Medical device for modification of left atrial appendage and related systems and methods

• US 8,636,764 B2
• Filed: 06/17/2010
• Issued: 01/28/2014
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Davis, Clark C., Edmiston, Daryl R., Linder, Richard J.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/818,046
• Publication Number:
  US 20100324586A1
• Time in Patent Office: 1,321 Days
• Field of Search: 606/213, 606/192, 606/200, 606/214, 606/215, 606/139, 606/153, 606/151, 606/157, 606/158
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0069 with universal joint, cardan joint
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device

Abstract

Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Claims

1. A medical device for modifying a left atrial appendage (“

LAA”

) of a heart, the medical device comprising;

an occluder portion coupled to a hub having an axis; and

an anchor portion including multiple anchor segments each extending between a first end and a second end, each first end of the multiple anchor segments operably coupled to the occluder portion, each second end of the multiple anchor segments coupled to an anchor hub, the anchor hub moveable along the axis so as to facilitate the anchor portion to roll-inward to a retracted position with a portion of the anchor segments moved through the hub and with the anchor hub moved to a proximal position of the hub and the anchor portion to roll-outward to a deployed position with the anchor hub being moved distal of the proximal position.

2. The medical device of claim 1, wherein the multiple anchor segments include an intermediate portion extending between the first end and the second end of the multiple anchor segments.

3. The medical device of claim 1, wherein the anchor portion is configured to roll-inward to a retracted position such that an outer surface of the anchor portion in the deployed position is moved to an inner surface of the anchor portion in the retracted position.

4. The medical device of claim 2, further comprising engaging members associated with the intermediate portion of the anchor portion, the engaging members being sized, oriented and configured to engage tissue in the LAA.

5. The medical device of claim 1, wherein the anchor portion includes engaging members configured and oriented to extend proximally and to engage tissue of the LAA.

6. The medical device of claim 1, wherein the anchor portion comprises engaging members configured and oriented to extend proximally when the anchor portion is in the deployed position and configured and oriented to extend distally when the anchor portion is in the retracted position.

7. The medical device of claim 1, wherein the occluder portion comprises a tissue growth member having an inner surface and an outer surface, the tissue growth member being configured to induce tissue growth therewith.

8. The medical device of claim 7, wherein the anchor portion is sized and configured to bias against the inner surface of the tissue growth member such that the outer surface of the tissue growth member contacts tissue in the LAA.

9. The medical device of claim 7, wherein the anchor portion comprises engaging members configured to engage tissue distal the tissue growth member.

10. The medical device of claim 1, further comprising a guide configured and oriented to guide and align anchor segments of the anchor portion being moved between the retracted position and the deployed position.

11. The medical device of claim 1, wherein the multiple anchor segments include a wire wrapped around a portion of the anchor segments in a coiled configuration.

12. The medical device of claim 1, further comprising engaging members associated with the anchor portion, each engaging member exhibiting a wave crest geometry.

13. The medical device of claim 1, wherein the occluder portion is configured to be moved to a deployed state while the anchor portion is in the retracted position.

37. The medical device of claim 1, wherein the occluder portion comprises occluder frame segments.

38. The medical device of claim 1, wherein the occluder portion comprises a tissue growth member.

39. The medical device of claim 38, wherein the tissue growth member comprises at least one of foam and ePTFE.

40. The medical device of claim 1, wherein the first end of the anchor segments is coupled to at least one of the hub and the occluder portion.

14. A medical device for modifying a left atrial appendage (LAA) of a heart, the medical device comprising:

an occluder portion coupled to a hub having an axis; and

an anchor portion including multiple anchor segments each extending between a first end and a second end, each first end of the multiple anchor segments operably coupled to the occluder portion, each second end of the multiple anchor segments coupled to an anchor hub, the anchor hub moveable along the axis so as to facilitate the anchor portion to at least partially invert to a retracted position with a portion of the anchor segments moved through the hub and with the anchor hub moved to a proximal position of the hub and the anchor portion to at least partially evert to a deployed position with the anchor hub moved distal of the proximal position.

15. The medical device of claim 14, wherein the anchor portion comprises a tissue engaging surface that, when in the deployed position, is an outer surface of the anchor portion and, when in the retracted position, is an inner surface of the anchor portion.

16. The medical device of claim 14, further comprising engaging members oriented and configured to extend proximally from the anchor portion and engage tissue of the LAA when the anchor portion is in the deployed position.

17. The medical device of claim 14, further comprising engaging members oriented and configured to extend proximally from the anchor portion when the anchor portion is in the deployed position and oriented and configured to extend distally from the anchor portion when the anchor portion is in the retracted position.

