Intragastric device for treating obesity

• US 9,526,648 B2
• Filed: 03/14/2014
• Issued: 12/27/2016
• Est. Priority Date: 06/13/2010
• Status: Active Grant

• Current Assignee: SynerZ Medical, Inc.
• Original Assignee: SynerZ Medical, Inc.
• Inventors: Sharma, Virender K.
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US14/214,609
• Publication Number:
  US 20140276336A1
• Time in Patent Office: 1,019 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

A gastrointestinal device for treating obesity includes a three-dimensional porous structure configurable between a compressed pre-deployment configuration to facilitate delivery and an expanded post-deployment configuration. The porous structure includes a first opening at its proximal end and a larger second opening at its distal end. The porous structure also includes a sleeve coupled to its distal end. Optionally, the device further includes a suture at the proximal end of the wire mesh structure to facilitate retrieval and an anti-migration component positioned at the junction of the porous structure with the sleeve. The porous structure is deployed in a patient'"'"'s stomach such that the anti-migration component sits proximal to the patient'"'"'s pylorus and prevents migration of the entirety of the device into and through the pylorus. The sleeve extends through the pylorus, into the duodenum and ends in the duodenum or jejunum. Food enters the device from the first opening at the proximal end of the porous structure, passes through the porous structure and sleeve, and exits at the distal end of the sleeve. The device treats obesity by providing a relatively immovable volume occupying structure in the stomach and a bypass for food past the pylorus and proximal portion of the small intestine. Optionally, the device further acts to slow the passage of food through the digestive tract. Patients with the device experience satiety more quickly and have a prolonged sensation of satiety.

Claims

1. An intragastric device comprising:

a wire mesh structure comprising a top, a bottom, and an interior and having a pre-deployment shape with a first volume and a post-deployment shape with a second volume greater than said first volume, wherein, in said post-deployment shape, said wire mesh structure includes at least one first opening proximate said top and at least one second opening proximate said bottom such that at least some food enters said wire mesh structure through said at least one first opening, passes through said interior, and exits said wire mesh structure through said at least one second opening and wherein, when in said post-deployment configuration, wires of said wire mesh structure comprise 50% or less of a total surface area of said wire mesh structure and openings between said wires comprise a remaining surface area;

an anti-migration component positioned at the bottom of said wire mesh structure and attached to said wire mesh structure, wherein said anti-migration component comprises a compressed pre-deployment configuration and an expanded post-deployment configuration and is designed to sit proximal to a patient'"'"'s pylorus and prevent migration of the wire mesh structure into or through said pylorus; and

a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein said sleeve is coupled to said anti-migration component such that food exiting said at least one second opening enters said sleeve through said third opening, passes through said sleeve interior, and exits said sleeve through said fourth opening.

2. The intragastric device of claim 1, wherein a first surface area defined by said at least one first opening is greater than a second surface area defined by said at least one second opening.

3. The intragastric device of claim 1, wherein a first surface area defined by said at least one first opening is less than a second surface area defined by said at least one second opening.

4. The intragastric device of claim 1, wherein a first surface area defined by said at least one first opening is substantially equal to a second surface area defined by said at least one second opening.

5. The intragastric device of claim 1, wherein said at least one first opening has a diameter of 50 mm or less.

6. The intragastric device of claim 1, wherein said at least one second opening has a diameter of 100 mm or less.

7. The intragastric device of claim 1, wherein said pre-deployment shape is at least one of linear, cylindrical, or conical.

8. The intragastric device of claim 1, wherein, when in said pre-deployment configuration, said device has a diameter or 25 mm or less.

9. The intragastric device of claim 1, wherein said post-deployment shape of said wire mesh structure is at least one of an expanded cylinder, ovoid, sphere, bean, stomach shape, football, cube or cuboid.

10. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure occupies at least 10% of a patient'"'"'s stomach volume.

11. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure has a volume of at least 100 mL.

12. The intragastric device of claim 1, wherein, when in said post-deployment configuration, a diameter of said wire mesh structure is greater than a diameter of an open pylorus.

13. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure is capable of moving no more than 15 inches proximally, distally, and laterally within a patient'"'"'s stomach.

14. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure has a width within a range of 1 cm to 25 cm and a length within a range of 1 cm to 25 cm.

15. The intragastric device of claim 1, wherein an average size of said mesh openings between the wires of said wire mesh structure is greater than 1 mm in diameter.

16. The intragastric device of claim 1, wherein said wire mesh structure has a plurality of vertical and horizontal elements which, when expanded, create the at least one first opening and the at least one second opening.

17. The intragastric device of claim 16, wherein said vertical and horizontal elements comprise at least one of a metal, an alloy, a polymer, a shape memory metal, or a shape memory polymer.

18. The intragastric device of claim 1, wherein, when in said post-deployment configuration, the wire mesh structure has a length from its proximal end to its distal end that is greater than a width of the wire mesh structure that extends, at a midpoint between said proximal end and said distal end, from one side of said wire mesh structure to an opposite side of said wire mesh structure.

19. The intragastric device of claim 1, wherein, when in said post-deployment configuration, the wire mesh structure has a length from its proximal end to its distal end that is equal to a width of the wire mesh structure that extends, at a midpoint between said proximal end and said distal end, from one side of said wire mesh structure to an opposite side of said wire mesh structure.

20. The intragastric device of claim 1, wherein, when in said post-deployment configuration, the wire mesh structure has a length from its proximal end to its distal end that is less than a width of the wire mesh structure that extends, at a midpoint between said proximal end and said distal end, from one side of said wire mesh structure to an opposite side of said wire mesh structure.

21. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure comprises a wire mesh weave pattern which makes the wire mesh structure more easily compressible along a vertical axis relative to a horizontal axis.

22. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure comprises a wire mesh weave pattern which makes the wire mesh structure more easily compressible along a horizontal axis relative to a vertical axis.

23. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure comprises a wire mesh weave pattern which provides a consistent radial strength throughout said wire mesh structure, further wherein said radial strength is greater than a compressive force of a patient'"'"'s stomach.

24. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said wire mesh structure comprises an upper portion extending from said proximal end to a middle point halfway between said proximal end and said distal end and a lower portion extending from said distal end to a middle point halfway between said proximal end and said distal end.

25. The intragastric device of claim 24, wherein said upper portion comprises a first wire mesh weave pattern which provides said upper portion with a radial strength greater than a radial strength provided to the lower portion by a second wire mesh weave pattern of said lower portion.

26. The intragastric device of claim 24, wherein said upper portion comprises a wire mesh weave pattern which provides said upper portion with a radial strength greater than a compressive force of a patient'"'"'s stomach and said lower portion comprises a flexible membrane.

27. The intragastric device of claim 1, wherein said wire mesh structure is adapted to be self-expanding wherein said expansion is effectuated through a use of a shape memory metal.

28. The intragastric device of claim 27, wherein said shape memory metal is Nitinol.

29. The intragastric device of claim 1, said wire mesh structure is adapted to be self-expanding wherein said expansion is effectuated through a use of a temperature sensitive material.

30. The intragastric device of claim 1, wherein a shape of said wire mesh structure is adapted to be changed from said pre-deployment shape to said post-deployment shape by application of an expansion tool.

31. The intragastric device of claim 1, wherein said wire mesh structure is coated with a corrosion-resistant material preventing exposure of said wire mesh structure to gastric acid, further wherein said corrosion-resistant material covers wires of said wire mesh structure and does not cover said openings of said wire mesh structure.

32. The intragastric device of claim 31, wherein said corrosion-resistant material comprises any one or combination of silicone, polyester, polyether ether ketone (PEEK), a medical grade epoxy, ceramic, or metal.

33. The intragastric device of claim 1, wherein said wire mesh structure further includes a radiopaque marker to facilitate delivery using radiographic visualization.

34. The intragastric device of claim 1, further comprising at least one sensor.

35. The intragastric device of claim 34, wherein said sensor comprises any one or combination of a flow or impedance sensor, a glucose sensor, a temperature sensor, a pH sensor, and an accelerometer.

36. The intragastric device of claim 1, wherein said sleeve has a length sufficient to extend from said bottom of said wire mesh structure and through a patient'"'"'s pylorus.

37. The intragastric device of claim 1, wherein said sleeve is comprised of a corrosive resistant and biocompatible material.

