CONTROLLED DEGRADATION OF EXPANDABLE POLYMERS IN GASTRIC VOLUME REDUCTION TREATMENT

• US 20090035367A1
• Filed: 11/04/2005
• Published: 02/05/2009
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Eatlittle Incorporated
• Original Assignee: Electronic Dietary Foods Inc.
• Inventors: Mintchev, Martin Pavlov, Yadid-Pecht, Orly
• Granted Patent: US 8,691,269 B2
• Time in Patent Office: Days
• US Class Current: 424/452
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents

Abstract

Orally administrable polymer-carrying units for expanding in a stomach of a mammal to fill a space in the stomach, the polymer-carrying units including: a carrier; a plurality of polymer molecules expandable in aqueous solutions, releasably coupled to the carrier; and means for selectively decoupling the polymer molecules from the carrier so that the polymer molecules and carrier are released in the stomach, are provided.

Claims

1. An orally administrable polymer-carrying unit for expanding in a stomach of a mammal to fill a space in the stomach, the polymer-carrying unit comprising:

(a) a carrier;

(b) a plurality of polymer molecules, expandable in the presence of an aqueous solution, releasably coupled to the carrier; and

(c) a decoupler to decouple the polymer molecules from the carrier so that the polymer molecules and carrier are released in the stomach.

2. The polymer-carrying unit of claim 1, wherein the decoupler comprises a timing mechanism to decouple the polymer molecules at selected intervals of time.

4. The polymer-carrying unit of claim 1, wherein the polymer molecules are a mixture of a natural clay and a biocompatible polymer.

5. The polymer-carrying unit of claim 1, wherein the polymer molecules are biodegradable.

6. The polymer-carrying unit of claim 1, further comprising at least one active agent releasably associated with either the carrier or polymer molecules, or both.

8. The polymer-carrying unit of claim 1, wherein the polymer molecules are releasably coupled to the carrier by frictional forces.

9. The polymer-carrying unit of claim 1, wherein the polymer molecules are releasably coupled to the carrier by a force selected from the group consisting of electric forces, magnetic forces, electrostatic forces, mechanical forces, electromagnetic forces, and combinations thereof.

10. The polymer-carrying unit of claim 1, wherein the polymer molecules are releasably coupled to the carrier by a fiber.

11. The polymer-carrying unit of claim 1, wherein the polymer molecules are releasably coupled to the carrier by piezoelectric hinges.

27. A orally administrable dosage form, the dosage form comprising:

(a) one or more polymer-carrying unit as claimed in claims 1 or 12; and

(b) at least one pharmaceutically acceptable excipient.

28. The orally administrable dosage form of claim 27, wherein the dosage form is a capsule.

38. A method for the non-invasive reduction of gastric volume, the method comprising the steps of:

(a) orally administering at least one polymer-carrying unit as claimed in one of claims 1, 12, and 30;

(b) contacting the polymeric-carrying unit with gastric juice to allow for the polymer molecules to expand and prevent the polymer-carrying unit from exiting the stomach; and

(c) after a desired period of time has passed, selectively decoupling the polymer molecules from the unit so that exit from the stomach is permitted.

3. (canceled)

7. (canceled)

12. An orally administrable polymer-carrying unit for expanding in a stomach of a mammal to fill a space in the stomach, the polymer-carrying unit comprising:

(a) a carrier having at least one outer surface;

(b) at least one coupling member having a first surface and a second surface;

(c) a plurality of polymer molecules, expandable in the presence of an aqueous solution, associated with the first surface of the coupling member;

(d) a coupling means for releasably coupling the second surface of the coupling member to the outer surface of the carrier; and

(e) a decoupling means for selectively decoupling the coupling member from the carrier.

13. The polymer-carrying unit as claimed in claim 12, the carrier having a sphere-like shape or a cube-like shape.

14. The polymer-carrying unit as claimed in claim 12, the carrier having a triangular-like or pyramid-like internal shape.

16. The polymer-carrying unit as claimed in claim 12, wherein the coupling means is selected from the group consisting of means for producing a mechanical force, means for producing an electromagnetic force, means for producing a frictional force, piezoelectric hinges, or combinations thereof.

17. The polymer-carrying unit as claimed in claim 12, wherein the decoupling means comprises an electronic device selected from the group consisting of a timer, a battery, a radio-frequency receiver, or combinations thereof, the electronic device being operably associated with the carrier.

