psychiatry supplement 34 : 24 - 8 ( 1998 )) and , when it does , it needs to be treated as well . symptoms of depression include feelings of sadness , hopelessness , changes in appetite or sleep , low energy , and difficulty concentrating . most people with depression can be effectively treated with antidepressant medications , certain types of psychotherapy , or a combination of both . major depression is manifested by a combination of symptoms ( see symptom list ) that interfere with the ability to work , study , sleep , eat , and enjoy once pleasurable activities . such a disabling episode of depression may occur only once but more commonly occurs several times in a lifetime . a less severe type of depression , dysthymia , involves long - term , chronic symptoms that do not disable , but keep one from functioning well or from feeling good . many people with dysthymia also experience major depressive episodes at some time in their lives . another type of depression is bipolar disorder , also called manic - depressive illness . not nearly as prevalent as other forms of depressive disorders , bipolar disorder is characterized by cycling mood changes : severe highs ( mania ) and lows ( depression ). sometimes the mood switches are dramatic and rapid , but most often they are gradual . when in the depressed cycle , an individual can have any or all of the symptoms of a depressive disorder . when in the manic cycle , the individual may be overactive , overtalkative , and have a great deal of energy . mania often affects thinking , judgment , and social behavior in ways that cause serious problems and embarrassment . for example , the individual in a manic phase may feel elated , full of grand schemes that might range from unwise business decisions to romantic sprees . mania , left untreated , may worsen to a psychotic state . gamma - aminobutyric acid ( gaba ) is the major inhibitory neurotransmitter in the mammalian central nervous system ( cns ). gaba participates in the regulation of neuronal excitability through interaction with specific membrane proteins ( the gabaa receptors ). the binding of gaba to these postsynaptic receptors , results in an opening of a chloride channel integrated in the receptor which allows the entry of cl — and consequently leads to hyperpolarization of the recipient cell . the action of gaba is allosterically modulated by a wide variety of chemical entities which interact with distinct binding sites at the gabaa receptor complex . one of the most thoroughly investigated modulatory site is the benzodiazepine binding site . the benzodiazepines constitute a well - known class of therapeutics displaying hypnotic , anxiolytic and anticonvulsant effects . their usefulness , however , is limited by a broad range of side effects comprising sedation , ataxia , amnesia , alcohol and barbiturate potentiation , tolerance development and abuse potential . consequently , there has been an intensive search for modulatory agents with an improved profile , and a diversity of chemical entities distinct from the benzodiazepines , but with gaba modulatory effects have been identified . the existence of endogenous ligands for the gabaa receptor complex beside gaba has often been described , but their role in the regulation of gaba action is still a matter of controversy . the progress of molecular biology during the last decade has contributed enormously to the understanding of benzodiazepine receptor pharmacology . a total of 14 gabaa receptor subunits have been cloned from mammalian brain and have been expressed / co - expressed in stable cell lines . these transfected cells constitute an important tool in the characterization of subtype selective ligands . in spite of the rapidly expanding knowledge of the molecular and pharmacological mechanisms involved in gaba / benzodiazepine related cns disorders , the identification of clinically selective acting drugs is still to come ( teuber et al ., curr pharm des 5 ( 5 ): 317 - 43 ( 1999 )). control of neurotransmitter receptor expression and delivery to the postsynaptic membrane is of great importance for neural signal transduction at synapses . the gaba type a ( gaba ( a )) receptor - associated protein gabarap was reported to have an important role for movement and sorting of gaba ( a ) receptor molecules to the postsynaptic membrane . gabarap not only binds to gaba ( a ) receptor gamma2 - subunit but also to tubulin , gephyrin , and ulk1 , suggesting regulation through the interaction with the microtubular network ( stangler et al ., j biol . chem . 19 : 277 ( 2002 ), 16 : 13363 - 6 . epub 2002 mar . 1 ) anxiety is often defined as an organism &# 39 ; s response to potential threat , as opposed to direct or immediate threat . anxiety and depression also encompass disorders of mood such as affective disorders . the severity of these conditions covers an extraordinarily broad range from normal grief reactions and dysthymia to severe , incapacitating illnesses that may result in death . thus , according to the instant invention , nap and adnf polypeptides may be used to treat anxiety and / or depression and diseases or disorders related thereto , as defined herein . the identification of tubulin as the nap - binding site allows the use of tubulin and tubulin — derived peptides as targets for further drug discovery , e . g ., for the treatment of diseases related to adnf polypeptides such as anxiety , depression , disease related to neuronal cell death and oxidative stress , neurodegenerative diseases such as alzheimer &# 39 ; s disease , aids - related dementia , huntington &# 39 ; s disease , and parkinson &# 39 ; s disease , hiv - related dementia complex , stroke , head trauma , cerebral palsy , conditions associated with fetal alcohol syndrome . such therapeutics can also be used in methods of enhancing learning and memory both pre - and post - natally . experiments can be carried out with the intact tubulin structure and nap as a displacing agent , or by further identification of the precise tubulin - nap interacting site ( e . g ., as described katchalski - katzir et al ., biophys chem . 100 ( 1 - 3 ): 293 - 305 ( 2003 ); chang et al ., j comput chem . 24 ( 16 ): 1987 - 98 ( 2003 )). preliminary screens can be conducted by screening for agents capable of binding to a polypeptide of the invention , as at least some of the agents so identified are likely modulators of polypeptide activity . the binding assays usually involve contacting a polypeptide of the invention with one or more test agents and allowing sufficient time for the protein and test agents to form a binding complex . any binding complexes formed can be detected using any of a number of established analytical techniques . protein binding assays include , but are not limited to , methods that measure co - precipitation , co - migration on non - denaturing sds - polyacrylamide gels , and co - migration on western blots ( see , e . g ., bennet and yamamura , ( 1985 ) neurotransmitter , hormone or drug receptor binding methods , in neurotransmitter receptor binding ( yamamura et al ., eds . ), pp . 61 - 89 . the protein utilized in such assays can be naturally expressed , cloned or synthesized . agents that are initially identified by any of the foregoing screening methods can be further tested to validate the apparent activity . preferably such studies are conducted with suitable animal models . the basic format of such methods involves administering a lead compound identified during an initial screen to an animal that serves as a model for humans and then determining if expression or activity of a polynucleotide or polypeptide of the invention is in fact upregulated . the animal models utilized in validation studies generally are mammals of any kind specific examples of suitable animals include , but are not limited to , primates , mice , and rats . in one embodiment , the elevated plus maze and the morris water maze tests are used , as described in example 1 . the agents tested as modulators of the polypeptides of the invention can be any small chemical compound , or a biological entity , such as a protein , sugar , nucleic acid , rnai , or lipid . typically , test compounds will be small chemical molecules and peptides . essentially any chemical compound can be used as a potential modulator or ligand in the assays of the invention , although most often compounds that can be dissolved in aqueous or organic ( especially dmso - based ) solutions are used . the assays are designed to screen large chemical libraries by automating the assay steps and providing compounds from any convenient source to assays , which are typically run in parallel ( e . g ., in microtiter formats on microtiter plates in robotic assays ). it will be appreciated that there are many suppliers of chemical compounds , including sigma ( st . louis , mo . ), aldrich ( st . louis , mo . ), sigma - aldrich ( st . louis , mo . ), fluka chemika - biochemica analytika ( buchs , switzerland ) and the like . modulators also include agents designed to reduce the level of mrna of the invention ( e . g . antisense molecules , ribozymes , dnazymes and the like ) or the level of translation from an mrna . in one preferred embodiment , high throughput screening methods involve providing a combinatorial chemical or peptide library containing a large number of potential therapeutic compounds ( potential modulator or ligand compounds ). such “ combinatorial chemical libraries ” or “ ligand libraries ” are then screened in one or more assays , as described herein , to identify those library members ( particular chemical species or subclasses ) that display a desired characteristic activity . the compounds thus identified can serve as conventional “ lead compounds ” or can themselves be used as potential or actual therapeutics . libraries available for screening for small active molecules include the available chemical directory ( acd , 278 , 000 compounds ), acd screening library (& gt ; 1 , 000 , 000 compounds ), crc combined chemical dictionary (˜ 350 , 000 compounds ) anisex ( 115 , 000 compounds ) maybridge ( 62 , 000 compounds ) derwent and nci libraries . the pharmaceutical compositions of the present invention are suitable for use in a variety of drug delivery systems . peptides that have the ability to cross the blood brain barrier can be administered , e . g ., systemically , nasally , etc ., using methods known to those of skill in the art . larger peptides that do not have the ability to cross the blood brain barrier can be administered to the mammalian brain via intracerebroventricular ( icv ) injection or via a cannula using techniques well known to those of skill in the art ( see , e . g ., motta & amp ; martini , proc . soc . exp . biol . med . 168 : 62 - 64 ( 1981 ); peterson et al ., biochem . pharamacol . 31 : 2807 - 2810 ( 1982 ); rzepczynski et al ., metab . brain dis . 3 : 211 - 216 ( 1988 ); leibowitz et al ., brain res . bull . 21 : 905 - 912 ( 1988 ); sramka et al ., stereotact . funct . neurosurg . 58 : 79 - 83 ( 1992 ); peng et al ., brain res . 632 : 57 - 67 ( 1993 ); chem et al ., exp . neurol . 125 : 72 - 81 ( 1994 ); nikkhah et al ., neuroscience 63 : 57 - 72 ( 1994 ); anderson et al ., j . comp . neurol . 357 : 296 - 317 ( 1995 ); and brecknell & amp ; fawcett , exp . neurol . 138 : 338 - 344 ( 1996 )). suitable formulations for use in the present invention are found in remington &# 39 ; s pharmaceutical sciences ( 17th ed . 1985 )), which is incorporated herein by reference . in addition , for a brief review of methods for drug delivery , see langer , science 249 : 1527 - 1533 ( 1990 ), which is incorporated herein by reference . suitable dose ranges are described in the examples provided herein , as well as in wo 9611948 , herein incorporated by reference in its entirety . as such , the present invention provides for therapeutic compositions or medicaments comprising one or more of the nap or adnf polypeptides described hereinabove in combination with a pharmaceutically acceptable excipient , wherein the amount of the nap or adnf polypeptide is sufficient to provide a therapeutic effect . in a therapeutic application , the nap and adnf polypeptides of the present invention are embodied in pharmaceutical compositions intended for administration by any effective means , including parenteral , topical , oral , pulmonary ( e . g . by inhalation ) or local administration . preferably , the pharmaceutical compositions are administered parenterally , e . g ., intravenously , subcutaneously , intradermally , or intramuscularly , or intranasally . thus , the invention provides compositions for parenteral administration that comprise a solution of nap or adnf polypeptide , as described above , dissolved or suspended in an acceptable carrier , preferably an aqueous carrier . a variety of aqueous carriers may be used including , for example , water , buffered water , 0 . 4 % saline , 0 . 3 % glycine , hyaluronic acid and the like . these compositions may be sterilized by conventional , well known sterilization techniques or , they may be sterile filtered . the resulting aqueous solutions may be packaged for use as is or lyophilized , the lyophilized preparation being combined with a sterile solution prior to administration . the compositions may contain pharmaceutically acceptable auxiliary substances as required to approximate physiological conditions including ph adjusting and buffering agents , tonicity adjusting agents , wetting agents and the like , such as , for example , sodium acetate , sodium lactate , sodium chloride potassium chloride , calcium chloride , sorbitan monolaurate , triethanolamine oleate , etc . for solid compositions , conventional nontoxic solid carriers may be used that include , for example , pharmaceutical grades of mannitol , lactose , starch , magnesium stearate , sodium saccharin , talcum , cellulose , glucose , sucrose , magnesium carbonate , and the like . for oral administration , a pharmaceutically acceptable nontoxic composition is formed by incorporating any of the normally employed excipients , such as those carriers previously listed , and generally 10 - 95 % of active ingredient and more preferably at a concentration of 25 %- 75 %. for aerosol administration , the nap or adnf polypeptides are preferably supplied in finely divided form along with a surfactant and propellant . the surfactant must , of course , be nontoxic , and preferably soluble in the propellant . representative of such agents are the esters or partial esters of fatty acids containing from 6 to 22 carbon atoms , such as caproic , octanoic , lauric , palmitic , stearic , linoleic , linolenic , olesteric and oleic acids with an aliphatic polyhydric alcohol or its cyclic anhydride . mixed esters , such as mixed or natural glycerides may be employed . a carrier can also be included , as desired , as with , e . g ., lecithin for intranasal delivery . an example includes a solution in which each milliliter included 7 . 5 mg nacl , 1 . 7 mg citric acid monohydrate , 3 mg disodium phosphate dihydrate and 0 . 2 mg benzalkonium chloride solution ( 50 %) ( gozes et al ., j mol neurosci . 19 ( 1 - 2 ): 167 - 70 ( 2002 )). in therapeutic applications , the nap or adnf polypeptides of the invention are administered to a patient in an amount sufficient to reduce or eliminate symptoms of anxiety and / or depression . an amount adequate to accomplish this is defined as “ therapeutically effective dose .” amounts effective for this use will depend on , for example , the particular nap or adnf polypeptide employed , the type of disease or disorder to be prevented , the manner of administration , the weight and general state of health of the patient , and the judgment of the prescribing physician . for example , an amount of polypeptide falling within the range of a 100 ng to 10 mg dose given intranasally once a day ( e . g ., in the evening ) would be a therapeutically effective amount . alternatively , dosages may be outside of this range , or on a different schedule . for example , dosages may range from 0 . 0001 mg / kg to 10 , 000 mg / kg , and will preferably be about 0 . 001 mg / kg , 0 . 1 mg / kg , 1 mg / kg , 5 mg / kg , 50 mg / kg or 500 mg / kg per dose . doses may be administered hourly , every 4 , 6 or 12 hours , with meals , daily , every 2 , 3 , 4 , 5 , 6 , or 7 days , weekly , every 2 , 3 , 4 weeks , monthly or every 2 , 3 or 4 months , or any combination thereof . the duration of dosing may be single ( acute ) dosing , or over the course of days , weeks , months , or years , depending on the condition to be treated . those skilled in the art can determine the suitable dosage , and may rely on preliminary data reported in gozes et al ., 2000 , gozes et al ., 2002 ), bassan et al . 1999 ; zemlyak et al ., regul . pept . 96 : 39 - 43 ( 2000 ); brenneman et al ., biochem . soc . trans . 28 : 452 - 455 ( 2000 ); erratum biochem soc . trans . 28 : 983 ; wilkemeyer et al . proc . natl . acad . sci . usa 100 : 8543 - 8548 ( 2003 )). intranasal administration of nap decreases anxiety - like behavior in aging mice in the elevated plus maze the present study was designed to evaluate the long - term behavioral outcome of chronic intranasal exposure to nap . nd - swiss male mice ( 8 months old ; harlan sprague dawley , inc ., indianapolis , ind .) were kept under a 12 : 12 hour light / dark regimen , with food and water available at all times . the mice were kept in the animal care facility of the tel aviv university in compliance with institutional and state guidelines . nap was custom synthesized by peninsula ( bachem , torrance , calif ., usa ) or peptide technologies ( bethesda , md ., usa ). the peptide was dissolved in a solution dd , in which each milliliter included 7 . 5 mg nacl , 1 . 7 mg citric acid monohydrate , 3 mg disodium phosphate dihydrate and 0 . 2 mg benzalkonium chloride solution ( 50 %). the peptide was administered intranasally every day , 5 days a week , 0 . 5 μg in 10 μl for each mouse , half the portion in each nostril . the control group received 10 μl of the inert carrier per day . the mice were treated at least 1 h prior to the daily experiment ( water maze ). the elevated plus maze was built in a ‘ plus ’ form with two open arms ( 68 × 7 . 5 × 1 cm ) and two closed arms ( 68 × 7 . 5 × 17 . 5 cm ) opposing each other . the center of the four arms included a middle square ( 7 . 5 × 7 . 5 cm ). the maze was elevated , at a height of 51 cm above ground level . each mouse was placed separately in the center of the maze , facing an open arm . each trial lasted 5 min . parameters measured included : ( 1 ) number of closed arms entries , an accepted index of motor function ; ( 2 ) total number of open arms entries ; ( 3 ) length of time spent in the open arms ; ( 4 ) length of time spent in the closed arms . an entry was counted only after the mouse entered the arm with all four paws . the percentage of open arm entries out of total arms entries and the percentage of time spent in the open arms , accepted measures of anxiety levels , were further calculated . mice were also subjected to two daily tests in a morris water maze ( diameter 90 cm ; depth , 20 cm ), as described in wo 01 / 092333 , incorporated herein by reference . latency to reach the hidden platform over a 90 second test period was recorded . the experiment was performed for 4 - 5 consecutive days . to measure motor functions , mice were placed on a platform for 30 seconds and then in the water facing the wall . the platform was then removed from the maze and the time spent by the mice in the pool &# 39 ; s quarter where the platform used to be was recorded ( for 90 seconds ). measurements were performed with the hvs video tracking system ( hvs image ltd ., hampton , uk ). the water maze was chosen as a test as current medication against anxiety often present a side effect of reduced cognitive functions . statistical tests used one - way analysis of variance with pairwise multiple comparison procedure ( student - newman - kuels method ). when only two groups were compared , the student t - test was used . when tested in the elevated plus maze , at 13 months age , after 5 months of chronic treatment with nap , the percentage of time spent in the open arms was significantly higher in the nap - treated mice ( fig1 a ). however , the mean percentage of open arm entries out of total arms entries , the number of closed arms entries and the total number of arms entries was similar in the control group and the nap - treated group ( fig1 b - 1 d ). when the same group of mice was re - tested 3 months later at the age of 16 months and after 8 months of chronic intranasal treatments , again measurements indicated a decreased level of anxiety . the decreased anxiety level in the nap - treated older mice was even more prominent than in the younger animals . similar to the results in 13 - month old mice , the percentage of time spent in the open arms by the 16 - month old animals was significantly higher in the nap - treated group as compared to the control group ( fig2 a ). however , in contrast to the younger mice that were treated with nap for 5 months , in the older mice , treated for 8 months , the percentage of open arm entries out of total arms entries was significantly higher in the nap treated mice ( fig2 b ). motor function indices including the number of closed arms entries and the total amount of arms entries were not significantly different between the two groups ( fig2 c and 2 d ). as anxiolytics tend to reduce learning and memory functions , long - term effects of nap exposure were assessed in a spatial memory test using the morris water maze paradigm . at the age of 15 months , and after 7 months of chronic intranasal nap treatment an apparent improvement ( measured over four testing days ) was observed in the nap - treated mice but not in the control mice , in the first daily trial , but not in the second daily trial ( fig3 , a , b respectively ). no significant differences were found when comparing the first to last daily trial in either group . yet , a comparison of a block of the first daily trial in the first and the second testing days vs . a block of the first daily trials in the third and fourth testing days showed that only the nap - treated mice were significantly faster in finding the platform in the last two days ( second block ) demonstrating learning ( p & lt ; 0 . 04 ). these experiments show a moderate improvement of spatial learning resulting from long - term exposure to intranasal nap . no differences in motor behavior were apparent in eight month or 16 - month - old mice measured as the time to reach the visible platform ( 24 + 7 . 6 ; nap and 24 + 6 . 8 ; control , eight - month - old mice ). furthermore , only a small effect was seen at 15 months in the probe test , with the nap - treated animals spending 25 . 8 + 3 . 4 sec / 90 sec in the area of the pool where the platform used to be vs . 21 . 96 + 2 . 9 in the sham - treated mice . in the elevated plus model , anxiety - like behavior is measured by the percentage of time spent in the open arms and the percentage of open arms entries . curiosity will lead mice to spend more time in the open arms which anxiety will probably make them stay in the closed , protected arms of the model . the number of closed arms entries is an accepted parameter of motor function . intranasal nap significantly increased the percentage of time spent in the open arms and longer exposure to nap also increased open arm entries , thus demonstrating reduced anxiety - like behavior in nap treated mice . furthermore , in spatial learning and memory tests , an effect was observed after long - term nap administration in aged mice , on the first daily test , indicative of reference memory . the present study was conducted to identify primary targets for nap for neuroprotection , and to identify nap binding proteins . cell cultures . rat pheochromocytoma cells ( pc12 ) were grown in dulbecco &# 39 ; s modified eagle &# 39 ; s medium ( dmem ) supplemented with 8 % fetal calf serum ( fcs ), 8 % horse donor serum , 2 mm glutamine , and 1 % penicillin streptomycin solution for 48 h . nih3t3 were grown in dmem supplemented with 10 % fetal calf serum ( fcs ), 2 mm l - glutamine , 0 . 1 mg / ml streptomycin , 100 units / ml penicillin . for the experiments , cells were harvested , resuspended and seeded in 96 well dishes at a concentration of 2 × 10 ( 4 ) cells / well . the cells were allowed to attach to the dish for 3 h and were then exposed to 300 um h 2 o 2 for 24 h . when neuroprotective activity was tested , the peptides were added while seeding . additional studies with nerve growth factor ( ngf , 0 . 1 ug / ml )- treated pc12 cells plated on collagen ( 100 ug / ml ) were conducted . in these experiments , nerve growth factor ( ngf ) was added at seeding . rat cerebral cortical cells from newborn pups were prepared as before ( bassan et al ., 1999 ). all procedures performed in these studies were conducted in accordance with the tel aviv university regulations and were approved by the animal care and use committee of tel aviv university . the use of animals was not excessive and no animal suffering occurred . in short , cerebral cortical tissue was incubated for 20 minutes at 37 ° c . in hanks &# 39 ; balanced salt solution + 15 mm hepes , ph 7 . 3 containing trypsin b ( biological industries , beit haemek , israel ). dissociated cerebral cortical cells were added to the culture dish with 5 % horse serum in dmem . cells were plated in a ratio of 1 cortex per two 75 cm 2 cell culture flasks ( polystyrene , corning , n . y .). the medium was changed 1 day after plating . for astrocyte cultures , cells were split after 10 incubation days and plated in 24 well plates ( each flask into 60 wells containing microscope cover glasses ( 12 mm diameter ) and 250 μl medium ). cells were then incubated two additional weeks . for mixed neuroglial cultures , dissociated cerebral cortical cells were plated on a bed of astrocytes 2 weeks after the split and incubated in neuron - specific medium as before ( bassan et al ., 1999 ; brenneman , & amp ; gozes , j . clin . invest . 97 : 2299 - 2307 ( 1996 ); based on forsythe & amp ; westbrook , j . physiol . 396 : 515 - 533 ( 1988 )). metabolic activity measurements . metabolic activity of viable cells in culture was measured by a calorimetric method using a tetrazolium compound [ 3 -( 4 , 5 - dimethylthiazol - 2 - yl - 5 -( 3 - carboxymethoxyphenyl )- 2 -( 4 - sulfophenyl )- 2h tetrazolium , mts ] and an electron - coupling reagent phenazine methasulfate ( pms ). mts is bio - reduced by the living cells to the formazan form that is detected at 490 nm ( promega , madison , wis .). affi - gel 10 nap affinity chromatography . a protein lysate was prepared from one - day - old rat brains in a buffer containing the following ingredients : 150 mm nacl , 1 mm edta , 50 mm tris - hcl , ph 4 . 5 , 0 . 1 % triton x - 100 , 1 % np40 and a protease inhibitor cocktail ( roche diagnostics , mannheim , germany ). dna was fragmented by sonication . cell debris was discarded following 30 minutes centrifugation at 30 , 000 × g . an affinity column containing nap was prepared using elongated nap ( kkkggnapvsipqc ( seq id no : 28 ) and affi - gel 10 in 0 . 2m nahco 3 / 0 . 5 m nacl , ph 7 . 5 . further column preparation was according to the manufacturer &# 39 ; s instructions ( amersham pharmacia biotech , ab , uppsala ). the brain extract prepared as above was loaded ( 2 mg / ml ) on the column at 20 ° c . and incubated for an hour ; the column was then washed with pbs until all unbound protein eluted as confirmed by protein assay ( bradford , biorad , mannheim ). nap - binding proteins were eluted in 0 . 1 m glycine ( ph 3 . 0 ); the eluted protein fractions were then adjusted to ph 7 . 5 with tris - hcl buffer . electrophoresis on a 12 % polyacrylamide sds - containing gel was performed as before ( zamostiano et al ., 2001 ). sulfolink coupling gel nap affinity chromatography . the second isolation efforts utilized a different affinity column , sulfolink coupling gel ( pierce , rockford , ill .). binding of ckkggnapvsipq ( seq id no : 29 ) was performed according to the manufacturer &# 39 ; s instruction . brain extract was prepared as above and binding was performed at 4 ° c . for 20 h , washing was as above and bound proteins were eluted by incubation in the presence of excess soluble nap ( napvsipq ) 2 mg / ml pbs ( 2 ml / 2 ml column ) at 4 ° c . for 20 hours . sequence analysis . to further identify nap binding protein ( s ) the polyacrylamide gel portion containing the affinity purified protein bands was subjected to in - gel proteolysis with trypsin and mass spectrometry analysis ( technion , israel institute of technology , smoler protein center , department of biology ). direct nap binding to proteins assessed by dot blot analysis . each protein ( tubulin or muscle actin ( sigma , rehovot , israel ), or non - muscle actin from human platelets ( cytoskeleton , denver , colo .) was applied on nitrocellulose membrane ( schleicher & amp ; schuell , dassel , germany ) at a concentration of 1 - 4 microgram / 1 microliter / spot and dried ( 45 min 20 ° c .). the membrane was incubated in a blocking solution ( 10 mm tris , 6 mm nacl , 0 . 05 % tween - 20 and 10 % lowfat milk ) for 16 h at 4 ° c . detection was with biotin - labeled nap ( gottlieb et al ., eur . j . biochem . 125 : 631 - 638 ( 1982 )) with excess amount of nap ( e . g ., 5 microgram ) added to tubulin ( e . g ., 1 microgram ) or actin being attached to the membrane support ). avidin - horse radish peroxidase conjugate and ecl +( western blotting detection system , amersham pharmacia biotech , buckinghamshire , uk ) was used for further identification of interacting molecules . confocal microscopy . synthetic nap or fluorescein - labeled nap ( fitc - nap ) was added to tissue culture cells ( ascending concentrations ) and incubated for 15 mins - 24 hours . after incubation , cells were extensively washed and fixed in 4 % paraformaldehyde . following fixation , triton x - 100 ( 0 . 2 % was added to allow antibody cellular penetration for mouse monoclonal tubulin antibodies ( tub 2 . 5 ; gozes & amp ; barnstable , proc . natl . acad . sci . usa 79 : 2579 - 2583 ( 1982 )) and rhodamin - labeled secondary goat antimouse igg ( jackson immunoresearch , west grove , pa .). for specific neuronal staining in primary neuronal cultures , mouse monoclonal tubulin antibodies tub2 . 1 ( gozes & amp ; barnstable , 1982 ) were used . further neuronal identification was obtained by staining with antibodies against neuron specific enolase as before ( brenneman & amp ; gozes , 1996 ). fluorescent cells were analyzed with a zeiss confocal laser scanning microscope . zeiss lsm 410 inverted ( oberkochen , germany ) is equipped with a 25 - milliwatt krypton - argon laser ( 488 and 568 nm maximum lines ). a 40 ×/ 1 . 2 w apochromat water - immersion lens ( axiovert 135m , zeiss ) was utilized for all imaging . microtubule assembly . a microtubule assembly kit cytodynamix screen 01 ( cds01 ) was obtained from cytoskeleton ( denver , colo .). bovine map - rich tubulin ( hts01 ) was resuspended in g - pem buffer ( 80 mm pipes ph 6 . 9 , 1 mm mgcl , 1 mm egta and 1 mm gtp ) and subjected to polymerization at 37 ° c . the reaction was performed in 96 - well plate . assembly was monitored with a spectrophotometer spectramax 190 ( molecular devices , sunnyvale , calif .) employing continuous recording at 350 nm . in this example , affinity chromatography of brain extracts identified tubulin , the brain major protein and subunit protein of the microtubules as a nap - binding ligand . microtubules have been shown before to be associated with the mechanism of anxiety - associated neurotransmission (( stangler et al ., 2002 ). in addition , nap binding to non - muscle actin was also detected , suggesting interaction with polymerizing proteins . tubulin and non - muscle actin nap binding was also confirmed by dot blot analysis . in a cell free system , nap stimulated tubulin assembly into microtubules . when added to cerebral cortical astrocytes , mixed neuroglial cultures or pheochromocytoma cells ( a neuronal - like model ), nap caused rapid microtubule re - organization into distinct microtubular structures . furthermore , treatment of astrocytes with zncl 2 that induces the formation of tubulin zinc sheets ( melki & amp ; carlier , biochemistry 32 ( 13 ): 3405 - 13 ( 1993 )) induced cell death as suggested before ( juarranz et al ., photochem photobiol . 73 ( 3 ): 283 - 9 ( 2001 ); haase et al ., biol . chem . 382 ( 8 ): 1227 - 34 ( 2001 ); lobner et al ., cell mol biol ( noisy - le - grand ) 46 ( 4 ): 797 - 806 ( 2000 )). co - treatment with nap inhibited the zn - associated death . these functional results support the role of nap as a microtubule stabilizing agent by direct association with tubulin . as depression may be associated with cell death ( eilat et al ., j immunol . 163 ( 1 ): 533 - 4 ( 1999 )) the neuroprotective properties of nap , through interaction with key cytoskeletal elements is suggested to protect against anxiety . nap structure is a random coil and it may require a conformational epitope on tubulin for it &# 39 ; s catalytic - like activity enucleating tubulin polymerization . regardless , the tubulin interaction site for nap offers a target platform for drug discovery against anxiety - like conditions . nap specificity : in order to test for nap specificity and establish the identity of cell systems relevant for nap activity tests , a number of cell lines were screened . the rat pheochromocytoma ( pc12 ) cell line ( a neuronal - like cell system ) responded to nap neuroprotection against the effects of oxidative stress ( see also steingart et al . j . mol . neurosci . 15 : 137 - 145 ( 2000 )). cells that did not respond to nap included african green monkey kidney cell ( cos - 7 ), adenocarcinoma cells from human breast ( mcf - 7 ) and human colon ( ht - 29 ), human fibroblasts ( bj ) as well as mouse fibroblasts ( nih3t3 ). no cell proliferation effect was seen on any of the above tested cell lines ( gozes et al ., j mol neurosci . 20 ( 3 ): 315 - 22 ( 2003 )). these results imply specificity for nap &# 39 ; s activity and suggest a nap binding protein of neuronal lineage origin . isolation of nap binding proteins by affinity chromatography : based on the previous results , brain homogenates were chosen as a putative enriched source for nap interacting molecules . extracts were subjected to affinity chromatography comprising nap bound to either affi - gel 10 or sulfolink coupling gel , two different solid supports . elution of the nap interacting molecules was obtained by either reducing the ph or by competing the binding to the insoluble nap with excess free soluble nap . electrophoresis on a 12 % polyacrylamide sds - containing gel revealed a purified protein band at about 50 , 000 dalton and an additional protein at about 42 , 000 dalton . tubulin and actin are nap binding proteins : when the gel portions containing the purified protein bands were submitted to in gel proteolysis with trypsin followed by mass spectrometry analysis , the ˜ 50 , 000 dalton nap - binding protein was identified as rat alpha tubulin ( molecular mass 50 , 242 ); gi223556 ; the second band identified was beta actin , mass 41 , 737 , gi450885 . the identification of tubulin included the characterization of 6 different tryptic peptides . a dot blot assay on a cellulose nitrate filter was performed with spotted muscle and non - muscle actin and tubulin ( 1 microgram protein / microliter / spot ). results indicated binding to brain tubulin and to non - muscle actin , while no interaction with muscle actin was detected . nap interaction with tubulin / microtubules : confocal microscopy . to further establish an association between tubulin and nap in the living cell , confocal microscopy analysis of fluorescent nap and immunodetection of tubulin was performed . as a first experiment , pc12 cells and nih3t3 cells 2 h after exposure to nap were analyzed . tubulin is a heterodimer composed of two related but non - identical , ˜ 55 - kda subunits , α - and β - tubulin that exhibit microheterogeneity ( gozes & amp ; littauer , nature 276 ( 5686 ): 411 - 3 ( 1978 ); gozes & amp ; sweadner , nature 294 ( 5840 ): 477 - 80 ( 1981 )). to visualize the microtubule structure , monoclonal beta tubulin antibodies ( tub2 . 5 ; gozes & amp ; barnstable , proc . natl . acad . sci . usa 79 : 2579 - 2583 ( 1982 )) were used . results have shown that in pc12 cells , the microtubules seemed to assume a more definitive structure after nap application . in contrast , in cells not responsive to nap , such as nih3t3 cells , no apparent change in the microtubule organization was observed . to study microtubule rearrangement in differentiated neuronal - like pc12 , cells were exposed to nerve growth factor ( ngf ). results indicated robust microtubule rearrangement ( 100 % of the cells ) in these differentiated pc12 cells as well . two additional cell populations were tested : astrocytes as well as mixed astrocytes and neurons from newborn rat cerebral cortex . either fluoresceine - labeled nap ( fitc - nap ) or native nap was added to two - week - old astrocyte cultures and to one - week - old neuronal cultures originally plated on a bed of astrocytes . astrocytes were used as a model , since previous results have indicated that while nanomolar concentrations of nap protected neuronal - enriched cultures against beta amyloid toxicity ( zemlyak et al ., 2000 ); a more potent protection at femtomolar concentrations of nap was observed when neurons were plated on a bed of astrocytes ( bassan et al ., 1999 ). in astrocytes , like in the pc12 cells , an effect of microtubule re - organization was observed . a time course experiment suggested that the microtubule re - organization effect was occurring 2 h after nap application , with the microtubules undergoing an additional condensation 4 h after nap application and returning to the original morphology 24 h after nap application . mitotic spindles were not apparent . similar microtubule re - organizations were observed with nap at concentrations ranging from 10 − 15 m - 10 − 10 m with fluoresceine - labeled and with native nap . evaluation of the number of cells undergoing microtubule re - organization following nap treatment showed maximal organization at 2 - 4 h with a decline at 24 h . a control peptide , c2 ( vlgggsall ) ( seq id no : 30 ) that does not protect neurons in vitro did not induce a microtubule - associated morphological change . detection of fluoresceine labeled nap inside cells : nap can internalize cells and exhibit structural similarity to proteins / peptides used to permeate membranes : after a 2 h incubation period at 37 ° c ., fluoresceine - labeled nap was detected inside the cell . a critical question is whether nap induces microtubule re - organization through interaction with a surface receptor , or is a pore - forming peptide that interacts with the lipid bilayer and is then internalized into cells . to evaluate potential surface labeling , initial incubation was carried out at 4 ° c . and in a parallel experiment at ph 3 . 