Methods and devices to curb appetite and/or to reduce food intake

• US 20070293885A1
• Filed: 05/25/2007
• Published: 12/20/2007
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: Endosphere, Inc
• Original Assignee: Endosphere, Inc
• Inventors: Binmoeller, Kenneth
• Granted Patent: US 8,585,771 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The present invention relates to devices and methods of operating the devices that contribute to curbing appetite and/or reducing food intake. In some embodiments, the methods and devices of the present invention include as intestinal/duodenal insert comprising an elongated member with at least one flow reduction element that can cause the stimulation of one or more biological signals of satiety. Some embodiments of the inserted device are anchored at the duodenal site by an anchoring member residing in the stomach, other embodiments of the device are stabilized at a targeted site by appropriate dimensions of length as well as one or more angled portions of the device that correspond to angled portions of the targeted site in the dodenum. Embodiments of the device exert effects by virtue of physical presence, as well as by more active forms of intervention, including release of bioactive materials and electrical stimulation of neurons.

Claims

1. A small intestinal insert comprising

an elongated member including a proximal end;

a distal end;

at least one angled portion between the proximal end and the distal end, the angled portion corresponding to at least one angled target site within the small intestine; and

at least a portion of the insert formed of a biodegradable material;

the elongated member configured initially to sit stably within the targeted site, and then, following degradation of the biodegradable material, configured to destabilize such that it becomes unseated from the target site.

2. The insert of claim 1 wherein the angled portion comprises biodegradable material.

3. The insert of claim 1 wherein the angled portion comprises a shape memory material.

4. The insert of claim 3 wherein the shape memory material comprises any of a shape memory alloy or a biodegradable shape memory polymer.

5. The insert of claim 1 wherein the angled portion comprises a shape memory alloy portion and a biodegradable portion.

6. The insert of claim 5 wherein the biodegradable portion, upon degradation, is configured to facilitate the elimination of the shape memory alloy portion.

7. The insert of claim 5 wherein the shape memory alloy portion and the biodegradable portion are joined at a junction, the junction configured to degrade as the biodegradable portion degrades.

8. The insert of claim 1 wherein the angled target site in the small intestine is in the duodenum.

9. The insert of claim 8 wherein the angled target site in the duodenum comprises two angles, the insert having two angles corresponding to two angles of the duodenum.

10. The insert of claim 1 further comprising at least one flow reduction element supported by the elongated member, the flow reduction element configured to reduce the flow rate of chyme in the small intestine.

11. The insert of claim 10 wherein the flow reduction element is formed at least in part from a biodegradable material.

12. The insert of claim 10 wherein the flow reduction element includes any of a rib, a net, a sleeve, a basket, a centrally mounted baffle, a peripherally mounted baffle, a foam-like material, or a fan.

13. The insert of claim 12 wherein the foam-like material includes any of an open cell foam, a closed cell foam, or a hydrogel.

14. The insert of claim 13 wherein the foam-like material comprises a bioactive material incorporated thereinto.

15. The insert of claim 14 wherein the foam-like material is biodegradable, and wherein the bioactive material is released upon degradation of the foam-like material.

16. The insert of claim 10 wherein the flow reduction element includes at least one releasable reservoir of one or more bioactive materials.

17. The insert of claim 10 wherein the at least one flow reduction element reduces the rate of the chyme flow sufficiently to alter its biochemical profile.

18. The insert of claim 17 wherein the biochemical profile is altered sufficiently to cause the generation of a hormonal signal of satiety.

19. The insert of claim 1 wherein a physical feature of the insert is such the insert distends a portion of the small intestine when the insert is seated therein, the distension sufficient to cause one or more nerves of the small intestine to generate a satiety signal in response thereto.

20. The insert of claim 19 wherein the physical features of the insert include any of length, width, volume, weight, density, porosity.

21. The insert of claim 1 further comprising:

one or more releasable reservoirs containing one or more bioactive materials, the one or more reservoirs supported by the elongated member; and

an active drug release mechanism supported by the elongated member, the active drug release mechanism and the one or more releasable reservoirs in operable communication with each other.

22. The insert of claim 1 further comprising a pump for delivering a bioactive material, the pump supported by the elongate member and coupled to the one or more releaseable reservoirs.

23. The insert of claim 22 wherein the pump is any of an osmotic pump, an electrically-driven mechanical pump, a piezoelectric pump, a flow-driven pump, a peristaltic-action driven pump.

24. The insert of claim 22 further comprising an energy storage element configured to provide energy to the pump.

25. The insert of claim 22 wherein the pump is controlled by a remote device.

26. The insert of claim 1 further comprising an electronic emitter configured to apply an electrical potential to a site in any of the small intestine or stomach, the emitter supported by the elongate member.

27. The insert of claim 26 wherein the emitter, upon activation, stimulates a neuronal response that contributes to a signal of satiety.

