Abstract:
Expanding or foaming adhesives are used to reduce the stomach volume to reduce the caloric intake and weight of a patient. A web structure is attached inside the stomach and an expanding or foaming adhesive is applied to the web structure. The expanding or foaming adhesive attaches to the web structure and to the stomach to partition the stomach. The partition barrier divides the stomach volume into a reduced volume available for food storage and an empty volume that the food cannot enter. The reduced volume enables the patient to feel full faster and reduce caloric intake. A passageway can be provided between the two volumes near the base of the stomach to allow food or fluids to exit from the empty volume.

Description:
FIELD OF THE INVENTION 
     The present invention relates, in general, to medical instruments used for bariatrics and, more particularly, to instruments and methods for reducing the size of a stomach by placing an implantable barrier structure within the stomach. 
     BACKGROUND OF THE INVENTION 
     Food passes from the esophagus to the stomach. After entering the stomach, the food is stored in order to allow the stomach to chemically and mechanically prepare the food for receipt in the small intestine where the food is further digested. Food does not enter the bloodstream through the walls of the stomach. Thus, the stomach has complete control over the passage of food to the small intestine to ensure the food is ready both chemically and physically. 
     Statistics estimate that approximately sixty-four percent of Americans are overweight including the thirty percent of Americans whom are obese. As medical problems mount relating to overweight lifestyles, more Americans opt to undergo medical operations as a means for decreasing their appetite. A common theme among the operations is to reduce the volume size of the stomach. Reducing the volume size of the stomach physically prevents an individual from eating an excessive amount of food. 
     A wide range of methods exist for decreasing the volume size of a stomach. These methods range from stapling the stomach to inserting a volumetric object inside the stomach to reduce the stomach volume available for food retention. Both options limit the amount of food entry possible as compared to the period before the procedure is performed. Certain advantages and drawbacks of each method relate to the invasiveness of the procedure, success rate, maintenance, cost, length, and removability. 
     Stapling a patient&#39;s stomach or resecting the stomach with a stapler are both ways to create a smaller stomach volume. Attaching a volumetric object or reducer within a patient&#39;s stomach is another. An inflatable balloon placed in the stomach is taught in U.S. Pat. No. 6,981,978 by J. Gannoe as a way to decrease the stomach volume. The inflatable balloon can be inserted trans-orally in a deflated condition and inflated within the patient. 
     Suturing the stomach walls together and creating stomach partitions are also techniques used to reducing the caloric intake of a patient. U.S. Pat. No. 7,037,344 by Kagan et al. teaches bringing the walls of the stomach together with suture or staples to create a partition or pouch for the treatment of morbid obesity. 
     Creating a stomach partition by bringing stomach walls together and inflating a volumetric object are both known in the art. Building an implantable partition within the stomach from an expanding foam is not well known to those skilled in the art. Attaching a balloon or a foam structure to a stomach wall within a harsh stomach environment can also present challenges. U.S. Patent Application 2002/0147462 discloses foaming adhesives and is hereby incorporated by reference in its entirety. International publication WO 92/09651 by Cooke et al entitled “Polycyanoacrylate Foam” also describes expanding foams. 
     At present, there are no known surgical implants, instruments to apply the implants, or methods of placing the implant that can meet all of the needs outlined above. These and other advantages will become more apparent from the following detailed description and drawings. 
     SUMMARY OF THE INVENTION 
     The present invention An implant device for partitioning a stomach to achieve weight loss is disclosed. The implant device has a web structure that comprises one or more filaments that are attachable to the stomach wall. A foam partition is provided about the web structure. The foam partition partitioning the stomach into a food digestion portion and at least one empty portion. The partition reduces the size of the stomach available for food storage and digestion. 
     Alternately, a surgical device for reducing the weight of a patient by partitioning a stomach is disclosed. The surgical device has a web structure attached about the inner wall of the stomach, an expandable adhesive foam, and an adhesive foam system to apply the expandable adhesive foam. The expandable adhesive foam is applied to one or more of the attached web structure and the inner wall of the stomach. The expandable adhesive foam and the web structure partitions the stomach into a digestion portion and an empty portion. 
     These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which: 
         FIG. 1  is a perspective view of a surgical device for the creation of an expanding foam used as a surgical implant. 
         FIG. 2  is a front cross-sectional view of the stomach with an endoscope penetrating the stomach and a dashed line representing the planned location for a plurality of stitches. 
         FIG. 3  is a front cross-sectional view of the stomach with an endoscope penetrating the stomach and beginning to stitch a suture web across the stomach along the dashed line. 
         FIG. 4  is a front cross-sectional view of the stomach illustrating the completed suture web structure across the stomach. 
         FIG. 5  is a front cross-section view of the stomach illustrating the surgical device applying the expandable foam across the suture web and the stomach to create a surgical implant that partitions the stomach. 
