BIOERODIBLE SELF-DEPLOYABLE INTRAGASTRIC IMPLANTS

• US 20110022072A1
• Filed: 07/22/2010
• Published: 01/27/2011
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Tulip Medical Ltd.
• Original Assignee: Tulip Medical Ltd.
• Inventors: Marco, Doron, Eckhouse, Shimon
• Granted Patent: US 8,267,888 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

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.

Claims

1. A compacted, swallowable, self-expanding, temporary gastric implant comprising:

a. a plurality of at least one discrete expandable elements, each of said expandable elements comprising;

i. at least one expandable envelope having an interior and an exterior, configured to temporarily seal, after the implant has been swallowed, the envelope interior from gastric fluid in a human 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, and wherein the envelope is configured so that the selected size of the expanded envelope contacts walls of the stomach sufficiently to produce a sensation of fullness in that stomach; and

,

ii. the integral, gas-producing composition configured to produce a gas after being swallowed by a human being and,

b. attachment means adapted to attach each of said expandable elements to at least one other expandable element;

wherein interconnection of said plurality of discrete expandable elements by said attachment means provides a single implant unit comprising a plurality of discrete elements.

3. The gastric implant according to either one of claim 1 or 2, wherein said expansion being effected by the implant being present in said stomach.

4. The gastric implant according to either one of claim 1 or 2, wherein said discrete expandable element is either one of a tubular member (102) surrounding a central passageway (104);

or in the form of a cylinder (122).

5. The gastric implant according to either one of claim 1 or 2, wherein each of said plurality of discrete expandable members adapts, upon expansion, a shape chosen from the group consisting of toric, 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.

6. The gastric implant according to either one of claim 1 or 2, wherein each of said plurality of discrete expandable members further includes, in its compacted form, at least one shape stabilizer adapted to hold said member in said compacted form until said implant reaches the stomach.

7. The gastric implant according to either one of claim 1 or 2, wherein each of said plurality of discrete expandable members further includes:

a. at least one panel (186); and

,

b. at least one structural member chosen from the group consisting of circumferential structural members (182) and longitudinal structural members (184) connected to said at least one panel.

8. The gastric implant according to claim 7, wherein said at least one panel comprises a plurality of grooves, protrusions or any combination thereof.

9. The gastric implant according to claim 7, wherein said at least one panel comprises at least one material chosen from the group consisting of membranes, sheets, onlays, woven fabrics, non-woven fabrics, meshes, screens, and knits.

10. The gastric implant according to either one of claim 1 or 2, wherein each of said plurality of discrete expandable members is adapted to expand at a discrete predetermined time.

11. The gastric implant according to claim 8, wherein said plurality of discrete expandable members is adapted to expand according to a predetermined sequence.

12. The gastric implant according to either one of claim 1 or 2, wherein each of said plurality of discrete expandable members is adapted to expand at a predetermined time of between about 0.25 hour and about 30 days from the time that said member reaches the stomach.

13. The gastric implant according to either one of claim 1 or 2, wherein upon destruction of said attaching means connecting a particular discrete expandable member to said gastric implant, said particular discrete expandable member is eliminated from the stomach without further dissolution or bioerosion or any combination thereof.

14. The gastric implant according to either one of claim 1 or 2, wherein said attaching means are chosen from the group consisting of thread, cord, and wire.

15. The gastric implant according to either one of claim 1 or 2, wherein said attaching means are constructed from a material selected from a group consisting of elastomeric material, a shape-memory material.

16. The gastric implant according to either one of claim 1 or 2, wherein said attaching means comprise dual, substantially parallel elastic wires;

further wherein said dual, substantially parallel elastic wires are separated by separating means chosen from the group consisting of pinch-point joints, joints, and flexible ties.

18. The gastric implant according to claim 1, wherein said attaching means comprise at least one bioerodable material.

20. The gastric implant according to either one of claim 1 or 2, wherein said gas is carbon dioxide.

21. The gastric implant according to either one of claim 1 or 2, wherein said gas-producing composition comprises a base and an acid.

22. The gastric implant of claim 21, wherein said gas-producing composition comprises (a) a base selected from the group consisting of sodium bicarbonate (NaHCO₃), sodium carbonate (Na₂CO₃), calcium bicarbonate (Ca(HCO₃)₂), calcium carbonate (CaCO₃), and any mixture thereof, and (b) an acid 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 any mixture thereof.

23. The gastric implant according to claim 1, wherein said envelope comprises at least one bioerodible material.

26. The gastric implant of any one of claim 23 or 24, wherein said envelope is made of at least one material selected from the group consisting of polyesters, polyamides, polypeptides, polysaccharides, polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, polyurethanes, polyesteramides, polyorthoesters, polydioxanones, polyacetals, 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(dl-lactic acid) (PLA), poly(glycolic acid) (PGA), polycaprolactones, their block and intimate copolymers, terpolymers, 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, NiTi and combinations or mixtures thereof;

said at least one material is integrated into a single combination or a mixture of several combinations thereof;

further wherein at least one layer is configured in said envelope.