0 . when nap ( 10 − 15 m ) was incubated with astrocytes at ph 3 . 0 for 15 minutes , microtubule reorganization was apparent and fluoresceine labeled nap was visualized inside the cells . at 4 ° c ., while microtubule reorganization did not take place , as microtubules undergo disassembly at 4 ° c ., a dose - dependent intracellular accumulation of nap was apparent . nap structural analysis suggest similarities to peptides / proteins that transverse the cellular membrane , such as the vp22 translocation domain from hsv and signal peptides such as the kaposi fibroblast growth factor ( k - fgf ) region . bacterial toxins such as the c . perfringens iota toxin , diphtheria toxin , pseudomonas exotoxin a , pertussis toxin , and b . anthracis toxin can deliver translocate peptide through the cell membrane . — do we need references here ? changes in neuronal morphology toward a differentiated neuronal structures ( neurotrophism ): previous results indicated that nap protects neurons ( e . g ., bassan et al ., 1999 ). in the assay system of mixed cerebral cortical cells from newborn rat brains , the effect of nap on the microtubule system was tested . results , using confocal microscopy as above , identified fluorescent nap in the neurons . these studies were extended to determine the degree of microtubule re - organization in the neurons using the tubulin monoclonal antibody tbu2 . 1 that shows preferential binding to neuronal tubulin ( gozes & amp ; barnstable , 1982 ) as verified by staining with antibodies directed against neuron - specific enolase . here , results showed extensive microtubule re - organization in the nap - treated neurons . further quantitations indicated that of 145 neurons counted in the control ( untreated neurons ) only 4 neurons exhibited a similar microtubule arrangement to that seen 2 h after 10 − 15 m nap treatment . after nap treatment , out of 213 cells counted , 208 exhibited the nap - related re - rearrangement , suggesting an effect on ˜ 97 % of the treated neurons . statistical analysis of the changes in neuronal morphology ( number of processes per cell ) indicated that in untreated neurons the number was 2 . 56 +/− 0 . 14 / cell ( mean +/− sem , in 62 neurons ). in nap - treated neurons the number of processes was 6 . 47 +/− 0 . 3 ( mean =+/− sem , in 64 neurons , as also found in nap 2 h - neurites ). the difference was significant ( p & lt ; 0 . 001 , student &# 39 ; s t - test ). nap promotes tubulin assembly : using a high through - put analysis kit containing bovine tubulin ( cytoskeleton , inc . ), tubulin assembly was determined in the presence of increasing nap concentrations . measurements included absorbance determinations at 350 nm . while 10 − 18 m nap did not influence microtubule assembly in the test tube , 10 − 15 m nap stimulated microtubule assembly in a similar way to paclitaxel . paclitaxel and taxol - like compounds have been suggested as possible neuroprotective agents , however , brain penetration issues and toxic side effects may exist ( rice et al ., j mol neurosci . 20 ( 3 ): 339 - 43 ( 2003 )). in contrast , nap toxicology studies to - date indicate no adverse side effects ( gozes et al ., 2000 ; gozes et al ., 2003 ). further studies also indicate nap brain penetration ( gozes et al ., 2000 ) following intranasal administration using either radiolabeled nap ( gozes et al ., 2000 ) or mass spectrometry validated assays . nap at 10 − 10 m promoted tubulin assembly t the same degree as at a concentration of 10 − 15 m . at higher concentrations of 10 − 8 m nap , no significant stimulation was observed over the 40 minutes assembly period at 37 ° c ., paralleling the dose dependent survival - promoting response curve . paclitaxel was used as a positive control and c2 a peptide that was utilized as a negative control in the cellular assay did not affect microtubule assembly as well . tubulin as a discovery platform for neuroprotective and anxiolytic drug discovery : results demonstrated that nap cellular protection is specific and is paralleled by microtubule re - organization in glial cells and in differentiated neurons . a potential mechanism of action involves internalization into cells without a classical peptide receptor , followed by direct binding to tubulin and acceleration of microtubule formation . because nap activity is selective for cells of neuronal origin ( pc12 ) not fibroblasts ( nih3t3 ) as well as to astrocytes , it suggests tubulin / microtubule microheterogeneity in these cells that is specific for nap &# 39 ; s activity ( gozes et al ., 1978 and 1981 ). microheterogeneity may result from expression of different tubulin isotypes in different cells , or it may result from post - translational modifications , or both . the nap doses required for tubulin polymerization concurred with the doses required for cellular protection against oxidative stress . nap and related peptide protection against anxiety , depression , and other anxiety disorders and mood disorders may be direct through interaction with the microtubular network or indirect through glial and neuroprotection . the examples set out above are intended to be exemplary of the effects of the invention , and are not intended to limit the embodiments or scope of the invention contemplated by the claims set out below . other variants of the invention will be readily apparent to one of ordinary skill in the art and are encompassed by the appended claims . all publications , databases , genbank sequences , go terms , patents , and patent applications cited herein are hereby incorporated by reference . this application is related to pct wo 1 / 92333 ; u . s . ser . no . 07 / 871 , 973 filed apr . 22 , 1992 , now u . s . pat . no . 5 , 767 , 240 ; u . s . ser . no . 08 / 342 , 297 , filed oct . 17 , 1994 ( published as wo96 / 11948 ), now u . s . pat . no . 6 , 174 , 862 ; u . s . ser . no . 60 / 037 , 404 , filed feb . 7 , 1997 ( published as wo98 / 35042 ); u . s . ser . no . 09 / 187 , 330 , filed nov . 11 , 1998 ( published as wo00 / 27875 ); u . s . ser . no . 09 / 267 , 511 , filed mar . 12 , 1999 ( published as wo00 / 53217 ); u . s . pat . no . 6 , 613 , 740 , u . s . ser . no . 60 / 149 , 956 , filed aug . 18 , 1999 ( published as wo01 / 12654 ); u . s . ser . no . 60 / 208 , 944 , filed may 31 , 2000 ; and u . s . ser . no . 60 / 267 , 805 , filed feb . 8 , 2001 ; herein each incorporated by reference in their entirety .
this invention relates to the use of adnf polypeptides in the treatment of anxiety and / or depression . the present invention also relates to drug discovery assays using the adnf polypeptide mechanism of action and target interaction , as well as the manufacture of medicaments , methods of application and formulation therefor . embodiments of the invention provide methods for preventing and / or treating anxiety and depression disorders in a subject by administering a nap , an 8 - amino - acid peptide derived from activity dependent neurotrophic factor , in an amount sufficient to improve postnatal performance . the adnf polypeptides include adnf i and adnf iii polypeptides , analogs , subsequences , and d - amino acid versions , and combinations thereof which contain their respective active core sites and provide neuroprotective and anti - anxiety functions .
referring first to fig1 - 2 and 6 - 7 , there is shown a vaporizer 10 which includes a cover 12 having a air grill 13 , a ptc heater 14 , an impregnated mat 16 , and a housing bottom 18 . as will be apparent from fig3 , ptc heater 14 includes a first housing part 20 , a second housing part 22 , a first electrical contact 24 , a ptc pill form heating element 26 , a second electrical contact 28 , and most importantly spring 30 . the first housing part 20 supports the first electrical contact 24 , which abuts a second side 25 of the ptc heating element 26 . the second electrical contact 28 abuts a side 27 of the ptc heating element 26 opposite the side abutting the first electrical contact 24 . as shown in fig3 and 4 , the first housing part 20 and second housing part 22 form a clamshell type housing to define a cavity 33 there between . first housing part 20 has support pegs 32 integrally formed therewith and extending into the cavity 33 . these pass the first electrical contact 24 by virtue of cut outs 37 . the ends of the spring 30 can be pinned or otherwise fastened to the support pegs 32 spanning the distance between them . the second housing part 22 also has pegs 34 protruding inwards towards the first housing part 20 . these pegs 34 help fix the first electrical contact 24 in place when the housing is closed . the first electrical contact 24 preferably comprises a flat heat diffuser plate section 36 linked by a right angle bend to an elongated leg 38 . the leg 38 forms one terminal of a linkage to the power supply , and thus after assembly extends outside the housing . there are also apertures 40 for receiving additional pegs 32 from the first housing part 20 . the ptc heating element 26 includes a first side 27 and a second side 25 . while heating element 26 is shown in a “ pill ” form , other conventional ptc element shapes could also be used . further , heating element 26 can have metallization on either or both sides ( not shown ). the second electrical contact 28 preferably comprises a u - shaped plate 50 including an elongated leg 52 extending away from the plate 50 at a right angle . elongated leg 52 forms the second terminal of a linkage to the power supply and ultimately remains extending outside the housing . there is also a curved dome having a contact portion 56 . the dome can have a convex side 62 . a spring 30 is in the form of a stainless steel strip having apertures 68 , 70 in opposing ends 72 , 74 . the apertures 68 , 70 receive the tapered ends 39 of pegs 32 in wedging fashion , to thereby suspend the spring 30 over and against second electrical contact 28 . the middle suspended portion 76 of the spring 30 is convex in shape ( i . e ., bulges outwardly , away from the second electrical contact 28 ). while stainless steel is an optimal metal for the spring in this environment , it is not optimal for the second electrical contact 28 . for that we prefer a metal such as aluminum . referring most specifically to fig5 , alternate spring embodiments 30 a and 30 b of the spring 30 are shown . for spring 30 a two of the spring 30 elements are attached to each other face - to - face to create a convex bulge 86 and a concave bulge 88 . in spring 30 b the middle portion of a single spring 30 is split lengthwise , leaving three thinner strips 80 , 82 and 84 . strips 80 and 82 are convex ( curving away from the second electrical contact 28 ), while the middle strip 84 is concave in shape ( curving toward the second electrical contact ). the convex portion 76 of the spring 30 presses against the interior side of the second housing part 22 when the housing is assembled , somewhat compressing the convex portion of the spring . the convex portion 76 is sufficiently compressed that , when the housing expands in response to the heating of the heating element 26 , the convex portion rebounds to cause the spring 30 to remain in contact with the second housing part 22 and to continue to apply pressure against the second electrical contact 28 . the convex portions 80 and 82 of alternative embodiment spring 30 b and 86 of alternative embodiment spring 30 b function in that same way . thus , regardless of the spring embodiment 30 , 30 a , 30 b used , the spring helps maintain a positive pressure contact between the second electrical contact 28 and the ptc heating element 26 , and thus indirectly between the first electrical contact 24 and the ptc heating element , even during thermal expansion of the housing . in fact , because the spring 30 receives heat directly from the heating element 26 by conduction through the second electrical contact 28 , the spring tends to expand to an extent proportionally greater than the expansion of the housing , which tends to urge the convex portion of the spring even more securely against the housing . the combination of convex and concave portions of alternative spring embodiments 30 a and 30 b allows those curved parts to be compressed so as to achieve the same overall displacement as is achieved by compression of the convex portion of spring 30 but with less distortion of each individual curved part . note also that because the parts are held close together , heat can readily transfer from the pill form heating element 26 to the heat diffusing plate portion of the first electrical contact 24 . thus , the process of transferring heat to an outer surface 92 of the ptc heater remains efficient even during thermal expansion . note that the thermal expansion problem occurs even if preferred plastics are used for the outer housing . as seen in fig6 and 7 , the heater 14 is , after final assembly enclosed by protective cover 12 and housing bottom 18 of the vaporizer 10 . the mat 16 fits between that cover and outer surface 92 . while the present invention has been described with reference to a particular embodiment , various other embodiments are possible as well . for example , it is not essential that the heater be in pill form , or even be a ptc heater . thus , the claims should be looked to in order to judge the full scope of the invention . the present invention provides a heating device with an improved spring / electrical contact assembly to adjust for heat expansion .
an electrical heating device is disclosed that is suitable to vaporize air treatment chemicals from an impregnated substrate . the device is provided with a pct heater held between electrical contacts and a spring that is compressed between the housing of the heating device and one of the electrical contacts to maintain pressure thereon in spite of thermal expansion of the housing , ensuring good electrical contact between the pct heater and the electrical contacts .
the entire device is referred to generally by the reference numeral 10 . a golf ball is referred to generally by the reference numeral 12 . a golf tee is referred to generally by the reference numeral 14 , having a head 16 , and a shank 18 . a golf club grip is referred to generally by the reference numeral 20 . the perferred embodiment of the present invention is illustrated in fig1 . the invention comprises a housing 22 , which includes an upper portion 24 , and a lower portion 26 . the upper portion 24 includes a top wall 28 , a rear wall 30 , left vertical side wall 32 , and a right vertical side wall 34 . side walls 32 and 34 incorporate a recessed portion 36 and 38 respectively to facilitate easy removal of the device 10 from the teed golf ball 12 . the lower end of the rear wall 30 contains an opening 40 that extends between the two side walls 32 and 34 . the opening 40 has a height that will permit passage of the golf tee shank 18 but will not allow passage of the golf tee head 16 and is used to facilitate the retrieval of the golf tee 14 lying horizontally on the ground . the lower portion 26 of the housing 22 includes a bottom wall 42 which contains a slot 44 that extends inward from the edge of the bottom wall 42 . the slot 44 terminates with a rounded end 46 . the entire wall of the slot 44 is angled such that the slot is larger on the top surface of the bottom wall 42 than the bottom surface of the bottom wall 42 . the edges of the housing 22 are typically chamfered or rounded to avoid snagging or personal injury . attached to the lower surface of the top wall 28 is a delayed urging means 48 which exhibits a delayed rebound after being compressed . examples of such delayed urging means 48 are the isodamp ® c - 3000 series of energy absorbing foams manufactured by e - a - r division , cabot corporation , indianapolis , ind . these foams rebound very slowly after being compressed . in the preferred embodiment , a cylindrical piece of e - a - r c - 3002 - 50 low - recovery foam is used . however , means other than low - recovery foam could be used to provide a delayed urging function . the delayed urging means 48 is typically fastened to the top wall 28 by means of an adhesive . the placement of the delayed urging means 48 on the underside of the top wall 28 is such that it will be directly over the golf ball 12 when placed in the housing 22 . attached to the bottom of the delayed urging means 48 is a rigid ball interface member 50 used to provide a uniform surface to contact the golf ball 12 . in the preferred embodiment , this member is a ring shaped object with an outer diameter equal to the delayed urging means 48 diameter and an inner diameter sufficiently large enough to provide engagement of the golf ball 12 . however interface members of other shapes would equally suffice . the interface member 50 is typically attached to the delayed urging means 48 by means of an adhesive . fig3 shows a better view of the interface member 50 . the housing 22 height , interface member 50 size , slot 44 dimensions , and delayed urging means 48 size all affect the performance of the device 10 . this combination of dimensions must be such that when the golf ball 12 is placed in the housing 22 below the interface member 50 and the golf tee 14 is slid into the slot underneath the ball 12 , the delayed urging means 48 is slightly compressed exerting enough of a downward force to securely hold the ball 12 and tee 14 into the device 10 . additionally , these dimensions must be such that the delayed urging means 48 sufficiently further compresses due to the upward force on the tee 14 when the device 10 is used to insert the tee 14 into the ground . in the preferred embodiment , the interior height of housing 22 is 2 . 24 inches , slot 44 is 0 . 36 inches wide with angled walls at 21 °, the interface member height is 0 . 12 inches with an inner diameter of 0 . 64 inches , and the delayed urging means 48 has a diameter of 0 . 75 inches and a height of 0 . 50 inches in its uncompressed state . these dimensions describe one possible embodiment of the invention . other combinations of dimension values could also be used to achieve successful operation of the device 10 . extending from the upper side of the top wall 28 is the portion used to attach the device 10 to a golf club grip 20 as shown in fig4 . from the top wall 28 , an annular wall 52 extends upward vertically and then flares outward becoming a taper 54 . the annular wall 52 provides clearance for the end of the golf club grip 20 which is often convex in shape . the taper 54 ensures that the device 10 is aligned with the axis of the golf club by centering the end of the golf club grip 20 . the diameters at the bottom and top of the taper 54 are sized to accommodate the full range of golf club grip 20 diameters available in the market place . above the taper 54 the wall angles inward forming a plurality of individual gripping fingers 56 capable of flexing outward . in the preferred embodiment four gripping fingers 56 are used ; however , any number greater or equal to two would work . fig1 shows how the gripping fingers 56 are separated from each other by voids 58 . the voids 58 incorporate rounded bottoms 60 to reduce stress concentrations in the flexing material . the gripping fingers 56 are of sufficient height to prevent the device 10 from becoming skewed with respect to the axis of the golf club . fig4 shows how the gripping fingers 56 incorporate outward flares 62 at the top to provide easy insertion of the golf club grip 20 . the very top of the gripping fingers 56 incorporate chamfered edges 64 to also aid in the insertion of the golf club grip 20 . fig1 shows a series of supporting ribs 66 used to provide strength to the annular wall 52 and to the taper 54 below the gripping fingers 56 . these ribs 66 ensure that the stress created in the material during insertion of a golf club grip 20 will not cause a fracture in the material . fig2 shows a clip 68 extending from the rear of the housing 22 just above the opening 40 . the clip 68 is shaped with a large enough radius 70 to permit the device 10 to be clipped to the side of a typical golf bag . the clip 68 incorporates an inward bend 72 towards the housing 22 permitting the device 10 to be securely clipped to the pocket of a golfer &# 39 ; s clothing . an outward bend 74 at the top of the clip 68 allows the device 10 to be easily clipped to a golf bag , pocket , or belt . in the preferred embodiment the entire device 10 , except delayed urging means 48 , is molded from an economical , flexible plastic material such as abs . however , the device 10 can consist of any other material that exhibits the elasticity and impact resistance characteristics suitable for the application . from the description above , a number of advantages of the present invention become evident : ( a ) the device automatically unclamps the ball and tee once the tee is pushed into the ground since the delayed urging means becomes further compressed and will not immediately rebound . ( b ) the golfer can use a golf club as the device handle since no handle mounted unclamping control is needed . ( c ) the device makes it possible to tee up a golf ball from a standing position without the cumbersome use of relatively very large prior mechanisms . ( d ) the device allows a golfer to tee up golf balls without bending over by only carrying a small , lightweight device during a golf outing . ( e ) the device can be used to retrieve golf tees from the ground even if they are in a horizontal orientation . in use , the golfer removes the desired golf club from the golf bag and then unclips the device 10 from the golf bag , a pocket , a belt , or wherever the device 10 is stored . the device 10 is then attached to the golf club by pushing the gripping fingers 56 fully onto the end of the golf club grip 20 until the end of grip 20 comes in contact with the taper 54 . a golf ball 12 is then placed in the housing 22 below the ball interface member 50 . a golf tee 14 is then slid into slot 44 causing the ball 12 to push against the interface member 50 somewhat compressing the delayed urging means 48 . the delayed urging means 48 exerts a downward force on the ball 12 clamping the ball 12 and tee 14 securely to the device 10 as shown in fig5 a the golf club is then held by the golfer at the club head end with the grip end towards the ground . the golf club is positioned in a vertical orientation with the shaft of the golf club perpendicular to the ground . the golfer holds the golf club at a height such that the tip of the golf tee 14 is a short distance above the ground as also shown in fig5 a . the golfer then moves the golf club straight down sinking the golf tee 14 into the ground . as the tee 14 enters the ground it exerts an upward force on the ball 12 causing the delayed urging means 48 to substantially compress . as this happens , the device 10 lowers with respect to the ball 12 and tee 14 such that the slot 44 is no longer in full contact with the underside of the tee head 16 as shown in fig5 b . once the golf tee 14 has been sunk to the desired depth into the ground , the golfer releases the ball 12 and tee 14 from the device 10 by slightly moving the golf club straight up until the interface member 50 no longer is in contact with the ball as shown in fig5 c . the delayed urging means 48 remains compressed for a period of several seconds allowing the device 10 to be laterally removed from the teed ball 12 by moving the golf club in a motion parallel to the ground . after teeing up the ball 12 , the golfer then pulls the device 10 off the end of the golf club and uses clip 68 to temporarily fasten the device 10 to a pocket or belt while the ball 12 is hit . the device 10 can then be reinstalled on the golf club grip 20 to be used to retrieve the golf tee 14 without bending over . for instances when the tee 14 remains in the ground while hitting the ball 12 , the golfer uses the golf club as a long handle and maneuvers slot 44 of the device 10 under the head 16 of the tee 14 . the tee 14 can then be pulled out of the ground and retrieved without bending . for instances when the tee 14 comes out of the ground while hitting the ball 12 and is lying horizontally on the ground , the golfer again uses the golf club as a long handle and retrieves the tee 14 using the device 10 . this is accomplished by maneuvering the bottom wall 42 of housing 22 underneath the shank 18 of the tee such that the tip of the tee 14 protrudes through opening 40 of the housing 22 . the opening 40 will not permit passage of the tee head 16 allowing the tee 14 to be scooped up without bending . accordingly , this invention allows a golfer to easily tee up a golf ball without bending over . in addition , the invention permits a golfer to easily retrieve a golf tee without bending over whether or not the tee came out of the ground while hitting the ball . furthermore , the teeing device has the additional advantages in that it permits a golf club to be utilized as the handle reducing the weight and size of the device ; it is very simple to use with no cumbersome controls to release the tee and ball ; it can easily and nonintrusively be clipped onto a golfer &# 39 ; s apparel while hitting the ball ; it can be made from far fewer parts than prior tee setting devices . although the description above contains many specifics , these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention . for example , a means other than low - recovery foam could be used to provide a delayed urging means . furthermore , the dimensions given of the housing , interface member , low - recovery material , and slot could be different , the ball interface member could be eliminated ; the gripping fingers could be of a different shape , the clip could be shaped differently , the supporting ribs could be eliminated , etc . thus the scope of the invention should be determined by the appended claims and their legal equivalents , rather than by the examples given .
a small , lightweight golf ball teeing device is disclosed for allowing a golfer to tee up a golf ball without bending over using a golf club as a handle for the device . a housing positions the golf ball over the golf tee . a delayed urging means is used to clamp the ball and tee to the housing . while the tee is inserted into the ground , the delayed urging means compresses and rebounds slowly releasing the ball and tee from the device . gripping fingers are positioned on top of the housing to provide a secure , aligned attachment to a golf club grip . an opening in the housing permits horizontal golf tees to be scooped up without bending . a clip is incorporated with the housing to provide attachment to golf bags , belts , etc .
hospital beds typically include a deck supporting a mattress or other patient support element ( not shown in the figs .). the deck may be divided into articulated sections so as to create various seating and lying down configurations . articulated beds with a controllable articulation system for the patient support surface are known and are not a novel and inventive part of embodiments of the subject disclosure so will not be described in detail . an example of such an articulated patient support surface is shown in ep 2 181 685 and wo 2004 / 021952 to which reference should now be made and whose contents are hereby expressly incorporated herein by reference . referring to fig1 to 3 , a hospital bed support assembly according to one embodiment of the present disclosure includes a deck support frame 3 to which a headboard and a footboard may be mounted at , respectively , its head 4 and foot 5 ends . the head board is mountable on head board plates 33 and the foot board on foot board plates 34 . the deck support frame has two leg or support structures 6 pivotally mounted to its under surface . each of the leg structures or assemblies 6 includes a pair of legs 7 each coupled to the deck support frame 3 by a moveable upper pivot or guide element 8 at their deck or upper end 9 . the moveable upper guide elements can move parallel to the longitudinal axis of the deck frame . for example , the moveable upper guide element 8 of the left - hand leg in fig2 and 3 can move in the directions shown by arrows d1 and d2 . the lower portions of the legs 7 of each pair of legs are connected together by a lower bracing cross - element 10 at the bottom 12 of the legs . the lower cross - elements 10 are each in turn connected to a lower longitudinal or side element and able to rotate about their longitudinal axis . in the embodiment shown in fig1 to 3 , each end of the foot end leg assembly lower cross - element is pivotally connected to a lower portion of a respective length extension element and the upper portion of each length extension element is pivotally connected to the lower longitudinal side element . the foot and head ends of the lower side elements 35 each have a castor or castor device 14 so that the support assembly can move over a floor or surface on which it is placed . a pair of stabilizer elements 16 is connected to each pair of legs . a stabilizer element is connected to and links each leg to the underside of the deck support frame . the stabilizer elements 16 , which are each coupled to a leg 7 , are pivotally connected at their first upper ends 17 to the underside of the deck support frame 3 . the upper ends 17 of each stabilizer are connected to a fixed upper pivot 18 displaced from the leg upper moveable pivot 8 of the respective leg , and are pivotally connected at their second lower ends 19 to the respective pair of legs at a pair of respective lower stabilizer pivots 20 . a stabilizer cross - element 37 is pivotally connected between the pair of stabilizers 16 for each leg assembly . the respective stabilizer cross - element is connected to each respective stabilizer at a point 36 between its upper 17 and lower 19 ends . an actuator - stabilizer yoke 21 is connected to each stabilizer cross - element at a point substantially mid - way along the stabilizer cross - element so that it is in the middle of the bed . the actuator - stabilizer yoke 21 is pivotally coupled to an end of an actuator 22 ( which may be a hydraulic actuator , or a linear actuator such as model no la27 actuators supplied by linak u . s . inc . located at 2200 stanley gault parkway , louisville ky . 40223 ) which controllably extends and retracts an actuator rod 23 connected to the actuator - stabilizer yoke 21 . extension and retraction of the actuator rod 23 causes the respective stabilizer cross - element 37 and hence the pair of stabilizers 16 connected to that stabilizer cross - element 37 to move and thence the pair of legs 7 connected to that stabilizer 16 to rotate relative to the deck support frame 3 and thence raises or lowers the deck support frame 3 and the patient support surface arranged on that deck support frame . the actuators 22 may be controlled by either the patient or a care - giver . control mechanisms for such actuators are well known and may be either a foot operated pedal , control panel on the side of the bed , remote control or other control mechanism . suitable actuators are well known and are therefore not described in detail in this application . they may be hydraulic , electric or pneumatic . an example of hydraulic actuators controlling the height of a deck is described in ep 2 181 685 and wo 2004 / 021952 . referring to fig1 , the deck support frame 3 is formed by three sides of a rectangle and comprises parallel side elements 24 connected at their head ends by a head frame element 25 . in the described embodiment there is no foot frame element closing the rectangle other than the foot board ( not shown ) when that is attached to the foot board plates 34 ( not shown ) but one could be provided if appropriate . one of the known patient support deck arrangements such as that described in ep 2 181 685 and wo 2004 / 021952 may be secured to the patient support frame . as shown in , for example , fig4 , the side rail elements each comprise a hollow channel element open , along at least a portion of its length , on its lower side 27 . the channel element is a modified inverted u - shaped channel in which a portion of the bottom edges 28 are lipped such that the sides of the channel extend partially across the bottom of the inverted u - shaped channel . the upper end of each leg is connected to two rollers 29 . the rollers 29 are supported on axles 30 running through the leg 7 and can rotate relative to the leg 7 . the upper end 31 of each leg passes through the gap or space 32 in the bottom of the channel elements 24 defining the sides of the deck support frame . the rollers 29 each engage the inner surface of the channel element . referring to fig2 and 3 , when the actuators 22 extend their respective rods 23 together to move the deck support frame 3 from a lowered position ( see fig3 ) to a raised position ( see fig2 ), the stabilizer element moves in direction e and pivots about its upper pivot . at the same time , the leg element pivots in direction f with its respective guide element moving in direction d1 . as the guide element moves in direction d1 while the deck support surface is being raised , the respective set of rollers 29 roll relative to the respective channel element 24 . when the actuators 22 retract their respective rods 23 together to move the deck support surface from a raised position ( fig2 ) to a lowered position ( fig3 ), the stabilizer element moves in direction g and pivots about its upper pivot . at the same time , the leg element pivots in direction h with its respective guide element moving in direction d2 . as the guide element moves in direction d2 while the deck support surface is being raised , the rollers roll relative to the channel element . movement of the legs 7 and associated rollers 29 brought about by extension of the actuator rod to raise the deck support frame , pushes the rollers against the inner surface of the top of the respective channel element 24 so the roller rolls against that inner top surface of the channel . when the deck support frame is lowered by retraction of the actuator rod , the weight of the deck support frame and the patient support surface and patient supported thereon presses the inner top surface of the channel 24 against the respective rollers so that again the rollers roll along that top inner surface . the channel 24 is provided along a substantial part of its length with a lip portion 28 welded or otherwise attached to each of the bottom edges of the two sides of the channel element . this helps hold the rollers in place and , if the patient support deck is lifted manually or otherwise than using the actuators , pushes up against the bottom of the rollers such that they roll against the lipped bottom edges 28 . moving the deck support frame into the trendelenburg position or reverse trendelenburg position is not illustrated in the figs . however , it is achieved by having one of the leg assemblies in the raised position and the other in the lowered position and is otherwise the same as for lowering or raising the whole height of a substantially horizontal deck support frame . for the trendelenburg position the foot end is raised to be about 15 - 30 degrees above the head end , whereas in the reverse trendelenburg the head end is raised to be above the foot end . in a one embodiment of the patient support apparatus according to the present disclosure , at least one of the castors and / or castor devices at each of the foot and head ends of the apparatus are provided with a brake assembly with a brake lever as described in , for example , u . s . pat . no . 7 , 703 , 157 and arranged to be contacted and pressed down by the lower surface of the channel element to lock or brake the respective castor or castor device when the respective portion of the deck support frame is lowered . each of the castors includes a braking mechanism . fig5 to 7 show how a braking mechanism of the type used in castors of the type supplied by tente as parts reference 5944 usc125 r36 may be incorporated in an embodiment according to the present disclosure . in such castors , the castor wheels 38 are braked when a pliable braking element 39 is squeezed down by a braking surface 40 so that the sides of the braking element contact and push against the sides of the castor wheels . an alternative braking element is shown in u . s . pat . no . 7 , 703 , 157 in which braking is by means of a floor engaging element which is pushed into contact with the floor when the braking surface is ousted downwards . any castor with an actuator mechanism operable by being pressed down or contacted may be used . the braking surface 40 at the foot ends of the bed is pushed downward by the action of a braking lever 41 which may be actuated by , for example , the foot of a care giver on , as is shown in fig5 to 7 , by contact with the underside of the channel element 24 as the bed is lowered to the lowermost position . the use of a guide element 8 which moves inside a channel 24 allows one to position the longitudinal channel 24 closer to the edges of the bed than is possible with the previous arrangements with a guide element on the outside of a channel . this means that the channel or longitudinal rod 24 can be positioned so it moves in a place sufficiently close to the wheels to itself directly engage the brake lever 41 . the brake surfaces ( not shown ) of the head end castors are connected to a respective foot end braking levers 41 by a rod element running inside each of the lower rail elements 35 . movement of the braking lever 41 causes the rod to rotate and hence push the braking surfaces associated with the head end castors to move and hence brake or release the head end castors . although certain illustrative embodiments have been described in detail above , variations and modifications exist within the scope and spirit of this disclosure as described and as defined in the following claims .
