Heart valve prosthesis and method of implantation thereof

• US 20110029072A1
• Filed: 08/03/2009
• Published: 02/03/2011
• Est. Priority Date: 08/03/2009
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 8,845,722 B2
• Time in Patent Office: Days
• US Class Current: 623/2.23
• 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 can include a supported valve including a biological valve portion mounted within a support structure. The supported valve is configured to provide for substantially unidirectional flow of blood through the supported valve. The supported valve has inflow and outflow ends that are spaced axially apart from each other. A fixation support member includes inflow and outflow portions. The inflow portion of the fixation support member 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. The 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. The supported valve and the fixation support member are deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension thereof, whereby implantation of the heart valve prosthesis is facilitated.

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 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 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, whereby implantation of the heart valve prosthesis is facilitated.

2. The prosthesis of claim 1, wherein the fixation support member further comprises:

a flexible and deformable annular support having a substantially V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in its expanded cross-sectional dimension, a 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 annular support comprises a continuous monolithic structure in which the support features alternate extending between the inflow and outflow directions along a circumferential path corresponding to the radially inner contact surface.

4. The prosthesis of claim 2, wherein the flexible and deformable annular support comprises separate inflow and outflow support portions supports that are connected together to define the radially inner contact surface of the fixation support member.

5. 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.

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

7. 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 about forty degrees, space between axially opposed surfaces of the inflow and outflow portions defines an receptacle dimensioned and configured for receiving therein tissue at a valve annulus.

8. The prosthesis of claim 7, wherein the angle between the inflow and outflow portions of the fixation support member ranges between approximately 70 and approximately 100 degrees.

9. The prosthesis of claim 7, 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.

10. The prosthesis of claim 1, wherein the fixation support member has a substantially V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in its expanded cross-sectional dimension, in which the radially inner contact surface defines an apex and each of the inflow and outflow portions of the fixation support member define legs of the V-shaped cross-sectional configuration, a space between the legs of the V-shaped cross-sectional configuration defines a generally toroidal receptacle channel dimensioned and configured for receiving a valve annulus.

11. 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 between the inflow and outflow portions of the fixation support member dimensioned and configured for receiving a tissue at a valve annulus.

12. The prosthesis of claim 1, wherein a valve portion of the supported valve comprises an animal tissue heart valve.

13. The prosthesis of claim 12, wherein the animal tissue valve comprises a porcine valve.

14. A method for implanting the heart valve prosthesis of claim 1 into a patient'"'"'s heart, the method comprising:

inserting the heart valve prosthesis into a barrel of an implanter, such that the prosthesis has the reduced cross-sectional dimension relative to the expanded cross-sectional dimension of the prosthesis;

opening the patient'"'"'s chest;

creating an opening in the patient'"'"'s heart to provide a path from the opening in the patient'"'"'s heart to a desired implantation site in the patient'"'"'s heart;

passing a length of the barrel through the opening to position an end of the implanter near the desired implantation site in the patient'"'"'s heart;

discharging the prosthesis from the barrel of the implanter; and

expanding the prosthesis at the desired implantation site from the reduced cross-sectional dimension toward the expanded cross-sectional dimension, such that tissue adjacent the implantation site occupy space between the inflow and outflow portions of the fixation support member to thereby mitigate at least axial movement of the prosthesis relative to the desired implantation site.

15. The method of claim 14, the expanding occurring automatically in response to removal of the heart valve prosthesis from the barrel.

16. The method of claim 14, wherein the method occurs in the absence of cardiopulmonary bypass.

17. The method of claim 14, wherein the desired implantation site comprises a mitral valve annulus and the opening is created in the one of an atrial appendage or heart muscle of the patient to provide a substantially direct path from the opening to the mitral valve annulus.

18. The method of claim 17, wherein the opening is created in the apex of the patient'"'"'s heart muscle, the method further comprises:

creating another opening in an atrial appendage; and

inserting a finger or instrument through the another opening in the atrial appendage to guide positioning a distal end of the barrel of the implanter to approximate the desired implantation site for discharging the prosthesis.

19. The method of claim 14, wherein the opening is created in an atrial appendage of the patient'"'"'s heart, the method further comprises:

creating another opening through an apex of the patient'"'"'s heart muscle; and

inserting an instrument through the another opening in the apex to guide positioning a distal end of the implanter to approximate the desired implantation site for discharging the prosthesis.

20. A method for implanting a biological heart valve prosthesis at an atrio-ventricular position in a patient'"'"'s heart, the method comprising:

inserting the heart valve prosthesis into a generally cylindrical and elongated barrel, such that the prosthesis has a reduced cross-sectional dimension corresponding to a dimension of the barrel, the prosthesis being configured to expand from the reduced cross-sectional dimension to an expanded cross-sectional dimension, which is greater than the reduced cross-sectional dimension, the heart valve prosthesis comprising an fixation support member adjacent an inflow end of a supported valve, the fixation support member comprising inflow and outflow portions that extend radially outwardly and in opposite axial directions away from each other to define a tissue-receiving receptacle therebetween;

creating an opening in tissue to provide a substantially direct path to the atrio-ventricular position in the patient'"'"'s heart;

passing an open end of the barrel through the opening;

positioning the open end of the barrel near a valve annulus at the atrio-ventricular position; and

discharging the heart valve prosthesis from the open end of the barrel, the heart valve prosthesis expanding from the reduced cross-sectional dimension to the expanded cross-sectional dimension, such that tissue at the valve annulus occupies at least a substantial portion of the receptacle and engages adjacent surfaces of the inflow and outflow portions of the fixation support member to mitigate movement of the prosthesis relative to the valve annulus at the atrio-ventricular position.