Method for transvascular implantation of neo chordae tendinae

• US 10,675,150 B2
• Filed: 10/31/2017
• Issued: 06/09/2020
• 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:
  US15/799,635
• Publication Number:
  US 20180185151A1
• Time in Patent Office: 952 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 increasing mitral valve leaflet coaptive area during systole, comprising the steps of:

advancing a catheter into a left ventricle;

securing with the catheter at least a first ventricular tension element to a wall of the ventricle;

securing with the catheter at least a first leaflet tension element to a mitral valve leaflet;

proximally retracting the leaflet tension element to move the limit of travel of the leaflet during systole in a direction of the atrium, thereby increasing mitral valve leaflet coaptive area during systole; and

securing the leaflet tension element to the ventricular tension element.

2. The method of increasing mitral valve leaflet coaptive area as in claim 1, wherein the ventricular tension element comprises a neo papillary muscle having a distal end facing a ventricular anchor, and a proximal end approximately at the height of the top of a native papillary muscle, wherein the securing step comprises securing the leaflet tension element to the ventricular tension element at the proximal end of the neo papillary muscle.

3. The method of increasing mitral valve leaflet coaptive area as in claim 2, wherein the neo papillary muscle comprises an elongate, atraumatic body.

4. The method of increasing mitral valve leaflet coaptive area as in claim 3, wherein the neo papillary muscle comprises ePTFE.

5. The method of increasing mitral valve leaflet coaptive area as in claim 1, wherein the securing with the catheter a leaflet tension element comprises advancing a needle guide having a distal end through the mitral valve and into the left ventricle, and deflecting the needle guide through an angle of at least 160 degrees to place the distal end into contact with the leaflet during diastole.

6. The method of increasing mitral valve leaflet coaptive area as in claim 5, further comprising advancing a leaflet anchor deployment needle out of the distal end of the needle guide and through the leaflet, and deploying an anchor from the needle.

7. The method of increasing mitral valve leaflet coaptive area as in claim 6, wherein the deploying an anchor step comprises deploying an anchor from a first, reduced cross section within the deployment needle, to a second, enlarged cross section for seating against the atrial side of the leaflet.

8. The method of increasing mitral valve leaflet coaptive area as in claim 6, wherein the deploying an anchor step comprises deploying a pledget.

9. The method of increasing mitral valve leaflet coaptive area as in claim 1, wherein the proximally retracting the leaflet tension element step comprises positioning an aperture in the left ventricle, with at least the leaflet tension element extending through the aperture, and proximally retracting the leaflet tension element with the aperture functioning as a fulcrum so that the tension element draws the leaflet in the direction of the ventricle.

10. The method of increasing mitral valve leaflet coaptive area as in claim 9, wherein the fulcrum is a distal opening of the catheter and the proximally retracting step comprises proximally retracting the leaflet tension element through the catheter.

11. The method of increasing mitral valve leaflet coaptive area as in claim 1, further comprising securing a second leaflet tension element to the leaflet and to the ventricular tension element.