BIOERODIBLE SELF-DEPLOYABLE INTRAGASTRIC IMPLANTS

• US 20110015666A1
• Filed: 07/22/2010
• Published: 01/20/2011
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Tulip Medical Ltd.
• Original Assignee: Tulip Medical Ltd.
• Inventors: Eckhouse, Shimon, Marco, Doron
• Granted Patent: US 8,845,673 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 method for curbing appetite in a patient, comprising steps of:

a. introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient;

b. inflating said gastric implant within the stomach to a predetermined size and shape;

thereby creating a feeling of fullness, and curbing said appetite;

wherein said step (b) of inflating is being effected by the implant being present in the stomach of said patient.

2. The method according to claim 1, wherein said step of introducing said gastric implant into the stomach of said patient further comprises a step of swallowing said gastric implant.

3. The method according to claim 1, wherein said step of introducing said gastric implant into the stomach of said patient further comprises a step of implanting endoscopically said gastric implant into the stomach of said patient.

4. The method according to claim 1, further including an additional step of contacting at least part of said gastric implant with at least part of the interior wall of said stomach, wherein said step of contacting creates a feeling of fullness, thereby curbing said appetite.

5. The method according to claim 1, wherein said step of introducing said gastric implant into the stomach of said patient further comprises a step of introducing a compacted, swallowable, self-expanding, temporary gastric implant, said gastric implant chosen from the group consisting of:

a. a gastric implant comprising;

i. at least one expandable envelope having an interior and an exterior, configured to seal temporarily, 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

the envelope being further operable to maintain such expansion for a selected period of time and,

ii. an 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; and

,

b. a gastric implant comprising;

i. at least one expandable envelope, comprising at least one bioerodible material, that is generally toric-shaped upon expansion, the envelope having an interior and an exterior, having a selected diameter that, upon such expansion, contacts the walls of the stomach sufficiently to produce a sensation of fullness in that stomach, and the envelope being further operable to maintain such expansion for a selected period of time;

ii. a gas-producing composition operable to produce carbon dioxide gas for the expansion of the at least one expandable envelope and further operable to produce the carbon dioxide after being swallowed by a human and the expansion being effected by the implant being present in the stomach, and,

iii. an enclosure comprising a bioerodible material, enclosing the envelope and gas-producing composition prior to such expansion, having a size suitable for swallowing by a human being.

6. The method according to claim 5, wherein said gas is carbon dioxide.

7. The method according to claim 5, wherein said gas-producing composition comprises a base and an acid.

8. The method according to claim 7, 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.

9. The method according to claim 5, 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.

10. The method according to claim 9, wherein said 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.

11. The method according to claim 10, wherein the at least one fracturable wall comprises a fracturable wall that wholly contains one of the base and the acid.

12. The method according to claim 10, wherein said at least one fracturable wall comprises more than one fracturable wall containing the base and the acid.

13. The method according to claim 10, wherein said 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.

14. The method according to claim 10, wherein said at least one fracturable wall comprises more than one fracturable wall that in combination with the envelope contains the base and the acid.

15. The method according to claim 9, wherein said 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.

16. The method according to claim 9, wherein the at least one of the base and the acid is partially contained by the envelope.

17. The method according to claim 1, wherein said step of inflating said gastric implant to a predetermined size and shape further includes a step of inflating said gastric implant to a shape that allows continued passage of material through the stomach while said implant is inflated.

18. The method according to claim 1, wherein said step of inflating said gastric implant to a predetermined size and shape further includes a step of inflating said gastric implant to 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.

19. The method according to claim 5, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further comprises a step of introducing a compacted, swallowable, self-expanding, temporary gastric implant that further comprises:

a. a plurality of discrete expandable elements; and

,

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

20. The method according to claim 19, wherein said step of inflating said gastric implant to a predetermined size and shape further includes a step of inflating each of said plurality of discrete expandable elements according to a predetermined sequence.

21. The method according to claim 19, wherein said step of inflating said gastric implant to a predetermined size and shape further includes a step of inflating each of said plurality of discrete expandable elements at a predetermined time of between about 0.25 hour and about 30 days from the time that said member reaches the stomach.

22. The method according to claim 1, additionally comprising step of disassembling said gastric implant.

23. The method according to claim 19, additionally comprising step of disassembling said gastric implant by:

a. disassembling each of said discrete expandable elements individually; and

,

b. detaching said discrete expandable elements from said attachment means individually,

and further wherein said step of evacuating said gastric implant from said stomach of said patient further includes a step of evacuating each of said discrete expandable elements individually from said stomach.

