Bioerodible self-deployable intragastric implants

• US 7,699,863 B2
• Filed: 09/11/2006
• Issued: 04/20/2010
• 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:
  US11/519,508
• Publication Number:
  US 20070156248A1
• Time in Patent Office: 1,317 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604 65- 67, 604 23- 26, 604/45, 604/143, 604/145, 604/146, 604/147, 604/197.01, 606/192
• 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 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, and

c.) 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.

2. The gastric implant of claim 1 wherein the envelope is compacted for swallowing by rolling.

3. The gastric implant of claim 1 wherein the envelope is compacted for swallowing by folding.

4. The gastric implant of claim 1 wherein the enclosure comprises a bioerodible capsule.

5. The gastric implant of claim 4 wherein the bioerodible capsule comprises gelatin.

6. The gastric implant of claim 1 wherein the enclosure comprises a bioerodible covering.

7. The gastric implant of claim 1 where the gas-producing composition comprises a member selected from sodium bicarbonate (NaHCO₃), sodium carbonate (Na₂CO₃), calcium bicarbonate (Ca(HCO₃)₂), calcium carbonate (CaCO₃), and their mixtures.

8. The gastric implant of claim 1 where the gas-producing composition comprises a member selected from vinegar, acetic acid, citrus juices, ascorbic acid, tartaric acid, and their mixtures.

9. The gastric implant of claim 1 where the gas-producing composition comprises a member selected from lime, lemon, orange, and grapefruit juices, and their mixtures.

10. The gastric implant of claim 1 wherein the envelope comprises at least one bioerodible material selected from polyesters, polyamides, polypeptides, and polysaccharides.

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

12. The gastric implant of claim 1 wherein the envelope comprises at least one bioerodible material selected from polymers of polyvinylacetate and polyacrylic acid, methylcellulose, carboxymethylcellulose, hydroxypropylcellulose, and hydroxypropylmethylcellulose, polyvinyl acetyldiethylaminoacetate, cellulose acetatephthalate and ethyl cellulose, and copolymers of methacrylic acid and methyl methacrylate.

13. The gastric implant of claim 1 wherein the envelope comprises at least one bioerodible material selected from members obtained by esterifying a carboxyalkyl group of carboxyalkyl cellulose.

14. The gastric implant of claim 13 wherein the carboxyalkyl cellulose comprises at material selected from hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), carboxymethylcellulose, and sodium or calcium salts thereof.

15. The gastric implant of claim 1 wherein the envelope comprises at least one hydrogel.

16. The gastric implant of claim 1 wherein the envelope comprises at least one biodegradable polymers of polyethylene glycol and its derivatives.