Methods of implanting a cardiac implant with integrated suture fasteners

• US 10,314,706 B2
• Filed: 06/16/2017
• Issued: 06/11/2019
• Est. Priority Date: 06/12/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marquez, Salvador, Conklin, Brian S., Miraki, Manouchehr A., Kwon, Yoon H.
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Lauer, Christina C
• Application Number:
  US15/625,801
• Publication Number:
  US 20170281346A1
• Time in Patent Office: 725 Days
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• 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 2017/0237 for heart surgery
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings

Abstract

A cardiac implant system including a cardiac implant such as an annuloplasty ring, a prosthetic heart valve, or a valved conduit pre-assembled at the time of manufacture with devices for securing the implant to a heart valve annulus using knotless suture fasteners. The knotless suture fasteners may be embedded within a pliant sealing edge of the cardiac implant, or they may be positioned adjacent to the sealing edge. The knotless suture fasteners are spring-biased so as to grip onto annulus anchoring sutures pass to therethrough upon removal of a restraining device, such as a hypotube inserted within the suture fasteners. Guide tubes are assembled in line with the suture fasteners to permit introduction of suture snares that pass through the suture fasteners and through the sealing edge to facilitate capture of the pre-installed annulus anchoring sutures.

Claims

1. A method of securing a cardiac implant to a heart valve annulus, comprises:

providing a pre-assembled cardiac implant system including an implant defining a flow orifice through which blood will flow when implanted from an inflow side to an outflow side of the implant, the implant including a pliant sealing edge extending outward therefrom having a plurality of generally axial slits that open radially outward, the system further including a plurality of knotless suture fasteners attached to and distributed around the sealing edge, each fastener having an axial slot sized to receive a suture and facing radially outward so as to align with one of the axial slits;

pre-installing a plurality of anchoring sutures at the annulus, each anchoring suture being passed through the annulus with at least one free end extending away from the annulus;

passing each of the free ends of the anchoring sutures radially inward through one of the axial slits in the sealing edge and into the aligned suture fastener slot;

advancing the cardiac implant distally until the sealing edge seats against the annulus; and

deploying the suture fasteners to clamp onto the free ends of the anchoring sutures.

2. The method of claim 1, wherein the cardiac implant is a prosthetic heart valve, comprising:

occluding members that provide one-way flow through the valve, and

wherein the pliant sealing edge comprises a sealing ring secured to the outside of the valve.

3. The method of claim 1, wherein the implant is an annuloplasty ring, wherein an inner frame comprises a metallic core and the pliant sealing edge surrounds the core and has a fabric cover.

4. The method of claim 1, wherein the cardiac implant is a valved conduit comprising a valve having a conduit coupled thereto and the pliant sealing edge surrounds an inflow end thereof.

5. The method of claim 1, wherein each fastener has an open state which permits a suture to slide axially therethrough and a closed state which prevents distal axial movement of the suture through the suture fasteners, wherein the step of deploying occurs prior to the step of advancing.

6. The method of claim 1, wherein the plurality of suture fasteners are at least partially embedded into the sealing edge and secured therein.

7. The method of claim 6, wherein each suture fastener has a proximal end flange extending outward therefrom sufficiently large to prevent the fastener from pulling through the sealing ring in a distal direction.

8. The method of claim 1, wherein each suture fastener includes a retention member coupled thereto in an open state which permits a suture to slide axially therethrough and when removed converts the fastener to a closed state which prevents axial movement of the suture in at least one direction.

9. The method of claim 8, wherein each suture fastener has an outer wall defining a lumen extending from a proximal end to a distal end and a collapsible wall structure, wherein the collapsible wall structure is held outward by the retention member in the open state and the collapsible wall structure in a closed state restricts movement of a suture through the fastener in at least one direction, the method including removal of the retention members such that the collapsible wall structure collapses inward to convert the fastener to the closed state.

10. The method of claim 8, wherein a plurality of the retention members are tethered together, the method including sequentially removing the retention members from adjacent fasteners.

11. A method of securing a prosthetic heart valve to a heart valve annulus, comprises:

providing a pre-assembled prosthetic heart valve system including a prosthetic heart valve defining a flow orifice through which blood will flow when implanted from an inflow side to an outflow side thereof and occluding members that provide one-way flow through the valve, the valve including a pliant sealing ring extending outward therefrom having a plurality of generally axial slits that open radially outward, the system further including a plurality of knotless suture fasteners attached to and distributed around the sealing edge, each fastener having an axial slot sized to receive a suture and facing radially outward so as to align with one of the axial slits;

pre-installing a plurality of anchoring sutures at the annulus, each anchoring suture being passed through the annulus with at least one free end extending away from the annulus;

passing each of the free ends of the anchoring sutures radially inward through one of the axial slits in the sealing ring and into the aligned suture fastener slot;

advancing the valve distally until the sealing ring seats against the annulus; and

deploying the suture fasteners to clamp onto the free ends of the anchoring sutures.

12. The method of claim 11, wherein each fastener has an open state which permits a suture to slide axially therethrough and a closed state which prevents distal axial movement of the suture through the suture fasteners, wherein the step of deploying occurs prior to the step of advancing.

13. The method of claim 11, wherein the plurality of suture fasteners are at least partially embedded into the sealing ring and secured therein.

14. The method of claim 13, wherein each suture fastener has a proximal end flange extending outward therefrom sufficiently large to prevent the fastener from pulling through the sealing ring in a distal direction.

15. The method of claim 11, wherein each suture fastener includes a retention member coupled thereto in an open state which permits a suture to slide axially therethrough and when removed converts the fastener to a closed state which prevents axial movement of the suture in at least one direction.

16. The method of claim 15, wherein each suture fastener has an outer wall defining a lumen extending from a proximal end to a distal end and a collapsible wall structure, wherein the collapsible wall structure is held outward by the retention member in the open state and the collapsible wall structure in a closed state restricts movement of a suture through the fastener in at least one direction, the method including removal of the retention members such that the collapsible wall structure collapses inward to convert the fastener to the closed state.

17. The method of claim 15, wherein a plurality of the retention members are tethered together, the method including sequentially removing the retention members from adjacent fasteners.

18. The method of claim 11, wherein there are only three of the suture fasteners evenly spaced around the sealing ring, and the valve has an inner frame that partly extends in an outflow direction to form three cantilevered commissures evenly distributed around the flow axis that support flexible leaflets defining the occluding members, and the valve further includes a plastically-expandable anchoring skirt extending from an inflow end thereof, the three suture fasteners being located around the sealing ring intermediate the commissures, the method including first deploying the three suture fasteners and then outwardly expanding the plastically-expandable anchoring skirt.

19. The method of claim 11, further including severing each of the free ends of the anchoring sutures close to a proximal end of the respective suture fastener.

20. The method of claim 11, wherein each suture fastener comprises:

a bifurcated locking clamp including a pair of substantially similar clamp halves each having an exterior surface and an inner surface facing the inner surface of the other clamp half to form the slot therebetween, the clamp halves being connected for movement toward or away from one another while being fixed axially with respect to one another, wherein a suture extends through the slot between the inner surfaces of the clamp halves;

a biasing member positioned on the outside of the locking clamp having a relaxed size that, in the absence of an object in the slot, urges the inner surfaces of the clamp halves together; and

a retention member positioned between the clamp halves against the force of the biasing member and having a thickness that maintains the slot width large enough to permit passage of a suture therethrough, the method including removal of the retention member to permit the biasing member to urge the inner surfaces of the clamp halves together and clamp the suture therebetween.