24. The method according to claim 23, additionally comprising steps of (a) extracting said deflated gastric implant from said stomach of said patient;

(b) bioeroding further each discrete expandable member prior to its elimination from the stomach.

25. The method according to claim 19, wherein said attaching means are chosen from the group consisting of thread, cord, and wire.

26. The method according to claim 19, wherein said attaching means are constructed from material chosen from the group consisting of (a) elastomeric materials and (b) shape-memory materials.

27. The method according to claim 19, wherein said attaching means comprise dual, substantially parallel elastic wires.

28. The method according to claim 27, 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.

29. The method according to claim 19, wherein said attaching means comprise at least one bioerodable material.

30. The method according to claim 5, wherein layers are configured in said envelope so as to maintain said expansion for said selected period of time.

31. The method according to claim 5, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further comprises a step of introducing a compacted, swallowable, self-expanding, temporary gastric implant the envelope of which comprises at least one bioerodable material.

32. The method according to claim 29, wherein said at least one bioerodible material is 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(1-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.

33. The method according to claim 1, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further includes a step of introducing a gastric implant the envelope of which is compacted by a method chosen from the group consisting of (a) rolling and (b) folding.

34. The method according to claim 5, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further includes a step of introducing a gastric implant comprising a bioerodable capsule enclosing the envelope and gas composition.

35. The method according to claim 5, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further includes a step of introducing a gastric implant comprising either a bioerodable coating enclosing the envelope and gas composition;

or (b) an enteric coating enclosing the envelope and gas composition, or any combination thereof.

36. The method according to claim 35, wherein said bioerodable coating comprises gelatin.

37. The method according to claim 5, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further includes a step of introducing a gastric implant comprising a bioerodable shape stabilizer maintaining the compacted shape of said implant.

38. The method according to claim 1, wherein said step of inflating said gastric implant to a predetermined size and shape further comprises a step of applying an external stimulus to initiate inflation of said gastric implant;

said external stimulus is selected from a group consisting of physical manipulation, external magnetic field, digestive movements, application of radio-frequency energy or any combination thereof.

39. The method according to claim 1, wherein said step of inflating said gastric implant to a predetermined size and shape further comprises a step of manipulating externally the stomach of said patient in order to initiate inflation of said gastric implant.

40. The method according to claim 1, wherein said step of inflating said gastric implant to a predetermined size and shape further comprises a step of bringing to a predetermined value a condition chosen from (a) temperature, (b) pH, (c) water activity (a_w), (d) water availability in the stomach, and (e) availability of digestive enzymes in order to initiate inflation of said gastric implant.

41. The method according to claim 1, additionally comprising a step of disassembling said gastric implant after a predetermined period of time;

further wherein said step of disassembling further comprises a step selected from (a) at least partially deflating said gastric implant;

(b) at least partially dissolving at least part of the material of said gastric implant;

(c) at least partially eroding at least part of the material of said gastric implant;

(d) at least partially disintegrating at least part of the material of said gastric implant into smaller pieces;

(e) at least partially digesting said gastric implant or any combination thereof.

42. The method according to claim 1, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further includes a step of introducing a gastric implant that further comprises either (a) grooves on its external surface, said grooves adapted to accelerate the rate of said step of disassembling said gastric implant;

or (b) protrusions on its external surface, said protrusions adapted to accelerate the rate of said step of disassembling said gastric implant;

or any combination thereof.

43. A method of treating obesity, comprising steps of:

a. curbing the appetite of an obese patient according to the method according to claim 1; and

,

b. repeating step (a) at times determined by a predetermined protocol;

wherein the amount of food ingested by said patient while said implant is within said stomach of said patient is less than that ingested prior to commencement of said method.

44. The method according to claim 43, further comprising a step of leaving said gastric implant within said stomach of said patient for a predetermined period of time.

45. The method according to claim 1, wherein said step of introducing a gastric implant into the stomach of said patient further includes an additional step of introducing a gastric implant adapted to provide upon inflation a predetermined amount of pressure against the wall of the stomach.

46. The method according to claim 45, wherein said predetermined amount of pressure is the maximum pressure obtainable for a given quantity of gas-producing composition.

47. The method according to claim 1, wherein said step of introducing a compacted, swallowable, self-expanding, temporary gastric implant into the stomach of said patient further includes a step of introducing a gastric implant that further comprises 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.

48. The method according to claim 47, wherein said adjuvant composition is at least partially infused into, mixed with, coated onto said implant, or any combination thereof.

49. The method according to claim 5, wherein said step of creating a feeling of fullness, and curbing said appetite is obtained after said step of inflating said gastric implant and after said patient introduced food into said stomach.