Support device for heart valve prostheses

Patent metadata

Field	Value
Publication number	US-9358105-B2
Application number	US-201313835593-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Apr 4, 2012
Publication date	Jun 7, 2016
Grant date	Jun 7, 2016

Abstract

A support device for implanting a stentless heart valve prosthesis having three leaflets adapted for coapting and defining three corresponding commissures is disclosed. The support device includes a shaft defining a manipulation axis, the shaft having a proximal portion and a distal portion, and three support formations integrally formed and extending from the proximal end of the shaft, the support formations angularly distributed about the manipulation axis of the shaft, such that each of the support formations correspond to locations of each of the commissures of the stentless heart valve prosthesis. The shaft includes a connection portion flexibly connecting the shaft and the support formations to permit a displacement of the manipulation axis with respect to the support formations. The shaft, the plurality of support formations and the connection portion are integrally formed from a single tubular element.

First claim

We claim:

1. A support device for implantation of a stentless aortic heart valve prosthesis having three leaflets adapted for coapting and defining three corresponding commissures, the support device including:
a shaft defining a manipulation axis, the shaft having a distal portion and a proximal portion having a coupling formation adapted for coupling with a manipulation tool; and
three support formations integrally formed and extending from the distal portion of the shaft, the support formations disposed with even angular spacing around the manipulation axis of the shaft, such that each of the support formations correspond to locations of each of the commissures of the stentless heart valve prosthesis;
wherein each of the support formations includes a first portion, the first portion of each support arm extends distally away from the shaft and radially away from the manipulation axis and a second portion of each support arm is bent with respect to the first portion and extends proximally and parallel to the manipulation axis, the first portion having a longitudinal length and a first cross-sectional configuration along the longitudinal length, and a second portion, having a second cross-sectional configuration, and extending from the first portion, the first cross-sectional configuration along the longitudinal length of the first portion having a U-shape and configured such that the first portion has a greater bending moment of inertia than the second portion;
wherein the shaft includes a flexible portion connecting the shaft and the support formations to permit a displacement of the manipulation axis with respect to the support formations, the flexible portion consisting of a helical track extending about a circumference of the shaft; and
wherein the shaft, the plurality of support formations and the flexible portion are integrally formed from a single tubular element.

2. The support device claim 1 , wherein the tubular element is made of a shape memory material.

3. The support device of claim 1 , wherein the support formations departing from a hub on the shaft are disposed adjacent to the connection portion.

4. The support device of claim 1 , wherein the first portion of each support arm also extends in an axial direction from the distal portion of the shaft.

5. The support device of claim 1 , wherein the flexible portion consists of a helical track extending at least three times around the shaft.

6. The support device of claim 1 , further comprising a manipulation tool having a feature for releasably coupling with the coupling formation on the proximal end of the shaft and the manipulation tool having an ergonomic handle.

7. The support device of claim 1 , wherein the shaft includes a plurality of through holes distributed and axially staggered around the shaft, such that each through hole is disposed at a position aligned with a corresponding supporting formation.

8. The support device of claim 7 , wherein each of the through holes is disposed on the hub.

9. The support device of claim 1 , wherein each support arm includes a first eyelet located at a position between the first and second portions and a second eyelet located at a free end of the second portion.

10. The support device of claim 1 , wherein the stentless aortic heart valve prosthesis is coupled to the support device with suturing coupling each of the commissures of the stentless heart valve prosthesis to a corresponding support arm.

11. A support device for implantation of a stentless heart valve prosthesis having three leaflets adapted for coapting and defining three corresponding commissures, the support device including:
a shaft defining a manipulation axis, the shaft having a proximal portion and a distal portion; and
three support formations integrally formed and extending from the distal end of the shaft, the support formations disposed with even angular spacing around the manipulation axis of the shaft, such that each of the support formations correspond to locations of each of the commissures of the stentless heart valve prosthesis;
wherein each of the support formations includes a first proximal portion extending from the distal end of the shaft with both a radial and an axial extension component, the axial extension component extending distally with respect to the shaft, the radial extension component extends radially away from the manipulation axis, and a second distal portion having a first end extending from the first proximal portion and having a second end that is free and that extends proximally with respect to the first end, the second distal portion extending parallel to the shaft and radially aligned with the first proximal portion, and the second distal portion of each support arm is bent with respect to the first proximal portion and extends proximally and parallel to the manipulation axis;
wherein the shaft includes a flexible portion connecting the shaft and the support formations to permit a displacement of the manipulation axis with respect to the support formations; and
wherein the shaft, the plurality of support formations and the flexible portion are integrally formed from a single tubular element.

12. The support device of claim 11 , wherein each of the first proximal portions has a first cross-sectional configuration and each of the second distal portions has a second cross-sectional configuration, the first cross-sectional configuration having a greater bending moment than the second cross-sectional configuration.

13. The support device of claim 12 , wherein the first proximal portion has a U-shaped cross section.

14. The support device of claim 11 , wherein each of the first proximal portions has a first dimension and each of the second distal portions has a second dimension, such that the first proximal portion has a greater bending stiffness than the second distal portion.

15. The support device of claim 11 , further comprising a manipulation tool having a feature for releasably coupling with the coupling formation on the distal end of the shaft and the manipulation tool having an ergonomic handle.

16. The support device of claim 11 , wherein the stentless aortic heart valve prosthesis is coupled to the support device with suturing coupling each of the commissures of the stentless heart valve prosthesis to a corresponding support arm.

17. The support device of claim 11 , wherein the coupling formation is a helical track extending around a circumference of the shaft.

18. The support device of claim 17 , wherein the helical track extends at least three times around the circumference of the shaft.

Assignees

• Sorin Group Italia Srl

Inventors

• Marchisio Andrea
• Rolando Giovanni
• Gaschino Paolo

Classifications

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title