Apparatus for the introduction and manipulation of multiple telescoping catheters

Patent metadata

Field	Value
Publication number	US-11517718-B2
Application number	US-202016870790-A
Country	US
Kind code	B2
Filing date	May 8, 2020
Priority date	Nov 7, 2016
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

A delivery apparatus includes a steerable shaft having a pull-wire conduit. A pull wire extends through the pull-wire conduit. The steerable shaft includes one or more layers. A compression-resistance portion is incorporated into at least one of the one or more layers. A cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft. The compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into.

First claim

What is claimed is:

1. A delivery apparatus, comprising:
a steerable shaft having a pull-wire conduit;
a pull wire extending through the pull-wire conduit;
wherein the steerable shaft has one or more layers;
wherein the steerable shaft includes a compression-resistance portion incorporated into at least one of the one or more layers of the steerable shaft;
wherein a cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft;
wherein the compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into;
wherein the steerable shaft comprises a first inner layer that defines an inner diameter of the shaft and a second outer layer that defines an outer diameter of the shaft; and
wherein the compression-resistance portion is incorporated into the second outer layer of the shaft.

2. The delivery apparatus of claim 1 , further comprising an adjustment mechanism operatively connected to a proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of a distal portion of the steerable shaft.

3. The delivery apparatus of claim 1 , wherein the compression-resistance portion is located opposite the pull-wire conduit.

4. The delivery apparatus of claim 1 , wherein the compression-resistance portion extends from 10 degrees to 180 degrees along the cross-section of the steerable shaft.

5. The delivery apparatus of claim 4 , wherein the compression-resistance portion extends about 60 degrees along the cross-section of the steerable shaft.

6. The delivery apparatus of claim 1 , wherein the steerable shaft further comprises a third helically coiled layer between the inner layer and the outer layer.

7. The delivery apparatus of claim 6 , wherein the steerable shaft further comprises a fourth braided layer braided over at least a portion of the third helically coiled layer.

8. The delivery apparatus of claim 7 , wherein the steerable shaft further comprises a pull-wire conduit encapsulating layer between the first inner layer and the third helically coiled layer that encapsulates the pull-wire conduit.

9. The delivery apparatus of claim 1 , wherein the first inner layer defines a recess configured to receive the pull-wire conduit.

10. The delivery apparatus of claim 1 , wherein a ratio of the hardness of the compression-resistance portion to the hardness of the second outer layer is from 1.5:1 to 5:1.

11. The delivery apparatus of claim 10 , wherein the ratio is 3:1.

12. The delivery apparatus of claim 1 , wherein the steerable shaft is a guide sheath, and the delivery apparatus further includes an implant catheter coaxially disposed within the guide sheath including a prosthetic device mounted on a distal end of the implant catheter.

13. The delivery apparatus of claim 1 , further comprising a pull ring embedded in a distal portion of the shaft and coupled to a distal end of the pull wire, wherein the compression-resistance portion is proximally spaced apart from the pull ring.

14. The delivery apparatus of claim 1 , wherein the first inner layer defines a recess configured to receive the pull-wire conduit at a location radially inward of the second outer layer.

15. A system, comprising:
a steerable guide sheath comprising:
a steerable shaft having a pull-wire conduit;
a pull wire extending through the pull-wire conduit;
wherein the steerable shaft has one or more layers;
wherein the steerable shaft includes a compression-resistance portion incorporated into at least one of the one or more layers of the steerable shaft;
wherein a cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft; and
wherein the compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into;

an adjustment mechanism connected to a proximal end portion of the guide sheath and configured to increase and decrease tension in the pull wire to adjust the curvature of a distal portion of the steerable guide sheath;
an implant catheter coaxially disposed within the guide sheath; and
a prosthetic device mounted on a distal end of the implant catheter,
wherein the steerable shaft comprises a first inner layer that defines an inner diameter of the shaft and a second outer layer that defines an outer diameter of the shaft; and
wherein the compression-resistance portion is incorporated into the second outer layer of the shaft.

16. The system of claim 15 , wherein a ratio of the hardness of the compression-resistance portion to the hardness of second outer layer is from 1.5:1 to 5:1.

17. The system of claim 15 , wherein the compression-resistance portion is located opposite the pull-wire conduit.

18. The system of claim 15 , wherein the compression-resistance portion extends from 10 degrees to 180 degrees along the cross-section of the steerable shaft.

19. The system of claim 18 , wherein the compression-resistance portion extends 60 degrees along the cross-section of the steerable shaft.

20. A delivery apparatus, comprising:
a steerable shaft having a distal portion and a pull-wire conduit;
a pull wire extending through the pull-wire conduit;
a pull ring embedded in the distal portion of the shaft and coupled to a distal end of the pull wire,
wherein the steerable shaft has one or more layers;
wherein the steerable shaft includes a compression-resistance portion proximally spaced apart from the pull ring and incorporated into at least one of the one or more layers of the steerable shaft;
wherein a cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft; and
wherein the compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into.

21. The delivery apparatus of claim 20 , wherein the compression-resistance portion is located opposite the pull-wire conduit.

22. The delivery apparatus of claim 20 , wherein the compression-resistance portion extends from 10 degrees to 180 degrees along the cross-section of the steerable shaft.

23. The delivery apparatus of any of claim 20 , wherein:
the steerable shaft comprises a first inner layer that defines an inner diameter of the shaft and a second outer layer that defines an outer diameter of the shaft; and
the compression-resistance portion is incorporated into the second outer layer of the shaft.

24. The delivery apparatus of claim 23 , wherein the shaft further comprises a third helically coiled layer between the first inner layer and the second outer layer, and a fourth braided layer braided over at least a portion of the third helically coiled layer.

25. The delivery apparatus of claim 23 , wherein the first inner layer defines a recess configured to receive the pull-wire conduit at a location radially inward of the second outer layer.

Assignees

• Edwards Lifesciences Corp

Inventors

• Winston Matthew T
• Olson Christopher J
• Metchik Asher L
• Tran Tri D
• Siegel Alexander J

Classifications

• A61F2/2433

  using balloon catheter · CPC title

• A61M25/0133

  Tip steering devices · CPC title

• A61F2/2427 Primary

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

• A61M25/005

  with embedded materials for reinforcement, e.g. wires, coils, braids · CPC title

• A61M2025/015

  Details of the distal fixation of the movable mechanical means · CPC title