Stent for heart valve

• US RE30,912 E
• Filed: 06/14/1978
• Issued: 04/27/1982
• Est. Priority Date: 09/16/1968
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Hancock Jaffe Laboratories, Inc.
• Inventors: Hancock, Warren D.
• Primary Examiner(s): FRINKS, RONALD
• Application Number:
  US05/915,451
• Time in Patent Office: 1,413 Days
• Field of Search: 3/1.5, 3/1
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents

Abstract

A heart valve stent that includes an annular framework, preferably of bendable material, having three rounded apexes interconnected by support arms curved to incline away from the apexes. Additional support arms are included parallel to and axially beyond the first support arms. For use in the mitral position, the framework is circumscribed by an outer ring, which receives an annular element of felt or other suitable material. The heart valve is positioned on the stent, with its marginal portions overlapping it and affixed to it by sutures.

Claims

1. A stent for .[.a.]. .Iadd.an animal .Iaddend.heart valve .Iadd.for supporting such a heart valve in its natural contour .Iaddend.comprising a framework of annular configuration,

said framework including .[.spaced.]. .Iadd.three rounded .Iaddend.apical portions .Iadd.at one end thereof, said apical portions being rounded convexly as viewed from said one end and being spaced apart unequal angular distances, .Iaddend.and arms interconnecting said apical portions,

.Iadd.each of said apical portions having a substantial circumferential dimension for permitting said apical portions to accommodate heart valves of different dimensions, .Iaddend.for thereby providing an attachment for the commissures and cusps of a heart valve, said arms being in two sets .Iadd.spaced apart axially.Iaddend.,

one of said sets being adjacent said apical portions and the other of said sets being remote from said apical portions.[...]..Iadd.,

all of said arms in at least the one of said sets adjacent said apical portions being curved in a scalloped configuration so as to incline away from said apical portions intermediate said apical portions, for conforming to the shape of and supporting the margins of the cusps of an animal heart valve such that the peripheral parts of said heart valve can be attached to said arms while preserving the natural contour of said heart valve,

said arms of said set remote from said apical portions being more nearly flat than are said arms of said set adjacent said apical portions. .Iaddend.

2. A device as recited in claim 1 in which said arms in both of said sets incline axially away from said apical portions intermediate said apical portions. .[.3. A device as recited in claim 2 in which at least some of said arms are deflectable for varying the distances thereof from the axis

3. of said framework..]. 4. A device as recited in claim 2 in which said sets of said arms .[.are spaced apart axially and.]. are generally equally spaced from the axis of said framework,

thereby providing said set of said arms adjacent said apical portions and

6. of said arms in said one set toward said apical portions..]. 10. A device as recited in claim 1 including in addition a ring attached to said framework for providing a means for attachment of said framework in a heart in the mitral position, said ring circumscribing said framework adjacent said arms. .[.11. A device as recited in claim 10 in which said

7. ring is a rigid member integral with said framework..]. 12. A device as recited in claim 10 in which said ring is a cloth member secured to said arms. .[.13. A device as recited in claim 1 in which each of said apical portions is rounded and has a substantial circumferential dimension for permitting said apical portions to accommodate heart valves of different dimensions..]. .[.14. A device as recited in claim 1 in which

said arms are arcuate and concave on the sides thereof adjacent said apical portions,

said arms in said one set being bendable toward said apical portions for

8. thereby increasing their spacing from the axis of said framework..]. 15. A device as recited in claim 1 in which the spacing between two adjacent apical portions is less than the spacing between either of said two

10. of said apical portions. 17. A device as recited in claim 15 in which said spacing between said two adjacent apical portions is within the range of 20% to 25% less than said spacing between either of said two adjacent apical portions and the third of said apical portions. .[.18. A device as recited in claim 1 in which said framework is an integral member of substantially noncorrosive metal..]. .[.19. A device as recited in claim 18 in which said metal is malleable..]. .[.20. A device as recited in claim 1 in which said framework is an integral member of plastic

11. material..]. 21. The invention as claimed in claim 1 in which there are three apical portions spaced unequal angular distances from each other, one space between two adjacent apical portions being a reference space, another space between two adjacent apical portions being 4-10% less than said reference space, another space between two adjacent apical portions

4. said set of said arms remote from said apical portions. 5. A device as recited in claim 4 including, in addition, a cloth member extending over

5. and receiving said arms. 6. A device as recited in claim 4 including, in addition, a cloth ring attached to and extending outwardly from said remote set of said arms for providing a means for attachment to a heart. .[.7. A device as recited in claim 4 including in addition

a ring circumscribing said framework adjacent said remote set of arms,

and including means projecting radially outwardly from said framework for securing said ring thereto..]. .[.8. A device as recited in claim 4 in which said arms in said one set are deflectable toward said apical portions for thereby increasing the radial spacing of said adjacent arms from the axis of said framework..]. .[.9. A device as recited in claim 4 in which said arms are curved in a scalloped configuration to so incline away from said apical portions intermediate said apical portions,

said arms in said one set being deflectable and having a greater inclination away from said apical portions than that of said arms in said other set,

for providing a relatively large increase in the spacing of said arms in said one set from the longitudinal axis of said framework upon deflection

12. being 17-33% less than said reference space. .[.22. A heart valve assembly comprising a stent,

said stent including a generally tubular framework having spaced apexes at one end,

a first seet of arms adjacent and interconnecting said apexes,

and a second set of arms spaced from said first set of arms and remote from said apexes,

said arms being inclined away from said apexes at locations intermediate said apexes,

a heart valve on said framework,

said heart valve having commissures substantially at said apexes and cusps having marginal portions adjacent said arms, the marginal portions of said heart valve overlapping said framework so that the interior of said framework is covered by said marginal portions of said heart valve,

