Method and apparatus for transvascular implantation of neo chordae tendinae

• US 10,667,910 B2
• Filed: 11/09/2017
• Issued: 06/02/2020
• Est. Priority Date: 12/30/2016
• Status: Active Grant

• Current Assignee: Pipeline Medical Technologies, Inc.
• Original Assignee: Pipeline Medical Technologies, Inc.
• Inventors: Bishop, Gordon B., Lashinski, Randall T.
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US15/808,158
• Publication Number:
  US 20180185152A1
• Time in Patent Office: 936 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• 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 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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

Abstract

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium, through the mitral valve, and into the left ventricle. A ventricular anchor is deployed 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. A leaflet anchor is deployed to secure a mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the catheter. The leaflet suture is secured to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium. Also disclosed is an assembled in situ mitral valve leaflet restraint, having a neo papillary muscle and a neo chordae tendinea.

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;

advancing a leaflet anchor into a mitral valve leaflet from the ventricle to secure the mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the 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,

wherein the ventricular suture is attached to the ventricular anchor through a ventricular tension element.

2. The method as in claim 1, wherein the advancing a leaflet anchor step comprises securing the leaflet anchor to the leaflet within the range of from about 3 mm to about 10 mm from a leaflet coaptive edge.

3. The method as in claim 1, wherein the deploying a ventricular anchor step comprises attaching the ventricular anchor to a ventricular septum.

4. The method as in claim 1, wherein the deploying a ventricular anchor step comprises advancing an anchor driver through the mitral valve, rotating the driver to secure the ventricular anchor, and proximally retracting the anchor driver to expose the ventricular suture carried by the ventricular anchor.

5. The method as in claim 1, wherein the securing step comprises applying a suture lock to the ventricular suture and the leaflet suture.

6. The method as in claim 1, further comprising applying tension to the leaflet suture prior to the securing step, to improve leaflet function.

7. The method as in claim 6, comprising applying sufficient tension to the leaflet suture to pull the limit of leaflet travel during systole to approximately to the level of an annulus.

8. The method as in claim 1, wherein the securing step comprises engaging a knot to secure the leaflet suture and the ventricular suture.

9. The method as in claim 8, additionally comprising a step of cutting the leaflet suture and the ventricular suture proximally of the knot, leaving the leaflet suture and the ventricular suture to function as a native chordae.

10. The method as in claim 1, additionally comprising identifying a mitral valve that is incompetent due to leaflet tethering and cutting at least a portion of a native chordae of the mitral valve.

11. The method as in claim 1, further comprising an initial step of identifying a patient including at least three characteristics selected from the group consisting of:

the patient has been diagnosed with primary or degenerative mitral regurgitation;

the patient has been diagnosed with secondary or functional Mitral Regurgitation;

the patient has been diagnosed with Mixomotous Mitral Regurgitation;

the patient has been diagnosed with a flail leaflet, ruptured chordae, or leaflet prolapse;

the patient has Mitral regurgitation grade 1 or more;

the patient has annular diameter from A2 leaflet to P2 leaflet at least 5 mm less than sum of length of P2+A2 leaflet;

the patient has annular diameter from A2 to P2 leaflet of at least 10 mm; and

the patient has an access vessel diameter of at least 2 mm.

12. The method as in claim 11, wherein the patient additionally has at least one characteristic selected from the group consisting of:

the patient has been evaluated by a heart team including at least one cardiac surgeon and determined not to be an appropriate candidate for conventional open surgical repair;

the patient has STS predicted operative mortality (STS Score) of 2 or greater;

the patient was offered and refused open surgical repair;

the patient is age between 18 and 90;

the patient will not accept blood transfusion;

the patient has had prior open chest surgery; and

the patient has an ejection fraction of at least 10 percent.

13. 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;

advancing a leaflet anchor into a mitral valve leaflet from the ventricle to secure the mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the 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,

wherein the ventricular suture is attached to the ventricular anchor through a ventricular tension element,

wherein the ventricular tension element comprises ePTFE.

14. The method as in claim 13, wherein the advancing a leaflet anchor step comprises securing the leaflet anchor to the leaflet within the range of from about 3 mm to about 10 mm from a leaflet coaptive edge.

15. The method as in claim 13, wherein the deploying a ventricular anchor step comprises attaching the ventricular anchor to a ventricular septum.

16. The method as in claim 13, wherein the securing step comprises applying a suture lock to the ventricular suture and the leaflet suture.

17. The method as in claim 13, further comprising applying tension to the leaflet suture prior to the securing step, to improve leaflet function.

18. The method as in claim 13, comprising applying sufficient tension to the leaflet suture to pull the limit of leaflet travel during systole to approximately to the level of an annulus.

19. The method as in claim 13, wherein the securing step comprises engaging a knot to secure the leaflet suture and the ventricular suture.

20. The method as in claim 17, additionally comprising a step of cutting the leaflet suture and the ventricular suture proximally of the knot, leaving the leaflet suture and the ventricular suture to function as a native chordae.