Patent Document

1. RELATED APPLICATIONS 
     This application: is a continuation of co-pending U.S. patent application Ser. No. 12/361,151, filed Jan. 28, 2009, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/025,230, filed Jan. 31, 2008, both of which are hereby incorporated by reference in their entirety. 
    
    
     2. THE FIELD OF THE INVENTION 
     This invention relates to treatments providing nitric oxide as a vasodilator, and, more particularly, to generation and delivery of gaseous nitric oxide for inhaling. 
     3. BACKGROUND 
     The discovery of the nitric oxide effect in live tissues garnered a Nobel prize. Much of the work in determining the mechanisms for implementing and the effects of nitric oxide administration are reported in literature including papers, advertising, catalogs, and patents. Much of the work deals with introduction of substances that provide a nitric oxide effect in the body. Still other applications may involve topical preparations introducing nitric oxide. Still other applications rely on bottled nitric oxide gas. Introduction of nitric oxide to the human body has traditionally been expensive. 
     The therapies, compositions, and preparations are sufficiently expensive to inhibit more widespread use of such therapies. What is needed is a comparatively inexpensive mechanism for introducing nitric oxide in a single dosage over a predetermined period of time. Also, what is needed is a simple introduction method for providing nitric oxide suitable for inhaling. 
     BRIEF SUMMARY OF THE INVENTION 
     In accordance with the foregoing, certain embodiments of an apparatus and method in accordance with the invention provide a reactive kit having two compounds, typically disposed in carriers. The two compounds are separated from one another prior to administration. In order to administer the nitric oxide, reactants are mixed in with one another beginning a reaction releasing nitric oxide. 
     An adhesive member may secure a distributor to a mask or directly to the skin of a user proximate the nose. Nitric oxide may thus be introduced into the breathing air of a subject. Nitric oxide amounts may be engineered to deliver at a comparatively low rate in the hundreds of parts per million, or in a therapeutically effective amount on the order of thousands of parts per million. For example, sufficient nitric oxide may be presented through nasal inhalation to provide approximately five thousand parts per million in breathing air. This may be diluted due to additional bypass breathing through nasal inhalation or through oral inhalation. 
     One embodiment of an apparatus and method in accordance with the present invention may rely on a small reactor feeding a distributor secured to an upper lip of a user. A diffuser may secure to one side of an adhesive strip, while a treated backing paper, easily removable, may be secured to the opposite side of the adhesive strip. A reactor may be sized to contain reactants as solids, liquids, or gels compounded to have an appropriate moisture content to support reaction of reactants. A second reactant composition in a carrier may be sealed or otherwise separated from the first reactant composition. For example, the two reactants may be contained in separate volumes. Alternatively, reactive solids may simply be appropriately combined dry, or even separated by an intervening layer, such as a film, paper, or the like. The reaction may begin upon introduction of a liquid transport material to support ionic or other chemical reactions. The reactants held in separate, sealed volumes may be opened and mixed or otherwise placed in contact with one another to permit combination of the ingredients needed to form nitric oxide. In one embodiment, the reactants may include an acid, such as ascorbic acid, citric acid, or the like as a hydrogen donor. The other reactant may include potassium nitrite, sodium nitrite or the like. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing features of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are, therefore, not to be considered limiting of its scope, the invention will be described with additional specificity and detail through use of the accompanying drawings in which: 
         FIG. 1  is a perspective view of one embodiment of a system for generating and delivering nitric oxide in accordance with the invention; 
         FIG. 2  is an exploded view of alternative, cross-sectional, end views of the distributor of  FIG. 1 ; 
         FIG. 3  is a perspective view of various alternative embodiments for a reaction chamber for the apparatus of  FIG. 1 ; 
         FIG. 4  is a partially cut-away, perspective view of one embodiment of a reactor for use in the apparatus of  FIGS. 1-3 ; and 
         FIG. 5  is a schematic block diagram of one embodiment of a method in accordance with the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     It will be readily understood that the components of the present invention, as generally described and illustrated in the drawings herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the system and method of the present invention, as represented in the drawings, is not intended to limit the scope of the invention, as claimed, but is merely representative of various embodiments of the invention. The illustrated embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. 
