Abstract:
A dermal punch device for automatically extracting a sample of tissue of a predetermined size and shape from a body comprising a retractable cutter and a sutureless biopsy closure mechanism that includes a wound closure fastener member adapted to be disposed over a biopsy region after the performance of the biopsy, wherein wound closure fastener member is automatically applied without the need of several instruments to seal the wound. The wound closure fastener member is dispensed by a sutureless biopsy closure dispenser located at the same distal end of the biopsy punch device surrounding the biopsy punch cutter assembly avoiding the need of separates instruments, reducing the wound closing steps and surgical procedure time.

Description:
RELATED APPLICATIONS 
       [0001]    This application is related to Non-Provisional U.S. patent application Ser. No. 13/089,056 filed on Apr. 18, 2011. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT 
       [0002]    N/A 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    This application relates generally to the field of extracting tissue samples from solid bodies, and more specifically to surgical instruments for extracting a biopsy or sample of tissue while providing a sutureless biopsy wound site closure. 
         [0005]    2. Discussion of the Background 
         [0006]    Annually thousands of persons and animals are tested for numerous skin problems such as abnormal skin growths and cancers, as well as skin eruptions. Surgical instruments, such as a dermal punch and others are used to obtain samples of skin lesions for diagnostic purposes. The procedure involves the insertion of a cutting surgical instrument into the patient&#39;s skin wherein the cutting surgical instrument comprises a cylindrical blade at the distal end of an inert plastic or metal rod. After abutting the cylindrical blade to the skin the cutting instrument is rotated so as to cut out and remove a plug of the tissue of interest. The tissue is then submitted to be analyzed by a pathologist in order to obtain a diagnosis. 
         [0007]    For example in a skin punch biopsy, the skin surrounding the lesion is pulled taut, and the punch is firmly introduced into the lesion and rotated to obtain the tissue specimen. The punch must go deep enough to include an average of a 6 mm depth in order to include the lower dermis and subcutaneous fat. The plug is lifted with forceps or a needle. The specimen is placed in a properly labeled sterile container. 
         [0008]    After the removal of the tissue, the traditional dermal punch biopsy usually leaves a circular wound opening which is then normally closed by a suture. Some of the problems associated with this technique include, but are not limited to, the use of multiple instruments in performing the suturing which typically requires at least a needle holder, scissors, suture material and forceps. Other problems are the potential for a needle stick injury and the increased cost of the suture and sterilization of the instruments used. Furthermore, there is also a need for more than one person to perform the procedure, for example a nurse has to prepare a sterile instrument tray, pass the instruments to the surgeon, place a bandage on the wound following the procedure and finally pick up and resterilize the instruments. 
         [0009]    There is a need for a device that provides a streamlined procedure which does away with the time consuming pre and post operative phase, reduces the currently needed personnel, and instruments and provides an improved sutureless wound closure at the site of the biopsy wound. It should be relatively inexpensive, easy to apply, efficient and not require subsequent procedures. 
       SUMMARY OF THE INVENTION 
       [0010]    The present disclosure describes a biopsy punch device operated by a single operator, wherein the biopsy punch device comprises a mean to obtain the tissue sample while achieving sutureless closing of the biopsy wound site without a need of other instruments. Comparable to biopsy punch device disclose in patent application Ser. No. 13/089,056 filed on Apr. 18, 2011, herein included by reference, the present biopsy punch device cuts and extracts the tissue without lifting the device from the skin. After the tissue is removed the biopsy punch device achieves sutureless closing of the biopsy wound site without the need for additional instruments such as needles, suture material, forceps and scissors. The suture process is achieved by deploying a fastener member having resilient properties configured for this purpose and mechanically activated by the cutter assembly. 
         [0011]    The first embodiment of the biopsy punch device comprises an elongated hollow cylinder with a distal end having an preloaded exposed cylindrical cutter which rotates during the incision procedure and is then retracted into the body of the elongated hollow cylinder while the cylindrical cutter assists with the grasping and removing of the tissue sample and; wherein said cylindrical cutter is coupled to a sutureless fastening mechanism. The sutureless fastening mechanism comprises a sutureless dispenser to dispense a biopsy closure fastener member. The sutureless biopsy closure dispenser, more particularly the trigger is activated by a means of a linear motion provided by the cutter assembly which assists to release at least a biopsy closure fastener member at the wound site which renders the biopsy wound site closed by approximating the opposing edges of the wound. The biopsy closure fastener member comprises at least two-pronged fastener having resilient properties, wherein the two-pronged fastener may expand to a distance at least equal to the diameter of the wound created by the cylindrical cutter and then contracts when released therein. The present biopsy punch device eliminates the need for multiple instruments and their handling, sutures and speeds-up the process. 
