Tissue heart valves

Claim 2

A tissue-type heart valve comprising: a dimensionally stable, pre-aligned and pre-assembled tissue leaflet subassembly including a plurality of leaflets, wherein each leaflet includes a cusp edge opposite from a coapting edge and two leaflet tabs extending from the junctions between the cusp and coapting edges in generally opposite directions, the pre-alignment of the leaflets in the subassembly creating a plurality of pairs of mating leaflet tabs extending outward from the subassembly, one pair of mating leaflet tabs per adjacent pair of leaflets; a generally circular wireform having a bottom surface dimensioned to receive said pre-aligned tissue leaflet subassembly in fixed, mating engagement said wireform having lower cusps interrupted by upwardly extending commissures, the cusp edges of the leaflets in the pre-assembled tissue leaflet subassembly being attached along the cusps of the wireform to form a leaflet/wireform subassembly; and a generally circular support stent having an upper surface dimensioned to seat and fix in mating engagement with said leaflet/wireform subassembly, the support stent having upwardly extending flexible commissure posts to which the pairs of mating leaflet tabs attach.

Claim 3

The tissue-type heart valve of claim 1 wherein said wireform is provided with a cloth cover.

Claim 4

The tissue-type heart valve of claim 1 wherein said support stent upper surface is provided with a deformable, leaflet engaging seat.

Claim 5

The tissue-type heart valve of claim 1 wherein said support stent is provided with a cloth cover.

Claim 6

The tissue-type heart valve of claim 1 further comprising an adaptable structural interface fixedly disposed upon said support stent.

Claim 7

The tissue-type heart valve of claim 5 wherein said adaptable structural interface comprises a suture ring.

Claim 8

The tissue-type heart valve of claim 5 wherein said adaptable structural interface comprises a flange.

Claim 9

The tissue-type heart valve of claim 5 wherein said adaptable structural interface comprises a conduit.

Claim 10

The tissue-type heart valve of claim 1 further comprising an outlet conduit fixedly disposed about said wireform.

Claim 11

The tissue-type heart valve of claim 9 further comprising an inlet conduit fixedly disposed upon said support stent.

Claim 12

The valve of claim 1, wherein each commissure of the wireform defines a generally axial space between two sections of wire through which one of the pairs of outwardly extending leaflet tabs extend, the flexible stent commissures extending radially outside of the wireform commissures, and wherein each pair of mating leaflet tabs is separated within the axial space and the separated tabs pass on opposite sides of the associated stent commissure and attach thereto so as to be clamped between the stent commissure and wireform commissure upon a radially inward force being applied to the leaflets.

Claim 13

The valve of claim 11, wherein the leaflet ends extend around the outside of the stent commissure and are rejoined at a stitched butt joint.

Claim 14

A tissue-type heart valve comprising: a dimensionally stable, pre-aligned tissue leaflet subassembly formed of a plurality of substantially identical tissue coapting leaflets, each of said leaflets having a generally linear coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween, said opposing ends of adjacent leaflets having been templated and attached to one another to define a plurality of pairs of aligned, mating, leaflet ends; a generally circular, cloth-covered wireform having top and bottom surfaces and a generally sinusoidal periphery defining a plurality of axially projecting commissures, each of said commissures corresponding to one of said pairs of aligned, mating, leaflet ends, said wireform bottom surface dimensioned to receive and fixedly dispose in mating engagement with said pre-aligned tissue leaflet subassembly; and a generally circular support stent having an upper surface dimensioned to seat and fix in mating engagement with said tissue leaflet subassembly fixedly disposed in mating engagement with said bottom surface of said wireform, the support stent including a generally stiff lower ring portion and a plurality of flexible commissure posts axially projecting up from the ring portion approximately the same height as the commissures of the wireform.

Claim 15

A tissue-type heart valve comprising: a dimensionally stable, pre-aligned tissue leaflet subassembly formed of a plurality of substantially identical tissue coapting leaflets, each of said leaflets having a generally linear coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween, said opposing ends of adjacent leaflets having been templated and attached to one another to define a plurality of pairs of aligned, mating, leaflet ends; a generally circular, cloth-covered wireform having top and bottom surfaces and a generally sinusoidal periphery defining a plurality of axially projecting commissures, each of said commissures corresponding to one of said pairs of aligned, mating, leaflet ends, said wireform bottom surface dimensioned to receive and fixedly dispose in mating engagement with said pre-aligned tissue leaflet subassembly; and a generally circular support stent having an upper surface dimensioned to seat and fix in mating engagement with said tissue leaflet subassembly fixedly disposed in mating engagement with said bottom surface of said wireform, the support stent including a generally stiff lower ring portion and a plurality of flexible commissure posts axially projecting up from the ring portion approximately the same height as the commissures of the wireform.

