Support apparatus and heart valve prosthesis for sutureless implantation

• US 7,311,730 B2
• Filed: 02/13/2004
• Issued: 12/25/2007
• Est. Priority Date: 02/13/2004
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Blanco, Javier G.
• Application Number:
  US10/778,278
• Publication Number:
  US 20050182486A1
• Time in Patent Office: 1,411 Days
• Field of Search: 623/1.14, 623/1.36, 623/2.11, 623/2.14, 623/2.17, 623/2.18, 623/2.23, 623 236- 24, 623/900, 623/1.24, 623/2.1, 606/153
• US Class Current: 623/2.38
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An apparatus is disclosed for supporting a heart valve at an annulus of an implantation site. The apparatus includes a base portion operative to maintain a circumferential dimension thereof. A plurality of fingers extend axially and radially outwardly from the first end of the support element. A heart valve can be located within the apparatus to provide a prosthesis that can be suturelessly implanted at an annulus of a patient.

Claims

1. A combination comprising:

a heart valve prosthesis comprising;

a valve member that permits substantially unidirectional flow of fluid through the valve member;

an annular support element, having a fixed annular length, positioned generally around at least a substantial part of a sidewall portion of the valve member, the support element having axially spaced apart first and second ends;

a first set of substantially resilient fingers extending axially and radially outwardly from the first end of the support element and curving toward the second end of the support element; and

a second set of substantially resilient fingers extending axially and radially outwardly from the second end of the support element in a generally opposing relationship relative to the first set of fingers curving toward the first end of the support element such that distal ends of the respective fingers cross through a plane that extends through the annular support element, the first and second sets of fingers are monolithically formed with the support element, wherein the first and second sets of fingers comprise a resilient material moveable from a first condition, in which the distal ends of the first and second sets of fingers extend axially and radially to provide a generally clamp-like structure, to a second condition, in which the distal ends of the first and second sets of fingers extend generally parallel relative to the support element, the fingers being capable of returning from the second to the first condition;

a covering of a biocompatible flexible material that extends from the support element to cover a substantial part of an axially exposed surface of at least one of the first and second sets of the fingers, the covering having first and second end portions spaced apart from each other by a generally tubular body portion that is located within the support element, the first and second end portions of the covering extending radially outwardly from the tubular body portion and connected to a respective one of the first and second sets of fingers, such that the first and second end portions are moveable with movement of the first and second sets of the fingers for covering at least part of an axially exposed surface of the first and second sets of the fingers, the first and second end portions terminating in a peripheral edge that is spaced apart from the distal ends of the respective fingers so as to cover part of the respective first and second sets of fingers; and

an implanter that includes a cylindrical member having an interior dimension substantially commensurate with an outer diameter of the support element and operative to hold the first and second sets of fingers in the second condition while located within the cylindrical member, the first and second sets of fingers moving from the second condition to the first condition after being discharged from the cylindrical member.

2. The combination of claim 1, further comprising a bulbous portion on the outside of the cylindrical member that spans at least a part of a circumference of the cylindrical member.

3. A heart valve prosthesis comprising:

a base portion curved about an axis and having axially spaced apart first and second ends;

a first set of substantially resilient fingers extending axially and radially outwardly from the first end of the base portion;

a second set of substantially resilient fingers extending axially and radially outwardly from the second end of the base portion in a generally opposing relationship relative to the first set of fingers;

a covering formed of two annular sheets of substantially biocompatible material attached together at radially inner peripheries thereof to provide a generally tubular body portion that is located within and extends through an interior of the base portion, radially outer portions of each of the two annular sheets extending radially outwardly from respective first and second ends of the base portion so as to cover at least part of an axially exposed surface of a respective one of the first and second sets of fingers; and

a valve located within the base portion and the tubular body portion of the covering to provide for substantially unidirectional flow of fluid through the prosthesis.

4. The prosthesis of claim 3, wherein the biocompatible material is a biological material.

5. The prosthesis of claim 3, further comprising sutures that attach the radially inner peripheries of the two annular sheets.

6. A heart valve prosthesis comprising:

an annular support element having a fixed annular length and axially opposed first and second ends;

a valve member positioned within the annular support element to provide for substantially unidirectional flow of fluid through the valve member;

a first set of substantially resilient fingers extending axially and radially outwardly from the first end of the support element and curving toward the second end of the support element; and

a second set of substantially resilient fingers extending axially and radially outwardly from the second end of the support element curving toward the first end of the support element in a generally opposing relationship relative to the first set of fingers; and

a flexible covering having first and second end portions spaced apart from each other by a central tubular body portion that is located within the annular support element, the first and second end portions extending radially outwardly from the tubular body portion along corresponding surfaces of the respective first and second sets of fingers and terminating in a peripheral edge that is spaced apart from the distal end of the respective fingers to cover axially exposed portions of the respective first and second sets of fingers without the first and second sets of fingers penetrating through the covering.

7. The prosthesis of claim 6, wherein the resilient material comprises a shape memory alloy.

8. The prosthesis of claim 6, wherein each of the first and second end portions of the covering is connected to a respective one of the first and second sets of fingers, such that the first and second end portions of the covering are moveable as a function of movement of the first and second sets of the fingers for covering the axially exposed portions of the respective first and second sets of fingers.

9. The prosthesis of claim 6, wherein the first and second sets of fingers are monolithically formed with the support element.

10. The prosthesis of claim 9, wherein each finger of the first set of fingers comprises an elongate body having a first portion that extends from the first end of the support element axially away from the second end of the support element and a second portion that extends arcuately radially outwardly and axially from the first portion toward the second end to terminate in the distal end thereof, and

wherein each finger of the second set of fingers comprises an elongate body having a first portion that extends from the second end of the support element axially away from the first end of the support element arid a second portion that extends arcuately radially outwardly and axially from the first portion toward the first end to terminate in the distal end thereof.

11. The prosthesis of claim 6, wherein the covering comprises a biological material.

12. The prosthesis of claim 6, further comprising outflow extensions at an outflow end of the valve member generally aligned with commissures of adjacent leaflets of the valve.

13. The prosthesis of claim 6, the valve member further comprising one of a biological tissue valve, a mechanical valve, and a bio-mechanical valve.