         [0012]    It is another objective to provide a retractable biopsy punch actuated by an manual, wherein the biopsy punch cutter comprises a constant and uniform depth to provide a tissue specimen having a uniform thickness for accurate diagnosis. 
         [0013]    It is a further objective to provide a biopsy punch device that is inexpensive to manufacture such that it can be made disposable. 
         [0014]    It is a further objective to provide a biopsy punch cutter blade that is configured to assist with the removal of the tissue sample. 
         [0015]    Another objective is to provide a mechanical structure that automatically activates the sutureless dispenser for suturing during the procedure without the need of several instruments. 
         [0016]    Another objective is to minimize time and effort during the process of closing the wound site. 
         [0017]    The preferred embodiment for a biopsy and sutureless device constructed pursuant to this application, both as to its configuration and its mode of operation will be best understood, and additional objects and advantages thereof will become apparent, by the following detailed description taken in conjunction with the accompanying drawings. 
         [0018]    The applicant hereby asserts, that the disclosure of the present application may include more than one invention, and, in the event that there is more than one invention, that these inventions may be patentable and non-obvious one with respect to the other. 
         [0019]    Furthermore, the purpose of the accompanying abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers, and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the disclosure of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the disclosure in any way. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]    The accompanying drawings which are incorporated herein constitute part of the specifications and illustrate the preferred embodiment of a biopsy and sutureless device constructed pursuant to an example embodiment of the present invention. 
           [0021]      FIG. 1  is a perspective view of an exemplary biopsy punch device in accordance with the principles of the present example embodiment of the present invention. 
           [0022]      FIGS. 2A through 2B  are perspective views of an exemplary biopsy punch device without housing in accordance with the principles of the present example embodiment of the present invention. 
           [0023]      FIG. 3  is a perspective view of an exemplary biopsy punch device housing in accordance with the principles of the present example embodiment of the present invention. 
           [0024]      FIG. 4  is a sectioned view of an exemplary biopsy punch device in accordance with the principles of the present example embodiment of the present invention. 
           [0025]      FIG. 5  is a sectioned view of an exemplary biopsy punch device housing in accordance with the principles of the present example embodiment of the present invention. 
           [0026]      FIG. 6  is a sectioned view of an exemplary biopsy punch device without housing in accordance with the principles of the present example embodiment of the present invention. 
           [0027]      FIG. 7  is a perspective view of an exemplary cutter assembly in accordance with the principles of the present example embodiment of the present invention. 
           [0028]      FIG. 8  is a perspective and exploded view of an exemplary biopsy cutter in accordance with the principles of the present example embodiment of the present invention. 
           [0029]      FIG. 9  is a perspective sectional view of an exemplary biopsy cutter in accordance with the principles of the present example embodiment of the present invention. 
           [0030]      FIG. 10  is a perspective view of an exemplary embodiment of the cutter assembly shaft in accordance with the principles of the present example embodiment of the present invention. 
           [0031]      FIG. 11  is a perspective view of an exemplary embodiment of the cutter assembly shaft upper section in accordance with the principles of the present example embodiment of the present invention. 
           [0032]      FIG. 12  is a perspective view of an exemplary embodiment of the cutter assembly shaft gearing in accordance with the principles of the present example embodiment of the present invention. 
           [0033]      FIG. 13  is a perspective view of an exemplary embodiment of the cutter assembly shaft rotational pivot in accordance with the principles of the present example embodiment of the present invention. 
           [0034]      FIG. 14  is a perspective view of an exemplary embodiment of the sutureless dispenser actuator surrounding the cutter assembly shaft in accordance with the principles of the present example embodiment of the present invention. 
           [0035]      FIG. 15  is a perspective view of an exemplary embodiment of the sutureless dispenser actuator in accordance with the principles of the present example embodiment of the present invention. 