Claim 16

The tissue-type heart valve of claim 13 wherein each of said tissue leaflet peripheral cusps is sewn to said cloth-covered wireform from commissure to commissure.

Claim 17

The tissue-type heart valve of claim 13 wherein said support stent upper surface is provided with a leaflet cusp engaging seat.

Claim 18

The tissue-type heart valve of claim 11 wherein said support stent is provided with a cloth cover.

Claim 19

The tissue-type heart valve of claim 13 wherein said support stent includes a two-part structure with a flexible inner member including the axially projecting commissures, and a stiff outer member defining the stiff lower ring portion.

Claim 20

The tissue-type heart valve of claim 17 wherein the flexible inner member has an upper surface defining cusps and the axially projecting commissures, and the stiff outer member has an upper surface defining cusps juxtaposed with the inner member cusps, the combined upper surfaces of the inner and outer members defining the support stent upper surface.

Claim 21

The tissue-type heart valve of claim 13 further comprising an adaptable structural interface fixedly disposed upon said support stent.

Claim 22

The tissue-type heart valve of claim 19 wherein said adaptable structural interface comprises a suture ring.

Claim 23

The tissue-type heart valve of claim 19 wherein said adaptable structural interface comprises a flange.

Claim 24

The tissue-type heart valve of claim 19 wherein said adaptable structural interface comprises a conduit.

Claim 25

The tissue-type heart valve of claim 13 further comprising an outlet conduit fixedly disposed about said wireform.

Claim 26

The tissue-type heart valve of claim 23 further comprising an inlet conduit fixedly disposed upon said support stent.

Claim 27

The valve of claim 13, wherein each commissure of the wireform defines a generally axial space between two sections of wire through which one of the pairs of mating leaflet ends extend and attaches to one of the stent commissures.

Claim 28

The valve of claim 25, wherein the flexible stent commissures are disposed adjacent and radially outside of the wireform commissures, and wherein each pair of mating leaflet ends is separated within the axial space and the separated ends pass on opposite sides of the associated stent commissure and attach to one another so as to be clamped between the stent commissure and wireform commissure upon a radially inward force being applied to the leaflets.

Claim 29

The valve of claim 26, wherein the separated leaflet ends extend around the outside of the stent commissure and are attached together at a stitched butt joint.

Claim 30

A tissue-type heart valve comprising: an annular wireform having a plurality of axially projecting commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips; a tissue leaflet subassembly attached within the annular wireform and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the wireform cusps, the opposing ends of adjacent leaflets being attached to one another to define a plurality of pairs of mating leaflet ends each of which is associated with and extends between the spaced apart wireform portions of one of the commissures; and a generally cylindrical support stent having on one edge a plurality of alternating cusps and commissures adapted to matingly engage with the attached annular wireform and tissue leaflet subassembly, each stent commissure being associated with and extending substantially the same axial distance as one of the wireform commissures, wherein each pair of mating leaflet ends is separated by and attached around opposite sides of the associated stent commissure.

Claim 31

A tissue-type heart valve comprising: an annular wireform having a plurality of axially projecting commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips; a tissue leaflet subassembly attached within the annular wireform and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the wireform cusps, the opposing ends of adjacent leaflets being attached to one another to define a plurality of pairs of mating leaflet ends each of which is associated with and extends between the spaced apart wireform portions of one of the commissures; and a generally cylindrical support stent having on one edge a plurality of alternating cusps and commissures adapted to matingly engage with the attached annular wireform and tissue leaflet subassembly, each stent commissure being associated with and extending substantially the same axial distance as one of the wireform commissures, wherein each pair of mating leaflet ends is separated by and attached around opposite sides of the associated stent commissure.

Claim 32

The valve of claim 28, wherein the wireform is cloth-covered with the tissue leaflet subassembly connected to the cloth with sutures.

Claim 33

The valve of claim 29, wherein the tissue leaflets are stitched along their cusps to the cusps of the wireform cloth.

Claim 34

The valve of claim 28, wherein each pair of separated leaflet ends is jointly attached to the wireform and stent commissures with stitching.

Claim 35

The valve of claim 31, wherein the leaflet ends are trimmed flush with the outside of the stent commissure.

Claim 36

The valve of claim 31, wherein the leaflet ends extend around the outside of the stent commissure and are rejoined at a stitched butt joint.

Claim 37

The valve of claim 28, further comprising a flange fixedly disposed upon said support stent.

Claim 38

The valve of claim 28, further comprising a conduit fixedly disposed upon said support stent.

Claim 39

The valve of claim 28, further comprising an outlet conduit fixedly disposed about said wireform.

Claim 40

The valve of claim 36, further comprising an inlet conduit fixedly disposed upon said support stent.