27. The gastric implant of either one of claim 1 or 2, wherein the envelope is compacted by either rolling or folding or any combination thereof.

28. The gastric implant of either one of claim 1 or 2, further comprising a bioerodible capsule or coating enclosing the envelope and gas composition.

29. The gastric implant of claim 27, wherein the bioerodible coating comprises gelatin.

30. The gastric implant of either one of claim 1 or 2, further comprising a bioerodible shape stabilizer maintaining the compacted shape of the implant.

31. The gastric implant of either one of claim 1 or 2, further comprising an enteric coating.

32. The gastric implant of either one of claim 1 or 2, wherein said 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 and said fracturable region being configured to allow contact of the base and the acid upon fracture of said fracturable region after the swallowing by a human being.

33. The gastric implant of claim 32, wherein said integral, gas-producing composition comprises at least one fracturable region;

said fracturable region comprises at least one fracturable wall that at least partially contains at least one of the base and the acid.

34. The gastric implant of claim 33, wherein the at least one fracturable wall comprises a fracturable wall that (a) at least partially contains one of the base and the acid;

(b) wholly contains one of the base and the acid;

or (c) in combination with the envelope contains at least one of the base and the acid.

35. The gastric implant of claim 32, wherein the at least one fracturable region comprises at least one fracturable joint configured to allow contact of the base and the acid upon fracture of said at least one fracturable joint after the swallowing by a human being.

36. The gastric implant of claim 33, wherein the at least one of the base and the acid is partially contained by the envelope.

37. The gastric implant of claim 1, wherein the shape of said gastric implant is adapted to provide upon inflation a predetermined amount of pressure against the wall of the stomach.

38. The gastric implant of claim 37, wherein said predetermined amount of pressure is the maximum pressure obtainable for a given quantity of gas-producing composition.

39. The gastric implant of claim 1, additionally comprising at least one adjuvant composition selected from therapeutic compositions, slow-release therapeutic compositions, medications, pH buffers, anti-acid compositions, anti-inflammatory agents, antihistamines, additives, lubricants, uv contrasting agents, ultrasound contrast agents, radio-opacifiers, diagnostic agents, digestive-related therapeutic agents, probiotic bacteria cultures or any combination thereof.

40. The gastric implant of claim 39, wherein said adjuvant composition is at least partially infused into, mixed with, coated onto said implant, or any combination thereof.

41. The gastric implant of claim 1, wherein said gas-producing composition is adapted to produce said gas upon application of an external stimulus selected from a group consisting of physical manipulation, external magnetic field, digestive movements, application of radio-frequency energy or any combination thereof.

42. The gastric implant according to claim 41, wherein said external stimulus is a predetermined value of a condition within the stomach, said condition chosen from the group consisting of (a) temperature, (b) pH, (c) water activity (a_w), (d) water availability in the stomach, and (e) availability of digestive enzymes.

43. The gastric implant of claim 1, wherein said outer surface of said envelope comprises selectively erodible pathways adapted to allow the structure of said gastric implant to retain its effective shape in the stomach and after said selected period of time to degenerate into smaller portions according to said erodible pathways.

44. The gastric implant of either one of claim 1 or 2, wherein said integral, gas-producing composition is frangible such that said integral, gas-producing composition is configured to produce a gas upon fracture of at least a portion of the integral, frangible gas-producing composition.

45. The gastric implant of either one of claim 1 or 2, wherein said envelope being further operable to maintain such expansion for a selected period of time.

46. The gastric implant of either one of claim 1 or 2, wherein said implant is swallowed before meals such that the food intake during the meal and afterwards is decreased and said sensation of fullness is obtained.

2. A compacted, swallowable, self-expanding, temporary gastric implant comprising:

a. a plurality of at least one of discrete expandable elements, each of said expandable elements comprising;

i. at least one expandable envelope having an interior and an exterior, configured to temporarily seal, after the implant has been swallowed, the envelope interior from gastric fluid in a human 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, and wherein the envelope is configured so that the selected size of the expanded envelope contacts walls of the stomach sufficiently to produce a sensation of fullness in that stomach; and

,

ii. the integral, gas-producing composition configured to produce a gas after being swallowed by a human being; and

,

b. attaching means adapted to attach each of said expandable elements to a framework;

wherein connection of said plurality of discrete expandable elements to said framework by said attachment means provides a single implant unit comprising a plurality of discrete elements.

17. The gastric implant according to claim 2, wherein said framework comprises at least one selected from a group consisting of (a) at least one spring-like member;

(b) a plurality of ribs.

19. The gastric implant according to claim 2, wherein said attaching means comprise at least one bioerodable material.

24. The gastric implant according to claim 2, wherein said envelope comprises at least one bioerodible material.

25. The gastric implant of claim 24, wherein at least one layer is configured in said envelope.