a patient support apparatus includes a frame having a first portion that is movable between a raised position and a lowered position to change an elevation at which a person is supported above a floor . castors are coupled to the frame and are configured to rest upon the floor . an actuator is movable between a brake position in which at least one castor of the castors is braked and a release position in which the at least one castor is released . as the first portion of the frame is moved to the lowered position , the first portion automatically engages the actuator and moves the actuator to the brake position thereby to automatically brake the at least one castor .
the apparatus illustrated very diagrammatically in fig1 . comprises a probe 10 , a measuring device 30 and a flexible connection 20 in fiber optics connecting the measuring device to the probe 10 . the probe 10 is designed to be placed in contact with the skin p in order to light up the part of the skin surface requiring to be examined . the connection 20 comprises three optical channels 21 , 22 , channel 21 conveys to the probe the light produced from a light - emitting device 31 in order to illuminate the skin surface to be examined . channel 22 transmits to a receiving device 32 the light reflected specularly ( normally ) by the examined part of surface whereas channel 23 transmits to the receiving device part of the light reflected in non - specular or diffuse manner . in the illustrated example , the diffuse reflection is measured in the direction opposite to the direction of incidence of the light on the surface to be examined . channels 21 and 23 can therefore be re - grouped , at least at their end portions connected to the probe , into a bi - directional optical cable . the emitting 31 and receiving 32 devices are connected to a control and processing device 33 via an interface circuit 34 . said device 31 comprises means of regulating the intensity of the emitted light and is operated by control signals issued by the processing device 33 . the receiving device 32 comprises photo - electrical transducers working out electrical signals representing the normal reflection and the diffuse reflection . said signals are transmitted to processing device 33 through the interface circuit 34 , this transmission being achieved under the control of signals produced by the processing device . in conventional manner , said processing device 33 comprises memory circuits 35 , an arithmetical and logical unit 36 and interface circuits 37 permitting the connection with a display device 38 , such as a cathod ray tube , with a keyboard 39 and with a printer 40 . the processing device may be constituted by any of the existing micro - computers , therefore it will not be described any further herein . supply of the different circuits of the apparatus is ensured by supply circuits ( not shown ). fig2 is a diagrammatical cross - section showing the probe 10 in more details . said probe 10 comprises a casing 11 of which the front face 12 is provided in its center with an opening 13 such as of circular shape . the casing also presents two connecting parts 14 , 15 in which are respectively secured the ends of channels 21 and 23 and the end of channel 22 . channels 21 , 23 are re - grouped at their ends into a bidirectional optical cable 24 provided with an end socket 25 screwed into the connecting part 14 , whereas optical cable 26 forming the channel 22 is provided with a ring 27 and is inserted in a tubular guide 17 housed in the connecting part 15 . the axis of optical cable 24 , namely the axis of connecting part 14 , traverses the center of aperture 13 and is inclined with respect to the perpendicular n to the front face 12 of an angle i , said angle i corresponding to the angle selected for the incidence under which the part of skin surface to be examined is illuminated . in the illustrated example , the angle of incidence i is equal to about 45 °, but another value could also be selected . the axis of optical cable 26 , namely the axis of connecting part 15 is symmetrical to the axis of cable 24 with respect to the perpendicular n traversing the center of aperture 13 since channel 22 is designed to pick up the normally reflected light . cables 24 and 26 are secured to the casing 11 in such a way that the ends of the fiber optics composing them are at predetermined distances d1 and d2 from the center of aperture 13 . adjustment of the position of the end of cable 24 is achieved by interposition of wedges 16 between the socket 25 and the connecting part 14 whereas the end of cable 26 is fixed in the required position in the guide 17 by a locking screw 18 traversing the connecting part 15 and resting against the ring 37 . by way of example , distances d1 and d2 are about 20 mm . the use of a flexible connection composed of fiber optics of which the ends are secured to the probe , presents several advantages . for example , the probe may be small , its overall dimensions being determined by the connecting means of the optical cables . moreover , the probe has no optical elements such as lenses which require high positioning accuracy . the measuring area , determined by the size of aperture 13 may then be small enough to allow significant measurements over a surface with as little rigidity and uniformity as the skin . for example , the surface of the measuring area may be between 10 and 50 mm2 , such as about 25 mm2 . the miniaturization of the probe and its flexible connection with the rest of the apparatus , also allow ready handling for taking measurements over different areas of the skin surface . fig3 diagrammatically illustrates the structure of the emitter of the light emitting device 31 . said emitter comprises a casing 311 to which is connected the starting end of optical channel 21 . said casing 311 is provided with walls 312 used as support for the different elements housed in the casing . the light source is a lamp 314 with tungsten filament . the beam produced by the lamp is focussed by means of a lens 315 in order to obtain an adequate light intensity at the input 21a to optical channel 21 . an infrared filter 316 may be interposed between the lamp 314 and the input to optical channel 21 in order to carry out measurements within the field of the infrared - free visible light . two photodiodes 317 , 318 are placed on both sides of the input to optical channel 21 so as to supply signals representing the light intensity at that input . photodiodes 317 and 318 are connected to a circuit 319 for regulating the light intensity produced by lamp 314 . regulation circuit 319 ( fig4 ) comprises a source of voltage consisting of a transistor t1 of which the collector is at potential + v of a supply source and the emitter is connected to a terminal at the reference potential ( earth ) via the lamp 314 . photodiodes 317 , 318 are connected to an amplifier circuit amp which delivers a voltage v mes representing the real intensity of the light beam applied to the input of channel 21 . voltage v mes is compared to a reference voltage v ref , supplied by a voltage - adjustable generator sv ; the comparison is carried out by means of a differential circuit cp which delivers a voltage v com which is function of the difference between v ref and v mes . the voltage v com is applied to the base of t1 and determines the voltage in the lamp 314 so as to return towards zero the difference between voltages v ref and v mes . the circuit 319 receives a start control signal sca applied via a resistor r1 to the base of a transistor t2 . the emitter thereof is connected to earth whereas its collector is connected , on the one hand , to the voltage source + v via a resistor r2 and , on the other hand , to the base of a transistor t3 via a resistor r3 . transistor t3 has its emitter - collector circuit connected between the base of t1 and the earth . when the start control signal is at a level between the triggering signal of transistor t2 ( sca = 0 , or low logic level ), transistor 2 is in the off state , but transistor t3 is in the on state , bringing the base of t1 to the earth potential ; lamp 314 is switched off . when the on control signal exceeds the triggering threshold of t2 ( sca = 1 , or high logic level ), transistor t2 is turned to the on state , this keeping t3 in the off state and lamp 314 is switched on , the intensity of the current through the lamp being determined by v com . two photodiodes 322 , 323 receive light beams transmitted respectively by optical channels 22 , 23 . diodes 322 , 323 are silicon diodes connected in reverse . the cathodes of diodes 322 , 323 are connected to the middle point of a voltage divider formed by two resistors r4 , r5 connected in series between the earth and a terminal of potential v . diodes 322 , 323 thus produce a voltage substantially proportional to the intensity of the picked up light beams . the anodes of diodes 322 , 323 are connected to two input contacts of an analog switch 324 of which the output contact is connected to the input of a logarithmic amplifier apl producing an analog signal s rfx representative of the specular reflection or of the diffuse reflection , depending on the position of switch 324 . the use of a logarithmic amplifier procures greater dynamics . moreover , the human eye constituting a logarithmic type receiver , the measuring apparatus makes it possible to come closer to the visual judgement which it is required to quantify . the receiving device receives a switch control signal scm controlling the position of the switch . for example , when signal scm has a high logic level ( scm = 1 ), switch 324 connects photodiode 232 with amplifier apl to measure the specular reflection , whereas when signal scm has a low logical level ( scm = 0 ) switch 234 connects photodiode 233 to amplifier apl to measure the diffuse reflection . interface circuit 34 comprises an analog - to - digital converter can which receives the signal s rfx to convert it in the form of a digit word n rfx of n bits . a connection circuit pia (&# 34 ; parallel interface adapter &# 34 ;) is interposed between the converter can and the micro - computer 33 . said circuit pia also transmits signals sca and scm as well as the control signals of converter can . circuit pia is controlled in known manner by control signals produced by the micro - computer . the emitting and receiving devices are controlled to produce a reflectance measurement from the specular and diffuse reflection values ; in the illustrated case , the worked out value represents the difference between the specular reflection intensity and the diffuse reflection intensity . moreover , in order to take into account the influence of ambient light , the reflection is measured according to a principle of &# 34 ; synchronous detection &# 34 ; namely by alternately controlling the switching on and off of the light source . the light flux φs carried by channel 22 ( specular reflection is composed of flux φsp effectively reflected by the skin , of flux φsa coming from the outside ( ambient light ) and from leaks from the detectors , and of flux φss sent back by the casing of the probe . likewise , the light flux φd carried by channel 23 ( diffuse reflection ) comprises components φdp , φda and φds . during a measuring cycle , the flux φda , φsa are successively measured by actuating switch 324 , the lamp being switched off , then after switching the lamp on , the flux φs and φd are measured successively by actuating the switch 324 . k being a corrective factor taking into account the geometry of the probe and of the optical channels 22 , 23 since the reflectance is assessed by differences between intensities of the specular and diffuse reflections , and not by differences between flux . the quantities φss , φds and k are determined by calibration . by placing the probe before a light trap ( instead of the skin ) φsa + φss and φda + φds are measured , when the lamp is switched on , and φsa and φda are measured when the lamp is switched off , wherefrom φss and φds are deduced . the value of k is thereafter determined by placing the probe before a matt surface used as a reference of nil reflectance ( re = 0 ) by measuring φd , φs , φda and φss , and by calculating : a scale coefficient sc is also determined by placing the probe before a reflecting surface of reference such as a calibrated mirror at 80 % reflection , the reflectance being then arbitrarily fixed to a predetermined value rem ( for example 1000 ). after measuring φd , φs , and φss , the coefficient sc is determined by dividing rem by the quantity : the values of φss , φds , k and sc , determined by calibration , are stored in the memory circuits 34 of the micro - computer . fig5 shows the variation in time of voltage s rfx in output of logarithmic amplifier apl . the times t . sub . φsa , t . sub . φda , t . sub . φd , t . sub . φs correspond to the times of measurement of quantities φsa , φda , φd and φs . the times t a and t e correspond to the switching on and switching off of the lamp , whereas times t s and t d correspond to the times of actuation of switch 234 , respectively , towards photodiode 232 ( specular reflection ) and towards photodiode 233 ( diffuse reflection ). the successive measuring cycles are performed under the control of the micro - computer . the duration of one cycle may be less than 1 sec ., for example around 0 . 7 sec ., said duration being for example function of the times necessary for the stabilization of the lamp when this is switched on and off . the values of reflectance re calculated during successive measurement cycles are displayed as successive positions of a cursor on the screen of tube 38 . the operator can thus correct any incorrect positioning of the probe by observing the position variations in y - axis of the cursor when moving the probe slightly . instantaneous display of the reflectance calculated value thus contributes to positioning the probe . the reflectance value finally retained may be a mean value worked out from the results of a predetermined number of measurement cycles . said final value may be edited on the printer 40 and is displayed on the screen . the resulting reflectance value is recorded in a computer file which may contain other information concerning the patient whose skin is being examined , the date of examination and any special conditions of examination . the recorded information may be edited on paper via the printer , at the operator &# 39 ; s request . the main programme including the operations of initialization of the system and the subroutines of recording on file and file readout are not specific phases of the proposed application ; therefore they are not explained hereinafter in details . the measuring and calibrating operations use programmes such as per flow - charts illustrated in fig6 and 7 . initialization of the graph , and tracing of the outline of the screen with a view to displaying the measurement results as a curve representing the variation of the reflectance ( phase 400 ); positioning of the cursor in abscissa l = 1 on the screen ( phase 401 ); if the operator , by actuating the keyboard , requests the exit of the subroutine ( test 403 ), return to the main programme ; if the operator , by actuating the keyboard , requests an integration on the reflectance values obtained during the successive cycles of measurement ( test 404 ), a subroutine ( 420 ) is called during which a test is carried out on the positioning of an averaging indicator ( e =- 1 ! ), so as , in the affirmative , to arrive at end of averaging , to return indicator e to zero , and to return to the programme , and , in the negative , to bring sum s and parameter n to zero , to position e to - 1 and to return to the programme ; measurement of the flux φda , the signals sca and scm being in zero position , and readout of the corresponding digital value ( phase 405 ); switching from channel 23 to channel 22 by placing scm in position 1 , measurement of flux φsa and readout of the corresponding digital value ( phase 406 ); switching on of the lamp by bringing sca to position 1 , measurement of the flux φs and readout of the corresponding digital value ( phase 407 ); switching from channel 22 to channel 23 by bringing scm to position 0 ; measurement of φd and readout of the corresponding digital value ( phase 408 ); calculation of re from the readout values of φda , φsa , φs and φd , and of the pre - recorded values of φss , φds , k and fe ( phase 409 ) if an integration is called ( test 410 ) calling of a summation subroutine 430 including updating of sum s ( s = s + re ), incrementing of n ( n = n + 1 ), calculation of an &# 34 ; instant mean value &# 34 ; of reflectance m i ( re )= s / n , control of the display on the screen of the digital value of m i ( re ) and return to the programme ; editing of the digital values of re or , optionally , of m i ( re )( phase 411 ); graphic display of the digital value of re by control of the ordinate of the cursor on the screen ( phase 412 ); if the value of l is equal to the maximum abscissa possible l max ( test 414 ), clearing of the screen ( phase 415 ) and return to initialization of the graph , if not , return to phase 402 ; display on the screen of a message ( phase 503 ) for placing the probe before the surface corresponding to the constant value to be determined ( light trap , matt surface of reference , reference mirror ); if the operator , by actuating the keyboard , requests the exit of the subroutine ( test 505 ), return to the main programme without changing the calibration ; for every constant to be determined k1 to k4 ( k1 = φss , k2 = φds , k3 = k and k4 = sc ), performance of m successive cycles of measurement , for example 10 cycles , ( phase 506 ) each one including : measurements of flux φda , φsa , φs and φd ( phases 405 to 408 of the aforesaid measuring programme ): calculations of mean value and standard deviation for every constant ( phase 507 ), namely mean value xi = si / m , standard deviation vi = σi / m - xi 2 and reduced standard deviation if the reduced standard deviation is greater than a predetermined threshold ( test 509 ), it is displayed on the screen , if not , then direct passage to the next phase ; if the operator , by actuating the keyboard , requests a new assessment of the same constant ( test 512 ), return to phase 503 ; if the operator , by actuating the keyboard , requests that the new constant be kept ( test 513 ), then ki = xi ( phase 514 ) and passage to the next constant ( phase 515 ); if the operator , by actuating the keyboard , refuses the value xi ( test 516 ), then the actual value of the constant is kept ( phase 517 ) with passage to the next constant ( phase 515 ); if the operator , by actuating the keyboard , requests the exit ( test 518 ), then return to the main programme without modifying the calibration ; when passing to the next constant ( phase 515 ) and if the four constants have not yet been calculated ( test 519 ), return to phase 503 ; if all the constants have been calculated , exit with modification of the calibration and return to the main programme . tests have been conducted with a mesuring apparatus suc as described hereinabove by using a scale of reflectance re ranging from 0 for the matt surface of reference to 1000 for the reflecting surface of reference ( mirror with 80 % reflection ). the measurements taken on 34 people have given reflectance values within a range of 8 to 12 . 5 for the fore - arm and from 6 to 13 . 9 for the forehead . in the case of people ( 7 cases ) whose skin appears to be greasy to the eye , the mean reflectance value measure on the forehead has been 11 . 7 , to be compared with the general means value of 9 . 56 obtained from measurements taken in 32 random cases . moreover , measurements taken on five subjects have shown a deviation of 5 . 4 between the mean reflectance values obtained before and after application of &# 34 ; vaselin &# 34 ; on the fore - arm . these results show the effective correlation between the visual aspect of reflectance and the measurements taken , thereby justifying the use of the measuring apparatus according to the invention as an &# 34 ; objective &# 34 ; means of quantifying the reflectance of the skin .
a probe comprising a casing of which one face which will be in contact with the skin is providied with an aperture , is connected to a measuring device by means of a flexible connection in fiber optics comprising at least three optical conductors which , at a first end , are secured in the casing of the probe such as to face the aperture thereof , the first and second conductors having their first end portions directed respectively in a first and a second directions which are symmetrical to each other with respect to an axis extending normally through the aperture , while the third conductor has its first end portion directed in another direction than said second direction .
embodiments of the presently disclosed merchandising system are described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views . as is common in the art , the term “ proximal ” refers to that part or component closer to the user , e . g ., customer , while the term “ distal ” refers to that part or component farther away from the user . generally , with particular reference to fig1 - 3 , a merchandising system 10 is disclosed that includes a plurality of guide assemblies 100 . each guide assembly 100 includes a base 200 , a pusher assembly 300 , a pair of lateral guides 400 , a distal section 450 , and a proximal member 500 . the base 200 , which is designed to be placed on a horizontal or included store shelf , is configured to support a plurality of products “ p ” thereon . the pusher assembly 300 is configured to urge product ( s ) “ p ” on the base 200 toward the proximal member 500 . the lateral guides 400 are disposed in mechanical cooperation with base 200 ( e . g ., are integrally formed therewith , connectable thereto , etc .) and help maintain the products “ p ” on the base 200 . a distal rail 452 of the distal section 450 and the proximal member 500 are also configured to help maintain the products “ p ” on the base 200 . one merchandising system 10 includes a plurality guide assemblies 100 . in the embodiment illustrated in fig2 a , merchandising system 10 includes five guide assemblies 100 , which , as shown , includes six lateral guides 400 . in disclosed embodiments , merchandising system 10 includes more or fewer than five guide assemblies 100 and that the number of lateral guides 400 equals one more than the number of guide assemblies 100 . as can be appreciated , several merchandising systems 10 are able to be positioned adjacent one another on a shelf . with reference to fig4 - 9 , the base 200 includes a product - supporting surface 210 , a lower surface 220 , a gap 230 , a plurality of longitudinally extending ribs 240 , and a track 250 . the product - supporting surface 210 is the portion of the base on which products “ p ” are positioned . the lower surface 220 is the underside of the base 200 . the gap 230 is the space between the product - supporting surface 210 and the lower surface 220 . the ribs 240 extend along at least a portion of the base 200 between a proximal end 202 of the base 200 and a distal end 204 of the base 200 ( see fig3 ), and are configured to provide stability to base 200 and to reduce friction when a product “ p ” slides along the product - supporting surface 210 , for example . the track 250 includes a plurality of spaced - apart tabs 252 that are positioned within the gap 230 . the track 250 is configured to guide legs 340 of the pusher assembly 300 ( as discussed in further detail below ). referring now to fig3 - 13 , the pusher assembly 300 includes a pusher member 310 and a biasing member 360 ( e . g ., a coiled spring ). pusher member 310 includes a horizontal member 320 and a substantially vertical member 321 . in the illustrated embodiment , the vertical member 321 has an arcuate shape , which is configured to correspond to the contour of the product “ p ” ( e . g ., bottle ) supported thereagainst . the horizontal member 320 includes an upper surface 322 ( e . g ., for supporting a product “ p ”), and a lower surface ( or base - contacting surface ) 324 that is configured to longitudinally slide along the product - supporting surface 210 of the base 200 . the horizontal member 320 also includes a proximal portion 326 , and a distal portion 328 . the proximal portion 326 is configured to support a distal - most product “ p ” thereon , and the distal portion 328 supports at least a portion of the biasing member 360 thereon ( fig4 ). the horizontal member 320 also includes a track 330 ( fig5 and 11 ) within its lower surface 324 , and an opening 332 ( fig5 and 11 ) extending between the upper surface 322 and the lower surface 324 . a portion of the biasing member 360 extends through the opening 332 and along the track 330 . the pusher member 310 also includes a plurality of legs 340 ( fig5 a , 8b , 9 and 11 - 13 ) that extend below the lower surface 324 of the horizontal member 320 . with particular reference to fig1 , the pusher assembly 300 includes a first leg 340 a , a second leg 340 b , a third leg 340 c and a fourth leg 340 d . in the illustrated embodiments , each leg 340 includes a vertical portion 342 , and a horizontal portion 344 ( fig1 ) extending inwardly from the vertical portion 342 , such that each leg 340 includes a substantially l - shaped cross - section . when the pusher assembly 300 is engaged with the base 200 , the legs 340 of the pusher assembly 300 extend below the product - supporting surface 210 of the base 200 and mechanically engage the tabs 252 of the track 250 , and are longitudinally slidable along the track 250 . more particularly , and with particular reference to fig9 , when the pusher assembly 300 and the base 200 are mechanically engaged , the vertical portion 342 of each leg 340 abuts or is adjacent a lateral wall 254 of the tab 252 , and the horizontal portion 344 of each leg 340 abuts or is adjacent a lower wall 256 of the tab 252 . this engagement between the legs 340 of the pusher member 310 and the track 250 of the base 200 helps ensure the pusher member 310 remains on the base 200 during use of the merchandising system 10 . more particularly , when torque is applied to the merchandising system ( e . g ., during loading of the merchandising system 10 with products “ p ,” when a consumer &# 39 ; s shopping cart bumps into the merchandising system 10 or the shelf that the merchandising system 10 is positioned on , etc .) the engagement between the pusher member 310 ( e . g ., the legs 340 ) and the base 200 ( e . g ., the track 250 ) helps prevent the pusher member 310 from toppling over . for instance , when a downward force is applied to right side of the pusher member 310 ( e . g ., during torquing of the merchandising system 10 ), the legs 340 a and 340 b on the left side of the pusher member 310 are forced upward . there engagement between the horizontal portions 344 of these legs 340 a and 340 b and the lower wall 256 ( fig9 ) of a tab 252 of the track 250 helps prevent the pusher member 310 from becoming separated from the base 200 at that location . additionally , the engagement between the legs 340 and the track 250 helps prevent the pusher member 310 from intentionally being separated from the base 200 ( e . g ., by vandals ). with particular reference to fig4 , to install the pusher member 310 onto the base 200 , a user positions each leg 340 adjacent a shortened tab 253 ( i . e ., a discontinuity in the track 250 ), and moves the pusher member 310 proximally or distally such that the horizontal portion 344 of each leg is under a tab 252 or a shortened tab 253 of the track 250 . it is envisioned that in lieu of , or in addition to shortened tabs 253 , track 250 includes a space between adjacent tabs 252 that is large enough to accommodate the legs 340 of the pusher member 310 . it is further envisioned that shortened tabs 253 ( and / or the large space ) are located at one or a plurality of locations between the proximal end 202 and the distal end 204 of the base 200 ( e . g ., not the proximal - most portion of the base 200 and not the distal - most portion of the base 200 ). with reference to fig3 , the proximal member 500 of the merchandising system 10 is configured to attach to a proximal end of the base 200 via a snap - fit connection , for example . it is envisioned that at least a portion of the proximal member 500 is transparent or translucent to allow a consumer to view a portion of the proximal - most product “ p 1 ” on the merchandising system 10 therethrough . additionally , in the illustrated embodiment , the proximal member 500 has an arcuate shape , which is configured to correspond to the contour of the product “ p ” ( e . g ., bottle ) supported thereagainst . it is also envisioned that the proximal member 500 includes a scooped portion 510 . the scooped portion 510 allows the proximal - most product “ p 1 ” to be better viewed by a consumer , allows the proximal - most product “ p 1 ” to be tipped down by a consumer to facilitate shopping of the products “ p ,” and / or facilitates the loading of the products “ p ” onto the merchandising system 10 , e . g ., by a store employee . with particular reference to fig8 a and 8b , a lower surface 522 of a base 520 of the proximal member 500 includes a pin 530 extending downwardly therefrom . the pin 530 is configured to mechanically engage a hole 362 disposed on a proximal portion 364 of the biasing member 360 ( see also fig3 ). therefore , when the hole 362 is engaged with the pin 530 ( fig7 b ), the biasing member 360 , and thus the pusher assembly 300 , is mechanically coupled to the proximal member 500 . additionally , the merchandising system 10 is configured to be used on shelves of various depths ( i . e ., the distance the shelf extends from the wall / support ). specifically , portions of the guide assemblies 100 are able to be broken - off or otherwise removed to effectively shorten the length of the guide assemblies 100 . more particularly , and with reference to fig3 , 14a and 14b , the base 200 includes breakaway features 260 , and the lateral guides 400 include breakaway features 410 , that each allow for selective removal of portions of the base 200 and the lateral guides 400 to shorten the length of the guide assemblies 100 . referring now to fig1 a and 14b , the distal section 450 includes the distal rail 452 , a distal base 460 , and distal lateral walls 470 . the distal base 460 includes a proximally - extending finger 462 that is configured to engage and interlock with a corresponding cut - out 262 disposed at a distal end of the base 200 . accordingly , the distal section 450 is able to be removed ( fig1 a ), and re - installed ( fig1 b ) after one or more portions of the base 200 and lateral guides 400 have been removed . further , the pusher assembly 300 of the merchandising system 10 is still able to properly function across the breakaway features 260 and 410 , the proximally - extending finger 462 and the cut - out 262 , after some or all of the portions of the base 200 and the lateral guides 400 have been removed , and after the distal section 450 has been removed and re - installed . the present disclosure also includes a method of displaying items using the merchandising system 10 described above , and a method of engaging the pusher assembly 300 with the base 200 , as discussed above . while several embodiments of the disclosure have been shown in the figures , it is not intended that the disclosure be limited thereto , as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise . therefore , the above description should not be construed as limiting , but merely as exemplifications of various embodiments . those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto .
a merchandising system for a displaying a plurality of products is disclosed . the system comprises a base and a pusher member . the base includes a product - supporting surface and a track disposed beneath the product - supporting surface . the base defines a longitudinal axis . the pusher member is disposed in mechanical cooperation with the base and is configured to slide longitudinally with respect to the base . the pusher member includes a base - contacting surface and a plurality of legs downwardly depending from the base - contacting surface . each of the plurality of legs is configured to mechanically engage the track . the track includes a discontinuity to enable the legs of the pusher member to selectively mechanically engage the track .