           [0036]      FIG. 16  are alternative perspective view of an exemplary embodiment pointing out the hammer configuration of the sutureless dispenser actuator in accordance with the principles of the present example embodiment of the present invention. 
           [0037]      FIGS. 17A and 17B  are perspective views of an exemplary embodiment of the hammer configuration of the sutureless dispenser actuator in accordance with the principles of the present example embodiment of the present invention. 
           [0038]      FIG. 18  is a perspective view of an exemplary embodiment of the sutureless dispenser actuator body in accordance with the principles of the present example embodiment of the present invention. 
           [0039]      FIG. 19  is sectional view of an exemplary embodiment of the sutureless dispenser actuator body in accordance with the principles of the present example embodiment of the present invention. 
           [0040]      FIGS. 20A-20C  are side views of an exemplary embodiment of the biopsy punch device loading process in accordance with the principles of the present example embodiment of the present invention. 
           [0041]      FIGS. 21A-21C  are perspective view of an exemplary embodiment of the biopsy punch device loading process in accordance with the principles of the present example embodiment of the present invention. 
           [0042]      FIG. 22  is perspective view of an exemplary embodiment of the interaction between the cutter and sutureless dispenser assembly at the compress stage in accordance with the principles of the present example embodiment of the present invention. 
           [0043]      FIG. 23A-23B  are perspective views of an exemplary embodiment of the interaction between the cutter and sutureless dispenser assembly at the decompress stage in accordance with the principles of the present example embodiment of the present invention. 
           [0044]      FIG. 24  is a perspective view of an exemplary embodiment of the hammer at the suturing stage in accordance with the principles of the present example embodiment of the present invention. 
           [0045]      FIG. 25A-25B  is a perspective view of an exemplary embodiment of the sutureless fastener member in accordance with the principles of the present example embodiment of the present invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0046]      FIG. 1  shows an exemplary biopsy punch device in accordance with the principles of the present application. The first embodiment for a biopsy punch device  1  constructed in accordance with this application comprises an elongated hollow body housing comprising a grip zone  2   a , wherein said housing  2  surrounds the sutureless dispenser assembly  3  and the cutter assembly  4 . A rotational pivot is located and mechanically attached to the cutter assembly  4  with a distal end having an exposed cylindrical cutter  3 . 
         [0047]      FIGS. 2A through 2B  are perspective views of an exemplary biopsy punch device without housing  2  in accordance with the principles of the present example embodiment of the present invention.  FIG. 2A  shows the portion of the sutureless dispenser actuator  3 , wherein a housing stopper  31  protrudes from the sutureless dispenser actuator body. The housing stopper  31  avoids or prevents the unwanted displacement of the housing  2 . Further a piston or hammer  7 , is designed to be in close contact with the sutureless fastener member F. As shown in U.S. patent application Ser. No. 13/089,056 hereby included by reference, the hammer serves to punch the fastener into patience skin during the pushing action. The hammer  7  is mechanically coupled to a resilient member  6 , such as spring. The resilient member  6  limits the displacement of the hammer  7 .  FIG. 2B  represents opposite side of the sutureless dispenser actuator  3 . The distal end  8  of the sutureless dispenser actuator  3  is configured to matches the hammer  7  body in such way that provides a path, aligns and limits the displacement of the hammer  7  during the reciprocal displacement and avoids or prevents that the hammer travels further than the distal end  8 . 
         [0048]      FIG. 3  is directed to the housing  2  which comprises a durable material which is not easily deformed when an user provides pressure over the housing  2  structure. Further the housing  2  comprises a grip zone  2   a  in order to assists the transmission of rotational movement over the biopsy punch device  1  by the user. 
