Rotatable suturing ring for prosthetic heart valve

• US 5,766,240 A
• Filed: 10/28/1996
• Issued: 06/16/1998
• Est. Priority Date: 10/28/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Johnson, Keith M.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): NGUYEN, TRAM A
• Application Number:
  US08/739,093
• Time in Patent Office: 596 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.39
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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

An implantable prosthetic heart valve with a suturing ring having an interiorly disposed split ring of constant diameter for securing the suturing ring fabric to the heart valve body and providing a constant rotational torque for facilitating rotation of the heart valve body with respect to the suturing ring. The split ring is formed of a stiff band having opposed split ring ends that are drawn together and held in place by fixation cords. The split ring may include flanges extending in the inflow and/or outflow directions to inhibit passage of suture needles through inflow and/or outflow rim bands of the suturing ring fabric to encourage proper surgical installation. The flanges may be extended in the inflow and/or outflow directions sufficiently to increase blood flow velocity past the inflow and/or outflow rim bands and discourage pannus growth over the interface of the respective rim bands and valve body flanges and into the valve body annulus and to provide added safety by forming a barrier against impingement of the occluder by suture tails and heart tissue.

Claims

1. An implantable heart valve having at least one valve mechanism movable between an open position and a closed position, a valve body for supporting the valve mechanism having a circular exterior wall extending between inflow and outflow valve body rims and an interior valve opening annulus, and an exterior rotatable suturing ring formed of suturing ring fabric for suturing the heart valve to a natural heart tissue orifice, apparatus for securing the suturing ring for rotation about the valve body exterior wall upon application of a rotational torque comprising:

rotational guide means formed on the annular exterior wall of the heart valve body providing a rotational guide about which the suturing ring is rotatable; and

means formed within the suturing ring for compressing an annular section of the suturing ring fabric into engagement against the rotational guide with a consistent force, the compressing means further comprising;

a split ring formed of ring-shaped band having opposed split ring ends, an interior wall having a major diameter and a tracking surface shaped to be engaged by and spaced apart from the rotational guide and to provide a continuous gap when the split ring ends are maintained in contact for receiving the annular section of the sewing ring fabric therebetween, the ring shaped band being formed of a resilient material and adapted to be expanded in diameter to separate the split ring ends and to allow the split ring band tracking surface to be aligned with the rotational guide; and

contact maintaining means for maintaining the split ring ends in contact such that a continuous gap is maintained between the rotational guide and the tracking surface, whereby the suturing ring fabric is entrapped in the continuous gap and frictionally engages the opposed tracking surface and rotational guide providing a consistent frictional force that may be overcome by a consistent rotational torque applied between the valve body and the suturing ring for rotation thereof.

2. The heart valve of claim 1 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending at least to the inflow and outflow valve body rims.

3. The heart valve of claim 1 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending at least to the inflow valve body rim.

4. The heart valve of claim 1 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending at least to the outflow valve body rim.

5. The heart valve of claim 1 wherein:

the rotational guide means comprises an annular valve body flange extending outward of the exterior wall of the valve body; and

the tracking surface is an annular groove formed in the interior wall of the ring-shaped band adapted to fit over the annular valve body flange providing a gap therebetween for entrapping an annular section of the suturing ring fabric in the gap.

6. The heart valve of claim 1 wherein:

the rotational guide means comprises an annular exterior wall having a flat-bottomed groove formed therein between outflow and inflow groove flanges having flange diameters exceeding the flat-bottomed groove diameter for defining a gap from the interior wall of the ring-shaped band disposed circumferentially within the groove for receiving an annular section of suturing ring fabric.

7. The heart valve of claim 1 wherein the suturing ring fabric further comprises a biocompatible fabric of a mesh weave having interstices permeable to tissue ingrowth and fashioned into a generally toroidal shaped fabric ring having an interior directed surface adapted to be fitted against the valve body rotational guide means and an exterior directed surface adapted to receive sutures for implantation of the valve in a prepared site in the heart and defining an outflow annular rim fabric surface adjacent the outflow rim of the valve body and an inflow annular rim fabric surface adjacent the inflow rim of the valve body.

8. The heart valve of claim 7 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending past the inflow and outflow valve body rims thereby extending the inflow and outflow annular rim fabric surfaces into high blood velocity regions.

9. The heart valve of claim 7 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending past the inflow valve body rim thereby extending the inflow annular rim fabric surface into a high inflow blood velocity region.

10. The heart valve of claim 7 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending past the outflow valve body rim thereby extending the outflow annular rim fabric surface into a high outflow blood velocity region.

11. The heart valve of claim 7 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending at least to the inflow and outflow valve body rims thereby separating the exterior directed surface of the suturing ring fabric from the inflow and outflow annular rim fabric surfaces and inhibiting the extension of suturing knots and tails into the valve body annulus.

12. The heart valve of claim 11 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending past the inflow and outflow valve body rims.

13. The heart valve of claim 7 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending past the inflow valve body rim, thereby separating the exterior directed surface of the suturing ring fabric from the inflow annular rim fabric surface and inhibiting the extension of suturing knots and tails into the valve body annulus.

14. The heart valve of claim 13 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending past the inflow valve body rim.

15. The heart valve of claim 7 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending past the outflow valve body rim, thereby separating the exterior directed surface of the suturing ring fabric from the outflow annular rim fabric surface and inhibiting the extension of suturing knots and tails into the valve body annulus.

16. The heart valve of claim 15 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending past the outflow valve body rim.