38. The intragastric device of claim 1, wherein said sleeve comprises at least one of silicone, latex, parylene, polyurethane, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (PTFE), fluorinated ethylene-propylene, Dacron, or Polyethylene terephthalate (PET).

39. The intragastric device of claim 1, wherein said fourth opening of said sleeve is positioned on said elongate body proximal to said distal end and said sleeve further comprises a pouch at said distal end beyond said fourth opening.

40. The intragastric device of claim 1, wherein fourth opening of said sleeve is positioned at said distal end of said sleeve.

41. The intragastric device of claim 1, wherein said sleeve has a length within a range of 6 inches to 120 inches.

42. The intragastric device of claim 1, wherein said sleeve has a length of 24 inches.

43. The intragastric device of claim 1, wherein said sleeve has a diameter within a range of 1 cm to 10 cm.

44. The intragastric device of claim 1, wherein said sleeve has a diameter of 3 cm.

45. The intragastric device of claim 1, wherein said distal end of sleeve is weighted to maintain sleeve in an elongate shape.

46. The intragastric device of claim 1, wherein said sleeve is coupled to said anti-migration component via at least one of sutures, glue, and thermal fusion.

47. The intragastric device of claim 1, wherein said sleeve comprises a flexible coil or mesh having a weave pattern which provides the sleeve with anti-torsional properties and structural support such that said sleeve remains in an elongate shape.

48. The intragastric device of claim 1, wherein said sleeve comprises a membrane having a plurality of horizontal and vertical support elements which provide the sleeve with anti-torsional properties and structural support such that said sleeve remains in an elongate shape.

49. The intragastric device of claim 48, wherein said horizontal support elements are spaced between 1 inch and 24 inches apart from one another and said vertical support elements are between 1 inch and 60 inches in length.

50. The intragastric device of claim 48, wherein said horizontal support elements are spaced 6 inches apart from one another and said vertical support elements are 6 inches in length.

51. The intragastric device of claim 1, wherein said sleeve comprises a membrane having a spiral metal wire extending its entire length which provides the sleeve with anti-torsional properties and structural support such that said sleeve remains in an elongate shape.

52. The intragastric device of claim 1, wherein said sleeve is capable of telescoping into itself.

53. The intragastric device of claim 1, wherein said sleeve comprises a membrane and said membrane of said sleeve extends onto a portion of said wire mesh structure.

54. The intragastric device of claim 1, wherein said sleeve further comprises a radiopaque marker to facilitate delivery using radiographic visualization.

55. The intragastric device of claim 1, further comprising a retrieval mechanism fixedly attached to the top of said wire mesh structure.

56. The intragastric device of claim 55, wherein said retrieval mechanism comprises a suture or wire having a loop shape.

57. The intragastric device of claim 1, wherein, when in said pre-deployment configuration, said anti-migration component has a shape comprising any one of linear, cylindrical, or conical.

58. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said anti-migration component has a shape comprising any one of donut, discoid sloping proximally, discoid sloping proximally, flat discoid or circular, a half bumper, a full bumper, a flower shape, or a saucer shape.

59. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said anti-migration component has a width that is greater than the diameter of the wire mesh structure.

60. The intragastric device of claim 1, wherein, when in said post-deployment configuration, said anti-migration component has a radial strength that is greater than a compressive force of a patient'"'"'s stomach.

61. The intragastric device of claim 1, wherein said anti-migration component is comprised of metal.

62. The intragastric device of claim 61, wherein said metal is a shape memory metal.

63. The intragastric device of claim 62, wherein said shape memory metal is Nitinol.

64. The intragastric device of claim 61, wherein said metal is temperature sensitive.

65. The intragastric device of claim 1, wherein said anti-migration component is coated with a corrosive resistant material.

66. The intragastric device of claim 65, wherein said corrosive resistant material is any one or combination of silicone, polyester, a medical grade epoxy, ceramic, or metal.

67. The intragastric device of claim 1, wherein said anti-migration component further includes a radiographic marker to facilitate delivery using radiographic visualization.

68. The intragastric device of claim 1 wherein at least a portion of the total surface area is covered by a membrane.

69. The intragastric device of claim 1 wherein the total surface area is not covered by a membrane.