         FIG. 6  is a front cross-sectional view of the stomach illustrating the completed implant partition structure and a route whereby food travels from the esophagus through the stomach. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. 
     Bariatrics plays a major role in obesity. Generally, obesity is a condition that when left unaddressed leads to numerous health problems. Surgical intervention to reduce stomach volume to avoid health problems is common today.  FIGS. 1 through 6  illustrate a trans-oral method for reducing stomach volume by placing a foam partition in the stomach that may be performed quicker and with less intrusion into the body. Quicker surgery and reduced invasiveness lead to a lower surgery cost, a shorter recovery time, and reduced pain. 
     The Device 
     Turning to the Drawings, wherein like numerals denote like components throughout the several views,  FIG. 1 , shows a foam-producing surgical device  15  capable of partitioning a patient&#39;s stomach with an expanding adhesive foam structure or wall  29 . The wall  29  divides the patient&#39;s stomach into a food digestion portion and an empty portion and reduces the stomach volume available for food. This volume reduction enables a patient to eat a small amount, fill up the smaller available digestive portion of the stomach, and feel full. Surgical device  15  dispenses an expandable foam  28  ( FIG. 5 ) through a cannula or hose  16  inserted into a patient&#39;s stomach. 
     The expandable foam  28  is a combination of foam components. For the example shown, the expandable foam  28  is a mix of foam components comprising an adhesive (not shown), a foaming agent (not shown), and an adhesive initiator (not shown). Combining the adhesive and foaming agent produces an expanding adhesive foam. Adding the adhesive initiator (not shown) to the adhesive (not shown) and foaming agent (not shown) sets or polymerizes the expanding foam  28  containing into a solid structure. 
     The foam-producing device  15  has a housing  17  to contain the foam components therein. The housing comprises a handle  18  for the surgeon to hold, a first chamber  19   a , a second chamber  19   b  and a third chamber  19   c  to hold the foam components therein and at least one plunger or pump  21  to dispense the foam components from the foam producing device in a mixed or neat state. A mixer  20  is provided downstream of the pump  21  to mix the foam components into expanding foam  28 . Pump  21  dispenses the foam components as pressure is applied to advance the pump  21  towards the handle  18  and through the chambers  19   a ,  19   b , and  19   c . The foam components are mixed together in mixer  20  after exiting chambers  19   a ,  19   b , and  19   c . After mixing, the foam  28  travels through the hose  16  and exits from a nozzle  60  having one or more foam dispersement ports  40  at a distal end of the hose  16 . To create an implantable wall  29  or surgical implant in the stomach, a suture web  27  is first created from suture  30  and attached about the inner stomach wall with a piercing device. Second, the expanding foam  28  is dispensed from the surgical device  15  to adhere to the suture web  27  and the stomach wall, and create the surgical implant device to partition the stomach. 
     The Method 
       FIG. 2  illustrates a front, cross-sectional view of a stomach  24 . An endoscope  22  travels trans-orally through an esophagus  23  into the stomach  24 . The endoscope  22  is positioned in such a manner whereby the surgeon is viewing the inside of the stomach  24  and planning to sew suture  30  along a dashed line  25 . The dashed line  25  represents a desired location of suture attachment points. The endoscope  22  has a plurality of access passageways extending through to a distal end  35  permitting the surgeon to insert numerous tools through the endoscope  22 . The passageways are capable of permitting the advancement of such tools as cameras, needles, suture, and foam through the apertures. The distal end  35  of the endoscope  22 , as seen in  FIG. 2 , has two passageway apertures  37  and  41  and a camera  34 . A grasper  32  is shown extending from aperture  37  and holds a needle  33  with suture  30  within jaws  36  of grasper  32 . The suture  30  is of sufficient strength to be capable of withstanding the harsh environment of the stomach  24 . In the medical device world, suture  30  can be a separate strand, or suture  30  can be attached to needle  33 . In either case, the strand and/or combination of strand and needle are generally referred to as suture. 
       FIG. 3  represents a front, cross-sectional view of the stomach  24  where the surgeon advances the endoscope  22  adjacent to the dashed line  25  representing the desired location of suture attachment points. As seen in  FIG. 3 , after advancing the endoscope  22  adjacent to the dashed line  25 , the surgeon begins weaving a loose suture web  27  ( FIG. 4 ) inside the stomach  24  along dashed line  25 . The surgeon is using a penetration device or needle  33  to attach the suture web  27  to a stomach wall  24   a  by placing needle  33  through tissue at a first point on line  25 . 