     Referring to  FIG. 1 , an apparatus  10  in accordance with the invention may include a vessel  12  or distributor  12 . The distributor  12  may be configured to be flexible or may be pre-formed to fit the anatomy of a user. Typically, the distributor  12  will be placed on the upper lip of a user to provide the outputs  14  (e.g., output ports  14 , or simply ports  14 ) access to the nostrils of a user during breathing. Each of the outputs  14  has an opening  15  for delivering nitric oxide directly into the nostrils of a user. Typically, sufficient clearance provides a bypass for air in addition to the nitric oxide from the distributor  12 . 
     In certain embodiments of an apparatus in accordance with the invention, a distributor  12  may include a port  16  to operate as an input  16  for receiving nitric oxide from another source. For example, the port  16  may have an opening  17  for receiving from a line  18  a supply of nitric oxide. 
     In the illustrated embodiment, a reactor  20  provides a supply of nitric oxide to the distributor  12 . As illustrated, one end  22  of a line  18  may connect to the input port  16  of the distributor  12 . The opposite end  24  of the line  18  connects to the reactor  20 . The opening  26  of the line  18  provides a lumina  26  value or passage  26  for passing the nitric oxide gas from the opening  28  of the fitting  30  on the reservoir  20 . 
     In certain embodiments, the reactor  20  may be manufactured in a single-dose size. Accordingly, the distributor may be reused or disposed of. The reactor  20  may typically be disposed of after a single use. Circumferential hoop stresses are not high. Accordingly, the distributor  12 , the line  18 , and the reactor  20  may all be fabricated from comparatively lightweight and inexpensive materials such as plastic. Parts may be cast, molded, vacuum formed, assembled from film, or the like. 
     Referring to  FIG. 2 , the distributor  12  may be configured in various cross-sectional shapes. For example, the distributor  12  may typically have a principal wall  32  enclosing a chamber  34  or volume  34  containing all necessary materials for therapy, thereby creating a continuous, or monolithic, distributor  12  containing all necessary materials for therapy. In certain embodiments, the chamber  34  may simply act as a manifold or distributor channel conducting nitric oxide gas. In other embodiments, the chamber  34  may completely enclose the reaction constituents and structures. Thus, the distributor  12  may serve as both a distributor  12  and reactor  20  in a single, integrated apparatus  10  (monolithic apparatus). 
     In various embodiments, the chamber  34  may include a vessel  36  inside or completely enclosed within the wall  32  and chamber  34  of the distributor  12 . The internal vessel  36  may have a wall  38  that is permeable or impermeable. In certain embodiments, the vessel  36  may have a wall  38  formed of glass to maintain the vessel  36  sealed from the contents of the chamber  34 . Accordingly, upon fracture of the wall  38 , the contents of the vessel  36  may be spilled into the chamber  34  to mix with other reactants. 
     In certain embodiments, the chamber  40  formed by the wall  38  of the vessel  36  may contain a reactant. In other embodiments, the chamber  40  may simply contain a liquid. In yet other embodiments, the chamber  40  may contain dry ingredients that will become exposed to liquid from the chamber  34  upon fracture of the wall  38  and exposure of the chamber  40  to the contents of the chamber  34 . All the foregoing roles can likewise be traded or reversed. 
     As can be seen, reactants may be separated to render them inactive. The reactants may later be combined to render them active and initiate a reaction. Likewise, the reactants may be maintained in proximity to one another in the chamber  34 , the chamber  30 , or both, or one may be maintained in a chamber  30 ,  34  dry and another wet. However, once both reactants are present in the presence of a liquid (e.g., transport fluid) in the opposite chamber  34 ,  30 , the reaction to release nitric oxide may begin. 
     Any of the embodiments of  FIG. 2  may be provided with an adhesive strip  42 . One function of the adhesive strip is to secure the distributor  12  proximate the nostrils of a user in order that the distributor  12  may deliver nitric oxide through the openings  15  of the output ports  14 . For clarity, the adhesive strip  42  has not been illustrated in every embodiment, although it may. Nevertheless, each of the embodiments may be provided with an adhesive strip  42 . Meanwhile, any of the distributors  12  may be secured by some other method. 
