Transcatheter prosthetic heart valve delivery system with recapturing feature

• US 10,105,223 B2
• Filed: 03/29/2016
• Issued: 10/23/2018
• Est. Priority Date: 03/30/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Savage, Padraig John, Pellegrini, Gianfranco Melino, Rinne, Finn Olavi, Rust, Matthew J.
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/083,910
• Publication Number:
  US 20160220370A1
• Time in Patent Office: 938 Days
• Field of Search: 623 21, 623 211, 623 212, 623 111
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

A delivery system for percutaneously deploying a stented prosthetic heart valve. The system includes a delivery capsule and a recapture assembly. The capsule is configured to compressively retain the prosthesis. The recapture assembly includes a frame and sleeve attached to the frame. The recapture assembly is transitionable from a compressed arrangement to an expanded arrangement with a distally increasing diameter.

Claims

1. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising the steps of;

receiving a delivery system on which an expandable prosthetic heart valve is provided in a first compressed arrangement within a capsule of the delivery system;

wherein the delivery system further includes a recapture assembly that is longitudinally spaced apart from the prosthetic heart valve at a position proximal to the prosthetic heart valve when the prosthetic heart valve is in the first compressed arrangement;

wherein the recapture assembly includes a recapture frame and a sleeve;

further wherein the recapture frame includes a wire frame formed of a shape memory material;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system;

retracting the capsule to allow the prosthetic heart valve to partially expand at the implantation site; and

distally advancing the recapture assembly relative to the prosthetic heart valve such that the prosthetic heart valve transitions to a second compressed arrangement within the recapture assembly.

2. The method of claim 1, further comprising the step of repositioning the prosthetic heart valve when the prosthetic heart valve is in the second compressed arrangement within the recapture assembly.

3. The method of claim 1, further comprising the step of removing the prosthetic heart valve from the patient when the prosthetic heart valve is in the second compressed arrangement within the recapture assembly.

4. The method of claim 1, wherein the delivery system includes an inner shaft assembly over which the capsule is slidably disposed;

wherein the sleeve of the recapture assembly is also slidably disposed over the inner shaft assembly.

5. The method of claim 1, wherein upon retraction of the capsule, the recapture frame of the recapture assembly transitions to an expanded arrangement.

6. The method of claim 1, further comprising the step of evaluating a position of the prosthetic heart valve relative to the implantation site after retracting the capsule and distally advancing the recapture assembly relative to the prosthetic heart valve such that the recapture assembly is distal the capsule and expands to an expanded arrangement having a distally increasing diameter.

7. The method of claim 1, wherein, in a loaded state when the stented prosthetic heart valve is in the first compressed arrangement within the capsule, the recapture assembly is longitudinally displaced from the stented prosthetic heart valve.

8. The method of claim 1, wherein a maximum diameter of the stented prosthetic heart valve in a fully expanded arrangement is greater than a maximum diameter of the stented prosthetic heart valve in the first compressed arrangement and a maximum diameter of the stented prosthetic heart valve in the second compressed arrangement.

9. The method of claim 1, wherein a maximum diameter of the stented prosthetic heart valve in the first compressed arrangement is less than a maximum diameter of the stented prosthetic heart valve in the second compressed arrangement.

10. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising the steps of:

receiving a delivery system on which an expandable prosthetic heart valve is provided in a first compressed arrangement within a capsule of the delivery system;

wherein the delivery system further includes a recapture assembly that is longitudinally spaced apart from the prosthetic heart valve at a position proximal to the prosthetic heart valve when the prosthetic heart valve is in the first compressed arrangement;

wherein the recapture assembly includes a recapture frame and sleeve, further wherein the recapture frame forms a support structure defining an internal surface and wherein the sleeve is attached to the internal surface;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system;

retracting the capsule to allow the prosthetic heart valve to partially expand at the implantation site; and

distally advancing the recapture assembly relative to the prosthetic heart valve such that the prosthetic heart valve transitions to a second compressed arrangement with the recapture assembly.

11. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising:

receiving a delivery system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly in a loaded state of the system, and a recapture assembly including a recapture frame and sleeve slidably disposed over the inner shaft assembly, the recapture assembly being longitudinally spaced from the prosthetic heart valve in the loaded state;

wherein the capsule is provided as part of a delivery sheath assembly further including a delivery sheath shaft, and further wherein the recapture assembly is slidably disposed between the delivery sheath assembly and the inner shaft assembly;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system in the loaded state;

proximally retracting the capsule relative to the prosthetic heart valve such that a distal region of the prosthetic heart valve is exposed distal the capsule, wherein the distal region self-expands toward a deployed arrangement;

evaluating a position of the prosthetic heart valve relative to the implantation site;

distally advancing the recapture assembly relative to the prosthetic heart valve such that the recapture assembly is distal the capsule and expands to an expanded arrangement having a distally increasing diameter;

distally advancing the recapture frame over the prosthetic heart valve;

arranging the recapture assembly over the prosthetic heart valve to cause the distal region of the prosthetic heart valve to transition toward the collapsed arrangement within the recapture assembly; and

fully proximally retracting the recapture assembly from the prosthetic heart valve such that the prosthetic heart valve self-deploys from the inner shaft assembly.

12. The method of claim 11, wherein distally advancing the recapture assembly includes sliding the recapture assembly relative to the delivery sheath assembly.

13. The method of claim 11, wherein the sleeve is formed of a polymeric material.

14. The method of claim 11, wherein upon retraction of the capsule relative to the recapture assembly, the recapture frame transitions to the expanded arrangement.

15. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising:

receiving a delivery system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly in a loaded state of the system, and a recapture assembly including a recapture frame and sleeve slidably disposed over the inner shaft assembly, wherein the recapture frame includes a wire frame formed of a shape memory material;

the recapture assembly being longitudinally spaced from the prosthetic heart valve in the loaded state;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system in the loaded state;

proximally retracting the capsule relative to the prosthetic heart valve such that a distal region of the prosthetic heart valve is exposed distal the capsule, wherein the distal region self-expands toward a deployed arrangement;

evaluating a position of the prosthetic heart valve relative to the implantation site;

distally advancing the recapture assembly relative to the prosthetic heart valve such that the recapture assembly is distal the capsule and expands to an expanded arrangement having a distally increasing diameter;

distally advancing the recapture frame over the prosthetic heart valve;

arranging the recapture assembly over the prosthetic heart valve to cause the distal region of the prosthetic heart valve to transition toward the collapsed arrangement within the recapture assembly;

wherein arranging the recapture sheath assembly over the prosthetic heart valve to recapture the prosthetic heart valve includes sliding the frame and sleeve over the prosthetic heart valve; and

fully proximally retracting the recapture assembly from the prosthetic heart valve such that the prosthetic heart valve self-deploys from the inner shaft assembly.

16. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising:

receiving a delivery system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly in a loaded state of the system, and a recapture assembly including a recapture frame and sleeve slidably disposed over the inner shaft assembly, the recapture assembly being longitudinally spaced from the prosthetic heart valve in the loaded state;

wherein the recapture frame includes a wire frame formed of a shape memory material;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system in the loaded state;

proximally retracting the capsule relative to the prosthetic heart valve such that a distal region of the prosthetic heart valve is exposed distal the capsule, wherein the distal region self-expands toward a deployed arrangement;

evaluating a position of the prosthetic heart valve relative to the implantation site;

distally advancing the recapture assembly relative to the prosthetic heart valve such that the recapture assembly is distal the capsule and expands to an expanded arrangement having a distally increasing diameter;

distally advancing the recapture frame over the prosthetic heart valve;

arranging the recapture assembly over the prosthetic heart valve to cause the distal region of the prosthetic heart valve to transition toward the collapsed arrangement within the recapture assembly; and

fully proximally retracting the recapture assembly from the prosthetic heart valve such that the prosthetic heart valve self-deploys from the inner shaft.

17. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising:

receiving a delivery system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly in a loaded state of the system, and a recapture assembly including a recapture frame and sleeve slidably disposed over the inner shaft assembly, the recapture assembly being longitudinally spaced from the prosthetic heart valve in the loaded state;

wherein the recapture frame forms a support structure defining an internal surface and wherein the sleeve is attached to the internal surface;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system in the loaded state;

proximally retracting the capsule relative to the prosthetic heart valve such that a distal region of the prosthetic heart valve is exposed distal the capsule, wherein the distal region self-expands toward a deployed arrangement;

evaluating a position of the prosthetic heart valve relative to the implantation site;

distally advancing the recapture assembly relative to the prosthetic heart valve such that the recapture assembly is distal the capsule and expands to an expanded arrangement having a distally increasing diameter;

distally advancing the recapture frame over the prosthetic heart valve;

arranging the recapture assembly over the prosthetic heart valve to cause the distal region of the prosthetic heart valve to transition toward the collapsed arrangement within the recapture assembly; and

fully proximally retracting the recapture assembly from the prosthetic heart valve such that the prosthetic heart valve self-deploys from the inner shaft assembly.