Described herein are bioerodible, biodegradable, or digestible self-deploying intragastric implants that may be swallowed. Once swallowed, the implants undergo self-expansion in the stomach and apply a suitable pressure against the stomach wall to provide a feeling of satiety to the individual. The
Described herein are bioerodible, biodegradable, or digestible self-deploying intragastric implants that may be swallowed. Once swallowed, the implants undergo self-expansion in the stomach and apply a suitable pressure against the stomach wall to provide a feeling of satiety to the individual. The implants then dissolve or are disassembled perhaps using gastric liquids and pass out of the stomach. Methods of using the devices, perhaps for an individual participating in a dietary control regimen, are described.
대표청구항▼
1. A compacted, swallowable, self-expanding, temporary gastric implant comprising: a. at least one expandable envelope having an interior and an exterior, the envelope configured to temporarily seal, after the implant has been swallowed by a human being, the interior of the envelope from gastric flu
1. A compacted, swallowable, self-expanding, temporary gastric implant comprising: a. at least one expandable envelope having an interior and an exterior, the envelope configured to temporarily seal, after the implant has been swallowed by a human being, the interior of the envelope from gastric fluid in a stomach at least until an integral, gas-producing composition in fluid communication with the interior of the envelope produces a gas to expand the envelope to a selected size, the envelope configured so that the selected size of the expanded envelope contacts walls of the stomach sufficiently to produce a sensation of fullness in the stomach; and wherein the envelope is operable to maintain expansion for a selected period of time; and,b. an integral, gas-producing composition configured to produce a gas after being swallowed by the human being;wherein self-expansion of the implant is spontaneous upon contact with the gastric fluid and wherein the exterior of the envelope comprises selectively erodible pathways adapted to allow the gastric implant to retain an expanded shape in the stomach and after the selected period of time to degenerate into smaller portions according to the erodible pathways. 2. The gastric implant of claim 1, wherein expansion is effected by the presence of the implant in the stomach. 3. The gastric implant of claim 1, further comprising at least one panel, the at least one panel comprising a bioerodible material and a plurality of grooves adapted to allow the panel to be eroded in the stomach into smaller sections, whereby stepwise removal of the implant from the stomach in a controlled manner is achieved. 4. The gastric implant of claim 3, further comprising an enteric coating having grooves. 5. The gastric implant of claim 3, wherein the at least one panel at least partially a material having protrusions. 6. The gastric implant of claim 1, wherein the gas produced is carbon dioxide. 7. The gastric implant of claim 1, wherein the gas-producing composition comprises a base and an acid. 8. The gastric implant of claim 7, wherein the base is selected from the group consisting of sodium bicarbonate (NaHCO3), sodium carbonate (Na2CO3), calcium bicarbonate (Ca(HCO3)2), calcium carbonate (CaCO3), and mixtures thereof, and the acid is selected from the group consisting of vinegar, acetic acid, citrus juices selected from the group consisting of lime, lemon, orange, and grapefruit juices and their mixtures, ascorbic acid, tartaric acid, and mixtures thereof. 9. The gastric implant of claim 1, wherein the envelope is made of at least one material selected from the group consisting of polyesters, polyamides, polypeptides, polysaccharides, polylactides, polyglycolides, polyanhydrides, polyurethanes, polyesteramides, polyorthoesters, polydioxanones, polyacetyls, polyketals, polycarbonates, polyorthocarbonates, polyphosphazenes, polyhydroxybutyrates, polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, polymalic acid, poly(amino acids), polymethyl vinyl ether, polymaleic anhydride, chitin, chitosan, poly(l-lactic acid) (PlLA), poly(d-lactic acid) (PLA), poly(glycolic acid) (PGA), polycaprolactones and their block and intimate copolymers, terpolymers and higher poly-monomer polymers thereof, polyvinylacetate and polyacrylic acid, methylcellulose, carboxymethylcellulose, hydroxypropylcellulose, and hydroxypropylmethylcellulose, polyvinyl acetyldiethylaminoacetate, cellulose acetatephthalate and ethyl cellulose, and copolymers of methacrylic acid and methyl methacrylate, hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), carboxymethylcellulose, and sodium or calcium salts thereof, hydrogel, shape memory material, super elastic material, nickel titanium (NiTi), and combinations and mixtures thereof and wherein the at least one material is integrated into a single combination or a mixture of several combinations thereof and at least one layer is configured in the envelope. 10. The gastric implant of claim 1, wherein the envelope is compacted by a method selected from the group consisting of rolling, folding, and a combination thereof. 