Heart valve prosthesis and method of implantation thereof

• US 8,845,722 B2
• Filed: 08/03/2009
• Issued: 09/30/2014
• Est. Priority Date: 08/03/2009
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): COBURN, LESLIE ANN
• Application Number:
  US12/462,352
• Publication Number:
  US 20110029072A1
• Time in Patent Office: 1,884 Days
• Field of Search: 623 21- 24, 623 22- 223, 623/2.33, 623/2.38, 623/1.24, 623/1.26
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A heart valve prosthesis has a supported valve including a biological valve portion mounted within a support structure. The supported valve has inflow and outflow ends spaced axially apart from each other. A fixation support member includes an inflow portion that extends from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve. An outflow portion of the fixation support member extends from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member. The radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve.

Claims

1. A heart valve prosthesis comprising:

a supported valve comprising a biological valve portion mounted within a support structure, the supported valve being configured to provide for substantially unidirectional flow of blood through the supported valve, the supported valve having inflow and outflow ends that are spaced axially apart from each other; and

a fixation support member secured around an outer perimeter of the supported valve, the fixation support member comprising inflow and outflow portions, the inflow portion of the fixation support member extending from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve upon deployment of the heart valve prosthesis, the outflow portion of the fixation support member extending from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member upon deployment of the heart valve prosthesis, the radially inner contact surface being attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve, the supported valve and the fixation support member being deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension thereof when the heart valve prosthesis is deployed, whereby implantation of the heart valve prosthesis is facilitated,

wherein the fixation support member comprises an annular support formed from a plurality of support features and having one of a U-shaped or V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in its expanded cross-sectional dimension, the support features alternate extending between the inflow and outflow directions along a circumferential path corresponding to the radially inner contact surface, the support features being interconnected at first junctures at an axial extent of the inflow portion and being interconnected at second junctures at an axial extent of the outflow portion, each support feature being directly connected to only two other support features such that the support features collectively extend along the entire axial length of the fixation support member.

2. The prosthesis of claim 1, wherein the fixation support member is flexible and deformable, the plurality of support features extending from the radially inner contact surface to terminate in respective distal ends thereof for biasing each of the inflow and outflow portions of the fixation support member toward the expanded cross-sectional dimension;

and

at least one web of flexible biocompatible material covering at least an inflow surface of the support features for the inflow portion and at least an outflow surface of the support features for the outflow portion.

3. The prosthesis of claim 2, wherein the flexible and deformable fixation support member comprises a continuous monolithic structure.

4. The prosthesis of claim 2, wherein at least some of the support features further comprise spikes that extend outwardly from respective support features toward the other of inflow or outflow portion of the fixation support member.

5. The prosthesis of claim 2, wherein the support structure of the supported valve further comprises a cylindrical support extending between the axially spaced apart inflow and outflow ends thereof, the cylindrical support of the support structure of the supported valve including a plurality of support features extending axially between the axially spaced apart inflow and outflow ends of the cylindrical support, adjacent pairs of the plurality of support features being interconnected so as to bias the cylindrical support radially outwardly toward the expanded cross-sectional dimension.

6. The prosthesis of claim 1, wherein a longitudinal cross-section axially through the prosthesis in its expanded cross-sectional dimension provides an angle between the inflow and outflow portions of the fixation support member that is greater than forty degrees, space between axially opposed surfaces of the inflow and outflow portions defines a receptacle around the outer perimeter of the supported valve that is dimensioned and configured for receiving therein tissue at a valve annulus.

7. The prosthesis of claim 6, wherein an angle of the inflow portion of the fixation support member relative to a plane extending transversely through the prosthesis at the radially inner contact surface of the fixation support member is less than an angle of the outflow portion of the fixation support member relative to the plane.

8. The prosthesis of claim 1, wherein the radially inner contact surface defines an apex and each of the inflow and outflow portions of the fixation support member define legs of a V-shaped cross-sectional configuration, a space between the legs of the V-shaped cross-sectional configuration defines a toroidal channel around the outer perimeter of the supported valve dimensioned and configured for receiving a heart valve annulus.

9. The prosthesis of claim 1, wherein the supported valve has an expanded cross-sectional dimension that is greater than 24 mm, the inflow and outflow portions of the fixation support member extending outwardly beyond the expanded cross-sectional dimension of the supported valve to provide an annular receptacle extending around the outer perimeter of the supported valve between the inflow and outflow portions of the fixation support member, the receptacle being dimensioned and configured for receiving tissue when implanted at a valve annulus.

10. The prosthesis of claim 1, wherein a valve portion of the supported valve comprises an animal tissue heart valve that is one of a homograft or xenograft.