     For example, the distributor  12  may be positioned within a mask covering the nose, the mouth, or both. Likewise, the distributor may be positioned by an air inlet to such a mask. In other embodiments, the distributor  12  may be positioned directly near the mouth, nostrils, or both. Accordingly, the output ports  14  may be shaped to accommodate the positioning thereof for delivery of nitric oxide to the breathing air stream of a subject. 
     In certain embodiments, an additional volume  48  may be separated within the chamber  34 . For example, a layer  50  or wall  50  may seal the reactants away from one another. The wall  50  may be formed of a film, such as a molecular sieve. Such molecular sieves are available from suppliers and may be formed of various materials. One film produced under the trademark Nafion™ operates as a molecular sieve. 
     The value of a molecular sieve is that it is configured to have a pore size that will not permit passage of a compound of nitrogen having more than a single oxygen. Accordingly, only nitric oxide may pass through the molecular sieve. The molecular sieve, thus restrains the reactant liquids, any particulate matter, and all constituents larger than the nitric oxide molecule. Thus, the nitric oxide molecule may pass through the wall  50  and exit the chamber  34  through the output ports  14 . 
     In yet other embodiments, the basic chamber  34  may be separated away from an additional chamber  48  or volume  48  by a seal  50  or wall  50 . Meanwhile, the main chamber  34  may be further subdivided to create an additional volume  52  separated by a wall  54  or seal  54 . In the illustrated embodiment, a volume of a first reactant in the chamber  48  is separated entirely from a volume of a second reactant in a chamber  52 . Meanwhile, the remaining volume of the chamber  34  may be left as air space to receive the reactant gas passing through the molecular sieve of the layer  50 . 
     Referring to  FIG. 2 , embodiment A is configured simply as a distributor  12  in which the chamber  34  enclosed by the wall  32  merely passes the nitric oxide for distribution to the output ports  14 . Meanwhile, an adhesive layer  42  is bonded to the wall  32  and may be secured to the skin of a user upon removal of a layer  44  or cover  44  protecting the adhesive properties of the layer  42  from their environment during handling. 
     Embodiment B of  FIG. 2  includes an additional chamber  40  separated by a wall  36 . In this embodiments, one reactant may occupy the principal chamber  34 , while a second reactant occupies the chamber  40  within the wall  36 . If the wall  36  is formed of glass, then bending the distributor  12  may fracture the wall  36 , exposing the reactants in the chamber  34  to the reactants in the chamber  40 . Accordingly, the relative sizes of the chambers  34 ,  40  may be configured according to the necessary and appropriate quantities of the reactants contained therein, respectively. 
     The reactants in the chambers  34 ,  40  may be dry, wet, or one may be dry and one may be wet. Likewise, one chamber  34 ,  40  may contain both reactive ingredients mixed together but completely dry, while the other chamber  40 ,  34  contains a liquid capable of acting as a transport medium and thus activating the reaction between the dry ingredients. 
     Substantially all the illustrated embodiments for a reactor  20  or for a distributor  12  may benefit, as appropriate, from one of the foregoing configurations of dry, wet, or wet and dry ingredients, or dry ingredients and a wet transport material  12 . 
     Embodiment C provides for a distributor  12  having one volume  48  enclosed by a molecular sieve layer  50 . Meanwhile, a wall  36  encloses another chamber  40  containing another reactant. In this embodiment, the remainder of the volume of the chamber  34  outside the wall  50  of the molecular sieve is available as free space. Meanwhile, all reactants are contained within the molecular sieve layer  50 . 
     A fracture of the wall  36  may release the reactants from the chambers  40 ,  48  to mix with one another and react. Meanwhile, the molecular sieve layer  50  contains all the reactants, as well as species of reaction that may be other than nitric oxide. Typically, nitric oxide is the principal output of the proposed reactants. Nevertheless, when exposed to the reaction process too long or when provided with outside oxygen, nitric oxide may become a more oxygenated reactant of nitrogen. 
