ENDOSCOPIC IMPLANT SYSTEM AND METHOD

• US 20090024143A1
• Filed: 07/17/2008
• Published: 01/22/2009
• Est. Priority Date: 07/18/2007
• Status: Abandoned Application

• Current Assignee: Barosense, Inc. (Boston Scientific Scimed Incorporated)
• Original Assignee: Barosense, Inc. (Boston Scientific Scimed Incorporated)
• Inventors: Swope, Bretton, Crews, Samuel T., England, Justen
• Application Number:
  US12/175,242
• Publication Number:
  US 20090024143A1
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

Disclosed is a system for endoscopically implanting a medical implant within a body cavity such as a human stomach. The system includes one or more anchors positionable within one or more openings formed in tissue within the body cavity, such as cutouts formed in plicated body tissue. Tools are disclosed for positioning the anchors within the openings, and for coupling the implant to the anchors.

Claims

1. A method of coupling an implant to tissue having an opening formed therein, the method comprising:

providing an anchor having a head and a base;

drawing the head through the opening in the tissue to position the head on a first side of the plication and the base on a second side of the plication, and

coupling an implant to the anchor.

2. The method of claim 1, wherein the method includes, after drawing the head through the opening, expanding the head to a diameter larger than the diameter of the opening.

3. The method of claim 1, wherein drawing the head deforms the head for passage through the opening, an wherein expanding the head includes allowing the head to assume the larger diameter.

4. The method of claim 2, wherein the method includes:

coupling the anchor to a first tool;

advancing the first tool into a body cavity;

advancing a second tool into the body cavity and passing the second tool through the opening;

after passing the second tool through the opening, engaging the anchor using the second tool;

withdrawing the second tool from the opening to draw the head through the opening; and

releasing the anchor from the first tool.

5. The method of claim 4, wherein coupling the implant to the anchor includes passing the implant over the second tool and over the head.

6. The method of claim 2, wherein the method includes coupling a tool to the head, and wherein coupling an implant to the anchor includes, with the tool coupled to the head and with a portion of the anchor disposed in the tissue opening, advancing the implant over the tool and into engagement with the anchor.

7. The method of claim 6, wherein the implant includes an opening, and wherein advancing the implant over the tool and into engagement with the anchor includes threading the opening of the implant onto the tool and advancing the implant over the tool and the head.

8. The method of claim 1, wherein coupling the implant to the anchor includes coupling the implant to the anchor after drawing the head through the tissue opening.

9. The method of claim 4, wherein advancing the first tool into the body cavity includes advancing the first tool with the anchor thereon into the body cavity.

10. The method of claim 4, wherein the anchor is coupled to the first tool after the first tool is advanced into the body cavity.

11. The method of claim 7, wherein the method includes providing a plurality of the anchors and drawing the heads of the plurality of the anchors through a plurality of tissue openings, coupling a plurality of tools to the heads of the plurality of anchors, and advancing the implant over the plurality of tools and into engagement with the anchors.

12. The method of claim 6, wherein the tissue opening is in a plication extending from a tissue wall and wherein:

providing the anchor includes providing the head to include a laterally-extending loop

the method further includes positioning the anchor within the tissue opening such that the loop extends generally away from the most proximate second of the tissue wall.

13. The method of claim 12, wherein:

providing the anchor further includes providing the base to include a first edge having a first curvature and a second edge having a second, flatter curvature, the loop extending laterally in a direction opposite to the second edge of the base, and

positioning the anchor includes positioning the anchor with the second edge in contact with the wall to cause the loop to extend generally away from the most proximate section of the tissue wall.

14. The method of claim 12, wherein the tissue opening is in a plication in a stomach wall, and wherein positioning the anchor includes transorally introducing the anchor into the stomach and positioning the anchor with the second edge in contact with the interior wall of the stomach.

15. The method of claim 1, wherein the tissue opening is in a plication in a stomach wall, and wherein the method includes introducing the anchor and the implant transorally into the stomach.

