Cardiac implant with integrated suture fasteners

• US 9,468,527 B2
• Filed: 06/12/2014
• Issued: 10/18/2016
• 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): Anderson, Gregory
• Assistant Examiner(s): Lauer, Christina
• Application Number:
  US14/302,733
• Publication Number:
  US 20140371842A1
• Time in Patent Office: 859 Days
• US Class Current: 1/1
• 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 cardiac implant system, comprising:

a cardiac implant having an inner frame arranged around a flow axis through the implant along which blood will flow when implanted from an inflow side to an outflow side of the implant, and a pliant sealing edge extending outward from the inner frame and having inflow and outflow faces, the sealing edge having formed therein a plurality of generally axial slits that open radially outward; and

a plurality of knotless suture fasteners distributed around and at least partially embedded into the sealing edge and secured therein, each fastener having an axial slot sized to receive a suture and facing radially outward, and each fastener being located adjacent one of the axial slits in the sealing edge such that a suture may be passed through the slit and into the axial slot of the fastener, each fastener having an open state which permits a suture to slide axially therethrough and a closed state which prevents axial movement of the suture in at least one direction.

2. The cardiac implant system of claim 1, 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 in the open state does not restrict relative movement between the fastener and a suture therein and the collapsible wall structure in the closed state restricts movement of a suture through the fastener in at least one direction, and wherein each fastener further includes a retention member coupled thereto in the open state, the retention member having a hypotube which fits closely within the lumen of the fastener and maintains the collapsible wall structure in its open state, and upon removal of the retention member and hypotube, the fastener converts to the closed state and the collapsible wall structure collapses inward to clamp onto a suture.

3. The prosthetic heart valve system of claim 2, wherein each suture fastener has a flange extending outward from the outer wall at a proximal end thereof sufficiently large to prevent the fastener from pulling through the pliant sealing ring.

4. The cardiac implant system of claim 1, 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 a variable sized 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 the suture(s) extend 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, wherein removal of the retention member permits the biasing member to urge the inner surfaces of the clamp halves together and clamp the suture therebetween.

5. The system of claim 4, wherein the clamp halves are molded from a single piece of material with a living hinge on the first circumferential side.

6. The system of claim 4, wherein the clamp halves are hinged together on a first circumferential side such that the variable sized slot defines a variable sized opening on the side opposite the first circumferential side, and wherein the biasing member comprises a plurality of C-clips arranged around the locking clamp with their free ends located on either side of the variable sized slot opposite the first circumferential side.

7. The system of claim 1, wherein each fastener includes a retention member that when coupled to the fastener maintains the fastener in the open state and when removed converts the fastener to the closed state, and wherein a plurality of the retention members are tethered together.

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

occluding members that provide one-way flow through the valve movably mounted to move within the inner frame, and

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

9. The cardiac implant system of claim 8, wherein there are only three of the suture fasteners located around the sealing ring.

10. The cardiac implant system of claim 9, wherein the inner frame partly extends in an outflow direction to form three cantilevered commissures evenly distributed around the flow axis that support flexible leaflets, and the prosthetic heart valve further includes a plastically-expandable anchoring skirt coupled to the sealing ring and extending from an inflow end thereof, the three suture fasteners being located around the sealing ring intermediate the commissures.

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

12. The cardiac implant system of claim 1, wherein the cardiac implant is a valved conduit comprising a valve having a conduit coupled thereto and having a sealing edge surrounding an inflow end.

13. A cardiac implant system, comprising:

a cardiac implant having an inner frame arranged around a flow axis through the implant along which blood will flow when implanted from an inflow side to an outflow side of the implant, and a pliant sealing edge extending outward from the inner frame and having inflow and outflow faces, the sealing edge having formed therein a plurality of generally axial slits that open radially outward; and

a plurality of knotless suture fasteners distributed around and positioned on one of the inflow or outflow faces of the sealing edge and attached thereto, each fastener having an axial slot sized to receive a suture and facing radially outward, and each fastener being located adjacent one of the axial slits in the sealing edge such that a suture may be passed through the slit and into the axial slot of the fastener, each fastener having an open state which permits a suture to slide axially therethrough and a closed state which prevents axial movement of the suture in at least one direction.

14. The cardiac implant system of claim 13, 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 in the open state does not restrict relative movement between the fastener and a suture therein and the collapsible wall structure in the closed state restricts movement of a suture through the fastener in at least one direction, and wherein each fastener further includes a retention member coupled thereto in the open state, the retention member having a hypotube which fits closely within the lumen of the fastener and maintains the collapsible wall structure in its open state, and upon removal of the retention member and hypotube, the fastener converts to the closed state and the collapsible wall structure collapses inward to clamp onto a suture.

15. The prosthetic heart valve system of claim 13, wherein each suture fastener has a flange extending outward from the outer wall at a proximal end thereof sufficiently large to prevent the fastener from pulling through the pliant sealing ring.

16. The cardiac implant system of claim 13, 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 a variable sized 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 the suture(s) extend 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, wherein removal of the retention member permits the biasing member to urge the inner surfaces of the clamp halves together and clamp the suture therebetween.

17. The system of claim 16, wherein the clamp halves are molded from a single piece of material with a living hinge on the first circumferential side.

18. The system of claim 16, wherein the clamp halves are hinged together on a first circumferential side such that the variable sized slot defines a variable sized opening on the side opposite the first circumferential side, and wherein the biasing member comprises a plurality of C-clips arranged around the locking clamp with their free ends located on either side of the variable sized slot opposite the first circumferential side.

19. The system of claim 13, wherein each fastener includes a retention member that when coupled to the fastener maintains the fastener in the open state and when removed converts the fastener to the closed state, and wherein a plurality of the retention members are tethered together.

20. The cardiac implant system of claim 13, wherein the cardiac implant is a prosthetic heart valve, comprising:

occluding members that provide one-way flow through the valve movably mounted to move within the inner frame, and

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

21. The cardiac implant system of claim 20, wherein there are only three of the suture fasteners located around the sealing ring.

22. The cardiac implant system of claim 21, wherein the inner frame partly extends in an outflow direction to form three cantilevered commissures evenly distributed around the flow axis that support flexible leaflets, and the prosthetic heart valve further includes a plastically-expandable anchoring skirt coupled to the sealing ring and extending from an inflow end thereof, the three suture fasteners being located around the sealing ring intermediate the commissures.

23. The cardiac implant system of claim 13, wherein the implant is an annuloplasty ring, wherein the inner frame comprises a structural core and the pliant sealing edge surrounds the core and has a fabric cover.

24. The cardiac implant system of claim 13, wherein the cardiac implant is a valved conduit comprising a valve having a conduit coupled thereto and having a sealing edge surrounding an inflow end.