Method and apparatus for transapical procedures on a mitral valve

• US 9,681,864 B1
• Filed: 12/29/2014
• Issued: 06/20/2017
• Est. Priority Date: 01/03/2014
• Status: Active Grant

• Current Assignee: Harpoon Medical, Inc. (Edwards Lifesciences Corporation), University of Maryland Baltimore County (University of Maryland)
• Original Assignee: Harpoon Medical, Inc. (Edwards Lifesciences Corporation), University of Maryland Baltimore County (University of Maryland)
• Inventors: Wilson, Peter, Boyd, Peter, Niland, William, Gammie, James
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/584,561
• Time in Patent Office: 904 Days
• Field of Search: 623 211, 623 236, 623 237, 623 24, 606139, 606144, 606145, 606228, 606232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself

Abstract

Apparatus and methods for performing a non-invasive procedure to repair a cardiac valve are described herein. In some embodiments, apparatus and methods are described herein for repairing a mitral valve using an edge-to-edge repair to secure the mitral valve leaflets. Implant securing devices are also described that can be used during a procedure to repair a mitral valve. In some embodiments, an implant securing device includes an outer member and an inner member movably disposed within the outer member. The inner member can be used to hold or secure a suture extending from an implant deployed on an atrial side of a leaflet of a mitral valve, and the outer member can be used to push or move a half hitch knot toward a ventricular side of the leaflet, which can be used to secure the implant in the desired position.

Claims

1. A method, comprising:

disposing on an atrial side of a first leaflet of a mitral valve a first implant, the first implant including a first loop portion, a first suture portion extending from the first loop portion proximally through the first leaflet to the ventricular side of the first leaflet and a second suture portion extending from the first loop portion proximally through the first leaflet to the ventricular side of the first leaflet;

disposing on an atrial side of a second leaflet of the mitral valve a second implant, the second implant including a second loop portion, a third suture portion extending from the second loop portion proximally through the second leaflet to the ventricular side of the second leaflet and a fourth suture portion extending from the second loop portion proximally through the second leaflet to the ventricular side of the second leaflet;

placing the first suture portion within a lumen of an inner member of a securing device;

placing the third suture portion within the lumen of the inner member of the securing device;

inserting one of the second suture portion and the fourth suture portion through a distal opening defined by an outer member of the securing device and through a side opening defined by the outer member;

forming a knot with the second suture portion and the fourth suture portion outside the securing device; and

moving the knot distally toward the ventricular side of the mitral valve using the outer member of the securing device.

2. The method of claim 1, wherein the knot is a first knot, the method further comprising:

after moving the first knot, forming a second knot with the second suture portion and the fourth suture portion outside the securing device; and

moving the second knot distally toward the ventricular side of the mitral valve and toward the first knot using the outer member of the securing device.

3. The method of claim 2, further comprising:

after moving the second knot, removing the first suture portion and the third suture portion from the lumen of the inner member of the securing device;

inserting one of the first suture portion and the third suture portion through the distal opening of the outer member of the securing device and through the side opening of the outer member;

forming a third knot with the first suture portion and the third suture portion outside the securing device; and

moving the third knot distally toward the ventricular side of the mitral valve using the outer member of the securing device.

4. The method of claim 3, further comprising:

after moving the third knot, forming a fourth knot with the first suture portion and the third suture portion outside the securing device; and

moving the fourth knot distally toward the ventricular side of the mitral valve and toward the third knot using the outer member of the securing device.

5. The method of claim 4, further comprising:

after moving the fourth knot, securing at least one of collectively the first suture portion and the third suture portion or collectively the second suture portion and the fourth suture portion to a portion of a ventricular wall to provide a downward force on at least one of the first knot, the second knot, the third knot or the fourth knot.

6. The method of claim 2, further comprising:

after moving the second knot, removing the first suture portion and the third suture portion from the lumen of the inner member of the securing device;

inserting one of the first suture portion and the third suture portion through a distal opening defined by a pusher device and through a side opening defined by the pusher device;

forming a third knot with the first suture portion and the third suture portion outside the pusher device; and

moving the third knot distally toward the ventricular side of the mitral valve using the pusher device.

7. The method of claim 1, wherein the knot is a first knot, the method further comprising:

after moving the first knot, removing the first suture portion and the third suture portion from the lumen of the inner member of the securing device;

inserting one of the first suture portion and the third suture portion through the distal opening of the outer member of the securing device and through the side opening of the outer member;

forming a second knot with the first suture portion and the third suture portion outside the securing device; and

moving the second knot distally toward the ventricular side of the mitral valve using the outer member of the securing device.

8. The method of claim 1, further comprising:

prior to inserting one of the second suture portion and the fourth suture portion through the distal opening of the outer member of the securing device and through the side opening of the outer member, moving the outer member proximally relative to the inner member.

9. The method of claim 1, wherein moving the knot toward the ventricular side of the mitral valve using the outer member of the securing device includes moving the outer member distally relative to the inner member.

10. The method of claim 1, wherein the knot is a first knot, the method further comprising:

after moving the first knot, removing the first suture portion and the third suture portion from the lumen of the inner member of the securing device;

inserting one of the first suture portion and the third suture portion through a distal opening defined by a pusher device and through a side opening defined by the pusher device;

forming a second knot with the first suture portion and the third suture portion outside the pusher device; and

moving the second knot distally toward the ventricular side of the mitral valve using the pusher device.

11. The method of claim 1, wherein the forming the knot with the second suture portion and the fourth suture portion includes forming a half hitch knot.

12. A method, comprising:

disposing on an atrial side of a first leaflet of a mitral valve a first implant, the first implant including a first loop portion, a first suture portion extending from the first loop portion proximally through the first leaflet to the ventricular side of the first leaflet and a second suture portion extending from the first loop portion proximally through the first leaflet to the ventricular side of the first leaflet;

disposing on an atrial side of a second leaflet of the mitral valve a second implant, the second implant including a second loop portion, a third suture portion extending from the second loop portion proximally through the second leaflet to the ventricular side of the second leaflet and a fourth suture portion extending from the second loop portion proximally through the second leaflet to the ventricular side of the second leaflet;

forming a first knot with the first suture portion and the third suture portion;

moving the first knot distally toward the ventricular side of the mitral valve using a pusher device;

forming a second knot with the second suture portion and the fourth suture portion; and

moving the second knot distally toward the ventricular side of the mitral valve using the pusher device, the first knot and the second knot configured to secure the first implant and the second implant together to decrease the septal-lateral distance of the mitral valve annulus.

13. The method of claim 12, further comprising:

prior to forming the second knot, forming a third knot with the first suture portion and the third suture portion; and

moving the third knot distally toward the ventricular side of the mitral valve using the pusher device.

14. The method of claim 13, further comprising:

after forming the second knot, forming a fourth knot with the second suture portion and the fourth suture portion; and

moving the fourth knot distally toward the ventricular side of the mitral valve using the pusher device.

15. The method of claim 14, further comprising:

after moving the fourth knot, securing at least one of collectively the first suture portion and the third suture portion or collectively the second suture portion and the fourth suture portion to a portion of a ventricular wall to provide a downward force on at least one of the first knot, the second knot, the third knot or the fourth knot.

16. The method of claim 14, wherein the forming the first knot and the forming the second knot each include forming a half hitch knot.