         [0049]      FIG. 4  shows the inner structure of the biopsy punch device  1 , but more particularly the inner structure.  FIG. 5  and  FIG. 6  are directed to sectional views of the housing  2  and the punch device  1  without said housing  2 . The exemplary embodiment shows a housing  2  surrounding the sutureless dispenser  3  and the cutter assembly  4 . As mentioned before the hammer  7  and resilient member  6  surrounds the cutter shaft  42 . Further is clearly showed how the housing  2  is in contact with the stopper  31 . The cutter assembly  4 , more particularly the upper shaft section  42  is surrounded by a second resilient material  10 . The main purpose of the second resilient material  6  is to provide a linear displacement of the cutter shaft  4 . The second resilient material  10  is located between the sutureless dispenser  3  inner protrusion  300  and cutter shaft stopper  400 . The cutter  9  is located at a distal end of an upper shaft section  42 . In addition is clearly shown that the rotational pivot  5  is mechanically coupled to the cutter assembly shaft  4 . A portion a protrusion of said rotational pivot  5  extend inside the hollow body of the lower shaft section  41 . The sutureless dispenser  3 , has a hollow body with an inner surface configured to provide a several reduction in order to mechanically coupled some features such as resilient material  6  and particular shaped having a tapered zone  303  defining a circular contour toward the inner surface of the sutureless dispenser  3  structure in order to provide smooth contact with the cutter and assisting with the collapsing action of said cutter during the linear displacement. 
         [0050]      FIG. 7  is directed to the cutter shaft assembly. The cutter shaft assembly comprises a cutter  9  located at an elongated body, wherein said elongated body  4  comprises a distal end of a upper shaft section  42 , a lower section  41 , a second resilient material  10 , a gear assembling  9  and a rotational pivot  5 . 
         [0051]    The cutter  9 , as shown in  FIG. 8  and  FIG. 9 , comprises at a plurality of blades made of an inexpensive and durable metal and/or plastic materials such as stainless steel blade  92 , a middle cutter body  93 , tapered gap  94 , a cutter base  95  and fixing means  96 . The pluralities of blades are arranged in a substantially circular contour, wherein each blade is separated by the tapered gap  94 . The tapered gap  94  is configured to comprise a shape that assists the bending action of each blade with respect to the base  95 . For example, the reduce body portion  951  of the blade  92  closer to the base  95  is reduced in order to provide less resistance while the blade  92  is bend during the compression action of the middle cutter body  93 . The tapered gap  94  extends from the blade through the middle cutter body  93  until reaching the cutter base  95  as show in  FIG. 9 . 
         [0052]    Further the middle cutter body  93  is shaped to comprise an articulate configuration. The articulate configuration connects the blades  92  and the cutter base  95 . The articulate configuration serves to promote a distal compression or displacement of the tips  91  of the blades  92  toward each other when the middle cutter body  93  contacts the dispenser reduced inner diameter or tapered zone  303  during the retraction of the cutter  9  inside the sutureless dispenser  3 . 
         [0053]    The tapered gap  94  allows the bending action of each blade  92  without the deforming, in order word while the compressing force is exerted at the middle cutter body  93  each blade tip  91  move toward the blades that is facing in such way that substantially circular contour diameter is reduced. While applying compressing force to the middle body  93  the tapered tap  94  or space between the blades  92  is reduced and simultaneously the blades tips  91  get closer. The space reduction results in a reduction of diameter at the space between tip blades  91  serves as a grasping action. Further a receiving section  96  is provided at a proximal end of the cutter  9 . The attaching section  96  serves to hold the blade in position at the upper shaft section  42 . 
         [0054]      FIG. 10  is directed to the cutter shaft assembly without the cutter  9 . The upper section or upper shaft end  42  comprises a distal end  421 , a cutter holder  422 , a dispenser trigger  420 , a second resilient material stopper  400  and a proximal end  425 , as shown in  FIG. 11 . The dispenser trigger  420  comprises at least a groove  4201  and solid section  4202 . 
         [0055]      FIG. 12  is directed to the cutter shaft gear assembling  500 , wherein said assembling comprises a gear first end or follower  50  and a gear second end or push section  60 . The cutter shaft gear assembly  500  assists to retract and extend the cutter shaft, more particularly retract and extend the cutter  9  away and inside the housing  2 . In the preferred exemplary embodiment the cutter shaft gear assembly  500  is a cam follower mechanism comparable to the system used in ball points. The follower  50  comprises a transitional section  52 , a first extension  53  and a second extension  54 . The second gear end comprises a displacement actuator  62 . The second extension  54  is located inside the lower shaft end  41  in such way displacement actuator contacts the transitional section  52 . The geometry of the displacement actuator  62  and the transitional section  52  in combination with the spring  10  provides a linear displacement of the cutter  9 . The cam mechanism  500  at least provide two stages; the compressing stage, wherein the cutter  9  extends away from the housing  2  and a decompress stage wherein said cutter  9  is pushed inside the sutureless dispenser  3 . The combination of the first gear  50  and second gear  60  provides a linear displacement of the upper shaft  42 , more particularly the cutter  9 . It is important to understand that several gear mechanism  500  capable of retracting and extending the cutter  9  away and inside from the housing  2  can be used. 
