Bioerodible self-deployable intragastric implants

• US 7,785,291 B2
• Filed: 04/19/2007
• Issued: 08/31/2010
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Tulip Medical Ltd.
• Original Assignee: Tulip Medical Ltd.
• Inventors: Eckhouse, Shimon, Marco, Doron
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/788,574
• Publication Number:
  US 20090182424A1
• Time in Patent Office: 1,230 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604 65- 67, 604 23- 36, 604/45, 604/143, 604/145, 604/146, 604/147
• US Class Current: 604/104
• 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. 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, frangible 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

b. the integral, frangible gas-producing composition configured to produce a gas after being swallowed by a human being and upon fracture of at least a portion of the integral, frangible gas-producing composition.

2. The gastric implant of claim 1 where the gas is carbon dioxide.

3. The gastric implant of claim 1 where the gas-producing composition comprises a base and an acid.

4. The gastric implant of claim 3 where the gas-producing composition comprises a base selected from sodium bicarbonate (NaHCO₃), sodium carbonate (Na₂CO₃), calcium bicarbonate (Ca(HCO₃)₂), calcium carbonate (CaCO₃), and their mixtures and an acid selected from vinegar, acetic acid, citrus juices, ascorbic acid, and tartaric acid.

5. The gastric implant of claim 4 wherein the citrus juice is selected from lime, lemon, orange, and grapefruit juices and their mixtures.

6. The gastric implant of claim 1 wherein the envelope comprises at least one bioerodible material.

7. The gastric implant of claim 6 wherein the at least one bioerodible material is selected from polyesters, polyamides, polypeptides, and polysaccharides.

8. The gastric implant of claim 6 wherein the at least one bioerodible material is selected from 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, and their block and intimate copolymers, terpolymers, or higher polymer-monomer polymers and combinations and mixtures thereof.

9. The gastric implant of claim 6 wherein the at least one bioerodible material is selected from poly(l-lactic acid) (PlLA), poly(dl-lactic acid) (PLA), poly(glycolic acid) (PGA), polycaprolactones, copolymers, terpolymers, higher poly-monomer polymers thereof, and combinations or mixtures thereof.

10. The gastric implant of claim 6 further comprising an enteric coating.

11. The gastric implant of claim 1 wherein the envelope is compacted by rolling.

12. The gastric implant of claim 1 wherein the envelope is compacted by folding.

13. The gastric implant of claim 1 further comprising a bioerodible capsule enclosing the envelope and gas composition.

14. The gastric implant of claim 1 further comprising a bioerodible coating enclosing the envelope and gas composition.

15. The gastric implant of claim 14 wherein the bioerodible coating comprises gelatin.

16. The gastric implant of claim 1 further comprising a bioerodible shape stabilizer maintaining the compacted shape of the implant.

17. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a toric shape.

18. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a toric shape.

19. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a cross shape.

20. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a bridged toric shape.

21. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a skeletal pyramid shape.

22. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a donut shape.

23. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a double flexed washer shape.

24. The gastric implant of claim 1 wherein the envelope, when inflated, comprises a Moebius strip shape.

25. The gastric implant of claim 1 wherein the integral, frangible 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.

26. The gastric implant of claim 25 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.

27. The gastric implant of claim 26 wherein the at least one fracturable wall comprises a fracturable wall that wholly contains one of the base and the acid.

28. The gastric implant of claim 26 wherein the at least one fracturable wall comprises more than one fracturable wall containing the base and the acid.

29. The gastric implant of claim 26 wherein the at least one fracturable wall comprises a fracturable wall that in combination with the envelope contains at least one of the base and the acid.

30. The gastric implant of claim 26 wherein the at least one fracturable wall comprises more than one fracturable wall that in combination with the envelope contains the base and the acid.

31. The gastric implant of claim 25 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.

32. The gastric implant of claim 31 wherein the at least one of the base and the acid is partially contained by the envelope.

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

a.) at least one expandable flat, toric-shaped, 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, frangible gas-producing composition in fluid communication with the interior of the envelope is fractured to produce a carbon-dioxide gas, and 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,

b.) the integral, frangible, gas-producing composition configured to produce a carbon dioxide gas upon being swallowed by a human and being fractured after swallowing, and

c.) a bioerodible capsule enclosing the envelope and gas composition, wherein the expandable envelope and the gas-producing are rolled to a size suitable for swallowing.

34. The swallowable, self-expanding, temporary gastric implant of claim 33 wherein the envelope comprises at least one bioerodible material.

35. The swallowable, self-expanding, temporary gastric implant of claim 34 wherein the at least one bioerodible material is selected from poly(l-lactic acid) (PlLA), poly(dl-lactic acid) (PLA), poly(glycolic acid) (PGA), polycaprolactones, copolymers, terpolymers, higher poly-monomer polymers thereof, and combinations or mixtures thereof.

36. The swallowable, self-expanding, temporary gastric implant of claim 33 wherein the integral, frangible 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 between the base and the acid upon fracture of said fracturable region after the swallowing by a human being.

37. The swallowable, self-expanding, temporary gastric implant of claim 36 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.

38. The swallowable, self-expanding, temporary gastric implant of claim 37 wherein the at least one fracturable wall comprises a fracturable wall that wholly contains one of the base and the acid.

39. The swallowable, self-expanding, temporary gastric implant of claim 37 wherein the at least one fracturable wall comprises more than one fracturable wall containing the base and the acid.

40. The swallowable, self-expanding, temporary gastric implant of claim 37 wherein the at least one fracturable wall comprises a fracturable wall that in combination with the envelope contains at least one of the base and the acid.

41. The swallowable, self-expanding, temporary gastric implant of claim 37 wherein the at least one fracturable wall comprises more than one fracturable wall that in combination with the envelope contains the base and the acid.

42. The swallowable, self-expanding, temporary gastric implant of claim 36 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.

43. The swallowable, self-expanding, temporary gastric implant of claim 42 wherein the at least one of the base and the acid is partially contained by the envelope.