16. The method of claim 15, wherein the method is further for forming the opening in the tissue structure, and further includes:

forming a plication in the wall of the stomach;

forming an opening in the plication.

17. The method of claim 16, wherein the method includes introducing a plication tool transorally into the stomach and forming the plication with the plication tool.

18. The method of claim 17, wherein the method includes forming the opening in the plication with the plication tool.

19. A medical implant system for coupling an implant to an opening formed in body tissue, comprising:

an anchor comprising a head coupled to a base, the head having a first, natural, position in which the head has a diameter larger than a diameter of the opening, and a second, elongated, position in which the head is deformed for passage through the opening; and

an implant having an opening, the opening of the implant proportioned to allow passage of the head when the head is in the second position, and to resist passage of the head when the head is in the first position.

20. The medical implant system of claim 19, wherein the anchor head is moveable from the first position to the second position in response to application of tension in a generally longitudinal direction between the head and the base.

21. The medical implant system of claim 19, wherein the anchor head is moveable to a third position in response to application of tension to the head in a generally transverse direction, wherein in the third position the head is proportioned to resist passage through the opening.

22. The medical implant system of claim 19, wherein the head is more elastic than the base.

23. The medical implant system of claim 19, wherein the anchor includes a stem extending between the head and the base.

24. The medical implant system of claim 23, wherein the stem is more elastic than the base.

25. The medical implant of claim 23, wherein the head includes a ring coupled to the stem.

26. The medical implant system of claim 25, wherein the ring has an undulating surface.

27. The medical implant system of claim 25, wherein the head includes a loop extending laterally from the ring.

28. The medical implant system of claim 23, wherein at least one of the head and the base is asymmetrical relative to the longitudinal axis of the stem.

29. The medical implant system of claim 19, wherein the head includes a laterally-extending loop.

30. The medical implant system of claim 19, wherein the base has a first edge having a first curvature and a second edge having a second, flatter curvature.

31. The medical implant system of claim 29, wherein the head has a loop extending laterally in a direction opposite to the second edge of the base.

32. The medical implant system of claim 19, wherein the body cavity is a stomach and the opening is in stomach tissue and wherein the system further includes a tool proportioned for transoral insertion into the body cavity and for extension through the opening in the stomach tissue, the tool engageable with the head to deform the head into the second position, the opening of the implant slidable over the tool through an oral cavity into position within the stomach.

33. The medical implant system of claim 32, wherein the head includes a loop and wherein the tool is engageable with the loop.

34. The medical implant system of claim 33, wherein the tool includes a jaw having an open position and a closed position.

35. The medical implant system of claim 32, wherein:

the system includes a plurality of the anchors;

the implant includes a plurality of openings; and

the system includes a plurality of tools each transorally insertable into the stomach and extendable through separate openings formed in stomach tissue, each tool engageable with the head of a corresponding one of the anchors to deform the head into the second position, the opening of the implant slidable over the plurality of tools into engagement with the anchors.

36. The medical implant system of claim 32, wherein the system is further for forming the opening in the stomach tissue, and wherein the system further includes a plication tool and a tissue cutting element, wherein the anchor is positionable within an opening formed by the tissue cutting element in a plication formed by the plication tool.

37. The medical implant system of claim 36, wherein the tissue cutting element is on the plication tool.

38. The medical implant system of claim 37, wherein the plication tool includes a plurality of staples advanceable through tissue for forming a plication.

39. The medical implant system of claim 19, wherein the implant comprises a wall bounding an interior, and wherein the opening is formed in the wall.

40. The medical implant system of claim 39, wherein the implant is a flow-restrictive implant proportioned for implantation within a stomach having the tissue opening formed in tissue of the stomach.

41. The medical implant system of claim 35, further including:

an implant pusher having at least one engaging pin on a distal portion of the implant pusher, the implant pusher proportioned for transoral advancement into the stomach with the implant coupled to the engaging pin.