11. The prosthesis of claim 10, wherein the animal tissue heart valve comprises a porcine heart valve.

12. The prosthesis of claim 1, wherein the support features of the inflow portion of the fixation support member comprise triangular support features and the support features of the outflow portion of the fixation support member comprise triangular support features, the triangular support features of the outflow portion connecting the triangular support features of the inflow portion together and spacing the triangular support features of the inflow portion apart from one another.

13. The prosthesis of claim 1, wherein the support features of the inflow portion are directly connected to one another in pairs, each directly connected pair of support features of the inflow portion being spaced from each other directly connected pair of support features of the inflow portion.

14. The prosthesis of claim 1, wherein the support features of the outflow portion are directly connected to one another in pairs, each directly connected pair of support features of the outflow portion being spaced from each other directly connected pair of support features of the inflow portion.

15. The prosthesis of claim 1, wherein the radially inner contact surface of the fixation support member is positioned around the outer perimeter of the support structure of the supported valve.

16. The prosthesis of claim 1, wherein the cross-section of the annular support of the fixation support member is V-shaped with a pointed apex.

17. A heart valve prosthesis comprising:

a supported valve comprising a biological valve portion mounted within a support structure, the supported valve being configured to provide for substantially unidirectional flow of blood through the supported valve, the supported valve having inflow and outflow ends that are spaced axially apart from each other and

a fixation support member secured around an outer perimeter of the supported valve, the fixation support member comprising inflow and outflow portions, the inflow portion of the fixation support member extending from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve, the outflow portion of the fixation support member extending from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member, the angle between the inflow and outflow portions of the fixation support member ranging between 70 degrees and 100 degrees

wherein the radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve, the supported valve and the fixation support member being deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension thereof, whereby implantation of the heart valve prosthesis is facilitated,

wherein the fixation support member comprises an annular support formed from a plurality of support features and having one of a U-shaped or V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in its expanded cross-sectional dimension, the support features alternate extending between the inflow and outflow directions along a circumferential path corresponding to the radially inner contact surface, the support features being interconnected at first junctures at an axial extent of the inflow portion and being interconnected at second junctures at an axial extent of the outflow portion, each support feature being directly connected to only two other support features such that the support features collectively extend along the entire axial length of the fixation support member.

18. A heart valve prosthesis comprising:

a stented valve comprising a biological valve portion mounted within a stent, the stented valve being configured to provide for substantially unidirectional flow of blood through the stented valve, the stented valve having inflow and outflow ends that are spaced axially apart from each other; and

a fixation support member extending around an outer perimeter of the supported valve, the fixation support member comprising inflow and outflow portions, the inflow portion of the fixation support member extending from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve upon deployment of the heart valve prosthesis, the outflow portion of the fixation support member extending from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member upon deployment of the heart valve prosthesis, a space between the inflow and outflow portions of the fixation support member defining a toroidal receptacle around the perimeter of the supported valve that is dimensioned and configured for receiving a heart valve annulus when the prosthesis is implanted at the heart valve annulus,

wherein the fixation support member comprises a plurality of support features and having one of a U-shaped or V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in an expanded cross-sectional dimension thereof, the support features alternating extending between the inflow and outflow directions along a circumferential path corresponding to the radially inner contact surface, the support features being interconnected at first junctures at an axial extent of the inflow portion and being interconnected at second junctures at an axial extent of the outflow portion, each support feature being directly connected to only two other support features such that the support features collectively extend along the entire axial length of the fixation support member.

19. A heart valve prosthesis comprising:

a supported valve comprising a biological valve portion mounted within a support structure, the supported valve being configured to provide for substantially unidirectional flow of blood through the supported valve, the supported valve having inflow and outflow ends that are spaced axially apart from each other; and

a fixation support member secured around an outer perimeter of the supported valve, the fixation support member comprising inflow and outflow portions, the inflow portion of the fixation support member extending from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve, the outflow portion of the fixation support member extending from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member, the inflow portion and outflow portion of the fixation support member having essentially the same length from the radially inner contact surface,

wherein the radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve, the supported valve and the fixation support member being deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension thereof, whereby implantation of the heart valve prosthesis is facilitated,

wherein the fixation support member comprises an annular support formed from a plurality of support features and having one of a U-shaped or V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in its expanded cross-sectional dimension, the support features alternate extending between the inflow and outflow directions along a circumferential path corresponding to the radially inner contact surface, the support features being interconnected at first junctures at an axial extent of the inflow portion and being interconnected at second junctures at an axial extent of the outflow portion, each support feature being directly connected to only two other support features such that the support features collectively extend along the entire axial length of the fixation support member.