METHOD FOR ANCHORING A MEDICAL DEVICE

• US 20100222772A1
• Filed: 05/14/2010
• Published: 09/02/2010
• Est. Priority Date: 11/12/2003
• Status: Active Grant

• Current Assignee: Confluent Medical Technologies, Inc.
• Original Assignee: Nitinol Devices and Components
• Inventors: Ravenscroft, Adrian, Kleshinski, Stephen J.
• Granted Patent: US 8,398,672 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A method and apparatus for anchoring a medical implant device after the device has been brought to rest at a desired position within a blood vessel or other body passageway. An anchor delivery system is provided which houses one or more uniquely configured expandable anchors which are connected to the medical implant device. The anchors remain housed in a non expanded configuration until after the medical implant device has come to rest in a desired position within the body, and then the anchors are positively propelled through a body wall from a first side to a second side where each anchor expands outwardly from an anchor shaft. In one configuration, the anchors are each formed in the shape of a compressible closed loop which extends outwardly from an anchor shaft and loops back to cross over and extend beyond the anchor shaft. To positively propel the anchors, a drive shaft for the anchor shafts extends back to a triggering unit which, when activated, causes the drive shaft to drive the anchor shafts in a direction which results in propulsion of the anchors through the body wall.

Claims

1. A method for securing a medical device within a lumen, comprising:

positioning the medical device within the lumen so as to place a distal end of a hollow leg of the medical device against an inner surface of a wall of the lumen;

advancing an anchor from a stowed configuration within the hollow leg, the advancing including extending the anchor through an opening in the hollow leg such that the anchor completely penetrates the wall of the lumen from the inner surface to an outer surface; and

continuing to advance the anchor through the opening until the anchor reaches a deployed configuration, wherein, when in the deployed configuration, a central anchor portion forms a closed loop.

2. The method of claim 1, wherein the anchor is substantially straight when in the stowed configuration.

3. The method of claim 1, wherein, when in the deployed configuration, the central anchor portion extends arcuately toward the outer surface and a tip of the anchor extends away from the outer surface.

4. The method of claim 1, wherein, when in the deployed configuration, the central anchor portion extends arcuately away from the outer surface and a tip of the anchor extends toward the outer surface.

5. The method of claim 1, wherein, in response to a force applied to the medical device, the closed loop decreases in diameter.

6. The method of claim 5, wherein the force applied to the medical device results from expansion of the lumen.

7. The method of claim 1, wherein extending the anchor through the opening comprises extending the anchor laterally through the opening.

8. The method of claim 1, wherein a part of the central anchor portion is adjacent to the outer surface when the anchor is in the deployed configuration.

9. The method of claim 1, further comprising compressing the closed loop against the outer surface such that the wall is caught between the closed loop and the hollow leg.

10. A method for deploying a medical device in a vessel, wherein the medical device includes hollow leg and an opening proximal to the distal end, an elongate anchor shaft disposed within the hollow leg, and an anchor at the distal end of the anchor shaft, the anchor having a proximal anchor portion attached to the anchor shaft, a central anchor portion adjacent to the proximal anchor portion, and a tip at the distal end of the anchor adjacent to the central anchor portion, the method comprising:

advancing the anchor relative to the hollow leg so the anchor distal tip passes through the opening in the hollow leg;

penetrating the vessel wall with the anchor tip;

further advancing the anchor relative to the hollow leg until the central anchor portion is outside of the vessel wall; and

curving the central anchor portion such that the tip crosses over and extends beyond the proximal anchor portion.

11. The method of claim 10, wherein advancing the anchor relative to the hollow leg comprises extending the anchor laterally from the hollow leg.

12. The method of claim 10, wherein the central anchor portion comprises a shape-memory material, and wherein curving the central anchor portion comprises returning the central anchor portion to a pre-shaped form.

13. The method of claim 10, wherein curving the central anchor portion comprises curving the central anchor portion arcuately toward an outer surface of the vessel wall such that the tip of the anchor extends away from the outer surface.

14. The method of claim 10, wherein curving the central anchor portion comprises curving the central anchor portion arcuately away from an outer surface of the vessel wall such that the tip of the anchor extends towards the outer surface.

15. The method of claim 10, wherein curving the central anchor portion comprises forming a closed loop, and wherein the closed loop decreases in diameter in response to a force applied to the medical device.

16. The method of claim 15, wherein the force applied to the medical device results from expansion of the lumen.

17. The method of claim 10, wherein curving the central anchor portion comprises forming a closed loop and placing a part of the closed loop adjacent to an outer surface of the vessel wall.

18. The method of claim 10, wherein curving the central anchor portion comprises forming a closed loop, the method further comprising compressing the closed loop against the outer surface such that the vessel wall is caught between the closed loop and the hollow leg.