     Embodiment D illustrates a more easily bendable shape, that may be more comfortable and more practical for forming about the upper lip of a user. For example, in any illustrated embodiment, any of the materials used to form the wall  32  of the chamber  34  may be comparatively rigid, moderately flexible such as a soft plastic or elastomer, or very flexible such as the materials used to form a toothpaste tube or other collapsible tube for containing a paste or liquid. Accordingly, the distributor  12  may be formed to fit the lip a user. Internal materials such as a wire imbedded in part of the wall  32  may facilitate bending the distributor  12  to a specific and permanent shape. Meanwhile, the adhesive strip  42  may secure a comparatively weak and soft material to the lip of a user and thus maintain the desired shape. 
     In embodiment D, the molecular sieve layer  50  may be a flexible film that provides additional space in the chamber  34  as gas accumulation space, while still containing the volume  48  of one reactant. In the illustrated embodiment, the chamber  40  is maintained within the wall  38  of a vessel  36 . If the vessel  36  has a rigid wall  38 , such as one formed of glass, a simple bending of the distributor  12  may permit mixing of the reactants in the chambers  40 ,  48  and discharge of the nitric oxide reactant through the wall  50  to accumulate in the remaining dry portion of the chamber  34  for ultimate discharge through the output ports  14 . 
     Embodiment E provides a molecular sieve layer  50  permanently disposed across the chamber  34  separating a portion of the chamber  34  from a cavity  48  or volume  48  containing a reactant. Thus, a portion of the chamber  34  remains dry, while a portion is separated off as the volume  48  for containing a reactant. In this embodiment, the volume  40  is likewise contained by a wall  38  as a separate vessel  36  containing one of the reactants. Typical reactants are moderate acids such as citric acid, ascorbic acid, acetic acid, or the like. Meanwhile, typical reactants may involve compositions of nitrogen such as potassium nitrite, sodium nitrite, or the like. Reactants may be disposed as granules, powders, liquids in solution, solutions gelled to thixotropic consistency, or the like. 
     Embodiment F illustrates a distributor  12  that contains no reactants and does not act as a reactor  20  or reactant chamber  34 . Rather, the chamber  34  of embodiment F is simply an empty cavity for distributing nitric oxide to the output ports  14 . 
     Embodiment G may actually be configured in various shapes. However, as a manufacturing matter, alignment, assembly, and the like may be best served by more linear envelopes rather than curved ones. Nevertheless, the arrangement of embodiment G may actually be imposed on other shapes. In this embodiment, the chamber  34  may be separated by a molecular sieve layer  50  from a chamber  48  containing one reactant. Meanwhile, another seal  54  or wall  54  may separate the ingredients in the chamber  48  from the volume  52  or chamber  52  containing the second ingredient. 
     The entire reaction is contained within the wall  32 , but the individual wall  50  acts a molecular sieve and will not be ruptured. By contrast, in order to initiate the reaction, the wall  54  may be compromised by perforating, fracture, rupture, tearing, cutting, or the like. Meanwhile, the remainder of the chamber  34  provides head space for the gas to accumulate for discharge through the output ports  14 . 
     Referring to  FIG. 3 , a reactor  20  in the apparatus  10  may be configured in any suitable shape. Circular cross-sections tend to provide an equalization of hoop stresses. However, the reaction of materials contemplated for an apparatus  10  in accordance with the invention need not operate at an elevated pressure. Typically, the reaction may occur at about ambient conditions. 
     In embodiment A of  FIG. 3 , the reactor  20  may be configured as a rounded, yet somewhat flattened device having an aspect ration of width to thickness that is substantially larger than unity. Thus the width is more than the thickness, and in the illustrated embodiment is several times the thickness. Meanwhile, the aspect ratio of height to width may be selected according to space available in a convenient location for holding the reactor  20 . For example, embodiment D may be a suitable configuration for setting on a table top. By contrast, embodiment A may be better suited for slipping into a shirt pocket, jacket pocket, or the like for portability. Meanwhile, the reactor  20  of embodiment C may be suitable for holding in a jacket pocket, or sitting on a night stand beside a bed or other flat surface. 