     In  FIG. 4 , the suture web  27  is shown placed from side to side across the stomach  24  with no tension on the suture. Without tension, the suture web  27  does not approximate or bring together the stomach inner walls  24   a , and this reduces tissue stress loads at the suture locations. If the suture web  27  has tension, the tissue can tear, releasing the suture web. The suture web  27  described above is not limited solely to hand sutured suture webs  27  constructed from suture  30 . For example, the suture web  27  can be a pre-shaped or woven mesh or web structure that is inserted into the patient and attached to the stomach wall (not shown). The suture web  27  could be shaped or created in any manner deemed necessary by the surgeon whereby the suture web  27 , when combined with an expanding foam  28 , produces a wall  29  capable of partitioning the stomach  24 . The suture web  27  is shown attached to the stomach wall by suturing with a needle; however the attachment of suture web  27  is not solely limited to this type of attachment. For example, a pre-woven suture web could be attached to the stomach by a tissue piercing device or fastener such as a staple, a clip, a corkscrew fastener, a barb, a clamp, or any other fastener that can attach a suture web to tissue. 
     Suture web  27  can be absorbable or non-absorbable, depending on surgeon&#39;s preference. Suitable materials for an absorbable suture  27  can include, but is not limited to catgut, polyglycolic acid, polyglactin, polydioxanone, nylon and polyglyconate. Suitable non-absorbable suture materials can include, nylon, Dacron, polypropylene, braided polyester, and polybutester. 
     In  FIG. 4 , the surgeon has completed a suture web  27  and retracted any instruments into the endoscope  22 . The completed suture web  27  crisscrosses the patient&#39;s stomach along the dashed line  25  of  FIG. 2 . A lower attachment point  42  and an upper attachment point  43  illustrate a general scheme for weaving the suture web  27 . The general scheme involves varying the location of adjacent attachment points in a manner where the attachment points alternate being located on opposite locations within the stomach  24 . This alternating scheme generally produces the suture web  27 . The suture web  27  is tied at opposing ends to help ensure stability. Thus, a first tying point  44  is located on the suture web  27  at the first stitch of suture. Additionally, a second tying line  45  is located on the suture web  27  where the surgeon makes the last stitch. The location of the tie attachments may vary depending upon a variety of factors including but not limited to the size of stomach, size of partition, type of suture and surgeon&#39;s desires. After completing the suture web  27 , any remaining suture is removed from the stomach  24 . Whereas a suture web sewn into tissue is disclosed, other examples of web structures and fastening devices can include, but are not limited to a mesh or web structure attached to the stomach walls by any one of a number of fasteners such as staples. 
       FIG. 5  represents a front, cross-sectional view of the stomach  24  where the surgeon has begun dispensing an expandable foam  28  to partition the stomach  24 . As shown in  FIG. 5 , after constructing the suture web  27 , the grasper  32 , the needle  33  and any remaining suture  30  are removed from the stomach  24  by being retracted out of the endoscope  22 . Hose  16  is now advanced through the endoscope  22  until nozzle  60  and foam dispersement port  40  of the hose  16  exits aperture  37  of the endoscope  22 . Pressure from the plunger  21  forces the foam components of expandable foam  28  to travel from chambers  19   a ,  19   b  and  19   c . As the expandable foam  28  exits chambers  19  and  20 , the expandable foam  28  is mixed together. The expandable foam  28  then enters the hose  16 . The foam  28  then travels through the hose  16  and into the stomach  24 . After the foam travels the length of hose  16 , the foam  28  exits the distal end  40  of hose  16 . As stated earlier, the distal end  40  of hose  16  hangs adjacent to the aperture  37 . After exiting the distal end  40 , the expandable foam  28  is dispensed within the suture web  27  to produce a partition or wall  29  within the stomach  24 . The wall  29  partitions the stomach  24  into two distinct, smaller volumes. Food entering the stomach  24  may only pass through the stomach volume contained between the esophagus  23  and a pyloric sphincter  39 . The precise location of each wall  29  will vary according to multiple factors including but not limited to the surgeon&#39;s preference, the stomach size and the volume reduction required. 
     As stated earlier, the foam  28  is capable of expanding. The adhesive (not shown) used in the foam can be a polymerizable adhesive such as a polymerizable monomer or a cyanoacrylate. Suitable materials for adhesive (not shown) may be, for example, monomers and monomer systems, acrylate, epoxy, urethane, silicone, silicone rubber, photopolymerizable compositions, vinyl-terminated monomers, gelatin resorcinol formaldehyde, gelatin resorcinol glutaraldehyde, anhydrides cross-linked with polyols, hyaluronic acid cross-linked with hydrazines, mixed monomer systems and co-polymers. Particularly suitable polymerizable materials, such as polymerizable monomers, and the polymerization products thereof expand under certain conditions, such as with heat, or with an added agent, such as a foaming agent (not shown). 