42. The medical implant system of claim 32, further including instructions for use instructing the user to implant the anchor and implant according to the following steps:

coupling the anchor to the tool;

transorally advancing the tool into the stomach;

advancing a second tool into the stomach and passing the second tool through the tissue opening;

after passing the second tool through the opening, engaging the anchor using the second tool;

withdrawing the second tool from the opening to draw the head through the opening;

releasing the anchor from the first tool; and

passing the implant over the second tool and over the head.

43. A restrictive stomach implant, comprising:

a wall including a plurality of anchor points and compliant sections between the anchor points.

44. The restrictive stomach implant of claim 43, wherein the compliant sections include at least one fold positioned between each pair of anchor points.

45. The restrictive stomach implant of claim 43, wherein the wall is formed of first regions of a first material and second regions of a second material, the first regions more compliant than the second regions.

46. The restrictive implant of claim 45, wherein the wall is formed of the first material, and wherein the second regions include sections of the second material positioned on the first material.

47. The restrictive implant of claim 46, wherein the sections of second material include longitudinal ribs.

48. The restrictive implant of claim 45, wherein the wall includes a distal orifice, and wherein the sections of second material include a ring of second material encircling the distal orifice.

49. The restrictive implant of claim 43, wherein the wall defines a sleeve having a proximal edge, the proximal edge including proximally extending peaks.

50. The restrictive implant of claim 49, wherein the peaks define chutes for directing ingested food material from a proximal portion of the implant towards a distal portion of the implant.

51. The restrictive implant of claim 43, wherein the wall includes a distal orifice defined by an edge, wherein the edge includes a plurality of folds.

52. The restrictive implant of claim 43, wherein the anchor points comprise a plurality of anchor openings formed in the wall.

53. The restrictive implant of claim 52, wherein each of the anchor openings includes a circumferential reinforcement.

54. A medical implant system for use in a patient comprising:

an anchor configured to be coupled to tissue within a body cavity;

a first tool having a proximal portion, a distal portion, and a shaft between the proximal and distal portions, the distal portion including a coupling element operable to couple the first tool to the anchor, the first tool proportioned such that when the coupling element is coupled to the anchor within the body cavity, the proximal portion of the first tool extends out of the patient; and

an implant having an opening proportioned to slide over the shaft and distal end of the first tool and into engagement with the anchor.

55. The medical implant system according to claim 54 wherein the opening and the first tool are proportioned to allow the opening to slide over a proximal tip of the first tool.

56. The medical implant system according to claim 55, wherein the proximal tip is tapered in a proximal direction.

57. The medical implant system according to claim 54, further including a second tool having a distal end with a coupling element adapted to be detachably coupled to the implant, the implant opening slidable over the shaft of the first tool when the implant is coupled to the coupling element of the second tool, the second tool proportioned such that a proximal end of the second tool remains outside the patient during advancement of the implant over the distal end of the first tool and into engagement with the anchor within the body cavity.

58. The medical implant system according to claim 57, wherein the coupling element of the second tool includes at least one longitudinally-extending pin extendable through a portion of the implant.

59. The medical implant system according to claim 58, wherein the pin includes a free distal end, and wherein the coupling element further includes a distal containment element positioned such that relative movement of the free distal end of the pin and the distal containment element towards one another to a first position prevents detachment of the implant from the pin, and such that relative movement of the free distal end of the pin away from one another to a second position exposes the pin to allow detachment of the implant from the pin.

60. The medical implant system according to claim 59, wherein the coupling element of the second tool includes a plurality of longitudinally-extendable pins extendable through the implant, and wherein in the second position the distal containment element is positioned to detachment of the implant from the plurality of pins.

61. The medical implant system according to claim 60, wherein the implant includes a base, a wall coupled to the base and surrounding an interior, a first opening in the base, and a plurality of second openings surrounding the exit port, and wherein the plurality of pins are positionable within the plurality of second openings, with a shaft of the second tool extending through the exit port.