the exemplary embodiments of the present invention are described and illustrated below as a fluid container , referred to below as a “ sippy straw cup ”, comprising a cup and corresponding lid having a sliding actuator to regulate fluid communication between an interior of the sippy straw cup and an external environment . the various orientational , positional , and reference terms used to describe the elements of the present invention are therefore used according to this frame of reference . however , for clarity and precision , only a single orientational or positional reference will be utilized ; and , therefore it will be understood that the positional and orientational terms used to describe the elements of the exemplary embodiment of the present invention are only used to describe the elements in relation to one another . referring to fig1 and 2 , an exemplary embodiment of a sippy straw cup 10 includes a cup 12 , a lid 14 , a sliding actuator 16 , and a straw 18 providing a selectively sealed fluid reservoir 20 available for holding a fluid therein , that may include , without limitation , a beverage . in an open position , as shown , the straw 18 is erect and provides fluid communication between the fluid reservoir 20 and an external environment 22 . the straw 18 may include two or more sections , with a first section 24 being resilient and a second section 26 coupled to the first section 24 that is less resilient and not readily amendable to spatial deformation . referencing fig2 – 4 , the cup 12 includes a cavity 28 partially defined by an exterior wall 30 of an inner cup 32 and partially by an interior wall 34 of an outer cup 36 . the cavity 28 may be adapted to receive a graphical expression ( not shown ), in which case the outer cup may be transparent to facilitate visual appeal . the graphical expression may include a lenticular or holographic image on a medium positioned within the cavity 28 . those of ordinary skill in the art are familiar with the methods of forming lenticular , holographic , or other images onto various mediums . the inner cup 32 includes an interior wall surface 38 defining the reservoir 20 and a spout 40 having spiral protrusions 42 on an exterior surface 44 adapted to be received within corresponding grooves 70 within the lid 14 for securing the lid 14 to the cup 12 . the spout 40 includes a ledge 46 transitioning into a circumferential wall 48 forming a recess 50 between the circumferential wall 48 and the exterior wall 30 of the inner cup 32 . the recess 50 is adapted to receive a top portion 52 of the outer cup 36 , where the outer cup 36 and the inner cup 32 may be coupled together by spin sealing . the outer cup 36 transitions from the top portion 52 into a sill 54 circumferentially thereabout that tapers inward to create a first indentation 56 . the first indentation 56 leads into a first mound 58 that gives rise to a second indentation 60 and thereafter a second mound 62 . each indentation 56 , 60 and each mound 58 , 62 is circumferentially distributed about the outer cup 36 . the second mound 62 transitions into a smooth taper terminating at a bottom aspect 64 having a dome shaped underneath surface 66 . referencing fig5 – 8 , the lid 14 is substantially domed shaped having a plurality of raised areas 68 circumferentially distributed thereabout to facilitate gripping as the corresponding grooves 70 within an outer wall 72 receive the spiral protrusions 42 of the inner cup 32 to couple the lid 14 to the cup 12 ( see fig1 ). a fluidic seal is created between an interior surface 74 of the outer wall 72 and the exterior surface 42 of the inner cup 32 , as well as between an interior surface 76 of an inner lip 78 ( extending from the outer wall 72 ) and the interior surface 38 of the inner cup 32 . the outer wall 72 transitions upward from the inner lip 78 in an arcuate manner until terminating at a recess 80 . the recess 80 includes a side surface 82 being essentially square with an arcuate top surface 84 . the arcuate top surface 84 defines an orifice 86 therein and gives rise to a conduit 88 extending from the top arcuate surface 84 of the recess 80 to an underneath surface 90 of the lid 14 . the conduit 88 includes circumferential projection 92 separating a first cylindrical portion 94 and a second cylindrical portion 96 having a greater diameter than the first cylindrical portion 94 . a groove 97 , adapted to receive the straw 18 , is formed within the recess 80 and includes a finger 98 abutting the orifice 86 . the side surface 82 of the recess 80 includes a guide notch 100 cut therein following the generally arcuate shape of the recess that is adapted to receive guide pins 102 of the sliding actuator 16 ( see fig9 – 11 ). referring to fig9 – 12 , the sliding actuator 16 is adapted to be received within the recess 80 and includes a generally arcuate shape from the side , where an underneath surface 104 is adapted to ride along the top surface 84 of the recess 80 and a top surface 106 of the actuator 98 is adapted to be substantially flush with the outer wall 72 of the lid 14 upon being seated within the recess 80 . two guide pins 102 protrude from each side 108 of the actuator 16 and are operative to guide the actuator 16 within the recess 80 from a closed position where the straw 18 is wedged between the underneath surface 104 and the top surface 84 and an open position where the straw 18 is erect . a contoured ridge 110 extends across the actuator 16 and includes two sliding guides 112 adapted to slide along the outer wall 72 . the contoured ridge 110 provides an actuation point for a user to push against or pull on the ridge 110 to effect motion of the actuator 16 with respect to the recess 80 . the underneath surface 104 includes a pair of rectangular projections 113 forming a mating channel 114 therebetween . the front 116 of the actuator 16 is partially open to guide the cylindrical nature of the straw 18 into the mating channel 114 when the actuator 16 is in the closed position . the straw 18 may include exterior features such as guide grooves or ridges ( not shown ) to further facilitate alignment within the groove 97 and the mating channel 114 . referencing fig1 , the open position of the sippy straw cup 10 is shown having the first section 24 of the straw 18 partially received within the conduit 88 and includes an exposed section 120 with a tip 122 at the end not received within the conduit 88 . an orifice 124 defined by a wall 126 of the straw 18 provides a generally constant internal diameter providing a circular cross - sectional area available for fluid flow therethrough . this generally constant internal diameter continues for the length of the first cylindrical portion 94 and part of the second cylindrical portion 96 . the radius of orifice 124 and the radius of the wall 126 aggregate to approximate the internal diameter of the conduit 88 . the straw 18 includes an indentation 128 that receives the circumferential projection 92 seating the straw 18 within the conduit 88 . the wall 126 increases in thickness to abut an interior wall 130 of the second cylindrical portion 96 , and when teamed with the indentation 128 and the circumferential projection 92 , inhibits vertical movement of the straw 18 within the conduit 88 . just beyond the exit of the conduit 88 , a step change within the straw is present where the orifice 124 increases in cross - section to receive the second section 26 adapted be in direct contact with the beverage occupying the reservoir 20 of the sippy straw cup 10 . referring to fig1 , the closed position of the sippy straw cup 10 is shown having the straw 14 wedged between the underneath surface 104 of the actuator 16 and the top surface 84 of the recess 80 . in practice , as the actuator 16 is repositioned from the open position to the closed position , the front 116 of the actuator 16 contacts the external wall 126 of the exposed section 120 of the straw 18 and pushes the straw forward . the open section of the front 116 of the actuator 16 and the mating channel 114 receives the exposed section 120 of the straw 18 as the actuator 16 continues moving forward , thereby pushing the straw 18 over the finger 98 projecting outward from the conduit 88 and into the groove 97 formed within the recess 80 . as the straw 18 is received within the groove 97 and mating channel 114 , the finger 98 forces one side of the straw wall 126 against the other side of the straw wall 126 , discontinuing the orifice 124 within the straw 18 to inhibit fluid communication between the second section 26 and the tip 122 of the straw 18 . the forward movement of the actuator 16 pushes the straw 18 completely within the groove 97 and mating channel 114 while the rear section 118 of the actuator 16 covers the orifice 86 . when moving from the closed to the open position , the actuator 16 is moved backward , gradually uncovering the exposed section 120 of the straw 18 previously seated within the groove 97 and mating channel 114 such that the resiliency of first section 26 of the straw 18 gradually raises the straw 18 to an erect position abutting the front 116 of the actuator 16 . following from the above description and invention summaries , it should be apparent to those of ordinary skill in the art that , while the methods and apparatuses herein described constitute exemplary embodiments of the present invention , the inventions contained herein are not limited to these precise embodiments and that changes may be made to them without departing from the scope of the invention as defined by the claims . additionally , it is to be understood that the invention is defined by the claims and it is not intended that any limitations or elements describing the exemplary embodiments set forth herein are to be incorporated into the meanings of the claims unless such limitations or elements are explicitly recited in the claims . likewise , it is to be understood that it is not necessary to meet any or all of the identified advantages or objects of the invention disclosed herein in order to fall within the scope of any claim , since the invention is defined by the claims and since inherent and / or unforeseen advantages of the present invention may exist even though they may not have been explicitly discussed herein .
a closure for a container adapted to house a beverage therein , the closure comprising : a cap having a mating feature adapted to interface with a corresponding feature of a container to secure the cap thereto , the cap also including an orifice therethrough and a channel therewithin , the channel being adapted to receive a sliding member therein ; and a flexible conduit adapted to be in fluid communication with a beverage within the container , wherein the sliding member is operative to position the flexible conduit between an open position and a closed position , where the open position enables fluid communication between a drinking end and an interior of the container .
referring to the drawing , the invention comprises a mouthpiece 1 having an upper channel member 2 and a lower channel member 5 ( fig3 and 5 ). upper channel member 2 is essentially identical to the upper mouthpiece worn by a boxer but modified according to this invention ; and , similarly , lower channel member 5 is essentially identical to the lower mouthpiece worn by a boxer but modified according to this invention . this upper channel member 2 is designed to fit over the upper teeth of the user and to snugly fit against the upper gum and lower channel member 5 is designed to fit over the lower teeth of the user and to fit snugly against the lower gum . upper channel member 2 and lower channel member 5 are made of a relatively soft but semi - rigid material . holes 6 ( see fig4 and 6 ) are cut through both legs or sides of upper channel member 2 and lower channel member 5 . the function of these holes will be described later herein . a first or outer membrane 7 extends from upper channel member 2 downward to lower channel member 5 as is more clearly shown in fig3 . as shown in fig3 outer membrane 7 is integrally formed with the uppermost part of upper channel member 2 at one end and is integrally formed with the lowermost part of lower channel member 5 . instead of being integrally formed with upper and lower channel members 2 and 5 , respectively , outer membrane 7 can be and from a production standpoint preferably is secured by any suitable means such as a non - toxic adhesive at one end to upper channel member 2 and at its other end to lower channel member 5 . a second or inner membrane 8 extends from the uppermost part of upper channel member 2 downward to the lowermost part of lower channel member 5 ( see fig3 ). again , the top part of second membrane 8 is shown in fig3 as being integrally formed with upper channel member 2 at one end and with lower channel member 5 at its other end but can be and preferably is secured to the uppermost part of upper channel member 2 at one end and to the lowermost part of lower channel member 5 at its other end by any suitable means and is a non - toxic adhesive . outer membrane 7 and inner membrane 8 are conveniently made of a relative soft material that is somewhat elastic . from the foregoing description of outer member 7 and inner membrane 8 , it is apparent that the area between the uppermost part of upper channel member 2 and the lowermost part of the lower channel member 5 is enclosed by means of membranes 7 and 8 . although it is not clearly visible in fig1 and 2 , membranes 7 and 8 are brought around the back of upper and lower channel members 2 and 5 such that the closed area formed by membranes 7 and 8 is a sealed area . a plurality of the bite blocks 10 are located in both upper and lower channel members 2 and 5 . three bite blocks 10 are shown in upper channel member 2 . an identical number of bite blocks are located in lower channel member 5 directly below bite blocks 10 . one of these bite blocks , the bite block 11 , located in lower channel member 5 is shown in fig3 and 5 . referring specifically to fig3 and 5 , a rod or post 12 has one end secured to or integrally fabricated with bite block 10 . the other end of post or rod 12 is secured to or integrally fabricated with the block 13 . a rod or post 14 has one end secured to or integrally fabricated with bite block 11 and its other end is integrally fabricated with or secured to block 13 . a hole 15 is cut through block 13 . all three bite block structures are identical . thus , all three bite block structures comprise a bite block 10 in upper channel 2 , a bite block 11 in lower channel 5 , a post or rod 12 , a block 13 having a hole 15 and a post or rod 14 . while the number of bite block structures provided is not critical , it will be obvious later herein from the description of the operation that at least three bit block structures should be provided . a hose or tube 16 is positioned between the bottom of upper channel member 2 and the top of lower channel member 5 . the hose or tube 16 is shaped to extend along the entire bottom and top surfaces of upper channel members 2 and 5 , respectively , as is shown in fig2 . hose or tube 16 is threaded through holes 15 of blocks 13 as shown in fig3 and 5 . a plurality of air - sacks 17 are integrally formed along tube or hose 16 as shown in fig2 . conveniently , air - sacks 17 are areas formed along tube or hose 16 that are more elastic than the balance of hose 16 so that air - sacks 17 will expand when inflated by air while the balance of hose or tube 16 remains substantially unchanged when air - sacks 17 are inflated or deflated . while the number of air - sacks provided is not critical , four air - sacks located as shown in fig2 is probably the minimum number required for satisfactory operation . more air - sacks 17 could be provided or for that matter the entire hose or tube 16 could be made of the same material as air - sacks 17 so that the entire tube or hose 16 would expand when inflated except , of course , in the area where hose or tube 16 passes through the holes 15 of blocks 13 . air - sacks 17 are secured to upper and lower channel members 2 and 5 by a suitable adhesive or the like . referring specifically to fig1 and 2 , a hose or tube 18b has one end secured to or is integrally fabricated with hose 16 . the other end of hose 18b is secured to the coupler 18a . coupler 18a is secured to and passes through membrane 7 such that one end , the end secured to hose 18b , is located in the enclosed area formed by membranes 7 and 8 and the other end extends slightly beyond the outer surface of membrane 7 . a hose or tube 19b is secured along the outside of membrane 7 as shown more clearly in fig1 . both ends of tube 19b are open . a coupler 19a , one end of which communicates with the inside of hose 19b , is secured to hose 19b at approximately the mid - point of hose 19b . the other end of coupler 19a extends slightly beyond the outside surface of hose 19b . a hose or tube 20b is located in the area formed by membranes 7 and 8 . one end of hose 20b extends through membrane 8 . this end of hose 20b conveniently and preferably is flush with the outside surface of membrane 8 . the other end of hose 20b is secured to one end of the coupler 20a . coupler 20a is secured to membrane 7 such that one end of coupler 20a , the end secured to hose 20b , is located in the area formed by membranes 7 and 8 and the other end extends slightly beyond the outside surface of membrane 7 . a coupler 21a is secured to membrane 7 such that one end of coupler 21a extends into the enclosed area formed by membranes 7 and 8 and the other end extends slightly beyond the outer surface of membrane 7 . seals are provided around couplers 18a , 20a and 21a where they pass through membrane 7 so that a fluid tight seal is provided between membrane 7 and each of the couplers 18a , 20a and 21a . similarly , a seal is provided between hose 19b and the area adjacent the end of coupler 19a that communicates with the inside of hose 19b so that a fluid tight seal is provided between hose 19b and this end of coupler 19a . one end of each of the hoses or tubes 18 , 19 , 20 and 21 is coupled to a control box 22 . the other end of hoses 18 , 19 , 20 and 21 are coupled to couplers 18a , 19a , 20a and 21a , respectively . the end of each of the hoses 18 , 19 , 20 and 21 that is coupled to its mating coupler 18a , 19a , 20a and 21a , respectively , is preferably provided with a mating connector , not shown in the drawing , such that hoses 18 , 19 , 20 and 21 can be quickly coupled to and uncoupled from couplers 18a , 19a , 20a and 21a , respectively . any type of suitable well known quick connect and disconnect coupling arrangement can be used to couple hoses 18 , 19 , 20 and 21 to their respective couplers . in addition to quick disconnect , the couplers permit one control unit 22 to be used interchangeably with a plurality of mouthpieces . three on - off switches , the switches 23 , 24 and 25 , are provided on control box 22 . the outlet hoses 26 and 27 have one end coupled to control box 22 . control box 22 is provided with a remote control device 28 that is sized and shaped to be conveniently held in the hand of the user of the apparatus of this invention . remote control device 28 is provided with the switches 29 , 30 and 31 . the apparatus of this invention operates as follows : the user inserts mouthpiece 1 into his or her mouth such that upper channel member 2 fits over the upper teeth and snugly against the upper gum and lower channel 5 fits over the lower teeth and snugly against the lower gum . control box 22 is then activated to provide either air pulses and water or air pulses alone or water alone . the air pulses are provided to air - sacks 17 from control box 22 through hose 18 , coupler 18a , hose 18b and hose 16 . control box 22 is provided with an air pump that operates cyclically to alternately provide pulses of air with periods of no air between the air pulses . when air pulses are provided , air - sacks 17 are inflated and during the period between air pulses air - sacks 17 are deflated . the elasticity of air - sacks 17 and the elasticity of membranes 7 and 8 forces the air out of air - sacks 17 through hose 16 , hose 18b , coupler 18a and hose 18 during the period between air pulses . instead of relying solely on the elasticity of air - sacks 17 to drive out the air , the pump of control box 22 could alternately pump air in and such air out ; thereby ensuring positive inflation and deflation of air - sacks 17 . in any event , control box 22 must operate such that air - sacks 17 are alternately inflated and deflated . referring to fig4 and 5 , fig4 shows a single air - sack 17 in its inflated condition and fig5 shows an air - sack 17 deflated . all of the air - sacks 17 are inflated or deflated at the same time . when the air - sacks 17 are inflated , upper channel member 2 rides up on the upper gum and lower channel member 5 rides down on the lower gum . when air - sacks 17 are deflated , the upper channel member 2 will ride down on the upper gum and lower channel member 5 will ride up on the lower gum . thus , as air - sacks 17 are inflated and deflated , upper and lower channel members 2 and 5 provide a massaging action on the gums . the teeth are held in place by the bite blocks 10 and 11 so that the upper and lower channel members 2 and 5 will ride up and down on the gums with the teeth staying in place . the elasticity of the membranes and the air - sacks pulls upper and lower channel members toward each other when air - sacks 17 are deflated . at the same time that control box 22 is providing air to massage the gums , control box 22 also provides a source of water and / or cleaning fluid through hose 21 and coupler 21a into the area formed by membranes 7 and 8 . this water and / or cleaning fluid flows through holes 6 in upper and lower channel members 2 and 5 to clean and flush out the teeth and gums . this fluid is preferably introduced into mouthpiece 1 as a gentle steady stream . in addition to providing a cleaning action , the fluid serves as a lubricant during the massaging action . since some fluid will seep out between the gums and upper and lower channel members 2 and 5 , suction hose 9 is provided on the outside of membrane 7 . suction hose 9 is coupled to control box 22 by means of coupler 19a and hose 19 . control box 22 sucks any fluid seepage out of the mouth of the user through hose 9 , coupler 19a and hose 19 . similarly , hose 20b serves as a suction hose to suck out the fluid that seeps into the area of the mouth outside of inner membrane 8 . this seepage is drawn out by control box 22 through hose 20b , coupler 20a and hose 20 . a source of water is provided to control box 22 by means of the hose 26 . this water can be mixed with a cleaning fluid that is stored inside of control box 22 . if no cleaning fluid is to be used , no such fluid will be stored in control box 22 . similarly , if only cleaning fluid is used , the source of water is cut off . also , a mixture of water and cleaning fluid can be stored in control box 22 and hose 26 eliminated , if control box 22 is provided with a sufficiently large storage compartment for the fluid . the fluid drawn out of the mouth around mouthpiece 1 through hoses 19 and 20 is drained out of control box 22 by means of hose 27 . if a drain pan is provided in control box 22 , hose 27 can be eliminated . while under most circumstances , the apparatus will be used with both cleaning fluid and with air to provide the massaging action , the apparatus can be operated such that either air only is provided or cleaning fluid only is provided , or both air and cleaning fluid are provided . control box 22 is provided with three on - off switches to provide the three modes of operation . for example , switch 23 would provide both air and water , switch 24 air only and switch 25 water only . while the apparatus can be operated from control box 22 , a remote control device 28 is preferably provided . remote control device 28 is of such size and shape that it is easily hand held and is provided with switches 29 , 30 and 31 that correspond in operation to switches 23 , 24 and 25 , respectively . alternately , remote control device 28 can be and preferably is provided with a single on - off pushbuttom switch with the mode of operation set by switches 23 , 24 and 25 . this single switch or remote control device 28 would then operate to merely activate the control box 22 . while the invention has been described with reference to a specific embodiment , it will be obvious to those skilled in the art that various changes and modifications can be made to this embodiment without departing from the spirit and scope of the invention as set forth in the claims . for example , bristles can be added to the upper and lower channels to assist the massaging action and a single coupling arrangement could be used to couple the control panel to the mouthpiece .
apparatus for cleaning teeth and the gingival crevices and for massaging the gums is disclosed . the apparatus comprising a mouthpiece having an upper channel member adapted to fit over at least a part of the upper dentation and to snugly engage the upper gum and a lower channel member adapted to fit over at least a part of the lower dentation and to snugly engage the lower gum . the upper and lower channels are joined by a membrane means which form fluid chambers . pneumatic means are provided to move the upper and lower channel members upward and downward over the respective gums to massage the gums . in addition water or any suitable cleaning fluid is introduced into and out of the apparatus to clean the teeth and gingival crevices and to provide lubrication for the massaging action of the pneumatic means .
the base member 22 is shown in fig1 , 2 and 3 . referring particularly to fig3 , the base member is a molded plastic part with a projecting ridge 34 around the periphery with slight extensions of the ridge at 35 . the projections 35 are used as grippers to hold the body member with one &# 39 ; s fingers when the cover 24 is being removed or replaced on the body . the vertical walls are curved as at 62 and 64 in a shape approximating the curvature of a typical ear of corn . the base member is shaped to accommodate the ear of corn , both on the bottom surface 38 and the upper surface 36 . the brush structure 40 is illustrated in fig1 , 4 and 5 . the brush structure is a single molded part comprising a molded bristle base 42 and molded brush bristles formed in the same molding operation . low density polyethylene is the material of which the base and bristles are made so as to make them relatively soft and flexible . the underside of the brush unit is shown in fig5 . flexible vertical plastic walls 80 form an elongated rectangular shape to match that of the base member 22 and to fit into the cavity 60 shown in fig3 with an interference fit . tabs extend from the opposite short ends 44 of the bristle base to facilitate removing and replacing the bristle base in the base member 22 , thus providing means for separating the parts for washing . as it can be seen in fig4 , the upper surface of the bristles and the upper edge of the bristle base 42 are given with a curvature approximating that of an ear of corn . referring again to fig5 , in the longitudinal center of the bristle base structure shown in fig5 is a reinforcing rib 82 . a projection 84 is formed which , when the bristle base 42 is fitted into the base member 22 , extends downwardly by a predetermined distance to abut against a surface 90 ( see fig6 ) of a bridge member 86 which is fitted into the cavity 60 of the base member 22 shown in fig3 . this provides vertical support for the flexible bristle base and bristles to prevent undue distortion under the scrubbing force or cutting force applied by the user . the cover 24 , which is shown in fig1 , 2 and 4 , has a thumb - shaped recess 43 ( fig1 ), two pairs of slight projections 49 located above and below the projection or flange 34 , and two slight vertical projections on the internal surface of the side wall 28 of the cover to mate with the projections 49 to provide a secure but releasable friction fit between the cover and the base member . the thumb recess 43 increases the degree of effective projection outwardly of the areas 35 which facilitates gripping of the cover and the base to push them together or pull them apart . the cutter 48 and its blade 52 are best seen in fig2 , 4 and 8 . the cutter 48 comprises a blade which is generally u - shaped with a curvature in the direction shown in fig3 so as to approximate the curvature of an ear of corn . referring again to fig3 , the base member 22 has a pair of through holes 72 and 74 , and a pair of upstanding projections , 76 and 78 near the holes . referring to fig2 , the cutter 48 includes the blade 52 with two legs 54 extending through the body 22 . fig3 shows those legs 54 are attached to the projections 76 and 78 to anchor the legs of the cutter solidly . the legs are attached by adhesive and ultrasonic bonding . the bridge member 86 is shown in fig7 and it forms two vertical receptacles 92 and 94 into which the projections 76 and 78 fit , with a pair of tabs 98 and 100 to fit into the holes 72 and 74 . the bridge has a curved undersurface as shown at 96 to match the curvature of the lower surface of the structure shown in fig3 . that curvature includes a raised portion 66 flanked by recessed portions 68 and 70 . referring to fig2 , the cutter 48 includes a blade 52 with serrated cutting teeth 50 . the cutter blade preferably is made of hard stainless steel of the type and quality used in food processor blades so that it maintains its sharpness for a long time . the undersurface 38 of the cutter / de - silker device has a longitudinal recess 46 which helps to allow the corn kernels to pass underneath the blade without being cut up any more than necessary . fig8 is a broken - away , cross - sectional view of the blade 52 . the forward cutting edge is ground to be beveled on both sides of the cutting edge , as shown at 102 and 104 . this has the advantage that the edge shape does not force the blade downwardly towards the corn cob to cut more of the corn kernels than is desired , nor upwardly to cut too little . this is in contrast to those prior cutters whose blades have been ground only on one side . some of the advantages of the invention have been described above . others include the fact that the assembled device 20 is relatively broad compared with prior devices . this allows a somewhat greater width for the cutting blade of the cutter , therefore allowing more to be cut with each stroke than in some prior devices , and yet does not require the use of excessive force . similarly , the greater width increases the width of the brush 40 compared with some prior devices , thereby increasing the coverage of the brush and , hence , the speed of the de - silking process . some of the materials of which the device shown in the drawings is made have been mentioned above . the base 22 and the bridge 86 preferably are made of high impact polystyrene , and the cover 24 preferably is made of san . these materials can be replaced by other suitable materials , within the skill of those experienced in the art . the above description of the invention is intended to be illustrative and not limiting . various changes or modifications in the embodiments described may occur to those skilled in the art . these can be made without departing from the spirit or scope of the invention .
a device is provided for cutting and / or de - silking corn on the cob . a single unit has a base and a removable cover . a brush for use in removing silks is mounted on one side of the base , and a cutter is mounted on the other side . when it is desired to use the tool on one side instead of the other , the cover is placed over the other tool . the cover then is used as an easy - to - grip palm - fitting structure to push the brush or the cutter along the ear of corn .
with further reference to the drawings , there is illustrated a frame 10 having a front cross member 11 , a rear cross member comprising upper and lower plates 12 and 13 , right and left side members 14 and 15 extending perpendicularly rearwardly from the front cross member 11 , and inclined side members 16 and 17 extending to the ends of the rear cross member 12 and 13 . at the rear of the front cross member 11 an arcuate plate 20 bridges the sides 14 and 15 for purposes which will be described . extending upwardly from the central and forward portion of the front cross member is an upper hitch plate 22 , in two parallel sections , and having a hitch pin 23 extending therethrough for the purposes of attaching to the hitch point of the tractor &# 39 ; s three point hitch . spaced at either side of the upper hitch plate 22 are right and left lower hitch plates 25 and 26 each of which comprises a pair of spaced plate side members that are connected to the front cross member 11 . between the side members of each lower hitch plate is a cylinder and piston assembly including cylinders 27 and 28 , pistons 29 and 30 , which are connected to clevises 31 and 32 carrying hitch pins 33 and 34 projecting from the sides of the outer hitch plates where the hitch pin may be received by the lower connections of the three point hitch on the tractor . the cylinders 27 and 28 are mounted by pins 34 and 35 across the tops of the spaced hitch plates in order to permit any necessary swinging movement of the cylinder and piston assemblies . in order to reduce the wear on the hitch plates , a replaceable and reversible metal wear plate 36 is mounted at the rear of each of the clevises 31 and 32 . this protects the slot in which the pin 33 reciprocates from excessive wear . the frame mounts a longitudinal beam which may be in two sections 40 and 41 . the forward section 40 is received intermediate the upper and lower rear cross members 12 and 13 and connected thereto by a pivot 42 which permits the beam to swing laterally of the frame . the forward end of the frame has a ledge plate with upper and lower sections 45 , 45 and wear strips 46 , 47 which ride on the top and bottom of the arcuate plate 20 previously described , in order to support the forward end of the longitudinal beam . in order to control the position of the longitudinal beam within the frame 10 a pair of cylinders 50 and 51 are mounted , one on each side of the beam . thus a right cylinder 50 is mounted with its cylinder intermediate the upper and lower portions of the rear cross member 12 and 13 by a pivot or trunnion mounting 52 , its piston 53 extending to a pin 54 mounted between a pair of lugs 55 which are in spaced relation from the forward end of the beam . similarly the cylinder 51 has a trunnion mounting 56 and a piston 57 which is connected to a pin 58 between lugs 59 on the opposite side of the beam . it will be apparent therefore that by the simultaneous operation of the piston assemblies that the forward portion of the longitudinal beam may be angularly shifted from side to side within the frame 10 . the front and rear portions of the longitudinal beam 40 - 41 have a series of spaced brackets 60 which are connected to mounting plates 61 for holding a series of spaced moldboards 62 . for purposes of convenience and flexibility , as previously indicated , the longitudinal beam may be divided into two portions 40 and 41 . the rear portion 41 of the beam has supports 70 and 71 for a rear wheel beam 72 for carrying a gauge wheel 73 . suitable adjusting means 74 are carried in the support 71 in order that the height of the gauge wheel may be adjusted . with reference to fig1 , the moldboards 62 may be made of curved metal frame sections 90 having upper bracket means 91 , central bracket means 92 and lower bracket means 93 with protective follower members 94 that aid in the control of the tractor . the frame sections 90 are faced with a wear sheet 95 secured by fasteners 96 and holder strip 97 for reducing the wear on the moldboards and the need for frequent replacement . the hydraulic control circuit for the positioning cylinders and tilt cylinders is illustrated in fig1 . in this figure lines 100 - 101 may connect to the hydraulic control lines of the tractor . these are connected to a double dual lock out box 102 . in box 102 line 100 is connected to joints 104 and 105 ; line 101 is connected to joints 106 and 107 . joints 104 is connected to lines 110 and 111 to one side of tilt cylinders 27 and 28 . joint 105 is connected to lines 113 and 114 to one side of positioning cylinders 50 and 51 . the return side of tilt cylinders 27 and 28 are connected by lines 115 and 116 to joint 106 and line 101 back to the tractor . similarly , the return lines 118 and 119 from the positioning cylinders 50 and 51 are connected to the joint 107 and line 120 to the line 101 to the tractor . in the operation of the tractor hydraulics , the opening of the circuit will generally unlock the circuit with the less pressure , which is usually the positioning cylinder circuit , permitting movement of these cylinders until the plow beam goes the maximum extent and hits the stop , either on the right or the left side . at this point the pressure build up and causes the tilt cylinders to operate . after all of the hydraulic functions have been completed additional pressure will bleed over to the tractor relief . when the tractor lever is returned to neutral , the double dual lockout will lock all of the cylinders , preventing them from any movements during the plowing operation . it will be understood that at the end of each row , the tractor three - way hitch is generally operated to raise the frame and the beam with the moldboards attached clear of the field until the tractor has turned 180 ° and is in position to resume plowing in the opposite direction . then the three - way hitch is lowered in order that plowing in the opposite direction may be done . during the time that the three way hitch is raised the hydraulic circuit may be operated in order to properly position the beam with the moldboards in the proper position for plowing ( see fig4 ) and also to properly position the frame in its appropriately tilted position . fig8 - 11 illustrate a modification of the invention . the modification is in the mounting by means of which the height of the left and right hitch pins are controlled . instead of having a separate cylinder and piston assembly for each of the hitch pins , the modification includes a hitch plate pivot assembly , as particularly illustrated in fig8 and 9 . the assembly includes a hitch plate 150 that is mounted on and depends downwardly from the front cross member 11 , substantially centrally thereof . the hitch plate has a center pivot 152 which supports a hitch bar 153 that is pivotally mounted between left and right lower hitch plates 154 and 155 . the hitch plates have openings 156 and 157 , respectively , for receiving the ends of the hitch bar as it oscillates , the hitch bar carrying left and right lift pins 159 and 160 . a pair of spaced lugs 162 - 163 are mounted over an opening 164 on the right side of the front cross member 11 and substantially over the right lower hitch plate 155 . the lug 162 carries a pivot pin 166 which mounts a cylinder 167 which operates a piston 168 connected to a web 169 of a clevis 170 which engages the hitch bar 153 by means of a pin 171 . accordingly , by operation of the cylinder and piston assembly the hitch bar may be caused to pivot about the pivot support 152 in order to raise and lower the right and left lift pins 160 and 159 . a replacement tee - shaped wear plate 173 is held by a clamp 174 connected to the hitch plate 155 and engaging the clevis 170 . in order to control the operation of the positioning cylinders and the single tilt cylinder of the modification a hydraulic hookup as indicated on fig1 is provided . the hookup includes the lines 100 - 101 to the tractor disconnects . the line 100 is connected to joint 180 and joint 181 which are connected to lines 182 and 183 , respectively , to one side of the positioning cylinders and the tilt cylinder . the other line 101 is connected to line 184 and line 185 to the other side of the cylinders of the positioning cylinders and the tilt cylinder . ordinarily , activating the tractor hydraulics will unlock the circuit with the lesser pressure , usually the position cylinder circuit , permitting movement of the cylinders until the plow beam hits the stop on either the right or the left side . this will then permit the tilt cylinder to function . after all of the hydraulic functions have been completed the additional pressure bleeds over to the tractor relief . when the tractor lever is returned to neutral the double dual lock - out , as previously described , will lock all the cylinders preventing any movement during plowing .