19. A method for deploying a medical device in a vessel, wherein the medical device includes an elongate hollow leg having an opening proximal to the distal end, an elongate anchor shaft disposed within the hollow elongate leg, and an anchor at the distal end of the anchor shaft having a tip at the distal end of the anchor and a central anchor portion adjacent to the tip, the method comprising:

extending the tip of the anchor through the opening of the hollow leg such that the tip of the anchor completely penetrates the vessel wall to a position beyond an outer surface of the vessel wall; and

further extending the anchor beyond the outer surface such that the central anchor portion is curved to form a closed loop and compresses the outer surface, wherein, in response to a force applied to the anchor in a proximal direction, the closed loop decreases in diameter.

20. The method of claim 19, wherein extending the tip of the anchor through the opening comprises extending the tip laterally through the opening.

21. The method of claim 19, wherein the force applied to the anchor in the proximal direction results from expansion of the vessel.

22. The method of claim 19, wherein the central anchor portion comprises a shape-memory material, and wherein extending the anchor such that the central anchor portion is curved comprises returning the central anchor portion to a pre-shaped form.

23. The method of claim 19, wherein extending the anchor beyond the outer wall such that the central anchor portion is curved comprises curving the central anchor portion arcuately toward the outer surface such that the tip of the anchor extends away from the outer surface.

24. The method of claim 19, wherein extending the anchor beyond the outer wall such that the central anchor portion is curved comprises curving the central anchor portion arcuately away from the outer surface such that the tip of the anchor extends towards the outer surface.

25. The method of claim 19, wherein, when the central anchor portion compresses the outer surface of the vessel wall, the vessel wall is caught between the closed loop and the hollow leg.

26. A method of anchoring a medical device within a body lumen, comprising:

positioning a hollow leg of the medical device against an inner wall of the body lumen;

advancing an anchor from within the hollow leg through an opening in a wall of the hollow leg proximal to the distal most end of the hollow leg;

passing the distal most end of the anchor completely through the wall of the body lumen; and

compressing the lumen wall between a portion of the anchor that has passed completely through the vessel wall and a portion of the hollow leg.

27. The method of claim 26 wherein the portion of the anchor that has passed completely through the vessel wall crosses the hollow leg.

28. The method of claim 26 wherein the portion of the anchor that has passed completely through the vessel wall loops back to cross under the hollow leg.

29. The method of claim 26 wherein the portion of the anchor that has passed completely through the vessel wall loops back to cross over the hollow leg.

30. The method of claim 26 wherein the portion of the anchor that has passed completely through the vessel wall crosses the hollow leg proximal to the opening in the wall of the hollow leg.

31. The method of claim 26 further comprising:

looping the portion of the anchor that has passed completely through the vessel wall.

32. The method of claim 26 further comprising:

directing the distal most end of the anchor towards the outer wall of the body lumen.

33. A method for securing a medical device within a body lumen, comprising:

positioning a blunt distal end portion of the medical device against an inner surface of the body lumen;

advancing an anchor from a stowed configuration within the medical device though an opening in the medical device proximal to the blunt distal end portion; and

securing the medical device within the body lumen by continuing to advance a pointed lead end of the anchor away from the opening until the pointed lead end of the anchor passes completely through the vessel wall from the vessel wall inner surface to the vessel wall outer surface and then passes completely through the vessel wall from the vessel wall outer surface to the vessel wall inner surface.

34. The method of claim 33, wherein the anchor is substantially straight when in the stowed configuration.

35. The method of claim 33, wherein a portion of the anchor advanced through the opening forms a curved shape.

36. The method of claim 33, wherein during the advancing step the portion of the anchor advanced through the opening assumes a pre-formed shape.

37. The method of claim 36 wherein the pre-formed shape is a portion of a curve.

38. The method of claim 36 wherein the pre-formed shape is a portion of a closed loop.

39. The method of claim 36 wherein the pre-formed shape curves towards a proximal portion of the anchor.

40. The method of claim 36 wherein the pre-formed shape forms a loop with a portion of the anchor.

41. The method of claim 33, wherein after the positioning step, the opening is adjacent the inner surface of the body lumen.

42. The method of claim 33, wherein a portion of the anchor proximal to the pointed lead end is adjacent to the vessel outer wall after the securing step.

43. The method of claim 33, wherein after the securing step the anchor forms a closed loop proximal to the pointed lead end.

44. The method of claim 33 wherein the advancing and securing steps are completed sequentially by releasing a spring loaded trigger.

45. The method of claim 33 wherein the advancing and securing steps are performed through the continuous motion of a single drive shaft.

46. The method of claim 33, further comprising:

activating a triggering unit on the proximal end of the medical device to perform the advancing step and the securing step.