PROSTHETIC MITRAL VALVE WITH VENTRICULAR TETHERS AND METHODS FOR IMPLANTING SAME

• US 20130079873A1
• Filed: 09/25/2012
• Published: 03/28/2013
• Est. Priority Date: 09/26/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Migliazza, John F., LaFrance, Hugues, Chen, Harvey H., Oba, Travis Zenyo
• Granted Patent: US 8,900,295 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 17/0487 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• 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 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A prosthetic valve assembly and method of implanting same is disclosed. The prosthetic valve assembly includes a prosthetic valve formed by support frame and valve leaflets, with one or more tethers each having a first end secured to the support frame and the second end attached to, or configured for attachment to, to papillary muscles or other ventricular tissue. The tether is configured and positioned so as to avoid contact or other interference with movement of the valve leaflets, while at the same time providing a tethering action between the support frame and the ventricular tissue. The valve leaflets may be flexible (e.g., so-called tissue or synthetic leaflets) or mechanical.

Claims

1. A device for treating a heart, comprising:

a prosthetic valve comprising a support frame and a valve portion, the valve portion comprising a plurality of leaflets secured to the support frame and configured to coapt to permit blood flow in a first direction through the valve portion and to prevent blood flow in a second direction through the valve portion, wherein the first direction is opposite to the second direction, wherein the support frame comprises at least one attachment structure configured to be secured to tissue of an annulus of a native heart valve;

at least one elongate member extending from the support frame, wherein a distal end of the elongate member is configured to be secured to heart geometry within a ventricular chamber of the heart, wherein the elongate member comprises a usable length from the support frame to the distal end; and

an adjustment mechanism for altering the usable length of the elongate member.

2. The device of claim 1, wherein the at least one attachment structure comprises a sewing ring configured to be sutured to tissue of an annulus of a native heart valve.

3. The device of claim 2, further including a plurality of locking clips embedded within the sewing ring of the heart valve through each of which passes one of the elongate members.

4. The device of claim 3, wherein the locking clips include tubular bodies with collapsible wall structures.

5. The device of claim 1, wherein the support frame comprises a hollow channel passing circumferentially through the support frame, and the at least one elongate member passes circumferentially through at least a portion of the hollow channel.

6. The device of claim 1, wherein the adjustment mechanism comprises a locking mechanism configured to prevent sliding movement of the tether with respect to the support frame in at least one direction.

7. The device of claim 1, wherein the at least one elongate member passes slidingly through the support frame, and the adjustment mechanism comprises a lock configured to selectively prevent sliding movement of the elongate member through the support frame.

8. The device of claim 1, comprising at least two elongate members extending from the support frame.

9. A method of implanting a prosthetic heart valve assembly, comprising:

providing a prosthetic heart valve assembly comprising a prosthetic valve, at least two anchors, and at least two tethers, wherein the prosthetic valve comprises a support frame and leaflets with the leaflets secured to the support frame to form a one-way valve structure, and wherein each tether has a proximal end secured to the support frame and a distal end secured to at least one of said anchors, wherein each tether has a tether usable length extending from the support frame to the anchor, and wherein each tether is slidingly secured to the support frame at the proximal end;

securing the anchors to ventricular tissue within a ventricle below a native heart valve annulus;

advancing the prosthetic valve to the native heart valve annulus;

securing the support frame to tissue of the native heart valve annulus;

adjusting the tether usable length of each tether to a desired length to form the ventricle to a desired shape; and

locking each tether to the support frame to prevent sliding movement thereof and to thereby fix the tether usable length at the desired length.

10. The method of claim 9, further comprising:

temporarily ceasing heart function of the heart and placing the patient on cardiopulmonary bypass; and

resuming heart function of the heart and removing the patient from cardiopulmonary bypass;

wherein securing the support frame to tissue of the native heart valve annulus is performed after temporarily ceasing heart function of the heart and before resuming heart function of the heart.

11. The method of claim 10, wherein adjusting the tether usable length of each tether to a desired length is performed after temporarily ceasing heart function of the heart but before resuming heart function of the heart.

12. The method of claim 10, wherein adjusting the tether usable length of each tether to a desired length is performed after resuming heart function of the heart.

13. The method of claim 9, wherein the ventricular tissue comprises papillary muscle tissue.

14. The method of claim 9, wherein securing the anchors to ventricular tissue occurs prior to securing the support frame to the native heart valve annulus.

15. The method of claim 9, further including:

monitoring at least one of a function of the heart or a shape of the ventricle.

16. The method of claim 15, wherein adjusting the usable length of each tether is performed simultaneously with monitoring at least one of a function of the heart or a shape of the ventricle.

17. The method of claim 9, wherein the tether is selected from the group consisting of:

a shape memory alloy, a flexible metal or polymer.

18. The method of claim 9, wherein each tether has a proximal end secured to a locking clip embedded within a sewing ring of the heart valve.

19. The method of claim 18, further including a plurality of locking clips embedded within the sewing ring of the heart valve through each of which passes one of the tethers, the method including passing each of the tethers through one of the locking clips after it has been secured to ventricular tissue.

20. The method of claim 19, wherein the locking clips include tubular bodies with collapsible wall structures, and the method includes providing a hollow hypotube within each of the locking clips to maintain the collapsible wall structures flexed outward, and removing the hypo tube after passing each tether through the respective locking clip.