Sequential Heart Valve Leaflet Repair Device

• US 20110093063A1
• Filed: 10/19/2010
• Published: 04/21/2011
• Est. Priority Date: 03/26/2002
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Application Number:
  US12/907,811
• Publication Number:
  US 20110093063A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442

Abstract

A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers.

Claims

1. A method for in vivo repair of a heart valve having multiple leaflets in a beating heart, comprising:

providing a repair device having a grasping mechanism for independently and releasably grasping first and second heart tissue portions, respectively, and having a deployment mechanism for independently applying first and second fastener elements to the first and second heart tissue portions, respectively;

grasping the first heart tissue portion with the grasping mechanism of the repair device;

deploying the first fastener element into the grasped first heart tissue portion;

disengaging the first heart tissue portion from the repair device while leaving the first fastener element deployed therein;

grasping the second heart tissue portion within the beating heart with the grasping mechanism of the repair device, wherein grasping the second heart tissue portion occurs after deploying the first tissue fastener element and disengaging the first heart tissue portion from the repair device;

deploying the second fastener element into the grasped second heart tissue portion;

disengaging the second heart tissue portion from the repair device while leaving the second fastener element deployed therein; and

reducing the distance between the first and second tissue portions by adjusting the relative positions of the first and second fastener elements.

2. The method of claim 1, wherein the first heart tissue portion is a first heart valve leaflet.

3. The method of claim 1, wherein the second heart tissue portion is a second heart valve leaflet.

4. The method of claim 1, wherein the first and second fastener elements are portions of a common piece of suture material, the first fastener element is secured to a first needle, and the step of deploying the first fastener element into the grasped first heart tissue portion comprises advancing the first needle through the grasped first heart tissue portion.

5. The method of claim 1, further comprising adjusting the position of the repair device relative to the tissue portions while monitoring fluid pressure around a distal end of the repair device.

6. The method of claim 1, further comprising adjusting the position of the repair device relative to the tissue portions while observing pressure differentials between blood in an adjacent ventricle and an adjacent atrium.

7. The method of claim 1 wherein the first and second fastener elements are portions of a piece of suture material, and wherein the step of reducing the distance between the first and second heart tissue portions is performed by drawing together portions of the suture material and trimming any extraneous suture material.

8. The method of claim 1, further comprising:

removing the repair device from the patient'"'"'s heart, said removing of the repair device from the patient'"'"'s heart occurring after the step of deploying the first fastener element into the grasped first heart tissue portion but before the step of reducing the distance between the first and second tissue portions by adjusting the relative positions of the first and second fastener elements.

9. A method for repairing a heart valve having multiple leaflets, comprising:

providing a repair device having a grasping mechanism for independently and releasably stabilizing first and second heart tissue portions, respectively, and having a deployment mechanism for independently applying first and second fastener elements to first and second heart tissue portions, respectively;

advancing a distal portion of the repair device to a position adjacent the first heart tissue portion, wherein the first heart tissue portion is a first heart valve leaflet;

stabilizing the first heart tissue portion with the repair device using the grasping mechanism of the repair device;

deploying the first fastener element into the stabilized first heart tissue portion;

disengaging the first heart tissue portion from the repair device while leaving the first fastener element deployed therein;

stabilizing the second heart tissue portion with the repair device using the grasping mechanism of the repair device, wherein stabilizing the second heart tissue portion occurs after deploying the first tissue fastener element and disengaging the first heart tissue portion;

deploying the second fastener element into the stabilized second heart tissue portion; and

disengaging the second heart tissue portion from the repair device while leaving the second fastener element deployed therein.

10. The method of claim 9, wherein the grasping mechanism comprises a first vacuum port, and the step of stabilizing the first heart tissue portion comprises applying a vacuum force to the first vacuum port.

11. The method of claim 10, wherein the grasping mechanism comprises a second vacuum port, and the step of stabilizing the second heart tissue portion comprises applying a vacuum force to the second vacuum port.

12. The method of claim 9, wherein the first and second fastener elements are portions of a piece of suture material.

13. The method of claim 12, comprising the further step of:

reducing the distance between the first and second heart tissue portions by drawing together portions of the suture material.

14. The method of claim 13, comprising:

removing the repair device from the patient'"'"'s heart, said removing of the repair device from the patient'"'"'s heart occurring after the step of deploying the first fastener element into the stabilized first heart tissue portion but before the step of reducing the distance between the first and second tissue portions by drawing together portions of the suture material.

15. A method for repairing a heart valve in a human heart, comprising:

advancing a repair device into the human heart, the repair device having a handle portion along a proximal end and an elongated body extending distally from the handle portion, the elongated body having a tissue engaging tip comprising a grasping mechanism configured to releasably and independently grasp first and second heart tissue portions, respectively, and a deployment mechanism for independently applying first and second suture portions to first and second heart tissue portions, respectively;

positioning the tissue engaging tip adjacent to the first heart tissue portion, wherein the first heart tissue portion comprises a first heart valve leaflet in the heart valve;

capturing and holding only the first heart tissue portion using the grasping mechanism;

deploying the first suture portion from the tissue engaging tip and through a portion of the first heart tissue portion while holding the first heart tissue portion via the grasping mechanism;

releasing the first heart tissue portion from the grasping mechanism of the tissue engaging tip;

positioning the tissue engaging tip adjacent to the second heart tissue portion;

capturing and holding only the second heart tissue portion using the grasping mechanism;

deploying the second suture portion from the tissue engaging tip and through a portion of the second heart tissue portion while holding the second heart tissue portion via the grasping mechanism;

releasing the second heart tissue portion from the grasping mechanism of the tissue engaging tip; and

pulling the first and second tissue portions into closer proximity by drawing together portions of the suture material;

wherein each of the above steps for repairing the heart valve is performed substantially in the order recited.

16. The method of claim 15, wherein the first and second suture portions are portions of a common piece of suture material.

17. The method of claim 16, wherein the first and second suture portions are opposing ends of the common piece of suture material.

18. The method of claim 15, wherein the tissue engaging tip of the repair device is removed from the heart valve before pulling the first and second tissue portions into closer proximity.

19. The method of claim 15, wherein the step of pulling the first and second heart tissue portions into closer proximity comprises tying the suture material into a knot.

20. The method of claim 15, wherein all steps are performed in vivo without the heart being arrested.