     Referring to  FIG. 4 , any of the reactors  20  of  FIG. 3  may be configured to contain any or all of the chambers of  FIG. 2 . The reactor  20  may enclose various individual volumes. For example, in the illustrated embodiment, a volume  58  is enclosed within the wall  56  of the reactor  20 . The volume  58  is bounded below by a layer  60  or sieve layer  60 . Optionally, a region of expansion space  62  may exist above a closure layer  64 . The layer  64  initially forms a retainer or seal  64  to contain the volume  66  of a first reactant. The first reactant volume  66  is separated from a volume  68  containing the second reactant by a seal  70  that may be ruptured or otherwise compromised to initiate a reaction. 
     The closure layer  64  may be permeable. Alternatively it may be sealed impervious, to be breached in preparation for initiating the reaction in the reactor  20 . It may be burst or otherwise opened or by the reaction. 
     In one embodiment, the layers  64 ,  70  may be formed of a polymer film, wax, or the like capable of maintaining the volumes  66 ,  68  separated from one another with their reactants. A mechanism such as a plunger, perforator, mixer, spatula, or other apparatus extending through the wall  56  may serve to break, rupture, tear, cut, or otherwise compromise the layer  70 . Likewise, the layer  64  may be so opened and compromised in order to make the expansion space  62  available to the reactants. 
     The reactants in the volumes  66 ,  68  may be solid, liquid, one of each, or some other combination. For example, an additional layer, possibly even including the volume  62 , may contain a liquid to provide a transport fluid for dry reactants in the volume surface  66 ,  68 . 
     By whatever mechanism, the layers  64 ,  70  may be opened to expose the volumes  66 ,  68  with their reactant contents to one another in order to activate the reactor  20  and begin the chemical reaction to produce nitric oxide. Nitric oxide passes through the molecular sieve layer  60 , which may be optional, but is useful in maintaining the purity of nitric oxide. The molecular sieve  60  or the layer  60  may include not only a molecular sieve, such as a film or solid layer, but may also include any other barrier materials suitable to maintain reactants outside of the collection volume  58  collecting the nitric oxide. 
     Ultimately, the nitric oxide in the volume  58  is passed through the fitting  30  into a line  18  for delivery into a distributor  12 . Notwithstanding the illustrated embodiment of  FIG. 4 , any suitable shape may be used for the cross-section of the reactor  20 . Accordingly, the reactor of  FIG. 4  may actually be configured according to the relations, shapes, or both illustrated in any of the alternative embodiments illustrated in  FIGS. 1-3 . 
     In one alternative embodiment, the wall  56  may be highly flexible. Moreover, shape may be selected having an aspect ration of length to width that is comparatively larger than unity. The ratio of width to thickness may also be selected to be substantially larger than unity. Accordingly, the reactor  20  may be configured as a comparatively long, narrow tube, of a comparatively smaller thickness. Accordingly, the reactor  20  may be rolled up like a toothpaste tube or kneaded in order to rupture the seal layers  64 ,  70  and to mix the reactants in the volumes  66 ,  68 . 
     If the volumes  66 ,  68  are filled with solutions, for example, reactants disposed in a solute liquid, or freely flowing gel, then mixing may readily occur. In other embodiments, diffusion alone may control the migration of reactant species between the volumes  66 ,  68 . Thus, sealing layers  64 ,  70  may be formed, dividing the chambers or volumes  66 ,  68  containing reactants, which may then be extruded, mixed, drawn, flown, stirred, or otherwise introduced to one another to increase the available species participating in the reaction. 
     Referring to  FIG. 5 , one embodiment of an apparatus and method in accordance with the invention may rely on a series of process steps constituting a method  80  or process  80 . For example, providing  82  a distributor  12  may involve any one or more of the required tasks of identifying materials, selecting a shape, selecting a cross-sectional profile and area, selecting aspect ratios of length to width to thickness, and determining the structural and mechanical characteristics for such a distributor  12 . Accordingly, providing a distributor  12  may involve design, engineering, manufacture and acquisition of such a device. 
     Providing  80  a reactor may involve selection of materials, selection profile and of cross-sectional area, engineering, design, fabrication, acquisition, purchase, or the like of a reactor  20  in accordance with the discussion hereinabove. 
