Methods and apparatus for anchoring within the gastrointestinal tract

• US 20050125020A1
• Filed: 06/01/2004
• Published: 06/09/2005
• Est. Priority Date: 12/09/2003
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H., Cvinar, John F.
• Granted Patent: US 7,815,589 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics

Abstract

The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.

Claims

1. A gastrointestinal implant device comprising:

an unsupported, flexible sleeve, open at both ends, and adapted to extend into the intestine; and

a wave anchor coupled to a proximal portion of the sleeve, and adapted for attachment within an animal body.

2. The gastrointestinal implant device of claim 1, wherein the wave anchor is adapted for attachment in the intestine.

3. The gastrointestinal implant device of claim 2, wherein the wave anchor is adapted for attachment in the duodenum.

4. The gastrointestinal implant device of claim 2, wherein the wave anchor is adapted for attachment in the duodenal bulb.

5. The gastrointestinal implant device of claim 1, wherein the wave anchor is adapted for removable attachment in the intestine.

6. The gastrointestinal implant device of claim 1, wherein the wave anchor includes an elongated resilient member formed about a central axis, the wave anchor having a first end and a second end and defining a central lumen therebetween, the resilient member defining an oscillating pattern about the central axis alternating between the first and second ends.

7. The gastrointestinal implant device of claim 6, wherein the wave pattern has at least four oscillations.

8. The gastrointestinal implant device of claim 6, wherein the resilient member comprises a material selected from the group consisting of:

metals, alloys, plastics, and combinations thereof.

9. The gastrointestinal implant device of claim 6, wherein the resilient member comprises a super elastic alloy.

10. The gastrointestinal implant device of claim 9, wherein the super elastic alloy is a Nickel-Titanium alloy.

11. The gastrointestinal implant device of claim 6, wherein the resilient member includes a plurality of strands.

12. The gastrointestinal implant device of claim 11, wherein some of the plurality of strands have different physical properties.

13. The gastrointestinal implant device of claim 6, wherein the resilient member comprises a first length having an associated physical property and a second length having a different associated physical property.

14. The gastrointestinal implant device of claim 13, wherein the physical property is resiliency.

15. The gastrointestinal implant device of claim 13, wherein the physical property is thickness.

16. The gastrointestinal implant device of claim 13, wherein the physical property is cross-sectional profile.

17. The gastrointestinal implant device of claim 1, wherein the wave anchor defines a central lumen diameter that is variable between a relaxed state and a compressed state, the ends being separated by an axial length, wherein the ratio of the implanted axial length to diameter is at least about one.

18. The gastrointestinal implant device of claim 17, wherein the relaxed diameter is about 45 millimeters.

19. The gastrointestinal implant device of claim 1, further comprising a feature for attaching the wave anchor within a natural lumen of the gastrointestinal tract.

20. The gastrointestinal implant device of claim 19, wherein the feature for attaching comprises an interference fit formed between the wave anchor and the natural lumen.

21. The gastrointestinal implant device of claim 20, wherein the feature for attaching is selected from the group consisting of:

mechanical fasteners, chemical fasteners, and combinations thereof.

22. The gastrointestinal implant device of claim 21, wherein the chemical fastener includes a surgical adhesive.

23. The gastrointestinal implant device of claim 21, wherein the mechanical fasteners are selected from the group consisting of:

barbs, sutures, staples, and combinations thereof.

24. The gastrointestinal implant device of claim 20, wherein the implant device is attached using a first plurality of barbs.

25. The gastrointestinal implant device of claim 24, wherein each of the plurality of barbs comprises an elongated member, attached at one end to the wave anchor, the other end extending generally outward from the central axis, the barb sized to engage muscular tissue of the surrounding intestine.

26. The gastrointestinal implant device of claim 24, wherein the plurality of barbs are erodible.

27. The gastrointestinal implant device of claim 24, wherein the first plurality barbs are axially distributed and located substantially at one of the ends of the device.

28. The gastrointestinal implant device of claim 27, further comprising a second plurality of axially-distributed barbs located between the first plurality of barbs and the other end of the device.

29. A method of treatment comprising the steps of:

providing an unsupported, flexible sleeve, open at both ends;

extending at least one end of the sleeve into the intestine of an animal body; and

attaching a proximal portion the sleeve within the animal body using a wave anchor.

30. The method of claim 29, wherein attaching comprises attaching the wave anchor in the intestine.

31. The method of claim 30, wherein attaching comprises attaching the wave anchor in the duodenum.

32. The method of claim 30, wherein attaching comprises attaching the wave anchor in the duodenal bulb.

33. The method of claim 29, wherein the wave anchor is adapted for removable attachment in the intestine.

34. The method of claim 29, wherein the wave anchor includes an elongated resilient member formed about a central axis, the wave anchor having a first end and a second end and defining a central lumen therebetween, the resilient member defining an oscillating pattern about the central axis alternating between the first and second ends.

