Apparatus for the introduction and manipulation of multiple telescoping catheters

• US 10,653,862 B2
• Filed: 10/27/2017
• Issued: 05/19/2020
• Est. Priority Date: 11/07/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Winston, Matthew T., Olson, Christopher J., Metchik, Asher L., Tran, Tri D., Siegel, Alexander J.
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US15/796,436
• Publication Number:
  US 20180126124A1
• Time in Patent Office: 935 Days
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A delivery apparatus includes a steerable shaft having a proximal portion, a distal portion, and a pull-wire conduit that extends through the proximal and distal portions. A pull wire extends through the conduit and has a distal portion that is fixed to the shaft. An adjustment mechanism is connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the shaft. The distal portion of the shaft has a steerable portion including one or more layers. A compression-resistance portion is incorporated into a layer of the steerable portion, and extends angularly along a portion of a cross-section of the layer. The layer of the steerable portion into which the compression-resistance portion is incorporated has a first hardness, and the compression-resistance portion has a second hardness that is greater than the first hardness.

Claims

1. A delivery apparatus, comprising:

a steerable shaft comprising a proximal portion, a distal portion, and a pull-wire conduit that extends at least partially through the proximal and distal portions of the shaft;

a pull wire extending through the pull-wire conduit and having a proximal end portion and a distal end portion, wherein the distal end portion of the pull wire is fixed to the distal portion of the shaft; and

an adjustment mechanism operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft;

wherein the distal portion of the shaft comprises a steerable portion having 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, the steerable portion including a compression-resistance portion incorporated into the second outer layer of the steerable portion and extending angularly along a portion of a cross-section of the second outer layer, the second outer layer of the steerable portion into which the compression-resistance portion is incorporated having a first hardness, the compression-resistance portion having a second hardness that is greater than the first hardness.

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

3. The delivery apparatus of claim 1, wherein the compression-resistance portion extends from 10 degrees to 180 degrees along the cross-section of the second outer layer.

4. The delivery apparatus of claim 3, wherein the compression-resistance portion extends 60 degrees along the cross-section of the second outer layer.

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

6. The delivery apparatus of claim 5, wherein the shaft further comprises a fourth braided layer braided over at least a portion of the helically coiled layer.

7. The delivery apparatus of claim 6, wherein the shaft further comprises a pull-wire conduit encapsulating layer between the first inner layer and the helically coiled layer that encapsulates the pull-wire conduit.

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

9. The delivery apparatus of claim 8, wherein:

the pull wire is a first pull wire;

the pull-wire conduit is a first pull-wire conduit; and

the shaft further comprises a second pull wire received in a second pull-wire conduit disposed adjacent the first pull-wire conduit in the recess.

10. The delivery apparatus of claim 1, wherein a ratio of the second hardness to the first hardness 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 shaft is a guide sheath, and the delivery apparatus further includes an implant catheter coaxially disposed within the guide sheath including a prosthetic valve mounted on a distal end of the implant catheter.

13. A method, comprising:

inserting a shaft of a delivery apparatus into the body of a patient, the shaft having;

a proximal portion,

a distal portion,

a pull-wire conduit that extends at least partially through the proximal and distal portions, and

a pull wire extending through the pull-wire conduit,

the distal portion of the shaft comprising a steerable portion having 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,

the steerable portion including a compression-resistance portion incorporated into the second outer layer of the steerable portion that extends angularly along a portion of a cross-section of the layer, the second outer layer of the steerable portion into which the compression-resistance portion is incorporated having a first hardness, the compression-resistance portion having a second hardness that is greater than the first hardness; and

applying tension to the pull wire to adjust the curvature of the distal portion of the shaft.

14. The method of claim 13, further comprising torqueing the shaft to rotate the distal portion of the shaft after inserting the shaft into the body, and after adjusting the curvature of the distal portion of the shaft.

15. The method of claim 13, further comprising:

mounting a prosthetic valve in a radially compressed state on a distal end of an implant catheter extending coaxially through the shaft;

inserting the prosthetic valve into the body of the patient when inserting the shaft into the body; and

deploying the prosthetic valve within the body.

16. A delivery apparatus, comprising:

a steerable shaft comprising a proximal portion, a distal portion, and a pull-wire conduit that extends at least partially through the proximal and distal portions of the shaft;

a pull wire extending through the pull-wire conduit and having a proximal end portion and a distal end portion, wherein the distal end portion of the pull wire is fixed to the distal portion of the shaft;

an adjustment mechanism operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft; and

wherein the distal portion of the 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 a compression-resistance portion incorporated into the second outer layer of the distal portion, the compression-resistance portion extending angularly along a portion of a cross-section of the second outer layer and having a hardness that is greater than a hardness of the second outer layer into which the compression-resistance portion is incorporated, the compression-resistance portion being angularly offset from the pull-wire conduit along the cross-section of the layer.

17. The delivery apparatus of claim 16, wherein the compression-resistance portion is located opposite the pull-wire conduit.

18. The delivery apparatus of claim 16, wherein the compression-resistance portion extends from 10 degrees to 180 degrees along the cross-section of the second outer layer into which the compression-resistance portion is incorporated.

19. The delivery apparatus of claim 16, wherein a ratio of the hardness of the compression-resistance portion to the hardness of the second outer layer into which the compression-resistance portion is incorporated is from 1.5:

1 to 5;

1.