     Providing reactants  86  may include selection of reacting species, selecting a configuration, such as granules, powder, liquid, a solution, or the like. Likewise, the particular configuration of a solidous configuration of reactants may involve selecting a sieve size for the particles. This site can affect chemical reaction rates. Thus, selecting or otherwise providing  86  reactants for the reactor  20  may involve consideration of any or all aspects of chemistry, reaction kinetics, engineering, design, fabrication, purchase or other acquisition, delivery, assembly, or the like. 
     Assembling  88  the apparatus may involve a single distributor as an integrated embodiment as described with respect to  FIG. 2 , or assembly of a reactor, with a feed line  18 , connected to a distributor  12 . Likewise, assembling  88  may also include the disposition of reactants within various locations within a reactor  20 , distributor  12 , or the like as discussed hereinabove. 
     Deploying  90  the distributor may involve opening up a package provided during assembly  88  of the apparatus  10 . For example, assembling  88  may also include packaging. Accordingly, deploying  90  may involve opening packages, unsealing components, and otherwise rendering the apparatus  10  ready for use. Likewise, deploying  90  the distributor  12  may involve positioning the distributor  12  with respect to a user, including, for example, adhering the distributor  12  to the skin of a user proximate the nostrils for inhaling the nitric oxide provided by the distributor  12 . 
     Activating  92  the reactants in the reactor  20  may involve, either adding a liquid, mixing the reactant components together, dispersing individual reactants in respective solutes to provide solutions for mixing, adding a liquid transport carrier to dry ingredients in order to initiate exchange between reactants, a combination thereof, or the like. 
     Likewise, activation  92  of the reactants may also involve opening valves, opening seals, rupturing or otherwise compromising seals as described hereinabove, or otherwise moving or manipulating reactants with or without carriers in order to place them in chemical contact with one another. 
     In certain embodiments, nitric oxide may be separated  94  from the reactants themselves. For example, the concept of a molecular sieve  60  was introduced hereinabove as one mechanism to separate  94  nitric oxide form other reactants and from other species of nitrogen compounds. In other embodiments, pumps, vacuum devices, or the like may also tend to separate  94  nitric oxide. Accordingly, in certain embodiments, a suitably sized pump may actually be connected to the reactor  20  in order to draw nitric oxide away from other species of reactants or reacted outputs. 
     Conducting  96  therapy using nitric oxide may involve a number of steps associated with delivery and monitoring of nitric oxide through the distributor  12 . For example, in certain embodiments, conducting  96  therapy may involve activating a reactor  20  or the contents thereof. Likewise, conducting  96  a therapy session may involve proper application of the distributor  12  to the person of the user such as by adhering an adhesive strip  42  to the skin of a user in order to position the output ports  14  in the nostrils of a user for receiving nitric oxide therefrom. It may include assembling the necessary conduit  18  or line  18  with the distributor  12  to send nitric oxide from the reactor  20  to the distributor  12 , and ultimately to a user. 
     Monitoring may involve adding gauges or meters, taking samples, or the like in order to verify that the delivery of nitric oxide from the reactor  20  to the distributor  12  does meet the therapeutically designed maximum and minimum threshold requirements specified by a medical professional. 
     Ultimately, after the expiration of an appropriate time specified, or the exhaustion of a content of a reactor  20 , a therapy session may be considered completed. Accordingly, the apparatus  10  may be removed  98  from use, discarded, or the like. Accordingly, the removal or discarding  98  of the apparatus  10  may be by parts, or by the entirety. For example, the distributor  12 , if it does not include an integrated reactor therewithin, may simply act as a manifold and be reused with a new reactor  20 . 
     It is contemplated that the reactor  20  may typically be a single dose reactor but need not be limited to such. Multiple-dose or reusable reactors may also be used. For example, the reactor  20  may actually contain a cartridge placed within the wall  56 . The internal structure of the cartridge may be ruptured in the appropriate seal locations, such as the seals  64 ,  70  by a mechanism associated with the main containment vessel or wall  56 , and thus activated. Accordingly, the reactor  20  may be reused by simply replacing the cartridge of materials containing the reactant volumes  66 ,  68 . 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Technology Category: b