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

• US 10,582,929 B2
• Filed: 05/31/2017
• Issued: 03/10/2020
• 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): Louis, Richard G
• Application Number:
  US15/610,492
• Publication Number:
  US 20170290595A1
• Time in Patent Office: 1,014 Days
• 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 device includes a framework extending between a primary hub and a secondary hub. The secondary hub is moveable relative to the primary hub upon deploying the framework from a constricted position to a deployed position such that the secondary hub remains proximal a distal end of the framework. The framework, in the deployed position, includes engaging members proximal the distal end of the framework, and the framework includes multiple frame segments each extending with an arcuate configuration at a distal side of the framework such that the frame segments, at the distal side thereof, each extend radially and distally toward the distal end, then turn and extend radially and proximally inward toward the secondary hub.

Claims

1. A method of modifying a left atrial appendage of a heart, the method comprising:

advancing a medical device with a catheter of a delivery system through a vasculature and into the left atrial appendage of the heart, the medical device including a framework extending between a primary hub and a secondary hub, the primary hub and the secondary hub having a common axis;

deploying the framework adjacent the left atrial appendage from a constricted position to a deployed position so that the secondary hub is moveable along the axis relative to the primary hub such that the secondary hub remains proximal a distal end of the framework;

securing the framework to tissue in the left atrial appendage with engaging members positioned on the framework proximal the distal end of the framework, the framework at a distal side thereof extending radially and distally toward the distal end, and turns to extend radially and proximally inward toward the secondary hub; and

releasing the catheter from the medical device and withdrawing the delivery system from the heart to permanently leave the medical device in the left atrial appendage.

2. The method according to claim 1, wherein the deploying the framework comprises deploying the framework with a tissue growth member positioned over a proximal side of the framework.

3. The method according to claim 1, wherein the deploying the framework comprises deploying an occluder portion of the medical device and separately deploying an anchor portion of the medical device.

4. The method according to claim 1, wherein the deploying the framework comprises deploying the framework from the constricted position such that the framework is at least partially constricted within the catheter.

5. The method according to claim 1, wherein the deploying the framework comprising moving a portion of the framework through a bore of the primary hub.

6. The method according to claim 1, further comprising retracting the framework such that the engaging members move away from the tissue of the left atrial appendage and such that the framework moves to a retracted position.

7. The method according to claim 1, wherein the deploying the framework comprises deploying an occluder portion of the medical device;

and deploying an anchor portion of the medical device, subsequent to the occluder portion being deployed.

8. The method according to claim 1, wherein the deploying the framework comprises deploying an occluder portion having a tissue growth member positioned over a proximal side of the medical device.

9. The method according to claim 1, wherein the deploying the framework comprises deploying the framework with a porous polymeric material positioned over a proximal side of the framework.

10. The method according to claim 1, wherein the deploying the framework comprises deploying the framework with a porous material positioned over a proximal side of the framework.

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

LAA”

) of a heart, the method comprising;

advancing a medical device with a catheter through a vasculature and to the left atrial appendage, the medical device having a framework extending between a primary hub and a secondary hub, the primary hub and the secondary hub having a common axis;

deploying the framework adjacent the left atrial appendage from a constricted position to a deployed position so that the secondary hub is moveable along the axis relative to the primary hub such that the secondary hub remains proximal a distal end of the framework; and

securing the framework to tissue of the left atrial appendage with engaging members positioned on the framework proximal the distal end of the framework, the framework at a distal side thereof extending radially and distally toward the distal end, and turns to extend radially and proximally inward toward the secondary hub; and

releasing the medical device from the catheter with the framework of the medical device remaining secured to the tissue of the left atrial appendage of the heart.

12. The method according to claim 11, wherein the deploying the framework comprises distally moving the secondary hub along the axis to secure the engaging members of the framework into the tissue of the left atrial appendage.

13. The method according to claim 11, wherein the securing the framework comprises retracting the engaging members from the tissue by moving the secondary hub proximally and re-securing the framework to the tissue of the left atrial appendage by moving the secondary hub distally.

14. The method according to claim 11, wherein the deploying the framework comprises deploying the framework with a tissue growth member positioned over a proximal side of the framework.

15. The method according to claim 11, wherein the deploying the framework comprises deploying an occluder portion of the medical device and separately deploying an anchor portion of the medical device.

16. The method according to claim 11, wherein the deploying the framework comprises deploying the framework from the constricted position such that the framework is at least partially constricted within the catheter.

17. The method according to claim 11, wherein the deploying the framework comprising moving a portion of the framework through a bore of the primary hub.

18. The method according to claim 11, wherein the deploying the framework comprises deploying the framework with a porous polymeric material positioned over a proximal side of the framework.

19. The method according to claim 11, wherein the deploying the framework comprises deploying the framework with a porous material positioned over a proximal side of the framework.

20. The method according to claim 11, further comprising withdrawing the catheter from the left atrial appendage and the vasculature.