Medical device and delivery system for modification of left atrial appendage and methods thereof

• US 9,351,716 B2
• Filed: 04/19/2012
• Issued: 05/31/2016
• 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:
  US13/450,755
• Publication Number:
  US 20120316584A1
• Time in Patent Office: 1,503 Days
• Field of Search: 606/200
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00243 cardiac
• 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 2017/0053 Loading magazines or sutures into applying tools
• 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 delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.

Claims

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

advancing a delivery catheter and medical device through a sheath to the left atrium of a heart and to a distal portion of the sheath, the medical device having an occluder portion and an anchor portion independently moveable between a non-deployed position and a deployed position;

positioning the distal portion of the sheath within the left atrial appendage of the heart with both the occluder portion and anchor portion in the non-deployed position;

withdrawing the sheath relative to the medical device to move the occluder portion of the medical device from the non-deployed position to the deployed position with the anchor portion maintaining the non-deployed position such that the anchor portion is proximal a most distal end of the occluder portion;

actuating a portion of a handle operatively coupled to the medical device with distal movement to move the anchor portion distally from the non-deployed position to the deployed position while the occluder portion maintains the deployed position such that the anchor portion is moved from a proximal position to a distal position so that a portion of the anchor portion is distal the occluder portion;

stabilizing the medical device in the left atrial appendage with the anchor portion engaging tissue in the left atrial appendage in the deployed position; and

releasing the medical device from the delivery catheter in the left atrial appendage.

2. The method according to claim 1, wherein the positioning comprises exposing a distal end of the occluder portion from a distal tip of the sheath to expose a cushion tip without exposing any metallic portions of a frame of the medical device.

3. The method according to claim 1, wherein the actuating comprises moving an actuation element of the handle between a first position and a second position that corresponds with the non-deployed position and the deployed position of the anchor portion, respectively.

4. The method according to claim 3, wherein the actuating comprises moving the actuation element from the second position to a third position for locking-out actuation of the anchor portion of the medical device and enabling a float mode of the medical device.

5. The method according to claim 4, wherein the actuating comprises moving the actuation element from the third position to a fourth position for withdrawing the delivery catheter relative to the medical device to put the medical device in a float mode.

6. The method according to claim 1, further comprising floating the medical device by withdrawing the delivery catheter relative to the medical device to expose tethers coupled to the medical device.

7. The method according to claim 1, wherein the releasing comprises rotating a release knob and linearly moving the release knob to detach a coupling element from the medical device.

8. The method according to claim 1, wherein the stabilizing comprises atraumatically engaging tissue with engaging members that substantially minimize movement of the medical device in both a distal direction and a proximal direction.

9. The method according to claim 1, wherein subsequent to the stabilizing, further comprising modifying a position of the occluder portion in the left atrial appendage by actuating the portion of the handle to move the anchor portion from the deployed position to the non-deployed position.

10. A method of occluding a left atrial appendage of a heart, the method comprising:

providing a medical device having an occluder portion and an anchor portion, a handle having an actuation assembly, and a coupling member extending through a delivery catheter between the medical device and the actuation assembly of the handle;

advancing the medical device to the left atrial appendage through a sheath;

deploying the occluder portion in the left atrial appendage by withdrawing the sheath while the anchor portion maintains a retracted position such that the anchor portion is entirely proximal a most distal end of the deployed occluder portion;

moving an actuation element coupled to the actuation assembly from a first hard stop to a second hard stop so as to move the actuation element in a distal direction to move the anchor portion distally from the retracted position to a deployed position so that a portion of the anchor portion is distal the occluder portion while the occluder portion maintains a deployed position;

stabilizing the medical device in the left atrial appendage with the anchor portion engaging tissue in the left atrial appendage in the deployed position; and

releasing the medical device from the delivery catheter in the left atrial appendage.

11. The method according to claim 10, wherein the releasing comprises rotating a release knob to enable detachment of the medical device, and then linearly moving the release knob to detach the medical device from the coupling member extending through the delivery catheter.

12. The method according to claim 11, wherein the linearly moving the release knob comprises moving a pin wire and a pull wire operatively coupled to the release knob at the handle and directly coupled to the medical device.

13. The method according to claim 10, wherein the advancing comprises exposing a distal end of the occluder portion from a distal tip of the sheath to expose a portion of the occluder portion to provide a cushion tip without substantially exposing any metallic portions of a frame of the medical device.

14. The method according to claim 13, wherein the advancing comprises atraumatically positioning the distal tip of the sheath in the left atrial appendage with the cushion tip of the occluder portion exposed at the distal tip of the sheath.

15. The method according to claim 10, wherein the deploying the occluder portion further comprises movably positioning the occluder portion while in the deployed position in the left atrial appendage and while the anchor portion is in the retracted position.

16. The method according to claim 10, wherein subsequent to the stabilizing, further comprising moving the occluder portion to a different position in the left atrial appendage by actuating the handle to move the anchor portion from the deployed position to the retracted position.

17. The method according to claim 10, wherein the advancing comprises advancing the sheath into the left atrial appendage with a distal end of the occluder portion exposed from a distal tip of the sheath to provide a cushion tip without exposing any metallic portions of a frame of the medical device.