11. The gastric implant of claim 1, further comprising a bioerodible capsule enclosing the envelope and gas composition. 12. The gastric implant of claim 11, wherein the bioerodible capsule has grooves. 13. The gastric implant of claim 1, further comprising a bioerodible coating enclosing the envelope and gas composition. 14. The gastric implant of claim 13, wherein the bioerodible coating comprises gelatin. 15. The gastric implant of claim 1, further comprising a bioerodible shape stabilizer for maintaining a compacted shape of the implant. 16. The gastric implant of claim 1, wherein the envelope, when inflated, comprises a shape selected from the group consisting of toric-shaped, X-shaped, Plus shaped, ovoid, truncated ovoid, half-football shaped, toroid, bridged toroid, ring-shaped, spiral, Moebius strip, cylindrical, conical, truncated conical, cup-shaped, multiple-armed cross, skeletal pyramidal, double flexed washer, and stomach-shaped. 17. The gastric implant of claim 1, further comprising layers configured in the envelope to maintain expansion for the selected period of time. 18. The gastric implant of claim 1, wherein the integral gas-producing composition comprises a base and an acid, and further comprises at least one fracturable region that at least partially contains at least one of the base and the acid, the fracturable region configured to allow contact of the base and the acid upon fracture of the fracturable region after the swallowing by a human being. 19. The gastric implant of claim 18, wherein the at least one fracturable region comprises at least one fracturable joint, the fracturable joint configured to allow contact of the base and the acid upon fracture of the at least one fracturable joint after the swallowing by a human being. 20. The gastric implant of claim 18, wherein the at least one fracturable region comprises at least one fracturable wall that at least partially contains at least one of the base and the acid. 21. The gastric implant of claim 20, wherein the at least one fracturable wall wholly contains one of the base and the acid. 22. The gastric implant of claim 20, comprising more than one fracturable wall containing the base and the acid. 23. The gastric implant of claim 20, wherein the at least one fracturable wall in combination with the envelope contains at least one of the base and the acid. 24. The gastric implant of claim 20, wherein more than one fracturable wall in combination with the envelope contains the base and the acid. 25. The gastric implant of claim 20, wherein the at least one of the base and the acid is partially contained by the envelope. 26. The gastric implant of claim 1, further comprising: a. a plurality of discrete expandable members; and,b. attaching means adapted to attach each of the plurality of discrete expandable members to at least one other discrete expandable member; wherein each of the plurality of discrete expandable members is adapted to expand at a predetermined time. 27. The gastric implant of claim 1, wherein the expanded shape of the gastric implant is adapted to provide a predetermined amount of pressure against the walls of the stomach upon inflation. 28. The gastric implant of claim 27, wherein the predetermined amount of pressure is a maximum pressure obtainable for a given quantity of gas-producing composition. 29. The gastric implant of claim 1, further comprising at least one adjuvant composition selected from the group consisting of therapeutic compositions, slow-release therapeutic compositions, medications, pH buffers, anti-acid compositions, anti-inflammatory agents, antihistamines, additives, lubricants, ultraviolet contrasting agents, ultrasound contrast agents, radio-opacifiers, diagnostic agents, digestive-related therapeutic agents, probiotic bacteria cultures, and combinations thereof. 30. The gastric implant of claim 29, wherein the adjuvant composition is selected from the group consisting of an adjuvant composition at least partially infused into the implant, an adjuvant composition mixed with the implant, an adjuvant composition coated onto the implant, and combinations thereof 31. The gastric implant of claim 1, wherein the gas-producing composition is adapted to produce the gas upon application of an external stimulus, the external stimulus selected from the group consisting of physical manipulation, an external magnetic field, digestive movements, application of radio-frequency energy, and combinations thereof. 32. The gastric implant of claim 31, wherein the external stimulus is a predetermined value of a condition within the stomach, the condition selected from the group consisting of temperature, pH, water activity (aw,), water availability in the stomach, and availability of digestive enzymes. 33. The gastric implant of claim 1, wherein the gas-producing composition is configured to produce a gas upon fracture of at least a portion of the integral, gas-producing composition. 34. The gastric implant of claim 1, wherein the implant is swallowed by the human being before a meal such that food intake during the meal and afterwards is decreased and the sensation of fullness is obtained.
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