18. The medical device of claim 14, wherein the occluder portion comprises a tissue growth member having an inner surface and an outer surface, the tissue growth member configured to induce tissue growth therewith.

19. The medical device of claim 18, wherein the anchor portion is configured to bias against the inner surface of the tissue growth member such that the outer surface of the tissue growth member contacts tissue in the LAA.

20. The medical device of claim 18, further comprising engaging members oriented and configured to engage tissue of the LAA at a location that is distal the tissue growth member.

21. The medical device of claim 14, further comprising a guide configured to guide and align the multiple anchor segments of the anchor portion while they are displaced between the retracted position and the deployed position.

22. The medical device of claim 14, wherein the multiple anchor segments comprise a wire wrapped around a portion of the multiple anchor segments in a coiled configuration.

23. The medical device of claim 14, further comprising multiple engaging members associated with the anchor portion, each engaging member exhibiting a wave crest configuration.

24. The medical device of claim 14, wherein the occluder portion is configured to be moved to an occluder-deployed state while the anchor portion is in the retracted position.

41. The medical device of claim 14, wherein the occluder portion comprises occluder frame segments.

42. The medical device of claim 14, wherein the occluder portion comprises a tissue growth member.

43. The medical device of claim 42, wherein the tissue growth member comprises at least one of foam and ePTFE.

44. The medical device of claim 14, wherein the first end of the anchor segments is coupled to at least one of the hub and the occluder portion.

25. A medical device for modifying a left atrial appendage (“

LAA”

) of a heart, comprising;

an occluder portion coupled to a hub having an axis; and

an anchor portion including multiple anchor segments each extending between a first end and a second end, each first end of the multiple anchor segments operably coupled to the occluder portion and each second end of the multiple anchor segments coupled to an anchor hub, the anchor portion being moveable between a fully deployed state and a non-deployed state with movement of the anchor hub along the axis, the anchor portion including multiple engaging members extending therefrom such that the multiple engaging members are oriented to extend proximally from the anchor portion when the anchor portion is in the fully deployed state and the multiple engaging members are oriented to extend distally from the anchor portion when the anchor portion is in the non-deployed state;

wherein the multiple anchor segments comprise at least a portion that is moveable through the hub to move the anchor portion between the fully deployed state and the non-deployed state.

26. The medical device of claim 25, wherein the anchor hub is linearly displaceable along the axis and relative to the hub to move the anchor portion to the fully deployed state and the non-deployed state.

27. The medical device of claim 25, wherein the second end of each of the multiple anchor segments is positioned proximally relative to the hub when the anchor portion is in the non-deployed state and is positioned adjacent to the hub when the anchor portion is in the fully deployed state.

28. The medical device of claim 25, wherein the anchor hub is configured to be displaceable relative to the occluder portion to move the multiple engaging members away from tissue of the LAA.

29. The medical device of claim 25, wherein the anchor hub is moveable in a proximal direction to invert the anchor portion to the non-deployed state and the anchor hub is moveable in a distal direction to evert the anchor portion to the fully deployed state.

30. The medical device of claim 25, wherein the occluder portion is moveable between a constricted state and an expanded state, the anchor portion being independently moveable between the fully deployed state and the non-deployed state when the occluder portion is in the expanded state.

31. The medical device of claim 25, wherein the occluder portion comprises a tissue growth member having an inner surface and an outer surface, the tissue growth member configured to induce tissue growth therewith.

32. The medical device of claim 31, wherein the anchor portion is configured to bias against the inner surface of the tissue growth member such that the outer surface of the tissue growth member contacts tissue in the LAA.

33. The medical device of claim 31, wherein the multiple engaging members are configured to engage tissue in the LAA at a location that is distal of the tissue growth member.

34. The medical device of claim 25, further comprising a guide configured to guide and align the anchor segments of the anchor portion as the anchor portion is displaced between the fully deployed state and the non-deployed state.

35. The medical device of claim 25, wherein the multiple anchor segments include a wire wrapped around a portion of the anchor segments in a coiled configuration.

36. The medical device of claim 25, wherein the multiple engaging members exhibit a wave-crest geometry.

45. The medical device of claim 25, wherein the occluder portion comprises occluder frame segments.

46. The medical device of claim 25, wherein the occluder portion comprises a tissue growth member.

47. The medical device of claim 46, wherein the tissue growth member comprises at least one of foam and ePTFE.

48. The medical device of claim 25, wherein the first end of the anchor segments is coupled to at least one of the hub and the occluder portion.