Claim 41

A tissue-type heart valve comprising: an annular wireform having a plurality of axially projecting commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips; a tissue leaflet subassembly attached within the annular wireform and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the wireform cusps, the opposing ends of adjacent leaflets being attached to one another to define a plurality of pairs of mating leaflet ends each of which is associated with and extends between the spaced apart wireform portions of one of the commissures; and a generally cylindrical support stent having on one edge a plurality of alternating cusps and commissures adapted to matingly engage with the attached annular wireform and tissue leaflet subassembly, each stent commissure being associated with and extending substantially the same axial distance as one of the wireform commissures, wherein each pair of mating leaflet ends is separated and attached around opposite sides of the associated stent commissure, wherein the stent further includes inner and outer support members, with the inner support member exhibiting the cusps and commissures, and the outer support member conforming to the cusps but being truncated in the region of the inner support member commissures so as to provide stiffness to the combined support members except at the inner support member commissures.

Claim 42

A tissue-type heart valve comprising: an annular wireform having a plurality of axially projecting commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips; a tissue leaflet subassembly attached within the annular wireform and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the wireform cusps, the opposing ends of adjacent leaflets being attached to one another to define a plurality of pairs of mating leaflet ends each of which is associated with and extends between the spaced apart wireform portions of one of the commissures; and a generally cylindrical support stent having on one edge a plurality of alternating cusps and commissures adapted to matingly engage with the attached annular wireform and tissue leaflet subassembly, each stent commissure being associated with and extending substantially the same axial distance as one of the wireform commissures, wherein each pair of mating leaflet ends is separated and attached around opposite sides of the associated stent commissure, wherein the stent further includes inner and outer support members, with the inner support member exhibiting the cusps and commissures, and the outer support member conforming to the cusps but being truncated in the region of the inner support member commissures so as to provide stiffness to the combined support members except at the inner support member commissures.

Claim 43

The valve of claim 38, wherein the stent is cloth-covered.

Claim 44

The valve of claim 39, wherein the cloth covering the stent is folded to form a cloth sewing edge extending along the alternating stent cusps and commissures to facilitate attachment to the wireform and tissue leaflet subassembly.

Claim 45

The valve of claim 39, wherein the stent commissures include sewing holes and the cloth covering is secured to the stent commissures with sutures through the sewing holes.

Claim 46

A tissue-type heart valve comprising: an annular wireform having a plurality of axially projecting commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips; a tissue leaflet subassembly attached within the annular wireform and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the wireform cusps, the opposing ends of adjacent leaflets being attached to one another to define a plurality of pairs of mating leaflet ends each of which is associated with and extends between the spaced apart wireform portions of one of the commissures; a generally cylindrical support stent having on one edge a plurality of alternating cusps and commissures adapted to matingly engage with the attached annular wireform and tissue leaflet subassembly; and a suture ring fixedly disposed upon a lower end of said valve comprising a suturable annulus having upwardly opening depressions on an internal circumference corresponding in number to the number of cusps of the wireform, wherein the suture ring has a bore sized to receive the stent with the wireform cusps being positioned in the depressions.

Claim 47

A tissue-type heart valve comprising: an annular wireform having a plurality of axially projecting commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips; a tissue leaflet subassembly attached within the annular wireform and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the wireform cusps, the opposing ends of adjacent leaflets being attached to one another to define a plurality of pairs of mating leaflet ends each of which is associated with and extends between the spaced apart wireform portions of one of the commissures; a generally cylindrical support stent having on one edge a plurality of alternating cusps and commissures adapted to matingly engage with the attached annular wireform and tissue leaflet subassembly; and a suture ring fixedly disposed upon a lower end of said valve comprising a suturable annulus having upwardly opening depressions on an internal circumference corresponding in number to the number of cusps of the wireform, wherein the suture ring has a bore sized to receive the stent with the wireform cusps being positioned in the depressions.

Claim 48

The valve of claim 42, wherein the suture ring comprises a sponge waffle covered with cloth.

Claim 49

The valve of claim 43, wherein the sponge waffle comprises an upwardly facing outer ledge and an inner lip projecting up from the ledge in which said depressions are formed.

Claim 50

The valve of claim 44, further comprising a ring washer sized to closely surround the lip and rest on the ledge.

Claim 51

The valve of claim 45, further comprising a single cloth covering surrounding the sponge waffle, and folded around the external surfaces of the ring washer and tucked between the ring washer and the sponge waffle.

Claim 52

The valve of claim 42, wherein each stent commissure is associated with and extends substantially the same axial distance as one of the wireform commissures, and wherein each pair of mating leaflet ends is separated and attached around opposite sides of the associated stent commissure.