Tension management devices for stented prosthesis delivery device

Patent metadata

Field	Value
Publication number	US-11648121-B2
Application number	US-202016941158-A
Country	US
Kind code	B2
Filing date	Jul 28, 2020
Priority date	Mar 9, 2017
Publication date	May 16, 2023
Grant date	May 16, 2023

Abstract

Delivery devices and methods for delivering a stented prosthesis to a target site are disclosed. Disclosed delivery devices include a handle assembly including an actuator, an inner shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a tension management device that is configured to limit the amount of tension that can be applied via the actuator to the at least one tension member. Certain embodiments are configured to apply different tension limits to different tension members that are controlled by a one or more actuators. Other various embodiments include one or more tension adjustors to selectively adjust one or more tension limits.

First claim

What is claimed is:

1. A method comprising:
providing a delivery device comprising:
a handle assembly comprising an actuator,
an inner shaft assembly interconnected to the handle assembly,
at least one tension member, and
a tension management device comprising a first drive gear rotatable about a first axis and a first reel rotatable about the first axis, the first reel and the first drive gear are biased together into engagement in a direction of the first axis;

loading a prosthetic heart valve onto the inner shaft assembly;
rotating the actuator to rotate the first drive gear about the first axis while tension in the at least one tension member is below a predetermined tension limit, wherein the rotation of the first drive gear with the actuator causes the first reel to rotate together with the first drive gear due to the biased engagement of the first drive gear and the first reel, and the rotation of the first reel results in the at least one tension member being wound around the first reel to compress the prosthetic heart valve onto the inner shaft assembly with the at least one tension member; then
further rotating the actuator to further rotate the first drive gear about the first axis while the tension in the at least one tension member is at the predetermined tension limit, wherein the first drive gear rotatably disengages from the first reel such that the further rotation of the first drive gear about the first axis does not result in the first drive gear and the first reel rotating together in a manner that would further increase the tension of the at least one tension member above the predetermined tension limit, and
delivering the prosthetic heart valve to a target site.

2. The method claim 1 , wherein rotating the actuator to rotate the first drive gear comprises rotating the actuator to rotate an actuator gear that rotates the first drive gear.

3. The method of claim 2 , wherein the actuator comprises a generally cylindrical body comprising a threaded inner surface engaging with teeth of the actuator gear, wherein rotating the actuator rotates the actuator gear by the engagement between the threaded inner surface of the actuator and the teeth of the actuator gear.

4. The method of claim 2 , wherein the actuator gear and the first drive gear are positioned within the same plane.

5. The method of claim 1 , further comprising sheathing the compressed prosthetic heart valve with a capsule of the delivery device after the prosthetic heart valve is compressed onto the inner shaft assembly with the at least one tension member.

6. The method of claim 1 , wherein the first reel comprises a tooth that engages the first drive gear.

7. The method of claim 6 , wherein the tooth of the first reel is configured to engage a pocket in the first drive gear to achieved the biased engagement of the first drive gear and the first reel.

8. The method of claim 1 , wherein the at least one tension member comprises a first tension member and a second tension member, the method further comprising adjusting tension in the first and second tension members with the actuator.

9. The method of claim 8 , wherein the tension management device further comprises a second drive gear rotatable about a second axis and a second reel rotatable about the second axis, the second reel and the second drive gear are biased together into engagement in a direction of the second axis, the first tension member is configured to be wound around the first reel and the second tension member is configured to be wound around the second reel.

10. The method of claim 9 , further comprising rotating the first drive gear and the second drive gear by rotating a single actuating gear.

11. The method of claim 10 , wherein the single actuator gear and the first drive gear and the second drive gear are positioned within the same plane.

12. The method of claim 9 , wherein, further rotating the actuator comprises rotatably disengaging the first drive gear from the first reel and rotatably disengaging the second drive gear from the second real, wherein rotatably disengaging the first drive gear from the first reel occurs independently from rotatably disengaging the second drive gear from the second reel.

13. The method of claim 1 , wherein the actuator is directly connected to the first drive gear.

14. The method of claim 1 , further comprising adjusting the predetermined tension limit.

15. The method of claim 14 , further comprising adjusting a switch to adjust the predetermined tension limit.

16. The method of claim 15 , wherein the switch adjusts a biasing force that biases the first reel and the first drive gear together.

17. The method of claim 1 , wherein rotating the actuator achieves a maximum tension force in the at least one tension member, and the method further comprises maintaining the at least one tension member under tension when the maximum tensioning force is achieved.

18. The method of claim 1 , wherein the first reel and the first drive gear are biased into engagement with an axial face of the first reel engaging an axial face of the first drive gear and the axial faces of the first reel and the first drive gear are each perpendicular to the axis.

19. A method comprising:
providing a delivery device comprising:
a handle assembly comprising an actuator,
an inner shaft assembly interconnected to the handle assembly,
at least one tension member, wherein tension in the tension member can be adjusted with the actuator, and
a tension management device; wherein the tension management device is configured to limit the amount of tension that can be applied by the actuator to the at least one tension member; wherein a limit in the amount of tension that can be applied to the at least one tension member is adjustable with a switch;

loading a prosthetic heart valve onto the inner shaft assembly;
compressing the prosthetic heart valve onto the inner shaft assembly with the at least one tension member; and
delivering the prosthetic heart valve to a target site.

20. A method comprising:
providing a delivery device comprising:
a handle assembly comprising an actuator; wherein the actuator comprises a generally cylindrical body comprising a threaded inner surface,
an inner shaft assembly interconnected to the handle assembly,
at least one tension member, wherein tension in the tension member can be adjusted with the actuator, and
a tension management device; wherein the tension management device is configured to limit the amount of tension that can be applied by the actuator to the at least one tension member;

loading a prosthetic heart valve onto the inner shaft assembly;
compressing the prosthetic heart valve onto the inner shaft assembly with the at least one tension member; and
delivering the prosthetic heart valve to a target site.

Assignees

• Medtronic Vascular Inc

Inventors

• Vaughan Brendan

Classifications

• A61F2/95

  Instruments specially adapted for placement or removal of stents or stent-grafts · CPC title

• A61F2/2466 Primary

  Delivery devices therefor · CPC title

• A61F2/9517 Primary

  handle assemblies therefor · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title

• G01L5/0061

  Force sensors associated with industrial machines or actuators (for the specific machine or actuator involved see relevant class, e.g. F01, F04, F16, B66, E21) · CPC title