13. and means for attaching said heart valve to said framework..]. 23. A device as recited in claim .[.22.]. .Iadd.37 .Iaddend.in which said marginal portions of said heart valve are doubled over said framework. .[.24. A device as recited in claim 22 in which said heart valve includes a free marginal edge extending from said one end for providing a means for attachment to a heart..]. .[.25. A device as recited in claim 22 including in addition a ring of clothlike or spongelike material circumscribing said

14. framework inwardly of said one end of said framework..]. 26. A device as recited in claim .[.22.]. .Iadd.37 .Iaddend.including in addition a sleeve .Iadd.of cloth material .Iaddend.receiving said arms, portions of said heart valve extending over said sleeve. .[.27. A device as recited in claim 26 in which said sleeve is of cloth material..]. .[.28. A heart valve assembly for use in the mitral position comprising

a stent,

said stent including a generally tubular framework having spaced apexes at one end and arms interconnecting said apexes,

said arms being inclined away from said apexes at locations intermediate said apexes,

a ring extending outwardly of said arms adjacent the opposite end of said framework,

an annular member circumscribing said arms,

means attaching said annular member to said framework,

a heart valve on said framework,

said heart valve having cusps having marginal portions overlapping said framework,

means attaching said marginal portions to said framework,

said heart valve having additional portions extending over the end of said ring remote from said apexes and toward said annular member,

and means attaching said additional portion of said heart valve to said annular member..]. .[.29. A device as recited in claim 28 in which said annular member is constructed of felt..]. .[.30. A device as recited in claim 28 including in addition a layer of cloth over said overlapping marginal portions for covering the same and providing for fibrous ingrowth upon being grafted in a heart..]. .[.31. A device as recited in claim 28 in which said ring is integral with said framework..]. .[.32. A device as recited in claim 28 in which said ring is a cloth member attached to said arms..]. .[.33. A stent for a heart valve comprising

a framework of annular configuration,

said framework including spaced apical portions and arms interconnecting said apical portions,

for thereby providing an attachment for the commissures and cusps of a heart valve,

a ring attached to said framework for providing a means for attachment of said framework in a heart in the mitral position,

said ring circumscribing said framework adjacent said arms,

and an annular member interposed between said ring and said framework for providing a bed for the attachment of portions of the valve extended over the atrial aspect of said ring, and for providing a hemodynamic seal upon grafting in a heart..]. .[.34. A device as recited in claim 33 in which

15. said annular member is constructed of felt..]. 35. A stent for .[.a.]. .Iadd.an animal .Iaddend.heart valve .Iadd.for supporting such a heart valve in its natural contour .Iaddend.comprising

a framework of annular configuration,

said framework including .Iadd.three .Iaddend.spaced apical portions .Iadd.at one end thereof .Iaddend.and arms interconnecting said apical portions,

for thereby providing an attachment for the commissures and cusps of a heart valve, .Iadd.said arms being in two sets spaced apart axially, one of said sets being adjacent said apical portions and the other of said sets being remote from said apical portions, said arms in at least the one of said sets adjacent said apical portions being curved in a scalloped configuration so as to incline away from said apical portions intermediate said apical portions for conforming to the shape of and supporting the margins of the cusps of an animal heart valve such that the peripheral parts of said heart valve can be attached to said arms while preserving the natural contour of said heart valve, .Iaddend.

each of said apical portions being rounded .Iadd.convexly as viewed from said one end, .Iaddend.and having a substantial circumferential dimension for permitting said apical portions to accommodate heart valves of different dimensions, said apical portions being annular and of generally

9. adjacent apical portions and the third of said apical portions. 16. A device as recited in claim 15 in which said spacing between said two adjacent apical portions is within the range of 17% to 33% less than said spacing between either of said two adjacent apical portions and the third

16. oval shape. .[.36. A stent for a heart valve comprising

a framework of annular configuration,

said framework including spaced apical portions,

arms interconnecting said apical portions, for thereby providing an attachment for the commissures and cusps of a heart valve, said arms inclining away from said apical portions intermediate said apical portions, said arms including a set of at least two of said arms intermediate each adjacent pair of apical portions,

said arms in each set being spaced apart axially and generally equally spaced from the axis of said framework, thereby providing arms adjacent said apical portions and arms remote from said apical portions,

a ring circumscribing said framework adjacent said remote arms,

and a relatively short post extending axially away from said apical portions at the junctures of said remote arms,

said posts including portions bent outwardly to provide a radially

17. projecting means for securing said ring to said framework..]. .Iadd.37. A heart valve assembly comprising

a stent, said stent including

a generally tubular framework having three apexes at one end thereof,

said apexes being rounded convexly as viewed from said one end and being spaced apart unequal angular distances,

each of said apexes having a substantial circumferential dimension,

a first set of arms adjacent and interconnecting said apexes, and a second set of arms spaced from said first set of arms and remote from said apexes,

all of said arms of at least said first set being arcuate so as to incline away from said apexes at locations intermediate said apexes,

an animal heart valve on said framework,

said heart valve having commissures substantially at said apexes and cusps having marginal portions substantially conforming to said arms of said first set, the marginal portions of said heart valve overlapping said framework so that the interior of said framework is covered by said marginal portions of said heart valve,

sutures attaching said heart valve to said framework so that said commissures are secured to said apexes and said marginal portions of said cusps are secured to said arms, and said heart valve is supported in substantially its natural contour with all its peripheral parts securely attached to said framework,

and a ring of clothlike or spongelike material circumscribing said framework inwardly of said one end of said framework for conforming to and providing a hemodynamic seal at the aortic root of a heart upon implantation. .Iaddend.