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

• US 9,693,781 B2
• Filed: 11/01/2012
• 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: Miles, Scott D., Linder, Richard J., Davis, Clark C., Edmiston, Daryl R., Martin, John Alexander
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US13/666,612
• Publication Number:
  US 20130178889A1
• Time in Patent Office: 1,706 Days
• Field of Search: 606200
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/0069 with universal joint, cardan joint
• CPC Class Codes: A61B 2017/1205 Introduction devices
• 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

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 medical device includes an occluder portion and an anchor portion, the anchor portion hingably coupled to the occluder portion. With this arrangement, the anchor portion actuates and pivots relative to the occluder portion between an anchor deployed position and an anchor non-deployed position while the occluder portion is in an occluder deployed position.

Claims

1. A medical device system for modifying a left atrial appendage of a heart, the medical device system comprising:

a sheath having a length and defining a sheath lumen extending through the length of the sheath; and

a delivery system including a delivery catheter extending between a proximal end and a distal end, a handle coupled to the proximal end of the delivery catheter, and a medical device operatively coupled to the handle and disposed adjacent the distal end of the delivery catheter, the medical device comprising;

a hub including a bore defining an axis;

an occluder portion coupled to the hub, the occluder portion configured to be moved to an occluder non-deployed position with the occluder portion within a distal portion of the sheath, and the occluder portion configured to be moved to an occluder deployed position upon the sheath being moved proximally relative to the occluder portion; and

an anchor portion extending between a first end and a second end, the anchor portion having tines configured to engage tissue within the left atrial appendage, the first end being operatively coupled to the handle, the second end being pivotably coupled to a distal end portion of the occluder portion, wherein, upon the occluder portion maintaining the occluder deployed position, the anchor portion is pivotable relative to the occluder portion between an anchor non-deployed position and an anchor deployed position;

wherein the hub includes a hub distal end that remains proximal a distal end of the occluder portion; and

wherein the anchor portion is pivotably coupled to the distal end portion of the occluder portion with an eyelet to facilitate the anchor portion to pivot between the anchor deployed position and the anchor non-deployed position.

2. The medical device system of claim 1, wherein the second end of the anchor portion is coupled to the occluder portion with a hinge arrangement such that the anchor portion pivots relative to the occluder portion upon the anchor portion being moved between the anchor non-deployed position and the anchor deployed position.

3. The medical device system of claim 1, wherein the first end of the anchor portion is moveable along the axis of the hub to move the anchor portion between the anchor non-deployed position and the anchor deployed position.

4. The medical device system of claim 1, wherein the handle comprises a plunger shaft that is moveable between a first position and a second position that corresponds with the anchor non-deployed position and the anchor deployed position, respectively.

5. The medical device system of claim 1, wherein the anchor portion comprises multiple anchor actuator arms each extending to a v-extension, the v-extension including the tines to engage tissue of the left atrial appendage.

6. The medical device system of claim 1, wherein the anchor portion comprises an anchor zig-zag portion hingably coupled to the occluder portion.

7. The medical device system of claim 1, wherein the occluder portion comprises an occluder zig-zag portion and the anchor portion comprises an anchor zig-zag portion.

8. The medical device system of claim 1, wherein the occluder portion comprises a tissue growth member extending over a proximal face of the occluder portion and extending over a portion of the anchor portion.

9. The medical device system of claim 1, wherein the distal end of the delivery catheter is threadably connected to the medical device.

10. The medical device system of claim 1, wherein the delivery catheter comprises:

an actuator shaft configured to be actuated by actuation of the handle; and

multiple fingers extending distally from the distal end of the delivery catheter, the multiple fingers extending over the actuator shaft so that the multiple fingers maintain a latched position to the hub.

11. The medical device system of claim 10, wherein the medical device is configured to detach from the delivery catheter upon proximal movement of the actuator shaft to a position proximal of the multiple fingers such that the multiple fingers collapse to an inward unlatched position.

12. The medical device system of claim 1, wherein the sheath comprises an imaging device at a distal end of the sheath.

13. The medical device system of claim 1, wherein, upon the occluder portion being in the occluder deployed position and the anchor portion being in the anchor non-deployed position, the anchor portion is entirely proximal a distal most end of the occluder portion.

14. The medical device system of claim 1, wherein, upon the occluder portion being in the occluder deployed position and the anchor portion being in the anchor deployed position, a first portion of the anchor portion is distal a distal most end of the occluder portion and a second portion of the anchor portion is proximal the distal most end of the occluder portion.

15. A medical device for modifying a left atrial appendage of a heart, the medical device comprising:

a hub defining an axis;

an occluder portion coupled to the hub, the occluder portion independently moveable relative to the anchor portion between an occluder non-deployed position and an occluder deployed position; and

an anchor portion hingably coupled to a distal end portion of the occluder portion, the anchor portion having tines configured to engage tissue within the left atrial appendage, the anchor portion pivotable relative to the occluder portion between an anchor non-deployed position and an anchor deployed position upon the occluder portion being in the occluder deployed position;

wherein the hub includes a hub distal end that remains proximal a distal end of the occluder portion; and

wherein the anchor portion is hingably coupled to the distal end portion of the occluder portion with an eyelet to facilitate the anchor portion to pivot between the anchor deployed position and the anchor non-deployed position.

16. The medical device of claim 15, wherein the anchor portion comprises anchor actuator arms with a portion actuatable substantially along the axis of the hub to move the anchor portion between the anchor non-deployed position and the anchor deployed position.

17. The medical device of claim 15, wherein the anchor portion comprises multiple anchor actuator arms each extending to a v-extension, the v-extension including the tines to engage tissue of the left atrial appendage.

18. The medical device of claim 15, wherein the anchor portion comprises an anchor zig-zag portion hingably coupled to the occluder portion.

19. The medical device of claim 15, wherein the occluder portion comprises an occluder zig-zag portion and the anchor portion comprises an anchor zig-zag portion, the occluder zig-zag portion hingably coupled to the anchor zig-zag portion.

20. The medial device of claim 15, wherein the occluder portion comprises a tissue growth member extending over a proximal face of the occluder portion and extending over a portion of the anchor portion.

21. The medical device of claim 15, further comprising a sheath configured to move the occluder portion between the occluder non-deployed configuration and the occluder deployed configuration, the sheath including an imaging device at a distal end of the sheath.

22. The medical device of claim 15, wherein, upon the occluder portion being in the occluder deployed position and the anchor portion being in the anchor non-deployed position, the anchor portion is entirely proximal a distal most end of the occluder portion.

23. The medical device of claim 15, wherein, upon the occluder portion being in the occluder deployed position and the anchor portion being in the anchor deployed position, a first portion of the anchor portion is distal a distal most end of the occluder portion and a second portion of the anchor portion is proximal the distal most end of the occluder portion.