     Foaming agent  51  can be combined with the polymer material  50  to create the foam  28  or foaming agent  51  could be a catalyst that reacts with a compound in adhesive  50 . For example, an adhesive  50  such as various monomers, particularly cyanoacrylate monomers, may be mixed with organic liquids or foaming agents  51 , and polymerization initiators  52  (see below), to form a composition that polymerizes and expands into, for example, a polycyanoacrylate foam. Suitable foaming agents  51  include pentane, hexane, heptane, 1,1,2-trichlorotrifluoro-ethane, 1,1,1-trichlorotrifluoroethane-, petroleum ether, diethyl ether, cyclopentane, cyclohexane, benzene, carbon tetrachloride, chloroform, methylcyclopentane, dimethylsulfide, 1,1-dichloroethane, 1,1,1-trichloroethane, perfluorohexane, perfluoroheptane, 1-bromopropane and any combination thereof. Examples of suitable compositions that form expanding foams  28  are disclosed in U.S. patent application 2002/0147462 entitled “Bronchial Occlusion Method and Apparatus”, the entire disclosure of which is hereby incorporated in its entirety by reference. Additionally, pump  21  is not limited to the plunger embodiment described above. By way of example, one or more foaming agents  51  can be used as an aerosol or pump to draw, siphon, and/or propel components of adhesive  28  from the nozzle  60 . 
     An adhesion initiator (not shown) can be used to polymerize the foam  28  into a solid expanded foam structure. For this example, a polymer cyanoacrylate adhesive is chosen as the base polymer material of the foam. Polymerization of the foam  28  can be initiated by stomach moisture or by contact of the adhesive with an adhesion initiator (not shown). Adhesion initiator (not shown) can be mixed with the foaming agent (not shown), be a second part of a two part adhesive (not shown), or placed upon the suture  27  before or during the surgery. Contact with the adhesion initiator polymerizes the expandable foam  27 . Suitable adhesion initiators (not shown) can include, but are not limited to, detergent compositions; surfactants: e.g., nonionic surfactants such as polysorbate  20  (e.g., Tween  20 .TM. from ICI Americas), polysorbate  80  (e.g., Tween  80 .+-.from ICI Americas) and poloxamers, cationic surfactants such as tetrabutylammonium bromide, butyrylcholine chloride, anionic surfactants such as sodium tetradecyl sulfate, and amphoteric or zwitterionic surfactants such as dodecyldimethyl(3-sulfopropyl)ammonium hydroxide, inner salt; amines, imines and amides, such as imidazole, tryptamine, urea, arginine and povidine; phosphines, phosphites and phosphonium salts, such as triphenylphosphine and triethyl phosphite; alcohols such as ethylene glycol, methyl gallate, ascorbic acid, tannins and tannic acid; inorganic bases and salts, such as sodium bisulfite, magnesium hydroxide, calcium sulfate and sodium silicate; sulfur compounds such as thiourea and polysulfides; polymeric cyclic ethers such as monensin, nonactin, crown ethers, calixarenes and polymeric epoxides; cyclic and acyclic carbonates, such as diethyl carbonate; phase transfer catalysts such as Aliquat  336 ; organometallics such as cobalt naphthenate and manganese acetylacetonate; and radical initiators and radicals, such as di-t-butyl peroxide and azobisisobutyronitrile. The polymerizable and/or cross-linkable material may also contain an initiator that is inactive until activated by a catalyst or accelerator. Examples of suitable polymer materials, foaming agents and polymerization initiators are taught in U.S. Patent Application 2004/0147462 which is hereby incorporated by reference in its entirety. 
     As also seen in  FIG. 6 , a passageway  38  is provided between the two partitioned volumes for food to pass should any food accidentally enter the blocked volume. Arrow  31  represents the mode by which food will exit the stomach  24 . The food will exit via passageway  38 . Passageway  38  will be constructed generally adjacent to where the stomach  24  connects to the pyloric sphincter  39 . This passageway  38  will permit food that accidentally enters the blocked volume to exit the stomach  24 . 
     Finally,  FIG. 6  represents a front, cross-sectional view of the stomach  24  having the wall  29  partitioning the stomach  24  into two separate volumes. Food travels into the stomach  24  and passes through the stomach  24  in the area surrounded by the stomach  24  adjacent to the pyloric sphincter  39  and the wall  29 . Food exits the stomach by way of the pyloric sphincter  39 . Any food that accidentally travels into the blocked volume is still able to leave the stomach  24  via passageway  38 . 
     It will be recognized that equivalent structures may be substituted for the structures illustrated and described herein and that the described embodiment of the invention is not the only structure which may be employed to implement the claimed invention. As one example of an equivalent structure which may be used to implement the present invention, differing endoscopes may be used depending upon their structure, design, and complexity. As a further example of an equivalent structure which may be used to implement the present invention, a pressure source besides a plunger may be used to advance the expandable foam through the endoscope into the stomach. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function. 
     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.