a reversible moldboard plow has a plow carrying beam swingably mounted at the rear crossbar of a frame which carries trunnion mounted cylinders connected to the beam for moving the beam , the front of the frame carrying hitch pins for connection to a tractor hitch , the hitch pins being vertically movable in alternate relation in order to tilt the frame and the beam with the moldboards supported thereon . the hitch pins may be moved by independent cylinders and pistons or , alternately , by the movement of a transverse hitch bar on which they are mounted .
in the following detailed description , numerous specific details are set forth in order to provide a thorough understanding of the invention . however , it will be understood by those skilled in the art that the present invention may be practiced without these specific details . in some instances , well - known methods , procedures , components and circuits have not been described in detail , for the sake of brevity . fig1 illustrates an anterior implant according to one embodiment of the present invention . anterior implant 1 includes four straps 10 , each ending with a looped end 20 . anterior implant 1 may also include a loop 8 between two interior straps 10 . anterior implant 1 may include spaces 4 for reducing the weight thereof . fig2 illustrates an anterior view of the pelvic area before installing the anterior implant . the anterior view of pelvic area 34 refers to the side allowing surgical access through the patient &# 39 ; s vaginal opening . denoted bones are the ischial spine 27 extending from the posterior border of the ischium 26 , and the sacrum 46 . also shown are the perineal body 52 , and the cervix 50 extending from the uterus ( womb ) 48 . pelvic area 34 includes two ligaments of arcus tendineous fascia pelvic ( atfp ) 30 and two ligaments of sacrospinous ( ss ) 28 . fig3 illustrates the view of fig2 after installing the anterior implant . anterior implant 1 is used for reconstructing the anterior pelvic floor , including prolapse of the urinary bladder and / or the colon and the small intestine . two straps 10 of anterior implant 1 are threaded into two atfp ligaments 30 , and the other two straps 10 are inserted into two ss ligaments 28 . loop 8 may be sutured to cervix 50 for improving strength and security of the anchoring of anterior implant 1 . fig4 illustrates a posterior implant according to one embodiment of the present invention . posterior implant 2 includes two straps 10 , each ending with a looped end 20 . posterior implant 2 may include a loop 36 between two interior straps 10 , and another loop 9 at the opposing side . posterior implant 2 may include spaces 4 for reducing the weight thereof . fig5 illustrates the view of fig2 after installing the posterior implant . posterior implant 2 is used for reconstructing the posterior pelvic floor , including prolapse of the colon , the small intestine and / or the uterus ( womb ). two straps 10 of posterior implant 2 are inserted into two ss ligaments 28 . loop 36 may be sutured to cervix 50 , and loop 9 may be sutured to perineal body 52 for improving the strength and security of the connection . fig6 illustrates the head of a needle for threading the straps of the implants , according to one embodiment of the present invention . a needle 6 is used for threading each of straps 10 through atfp ligaments 30 and ss ligaments 28 . the head of needle 6 includes a rod 18 , which may be manually slid back and forth in a track 16 within a body 14 , as in brake cables . the edge 42 of rod 18 may be inserted into a niche 40 . the tip 12 of needle 6 is located at the edge of body 14 . fig7 illustrates the first step of threading the straps of the implants , using the needle of fig6 . the surgeon inserts looped end 20 of strap 10 into niche 40 , and traps it by rod edge 42 of rod 18 into looped end 20 . in case that the surgeon has not succeeded in inserting rod 18 into looped end 20 , the surgeon may trap looped end 20 by applying physical force of rod edge 42 towards the limiting wall thereof in niche 40 . according to another embodiment the surgeon may trap strap 10 directly by applying physical force of rod edge 42 on the end of strap 10 towards the limiting wall thereof in niche 40 . fig8 illustrates the second step of threading the straps of the implants , using the needle of fig6 . the surgeon then pushes tip 12 together with body 14 into an atfp ligament 30 or into an ss ligament 28 , threading looped end 20 and strap 10 through the ligament . fig9 illustrates the third step of threading the straps of the implants , using the needle of fig6 . the surgeon then slides rod edge 42 out of niche 40 , releasing looped end 20 from rod edge 42 . fig1 illustrates the fourth step of threading the straps of the implants , using the needle of fig6 . the surgeon then pulls body 14 together with tip 12 out of atfp ligament 30 or ss ligament 28 . since looped end 20 has been released at the third step , and since ligament 30 ( or 28 ) shrinks tightly , as shown by the arrows , strap 10 remains threaded while tip 12 exits . fig1 illustrates the needle of fig6 and its operation . the surgeon holds handle 24 of needle 6 , and slides rod 18 by toggling a toggle arm 22 , which is connected to rod 18 . needle 6 as a whole may be flexible like a brake cable , thin and long enough to occupy minimal surgery space . since tip 12 is inserted into the pelvic area , and toggle arm 22 is far away tip 12 , toggle arm is located outside the body of the patient and may be located farther and outside the surgical area . it may be appreciated according to these steps that the surgeon can thread strap 10 from the side having surgical access , without requiring any additional perforations of the body from the opposing direction . fig1 illustrates the operation of the needle of fig6 in aspect of the surgeon &# 39 ; s access to the pelvic area . the surgeon inserts finger 32 thereof into the vagina 44 between the patient &# 39 ; s legs 38 and reaches pelvic area 34 ( the lines of the parts inside are dashed ). the surgeon then separates an ss ligament 28 from the other organs , locates tip 12 of needle 6 on a selected threading point on ss ligament 28 , and traps trapping looped end 20 to niche 40 of needle 6 . the surgeon then penetrates tip 12 through ss ligament 28 and pushes into the desired depth ; then releases looped end 20 from needle 6 by toggling toggle arm 22 , using the other hand thereof . the surgeon can then pull tip 12 back , leaving looped end 20 and strap 10 at the side beyond , having tight shrinking of ss ligament 28 towards strap 10 at the threaded point . tying of strap 10 is not required due to natural tying of ss ligament 28 to strap 10 . fig1 illustrates the operation of the needle of fig6 in aspect fig1 , to another ligament . the surgeon inserts the finger 32 thereof into vagina 44 , then separates an atfp ligament 30 , and locates tip 12 of needle 6 on the selected threading point , after trapping looped end 20 to niche 40 of needle 6 . the surgeon then penetrates tip 12 through atfp ligament 30 and on to the desired depth ; then releases looped end 20 from needle 6 by toggling toggle arm 22 , using the other hand thereof , then pulls tip 12 back leaving looped end 20 and strap 10 at the side beyond , having tight shrinking of atfp ligament 30 towards strap 10 at the threaded point . in the figures and description herein , the following numerals and symbols have been mentioned : numeral 4 denotes a space for reducing the weight of an implant ; numeral 6 denotes a needle according to one embodiment of the present invention ; numeral 8 denotes a loop in the anterior implant for anchoring it to the cervix ; numeral 9 denotes a loop in the posterior implant for anchoring it to the perineal body ; numeral 16 denotes a track within the body of the needle ; numeral 18 denotes a rod traveling within the body of the needle ; numeral 20 denotes a looped end at the edge of the implant strap ; numeral 22 denotes a toggle arm for trapping and releasing the looped end ; numeral 30 denotes an arcus tendineous fascia pelvic ( atfp ) ligament ; numeral 36 denotes a loop in the posterior implant for anchoring it to the cervix ; numeral 40 denotes a niche in the needle for trapping the looped end of the strap ; numeral 42 denotes the edge of the rod sliding in the track ; numeral 44 denotes the vagina , into which the surgeon inserts the finger thereof ; while certain features of the invention have been illustrated and described herein , the invention can be embodied in other forms , ways , modifications , substitutions , canchores , equivalents , and so forth . the foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description . it is not intended to be exhaustive or to limit the invention to the precise form disclosed . many modifications and variations are possible in light of this disclosure . it is intended that the scope of the invention be limited not by this detailed description , but rather by the claims appended hereto .
in one aspect , the present invention may be directed to a needle for surgical threading of a strap of an implant through a tissue , the needle comprising : a trap for trapping the strap to the needle while the needle may be at the accessible side of the tissue ; a tip for threading the trapped strap from the accessible side to the opposing side ; and a mechanism for releasing the trap , the mechanism driven from the accessible side of the tissue , thereby allowing return of the tip to the accessible side of the tissue while abandoning the strap at the threaded point , thus performing the threading from the accessible side of the tissue .
the two embodiments to be described are ventilators that operate in a manner that seeks to simultaneously achieve the three goals stated above . apparatus to give effect to a first embodiment of the apparatus is shown in fig1 a . a blower 10 supplies a breathable gas to mask 11 in communication with the subject &# 39 ; s airway via a delivery tube 12 and exhausted via a exhaust diffuser 13 . airflow to the mask 11 is measured using a pneumotachograph 14 and a differential pressure transducer 15 . the mask flow signal from the transducer 15 is then sampled by a microprocessor 16 . mask pressure is measured at the port 17 using a pressure transducer 18 . the pressure signal from the transducer 18 is then sampled by the microprocessor 16 . the microprocessor 16 sends an instantaneous mask pressure request signal to the servo 19 , which compares said pressure request signal with actual pressure signal from the transducer 18 to the control fan motor 20 . the microprocessor settings can be adjusted via a serial port 21 . it is to be understood that the mask could equally be replaced with a tracheotomy tube , endotracheal tube , nasal pillows , or other means of making a sealed connection between the air delivery means and the subject &# 39 ; s airway . the microprocessor 16 is programmed to perform the following steps , to be considered in conjunction with tables 1 and 2 . 1 . set desired target values for the duration of inspiration ti tgt , duration of expiration te tgt , and minute ventilation v tgt . choose suitable constants p 0 and a std where p 0 is the desired end expiratory pressure , and a std is the desired increase in pressure above p 0 at end inspiration for a breath of duration tt tgt = ti tgt + te tgt . 2 . choose a suitable pressure waveform function π ( φ ), such as that shown in fig2 , such that the desired delivery pressure at phase φ will be given by : where the amplitude a equals the difference between the end inspiratory pressure and end expiratory pressure . however , other waveforms may be suitable for subjects with particular needs . 3 . initialize the phase φ in the respiratory cycle to zero , and initialize the current estimates of actual inspiratory and expiratory duration ti and te to ti tgt and te tgt respectively . 4 . initialize the rate of change of phase during inspiration δφ i between sampling intervals of length t to : 5 . initialize the rate of change of phase during expiration δφ e to : 8 . low pass filter the respiratory airflow with an adjustable time constant τf , where τf is a fixed small fraction of tt . 9 . calculate the instantaneous ventilation v , as half the absolute value of the respiratory airflow : 10 . from the target ventilation v tgt and the measured minute ventilation v , derive an error term v err , such that large values of v err indicate inadequate ventilation : 11 . take v bar as the result of low pass filtering v with a time constant τv bar which is long compared with tt . 13 . from f norm , calculate the degree of membership in each of the fuzzy sets whose membership functions are shown in fig3 . 14 . calculate a normalized rate of change df norm / dφ , equal to df norm / dt divided by the current estimate of the average respiratory cycle time tt . 15 . from the normalized rate of change , calculate the degree of membership in each of the fuzzy sets shown in fig4 . 16 . for each row n in table 1 , calculate the degree of membership g n in the fuzzy set shown in the column labelled fuzzy phase , by applying the fuzzy inference rules shown . 17 . associate with the result of each of the n rules a phase φ n as shown in table 2 , noting that φ 10 is the current phase φ . 18 . increase each of the φ n excepting φ 10 by 0 . 89 τ / tt , to compensate for the previous low pass filtering step . 19 . calculate a new instantaneous phase φ inst as the angle to the center of gravity of n unit masses at polar coordinates of radius g n and angle φ n revolutions . 20 . calculate the smallest signed difference δφ inst bewteen the phase estimated in the previous step and the current phase . δφ inst = 1 − ( δφ inst − φ ) ( φ inst − φ & gt ; 0 . 5 ) δφ inst = φ inst − φ + 1 ( φ inst − φ & lt ; − 0 . 5 ) δφinst = φ inst − φ ( otherwise ) 21 . derive a revised estimate δφ rev equal to a weighted mean of the value calculated in the previous step and the average value ( δφ i or δφ e as appropriate ). δφ = ( 1 − w ) δφ i + wδφ inst ( 0 & lt ; φ & lt ; 0 . 5 ) δφ = ( 1 − w ) δφ i + wδφ inst ( otherwise ) smaller values of w will cause better tracking of phase if the subject is breathing regularly , and larger values will cause better tracking of phase if the subject is breathing irregularly . 22 . derive a blending fraction b , such that the blending fraction is unity if the subject &# 39 ; s ventilation is well above v tgt , zero if the subject is breathing near or below v tgt , and increasing proportionally from zero to unity as the subject &# 39 ; s ventilation increases through an intermediate range . 23 . calculate δφ blend influenced chiefly by δφ calculated in step 21 from the subject &# 39 ; s respiratory activity if the subject &# 39 ; s ventilation is well above v tgt ; influenced chiefly by the target respiratory duration if the subject is breathing near or below v tgt ; and proportionally between these two amounts if ventilation is in an intermediate range : δφ blend = b δφ + 0 . 5 ( 1 − b ) t / ti tgt ( 0 & lt ; φ & lt ; 0 . 5 ) δφ blend = b δφ + 0 . 5 ( 1 − b ) t / te tgt ( otherwise ) 25 . update the average rate of change of phase ( δφ i or δφ e as appropriate ). δφ i = t / τ vbar ( δφ blend − δφ i ) ( 0 & lt ; φ & lt ; 0 . 5 ) δφ e = t / τ vbar ( δφ blend − δφ e ) ( otherwise ) 26 . recalculate the approximate duration of inspiration ti and expiration te : 27 . calculate the desired mask pressure modulation amplitude a d : a d = a std / 2 ( tt & lt ; tt std / 2 ) a d = 2 · a std ( tt & gt ; 2 · tt std ) a d = a std · tt / tt std ( otherwise ) 28 . from the error term v err , calculate an additional mask pressure modulation amplitude a e : a e = k · v err ( for v err & gt ; 0 ) a e = 0 ( otherwise ) where larger values of k will produce a faster but less stable control of the degree of assistance , and smaller values of k will produce slower but more stable control of the degree of assistance . 29 . set the mask pressure p mask to : p mask = p 0 +( a d + a e ) π ( φ ) 30 . wait for a sampling interval t , short compared with the duration of a respiratory cycle , and then continue at the step of measuring respiratory airflow . as follows from above , it is necessary to respiratory airflow , which is a standard procedure to one skilled in the art . in the absence of leak , respiratory airflow can be measured directly with a pneumotachograph placed between the mask and the exhaust . in the presence of a possible leak , one method disclosed in european publication no 0 651 971 incorporated herein by cross - reference is to calculate the mean flow through the leak , and thence calculate the amount of modulation of the pneumotachograph flow signal due to modulation of the flow through the leak induced by changing mask pressure , using the following steps : 1 . measure the airflow at the mask f mask using a pneumotachograph 2 . measure the pressure at the mask p mask 3 . calculate the mean leak as the low pass filtered airflow , with a time constant long compared with a breath . 4 . calculate the mean mask pressure as the low pass filtered mask pressure , with a time constant long compared with a breath . 5 . calculate the modulation of the flow through the leak as : a convenient extension as further disclosed in ep 0 651 971 ( incorporated herein by cross - reference ) is to measure airflow f turbine and pressure p turbine at the outlet of the turbine , and thence calculate p mask and f mask by allowing for the pressure drop down the air delivery hose , and the airflow lost via the exhaust : 1 . δp hos e = k 1 ( f turbine )− k 2 ( f turbine ) 2 2 . pmask = p turbine − δp hose 3 . f exhaust = k3 √ p mask 4 . f mask = f turbine − f exhaust the following embodiment is particularly applicable to subjects with varying respiratory mechanics , insufficient respiratory drive , abnormal chemoreceptor reflexes , hypoventilation syndromes , or cheyne stokes breathing , or to subjects with abnormalities of the upper or lower airways , lungs , chest wall , or neuromuscular system . many patients with severe lung disease cannot easily be treated using a smooth physiological pressure waveform , because the peak pressure required is unacceptably high , or unachievable with for example a nose - mask . such patients may prefer a square pressure waveform , in which pressure rises explosively fast at the moment of commencement of inspiratory effort . this may be particularly important in patients with high intrinsic peep , in which it is not practicable to overcome the intrinsic peep by the use of high levels of extrinsic peep or cpap , due to the risk of hyperinflation . in such subjects , any delay in triggering is perceived as very distressing , because of the enormous mis - match between expected and observed support . smooth waveforms exaggerate the perceived delay , because of the time taken for the administered pressure to exceed the intrinsic peep . this embodiment permits the use of waveforms varying continuously from square ( suitable for patients with for example severe lung or chest wall disease or high intrinsic peep ) to very smooth , suitable for patients with normal lungs and chest wall , but abnormal respiratory control , or neuromuscular abnormalities . this waveform is combined either with or without elements of proportional assist ventilation ( corrected for sudden changes in leak ), with servo - control of the minute ventilation to equal or exceed a target ventilation . the latter servo - control has an adjustable gain , so that subjects with for example cheyne stokes breathing can be treated using a very high servo gain to over - ride their own waxing and waning patterns ; subjects with various central hypoventilation syndromes can be treated with a low servo gain , so that short central apneas are permitted , for example to cough , clear the throat , talk , or roll over in bed , but only if they follow a previous period of high ventilation ; and normal subjects are treated with an intermediate gain . the integral gain of the servo - control of the degree of assistance is adjustable from very fast ( 0 . 3 cmh 2 o / l / sec / sec ) to very slow . patients with cheyne - stokes breathing have a very high ventilatory control loop gain , but a long control loop delay , leading to hunting . by setting the loop gain even higher , the patient &# 39 ; s controller is stabilized . this prevents the extreme breathlessness that normally occurs during each cycle of cheyne - stokes breathing , and this is very reassuring to the patient . it is impossible for them to have a central apnea . conversely , subjects with obesity - hypoventilation syndrome have low or zero loop gain . they will not feel breathless during a central apnea . however , they have much mucus and need to cough , and are also often very fidgety , needing to roll about in bed . this requires that they have central apneas which the machine does not attempt to treat . by setting the loop gain very low , the patient is permitted to take a couple of deep breaths and then have a moderate - length central apnea while coughing , rolling over , etc , but prolonged sustained apneas or hypopneas are prevented . sudden changes in leakage flow are detected and handled using a fuzzy logic algorithm . the principle of the algorithm is that the leak filter time constant is reduced dynamically to the fuzzy extent that the apparent respiratory airflow is a long way from zero for a long time compared with the patient &# 39 ; s expected respiratory cycle length . rather than simply triggering between two states ( ipap , epap ), the device uses a fuzzy logic algorithm to estimate the position in the respiratory cycle as a continuous variable . the algorithm permits the smooth pressure waveform to adjust it &# 39 ; s rise time automatically to the patient &# 39 ; s instantaneous respiratory pattern . the fuzzy phase detection algorithm under normal conditions closely tracks the patient &# 39 ; s breathing . to the extent that there is a high or suddenly changing leak , or the patient &# 39 ; s ventilation is low , the rate of change of phase ( respiratory rate ) smoothly reverts to the specified target respiratory rate . longer or deeper hypopneas are permitted to the extent that ventilation is on average adequate . to the extent that the servo gain is set high to prevent cheyne stokes breathing , shorter and shallower pauses are permitted . airflow filtering uses an adaptive filter , which shortens it &# 39 ; s time constant if the subject is breathing rapidly , to give very fast response times , and lenthens if the subject is breathing slowly , to help eliminate cardiogenic artifact . the fuzzy changing leak detection algorithm , the fuzzy phase detection algorithm with its differential handling of brief expiratory pauses , and handling of changing leak , together with the smooth waveform severally and cooperatively make the system relatively immune to the effects of sudden leaks . by suitably setting various parameters , the system can operate in cpap , bilevel spontaneous , bilevel timed , proportional assist ventilation , volume cycled ventilation , and volume cycled servo - ventilation , and therefore all these modes are subsets of the present embodiment . however , the present embodiment permits states of operation that can not be achieved by any of the above states , and is therefore distinct from them . note 1 : in this second embodiment , the names and symbols used for various quantities may be different to those used in the first embodiment . note 2 : the term “ swing ” is used to refer to the difference between desired instantaneous pressure at end inspiration and the desired instantaneous pressure at end expiration . note 3 : a fuzzy membership function is taken as returning a value between zero for complete nonmembership and unity for complete membership . fuzzy intersection a and b is the lesser of a and b , fuzzy union a or b is the larger of a and b , and fuzzy negation not a is 1 − a . note 4 : root ( x ) is the square root of x , abs ( x ) is the absolute value of x , sign ( x ) is − 1 if x is negative , and + 1 otherwise . an asterisk (*) is used to explicitly indicate multiplication where this might not be obvious from context . the apparatus for the second embodiment is shown in fig1 b . the blower 110 delivers air under pressure to the mask 111 via the air delivery hose 112 . exhaled air is exhausted via the exhaust 113 in the mask 111 . the pneumotachograph 114 and a differential pressure transducer 115 measure the airflow in the nose 112 . the flow signal is delivered to the microprocessor 116 . pressure at any convenient point 117 along the nose 112 is measured using a pressure transducer 118 . the output from the pressure transducer 118 is delivered to the microcontroller 116 and also to a motor servo 119 . the microprocessor 116 supplies the motor servo 119 with a pressure request signal , which is then compared with the signal from the pressure transducer 118 to control the blower motor 120 . user configurable parameters are loaded into the microprocessor 116 via a communications port 121 , and the computed mask pressure and flow can if desired be output via the communications port 121 . max permissible maximum permissible mask pressure pressure max swing maximum permissible difference between end inspiratory pressure and end expiratory pressure . min swing minimum permissible difference between end inspiratory pressure and end expiratory pressure . epap end expiratory pressure min permissible minimum permissible mask pressure pressure target ventilation minute ventilation is sevo - controlled to equal or exceed this quantity target frequency expected respiratory rate . if the patient is achieving no respiratory airflow , the pressure will cycle at this frequency . target duty cycle expected ratio of inspiratory time to cycle time . if the patient is achieving no respiratory airflow , the pressure will follow this duty cycle . linear resistance resistive unloading = linear resistance * f + andquad resistance quad_resistance * f 2 sign ( f ), where f is the respiratory airflow . where sign ( x ) = − 1 for x & lt ; 0 , + 1 otherwise elastance unload at least this much elastance servo gain gain for servo - control of minute ventilation to at least exceed target ventilation . waveform time constant elastic unloading waveform time constant as a fraction of inspiratory duration . ( 0 . 0 = square wave ) hose resistance δp from pressure sensing port to inside mask = hose resistance times the square of the flow in the intervening tubing . diffuser conductance flow through the mask exhaust port = diffuser conductance * root mask pressure the expected duration of a respiratory cycle , of an inspiration , and of an expiration are set respectively to : the standard rates of change of phase ( revolutions per sec ) during inspiration and expiration are set respectively to : the instantaneous elastic support at any phase φ in the respiratory cycle is given by : π ( φ ) = e − 2 τφ during inspiration , e − 4 t ( φ − 0 . 5 ) during expiration if τ = 0 , then π ( φ ) is a square wave . the maximum implemented value for τ = 0 . 3 , producing a waveform approximately as shown in fig5 . π bar = 0 . 5 ⁢ ∫ 0 . 05 ` ⁢ π ⁡ ( ϕ ) ⁢ ⁢ ⅆ ϕ the following is an overview of routine processing done at 50 hz : measure flow at flow sensor and pressure at pressure sensing port calculate mask pressure and flow from sensor pressure and flow calculate conductance of mask leak calculate instantaneous airflow through leak calculate respiratory airflow and low pass filtered respiratory airflow calculate mask on - off status and lead - in calculate instantaneous and recent peak jamming calculate time constant for leak conductance calculations calculate phase in respiratory cycle update mean rates of change of phase for inspiration and expiration , lengths of inspiratory and expiratory times , and respiratory rate add hose pressure loss to epap pressure add resistive unloading calculate instantaneous elastic assistance required to servo - control ventilation estimate instantaneous elastic recoil pressure using various assumptions weight and combine estimates add servo pressure to yield desired sensor pressure servo - control motor speed to achieve desired sensor pressure flow is measured at the outlet of the blower using a pneumotachograph and differential pressure transducer . pressure is measured at any convenient point between the blower outlet and the mask . a humidifier and / or anti - bacterial filter may be inserted between the pressure sensing port and the blower . flow and pressure are digitized at 50 hz using an a / d converter . the pressure loss from pressure measuring point to mask is calculated from the flow at the blower and the ( quadratic ) resistance from measuring point to mask . where sign ( x )=− 1 for x & lt ; 0 , + 1 otherwise . the mask pressure is then calculated by subtracting the hose pressure loss from the measured sensor pressure : the flow through the mask exhaust diffuser is calculated from the known parabolic resistance of the diffuser holes , and the square root of the mask pressure : the foregoing describes calculation of mask pressure and flow in the various treatment modes . in diagnostic mode , the patient is wearing only nasal cannulae , not a mask . the cannula is plugged into the pressure sensing port . the nasal airflow is calculated from the pressure , after a linearization step , and the mask pressure is set to zero by definition . the time constant for the two low pass filtering steps is initialized to 10 seconds and adjusted dynamically thereafter ( see below ). the instantaneous flow through the leak is calculated from the instantaneous mask pressure and the conductance of the leak : the respiratory airflow is the difference between the flow at the mask and the instantaneous leak : low pass filter the respiratory airflow to remove cardiogenic airflow and other noise . the time constant is dynamically adjusted to be 1 / 40 of the current estimated length of the respiratory cycle t tot ( initialized to std_t tot and updated below ). this means that at high respiratory rates , there is only a short phase delay introduced by the filter , but at low respiratory rates , there is good rejection of cardiogenic airflow . the mask is assumed to initially be off . an off - on transition is taken as occurring when the respiratory airflow first goes above 0 . 2 l / sec , and an on - off transition is taken as occurring if the mask pressure is less than 2 cmh 2 o for more than 1 . 5 seconds . lead - in is a quantity that runs from zero if the mask is off , or has just been donned , to 1 . 0 if the mask has been on for 20 seconds or more , as shown in fig6 . j is the fuzzy extent to which the impedance of the leak has suddenly changed . it is calculated as the fuzzy extent to which the absolute magnitude of the respiratory airflow is large for longer than expected . the fuzzy extent a i to which the airflow has been positive for longer than expected is calculated from the time t zi since the last positive - going zero crossing of the calculated respiratory airflow signal , and the expected duration std t i of a normal inspiration for the particular subject , using the fuzzy membership function shown in fig7 . the fuzzy extent b i to which the airflow is large and positive is calculated from the instantaneous respiratory airflow using the fuzzy membership function shown in fig8 . the fuzzy extent i i to which the leak has suddenly increased is calculated by calculating the fuzzy intersection ( lesser ) of a i and b i . precisely symmetrical calculations are performed for expiration , deriving i e . as the fuzzy extent to which the leak has suddenly decreased . a e is calculated from t ze and t e , b e is calculated from minus f resp , and i e is the fuzzy intersection of a e and b e . the instantaneous jamming index j is calculated as the fuzzy union ( larger ) of indices i i and i e . if the instantaneous jamming index is larger than the current value of the recent peak jamming index , then the recent peak jamming index is set to equal the instantaneous jamming index . otherwise , the recent peak jamming index is set to equal the instantaneous jamming index low pass filtered with a time constant of 10 seconds . an electrical analogy of the calculation is shown in fig9 . if the conductance of the leak suddenly changes , then the calculated conductance will initially be incorrect , and will gradually approach the correct value at a rate which will be slow if the time constant of the low pass filters is long , and fast if the time constant is short . conversely , if the impedance of the leak is steady , the longer the time constant the more accurate the calculation of the instantaneous leak . therefore , it is desirable to lengthen the time constant to the extent that the leak is steady , reduce the time constant to the extent that the leak has suddenly changed , and to use intermediately longer or shorter time constants if it is intermediately the case that the leak is steady . if there is a large and sudden increase in the conductance of the leak , then the calculated respiratory airflow will be incorrect . in particular , during apparent inspiration , the calculated respiratory airflow will be large positive for a time that is large compared with the expected duration of a normal inspiration . conversely , if there is a sudden decrease in conductance of the leak , then during apparent expiration the calculated respiratory airflow will be large negative for a time that is large compared with the duration of normal expiration . therefore , the time constant for the calculation of the conductance of the leak is adjusted depending on j peak , which is a measure of the fuzzy extent that the leak has recently suddenly changed , as shown in fig1 . in operation , to the extent that there has recently been a sudden and large change in the leak , j peak will be large , and the time constant for the calculation of the conductance of the leak will be small , allowing rapid convergence on the new value of the leakage conductance . conversely , if the leak is steady for a long time , j peak will be small , and the time constant for calculation of the leakage conductance will be large , enabling accurate calculation of the instantaneous respiratory airflow . in the spectrum of intermediate situations , where the calculated instantaneous respiratory airflow is larger and for longer periods , j peak will be progressively larger , and the time constant for the calculation of the leak will progressively reduce . for example , at a moment in time where it is uncertain whether the leak is in fact constant , and the subject has merely commenced a large sigh , or whether in fact there has been a sudden increase in the leak , the index will be of an intermediate value , and the time constant for calculation of the impedance of the leak will also be of an intermediate value . the advantage is that some corrective action will occur very early , but without momentary total loss of knowledge of the impedance of the leak . the current phase φ runs from 0 for start of inspiration to 0 . 5 for start of expiration to 1 . 0 for end expiration = start of next inspiration . nine separate features ( peaks , zero crossings , plateaux , and some intermediate points ) are identified on the waveform , as shown in fig1 . the filtered respiratory airflow is normalized with respect to the user specified target ventilation as follows : next , the fuzzy membership in fuzzy sets large negative , small negative , zero , small positive , and large positive , describing the instantaneous airflow is calculated using the membership functions shown in fig1 . for example , if the normalized airflow is 0 . 25 , then the airflow is large negative to extent 0 . 0 , small negative to extent 0 . 0 , zero to extent 0 . 5 , small positive to extent 0 . 5 , large positive to extent 0 . 00 . the rate of change of filtered respiratory airflow is calculated and normalized to a target ventilation of 7 . 5 l / min at 15 breaths / min as follows : now evaluate the membership of normalized df / dt in the fuzzy sets falling , steady , and rising , whose membership functions are shown in fig1 . ventilation = abs ( respiratory airflow ), low pass filtered with a time constant of stdt tot . hypopnea is the fuzzy extent to which the normalized ventilation is zero . the membership function for hypopnea is shown in fig1 . recent ventilation is also a low pass filtered abs ( respiratory airflow ), but filtered with an adjustable time constant , calculated from servo gain ( specified by the user ) as shown in fig1 . for example , if the servo gain is set to the maximum value of 0 . 3 , the time constant is zero , and recent ventilation equals instantaneous abs ( respiratory airflow ). conversely , if servo gain is zero , the time constant is twice std t tot , the expected length of a typical breath . hyperpnea is the fuzzy extent to which the recent ventilation is large . the membership function for hyperpnea is shown in fig1 . the fuzzy extent to which there is a big leak is calculated from the membership function shown in fig1 . membership in fuzzy sets switch negative and switch positive are calculated from the normalized respiratory airflow using the membership functions shown in fig1 , and membership in fuzzy sets insp_phase and exp_phase are calculated from the current phase f using the membership functions shown in fig1 . procedure w ( y ) calculates the area of an isosceles triangle of unit height and unit base , truncated at height y as shown in fig2 . in the calculations that follow , recall that fuzzy intersection a and b is the smaller of a and b , fuzzy union a or b is the larger of a and b , and fuzzy negation not a is 1 − a . the first fuzzy rule indicates that lacking any other information the phase is to increase at a standard rate . this rule is unconditionally true , and has a very heavy weighting , especially if there is a large leak , or there has recently been a sudden change in the leak , or there is a hypopnea . the next batch of fuzzy rules correspond to the detection of various features of a typical flow - vs - time curve . these rules all have unit weighting , and are conditional upon the fuzzy membership in the indicated sets : w peak insp = w ( large positive and steady and not recent peak jamming ) the next rule indicates that there is a legitimate expiratory pause ( as opposed to an apnea ) if there has been a recent hyperpnea and the leak has not recently changed : w pause =( hyperpnea and not j peak )* w ( steady and zero ) recalling that the time constant for hyperpnea gets shorter as servo gain increases , the permitted length of expiratory pause gets shorter and shorter as the servo gain increases , and becomes zero at maximum servo gain . the rationale for this is that ( i ) high servo gain plus long pauses in breathing will result in “ hunting ” of the servo - controller , and ( ii ) in general high servo gain is used if the subject &# 39 ; s chemoreceptor responses are very brisk , and suppression of long apneas or hypopneas will help prevent the subject &# 39 ; s own internal servo - control from hunting , thereby helping prevent cheyne - stokes breathing . finally , there are two phase - switching rules . during regular quiet breathing at roughly the expected rate , these rules should not strongly activate , but they are there to handle irregular breathing or breathing at unusual rates . they have very heavy weightings . for each of the ten fuzzy rules above , we attach phase angles f n , as shown in table zzz . note that φ are in revolutions , not radians . we now place the ten masses w ( n ) calculated above at the appropriate phase angles φ n around the unit circle , and take the centroid . rule n φ n standard 1 current φ trig insp 2 0 . 00 early insp 3 0 . 10 peak insp 4 0 . 30 late insp 5 0 . 50 trig exp 6 0 . 5 + 0 . 05 k early exp 7 0 . 5 + 0 . 10 k peak exp 8 0 . 5 + 0 . 20 k late exp 9 0 . 5 + 0 . 4 k exp pause 10 0 . 5 + 0 . 5 k note that if the user has entered very short duty cycle , k will be small . for example a normal duty cycle is 40 %, giving k = 40 / 60 = 0 . 67 . thus the expiratory peak will be associated with a phase angle of 0 . 5 + 0 . 2 * 0 . 67 = 0 . 63 , corresponding 26 % of the way into expiratory time , and the expiratory pause would start at 0 . 5 + 0 . 5 * 0 . 67 = 0 . 83 , corresponding to 67 % of the way into expiratory time . conversely , if the duty cycle is set to 20 % in a patient with severe obstructive lung disease , features 6 through 10 will be skewed or compressed into early expiration , generating an appropriately longer expiratory pause . the new estimate of the phase is the centroid , in polar coordinates , of the above ten rules : centroid = arc ⁢ ⁢ tan ⁡ ( ∑ w n ⁢ sin ⁢ ⁢ ϕ n ∑ w n ⁢ cos ⁢ ⁢ ϕ n ) the change in phase dφ from the current phase φ to the centroid is calculated in polar coordinates . thus if the centroid is 0 . 01 and the current phase is 0 . 99 , the change in phase is dφ = 0 . 02 . conversely , if the centroid is 0 . 99 and the current phase is 0 . 01 , then dφ =− 0 . 02 . the new phase is then set to the centroid : this concludes the calculation of the instantaneous phase in the respiratory cycle φ . estimated mean duration of inspiration , expiration , cycle time , and respiratory rate if the current phase is inspiratory ( φ & lt ; 0 . 5 ) the estimated duration of inspiration t i is updated : lp ( dφ i )= low pass filtered dφ with a time constant of 4 * stdt tot conversely , if the current phase is expiratory , ( φ & gt ;= 0 . 