Transcatheter prosthetic heart valve delivery system with recapturing feature and method

• US 9,522,063 B2
• Filed: 03/09/2015
• Issued: 12/20/2016
• Est. Priority Date: 04/09/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shipley, Adam, Shanahan, John P., Crisman, Andrew
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/641,679
• Publication Number:
  US 20150173895A1
• Time in Patent Office: 652 Days
• Field of Search: 623/1.11, 623/2.1, 623/2.11, 623/2.12, 606/108, 606/191, 606/194, 606/198, 606/200
• US Class Current: 1/1
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A delivery system for percutaneously deploying a prosthetic heart valve. The system includes an inner shaft assembly, a delivery sheath capsule and a handle maintaining a first actuator and a second actuator. The capsule is configured to compressively retain the prosthetic heart valve over the inner shaft assembly. The first actuator is operated to proximally retract the delivery sheath capsule and expose the prosthetic heart valve relative to the capsule. The second actuator is operated to proximally retract the prosthetic heart valve by transmitting forces to the inner shaft assembly.

Claims

1. 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 frame to which a valve structure is attached, the delivery system including a delivery sheath capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly in a loaded state of the delivery system;

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

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

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

proximally advancing the prosthetic heart valve relative to the delivery sheath capsule by applying proximal forces to the inner shaft assembly such that the delivery sheath capsule is arranged over the prosthetic heart valve to cause the distal region of the prosthetic heart valve to transition toward the collapsed arrangement within the delivery sheath capsule; and

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

2. The method of claim 1, further comprising:

applying distal forces to the delivery sheath capsule simultaneously with applying proximal forces to the inner shaft assembly to position the capsule over the distal region of the prosthetic heart valve to transition toward the collapsed arrangement.

3. The method of claim 1, wherein the delivery system includes a handle having a housing that maintains a first actuator operable relative to the housing to apply forces to the delivery sheath capsule and a second actuator operable relative to and proximal of the housing to apply forces to the inner shaft assembly.

4. The method of claim 3, wherein the housing includes a proximal end and a distal end, the first actuator being operated toward the proximal end to apply proximal forces to the delivery sheath capsule and the second actuator being operated away from the proximal end to apply proximal forces to the prosthetic heart valve.

5. The method of claim 3, further comprising:

sliding a user interface of the first actuator within a slotted opening of the housing to move the delivery sheath capsule relative to the prosthetic heart valve.

6. The method of claim 3, further comprising:

simultaneously operating the first actuator and the second actuator to apply forces to the delivery sheath capsule and inner shaft assembly to promote recapture of the prosthetic heart valve.

7. The method of claim 1, further comprising:

releasably engaging the prosthetic heart valve with a coupling structure on an intermediate portion of the inner shaft assembly.

8. The method of claim 1, wherein the delivery sheath capsule of the delivery system extends from a distal end of a delivery shaft.

9. The method of claim 1, wherein proximally advancing the prosthetic heart valve relative to the delivery sheath capsule such that the distal region of the prosthetic heart valve is transitioned toward the collapsed arrangement within the delivery sheath capsule includes the prosthetic heart valve having an outer diameter greater than in the collapsed arrangement.

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

loading a prosthetic heart valve into a delivery system, the delivery system including a delivery sheath assembly configured to be slidably disposed over an inner shaft assembly, a capsule of the delivery sheath assembly containing the prosthetic heart valve in a compressed state;

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

proximally operating a first actuator to retract the capsule of the delivery sheath assembly relative to the prosthetic heart valve to expose a distal end of the prosthetic heart valve, wherein the distal region self-expands; and

proximally operating a second actuator to apply proximal forces on the inner shaft assembly of the delivery system and proximally advance the prosthetic heart valve relative to the delivery sheath assembly to cause the distal end of the prosthetic heart valve to transition toward the compressed state.

11. The method of claim 10, wherein loading the prosthetic heart valve comprises:

selectively engaging a prosthetic heart valve with the inner shaft assembly of the delivery system;

slidably disposing the capsule of the delivery sheath assembly over the inner shaft assembly; and

compressively containing the prosthetic heart valve within the capsule.

12. The method of claim 10, further comprising:

evaluating the prosthetic heart valve placement after retracting the capsule.

13. The method of claim 12, further comprising:

simultaneously applying distal force to the delivery sheath assembly while applying proximal force to the inner shaft assembly to recapture the prosthetic heart valve within the capsule in a recaptured state.

14. The method of claim 13, wherein applying a distal force to the delivery sheath assembly includes applying a distal force to a first actuator relative to a housing and applying a proximal force to the inner shaft assembly includes applying a proximal force to a second actuator relative to the housing.

15. The method of claim 13, wherein the prosthetic heart valve in the recaptured state has an outer diameter greater than the prosthetic heart valve in the compressed state.

16. The method of claim 10, wherein the prosthetic heart valve is engaged with a coupling structure on an intermediate portion of the inner shaft assembly when loaded.

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

loading a prosthetic heart valve into a delivery system including engaging the prosthetic heart valve with a coupling structure and compressively containing the prosthetic heart valve within a capsule;

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

at least partially deploying the prosthetic heart valve by proximally retracting the capsule 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 placement of the prosthetic heart valve;

recapturing the prosthetic heart valve such that the prosthetic heart valve returns to the compressed state by proximally operating a first actuator away from a housing of the delivery system and distally operating a second actuator relative to the housing;

repositioning the prosthetic heart valve at the implantation site;

deploying the prosthetic heart valve at the implantation site by proximally retracting the capsule such that the prosthetic heart valve self-expands; and

releasing the prosthetic heart valve from the delivery system.

18. The method of claim 17, wherein the recapturing of the prosthetic heart valve includes operating the first actuator away from a proximal end of a housing of the delivery system such that a distal end of the capsule is distal to the coupling structure.

19. The method of claim 17, wherein the recaptured prosthetic heart valve in the compressed state has an outer diameter greater than the prosthetic heart valve in the compressed state.