Instrument and method for in situ development of cardiac valve prostheses

• US 9,056,008 B2
• Filed: 11/09/2011
• Issued: 06/16/2015
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Righini, Giovanni, Achiluzzi, Monica
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US13/292,236
• Publication Number:
  US 20120053684A1
• Time in Patent Office: 1,315 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

An instrument for deploying a cardiac valve prosthesis, including a plurality of radially expandable portions, at an implantation site, includes a plurality of deployment elements each independently operable to obtain the radial expansion of a radially expandable portion of the valve prosthesis. A method for deploying the cardiac valve prosthesis includes advancing the instrument to an implant site and independently actuating the radially expandable portions.

Claims

1. A cardiac valve implantation system for implanting a mitral valve prosthesis at an implantation site associated with a mitral valve annulus, the system comprising:

an expandable mitral valve prosthesis including an annular inflow portion, an annular outflow portion, and a plurality of valve leaflets;

a deployment instrument including;

a control handle;

a carrier portion for enclosing and carrying the mitral valve prosthesis, the carrier portion including;

a first independently operable deployment element operable to deploy the annular inflow portion at an atrial side of a mitral valve annulus, such that the annular inflow portion is located within the first deployment element when radially constrained;

a second independently operable deployment element operable to deploy the annular outflow portion at a ventricular side of a mitral valve annulus, such that the annular outflow portion is located within the second deployment element when radially constrained; and

a sheath that is attached to and extends proximal to the first deployment element;

a tubular member extending from the control handle and through the carrier portion, wherein the sheath of the carrier portion is configured to slide on the tubular member;

a wire extending from the control handle to the second deployment element and slidably arranged within the tubular member;

a locking member comprising a hub positioned on a distal end of the tubular member, the hub comprising a first end flange and a second end flange that are configured to maintain the annular outflow portion at a fixed axial position along the tubular member in order to prevent any undesired sliding movement of the annular outflow portion with respect to the second deployment element lengthwise of the carrier portion as long as the annular outflow portion is radially constrained by the second deployment element, wherein the first end flange is arranged proximal to the annular outflow portion and the second end flange is arranged distal to the annular outflow portion when the annular outflow portion is maintained at a fixed axial position by the locking member, and wherein the tubular member is connected to the first and second end flanges; and

a delivery device adapted to provide a pathway from outside the patient'"'"'s body for delivery of the deployment instrument to the implantation site.

2. The system of claim 1, wherein the mitral valve prosthesis comprises a plurality of expandable members.

3. The system of claim 1, wherein the mitral valve prosthesis is self-expandable.

4. The system of claim 1, wherein the deployment elements each comprise a sheath.

5. The system of claim 1, wherein the deployment elements each comprise a collar.

6. The system of claim 1, wherein the deployment elements each comprise a cap.

7. The system of claim 1, wherein the deployment elements are porous.

8. The system of claim 1, wherein the deployment elements include apertures.

9. The system of claim 1, wherein the annular outflow portion and annular inflow portion are releasable by axial movement of the deployment elements along the deployment instrument.

10. A system for implanting a mitral valve prosthesis in a patient'"'"'s heart, comprising, in combination,

an expandable, tissue, stented mitral valve prosthesis including an annular inflow portion and an annular outflow portion, and

a valve delivery device for delivering the stented mitral valve prosthesis to a mitral valve annulus in the patient'"'"'s heart, the delivery device comprising:

a deployment module for expanding the stented mitral valve prosthesis, the deployment module comprising;

a control handle;

a carrier portion for enclosing and carrying the mitral valve prosthesis, the carrier portion including;

a first deployment element operable to deploy the annular inflow portion at an atrial side of a mitral valve annulus and configured to enclose the annular inflow portion when radially constrained, wherein the first deployment element is actuatable in an axial direction to allow the annular inflow portion to expand;

a second deployment element operable to deploy the annular outflow portion at a ventricular side of a mitral valve annulus and configured to enclose the annular outflow portion when radially constrained, wherein the second deployment element is actuatable in an axial direction to allow the annular outflow portion to expand; and

a sheath that is attached to and extends proximal to the first deployment element;

a tubular member extending through the carrier portion, wherein the sheath of the carrier portion is configured to slide on the tubular member;

a wire extending from the control handle to the second deployment element and slidably arranged within the tubular member;

a locking member comprising a hub positioned on a distal end of the tubular member, the hub comprising a first end flange and a second end flange that are configured to maintain the annular outflow portion of the prosthesis at a fixed axial position when radially constrained;

wherein each of the first and second deployment elements are independently operable, and wherein the locking member is configured to prevent any undesired sliding movement of the annular outflow portion with respect to the second deployment element lengthwise of the carrier portion as long as the annular outflow portion is radially constrained by the second deployment element wherein the first end flange is arranged proximal to the annular outflow portion and the second end flange is arranged distal to the annular outflow portion when the annular outflow portion is maintained at a fixed axial position by the locking member, and wherein the tubular member is connected to the first and second end flanges.

11. The system of claim 10, wherein the mitral valve prosthesis comprises a plurality of expandable members.

12. The system of claim 10, wherein the mitral valve prosthesis is self-expandable.

13. The system of claim 10, wherein the deployment elements each comprise a sheath.

14. The system of claim 10, wherein the deployment elements each comprise a collar.

15. The system of claim 10, wherein the deployment elements each comprise a cap.

16. The system of claim 10, wherein the deployment elements are porous.

17. The system of claim 10, wherein the deployment elements include apertures.

18. The system of claim 10, wherein the annular outflow portion and annular inflow portion are releasable by axial movement of the deployment elements along the deployment module.