18. The polymer-carrying unit as claimed in claim 12, wherein the carrier comprises an internal cavity and the decoupling means comprises an electronic device selected from the group consisting of a timer, a battery, a radio-frequency receiver, or combinations thereof, housed within the internal cavity.

19. The polymer-carrying unit as claimed in claim 12, wherein the coupling means comprises means for producing a frictional force and the decoupling means comprises an electromagnet operatively associated with the outer surface of the carrier and means for activating the electromagnet to create a magnetic field.

20. The polymer-carrying unit as claimed in claim 19, wherein the coupling member comprises a material that can be repelled by the magnetic field.

21. The polymer-carrying unit as claimed in claim 12, wherein the coupling means is at least one piezoelectric hinge and the decoupling means produces an electric voltage.

22. The polymer-carrying unit as claimed in claim 12, wherein the polymer molecules are a mixture of natural clay and a biocompatible polymer.

23. The polymer-carrying unit as claimed in claim 12, wherein the polymer molecules are biodegradable.

24. The polymer-carrying unit as claimed in claim 12, further comprising an active agent releasably associated with the carrier, the coupling member, the polymer molecules, or a combination thereof.

25. The polymer-carrying unit as claimed in claim 24, wherein the active agent is selected from the group consisting of enzymatic agents, medicinal agent, chemical agents, or combinations thereof.

26. The polymer-carrying unit as claimed in claim 12 in an arrangement, the arrangement comprising a first unit and a second unit, wherein the outer surface of the first unit is releasably coupled to the outer surface of the second unit by means of mechanical forces, frictional forces, electric forces, magnetic forces, electrostatic forces, electromagnetic forces, or a combination thereof.

15. (canceled)

29. (canceled)

30. (canceled)

31. An orally administrable polymer-carrying unit for expanding in a stomach of a mammal to fill a space in the stomach, the polymer-carrying unit comprising:

(a) a carrier having an outer surface and an inner surface, the inner surface forming an internal cavity;

(b) at least one fiber for releasably supporting at least one sac, the at least one sac containing at least one polymer molecule, the fiber being threaded into or through the internal cavity of the carrier so that at least one segment of the fiber is located within the internal cavity;

(c) a decoupler located in the internal cavity to decouple the at least one sac from the carrier by cutting the internal segment of the fiber so that the sac is released.

32. The polymer-carrying unit of claim 31, wherein the decoupler comprises an electrical wire operably associated with the carrier, the electrical wire being heated when it is desirable to melt and cut through the internal segment of the fiber.

33. The polymer-carrying unit of claim 31, wherein the at least one polymer molecule is a mixture of Bentonite and a biocompatible polymer.

34. The polymer-carrying unit of claim 31, wherein the at least one polymer molecule is biodegradable.

35. The polymer-carrying unit of claim 31, wherein the unit is encapsulated in a shell.

36. (canceled)

37. (canceled)

39. A unit for expanding in situ, comprising:

(a) a carrier;

(b) at least one expandable module releasably coupled to the carrier; and

(c) a decoupler to selectively decouple the at least one module from the carrier when the unit is in situ.

40. The unit of claim 39, wherein the at least one expandable module is releasably coupled to the carrier by a force selected from the group consisting of electric forces, magnetic forces, electrostatic forces, mechanical forces, electromagnetic forces, and combinations thereof.

41. The unit of claim 39, wherein the at least one expandable module is releasably coupled to the carrier by a chemical or electrochemical force.

42. The unit of claim 39, wherein the at least one expandable module is releasably coupled to the carrier by a fiber.

43. The unit of claim 42, wherein the fiber is a surgical suture.

44. The unit of claim 42, further comprising at least one pharmaceutically acceptable excipient.

45. A unit for expanding in situ, comprising:

(a) a carrier;

(b) a plurality of expandable modules releasably coupled to the carrier; and

(c) a decoupler to selectively decouple at least one module from at least one other of the modules when the unit is in situ.

46. The unit of claim 45, wherein the at least one expandable module is releasably coupled to the carrier by a force selected from the group consisting of electric forces, magnetic forces, electrostatic forces, mechanical forces, electromagnetic forces, and combinations thereof.

47. The unit of claim 46, wherein the expandable modules are releasably coupled to the carrier by a chemical or electrochemical force.

48. The unit of claim 46, wherein the expandable modules are releasably coupled to the carrier by a fiber.

49. The unit of claim 48, wherein the fiber is a surgical suture.

50. The unit of claim 45, further comprising at least one pharmaceutically acceptable excipient.