17. An implantable heart valve having at least one valve mechanism movable between an open position and a closed position, a valve body for supporting the valve mechanism, and an exterior rotatable suturing ring for suturing to a natural heart tissue orifice and allowing rotation of the valve body with respect to the suturing ring, the valve body having an annular exterior wall having a groove formed therein between outflow and inflow flanges having flange diameters exceeding a diameter of the groove for receiving the suturing ring disposed circumferentially around the groove, the suturing ring further comprising:

a biocompatible fabric of a mesh weave having interstices permeable to tissue ingrowth and first and second axial ends fastened into a generally toroidal shaped fabric ring having an interior directed surface adapted to be fitted against the valve body groove and an outward directed surface adapted to receive sutures for implantation of the valve in a prepared site in the heart; and

means disposed entirely within interior of the fabric ring for fitting the interior directed surface of the fabric ring against the valve body groove leaving the outward directed surface exposed and defining an outflow annular rim surface adjacent the outflow flange of the valve body and an inflow annular rim surface adjacent the inflow flange of the valve body, the fitting means further comprising;

a split ring formed of ring-shaped band having opposed split ring ends adapted to be separated apart to allow the split ring to be fitted within the valve body groove and abutted together to form a continuous circular band having a fixed inner diameter greater than the groove diameter and less than the inflow and outflow flange diameters; and

contact maintaining means for maintaining the split ring ends in abutting contact such that a fixed gap is maintained between the split ring and the valve body groove, whereby the interior directed surface of the suturing ring fabric is entrapped in the fixed gap and frictionally engages the split ring and valve body groove providing a constant frictional force that may be overcome by rotational torque applied between the valve body and the suturing ring for rotation thereof.

18. The heart valve of claim 17 wherein the split ring further comprises inflow and outflow band flanges extending at least over the inflow and outflow valve body flanges within the fabric ring to provide a barrier to penetration of suture needles through the inflow and outflow annular rim surfaces.

19. The heart valve of claim 17 wherein the split ring further comprises an inflow band flange extending at least over the inflow valve body flange within the fabric ring to provide a barrier to penetration of suture needles through the inflow annular rim surface.

20. The heart valve of claim 17 wherein the split ring further comprises an outflow band flange extending over the at least the outflow valve body flange within the fabric ring to provide a barrier to penetration of suture needles through the outflow annular rim surface.

21. The heart valve of claim 17 wherein the split ring further comprises inflow and outflow band flanges extending over the inflow and outflow valve body flanges within the fabric ring, respectively, a distance effecting an increase in blood flow velocity past the inflow and outflow annular rims to inhibit formation of pannus and pannus overgrowth over the interface between the inflow and outflow valve body flanges and the adjacent inflow and outflow annular rims, respectively.

22. The heart valve of claim 17 wherein the split ring further comprises an inflow band flange extending over the inflow valve body flange within the fabric ring a distance effecting an increase in blood flow velocity past the inflow annular rim to inhibit formation of pannus and pannus overgrowth over the interface between the inflow valve body flange and the adjacent inflow annular rim.

23. The heart valve of claim 17 wherein the split ring further comprises an outflow band flange extending over the outflow valve body flange within the fabric ring a distance effecting an increase in blood flow velocity past the outflow annular rim to inhibit formation of pannus and pannus overgrowth over the interface between the outflow valve body flange and the adjacent outflow annular rim.

24. An implantable heart valve having at least one valve mechanism movable between an open position and a closed position, a valve body for supporting the valve mechanism having an exterior wall extending between inflow and outflow valve rims and an interior valve opening annulus, and an exterior rotatable suturing ring formed of suturing ring fabric for suturing the heart valve to a natural heart tissue orifice, apparatus for securing the suturing ring for rotation about the valve body exterior wall upon application of a rotational torque comprising:

rotational guide means formed on the annular exterior wall of the heart valve body providing a rotational guide about which the suturing ring is rotatable;

split ring means formed within the suturing ring for supporting said suturing ring in a generally toroidal shaped fabric ring, said fabric having an annular section adapted to be fitted against the valve body rotational guide means and an outward directed surface adapted to receive sutures for implantation of the valve in a prepared site in the heart and defining an outflow annular rim fabric surface adjacent the outflow rim of the valve body and an inflow annular rim fabric surface adjacent the inflow rim of the valve body, said split ring means compressing said annular section of the suturing ring fabric into engagement against the rotational guide with a consistent force; and

means for maintaining said split ring means with a constant diameter.

25. The heart valve of claim 24 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending past the inflow and outflow valve body rims thereby extending the inflow and outflow annular rim fabric surfaces into high blood velocity regions.

26. The heart valve of claim 24 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending past the inflow valve body rim thereby extending the inflow annular rim fabric surface into a high inflow blood velocity region.

27. The heart valve of claim 24 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending past the outflow valve body rim thereby extending the outflow annular rim fabric surface into a high outflow blood velocity region.

28. The heart valve of claim 24 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending at least to the inflow and outflow valve body rims thereby separating the exterior directed surface of the suturing ring fabric from the inflow and outflow annular rim fabric surfaces and inhibiting the extension of suturing knots and tails into the valve body annulus.

29. The heart valve of claim 28 wherein the split ring within the suturing ring fabric further comprises extended inflow and outflow band flanges extending past the inflow and outflow valve body rims.

30. The heart valve of claim 24 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending past the inflow valve body rim, thereby separating the exterior directed surface of the suturing ring fabric from the inflow annular rim fabric surface and inhibiting the extension of suturing knots and tails into the valve body annulus.

31. The heart valve of claim 30 wherein the split ring within the suturing ring fabric further comprises an extended inflow band flange extending past the inflow valve body rim.

32. The heart valve of claim 24 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending past the outflow valve body rim thereby separating the exterior directed surface of the suturing ring fabric from the outflow annular rim fabric surface and inhibiting the extension of suturing knots and tails into the valve body annulus.

33. The heart valve of claim 32 wherein the split ring within the suturing ring fabric further comprises an extended outflow band flange extending past the outflow valve body rim.