35. The method of claim 34, wherein the wave pattern has at least four oscillations.

36. The method of claim 34, wherein the resilient member comprises a material selected from the group consisting of:

metals, alloys, plastics, and combinations thereof.

37. The method of claim 34, wherein the resilient member comprises a shape-memory alloy.

38. The method of claim 37, wherein the shape-memory alloy is a Nickel-Titanium alloy.

39. The method of claim 34, wherein the resilient member includes a plurality of strands.

40. The method of claim 39, wherein some of the plurality of strands have different physical properties.

41. The method of claim 34, wherein the resilient member comprises a first length having an associated physical property and a second length having a different associated physical property.

42. The method of claim 41, wherein the physical property is resiliency.

43. The method of claim 41, wherein the physical property is thickness.

44. The method of claim 41, wherein the physical property is cross-sectional profile.

45. The method of claim 29, wherein the wave anchor defines a central lumen diameter that is variable between a relaxed state and a compressed state, the ends being separated by an axial length, wherein the ratio of the implanted axial length to diameter is at least about one.

46. The method of claim 45, wherein the relaxed diameter is about 45 millimeters.

47. The method of claim 29, further comprising providing a feature for attaching the wave anchor within a natural lumen of the gastrointestinal tract.

48. The method of claim 47, wherein the feature for attaching comprises an interference fit formed between the wave anchor and the natural lumen.

49. The method of claim 47, wherein the feature for attaching is selected from the group consisting of:

mechanical fasteners, chemical fasteners, and combinations thereof.

50. The method of claim 49, wherein the chemical fastener includes a surgical adhesive.

51. The method of claim 49, wherein the mechanical fasteners are selected from the group consisting of:

barbs, sutures, staples, and combinations thereof.

52. The method of claim 29, wherein the implant device is attached using a first plurality of barbs.

53. The method of claim 52, wherein each of the plurality of barbs comprises an elongated member, attached at one end to the wave anchor, the other end extending generally outward from the central axis, the barb sized to engage muscular tissue of the surrounding intestine.

54. The method of claim 52, wherein the plurality of barbs are degradible.

55. The method of claim 51, wherein the first plurality barbs are axially distributed and located substantially at one of the ends of the device.

56. The method of claim 55, further comprising a second plurality of axially-distributed barbs located between the first plurality of barbs and the other end of the device.

57. A gastrointestinal implant device comprising:

a first annular element configured for insertion into a natural lumen of a gastrointestinal tract of an animal;

a fastener for fixedly securing the first annular element within the natural lumen;

a gastrointestinal implant; and

a connector for removably coupling between the first annular element and the gastrointestinal implant.

58. The gastrointestinal implant of claim 57, wherein the fastener is selected from the group consisting of:

mechanical fasteners;

chemical fasteners; and

combinations thereof.

59. The gastrointestinal implant of claim 58, wherein the mechanical fasteners are selected from the group consisting of:

barbs;

sutures;

staples; and

combinations thereof.

60. The gastrointestinal implant of claim 57, wherein the gastrointestinal implant comprises a second annular element.

61. The gastrointestinal implant of claim 60, wherein the second annular element comprises an unsupported, flexible sleeve having a proximal end and a distal end defining a central lumen therebetween.

62. The gastrointestinal implant of claim 57, wherein the connector comprises a clasp attached to one of the first annular element and the gastrointestinal implant and configured for engaging a feature of the other of the first annular element and the gastrointestinal implant.

63. The gastrointestinal implant of claim 57, wherein the connector is actuated by magnetic attraction.

64. The gastrointestinal implant of claim 57, wherein the connector comprises a magnet attached to one of the first annular element and the gastrointestinal implant and configured for engaging a feature of the other of the first annular element and the gastrointestinal implant.

65. A method of treatment comprising the steps of:

inserting a first annular element into a natural lumen of a gastrointestinal tract of an animal;

fixedly securing the first annular element within the natural lumen;

providing a gastrointestinal implant; and

removably coupling the gastrointestinal implant to the first annular element.

66. The method of claim 65, wherein the step of fixedly securing the first annular element comprises using a fastener is selected from the group consisting of:

mechanical fasteners, chemical fasteners, and combinations thereof.

67. The method of claim 66, wherein the mechanical fastener is selected from the group consisting of:

barbs;

sutures;

staples; and

combinations thereof.

68. The method of claim 67, wherein the gastrointestinal implant comprises a second annular element.

69. The method of claim 68, wherein the second annular element comprises an unsupported, flexible sleeve having a proximal end and a distal end defining a central lumen therebetween.

70. The method of claim 65, wherein the step of removably coupling comprises:

providing a clasp;

attached the clasp to one of the first annular element and the gastrointestinal implant; and

engaging with the clasp a feature of the other of the first annular element and the gastrointestinal implant.

71. The method of claim 70, wherein the step of removably coupling comprises:

providing a connector actuated by magnetic attraction;

coupling the connector to one of the first annular element and the gastrointestinal implant; and

magnetically engaging with the connector a feature of the other of the first annular element and the gastrointestinal implant.