Method and apparatus for repairing a mitral valve

• US 10,076,414 B2
• Filed: 07/22/2016
• Issued: 09/18/2018
• Est. Priority Date: 02/13/2012
• Status: Active Grant

• Current Assignee: MitraSpan, Inc.
• Original Assignee: MitraSpan, Inc.
• Inventors: Rourke, Jonathan M., Kyi, Stanley B., Fishman, Robert B., Chang, Showna H.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/216,880
• Publication Number:
  US 20160324636A1
• Time in Patent Office: 788 Days
• Field of Search: 623 21- 219, 623 236
• 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 17/0485 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 17/132 Tourniquets sphygmomanometer A61B5/022
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/06104 interconnected at their distal ends, e.g. two hollow needles forming a loop for passing a suture
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22044 : with a pointed tip
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61F 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints

Abstract

A method for beneficially displacing a papillary muscle, the method comprising: anchoring one end of an implant suture to a trigone or central fibrous body of the mitral valve; passing another end of the implant suture through a papillary muscle so that the implant suture extends between a trigone or central fibrous body of the mitral valve and the papillary muscle; tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve; and securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve; wherein the foregoing steps of anchoring, passing, tensioning and securing are all effected while the heart is beating.

Claims

1. A method for beneficially displacing a papillary muscle, the method comprising:

anchoring one end of an implant suture to a trigone or central fibrous body of the mitral valve;

passing another end of the implant suture through a papillary muscle so that the implant suture extends between a trigone or central fibrous body of the mitral valve and the papillary muscle;

tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve; and

securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve;

wherein the foregoing steps of anchoring, passing, tensioning and securing are all effected while the heart is beating;

wherein a fixed anchor is used to anchor one end of the implant suture to a trigone or central fibrous body of the mitral valve;

wherein the fixed anchor is secured against the atrial side of the mitral annulus; and

wherein the fixed anchor is secured against the atrial side of the mitral annulus by;

passing a free end of a suture from the left ventricle, through the mitral annulus and into the left atrium;

retrieving the free end of the suture in the left atrium and drawing the free end of the suture through the mitral leaflets, into the left ventricle and out of the heart;

securing one end of an implant suture to the free end of the suture suture retrieved from the left atrium, wherein the implant suture has the fixed anchor secured to its other end; and

using the suture to tow the implant suture into the left ventricle, through the mitral leaflets, through the left atrium, through the mitral annulus and through the left ventricle until the fixed anchor is seated against the atrial side of the mitral annulus.

2. A method according to claim 1 wherein a pledget is disposed between the fixed anchor and the atrial side of the mitral annulus.

10. A method according to claim 1 wherein one end of an implant suture is anchored to one of the anterior lateral trigone, the central fibrous body and the posterior medial trigone.

11. A method according to claim 1 wherein the implant suture is passed through one of the anterior lateral papillary muscle and the posterior medial papillary muscle.

13. A method according to claim 1 comprising the additional step of reconfiguring the mitral annulus after a papillary muscle has been beneficially displaced.

3. A method for beneficially displacing a papillary muscle, the method comprising:

anchoring one end of an implant suture to a trigone or central fibrous body of the mitral valve;

passing another end of the implant suture through a papillary muscle so that the implant suture extends between a trigone or central fibrous body of the mitral valve and the papillary muscle;

tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve; and

securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve;

wherein the foregoing steps of anchoring, passing, tensioning and securing are all effected while the heart is beating;

wherein a fixed anchor is used to anchor one end of the implant suture to a trigone or central fibrous body of the mitral valve;

wherein the fixed anchor is secured to a trigone or central fibrous body of the mitral valve; and

wherein the fixed anchor comprises a screw anchor.

4. A method according to claim 3 wherein the screw anchor comprises a corkscrew anchor.

5. A method according to claim 4 wherein the corkscrew anchor is configured to provide radio frequency (RF) energy to the tissue so as to facilitate deployment of the corkscrew anchor into the fibrous trigones or the central fibrous body of the mitral valve.

6. A method for beneficially displacing a papillary muscle, the method comprising:

anchoring one end of an implant suture to a trigone or central fibrous body of the mitral valve;

passing another end of the implant suture through a papillary muscle so that the implant suture extends between a trigone or central fibrous body of the mitral valve and the papillary muscle;

tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve; and

securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve;

wherein the foregoing steps of anchoring, passing, tensioning and securing are all effected while the heart is beating; and

wherein the step of tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve is accomplished while observing the beating heart with echocardiogram.

7. A method for beneficially displacing a papillary muscle, the method comprising:

anchoring one end of an implant suture to a trigone or central fibrous body of the mitral valve;

passing another end of the implant suture through a papillary muscle so that the implant suture extends between a trigone or central fibrous body of the mitral valve and the papillary muscle;

tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve; and

securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve;

wherein the foregoing steps of anchoring, passing, tensioning and securing are all effected while the heart is beating;

wherein the step of tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve is accomplished by;

advancing a sliding anchor over the implant suture;

advancing a cannulated tool against the sliding anchor so that the sliding anchor engages the papillary muscle and displaces the papillary muscle toward the trigone or central fibrous body of the mitral valve; and

tensioning the implant suture while the cannulated tool is engaged with the sliding anchor.

8. A method according to claim 7 wherein the step of securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve is accomplished by:

securing a suture lock to the implant suture so as to prevent the sliding anchor from moving away from the papillary muscle.

9. A method according to claim 7 wherein a pledget is disposed between the sliding anchor and the papillary muscle.

12. A method for beneficially displacing a papillary muscle, the method comprising:

anchoring one end of an implant suture to a trigone or central fibrous body of the mitral valve;

passing another end of the implant suture through a papillary muscle so that the implant suture extends between a trigone or central fibrous body of the mitral valve and the papillary muscle;

tensioning the implant suture while displacing the papillary muscle toward the trigone or central fibrous body of the mitral valve; and

securing the tensioned implant suture to the displaced papillary muscle so as to maintain the displaced papillary muscle in position relative to the trigone or central fibrous body of the mitral valve;

wherein the foregoing steps of anchoring, passing, tensioning and securing are all effected while the heart is beating;

wherein the implant suture is applied to the anterior lateral papillary muscle, and further wherein the process is repeated with a second implant suture which is applied to the posterior medial papillary muscle.