Method and system for treatment of eating disorders

• US 20070104755A1
• Filed: 11/08/2005
• Published: 05/10/2007
• Est. Priority Date: 11/08/2005
• Status: Active Grant

• Current Assignee: Plensat LLC, Woolsthorpe Technologies, LLC
• Original Assignee: Woolsthorpe Technologies, LLC
• Inventors: Sterling, Bernhard, Mills, Alexander
• Granted Patent: US 7,879,355 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

The invention comprises a gastric device having a pouch formed from a degradable film. Preferably, the pouch contains a gas producing material. The gastric device hydrates within a patient'"'"'s stomach and the gas producing material expands the device to a greater volume. Accordingly, the volume of the hydrated, expanded gastric devices occupy space in the stomach cavity and reduce the amount of food the patient will ingest before reaching the feeling of fullness. Preferably, the gastric device is made from food grade materials. The gastric device is configured to expand to a desired volume and then degrade after a residence time, allowing the device to be passed by the patient'"'"'s normal digestive process.

Claims

1. A gastric device comprising a pouch formed from a degradable film, wherein said pouch encloses a sealed cavity.

2. The gastric device of claim 1, wherein said film comprises a sheet of gel-forming material.

3. The gastric device of claim 26, wherein said gel-forming agent is selected from the group consisting of acacia (gum Arabic), agar, agarose, alginate gels, alginic acid, alginate gums, amylopectin, arbinoglactan, carob bean gum, carrageenan, chondroitin sulfate, eucheuma, fucoidan, furcellaran, gelatin, gellan, guar gum, gum ghatti, gum karaya, hypnea, karaya, laminaran, locust bean gum, natural gum, pectins, starches, polypeptides, polyamino acids, tragacanth, xanthan, psyllium, maltodextrin, Carbopol®

acidic carboxy polymer, hydrophilic poly urethanes, hydroxypropyl methyl cellulose, HYPOL®

hydrophilic polyurethane polymers, polycarbophil, polymethylvinylether co-maleic anhydride, polyvinylpyrrolidone, polyethylene oxide, poly(hydroxyalkyl methacrylate), polymethacrylic acid, poly(electrolyte complexes), poly(vinyl acetate) cross-linked with hydrolysable bonds, polyvinyl alcohol, water-swellable N-vinyl lactams polysaccharides, hydroxypropyl cellulose, carboxylmethyl celluloses, hydroxyethyl cellulose, methyl cellulose, polyvinyl alcohol, hydroxymethyl methacrylate, Cyanmer®

polyacrylamides, Good-rite®

polyacrylic acid, starch graft copolymers, Aqua-Keeps®

acrylate polymer, ester cross linked polyglucan, polycellulosic acid, polyurea, polyether, poly(acrylic acid), polyacrylamide, or poly(2-hydroxyethyl methacrylate, hydroxymethyl methacrylate, methocel, alpha-polyhydroxy acids, polyglycolide (PGA), poly(L-lactide), poly(D,L-lactide), poly(.epsilon.-caprolactone), poly(trimethylene carbonate), poly(ethylene oxide) (PEO), poly(.beta.-hydroxybutyrate) (PHB), poly(.beta.-hydroxyvalerate) (PHVA), poly(p-dioxanone) (PDS), poly(ortho esters), tyrosine-derived polycarbonates, like materials and mixtures thereof.

4. The gastric device of claim 1, wherein said film further includes reinforcing fibers.

5. The gastric device of claim 4, wherein said reinforcing fibers comprise soluble reinforcing fibers selected from the group consisting of polysaccharide gums, including, without limitation, carboxymethyl cellulose, methocel, carrageenan, guar gum, algimate gels, pectins, xanthan, gum Arabic (acacia), gum tragacanth, karaya, agar, gellan, alpha-polyhydroxy acids, polyglycolide (PGA), poly(L-lactide), poly(D,L-lactide), poly(.epsilon.-caprolactone), poly(trimethylene carbonate), poly(ethylene oxide) (PEO), poly(.beta.hydroxybutyrate) (PHB), poly(.beta.-hydroxyvalerate) (PHVA), poly(p-dioxanone) (PDS), poly(ortho esters), tyrosine-derived polycarbonates, like materials and mixtures thereof.

6. The gastric device of claim 4, wherein said reinforcing fibers comprise insoluble reinforcing fibers selected from the group consisting of insoluble polysaccharides, cellulose, phenylpropane molecules polymers, lignin, bast fibers, Kozo, Gampi, grasses, kenaf, bagasse, jute, hemp, flax, like materials and mixtures thereof.

7. The gastric device of claim 4, wherein said reinforcing fibers have a length in the range of approximately 0.1 mm-12 cm.

8. The gastric device of claim 7, wherein said reinforcing fibers have a length in the range of approximately 0.3-10 mm.

9. The gastric device of claim 1, wherein said film includes an outer surface and an inner surface, said inner surface defining said cavity.

10. The gastric device of claim 9, wherein said outer surface of said film further includes a hydration modifying material.

11. The gastric device of claim 10, wherein said hydration modifying material comprises agar.

12. The gastric device of claim 9, wherein said outer surface of said film further includes an ingestion enhancing material.

