Rotatable cuff assembly for a heart valve prosthesis

• US 5,876,436 A
• Filed: 02/13/1997
• Issued: 03/02/1999
• Est. Priority Date: 10/21/1994
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Graf, James E., Anderson, Kimberly A., Girard, Michael J., Vanney, Guy P., Allan, Bob, Moore, Scott D., Kramlinger, William R., Runquist, Jonas A.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/799,289
• Time in Patent Office: 747 Days
• Field of Search: 623/2, 623/66, 623/900, 623/901, 137/515.7
• US Class Current: 623/2.39
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

The invention provides a sewing cuff assembly for mounting to the body of a heart valve prosthesis. The sewing cuff assembly comprises a resiliently deformed spring for exerting a force directed toward the orifice structure. When a torque is applied to the valve, the force results in a rotation-resisting torque sufficient to resist rotation during normal operation of the valve after implantation but low enough to permit assisted rotation, as during surgery.

Claims

1. A heart valve prosthesis comprising a generally annular orifice structure having an outer circumference and two circumferential shoulders extending in a radially outward direction from the outer circumference, the heart valve substantially blocking fluid flow through the orifice structure in one direction and permitting fluid flow through the orifice structure in the direction opposite to the first direction, and further including a sewing cuff assembly mounted to the orifice structure, the sewing cuff assembly comprising a resiliently deformed spring extending around the outer circumference of the orifice structure positioned between the two circumferential shoulders and having a shape which is resiliently deformable in a radial direction, the spring for actively and independently exerting a controlled force directed substantially radially inward on a surface of the outer circumference of the orifice structure due to a substantially radially outward deformation in the shape of the spring, the surface causing the deformation of the spring to thereby provide the controlled force which is selected to result in a rotation-resisting torque sufficient to resist rotation during normal operation of the valve after implantation but low enough to permit assisted rotation and wherein the radially inward force causes the resiliently deformed spring to be captured between the two circumferential shoulders which thereby substantially secure the spring from movement in an axial direction.

2. The heart valve prosthesis of claim 1 wherein the resiliently deformed spring exerts a controlled inwardly directed radial force on the circumferential surface of the orifice structure.

3. The heart valve prothesis of claim 1 wherein the resiliently deformed spring exerts a controlled axially directed force.

4. The heart valve prosthesis of claim 1 wherein the sewing cuff is mounted on the orifice by the force exerted by the resiliently deformed spring.

5. The heart valve prosthesis of claim 2 wherein the spring exerts the radial force through at least one layer of the fabric which is rotatable relative to the orifice structure.

6. The heart valve prosthesis of claim 2 wherein the spring is a helical spring oriented substantially coaxially with the circumferential surface of the orifice, the spring comprising at least one revolution, the free inside diameter of the helical spring being smaller than that assumed by the spring when in place over the circumferential surface, resulting in the application of a controlled inwardly directed radial force to the circumferential surface.

7. The heart valve prosthesis of claim 6 wherein the cross section of the helical spring is substantially rectangular.

8. The heart valve prosthesis of claim 7 wherein the cross section of the helical spring is substantially square.

9. The heart valve prosthesis of claim 6 wherein the cross section of the helical spring is substantially round.

10. The heart valve prosthesis of claim 2 wherein the spring is a substantially annular undulating spring oriented substantially coaxially with the circumferential surface, the spring having transitional sections defining an inside diameter and transitional sections defining an outside diameter, the free inside diameter of the undulating spring being smaller than that assumed by the spring when in place over the circumferential surface, resulting in the application of a controlled inwardly directed radial force to the circumferential surface.

11. The heart valve prosthesis of claim 10 wherein the transitional sections are relatively pointed.

12. The heart valve prosthesis of claim 2 wherein the sewing cuff assembly further comprises a ring element to circumferentially constrain the radial expansion of the spring about the entire circumference of the spring.

13. The heart valve prosthesis of claim 12 wherein the ring element has at least one flange extending radially inwardly to engage a lateral edge of the spring element to limit the lateral movement of the ring element relative to spring.

14. The heart valve prosthesis of claim 13 wherein the ring element has two radially extending flanges spaced axially to engage the opposed lateral edges of the spring element to maintain the spring element between the flanges.

15. The heart valve prosthesis of claim 12 wherein the sewing cuff assembly comprises two ring elements, each having a radially extending flange, the rings being oriented and the flanges being spaced to engage the opposed lateral edges of the spring element to maintain the spring element between the flanges.

16. The heart valve prosthesis of claim 2 wherein the orifice structure further comprises opposed retaining shoulders on each side of the circumferential surface, the inside diameter of the spring being sized relative to the outside diameter of the shoulders such that, once the spring is assembled between the shoulders, the spring must undergo forced radial expansion to be moved out of alignment in the axial direction with the circumferential surface.

17. The heart valve prosthesis of claim 11 wherein the transitional sections disposed defining the inner diameter of the spring comprise apertures, and the circumferential surface comprises an annular peak, the apertures of the spring being disposed along the peak once the spring is assembled such that the spring ring must undergo forced radial expansion to be moved out of alignment in the axial direction with the circumferential surface.

18. The heart valve prosthesis of claim 2 further comprising a ring element co-axial with and having an inside diameter larger than the circumferential surface to form an annulus therebetween wherein the spring is resiliently deformed within the annulus, the deformation resulting in the application of a controlled inwardly directed radial force to the circumferential surface.

19. The heart valve prosthesis of claim 18 wherein the spring is an undulating spring member resiliently constrained in the annulus created between the ring element and the circumferential surface.

20. The heart valve prosthesis of claim 18 wherein the spring is a helical spring having a diameter substantially smaller than the diameter of the annular surface but greater than the radial dimension of the annulus between the circumferential surface and the ring element and having a length about equal to the circumference of the circumferential surface, the coils of the spring being resiliently deflected into the annular space.

21. The heart valve prosthesis of claim 2 further comprising a ring element disposed between the spring and the surface of the orifice structure.