28. The insert of claim 27 further comprising an energy storage element configured to provide energy to the pump.

29. The insert of claim 26 wherein the electronic emitter is controlled by a remote device.

30. The insert of claim 1 further comprising an anchoring member engaged to the proximal end of the elongated member, the anchoring member configured to contribute to the stabilization of the device in the targeted site.

31. The insert of claim 30 wherein the anchoring member resides in the stomach when the elongate member is seated in the target site within the small intestine.

32. A small intestinal insert comprising

an elongated member including a proximal end;

a distal end;

at least one angled portion between the proximal end and the distal end, the angled portion corresponding to at least one angled target site within the small intestine, and

wherein the at least one angled portion of the insert corresponds to at least one angled target site within the small intestine; and

a neurological stimulator, supported by the elongate member.

33. The insert of claim 32 wherein the insert includes a portion formed from a biodegradable material.

34. The insert of claim 33 wherein the elongate member is configured initially to sit stably within the targeted site, and then, following degradation of the biodegradable material, configured to destabilize such that it becomes unseated from the target site.

35. The insert of claim 33 wherein the angled portion of the insert comprises biodegradable material.

36. The insert of claim 32 wherein the neurological stimulator is adapted to stimulate one or more nerves of the small intestine sufficiently to generate one or more signals of satiety.

37. The insert of claim 32 further comprising an energy storage element configured to provide energy to the neurological stimulator.

38. The insert of claim 32 wherein the neurological stimulator is controlled by a remote device.

39. The insert of claim 32 wherein the angled target site in the small intestine is in the duodenum.

40. The insert of claim 39 wherein the angled target site in the duodenum comprises two angles, the insert having two angles corresponding to two angles of the duodenum.

41. The insert of claim 32 further comprising at least one flow reduction element, the element configured to reduce the flow rate of chyme in the small intestine.

42. The insert of claim 41 wherein the flow reduction element is formed at least in part from a biodegradable material.

43. The insert of claim 32 further comprising an anchoring member engaged to the proximal end of the elongated member, the anchoring member configured to contribute to the stabilization of the device in the targeted site.

44. A small intestinal insert comprising:

an elongated member including a proximal end;

a distal end;

at least one angled portion between the proximal end and the distal end, the angled portion corresponding to at least one angled target site within the small intestine; and

wherein the at least one angled portion of the insert corresponds to at least one angled target site within the small intestine; and

one or more releasable reservoirs containing one or more bioactive materials, the one or more reservoirs supported by the elongated member; and

an active drug release mechanism supported by the elongated member, the active drug release mechanism and the one or more releasable reservoirs in operable communication with each other.

45. The insert of claim 44 wherein the insert includes a portion formed from a biodegradable material.

46. The insert of claim 45 wherein at least a portion of the insert is formed of a biodegradable material, the elongated member configured initially to sit stably within the targeted site, and then, following degradation of the biodegradable material, configured to destabilize such that it becomes unseated from the target site.

47. The insert of claim 46 wherein the angled portion of the insert comprises biodegradable material.

48. The insert of claim 44 wherein the active drug release mechanism includes any of an osmotic pump, an electrically-driven mechanical pump, a flow-driven pump, a peristaltic-action driven pump, or a piezoelectric pump.

49. The insert of claim 48 further comprising an energy storage element configured to provide energy to the pump.

50. The insert of claim 48 wherein the active drug release mechanism is controlled by a remote device.

51. The insert of claim 44 wherein the bioactive materials released by the active drug release mechanism are sufficient to generate a signal of satiety.

52. The insert of claim 44 wherein the angled target site in the small intestine is in the duodenum.

53. The insert of claim 52 wherein the angled target site in the duodenum comprises two angles, the insert having two angles corresponding to two angles of the duodenum.

54. The insert of claim 44 wherein the angled portion comprises a shape memory portion.

55. The insert of claim 44 wherein the angled portion comprises a shape memory alloy portion and a biodegradable portion.

56. The insert of claim 44 further comprising an electronic emitter configured to apply an electrical potential to a site in the small intestine, the site generating a neuronal response that contributes to a signal of satiety.

57. A method of generating satiety in a subject comprising:

positioning an insert in the small intestine, the insert including;

an elongated member including a proximal end;

a distal end;

at least one angled portion between the proximal end and the distal end, the angled portion corresponding to at least one angled target site within the small intestine; and

at least a portion of the insert formed of a biodegradable material;

the elongated member configured initially to sit stably within the targeted site, and then, following degradation of the biodegradable material, configured to destabilize such that it becomes unseated from the target site, and

generating one or more signals of satiety due to one or more effects of any of the presence of the insert or an active intervention by the insert.

58. The method of claim 57 further comprising biodegrading the biodegradable material of the insert, unseating the devise from the target site, and eliminating it from the body.