13. The gastric device of claim 12, wherein said ingestion enhancing material comprises gelatin.

14. The gastric device of claim 9, wherein said inner surface further includes a coating of a gel-forming material.

15. The gastric device of claim 14, wherein said inner surface coating comprises carrageenan.

16. The gastric device of claim 1, wherein said film comprises agar, has a density of approximately 0.28 g/cm³ and a thickness of approximately 30 micrometers, and includes reinforcing fibers with a length in the range of approximately 8-12 mm.

17. The gastric device of claim 16, wherein said film further includes a coating of a gel-forming material.

18. The gastric device of claim 1, wherein said film has a thickness in the range of approximately 30-100 micrometers.

19. The gastric device of claim 18, wherein said film has a thickness in the range of approximately 40-60 micrometers.

20. The gastric device of claim 1, further comprising a gas producing material in said cavity.

21. The gastric device of claim 20, wherein said gas producing material comprises a base.

22. The gastric device of claim 21, wherein said base is selected from the group consisting of sodium bicarbonate, sodium carbonate, hydrogen carbonates, alkali metals carbonates, organic cations, and sodium azide.

23. The gastric device of claim 22, wherein said base comprises sodium bicarbonate.

24. The gastric device of claim 21, further comprising an acid.

25. The gastric device of claim 24, wherein said acid is selected from the group consisting of ascorbic acid, citric acid, fumaric acid, oxalic acid, succinic acid, tartaric acid, maleic acid, and phosphoric acid/dihydrogen phosphate mixtures.

26. The gastric device of claim 25, wherein said acid comprises citric acid.

27. The gastric device of claim 24, wherein said acid and base comprise solid particles having a protective coating.

28. The gastric device of claim 20, wherein said gas producing material comprises a gel-forming agent.

29. The gastric device of claim 28, wherein said gel-forming agent is selected from the group consisting of acacia (gum Arabic), agar, agarose, alginate gels, alginic acid, alginate gums, amylopectin, arbinoglactan, carob bean gum, carrageenan, chondroitin sulfate, eucheuma, fucoidan, furcellaran, gelatin, gellan, guar gum, gum ghatti, gum karaya, hypnea, karaya, laminaran, locust bean gum, natural gum, pectins, polypeptides, polyamino acids, tragacanth, xanthan, like materials and mixtures thereof.

30. The gastric device of claim 20, wherein said gas producing material comprises a mixture of carrageenan, psyllium husk powder, an acid and a base.

31. The gastric device of claim 30, wherein said acid comprises citric acid embedded in said carrageenan and said base is mixed with said psyllium husk powder.

32. The gastric device of claim 1, wherein said pouch has a length in the range of approximately 2 to 20 cm and a thickness in the range of approximately 0.6-5 cm before said pouch is exposed to an aqueous material.

33. The gastric device of claim 32, wherein said pouch has a length in the range of approximately 4 to 12 cm and a thickness in the range of approximately 1-2 cm before said pouch is exposed to said aqueous material.

34. The gastric device of claim 1, wherein said gastric device is configured to hydrate after contact with an aqueous material for a period of time in the range of approximately 5-30 min.

35. The gastric device of claim 34, wherein said gastric device is configured to hydrate after contact with said aqueous material for a period of time in the range of approximately 5-10 min.

36. The gastric device of claim 1, wherein said gastric device is configured to hydrate substantially completely after contact with an aqueous material for a period of time less than approximately 1 hr.

37. The gastric device of claim 36, wherein said gastric device is configured to hydrate substantially completely after contact with said aqueous material for a period of time in the range of approximately 10-30 min.

38. The gastric device of claim 36, wherein said gastric device has a first volume before said pouch is exposed to said aqueous material and a second volume after substantially complete hydration that is greater than said first volume, wherein said second volume is in the range of approximate 10-50 times greater than said first volume.

39. The gastric device of claim 1, wherein said gastric device is configured to degrade after a first period of time to allow said gastric device to enter a patient'"'"'s duodenum.

40. The gastric device of claim 39, wherein said first period of time is in the range of approximately 1 hr-1 year.

41. The gastric device of claim 40, wherein said first period of time is in the range of approximately 3 hrs-3 weeks.

42. A method for treating a patient having an eating disorder, comprising the steps of:

providing a gastric device having a pouch formed from a degradable film, wherein said pouch encloses a sealed cavity containing a gas producing material and wherein said pouch has a first volume; and

ingesting said gastric device to position said gastric device within said patient'"'"'s stomach;

whereby said gastric device hydrates with an aqueous material in said patient'"'"'s stomach to produce gas and whereby said gastric device expands to a second volume greater than said first volume.

43. The method of claim 42, wherein said second volume is sufficient to restrict entry of said gastric device into the duodenum of said patient.

44. The method of claim 43, wherein said gastric device hydrates substantially completely after contact with said aqueous material for a period of time less than approximately 1 hr.

45. The method of claim 44, wherein said gastric device hydrates substantially completely after contact with said aqueous material for a period of time in the range of approximately 10-30 min.

46. The method of claim 42, wherein said gastric device degrades after a first period of time to allow said gastric device to enter said patient'"'"'s duodenum.

47. The method of claim 46, wherein said first period of time is in the range of approximately 1 hr.-1 year.

49. The method of claim 42, wherein said second volume is in the range of approximately 10-50 times greater than said first volume.

48. The method of claim 70, wherein said first period of time is in the range of approximately 3 hrs.-3 weeks.