5 ) the estimated duration of expiration t e is updated : lp ( dφ e )= low pass filtered dφ with a time constant of 4 * stdt tot the purpose of the clipping is firstly to prevent division by zero , and also so that the calculated t i and t e are never more than a factor of 4 shorter or a factor of 2 longer than expected . finally , the observed mean duration of a breath t tot and respiratory rate rr are : the resistive unloading is the pressure drop across the patient &# 39 ; s upper and lower airways , calculated from the respiratory airflow and resistance values stored in sram the purpose of the instantaneous elastic assistance is to provide a pressure which balances some or all of the elastic deflating pressure supplied by the springiness of the lungs and chest wall ( instantaneous elastic pressure ), plus an additional component required to servo - control the minute ventilation to at least exceed on average a pre - set target ventilation . in addition , a minimum swing , always present , is added to the total . the user - specified parameter elastance is preset to say 50 - 75 % of the known or estimated elastance of the patient &# 39 ; s lung and chest wall . the various components are calculated as follows : the quantity servo swing is the additional pressure modulation amplitude required to servo - control the minute ventilation to at least equal on average a pre - set target ventilation . minute ventilation is defined as the total number of litres inspired or expired per minute . however , we can &# 39 ; t wait for a whole minute , or even several seconds , to calculate it , because we wish to be able to prevent apneas or hypopneas lasting even a few seconds , and a pi controller based on an average ventilation over a few seconds would be either sluggish or unstable . the quantity actually servo - controlled is half the absolute value of the instantaneous respiratory airflow . a simple clipped integral controller with no damping works very satisfactorily . the controller gain and maximum output ramp up over the first few seconds after putting the mask on . if we have had a sudden increase in mouth leak , airflow will be nonzero for a long time . a side effect is that the ventilation will be falsely measured as well above target , and the amount of servo assistance will be falsely reduced to zero . to prevent this , to the extent that the fuzzy recent peak jamming index is large , we hold the degree of servo assistance at its recent average value , prior to the jamming . set recent servo swing = servo swing low pass filtered with a time constant of 25 sec . the instantaneous servo assistance is calculated by multiplying servo swing by the previously calculated pressure waveform template : the instantaneous pressure required to unload the elastic work of inspiring against the user - specified elastance is the specified elastance times the instantaneous inspired volume . unfortunately , calculating instantaneous inspired volume simply by integrating respiratory airflow with respect to time does not work in practice for three reasons : firstly leaks cause explosive run - away of the integration . secondly , the integrator is reset at the start of each inspiration , and this point is difficult to detect reliably . thirdly , and crucially , if the patient is making no efforts , nothing will happen . therefore , four separate estimates are made , and a weighted average taken . estimate 1 : exact instantaneous elastic recoil calculated from instantaneous tidal volume , with a correction for sudden change in leak the first estimate is the instantaneous elastic recoil of a specified elastance at the estimated instantaneous inspired volume , calculated by multiplying the specified elastance by the integral of a weighted respiratory airflow with respect to time , reset to zero if the respiratory phase is expiratory . the respiratory airflow is weighted by the fuzzy negation of the recent peak jamming index j peak , to partly ameliorate an explosive run - away of the integral during brief periods of sudden increase in leak , before the leak detector has had time to adapt to the changing leak . in the case where the leak is very steady , j peak will be zero , the weighting will be unity , and the inspired volume will be calculated normally and correctly . in the case where the leak increases suddenly , j peak will rapidly increase , the weighting will decrease , and although typically the calculated inspired volume will be incorrect , the over - estimation of inspired volume will be ameliorated . calculations are as follows : estimate 2 : based on assumption that the tidal volume equals the target tidal volume the quantity standard swing is the additional pressure modulation amplitude that would unload the specified elastance for a breath of a preset target tidal volume . estimate 3 : based on assumption that the tidal volume equals the target tidal volume divided by the observed mean respiratory rate rr calculated previously . estimate 4 : based on assumption that this breath is much like recent breaths the instantaneous assistance based on the assumption that the elastic work for this breath is similar to that for recent breaths is calculated as follows : lp elastic assistance = instantaneous elastic assistance low pass filtered with a time constant of 2 stdt tot the above algorithm works correctly even if π ( φ ) is dynamically changed on - the - fly by the user , from square to a smooth or vice versa . for example , if an 8 cmh 2 o square wave ( π bar = 1 ) adequately assists the patient , then a sawtooth wave ( π bar = 0 . 5 ) will require 16 cmh 2 o swing to produce the same average assistance . next , calculate the pressure required to unload a best estimate of the actual elastic recoil pressure based on a weighted average of the above . if π ( φ ) is set to the smoothest setting , the estimate is based equally on all the above estimates of instantaneous elastic recoil . if π ( φ ) is a square wave , the estimate is based on all the above estimates except for estimate 1 , because a square wave is maximal at φ = 0 , whereas estimate 1 is zero at φ = 0 . intermediate waveforms are handled intermediately . quantity smoothness runs from zero for a square wave to 1 for a waveform time constant of 0 . 3 or above . now add the estimates based on minimum and servo swing , truncate so as not to exceed a maximum swing set by the user . reduce ( lead in gradually ) if the mask has only just been put on . truncate i to be less than preset maximum permissible swing instantaneous elastic assistance = i * lead - in in the final step , the measured pressure at the sensor is servo - controlled to equal the desired sensor pressure , using for example a clipped pseudodifferential controller to adjust the motor current . reference can be made to fig1 in this regard . fig2 - 27 each show an actual 60 second recording displaying an aspect of the second embodiment . all recordings are from a normal subject trained to perform the required manoeuvres . calculated respiratory airflow , mask pressure , and respiratory phase are calculated using the algorithms disclosed above , output via a serial port , and plotted digitally . in fig2 - 26 respiratory airflow is shown as the darker tracing , the vertical scale for flow being ± l / sec , inspiration upwards . the vertical scale for the pressure ( light trace ) is 0 . 2 cmh 2 o . fig2 is recorded with the servo gain set to 0 . 1 cmh 2 o / l / sec / sec , which is suitable for subjects with normal chemoflexes . the subject is breathing well above the minimum ventilation , and a particularly deep breath ( sigh ) is taken at point ( a ). as is usual , respiratory effort ceases following the sigh , at point ( c ). the device correctly permits a short central apnea ( b ), as indicated by the device remaining at the end expiratory pressure during the period marked ( b ). conversely fig2 shows that if there is no preceding deep breath , when efforts cease at ( a ), the pressure correctly continues to cycle , thus preventing any hypoxia . fig2 is recorded with servo gain set high , as would be appropriate for a subject with abnormally high chemoreflexes such as is typically the case with cheyne - stokes breathing . now when effort ceases at arrow ( a ), pressure continues to cycle and a central apnea is no longer permitted , despite preceding deep breathing . this is advantageous for preventing the next cycle of cheyne - stokes breathing . the above correct behaviour is also exhibited by a time mode device , but is very different to that of a spontaneous mode bilevel device , or equally of proportional assist ventilation , both of which would fail to cycle after all central apneas , regardless of appropriateness . fig2 shows automatically increasing end - inspiratory pressure as the subject makes voluntarily deeper inspiratory efforts . the desirable behaviour is in common with pav , but is different to that of a simple bilevel device , which would maintain a constant level of support despite an increased patient requirement , or to a volume cycled device , which would actually decrease support at a time of increasing need . fig2 is recorded with a somewhat more square waveform selected . this figure shows automatically increasing pressure support when the subject voluntarily attempts to resist by stiffening the chest wall at point ( a ). this desirable behaviour is common with pav and volume cycled devices , with the expectation that pav cannot selectively deliver a squarer waveform . it is distinct from a simple bilevel device which would not augment the level of support with increasing need . fig2 shows that with sudden onset of a severe 1 . 4 l / sec leak at ( a ), the flow signal returns to baseline ( b ) within the span of a single breath , and pressure continues to cycle correctly throughout . although timed mode devices can also continue to cycle correctly in the face of sudden changing leak , the are unable to follow the subject &# 39 ; s respiratory rate when required ( as shown in fig2 ). other known bilevel devices and pav mis - trigger for longer or shorter periods following onset of a sudden sever leak , and pav can deliver greatly excessive pressures under these conditions . fig2 shows an actual 60 second tracing showing respiratory airflow ( heavy trace ± 1 l / sec full scale ) and respiratory phase as a continuous variable ( light trace , 0 to 1 revolution ), with high respiratory rate in the left half of the trace and low respiratory rate in the right half of the trace . this trace demonstrates that the invention can determine phase as a continuous variable . in the prior art , phase is taken as a categorical variable , with two values : inspiration and expiration . errors in the detection of start of inspiration and start of expiration produce categorical errors in delivered pressure . conversely , here , phase is treated as a continuous variable having values between zero and unity . thus categorical errors in measurement of phase are avoided . by using a short time constant when the subject is breathing rapidly , and a long time constant when the subject is breathing slowly , the filter introduces a fixed phase delay which is always a small fraction of a respiratory cycle . thus unnecessary phase delays can be avoided , but cardiogenic artifact can be rejected in subjects who are breathing slowly . furthermore , because phase is treated as a continuous variable , it is possible to largely compensate for the delay in the low pass filter . with all prior art there is an intrusive discontinuous change in pressure , either at the start of inspiration or at the start of expiration . here , the pressure change is continuous , and therefore more comfortable . with proportional assist ventilation , the instantaneous pressure is a function of instantaneous volume into the breath . this means that a sudden large leak can cause explosive pressure run - away . here , where instantaneous pressure is a function of instantaneous phase rather than tidal volume , this is avoided . average inspiratory duration is easier to calculate in the presence of leak than is tidal volume . by taking advantage of a correlation between average inspiratory duration and average tidal volume , it is possible to adjust the amplitude of modulation to suit the average tidal volume . provision of a pressure component for unloading turbulent upper airway resistance , and avoiding cardiogenic pressure instabilities . although younes describes the use of a component of pressure proportional to the square of respiratory airflow to unload the resistance of external apparatus , the resistance of the external apparatus in embodiments of the present invention is typically negligible . conversely , embodiments of the present invention describes two uses for such a component proportional to the square of respiratory airflow that were not anticipated by younes . firstly , sleeping subjects , and subjects with a blocked nose , have a large resistance proportional to the square of airflow , and a pressure component proportional to the square of airflow can be used to unload the anatomical upper airway resistance . secondly , small nonrespiratory airflow components due to heartbeat or other artifact , when squared , produces negligible pressure modulation , so that the use of such a component yields relative immunity to such nonrespiratory airflow . there is a smooth , seamless gradation from flexibly tracking the subject &# 39 ; s respiratory pattern during spontaneous breathing well above the target ventilation , to fully controlling the duration , depth , and phase of breathing if the subject is making no efforts , via a transitional period in which the subject can make progressively smaller changes to the timing and depth of breathing . a smooth transition avoids categorization errors when ventilation is near but not at the desired threshold . the advantage is that the transition from spontaneous to controlled ventilation occurs unobtrusively to the subject . this can be especially important in a subject attempting to go to sleep . a similar smooth transition can occur in the reverse direction , as a subject awakens and resumes spontaneous respiratory efforts .
the apparatus provides for the determination of the instantaneous phase in the respiratory cycle , subject &# 39 ; s average respiration rate and the provision of ventilatory assistance . a microprocessor receives an airflow signal from a pressure transducer coupled to a port at a mask . the microprocessor controls a servo , that in turn controls the fan motor and thus the pressure of air delivered by the blower . the blower is coupled to a subject &# 39 ; s mask by a conduit . the invention seeks to address the following goals : while the subject is awake and making substantial efforts the delivered assistance should be closely matched in phase with the subject &# 39 ; s efforts ; the machine should automatically adjust the degree of assistance to maintain at least a specified minimum ventilation without relying on the integrity of the subject &# 39 ; s chemoreflexes ; and it should continue to work correctly in the pesence of large leaks .
a dispensing container comprises a housing 14 , which encloses an interior 15 . the interior 15 has a cylinder shape and is open at the rear end . at the front end , the housing 14 has a discharge tip 17 with an outlet channel 18 in the interior thereof . a needle 19 extends in a continuation of the discharge tip 17 . in the state when ready for use , the interior 15 of the dispensing container is filled with a dental compound , and the open end of the interior 15 is closed off by a plunger 29 as shown in fig2 . the plunger 29 is guided by the inner surface of the housing , which inner surface serves as a slide surface 32 . when pressure is applied to the dental compound via the plunger 29 , the dental compound moves through the needle 19 and emerges at the front end of the needle . since the needle 19 is long and thin , the dental compound can be discharged with precision even at sites that are otherwise difficult to access . in order to apply pressure to the plunger 29 , a discharge tool ( not shown ) is provided that has a ram for pressing the plunger 29 forward . according to fig3 , the outlet channel 18 of the housing 14 comprises a first channel portion 20 and a second channel portion 21 . in the first channel portion 20 , the inner surface of the outlet channel 18 is adapted to the outer surface of the needle 19 . the needle 19 can be inserted into the first channel portion 20 only when the needle 19 is centered and correctly aligned . at the rear end of the first channel portion 20 , a limit stop 23 is formed against which the needle 19 abuts when it has reached its end position . in the first channel portion 20 , a slight gap is at most present between the outer wall of the needle 19 and the inner wall of the outlet channel 18 , such that the needle 19 can be inserted without great resistance . in a second channel portion 21 , the diameter of the outlet channel 18 narrows in the direction of the rear end . at the rear end , the diameter coincides with the first channel portion 20 , such that there is a seamless transition between the channel portions 20 , 21 . the second channel portion 21 is adjoined by a widening mouth 22 , by means of which the channel diameter markedly increases toward the mouth . the needle 19 has a length of approximately 20 mm , and the outlet channel 18 has a length of approximately 6 mm . the needle 19 therefore protrudes forward by 14 mm from the discharge tip 17 . depending on the embodiment , the diameter of the needle 19 can be between 0 . 5 mm and 1 . 8 mm . the needle 19 is made of a soft - annealed steel . the needle 19 can therefore be bent to the side without breaking or without the channel in the interior being closed . when the needle 19 is in its final position in the outlet channel , a gap 16 between the outer wall of the needle 19 and the outlet channel 18 remains in the area of the widening mouth 22 and of the second channel portion 21 . using a suitable tool , an adhesive 24 is injected into the area of the widening mouth 22 , such that the adhesive penetrates rearward along the gap 16 . adhesive 24 is introduced in such a quantity as to ensure that the gap 16 is filled completely with adhesive 24 . it is possible for some of the adhesive 24 also to penetrate into the first channel portion 20 . when the adhesive 24 has hardened and has formed a firm connection with the needle 19 and with the outlet channel 18 , the needle 19 is securely fixed in the outlet channel 18 . in fig4 , view a on the left shows a discharge tip 17 in which the outlet channel 18 has a smaller diameter , and view b on the right shows a discharge tip 17 in which the outlet channel has a greater diameter . it is a considerable advantage that a single injection mold suffices to produce both of the embodiments according to fig4 a and fig4 b . for this purpose , another insert , which defines the dimension of the outlet channel 18 , simply has to be fitted into the injection mold . alternatively , it is also possible to insert into the outlet channel 18 a needle 19 that has a smaller diameter than the outlet channel 18 along the entire length . the needle 19 is fixed only when the adhesive fills the gap and hardens . in this embodiment , the housing with the outlet channel 18 can be produced as a single injection - molded part and can be provided with needles 19 of different diameter depending on the intended use . a further difference from the embodiment according to fig3 is that , in the second channel portion 21 , elongate depressions 25 are formed in the wall of the outlet channel 18 . as a result of the depressions 25 , the adhesive 24 has more space to force its way rearward in the gap 16 . fig5 shows a dispensing container in which a cap 26 is fitted onto the discharge tip 17 . the cap 26 protects the dental compound from contact with the ambient air and protects the needle 19 from damage caused by impacts . to make fitting and removing the cap 26 easier , longitudinal ribs ( not visible in the cross - sectional view in fig6 ) are formed on the outer face of the cap 26 . the needle 19 is closed at its front end and instead has outlet openings 31 facing to the side . peripheral webs 27 are formed on the inner wall of the cap 26 and are adapted to the circumference of the discharge tip 17 . the webs 27 bear on the discharge tip 17 , as a result of which the cap 26 is held in place and a seal is provided with respect to the environment . at its rear end , the cap 26 is provided with an outwardly facing bulge 28 . according to fig7 , the bulge 28 can be used as an abutment for bending the needle 19 with the aid of the cap 26 . the cap 26 comprises a limit stop 30 at its rear end . the limit stop 30 abuts against the discharge tip 17 when the needle 19 is bent at the correct angle , about 30 ° in the example shown . in the embodiment in fig8 , the discharge tip 17 extends at an angle of about 40 ° relative to the longitudinal axis of the housing 14 . in this configuration , it is not necessary to bend the needle 19 before it can be inserted into the cavity of a molar . the needle 19 is made of elastic polypropylene , such that the needle 19 , during insertion , can easily follow the course of the root canal . in the embodiment in fig9 , the discharge tool 45 contains dispensing container 42 . inside the dispensing container 42 there is a dental compound 41 and a plunger 29 . the discharge tool 45 comprises a ram 43 for pressing the plunger 29 forward . the ram is operated by pushing the handle , which is shown in the left side of the figure . the ram 43 pushes against the back surface of the plunger 29 , thereby pressing the dental compound 41 through outlet channel 18 . in the embodiment depicted in fig9 , the dispensing container 42 is a disposable part . once the dispensing container 42 is used , it may be separated from the discharge tool 45 . in order to use the discharge tool 45 once again , another dispensing container 42 with another amount of dental compound 41 is attached to the discharge tool 45 . the plunger 29 is pushed against the ram 43 of the new dispensing container 42 for dispensing the dental compound . in the depicted embodiment , the plunger 29 and dental compound 41 are incorporated into a single , replaceable dispensing container 42 . in alternate embodiments , the plunger 29 may be separate from the dispensing container 42 and may be replaced separately .
a dispensing system comprising a discharge tool in the form of a compule gun and a replaceable dispensing container in the form of a compule for dental compound . the dispensing container comprises a housing , on the inside of which a slide surface is formed that is intended for engagement with a plunger . the housing encloses an interior and is provided with an outlet channel . a portion of a needle is inserted into the outlet channel . a gap is present between the circumference of the needle and the outlet channel . an adhesive is introduced into the gap . a ram in the discharge tool engages the plunger . a method also produces a dispensing system of this kind .
while the present invention may be susceptible to embodiment in different forms , there is shown in the drawings , and herein will be described in detail , an embodiment with the understanding that the present description is to be considered an exemplification of the principles of the invention and is not intended to limit the invention to that as illustrated and described herein . fig1 shows a grinder 20 of the present invention including a cabinet 22 having an upper portion 24 , a lower portion 26 and a lid 28 covering the upper portion . a discharge assembly 30 is positioned on a front side 32 of the cabinet 22 for dispensing a ground substance therethrough . a container or bag 34 ( shown herein in phantom line in the interest of clarity ) is positioned beneath the discharge assembly 30 and against a substance settling assembly 36 which is described in greater detail hereinbelow . the present invention includes the grinder 20 as well as various systems associated with and / or used with the grinder . while the grinder of the present invention is broadly used for grinding a material to produce a ground substance and the systems of the grinder may be used in a variety of different applications , the present description will generally refer to material as whole bean coffee or coffee beans and the ground substance as ground coffee . as the grinder may be used in other applications as will be evident upon review of this description , the description is not intended to limit the description of the present invention solely to a coffee grinder . with further reference to fig2 - 10 , the present invention includes a container retaining assembly 38 ( see fig2 and 4 - 7 ), a magnetic assembly 40 ( see fig2 ), an active ventilation system 42 ( see fig2 and 10 ), an activation switch assembly 44 ( see fig4 - 7 and 10 ), and a chaff retainer 46 operated by a clean - out member 48 ( see fig2 and 7 - 9 ). each of the foregoing portions of the present invention shall be described in greater detail hereinbelow . also , fig1 - 3 provide an illustration of the substance settling assembly 36 of the present invention . as shown in fig2 the substance settling assembly 36 includes a shaker arm 50 which has a shaker plate 52 on end thereof extending outside of the cabinet 22 and a mounting end 54 retained inside the cabinet 22 . the substance settling assembly 36 also includes an agitating device 56 which is coupled to a drive shaft 58 driven by a motor 60 . the motor 60 drives the drive shaft 58 to operate a grinder mechanism 62 . the agitating device 56 utilizes the rotary motion of the motor shaft 58 to agitate , reciprocate or move the shaker arm 50 . movement of the shaker arm 50 moves or gently shakes the container 34 positioned near the discharge assembly 30 in order to settle ground coffee dispensed by the grinder . the agitating device 56 includes an eccentric cam assembly 64 retained on the drive shaft 58 and an actuator rod 66 positioned to abut both the eccentric cam assembly 64 and the shaker arm 50 . the actuator rod 66 is retained in a bore 68 which permits axial movement of the actuator rod 66 in response to the eccentric movement of the cam assembly 64 . the actuator rod 66 translates the eccentric movement of the cam assembly 64 to displace or move the shaker arm 50 positioned thereagainst . the mounting end 54 of the shaker arm 50 is attached to the grinder 20 by a spring 70 . the spring 70 has a first end 72 and a second end 74 . the first end 72 is mounted to the grinder 20 on a wall 76 of the grinder body . the second end 74 of the spring 70 is attached to the mounting end 54 of the shaker arm 50 . as such , the spring 70 facilitates movement of the shaker arm 50 in response to the reciprocating action of the actuator rod 66 . in use , the substance settling assembly 36 operates to automatically move or shake ground coffee dispensed through the discharge assembly 30 into the container 34 . the shaking helps to settle the ground coffee which , as a result of grinding , has greater loft than the whole bean . for example , if the container 34 is filled with whole bean coffee and the whole bean coffee is then deposited into a hopper 78 of the grinder 20 , the resultant ground coffee will have a greater volume than the whole bean coffee which originally filled the container . as a result , the settling assembly 36 helps to prevent overflowing the container 34 . when operated , the drive shaft 58 rotates and thereby rotating the cam assembly 64 retained thereon . with further reference to fig3 the cam assembly 64 is mounted on an eccentric portion 80 of the shaft 58 . because the eccentric portion 80 of the shaft 58 is offset from a central axis 82 of the shaft 58 , the cam assembly 64 will oscillate relative to the axis 82 . the oscillating motion of the cam assembly 64 will drive against the actuator rod 66 to drive the rod 66 outwardly through the bore 68 and against the abutting portion of the shaker arm 50 . as can be seen from fig1 and 2 , the arm 50 extends from the cabinet 22 a sufficient distance to abut a container 34 retained relative to the discharge assembly 30 . the combination of the spring 70 to which the arm 50 is attached and the position of the arm 50 relative to the container creates a return force on the arm 50 as the container 34 fills with ground coffee . therefore , the container 34 rests against the plate 52 of the arm 50 to produce a return force on the actuator rod 66 to promote the reciprocating action of the rod 66 and the subsequent reciprocal movement of the arm 50 . with reference to fig3 as the actuator rod 66 is driven towards the shaker arm 50 as a result of the movement of the cam 64 , the arm 50 will create a return force driving the rod 66 towards the cam 64 in response to the continued eccentric rotation of the cam 64 relative to the axis 82 of the shaft 58 . ultimately , the operation of the substance settling assembly 36 while grinding coffee will result in simultaneously grinding coffee , dispensing coffee into the container 34 , and settling the ground coffee in the container during the grinding process . at the end of the grinding process , the user of the grinder will not need to tap or manually settle the ground coffee . also , the ground coffee will not overflow the container as a result of the lofting or fluffing of the ground coffee during the grinding process because the ground coffee will already be settled . settling of the ground coffee will help to prevent waste , cleanup , and clogging or entrapment of ground coffee in components of the grinder . having now described the substance settling assembly 36 , attention is now turned to the container retainer or container retaining assembly 38 and the activation switch assembly 44 . the container retaining assembly 38 and activation switch assembly 44 work in combination to retain a container 34 relative to the discharge assembly 30 and to prevent inadvertent operation of the grinder 20 in the absence of a container 34 . the retaining assembly 38 and switch assembly 44 are shown in fig2 and 4 - 7 . as shown in fig2 - 6 , the container retaining assembly 38 includes a cam body 84 which is pivotally retained on a portion of the grinder body 86 by attachment to a control rod 88 extending through the grinder body 86 and cam body 84 . a set screw 90 extends through the cam body 84 to hold the cam body 84 to the control rod 88 . as such , the cam body 84 may be moved from a release position ( see fig4 ) to a retaining position ( see fig5 ) whereby a portion of a container 34 is retained between the cam body 84 and a portion of the discharge assembly 30 . the length of the cam body 84 from an axis of rotation 92 to a distal end 94 thereof is greater than a dimension from the axis of rotation 92 to the portion of the discharge assembly against which the container is held . the cam body 84 also includes at least one and , as illustrated , a pair of o - rings 96 which increase the frictional contact between the cam body 84 and the surface of the container 34 engaged by the cam body 84 . the shape , mounting location and position of the cam body 84 prevents inadvertent disengagement of the container 34 from the discharge assembly 30 when the cam body 84 is in the retaining position ( see fig5 ). in fact , forces applied to the container to disengage the container from the discharge assembly will produce increased gripping forces by the cam body 84 on the container 34 . the ability of the container retaining assembly 38 to increase the engaging force against a container 34 upon applying a disengaging force to the container 34 is useful in combination with the substance settling assembly 36 of the present invention . the substance settling assembly acts against a side of the container 34 and thus applies a degree of disengaging force to the container . additionally , as the container 34 fills with ground coffee downward forces created by the weight of the coffee tend to work to disengage the container from the discharge assembly 30 . as such , the container retaining assembly 38 holds a container 34 in proper position below the discharge assembly 30 during the grinding process . in the present invention , as illustrated , the switch assembly 44 operates in combination with the container retaining assembly 38 . the switch assembly 44 includes a roller switch 100 generally of known construction . the roller switch 100 is attached to a switch bracket 102 and is positioned relative to an extending portion 104 of the control rod 88 . the switch 100 is coupled to the motor 60 to enable or disable the motor as a result of the presence or absence of a container beneath the discharge assembly for receiving ground coffee therein . the switch disables the motor when the container retaining assembly is in the release position ( see , fig4 ) thereby preventing grinding of coffee and dispensing of ground coffee through the discharge assembly when a container is not present . as shown in fig5 the switch 100 enables operation of the motor 60 when the container retaining assembly is in the retaining position . as such , the switch enables operation of the motor when a container is positioned relative to the discharge assembly . a switch arm 106 extends from the roller switch 100 towards the extending portion 104 of the control rod 88 . the terminal end of the extending portion 104 includes an arcuate portion 108 and a generally planar portion 110 . as shown in fig4 the switch arm 106 advances forwardly against the planar portion 110 when the cam body 84 is raised into the release position . as the cam body 84 is rotated towards the discharge assembly 30 to engage a container therebetween , the switch arm 106 is displaced by the arcuate portion 108 thereby enabling the operation of the motor 60 . the structure of the extending portion 104 is more clearly shown in fig6 and 7 and in which the cam body 84 is generally shown in the &# 34 ; retaining &# 34 ; position . in the preceding description , reference has been made to the discharge assembly 30 . as shown in fig1 and 7 - 9 , the discharge assembly 30 includes a number of components . as shown in fig1 the discharge assembly 30 includes a hood 112 extending from the cabinet 22 . underneath the hood 112 is a channel chute 114 which is positioned over a passage 116 extending from the grinder mechanism 62 to the discharge assembly 30 . the channel chute 114 is positioned with a discharge hole 118 coincident with the passage 116 to allow coffee dispensed from the grinder mechanism 62 to flow into the channel chute 114 and into a container positioned below the discharge assembly 30 . as shown in fig2 and 7 , a deflector 120 is attached to the channel chute 114 to deflect ground coffee dispensed through the passage 116 downwardly into the channel chute 114 . a pivoting cover 122 is attached to the channel chute proximate to the deflector 120 . the pivoting cover 122 allows for some degree of movement to accommodate fluctuation in the flow through the discharge assembly 30 . the chaff retaining plate or chaff retainer 46 is positioned over the discharge hole 118 to provide a degree of back pressure on the flow of ground coffee through the passage in order to retain chaff in the ground coffee . the retention of chaff in the ground coffee is generally known by the use of a chaff retaining plate . the chaff retaining plate 46 retained on the upper portion of the channel chute 114 by a pivot pin 124 . a torsion spring 126 is retained on the pivot pin 124 and biases the chaff retaining plate 46 over the discharge hole 118 against the dispensing flow of ground coffee through the passage 116 . a lever arm 127 extends from the pivot pin 124 and abuts a side of the chaff retaining plate 46 facing the discharge hole 118 . in use , as whole bean coffee flows under the influence of gravity from the hopper 78 to the grinder mechanism 62 , it is dispensed from the grinder mechanism 62 through the passage 116 and discharge hole 118 . ground coffee is initially deflected downwardly by the deflector 120 into and through the channel chute 114 . during the grinding process , as ground coffee is dispensed through the discharge hole 118 , the chaff retaining plate 46 acts against the flow of ground coffee to promote retention of the chaff within the ground coffee . the pivoting cover 122 freely pivots in response to fluctuations in the flow of ground coffee through the discharge assembly 30 . at the end of the grinding cycle , the pivot pin 124 is manually rotated in order to release chaff which may have accumulated on the surface thereof . rotation of the pivot pin upwardly ( see arrow 129 in fig8 ) engages the lever arm 127 against the plate 46 to overcome the biasing force of the spring 126 and move the plate 46 away from the hole 118 . chaff may also accumulate on the inside surfaces of the deflector 120 , the channel chute 114 and the pivoting cover 122 . as such , it would be desirable to quickly and easily remove the accumulated chaff from these surfaces . the present invention includes the clean - out rod or member 48 which is operated to remove the chaff from these surfaces . the clean - out member 48 includes a protruding portion 128 which extends to engage an arm 130 of the pivot pin 124 to move or tap the chaff retaining plate 46 ( see fig8 ). the clean - out member 48 can be rotated upwardly so that the protruding portion 128 taps against a shoulder 132 of the pivoting cover 122 . as such , the clean - out member 48 can be moved upwardly and downwardly to quickly and efficiently knock off the chaff from the chaff retaining plate 46 and the pivoting cover 122 , respectively . additionally , action of the pivoting cover 122 against the channel chute may vibrate chaff from the internal surfaces of the channel chute 114 as well as the deflector 120 . as briefly discussed hereinabove , the magnetic assembly 40 ( as shown in fig2 ) is positioned in the hopper 78 to prevent magnetic pieces , usually metallic pieces , from falling into the grinder mechanism 62 . the magnetic assembly 40 is important to prevent magnetic pieces from entering the ground coffee and to prevent such pieces from becoming mixed in a beverage brewed therefrom . additionally , it is important to keep magnetic pieces out of the grinder mechanism 62 to prevent damage to the grinding burrs . a top burr 134 is positioned over a bottom burr 136 . the top and bottom burrs 134 , 136 have faces with a plurality of grinding teeth or structures thereon . as at least one of the burrs is rotated , whole bean coffee is forced through the grinding burrs 134 , 136 and dispensed through the passage 116 . the magnetic assembly 40 includes a support 138 and a magnetic body 140 attached thereto . the support 138 is designed to position the magnetic body 140 in a throat area 142 of the hopper 78 communicating with the grinder mechanism 62 . the supports 138 and magnetic body 140 are sized and dimensioned to allow beans to flow from the hopper 78 through the throat 142 and into the grinder mechanism 62 . additionally , the supports 138 abut an internal surface of the hopper 78 and allow the magnetic assembly 40 to be fastened in place . this allows the magnetic assembly 40 may be periodically removed to clean magnetic pieces therefrom . as shown in fig2 the hopper 78 is positioned above the grinder mechanism 62 in a gravity feed relationship such that upon activation of the grinder mechanism 62 , beans will flow through the throat 142 for grinding . as the beans pass in close proximity or in contact with the magnetic body 140 , any magnetic pieces which may have been accidentally introduced into the coffee supply will be captured for later removal . a generally small clearance is provided between the hopper and / or throat and the magnetic body in order to facilitate a thorough removal of any metallic particle from the bean as a result of close or intimate contact with the magnetic body 140 . a problem which commonly limits the grinding activity of prior art grinders is that operation of the grinder motor 60 and grinder mechanism 62 creates a considerable amount of waste heat . in prior art devices , the accumulation of heat , or more appropriately heated air , in the cabinet may produce a temporary or permanent failure of the grinder . in order to prevent accumulation of heated air , the present invention incorporates an active ventilation system 42 . the active ventilation system 42 primarily include a thermostatic element or thermostat 144 , a fan 146 and vents 148 formed in the cabinet 22 . the active ventilation system 42 is operated when the thermostat 44 senses the temperature of the air within the cabinet 22 as being within a predetermined range . air is moved through the cabinet by the fan 146 for removal therefrom . as shown in the illustrated embodiment in fig2 the vents 148 are positioned in the upper area 24 of the grinder 20 . the fan 146 is positioned in the lower portion 26 of the grinder 20 . preferably , the thermostatic element 144 is positioned near the grinder mechanism 62 in order to accurately sense the temperature range of the grinder mechanism 62 . also shown in fig2 the fan 146 is positioned to draw air into the cabinet 22 and force air upwardly through the vents 148 . this configuration facilitates and exploits the natural convection phenomenon of heated air rising . even before the fan 146 is activated , the position of the vents 148 in the upper portion 24 of the body 30 facilitate natural removal of heated air from the cabinet . turning now to fig1 , a circuit diagram is provided . the electrical control of the present invention consists of a master on / off switch 150 which enables or disables power to the motor 60 . when the master switch 150 is in the on position and the switch assembly 44 is activated by positioning the cam body 84 in the retaining position , the motor 60 will start . if the cam body 84 is in the release position , the switch 100 will be open and thus prevent operation of the motor 60 . once the motor is started and it has achieved a running condition , an electric start switch in the motor 60 will open thus removing a start capacitor 152 from the circuit . a run capacitor 154 will be maintained in the circuit even after the start capacitor 152 has been removed from the circuit . the thermostatic element or motor temperature sensor 144 and fan 146 are also included in the circuit to remove heated air from the cabinet when the thermostat 144 senses excessive heat . while a preferred embodiment of the present invention is shown and described , it is envisioned that those skilled in the art may devise various modifications and equivalents without departing from the spirit and scope of the invention as defined by the appended claims . the invention is not intended to be limited by the foregoing disclosure .
