MEDICAL DEVICE FOR MODIFICATION OF LEFT ATRIAL APPENDAGE AND RELATED SYSTEMS AND METHODS

• US 20130178889A1
• Filed: 11/01/2012
• Published: 07/11/2013
• 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., Martin, John Alexander
• Granted Patent: US 9,693,781 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 (“

LAA”

) 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 coupled to 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 first end configured to be operatively coupled to the handle, the second end configured to be coupled to the occluder portion, wherein, upon the occluder portion being in the occluder deployed position, the anchor portion is configured to move relative to the occluder portion between an anchor non-deployed position and an anchor 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 second end of the anchor portion is pivotably coupled to the occluder portion.

4. 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.

5. 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.

6. The medical device system of claim 1, wherein the anchor portion comprises multiple anchor actuator anus each extending to a v-extension, the v-extension including hooks to engage tissue of the LAA.

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

8. 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.

9. 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.

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

11. 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.

12. The medical device system of claim 11, 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.

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

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

LAA”

) 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 the occluder portion, 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.

15. The medical device of claim 14, 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.

16. The medical device of claim 14, wherein the anchor portion comprises multiple anchor actuator arms each extending to a v-extension, the v-extension including hooks to engage tissue of the LAA.

17. The medical device of claim 14, wherein the anchor portion comprises an anchor zig-zag portion hingably coupled to the occluder portion.

18. The medical device of claim 14, 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.

19. The medial device of claim 14, 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.

20. The medical device of claim 14, 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.

21. A method for modifying a left atrial appendage (“

LAA”

) of a heart, the method comprising;

advancing a medical device coupled to a distal end of a delivery catheter through a sheath positioned in the vasculature and into the LAA of the heart, the medical device including an occluder portion and an anchor portion, the anchor portion coupled to the occluder portion;

deploying the occluder portion of the medical device from the sheath in the LAA with the anchor portion maintaining a non-deployed position; and

actuating the anchor portion of the medical deice between the non-deployed position and a deployed position while the occluder portion of the medical device is deployed.

22. The method according to claim 21, wherein the actuating the anchor portion comprises pivoting the anchor portion at a hinged coupling between the anchor portion and the occluder portion.

23. The method according to claim 21, wherein the actuating the anchor portion comprises actuating actuator arms of the anchor portion substantially along an axis of the medical device.

24. The method according to claim 21, wherein the deploying the occluder portion comprises manually withdrawing the sheath from over the occluder portion of the medical device.

25. The method according to claim 21, further comprising disengaging the medical device from fingers extending from the distal end of the delivery catheter by proximally moving an actuator shaft from the medical device to collapse the fingers from a huh of the medical device.

26. The method according to claim 21, further comprising imaging the medical device relative to the LAA from a distal end of the sheath.