Method of transvascular prosthetic chordae tendinae implantation

• US 10,548,733 B2
• Filed: 07/11/2019
• Issued: 02/04/2020
• Est. Priority Date: 12/30/2016
• Status: Active Grant

• Current Assignee: Pipeline Medical Technologies, Inc.
• Original Assignee: Pipeline Medical Technologies, Inc.
• Inventors: Purcell, Cameron Paul, Bishop, Gordon B., Griswold, Erik, McDaniel, Stephen, Pham, Trung Ho
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US16/509,220
• Publication Number:
  US 20190328526A1
• Time in Patent Office: 208 Days
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium. From an atrium side, the catheter can be anchored to a superior surface of a mitral valve leaflet and a leaflet anchor can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to a leaflet suture. A ventricular anchor is anchored to the wall of the ventricle to secure the ventricular wall to a ventricle suture. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

Claims

1. A method of transvascular prosthetic chordae tendinae implantation, comprising the steps of:

advancing a catheter into a left atrium, through a mitral valve, and into a left ventricle;

deploying a ventricular anchor from the catheter and into a wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter;

from an atrium side, securing a leaflet anchor catheter to a mitral valve leaflet;

with the leaflet anchor catheter secured to the leaflet, advancing a leaflet anchor from the leaflet anchor catheter through the mitral valve leaflet to secure the mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the leaflet anchor catheter; and

securing the leaflet suture to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium.

2. The method of claim 1, wherein the step of advancing a leaflet anchor from the catheter through the mitral valve leaflet to secure the mitral valve leaflet to a leaflet suture comprises advancing a needle preloaded with the leaflet anchor through a superior surface of the mitral valve leaflet.

3. The method of claim 2, wherein the securing a leaflet anchor catheter to a mitral valve leaflet comprises using a leaflet connector.

4. The method according to claim 3, wherein the leaflet connector comprises a helical anchor.

5. The method according to claim 3, wherein the leaflet connector comprises a hook.

6. The method of claim 3, wherein the securing a leaflet anchor catheter comprises anchoring the leaflet anchor catheter to the leaflet using a helical tissue anchor.

7. The method of claim 6, comprising advancing a leaflet anchor through the helical tissue anchor.

8. The method of claim 7, comprising advancing a needle through the helical tissue anchor and deploying the leaflet anchor through the needle.

9. The method of claim 1, wherein the step of deploying a ventricular anchor includes a step of engaging a core wire with the wall of the ventricle before deploying the ventricular anchor.

10. The method of claim 9, wherein the step of deploying a ventricular anchor comprises rotating a helical anchor into the wall of the ventricle following engaging the core wire.

11. The method of claim 1, wherein the step of deploying a ventricular anchor comprises rotating a helical anchor to engage the wall of the ventricle.

12. The method of claim 11, comprising advancing a depth marker proximally relative to the helical anchor, in response to distal advance of the helical anchor into tissue.

13. The method of claim 1, wherein the securing the leaflet suture step comprises applying a suture lock to the leaflet suture and the ventricular suture.

14. The method of claim 13, comprising aligning the suture lock with respect to the ventricular anchor.

15. The method of claim 14, wherein the aligning step comprises contacting the suture lock with a suture lock guide carried by the ventricular anchor.

16. The method of claim 15, wherein the suture lock guide comprises an alignment pin extending proximally from the ventricular anchor.

17. The method of claim 15, wherein the suture lock guide comprises a tubular sleeve extending proximally from the ventricular anchor.

18. The method of claim 13, comprising rotating a suture lock driver to clamp the suture lock against the leaflet suture and the ventricular suture.

19. The method of claim 1, comprising advancing the leaflet anchor in an unfolded configuration, and thereafter folding the leaflet anchor against the ventricular side of the leaflet.

20. The method of claim 19, wherein the folding step is accomplished by proximally retracting the leaflet suture.