a grinder for grinding materials to produce a ground substance . the grinder includes a cabinet , a grinder motor retained in the cabinet , and a grinder mechanism coupled to the motor to grind the materials . a hopper is positioned in communication with the grinder mechanism to deliver materials for grinding . the container retainer is attached to the grinder for retaining a container in close proximity for capturing ground material dispensed thereby . an activation switch assembly is included with the grinder to selectively control the grinder and activate the grinder when a container is placed in a desired location . a substance settling assembly is included with the grinder for removing a container retained by the grinder to settle the substance as it is dispensed from the grinder to the container . a chaff retainer is provided for maintaining chaff included with the ground substance in mixture with the ground substance . a clean - out member is operatively attached to the grinder and selectively engageable with the chaff retainer for removing chaff from the grinder . a magnetic collection device is positioned in the hopper for capturing magnetic pieces which may be deposited in the hopper . an active ventilation system is also included with the grinder for actively and controllably removing heat from the grinder cabinet .
preferred embodiments of the presently disclosed anastomosis apparatus will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements . in the drawings and in the description which follows , the term “ proximal ”, as is traditional , will refer to the end of the surgical device or instrument of the present disclosure which is closest to the operator , while the term “ distal ” will refer to the end of the device or instrument which is furthest from the operator . an anastomosis apparatus 100 , in accordance with an embodiment of the present disclosure , is shown in fig1 - 12 . although anastomosis apparatus 100 offers significant advantages to a radical prostatectomy procedure , it will be understood that the device is applicable for use in any anastomotic procedure where two body vessels are to be brought together and joined . as seen in fig1 - 6 , anastomosis apparatus 100 includes at least one fastener 102 and preferably a plurality of fasteners 102 radially disposed about a lumen 184 of an insertion sleeve 180 ( see fig7 ). each fastener 102 includes a first fastener portion 104 and a second fastener portion 106 . first fastener portion 104 of fastener 102 includes a locking leg portion 108 and an anchoring leg portion 110 integrally formed with locking leg portion 108 . in particular , locking leg portion 108 includes a proximal end 112 and a distal end 114 from which anchoring leg portion 110 extends . anchoring leg portion 110 includes a distal end 116 integrally coupled to distal end 114 of locking leg portion 108 and a sharpened proximal tip 118 . desirably , sharpened proximal tip 118 of anchoring leg portion 110 is oriented towards proximal end 112 of locking leg portion 108 . anchoring leg portion 110 has a first position “ a ” in which sharpened proximal tip 118 is spaced a distance from locking leg portion 108 and can be biased to a second position “ c ” ( as seen in phantom in fig2 and 3 ) in which sharpened proximal tip 118 is in close proximity to locking leg portion 108 . preferably , locking leg portion 108 of first fastener portion 104 includes fixing elements for engaging second fastener portion 106 . the fixing elements in certain embodiments comprise a series of projections 120 formed along a side thereof and extending from proximal end 112 toward distal end 114 . first fastener portion 104 of fastener 102 further preferably includes a lip 122 projecting distally from distal end 110 of locking leg portion 108 . second fastener portion 106 of fasteners 102 includes a locking leg portion 124 and an anchoring leg portion 126 integrally formed with locking leg portion 124 . in particular , locking leg portion 124 includes a distal end 128 and a proximal end 130 from which anchoring leg portion 126 extends . anchoring leg portion 126 includes a proximal end 132 integrally coupled to proximal end 130 of locking leg portion 124 and a sharpened distal tip 134 . desirably , sharpened distal tip 134 of anchoring leg portion 126 is oriented towards distal end 128 of locking leg portion 124 . anchoring leg portion 126 has a first position “ a ” in which sharpened distal tip 134 is spaced a distance from distal end 128 of locking leg portion 124 and can be biased to a second position “ c ” ( as seen in phantom in fig2 and 4 ) in which sharpened distal tip 134 is in close proximity to locking leg portion 124 . preferably , locking leg portion 124 of second fastener portion 106 includes a locking passage 136 formed along a side surface thereof . as seen in fig6 , locking passage 136 is defined by an upper wall 138 extending from an upper surface of locking leg portion 124 , a lower wall 140 extending from a lower surface of locking leg portion 124 and an interconnecting side wall 142 extending between the terminal ends of upper wall 138 and lower wall 140 . locking passage 136 includes at least one , and desirably a plurality of fixing elements for engaging the fixing elements of the first fastener portion 104 . the locking passage 136 shown has fixing elements in the form of a plurality of projections 144 formed along an inner surface of interconnecting side wall 142 and oriented toward locking leg portion 124 . locking passage 136 is sized and dimensioned to slidably receive an end of first fastener portion 104 therethrough . in particular , when locking leg portion 108 of first fastener portion 104 is inserted into locking passage 136 of second fastener portion 106 , projections 120 of locking leg portion 108 engage projections 144 of locking passage 136 to thereby effectively lock first fastener portion 104 of fastener 102 in position with respect to second fastener portion 106 of fastener 102 . similar to first fastener portion 104 of fastener 102 , second fastener portion 106 of fastener 102 includes a lip 148 projecting proximally from proximal end 130 of locking leg portion 124 . as seen in fig5 , it is contemplated that projections 120 of locking leg portion 108 and projections 144 of side wall 142 of locking passage 136 are teeth - like ( e . g ., saw toothed ) projections 146 a , 146 b , respectively , configured and adapted to permit locking leg portion 108 to be inserted into locking passage 136 and hindering withdrawal of locking leg portion 108 therefrom . in particular , projections 146 a , 146 b are configured and adapted to permit locking leg portion 108 to slide in direction “ d ” while locking passage 136 is permitted to slide in direction “ e ”. however , once projections 146 a and projections 146 b engage one another , projections 146 a , 146 b prevent locking leg portion 108 from sliding in a direction opposite to direction “ d ” and prevent locking passage 136 from sliding in the direction opposite from “ e ”. in other words , projections 146 a , 146 b are configured and adapted to allow uni - directional movement of locking leg portion 108 relative to locking passage 136 and in turn uni - directional movement of first fastener portion 104 relative to second fastener portion 106 . while projections 120 of locking leg portion 108 and locking passage 136 are shown and described as being formed along a side surface of first fastener portion 104 and second fastener portion 106 , respectively , it is envisioned and within the scope of the present disclosure that projections 120 can be provided along any surface of locking leg portion 108 of first fastener portion 104 and locking passage 136 can be provided along any surface of locking leg portion 124 of second fastener portion 106 . first fastener portion 104 and second fastener portion 106 of fastener 102 can be made from any surgical grade material , such as stainless steel or titanium . it is envisioned that first and second fastener portions 104 , 106 are preferably made from a medical grade bio - absorbable material , such as , for example , polyglycolic acid ( pga ) and / or polylactic acid ( pla ). preferably , the material and dimensions of fasteners 102 are selected such that fasteners 102 will dissolve after a predetermined period of time while retaining their structural integrity for a period of time sufficient to assure proper healing of the anastomosis site . as seen in phantom in fig3 and 4 , anastomosis apparatus 100 includes an anvil 150 , a pusher 170 , and a shaft 190 for mounting the fasteners 102 in an insertion sleeve 180 ( see fig7 ). anvil 150 includes an elongate body portion 152 and a hook 154 formed at a distal end 156 thereof . hook 154 of anvil 150 is configured and adapted to engage lip 120 of first fastener portion 104 of fastener 102 . pusher 170 includes an elongate body portion 172 and a recess 174 formed at a distal end 176 thereof . recess 174 of pusher 170 is configured and adapted to engage lip 146 of second fastener portion 106 of fastener 102 . as seen in fig7 - 11 , insertion sleeve 180 includes a distal end 182 , a proximal end ( not shown ) and defines a lumen 184 extending therethrough which defines a central axis . shaft 190 is configured and adapted to be slidably received in lumen 184 of insertion sleeve 180 . it is envisioned that shaft 190 include a plurality of radially oriented longitudinally extending grooves ( not shown ) formed therein . accordingly , each groove of shaft 190 can be configured and adapted to receive a respective anvil 150 , pusher 170 and fastener 102 . preferably , shaft 190 is sized such that when shaft 190 is inserted into sleeve 180 , anchoring leg portion 108 of first fastener portion 104 and anchoring leg portion 124 of second fastener portion 106 are in the second position “ c ” ( see fig7 ). anvil 150 and pusher 170 are arranged with respect to one another so as to form a recess for receiving fastener 102 between hook 154 and lip 120 . fastener 102 is disposed in the recess so that first fastener portion 104 and second fastener portion 106 are engaged with one another , leaving room for advancing the anchoring leg portions toward one another . anvil 150 , pusher 170 and fastener 102 are disposed in insertion sleeve 180 , with shaft 190 disposed therebetween . ( see fig7 ). a preferred method of use and operation of anastomosis apparatus 100 in performing a radical prostatectomy anastomosis will now be described in greater detail with reference to fig1 - 12 and in particular with reference to fig7 - 12 . anastomosis apparatus 100 can be used in either the retropubic or the perineal prostatectomy approaches . with the prostate removed , the bladder neck “ n ” of the bladder “ b ” is first reconstructed by everting the inner mucosal lining of bladder “ b ” and suturing it down to the outer wall of bladder “ b ”, using known surgical techniques . likewise , urethral stump “ s ” of urethra “ u ” is reconstructed by everting the inner mucosal lining of urethral stump “ s ” and suturing it down to the outer wall of urethra “ u ”, using known surgical techniques . preferably , with bladder neck “ n ” reconstructed , bladder neck “ n ” is sized to properly accommodate and retain distal end 180 of sleeve 180 within bladder “ b ” using a standard tennis racket type closure ( i . e ., the opening of the bladder neck constituting the head of the tennis racket and a radial incision extending from the bladder neck constituting the handle portion of the tennis racket ). the size of the bladder neck will vary depending on the patient . typically , the bladder neck “ n ” is sized to be approximately 7 - 8 mm in diameter . with bladder neck “ n ” reconstructed , apparatus 100 is passed trans - urethrally through urethra “ u ” until distal end 182 of insertion sleeve 180 extends out of urethral stump “ s ” and into bladder “ b ” through bladder neck “ n ”, as seen in fig7 . with apparatus 100 so positioned , insertion sleeve 180 is withdrawn in a proximal direction to expose sharpened proximal tips 118 of first fastener portions 104 . with sharpened proximal tips 118 exposed from within insertion sleeve 180 , anchoring leg portions 110 of first fastener portions 104 are deployed to the first position “ a ”. ( see fig8 ). with anchoring leg portions 110 deployed , hooks 154 of anvils 150 are withdrawn in a proximal direction to engage lips 122 of first fastener portions 104 and to drive sharpened proximal tips 118 through the wall of bladder “ b ”, see fig9 . as seen in fig9 , insertion sleeve 180 is further withdrawn in a proximal direction until sharpened distal tips 134 and anchoring leg portion 126 of second fastener portion 106 are exposed . with anchoring leg portions 126 completely exposed from within insertion sleeve 180 , anchoring leg portions 126 of second fastener portions 106 are deployed to first position “ a ”. ( see fig9 ). with anchoring leg portions 126 deployed , pushers 170 are advanced in a distal direction to engage lips 148 and to drive sharpened distal tips 134 through the wall of urethral stump “ s ”. with sharpened proximal tips 118 of first fastener portions 104 penetrating the wall of bladder “ b ” and with sharpened distal tips 134 penetrating the wall of urethral stump “ s ”, hooks 154 of anvils 150 are approximated toward recesses 174 of pushers 170 to thereby approximate anchoring leg portions 110 of first fastener portion 104 and anchoring leg portions 126 of second fastener portion 106 towards one another . concomitantly , as anchor leg portions 110 and 126 are approximated towards one another bladder neck “ n ” is approximated towards urethral stump “ s ”. ( see fig1 ). in accordance with the present disclosure , approximation of anchor legs 110 and 126 towards one another results in projections 120 and 144 incrementally engaging one another and maintaining the position of anchor leg 110 relative to anchor leg 126 . accordingly , projections . 120 and 144 prevent bladder “ b ” from separating from urethra “ u ”. after bladder neck “ n ” has been approximated toward urethral stump “ s ”, pushers 170 and shaft 190 are withdrawn from insertion sleeve 180 and anvils 150 unhooked from lips 122 . ( see fig1 ). thereafter , anvils 150 and insertion sleeve 180 are withdrawn from urethra “ u ”. an alternate embodiment of a fastener 200 , in accordance with the present disclosure , is shown in fig1 a and 13b . unlike fastener 102 from above , fastener 200 includes a first fastener portion 202 and a second fastener portion 204 . first fastener portion 202 includes a locking leg portion 206 and an anchoring leg portion 208 pivotally coupled to a proximal end of locking leg portion 206 . in the embodiment shown , anchoring leg portion 208 is pivotally coupled to locking leg portion 206 by a pivot pin 210 , but other means known in the art may also be used . alternatively , locking leg portion 206 or anchoring leg portion 208 can be provided with an integrally formed pin that extends outwardly for receipt in an aperture formed in the other of locking leg portion 206 or anchoring leg portion 208 . first fastener portion 202 includes a suture 212 connected to anchoring leg portion 208 for pulling on anchoring leg portion 208 and lifting a distal end of anchoring leg portion 208 away from locking leg portion 206 ( e . g ., from first position “ a ” to second position “ c ”). it is contemplated that the proximal end of locking leg portion 206 includes a stop ( not shown ) for stopping the lifting of anchoring leg portion 208 beyond a predetermined amount . as seen in fig1 b , second fastener portion 204 includes a locking leg portion 214 and an anchoring leg portion 216 pivotally coupled to a distal end of locking leg portion 214 by a pivot pin 218 . alternatively , locking leg portion 214 or anchoring leg portion 216 can be provided with an integrally formed pin and extending outwardly for receipt in an aperture formed in the other of locking leg portion 214 or anchoring leg portion 216 . second fastener portion 204 further includes a suture 220 connected to anchoring leg portion 216 , extending around the distal end of locking leg portion 214 , for pulling on anchoring leg portion 216 and lifting a proximal end of anchoring leg portion 216 away from locking leg portion 214 ( e . g ., from first position “ a ” to second position “ c ”). it is contemplated that the distal end of locking leg portion 214 includes a stop ( not shown ) for stopping the lifting of anchoring leg portion 216 beyond a predetermined amount . while apparatus in accordance with the present disclosure have been described as being used in connection with a radical prostatectomy procedure , it is envisioned that apparatus having similar structures and modes of operation can be used in various other surgical procedures . it will be understood that various modifications may be made to the embodiments of the presently disclosed anastomosis device and method disclosed herein . for example , one or more fasteners may be arranged in the insertion sleeve . in further embodiments , the insertion sleeve is sized to accommodate the fastener without requiring the anchoring leg portions to collapse to position “ c ”. the fastener may comprise a single part with a corrugated , hinged or collapsible portion . the fasteners , in certain embodiments , comprise a fixing element comprising a separated part . therefore , the above description should not be construed as limiting , but merely as an exemplification of a preferred embodiment . those skilled in the art will envision other modifications within the scope of the present disclosure .
apparatus and methods for performing a surgical anastomotic procedure are disclosed herein . apparatus according to the present disclosure include at least one fastener including a first fastener portion having an anchoring leg portion , a second fastener portion including an anchoring leg portion , wherein the first and second fastener portions are operatively associated with one another to selectively fix the position of the first fastener portion relative to the second fastener portion .
referring now to the drawings , there is seen in fig1 a first embodiment of the electro - surgical dissecting and cauterizing instrument 10 including a distal , working end 12 and a proximal end 14 which includes an electric plug such that instrument 10 may be releasably and operably connected to a conventional , electro - surgical control unit 16 . control unit 16 is supplied high frequency , electrical energy via power supply 18 and further includes a switch means 20 which is used to control the flow of electrical energy from unit 16 to instrument 10 . as such , a surgeon manually grasps unit 16 to work instrument 10 as described below . although unit 16 is shown and described herein for the purpose of illustrating a typical electrical unit with which instrument 10 would be used , it is understood that plug 14 may be easily adapted to connect to a variety of electro - surgical units available today . dissecting and cauterizing instrument 10 is used primarily in surgical procedures which may or may not include the use of an endoscope to view the operation site . for purposes of description , the surgical procedure using an endoscope will be discussed . also , surgical procedures of the type discussed herein are termed laparoscopic because they target the abdominal area . the type of endoscope used in the abdomen is therefore termed a laparoscope . in particular , the surgeon inserts distal end 12 into the abdomen of the anesthetized patient through a trochar ( not shown ) positioned within an incision made in the abdominal wall . the operation site is viewed at the eyepiece of the laparoscope and / or on a crt screen by passing the laparoscope ( also not shown ) through an adjacent incision in the abdomen which has been previously inflated with co 2 as is customary surgical procedure in laparoscopic surgery of this type . the raising of the abdominal wall above the innards of the patient with the co 2 creates a space therebetween which increases maneuverability of instrument 10 within the abdomen besides increasing the viewing area of the surgical site with the laparoscope . examples of typical laparoscopic procedures in which dissecting and cauterizing instrument 10 would be used are lysis of adhesions , cholecystectomy and appendectomy . dissecting and cauterizing instrument 10 includes a rigid insulating sleeve 22 which surrounds conducting rod 24 extending from plug 14 to distal end 12 . distal end 12 is seen to include a rigid arm 26 extending from substantially the center of the distal end 21 of sleeve 22 . a working tip 28 electrode in the shape of a hook in the embodiment of tool 10 seen in fig1 - 4 integrally extends from arm 26 . arm 26 and working tip electrode 28 are formed of electrically conductive material such as stainless steel and are supplied electrical energy via a conductive rod 24 extending through sleeve 22 . a thin layer or jacket of insulating material 30 in the form of a teflon heat - shrink tubing is disposed upon arm 26 from sleeve 22 to the base of working tip electrode 28 . prior art electro - surgical instruments of which the present inventors are aware do not include an arm such as 26 extending between the working tip electrode 28 and end of sleeve 22 but instead have their working tip electrodes extend directly from the sleeve . as such , the view of the operation site is obstructed because of the close proximity of the sleeve to the working tip electrode since the diameter of the sleeve is substantially larger than the size of the working tip electrodes . to overcome this problem , the present dissecting and cauterizing instrument 10 includes arm 26 to effectively space working tip electrode 28 from sleeve 22 . furthermore , arm 26 is seen to include portions laterally offset from the linear axis x -- x extending through the center of sleeve 22 and arm 26 . this feature also increases the visualization of the surgical work site by having the working tip electrode 28 extend from a portion of the arm 26 which lies along an axis y -- y which is parallel to and spaced from linear axis x -- x of sleeve 22 . referring to fig3 arm 26 is seen to extend linearly from sleeve 22 for a first length having a distance d 1 and bend downwardly at an approximately 150 degree angle a 1 , with respect thereto for a second length having a distance d 2 . arm 26 then bends upwardly at an approximately 150 degree angle a 2 to extend for a third length having a distance d 3 . as such , it may be seen that the first length of arm 26 labeled d 1 extends along linear axis x -- x of sleeve 22 which is spaced from and extends parallel to third length d 3 . working tip electrode 28 is seen to integrally extend from the distal end of third length d 3 and bend toward axis x -- x to form a hook which is used primarily for pulling at tissue . the electricity which flows through arm 26 and electrode hook 28 at the control of the surgeon augments the cutting capability of hook 28 and cauterizes bleeding blood vessels . to prevent unintentional cauterization with portions of instrument 10 other than hook 28 , an insulating jacket 30 is disposed upon the entire length of arm 26 . referring to fig5 and 6 , a second embodiment of instrument 10 is seen . in this second embodiment , arm 26 &# 39 ; linearly extends from sleeve 22 &# 39 ; for a first length having a distance d 1 as with the embodiment of fig1 - 4 , bending downwardly and then upwardly at approximately 135 degree angles a 1 and a 2 for second and third lengths having distances of d 2 and d 3 , respectively . as such , the third length of arm 26 &# 39 ; spanning distance d 3 lies along an axis y -- y which is parallel to and spaced downwardly from the linear axis x -- x of sleeve 22 &# 39 ; where the first length of arm 26 &# 39 ; spanning distance d 1 lies . arm 26 &# 39 ; includes a third bend in an upwardly direction at an approximately 159 degree angle a 3 and extends linearly therefrom for a fourth length having a distance d 4 , crossing linear axis x -- x such that the working tip electrode 32 lies on the side of axis x -- x opposite to which axis y -- y lies . it will be noticed in fig5 - 7 that working tip electrode 32 is in the shape of a flattened spatula which has a radial axis r -- r which intersects linear axis y -- y . spatula 32 proves especially useful for cauterizing bleeding blood vessels rather than removing tissue from the patient &# 39 ; s body . an insulating jacket 30 &# 39 ; is disposed upon arm 26 &# 39 ; from the distal end of sleeve 22 &# 39 ; to the base of working tip electrode 32 to prevent any portion of arm 26 &# 39 ; from unintentionally contacting and cauterizing healthy tissue surrounding the operation site . referring now to fig8 and 10 which show yet a third embodiment of the invention , arm 26 &# 34 ; is entirely linear and extends from sleeve 22 &# 34 ; along an axis z -- z which makes an approximately 6 degree acute angle a 4 with linear axis z -- z of sleeve 22 &# 34 ;. working tip electrode 32 &# 39 ;, which is also in the shape of a substantially circular , planar spatula , extends upwardly from arm 26 &# 34 ; toward axis z -- z . working tip electrode 32 &# 39 ; has a radial axis r -- r which intersects linear axis z -- z at an obtuse angle a 5 . an insulating jacket 30 &# 34 ; is disposed upon arm 26 &# 34 ; from sleeve 22 &# 34 ; to working tip electrode 32 &# 39 ;. based on the foregoing description of three embodiments of the invention , it may be realized that the length and configuration of the arms 26 , 26 &# 39 ; and 26 &# 34 ; permit each of the respective working tip electrodes 30 , 32 and 32 &# 39 ; to be significantly spaced from and laterally offset from the longitudinal axis of the sleeve . this permits an enhanced viewing area of the surgical work site and working tip electrode for the surgeon . while the invention has been shown and described with particular reference to preferred embodiments thereof , it will be appreciated to those skilled in the art that variations in working tip electrode configuration and specific lengths and angles of the arm portion of the tool may be made to fit a particular surgical need without departing from the full scope of the invention as is set forth in the claims which follow .
an electro - surgical dissecting and cauterization tool comprises a linear , rigid insulating sleeve surrounding means providing an electric conducting path between a proximal , electric plug end and working tip electrode distal end . the plug attaches the tool to a conventional electro - surgical unit which supplies electrical energy to the working tip electrode end of the tool . a rigid arm extends between the sleeve and the working tip electrode and includes portions laterally offset from the main axis of the sleeve to increase visualization of the working tip electrode during surgery .