         [0056]      FIG. 13  is directed to the rotational pivot  5  comprising an extended attaching member  510  and wheel  511 . As previously mentioned, the attaching member  510  is inserted and mechanically attached to rower shaft section  41 . The rotational pivot  5  rotates independently form the biopsy punch device  1  by means of a attaching member  510  serving as a bearing, therefore the user can rotate the punch device by the housing  2 , more particularly by means of the grip  2   a , while applying vertical pressure on the rotational pivot  5  during the insertion and tissue removing process of a patient. 
         [0057]      FIG. 15  through  FIG. 21  are directed to the sutureless dispenser actuator  3 . As shown in  FIG. 14  through  FIG. 16 , the sutureless dispenser actuator  3  comprises a sutureless fastener F, a dispenser sleeve divided into an upper dispenser section  30  and a lower dispenser section  32 , a stopper  31  and a actuator mechanism, wherein said actuator mechanism comprises a hammer  7  and a resilient material  6 . The upper dispenser section  30  comprises a reduce diameter outer section  33  and a distal end protrusion  8 . The distal end protrusion  8  comprises a reduce protrusion section  83 , a solid protrusion section  82  and a travel surface  81 . As mentioned before, the distal end protrusion  8  of the sutureless dispenser actuator  3  is configured to matches the hammer  7  body in such way that provides a path, aligns and limits the displacement of the hammer  7  during the reciprocal displacement and avoids or prevents that the hammer travels further than the distal end  8 . A portion of the hammer  7  travels on top of travel surface  81  of the distal end protrusion  8  until contacting the a solid protrusion section  82 . 
         [0058]    The hammer  7 , as shown in  FIG. 17A through 17B , comprises a hollow structure with a fastener contacting area  70 , a sectional area  72 , a solid hammer area  73  and a recess  71 . The sectional area  72  is configured to match distal end protrusion  8  in such way that contacts the solid protrusion section  82  and stop moving over the traveling surface  81 . 
         [0059]    Further, the recess  71  serves as a receiving section for holding element  300 . While the resilient material  6  is compressed the holding element  300  is inserted inside the recess  71  retaining the resilient material  6  in a compressed position. The holding element  300  is released or moved from the recess  71  by means of the dispenser trigger  420  when the cutter shaft  4  is retracted. As mentioned before the sutureless dispenser actuator  3  surrounds the cutter shaft assembly. The inner surface of the sutureless dispenser actuator  3  is configured to provide support to several features of the cutter shaft. In the instant case the sutureless dispenser actuator  3  comprises a dispenser reduced inner diameter or tapered zone  303 . The tapered zone  303  serves to promote a distal compression or displacement of the tips  91  of the blades  92  toward each other by contacting the middle cutter body  93  during the retraction of the cutter  9  inside the sutureless dispenser  3 . 
         [0060]    Further, as shown in  FIG. 19 , the sutureless dispenser  3  comprises a protrusion  301  which fits inside the groove  4201  in order to avoid rotational movement of the upper shaft  42 . The dispenser trigger  420  is configured to rests inside inner surface of the sutureless dispenser  3  wherein the solid section  4202  contacts the holding element  300  in such way that pushes away providing the insertion of the holding element  300  inside the recess  71 . The contact of the solid section  4202  with the holding element  300  is provided during the stage where the spring  10  is compressed and the cutter is extended away from the housing  2 . Once the stage changes to retract the cutter  9  said solid section  4202  stops or discontinues the contact with the holding element  300 . Therefore the holding member  300  is not pushed inside the recess  71  resulting in the release and linear movement of the hammer  7  due to the decompression of the resilient member  6 . 
