BIOERODIBLE SELF-DEPLOYABLE INTRAGASTRIC IMPLANTS

• US 20110040318A1
• Filed: 07/22/2010
• Published: 02/17/2011
• 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 8,858,496 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. 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

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

,

b. an integral, gas-producing composition configured to produce a gas after being swallowed by a human being;

wherein said integral, gas-producing composition is adapted to produce said gas upon application of an external stimulus, such that said external stimulus causes fracture of at least a portion of said integral, gas-producing composition, so as to inflate said at least one expandable envelope.

2. The gastric implant according to claim 1, wherein said external stimulus comprises physical manipulation of said frangible structure.

3. The gastric implant according to claim 1, wherein said external stimulus is digestive movements.

4. The gastric implant according to claim 1, 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.

5. The gastric implant according to claim 1, wherein said gastric implant further comprises:

a. at least one first volume (462) containing at least one component of said gas-producing composition;

b. at least one second volume (466) containing at least one other component of said gas-producing composition; and

,

c. a flapper (490) disposed between said first volume and said second volume, said flapper comprising a material that includes ferromagnetic particles at a loading sufficient that manipulation of a magnet external to said gastric implant is sufficient to move said flapper;

wherein manipulation of said magnet moves said flapper, thereby allowing said components of said gas-producing composition to interact, initiating a chemical reaction that leads to said inflation of said at least one expandable envelope.

6. The gastric implant according to claim 1, wherein said external stimulus is application of radio-frequency energy.

7. The gastric implant according to claim 6, further comprising:

a. at least one first volume (462) containing at least one component of said gas-producing composition;

b. at least one second volume (466) containing at least one other component of said gas-producing composition;

c. a passageway providing a fluid connection between said first volume and said second volume;

d. a flapper (504) disposed so as to block said fluid connection between said first volume and said second volume;

e. a spring (506); and

,

f. a thermoplastic sealant (502) holding said flapper (504) in place against said spring (506);

wherein said thermoplastic sealant is adapted to melt upon application of radio-frequency energy, thereby fracturing at least a portion of said integral, frangible gas-producing composition.

8. The gastric implant according to claim 1, further comprising:

a. at least one first volume (462) containing at least one component of said gas-producing composition;

b. at least one second volume (466) containing at least one other component of said gas-producing composition;

c. a passageway providing a fluid connection between said first volume and said second volume;

d. a plug (474) adapted to close said passageway;

e. a spring (478) adapted to hold said plug open;

f. a thread (476) attached to said spring and adapted to hold said plug against said said spring;

g. a digestible knot (480) external to said implant;

wherein, once said knot is digested or eroded in the stomach, said thread slips through the upper wall of said implant, thereby allowing said spring to push said plug into said first volume, thereby displacing at least part of the component within said first volume into said second volume, thereby initiating a chemical reaction between said components and inflating said gastric implant.

9. The gastric implant of claim 1, wherein said gas is carbon dioxide.

10. The gastric implant of claim 1, wherein said gas-producing composition comprises a base and an acid.

11. The gastric implant of claim 10, 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

12. The gastric implant of claim 1, wherein said envelope comprises at least one bioerodible material.

13. The gastric implant of claim 12, 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.

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

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

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

17. The gastric implant of claim 16, wherein the bioerodible coating comprises gelatin.

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

19. The gastric implant of claim 1, wherein the envelope, when inflated, comprises a shape selected from toric shape, X-shaped, Plus-shaped, ovoid, truncated ovoid, half-football shaped, toroid, ring-shaped, spiral, Moebius strip, cylindrical, conical, truncated conical, cup-shaped, multiple-armed cross, stomach-shaped, cross shape, bridged toric shape, skeletal pyramid shape, double flexed washer shape, Moebius strip shape or any combination thereof

20. The gastric implant of claim 1, further comprising an enteric coating.

21. The gastric implant of claim 1, wherein layers are configured in said envelope so as to maintain said expansion for said selected period of time.

22. 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.

23. The gastric implant of claim 22, 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.

24. The gastric implant of claim 23, wherein the at least one fracturable wall comprises a fracturable wall that wholly contains one of the base and the acid.

25. The gastric implant of claim 23, wherein the at least one fracturable wall comprises more than one fracturable wall containing the base and the acid.

26. The gastric implant of claim 23, 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.

27. The gastric implant of claim 23, 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.

28. The gastric implant of claim 22, 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.

29. The gastric implant of claim 23, wherein the at least one of the base and the acid is partially contained by the envelope.

30. The gastric implant of claim 1, wherein said implant comprises a plurality of discrete expandable elements.

31. The gastric implant of claim 1, wherein said exterior comprises either a plurality of grooves or a plurality of protrusions.

32. 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.

33. The gastric implant of claim 32, wherein said predetermined amount of pressure is the maximum pressure obtainable for a given quantity of gas-producing composition.

34. 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.

35. The gastric implant of claim 34, wherein said adjuvant composition is at least partially infused into, mixed with, coated onto said implant, or any combination thereof.

36. 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.

37. The gastric implant of claim 1, wherein said implant comprising:

a. a plurality 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, 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

,

ii. 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; and

,

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

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

wherein each of said plurality of discrete expandable members is adapted to expand at a discrete predetermined time.

40. The gastric implant of either one of claim 1 or 38, 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.

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

a. 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;

b. 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;

wherein said envelope is configured in layers.

39. The gastric implant of claim 38, additionally comprising 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.