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

• US 9,693,780 B2
• Filed: 06/17/2010
• Issued: 07/04/2017
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Davis, Clark C., Edmiston, Daryl R., Miles, Scott D., Linder, Richard J.
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/818,059
• Publication Number:
  US 20100324588A1
• Time in Patent Office: 2,574 Days
• Field of Search: 606200, 606213
• 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 method of modifying a left atrial appendage (“

LAA”

) of a heart, the method comprising;

advancing a medical device with a catheter of a delivery system through a vasculature and into the LAA of the heart, the medical device including an occluder portion coupled to a hub and an anchor portion operably coupled to the occluder portion;

deploying only the occluder portion from the delivery system within the LAA such that the anchor portion is in a proximal position relative to a distal end of the deployed occluder portion;

moving the deployed occluder portion within the LAA;

confirming a preferred position of the deployed occluder portion within the LAA;

moving the anchor portion between a retracted position and a deployed position subsequent to confirming the preferred position of the deployed occluder portion such that, upon the anchor portion being moved to the deployed position, at least a portion of the anchor portion is moved distal of the distal end of the deployed occluder portion;

engaging tissue within the LAA with the anchor portion to anchor the occluder portion in the preferred position within the LAA such that the anchor portion engages tissue at a distal position relative to the distal end of the deployed occluder portion; and

releasing the catheter from the medical device and withdrawing the delivery system from the heart to permanently leave the anchor portion and the occluder portion of the medical device in the LAA.

2. The method as recited in claim 1, wherein moving the anchor portion comprises moving a portion of anchor segments of the anchor portion through a bore of the hub to the deployed position so that the anchor segments engage tissue in the LAA.

3. The method as recited in claim 1, wherein moving the anchor portion comprises everting a portion of the anchor portion from the retracted position to the deployed position.

4. The method as recited in claim 1, wherein moving the anchor portion comprises rolling-out the anchor portion from the retracted position to the deployed position.

5. The method as recited in claim 1, wherein moving the anchor portion comprises inverting a portion of the anchor portion from the deployed position to the retracted position.

6. The method as recited in claim 1, wherein moving the anchor portion comprises rolling-in the anchor portion from the deployed position to the retracted position.

7. The method as recited in claim 1, wherein moving the anchor portion comprises moving engaging members that extend from anchor segments of the anchor portion between a tissue-nonengaging position and a tissue-engaging position subsequent to deploying the occluder portion.

8. The method as recited in claim 7, wherein moving the anchor portion comprises pulling an extension of the anchor segments proximally, the extension extending radially inward and proximally from adjacent the engaging members, to move the engaging members from the tissue-engaging position to the tissue-nonengaging position.

9. The method as recited in claim 7, wherein moving the anchor portion comprises pushing an extension of the anchor segments distally, the extension extending radially inward and proximally from adjacent the engaging members, to move the engaging members from the tissue-nonengaging position to the tissue-engaging position.

10. The method as recited in claim 7, wherein moving the anchor portion comprises orienting the engaging members proximally when in the tissue engaging position and orienting the engaging members distally when in the non-tissue engaging position.

11. The method as recited in claim 7, wherein moving the anchor portion comprises orienting the engaging members in a first orientation when in the tissue-engaging position and orienting the engaging members in a second orientation when in the tissue-nonengaging position.

12. The method as recited in claim 7, wherein moving the anchor portion comprises guiding the anchor segments and engaging members with a guide to maintain alignment of the anchor segments while moving the anchor portion between the retracted position and the deployed position.

13. The method as recited in claim 7, wherein engaging tissue within the LAA comprises engaging the tissue with the engaging members and biasing an inner surface of a tissue growth member of the occluder portion with the anchor segments such that the outer surface of the tissue growth member is directly contacting the tissue within the LAA.

14. The method as recited in claim 1, further comprising retracting the anchor portion to the retracted position subsequent to engaging tissue with the anchor portion.

15. The method as recited in claim 14, further comprising re-confirming a preferred position of the deployed occluder after moving the deployed occluder portion within the LAA.

16. The method as recited in claim 1, wherein confirming a preferred position comprises selecting the preferred position for the deployed occluder portion over multiple positions within the LAA.