the apparatus in fig1 has a support plate 1 that is arranged in longitudinally placeable fashion inside an examination volume of a magnet . within the scope of invention , the magnet can for example a cylindrical magnet 18 as shown in fig3 ( solenoid ) or a horseshoe magnet ( c - arm ) 19 as shown in fig2 . given cylindrically shaped magnets , the patient receptacle is fashioned as a patient tube as own in fig3 . the longitudinal displaceability of the support plate 1 is indicated with a double arrow 2 . due to the longitudinal displaceability of the support plate 1 , larger body sections of a patient 3 lying on the support plate 1 can be examined . the nuclear spin resonance apparatus shown in the drawing additionally has a predetermined number of transmit coils 4 and a predetermined number of receive coils 5 . the transmit coils 4 can be connected , in a desired configuration , to a generator 7 by means of a transmit coil changeover switch 6 . the generator 7 supplies the transmit coils 4 with current via a - transmit amplifier 8 and via a matching element 9 . the receive coils 5 can be connected , in a desired configuration , to a receiver 11 by means of a receive coil changeover switch 10 . the signals of the connected receive coils 5 are given to the receiver 11 via . a matching element 12 and via a receive amplifier 13 . the configurations of the transmit coils 4 and the receive coils 5 , defined by the transmit coils changeover switch 6 and by the receive coils changeover switch 10 , are supplied to an adjustment unit 14 as inputs . as a further input , the position of the support plate 1 , which is determined by a position sensor 15 , is supplied to the adjustment unit 14 . the adjustment unit 14 processes the inputs that it has received from the transmit coils changeover switch 6 , from the receive coils changeover switch 10 , and from the position sensor 15 , and at its output supplies corresponding control signals to the generator 7 , to the transmit amplifier 8 , to the matching elements 9 and 12 , as well as to the receive amplifier 13 and to the receiver 11 . in addition , the adjustment unit 14 supplies a control signal to a shim coil system 16 . the inputs and the control signals ( outputs ) are stored , as adjustment parameters , in a memory 17 until the conclusion of the examination . with the embodiment shown in the drawing of the inventive apparatus , larger bodily segments of the patient 3 can be examined . such examinations are , for example , the tracking of doses of contrast agent over a larger body region , as carried out for example in subtraction angiography or in physiologically controlled imaging . in the context of the preparation for measurement , which in the case of a peripheral angiography at the leg , includes slice positioning along the vascular tree , several measurements are already made without contrast agent . due to the homogeneity volume of the magnet being too small , in these measurements the support plate 1 must be displaced , and so must be newly adjusted . the associated adjustment parameters for each position of the support plate 1 are stored in the memory 17 . as additional adjustment parameters , the connected configuration of the transmit coils 4 , as well as the connected configuration of the receive coils 5 , are stored in the memory 17 . in addition , the adjustment parameters include the corresponding control signals for the generator 7 , for the transmit amplifier 8 , for the matching elements 9 and 12 , as well as for the receive amplifier 13 , for the receiver 11 and for the shim coil system 16 . after the conclusion of the measurement preparation , which includes the determination of the adjustment parameters , the support plate 1 is guided back into the initial position , and the contrast agent is administered . in the imaging measurement that now takes place , each of the positions of the support plate 1 used in the measurement preparation is newly set in succession , and the transmit coils 4 and the receive coils 5 are connected as in the measurement preparation . subsequently , an imaging measurement ( exposure ). is immediately carried out with the known adjustment parameters stored in the memory 17 , i . e . without a new adjustment . in the inventive apparatus , the required adjustment parameters are thus not determined immediately before each individual imaging measurement ; rather , the required adjustment parameters are completely determined in a preceding adjustment process , in the context of the measurement preparation . according to the invention , the adjustment process thus precedes the exposure process . only after the determination of the required adjustment parameters are the exposures ( imaging measurement ) carried out , in a separate exposure process . in examinations with the inventive apparatus , high - contrast exposures . are thereby obtained , since it is not necessary to omit an adjustment . in addition , due to the fact that the adjustment parameters are stored in a memory 17 until the conclusion of the examination , reduced examination times result . due to the short examination times , in subtraction angiography the course of the contrast agent can thus be tracked without chronological gaps . although modifications and changes may be suggested by those skilled in the art , it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art .
a magnetic resonance imaging apparatus has a magnet with at least one patient receptacle and at least one support plate , as well as a predetermined number of transmit and / or receive coils . in at least two predetermined exposure positions , at least one exposure respectively takes place using predetermined adjustment parameters . high - contrast exposures can be obtained in a short time , by the required adjustment parameters being determined in a preceding adjustment process , and the exposures are carried out in a subsequent exposure process .
turning now to the drawings , instrument 10 of the present invention is composed of a forcep body 11 having a pair of resilient legs 12 , 13 secured to and extending from body 11 ; an open ended tubular sleeve member 14 integrally secured to a leg extension 13a ; a linkage spring 15 having a pair of legs 16 , 17 ; linkage mount 18 ; and ejection collar 19 . sleeve member 14 is integrally secured to leg extension 13a which is set at a predetermined angle &# 34 ; x &# 34 ; ( fig5 ) appropriate to use of the instrument and is shown as approximately 120 °. leg 13 is slightly longer in length than leg 12 so that sleeve 14 resides outwardly from the free end of leg 12 . a mount 18 is integrally secured to the outer free end of leg 12 and comprises a small sleeve having a bore 20 extending throughout its length . linkage spring 15 is formed so that it passes through mount 18 by way of bore 20 and its legs 16 , 17 extend outwardly and at their outer ends are bent inwardly to resiliently engage ejection collar 19 and provide a pivotal connection . ejection collar 19 is designed to be slidably received by sleeve member 14 . collar 19 moves freely on sleeve member 14 between extension 13a which acts as a stop and the outer end of travel on sleeve member 14 . a pair of holes 21 , 22 are formed in the walls of collar 19 and receive the ends of legs 16 , 17 so that collar 19 is retained on sleeve member 14 . in a relaxed position , collar 19 rests against leg extension 13a and prevents any movement past this position . when leg 12 is forced toward leg 13 by the fingers of the operator , mount 18 abuts against leg 13 and spring legs 16 , 17 force collar 19 forward on sleeve member 14 to the hood or band ejection position seen in fig6 . turning now to a description of the operation of instrument 10 , instrument 10 as shown in fig1 - 6 receives a vacuum line 23 which is slidably mounted on the rear end of sleeve member 14 . with ejection collar 19 in a retracted position , see fig1 - 3 , a fimbrial hood 25 is placed on the forward , free end of sleeve member 14 , see fig4 . in order to do this , shoulder 26 must be stretched over the free end of sleeve member 14 as best seen in fig4 . once in position , shoulder 26 abuts against collar 19 . next , through application of vacuum through vacuum line 23 , hood 25 is inverted to the position of fig5 . sometimes , in addition to vacuum , hood 25 must be urged inward by the operator nudging hood 25 with some instrument at hand . once hood 25 is in position adjacent fimbria 28 as in fig5 fimbria 28 of fallopian tube 29 is guided into hood 25 , see fig5 . once fimbria 28 is positioned within hood 25 , leg 12 is depressed causing spring legs 16 , 17 and correspondingly collar 19 to move forward until shoulder 26 of hood 25 is forced from sleeve member 14 and engages fallopian tube 29 . at this point , instrument 10 is withdrawn allowing hood 25 to regain its form as illustrated in fig7 . hood 25 is now anchored in place on tube 29 by placing a sufficient number of sutures 35 through shoulder 26 and into tube 29 . another application of instrument 10 , although not illustrated , would be for situations where permanent occlusion is desired . such permanent occlusion may be desired for permanent sterilization , permanent occlusion of blood vessels or permanent occlusion of polyps . in this application , an elastomeric , silastic band 30 as illustrated in fig8 is employed and mounted on sleeve 14 and is ejected in the same manner as previously described with respect to hood 25 . the fact that the central axis of the longer leg member 13 resides at an obtuse angle with respect to the central axis of the sleeve member provides a convenient working arrangement . also , the natural resiliency of the leg members 12 , 13 is used to always bring the collar 19 to its retracted position . thus , the invention instrument may be used rapidly and efficiently in an occlusion procedure .
a forcep - like instrument is provided for mounting and ejecting either an elastic band or a hood for an occlusion procedure .
the fig1 , as mentioned above , shows a schematic diagram of the respiratory cycle with re - inhalation of a respiratory device provided with the ventilation system of the present invention . as illustrated in fig1 , the fresh gas coming from the anesthesia equipment ( 1 ), that adequately adjusts the composition of gases and the concentration of anesthetic agents , is introduced in the respiratory circuit through the fresh gas inlet ( 2 ). the gas is collected in a bag ( 3 ) or bellows ( 4 ), depending on the application requirements and according to the position of the selecting key ( 5 ), which determines the mode of operation of the device : manual or automatic through a lung ventilator ( 6 ). in case the selecting key ( 5 ) is in the manual position , the bag ( 3 ) is filled in with gas , so that the anesthesia physician or any other specialist may manually pump the gas to patient . when the bag is pressed , the gas passes through a carbon dioxide absorber ( 7 ), through the inhaling unidirectional valve ( 8 ), through the inhaling tube ( 9 ), and insufflates the lung of the patient . when the anesthesia physician releases the bag ( 3 ), the gas exhaled by the patient passes through the exhaling tube ( 10 ), through the unidirectional exhaling valve ( 11 ), and returns to the bag ( 3 ). the purpose of the unidirectional valves ( 8 ) ( 11 ) is to force the passage of the gas flow through the carbon dioxide absorber ( 7 ) before the re - inhalation by the patient . for this case , an adjustable pressure limit valve ( 12 ) releases to the environment the excess of gas within the respiratory circuit by means of an appropriate exhaustion system ( 13 ), since the fresh gas is continuously fed within the circuit . in case the selecting key ( 5 ) is in the ventilator / auto mode , the respiratory circuit works analogously to the manual mode . however , pumping is made by the bellows ( 4 ), which is filled in through the exhaling valve ( 21 ) by the route ( 14 ). pumping is made through the lung ventilator ( 6 ) that pressurizes the internal side of the rigid reservoir ( 15 ), where said bellows ( 4 ) is assembled , through the inhaling route ( 16 ). in this case , the control of gas excess is made by a set of release valves , which comprises a release valve ( 17 ) activated by said bellows ( 4 ) and a release valve ( 18 ) activated by the lung ventilator ( 6 ) through the route ( 26 ). said release valves ( 17 ), ( 18 ) are activated during the exhaling stage . this allows the excess of gas located inside the circuit to escape and to avoid circuit pressurization with values above the set up exhaling pressure value . the inhaling stage of the respiratory circuit starts with the ventilator ( 6 ) sending inhaling flow through the routes ( 16 ), ( 19 ), and ( 20 ) into the rigid reservoir ( 15 ). at the same time , the exhaling valve ( 21 ) and the release valve ( 18 ) are closed in order to pressurize the internal side of the rigid reservoir ( 15 ) and to compress the bellows ( 4 ). through the ventilation system according to the present invention , all parameters controlled by the lung ventilator ( 6 ), such as flow , pressure and volume , are fully transmitted to the gas located inside the bellows ( 4 ) and consequently transmitted to the gas flow inhaled by the patient . for these reasons , the ventilation system of this invention can be used in various modes of ventilation , including but not limited to volume control ventilation — vcv , pressure control ventilation — pcv , pressure support — psv , vaps , aprv , pav , etc . after the end of the inhaling stage , the exhaling stage starts . in this stage , the route ( 16 ) flow is closed , and the exhaling valve ( 21 ) and the release valve ( 18 ) are opened . the gas located inside the reservoir ( 15 ) is exhaled through the routes ( 20 ), ( 22 ), thus permitting the bellows ( 4 ) to expand up to the end of the exhaling stage of the patient . said bellows ( 4 ) fully expands and activates the release valve ( 17 ), causing the exhaustion of the excess gas from the respiratory circuit through the routes ( 23 ), ( 24 ), ( 25 ) and through the release valve ( 18 ) activated by the ventilator ( 6 ). fig2 illustrates the set constituted by the bellows ( 4 ) located upwardly within the reservoir ( 15 ) and by a manifold ( 27 ). said bellows ( 4 ) is manufactured with flexible and sterilizable material , preferably silicone , which shape presents an accordion - like shape ( 28 ) to allow the expansion and contraction of the bellows ( 4 ) and thus offering low resistance and inertia . the base of said bellows ( 4 ) is provided with a ring - shaped opening ( 29 ) with circular cross section that is fitted in the base ( 30 ) of said rigid reservoir ( 15 ). the top of said bellows ( 4 ) is formed by a hard disk ( 31 ), preferably manufactured with aluminum with relatively small thickness , which is fitted under pressure through an external ring ( 32 ) in order to hermetically fix the accordion - like profile ( 28 ) to the hard disk ( 31 ), thus forming a flat and stable surface at the top of the bellows ( 4 ), as better observed in the detail of fig2 . furthermore , said external ring ( 32 ) has the purpose to avoid eventual mixing between the control gas and the gas inhaled by the patient . therefore , the configuration of said bellows ( 4 ) permits the full transmission of all the pressure exerted over the external surface of the bellows to the gas of the respiratory circuit by the control gas inside the reservoir ( 15 ). furthermore , it permits the inhaling effort exerted by the patient to be transmitted by the gas of the respiratory circuit to the control gas located inside the reservoir ( 15 ), thus not generating any resistance to the spontaneous breathing of the patient . said reservoir ( 15 ) comprises a main body ( 33 ), a base ( 30 ) and a manifold ( 27 ). said main body ( 33 ) is manufactured with a transparent material , preferably polycarbonate or acrylics . said base ( 30 ) is provided with a first connection ( 35 ) to couple the re - inhalation tube ( not shown ) and a second connection ( 36 ) which is connected to the manifold ( 27 ) in the release valve ( 17 ) for the exit of excess gases . said base ( 30 ) is fitted in the lower portion of the main body ( 33 ) by means of a pressure screw ( 37 ). the edge of the circular opening ( 29 ) of said bellows ( 4 ) is hermetically pressed between said base ( 30 ) and the main body ( 33 ) to avoid the mixing between the respiratory circuit gas and the control gas . the manifold ( 27 ) is assembled over the main body ( 33 ) by means of pins ( 38 ) located alongside the main body . the pins are fitted in indentations ( 39 ) located at the edge of said manifold ( 27 ), also provided with a sealing ring ( 40 ) to seal the main body ( 33 ) against the manifold ( 27 ). the volume capacity of the bellows ( 4 ) may vary according to the application . bellows with varying capacity , for example from 250 to 1400 ml , are commonly used . for applications to newly born patients , the volume capacity should be small in order to minimize the total compressible volume of the respiratory circuit . fig3 shows an alternative embodiment of the bellows ( 4 ) and reservoir ( 15 ) set , which presents a lower volume capacity than that shown in fig2 , but keeping the same principle of operation . however , said set uses the same manifold ( 27 ) used for reservoirs with a higher volume capacity , since the diameter of the upper end of the reservoir ( x ) is equal to the diameter of the reservoir used in the embodiment shown in fig2 . the ventilation system of the invention may be used in various applications . no matter which is the volumetric capacity of the gases in the respiratory circuit , it is just required the substitution of the bellows / reservoir set . fig4 shows in detail said manifold ( 27 ), preferably of aluminum , comprising the exhaling valve ( 21 ) and the release valves ( 17 ), ( 18 ) responsible for the control of gas excess in the respiratory circuit . the exhaling valve of the control gas ( 21 ) comprises an air nozzle ( 41 ), which is opened and closed by means of the action of a flexible diaphragm ( 42 ), which in turn is activated by the pilot pressure through the gas inlet ( 43 ), with said pilot pressure being controlled by the lung ventilator ( 6 ) through a proportional solenoid valve and by an electronic control circuit provided with a pressure transducer , a microprocessor , and a pid control algorithm , such as those known by the man skilled in the art . in the inhaling stage , the lung ventilator ( 6 ) pressurizes the internal side of the reservoir ( 15 ) through the channel ( 44 ) in order to control the pilot pressure in the gas inlet ( 43 ), thus closing the air nozzle ( 41 ) and consequently closing the exhaustion channel ( 45 ). in the exhaling stage , the pilot pressure at the gas inlet ( 43 ) will be reduced , thus permitting said flexible diaphragm ( 42 ) to open the air nozzle ( 41 ) and permitting the control gas to be exhausted through the channel ( 44 ), through the air nozzle ( 41 ), and through the channel ( 45 ). in this stage , it is possible to control the pilot pressure with the purpose to keep a positive pressure over the bellows ( 4 ), which is called peep ( positive end expiratory pressure ). the control of gas excess in the respiratory circuit is made by means of the release valves ( 17 ), ( 18 ). each one of them is responsible for a control stage . more specifically , the first stage is performed by the valve ( 17 ), which is activated by the bellows ( 4 ) and comprises a cursor ( 46 ) which higher end is supported , under the action of a spring ( 47 ), over an air nozzle located within said manifold ( 27 ), and which lower end is supported over a flexible diaphragm ( 49 ). a second cursor ( 50 ) is assembled at the opposite side of the flexible diaphragm ( 49 ), which projects to the internal side of the reservoir ( 15 ) and has a disk ( 51 ) in its free end , which contacts the bellows ( 4 ). therefore , when the bellows ( 4 ) is fully filled in , the hard disk ( 31 ), located at the top of the bellows ( 4 ), touches the disk ( 51 ) of the cursor ( 50 ) and consequently activates the cursor ( 46 ) that opens the air nozzle ( 48 ), thus permitting the passage of the flow of gas excess from the inlet channel ( 52 ) to the outlet channel ( 53 ) and conducing the gas to the release valve ( 18 ) responsible for the second control stage . said inlet channel ( 52 ) is connected to the outlet connection for gas excess ( 36 ) located at the base ( 30 ) of the reservoir ( 15 ). furthermore , said diaphragm ( 49 ) safely separates the control gas located inside the reservoir ( 15 ) from the gas coming from the inlet channel ( 52 ), which is the excess of gas exhaled by the patient coming from the respiratory circuit . therefore , the mixing between gases is inhibited and consequently a safe and healthy respiratory circuit is obtained . the second stage is made by the release valve ( 18 ), similar to the exhaust valve of the control gas ( 21 ). the lung ventilator ( 6 ) also controls the release valve by the pilot pressure in the channel ( 54 ), which is equal to the pilot pressure of the channel ( 43 ). the release valve ( 18 ) is also provided with a flexible diaphragm ( 55 ) that closes and opens an air nozzle ( 56 ) according to the pilot pressure in the channel ( 54 ). during the inhaling stage , the lung ventilator ( 6 ), through the channel ( 44 ), sends control gas flow into the reservoir ( 15 ) simultaneously closing air nozzles ( 41 ) and ( 56 ) through the flexible diaphragms ( 42 ), ( 55 ) and consequently pressurizing the reservoir ( 15 ), compressing said bellows ( 4 ) and the gas contained inside it . the gas is pumped to the patient , passing through the carbon dioxide absorbing system , through the inhaling unidirectional valve and insufflating patient &# 39 ; s lung . as previously explained , during the exhaling stage , the pilot pressure in the channel ( 43 ) is reduced , and consequently the pilot pressure of the channel ( 54 ) is also reduced . the pressure within diaphragms ( 42 , 55 ) remain reduced , thus allowing the opening of the air nozzles ( 41 , 56 ) and allowing the control gas exhalation through the channels ( 44 , 55 ) and the interconnection of the channels ( 53 , 57 ). however , the first stage to control the excess of gas remains closed due the force of the spring ( 47 ) that acts over the cursor ( 46 ) of the release valve ( 17 ). the air nozzle ( 48 ) remains closed and inhibits the exhaustion of the excess of gases through the channels ( 53 ), ( 57 ). therefore , only when the bellows ( 4 ) is fully filled in , the hard disk ( 31 ) located on its top will activate the cursor ( 50 ), which will move the cursor ( 46 ) to open the air nozzle ( 48 ) to allow the passage of the excess of gas between the first stage and the second stage through the channels ( 53 , 57 ). the valve ( 18 ) of the second stage is controlled by the same pilot pressure of the exhaustion valve for the control gas ( 21 ). for this reason , the exhaustion pressure of the control gases and consequently the pressure inside the bellows is the same pressure kept by the ventilator inside the reservoir . this system allows the set up exhaling pressure value to be kept no matter which is the supplied fresh gas flow value , thus keeping the ventilation base line and allowing the spontaneous breathing of the patient with no additional effort to balance an eventual intrinsic peep . in an alternative embodiment of the manifold ( 27 ), as shown in fig5 , the control of gas excess is made by one stage . the control is formed by the release valve ( 58 ), which comprises an air nozzle ( 59 ) supporting a flexible diaphragm ( 60 ) activated by the pilot pressure through the channel ( 61 ), no matter which is the pilot pressure supplied through the channel ( 43 ) of the control gas exhaustion valve ( 21 ). in this case , the pilot pressure in the channel ( 61 ) is controlled by means of a second proportional solenoid that keeps the channel ( 62 ) closed during the inhaling stage . during the exhaling stage and only after the patient fully exhales , the air nozzle ( 59 ) is opened to allow the flow of gas excess to pass through the exhaustion channel ( 63 ). the release valve ( 58 ) opens in a proportionally manner depending on the monitoring of the internal pressure increase of the respiratory circuit . the monitoring in turn is made by means of a pressure transducer , since it is required to keep the pressure in the circuit at the same value of the peep set up exhaling pressure value , in order to balance the pressure exerted by the weight of said bellows ( 4 ) itself . the full exhalation by the patient can be monitored , for example , by means of a specific device , such as a pneumotacograph located at the “ y ” connection of the patient or even in the exhaling route . therefore , the release system for the excess of gases in the respiratory circuit of the invention solves the problems described in the state of the art , thus eliminating the risk of gas escape during the start of exhalation , besides keeping minimum residual pressure , of about 1 hpa , even by using high flow of fresh gas . additionally , the ventilation system of the present invention comprises a valve for the free flow of oxygen ( 64 ) provide with a solenoid valve ( 69 ) which is activated by the lung ventilator ( 6 ) synchronously with the inhaling stage of the respiratory cycle of the patient . the purpose of this valve ( 64 ) is quickly renewing the gases inside the respiratory circuit . the valve for the free flow of oxygen ( 64 ) is constituted by two stages , a pilot ( 65 ) and a main one ( 66 ). oxygen is fed through the channel ( 67 ) to the main stage and through the channel ( 68 ) by the “ usually open ” route of the solenoid valve ( 69 ), which is itself connected to the pilot stage through the channel ( 90 ) which in turn is interconnected to the manual activating valve ( 71 ). the oxygen flow to the respiratory circuit is released through the channel ( 72 ) and occurs simultaneously when the solenoid ( 69 ) is turned off and the cursor ( 73 ) is manually activated by the key ( 74 ), therefore overcoming the spring ( 75 ) pressure and consequently allowing the oxygen flow between the channel ( 70 ) and the chamber ( 76 ). hence , the activation of the pressure of the pilot stage over the diaphragm ( 77 ) causes the movement of the cursor ( 78 ), overcoming the force of the spring ( 79 ) and interconnecting the inlet ( 67 ) and outlet ( 72 ) channels of the main stage . the manual valve ( 71 ) is closed by the action of the spring ( 75 ) over the cursor ( 73 ) and by the depressurization of the chamber ( 76 ), which occurs through the restrictor ( 80 ) located in the channel ( 81 ), thus closing the main stage due to the action of the spring ( 79 ) under the cursor ( 78 ). the solenoid ( 69 ) is activated by the lung ventilator ( 6 ) synchronously with the inhaling stage of the respiratory cycle of the patient , i . e . during the inhaling stage . the feeding of oxygen through the channel ( 70 ) is interrupted and consequently the pilot pressure over the diaphragm ( 77 ) and the flow of oxygen through the outlet channel ( 72 ) is interrupted , even if the pilot stage had been manually activated . the valve for the free flow of oxygen of the present invention remains in operation even in the lack of power supply , thus allowing its operation for example by means of manual ventilation . this promotes a better safety during the administration of anesthesia , since it is possible to work even in case of lack of power supply or failure in the electronic system of the equipment . the synchronization of the free flow of oxygen during the exhaling stage avoids the risks of the equipments of the state of the art , allowing the operator to activate the flow at any moment of the ventilation , without the need to change the controlled standards , such as the respiratory frequency , and without need to interrupt the ventilation .
the present invention refers to a ventilation system used in hospital respiratory devices for the administration of anesthesia to newly born , pediatric and adult patients . more specifically , the present invention refers to a ventilation system that promotes a respiratory circuit with re - inhalation for the administration of anesthesia and that overcomes all inconveniences and deficiencies existing in respiratory devices of the state of the art . the ventilation system in respiratory devices comprises a bellows assembled within a reservoir , which is provided with a manifold with various gas exhaling valves , more specifically release valves to take out the excess of gases , and an exhaling valve for control gases . it is additionally constituted of a valve for the free flow of oxygen to quickly renew or replace the gases inside the respiratory circuit .
the present invention is directed to a massaging device that is particularly effective in stimulating body parts such as female genitalia . with reference to fig1 - 3 of the drawings , a massaging device 10 includes a motorized vibrator 12 mounted in an elongate housing 13 , a screw - on cap 14 detachably connected to the housing and having a control button 15 projecting therefrom , a battery pack 16 inserted within the housing , a control module 18 and a sensor module 20 mounted in the housing and including a sensor circuit board 21 supporting a longitudinally distributed plurality of sensor elements 22 according to the present invention , the elements being individually designated 22 a , 22 b , and 22 c , the element 22 c being closest to the control button 15 , the element 22 a being closest to the opposite end of the device 10 . the housing 13 is also covered with a sleeve 24 , and the assembly is sealed with an elastic o - ring 25 interposed between the sleeve and the cap 14 . in the exemplary configuration shown in the drawings , the device 10 has a cylindrical shape with spherically rounded ends , the control button 15 projecting from one end of the device . the control button 15 operates a “ push - on / push - off ” power switch 26 that is mounted on a switch structure 19 within the cap 15 for activating the device 10 . also included is appropriate wiring or other conductors ( not shown ) between the vibrator 12 , the battery pack 16 , the control module 18 , the sensor module 20 , and the control switch 26 . when activated , the device assumes an idle state unless and until a user &# 39 ; s body part comes into close proximity with one of the sensor elements 22 . as more particularly described in connection with fig2 and 3 below , proximity with the sensor element 22 a only produces a first or low level of activation of the vibrator 12 ; proximity with the sensor element 22 b ( but not 22 c ) produces a second or medium level of activation ; and proximity with the sensor element 22 c produces a third or high level of activation of the vibrator 12 . with further reference to fig4 and 5 , an alternative configuration of the massaging device , designated dildo 30 , includes counterparts of the motorized vibrator 12 , the housing , designated 13 ′, control button , designated power button 15 ′, the battery pack , designated 16 ′, the control module , designated 18 ′ and the control circuit board , designated 19 ′, the sensor module , designated 20 ′ and the sensor circuit board , designated 21 ′ with counterparts of the sensor elements , designated 22 ′ ( individually 22 ′ a , 22 ′ b , and 22 ′ c ), and a momentary counterpart of the power switch , designated 26 ′. the battery pack 16 ′ is supported within a handle 32 and retained in place by a screw - in cap 34 . the power button 15 ′ projects through the handle 32 , the control module 18 ′ being located within the handle . an elastic counterpart of the sleeve , designated 36 has a main portion 37 covering the housing 13 ′ and having the form of an erect penis with a head portion 38 , and an arm portion 39 projecting to one side in a shape and dimension preferably facilitating contact with the clitoris of a user of the dildo , the arm portion enclosing a motorized secondary vibrator 40 that is locatingly supported within an arm cavity 42 of the arm portion 39 . each of the sensor elements 22 ′ is biasingly pressed against the sleeve by a sensor spring 42 , the element 22 ′ a being closest to the head portion 38 of the sleeve 36 , the element 22 c being farthest therefrom . as described above in connection with the massager 10 , appropriate wiring or other conductors ( not shown ) connect the battery pack 16 ′, the control module 18 ′, the sensor module 20 , and the vibrators 12 and 40 . the exemplary configuration of the dildo 30 of fig2 and 3 further includes a mode switch actuator 44 protruding the handle 32 for operation by a user and having a mode switch 46 that is mounted directly on the control circuit board 19 ′. a plurality of intensity indicators 48 also project through the handle , being supported by the control circuit board . the mode switch 46 sequentially selects a plurality of vibration modes , selectively modifying operation of the vibrators 12 and 40 in combination with response to the sensors 22 ′ as described above for the massaging device 10 . suitable materials for the housings 13 and 13 ′, and the handle 32 include abs . suitable materials for the battery packs 16 and 16 ′ include polypropylene ; and suitable materials for the sleeve 36 ( and the control button 15 of fig1 ) include elastic plastic materials such as tpe . a suitable battery complement is four type aaa alkaline batteries . with particular reference to fig6 and 7 , a control circuit 50 of the dildo 30 is formed by a combination of the control module 18 ′ and the sensor module 20 ′. as shown in fig6 , the control circuit 50 includes a body touch detector 52 that operates in combination with a signal detector 54 that signals a microprocessor 56 , the microprocessor controlling a main driver 58 for powering the main vibrator 12 , and a secondary driver 59 for powering the secondary vibrator 40 . the touch detector 52 includes the sensor elements 22 ′ a , 22 ′ b , and 22 ′ c , the elements 22 ′ each having a coupling capacitor 60 connected to a common pulse output 62 of the signal detector 54 , and a grounded blocking diode 63 connected for maintaining a positive potential at the sensor element 22 ′. that potential is fed through a signal filter that includes a charging resistor 64 , a filter capacitor 65 , and a discharge resistor 66 , the resulting filtered touch signal 67 being fed to a corresponding input of the detector 54 . the touch signals are individually designated 67 a , 67 b , and 67 c in fig7 , corresponding respectively to the sensor elements 22 ′ a , 22 ′ b , and 22 ′ c . the signal detector 54 monitors each of the touch signals 67 , periodically communicating status signals to the microprocessor 56 . when any of the sensor elements comes into close proximity to a user &# 39 ; s body part , capacitive coupling alters ( increases ) loading of the associated coupling capacitor , correspondingly changing ( decreasing ) the resulting touch signal sufficiently to change the relevant status signal . in addition to the above - described communication with the signal detector 54 , the microprocessor is responsive to the power switch 26 ′ and the mode switch 46 for signaling the main and secondary drivers 58 and 59 as further described below , the microprocessor having separate outputs for driving each of the indicators 48 . in an exemplary configuration of the dildo 30 , the control circuit 50 , upon activation by the power switch 26 ′, is responsive to the mode switch 46 for controlling the secondary vibrator 40 as described herein , the main vibrator 12 being responsive to proximity of the sensor elements 22 ′ as described above regarding the sensor elements 22 of the massaging device 10 . in this configuration , successive activations of the mode switch 46 produces eight intensity modes of operation of the secondary vibrator 40 as set forth below in table 1 . it will be understood that other modes of operation of the secondary vibrator 40 are within the scope of the present invention . corresponding variations in operation intensity levels of the main vibrator 12 are possible also , an exemplary schedule being indicated below in table 2 . in table 2 , “ sensor a ” excludes activation of the sensor elements 22 ′ b and 22 ′ c ; “ sensor b ” excludes activation of the sensor element 22 ′ c . in both tables the activation levels are relative and arbitrary as is consistent with effective levels known to those skilled in the art . the indicators 48 are driven by the control circuit 50 at low intensity in modes 1 and 2 , medium intensity in mode 3 , high intensity in mode 3 , variable intensity in mode 4 , and blinking in modes 5 - 8 synchronously with activation of the secondary vibrator 40 . it will be understood that other and various indications in the different modes are possible . with reference to fig8 , there are shown graphical illustrations of intensity represented by a waveform , wherein the shape of the waveform represents the level of intensity generated by the different modes of op