Beating heart buttress and implantation method to prevent prolapse of a heart valve

• US 9,005,279 B2
• Filed: 11/11/2011
• Issued: 04/14/2015
• Est. Priority Date: 11/12/2010
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/294,453
• Publication Number:
  US 20120150290A1
• Time in Patent Office: 1,250 Days
• Field of Search: 623/2.11, 623 236- 237
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An apparatus and method for mitigating prolapsed are disclosed. The apparatus includes a contact member and an elongated rod that can be used to hold the contact member in position for coapting with a patient'"'"'s native leaflets. A similarly configured sizing apparatus can also be used to facilitate implantation.

Claims

1. An apparatus for mitigating prolapse comprising

a support member having a flexible buttress, the support member configured to position the buttress spaced apart from at least one viable leaflet of a patient'"'"'s own heart valve, the buttress configured to coapt with the at least one viable leaflet to provide for unidirectional flow of blood in the space between the buttress and the at least one viable leaflet;

an elongated tubular rod attached to and extending generally axially from the buttress and being dimensioned and configured with a length sufficient to extend from the annulus and anchor in tissue axially displaced from a valve annulus associated with the patient'"'"'s heart valve, the support member and the elongated tubular rod forming a unitary structure, the elongated tubular rod being configured to stabilize the support member and buttress at a desired axial position and angular orientation relative to the patient'"'"'s heart valve annulus; and

a lumen extending axially through the elongated tubular rod and through the support member.

2. The apparatus of claim 1, wherein the tissue is located at or adjacent the apex of the heart.

3. The apparatus of claim 1, wherein the support member further comprises a flexible annular structure configured to be deformable between a reduced and expanded cross-sectional dimension, the annular structure being dimensioned and configured in the expanded cross-sectional dimension to engage the valve annulus and to maintain a position of the buttress to facilitate coaptation of the at least one viable leaflet with the buttress.

4. The apparatus of claim 3, wherein the annular structure comprises a substrate of a compliant material covered with a substantially biocompatible layer of biological material.

5. The apparatus of claim 3, wherein the buttress further comprises a pair of opposing contact surfaces configured to engage opposing leaflets, the opposing contact surfaces of the buttress being connected between opposed sides of the annular structure and extending axially from the annular structure to terminate in a distal end thereof, the elongated tubular rod extending axially from the distal end of the buttress.

6. The apparatus of claim 1, Wherein the buttress further comprises a plurality of buttress portions extending radially from a central axial region of the buttress, each of the buttress portions extending axially from a proximal end to terminate in a distal end thereof, the elongated tubular rod extending from the distal end of the buttress,

each pair of adjacent buttress portion providing a continuous contact surface dimensioned and configured to be engaged by a respective leaflet of the heart valve when the apparatus is implanted in the heart valve, whereby the buttress permits flow of blood adjacent each contact surface of the buttress.

7. The apparatus of claim 1, wherein the support member further comprises:

a generally arcuate base portion,

the buttress being farther configured to extend radially inwardly and axially relative to the base portion so as to permit substantially bi-directional flow of blood axially relative to the apparatus, a contact surface of the buttress having a surface dimensioned and configured to be engaged by at least one leaflet of the heart valve when the apparatus is implanted at the heart valve, whereby when the apparatus is implanted at the heart valve, movement of the at least one leaflet of the heart valve relative to the surface of the buttress provides substantially unidirectional flow of blood relative to the apparatus.

8. The apparatus of claim 7, Wherein the elongated tubular rod extends from a distal end of the buttress that is spaced from the base portion.

9. The apparatus of claim 3, wherein the annular structure comprises a substrate of a compliant material covered with a layer of synthetic biocompatible material.

11. The apparatus of claim 1 further comprising a guidewire extending through the lumen, the guidewire being dimensioned and configured to permit relative movement between the unitary structure and the guidewire.

10. An apparatus for mitigating prolapse comprising:

a support member covered with a substantially biocompatible layer of biological material, the support member having a flexible buttress, the support member configured to position the buttress spaced apart from at least one viable leaflet of a patient'"'"'s own heart valve, the buttress configured to coapt with the at least one viable leaflet to provide for unidirectional flow of blood in the space between the buttress and the at least one viable leaflet;

an elongated tubular rod covered with a substantially biocompatible layer of biological material, the elongated tubular rod being attached to and extending generally axially from the buttress and being dimensioned and configured with a length sufficient to extend from the annulus and anchor in tissue axially displaced from a valve annulus associated with the patient'"'"'s heart valve, such that when implanted the elongated tubular rod can stabilize the support member and buttress at a desired axial position and angular orientation relative to the patient'"'"'s heart valve annulus; and

a lumen extending axially through the elongated road and through the support member.

12. The apparatus of claim 10, further comprising a guidewire extending through and axially moveable with respect to the lumen.

13. An apparatus for mitigating prolapsed comprising:

a support member having a flexible buttress, the support member configured to position the buttress spaced apart from at least one viable leaflet of a patient'"'"'s own heart valve, the buttress configured to coapt with the at least one viable leaflet to provide for unidirectional flow of blood in the space between the buttress and the at least one viable leaflet;

an elongated tubular rod attached to and extending generally axially from the buttress and being dimensioned and configured with a length sufficient to extend from the annulus and anchor in tissue axially displaced from a valve annulus associated with the patient'"'"'s heart valve, the elongated tubular rod being configured to stabilize the support member and buttress at a desired axial position and angular orientation relative to the patient'"'"'s heart valve annulus;

a lumen extending axially through the elongated tubular rod and through the support member; and

a guidewire extending axially through and moveable with respect to the lumen.

14. The apparatus of claim 13, wherein the support member further comprises a flexible annular structure configured to be deformable between a reduced and expanded cross-sectional dimension, the annular structure being dimensioned and configured in the expanded cross-sectional dimension to engage the valve annulus and to maintain a position of the buttress to facilitate coaptation of the at least one viable leaflet with the buttress.

15. The apparatus of claim 13, wherein the buttress further comprises a plurality of buttress portions extending radially from a central axial region of the buttress, each of the buttress portions extending axially from a proximal end to terminate in a distal end thereof, the elongated tubular rod extending from the distal end of the buttress,

each pair of adjacent buttress portions providing a continuous contact surface dimensioned and configured to be engaged by a respective leaflet of the heart valve when the apparatus is implanted in the heart valve, whereby the buttress permits flow of blood adjacent each contact surface of the buttress.

16. The apparatus of claim 13, wherein the support member further comprises:

a generally arcuate base portion,

the buttress being further configured to extend radially inwardly and axially relative to the base portion so as to permit substantially bi-directional flow of blood in the space axially relative to the apparatus, a contact surface of the buttress having a surface dimensioned and configured to be engaged by at least one leaflet of the heart valve when the apparatus is implanted at the heart valve, whereby when the apparatus is implanted at the heart valve, movement of the at least one leaflet of the heart valve relative to the surface of the buttress provides substantially unidirectional flow of blood relative to the apparatus.

17. The apparatus of claim 16, wherein the elongated rod extends from a distal end of the buttress that is spaced from the base portion.