         [0061]      FIG. 20A through 24  are directed to the different stages.  FIG. 20A  discloses the compressing stage, wherein the cutter  9  extends away from the housing  2 . During the compressing stage the resilient member  10  is compressed, as showed in  FIG. 21A , and the second resilient member  6  is also compressed holding the hammer  7 . This stage is also known as loading stage. Further the next stage is the decompress stage, as shown  FIG. 20B , wherein said cutter  9  is pushed inside the sutureless dispenser  3 . The decompress stage is accomplish by means of the shaft gear  500 . By pressing the first gear  50  the second gear  60  rotates and generates a linear motion of the cutter  9 . The resilient member  10  is decompressed and pushes the cutter  9  inside the housing  2 . Once the cutter  9  get inside of the sutureless dispenser the contact between the solid section  4202  stops or discontinues with the holding element  300 . This action results in the last and final stage, the suturing stage. 
         [0062]    As mentioned the holding member  300  is not pushed inside the recess  71  resulting in the release and linear movement of the hammer  7  due to the decompression of the resilient member  6 . The hammer  7  pushes the fastener F towards the patient body, as shown in  FIG. 20  C and  FIG. 21C . 
         [0063]      FIG. 22  clearly shows how the cutter  9  and dispenser reduced inner diameter or tapered zone  303  interact. The fastener F is located on top of the travel surface  81  waiting for being pushed by the hammer  7 . The housing  2  is surrounds and keeps the fastener F over the travel surface  81 .  FIG. 23A  through  23 B is directed to the decompress stage wherein the cutter  9  is retracted inside the sutureless dispenser  3 . At this stage the cutter  9  is basically fixed inside the sutureless dispenser  3 . Further,  FIG. 24  represents the suturing stage wherein the fastener F is pushed towards the patient. 
         [0064]      FIG. 25A through 25B  discloses the sutureless fastener member F. The sutureless fastener member F or biopsy closure fastener member comprises two prongs FA connected by a fastener body FC serving as a bridge between the prongs. The fastener body FC has resilient properties, wherein the two-pronged FA fastener may expand to a distance bigger than the diameter of the wound created by the cylindrical cutter, as shown in  FIG. 25A . The fastener body material is selected from a group or resilient plastic material, resilient ceramic plastic, resilient metal material or any combination. The resilient material selected has to be a no-toxic resilient material. 
         [0065]    The two-pronged FA are intended to be inserted at opposite sides of the wound site into the patient&#39;s skin. The sutureless fastener member F is stretched in order to be inserted into the patient&#39;s skin at opposite sides of the wound site. The stretching action is assisted by the reduce protrusion section  83  which keeps the two-pronged fasteners  4   b  separated enough to have a distance bigger than the diameter of the wound created by the cutter  9 . After the sutureless fastener member  4  is inserted into the patient&#39;s skin the resilient properties of the sutureless fastener member F acts on the wound site. Since no rigid body is retraining the fastener member F stretched the fastener member F returns to its original form consequently making the opposite sides of the wound to come together. The resilient properties of the sutureless member F close the wound without the need of additional instruments. 
         [0066]    While the invention has been described as having a preferred design, it is understood that many changes, modifications, variations and other uses and applications of the subject invention will, however, become apparent to those skilled in the art without materially departing from the novel teachings and advantages of this invention after considering this specification together with the accompanying drawings. For example, three stages where described however more stages can be included. For instance, if the first gear  50  is pressed the cutter shaft can returned to the load position and the cutter  9  come out of the housing  2 . The action should me comparable, but not necessarily similar, to an in/out movement of a ballpoint movement. By doing this the tissue removed from the patient can be easily removed from the inner surface of the cutter  9 . Accordingly, all such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by this invention as defined in the following claims and their legal equivalents. In the claims, means-plus-function clauses, if any, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. 
         [0067]    All of the patents, patent applications, and publications recited herein, and in the Declaration attached hereto, if any, are hereby incorporated by reference as if set forth in their entirety herein. All, or substantially all, the components disclosed in such patents may be used in the embodiments of the present invention, as well as equivalents thereof. The details in the patents, patent applications, and publications incorporated by reference herein may be considered to be incorporable at applicant&#39;s option, into the claims during prosecution as further limitations in the claims to patentable distinguish any amended claims from any applied prior art.