17. The method as recited in claim 16, wherein moving the anchor portion comprises selectively anchoring the deployed occluder portion based on selecting the preferred position over multiple positions within the LAA.

18. The method as recited in claim 1, wherein moving the anchor portion comprises selectively anchoring the deployed occluder portion by selecting the preferred position for the deployed occluder portion over multiple positions within the LAA.

19. A method of modifying a left atrial appendage (“

LAA”

) of a heart, the method comprising;

advancing a medical device with a catheter of a delivery system through a vasculature and into the LAA of the heart, the medical device including an occluder portion coupled to a hub and an anchor portion operably coupled to the occluder portion;

deploying only the occluder portion from the delivery system within the LAA such that the anchor portion is in a proximal position relative to a distal end of the deployed occluder portion;

moving the anchor portion from a retracted position to a deployed position subsequent to deploying the occluder portion such that, upon the anchor portion being moved to the deployed position, at least a portion of the anchor portion is moved distal of the distal end of the deployed occluder portion;

engaging tissue within the LAA with the anchor portion to anchor the occluder portion to the LAA such that the anchor portion engages tissue at a distal position relative to the distal end of the deployed occluder portion; and

releasing the delivery system from the medical device and withdrawing the delivery system from the heart to permanently leave the anchor portion and the occluder portion of the medical device in the LAA.

20. The method as recited in claim 19, wherein advancing the medical device comprises advancing the medical device through a sheath with the catheter coupled to the medical device such that the catheter is configured to distally push and proximally pull the medical device relative to the sheath.

21. The method as recited in claim 20, wherein deploying the occluder portion comprises moving the sheath proximally relative to the medical device.

22. The method as recited in claim 19, wherein moving the anchor portion comprises moving a portion of the anchor portion through the hub.

23. The method as recited in claim 19, wherein moving the anchor portion comprises moving the anchor portion such that engaging members extending from a portion of the anchor portion are positionable from a tissue-nonengaging position to a tissue-engaging position.

24. The method as recited in claim 23, wherein moving the anchor portion comprises moving extensions of the anchor portion such that the extensions each extend radially inward and proximally from adjacent the engaging members to an anchor hub.

25. The method as recited in claim 19, wherein moving the anchor portion comprises moving extensions of the anchor portion, the extensions each extending distally from adjacent engaging members of the anchor portion to extending radially inward and extending proximally toward the hub.

26. The method as recited in claim 19, wherein moving the anchor portion comprises reorienting engaging members such that the engaging members extend distally when the anchor portion is in the retracted position and the engaging members extend proximally when the anchor portion is in the deployed position.

27. The method as recited in claim 19, wherein engaging tissue within the LAA comprises engaging the tissue with the engaging members and radially pushing a surface of the occluder portion with the anchor portion such that the occluder portion directly contacts the tissue within the LAA.

28. The method as recited in claim 19, further comprising retracting the anchor portion to the retracted position subsequent to the engaging step while maintaining the occluder portion in a deployed occluder position.

29. A method of modifying a left atrial appendage (“

LAA”

) of a heart, the method comprising;

advancing a medical device with a catheter of a delivery system through a vasculature and into the LAA of the heart, the medical device including an occluder portion coupled to a hub and an anchor portion operably coupled to the occluder portion;

deploying only the occluder portion from the delivery system within the LAA such that the anchor portion is in a retracted position and positioned proximal of a distal end of the deployed occluder portion;

moving the anchor portion from the retracted position to a deployed position subsequent to deploying the occluder portion such that, upon the anchor portion being moved to the deployed position, at least a portion of the anchor portion is moved distal of the distal end of the deployed occluder portion;

engaging tissue within the LAA with the anchor portion to anchor the occluder portion to the LAA; and

releasing the delivery system from the medical device and withdrawing the delivery system from the heart to permanently leave the anchor portion and the occluder portion of the medical device in the LAA.

30. The method as recited in claim 29, further comprising retracting the anchor portion to the retracted position subsequent to the engaging step while maintaining the occluder portion in a deployed occluder position.

31. The method as recited in claim 29, wherein moving the anchor portion comprises actuating the anchor portion between the retracted position and the deployed position while maintaining the occluder portion in a deployed occluder position.