59. The method of claim 58 wherein the insert includes a portion with a shape memory alloy, and wherein biodegrading the biodegradable material facilitates elimination of the shape memory alloy portion.

60. The method of claim 57 further wherein the insert further comprises chyme flow reduction elements, the method further comprising slowing the passage of chyme with the flow reduction elements.

61. The method of claim 60 wherein slowing the passage of chyme changes the biochemical profile of the chyme.

62. The method of claim 61 wherein changing the biochemical profile of the chyme activates chemoreceptors in the intestine, the chemoreceptors secreting a bioactive material in response thereto.

63. The method of claim 57 wherein generating a satiety signal includes stretch-sensitive neurons of the intestine responding to distension of at least a portion of the duodenum due to the presence of the insert.

64. The method of claim 57 wherein generating a satiety signal includes cells of the intestine secreting one or more bioactive materials in response to the presence of the insert.

65. The method of claim 57 wherein the insert comprises bioactive materials in releasable reservoirs, and wherein an active intervention by the insert includes the insert releasing one or more bioactive materials.

66. The method of claim 65 wherein releasing one or more bioactive materials includes effluxing from the reservoir.

67. The method of claim 65 wherein the insert further includes a pump in operable connection with the releasable reservoirs, and wherein releasing one or more bioactive materials includes pumping the materials from the reservoir.

68. The method of claim 67 wherein pumping may be from any of an osmotic pump, an electrically-driven pump, a piezoelectric structure, a flow-driven pump, or a peristalsis-driven pump.

69. The method of claim 65 wherein the bioactive materials are included within a portion of the device comprising biodegradable materials, and wherein the bioactive materials are released upon degradation of the biodegradable material.

70. The method of claim 69 wherein the biodegradable materials are included in one or more flow reduction elements of the insert comprise a foam-like material.

71. The method of claim 70 wherein the flow reduction elements include a foam-like material includes any of an open cell foam, a closed cell foam, or a hydrogel.

72. The method of claim 57 wherein the insert further includes a neurological stimulator supported by the elongated member, and wherein the active intervention includes stimulating nerves of the duodenum with the stimulator.

73. A method of generating satiety in a subject comprising:

positioning an insert in the small intestine, the insert including;

an elongated member including a proximal end;

a distal end;

at least one angled portion between the proximal end and the distal end, the angled portion corresponding to at least one angled target site within the small intestine, wherein the at least one angled portion of the insert corresponds to at least one angled target site within the small intestine; and

a neurological stimulator, supported by the elongated member; and

stimulating nerves of the duodenum with the neurological stimulator.

74. The method of claim 73 wherein the nerves responding to the neurological stimulator are stretch-sensitive neurons of the intestine, which respond by sending a signal of satiety.

75. The method of claim 73 further comprising slowing the passage of chyme with the flow reduction elements, such slowing of chyme flow contributing to further generation of satiety signals.

76. The method of claim 73 further comprising endocrine cells of the intestine responding to the neurological stimulator by any of direct or neurally-mediated pathways, the response including secreting one or more hormones.

77. The method of claim 73 wherein the insert comprises bioactive materials releasable reservoirs, the method further comprising the insert releasing one or more bioactive materials.

78. The method of claim 73 wherein the insert comprises biodegradable materials, the method further comprising biodegrading the biodegradable material of the insert and eliminating the insert from the body.

79. A method of generating satiety in a subject comprising:

positioning an insert in the small intestine, the insert comprising

an elongated member including a proximal end;

a distal end;

at least one angled portion between the proximal end and the distal end, the angled portion corresponding to at least one angled target site within the small intestine; and

wherein the at least one angled portion of the insert corresponds to at least one angled target site within the small intestine; and

one or more releasable reservoirs containing one or more bioactive materials, the one or more reservoirs supported by the elongated member; and

an active drug release mechanism supported by the elongated member, the active drug release mechanism and the one or more releasable reservoirs in operable communication with each other; and

releasing one or more bioactive agents into the duodenum.

80. The method of claim 79 wherein releasing one or more bioactive materials includes pumping from the reservoir.

81. The method of claim 80 wherein pumping may be from any of an osmotic pump, an electrically-driven pump, a piezoelectric structure, a flow-driven pump, or a peristalsis-driven pump.

82. The method of claim 79 further comprising slowing the passage of chyme with the flow reduction elements, such slowing of chyme flow contributing to further generation of satiety signals.

83. The method of claim 79 further comprises stretch-sensitive neurons of the intestine responding to the physical presence of the insert.

84. The method of claim 79 further comprises endocrine cells of the intestine secreting one or more hormones in response to any of the physical presence of the insert of in response to the bioactive agents released by the active drug release mechanism.

85. The method of claim 79 further comprising biodegrading the biodegradable material of the insert and eliminating the insert from the body.