Multi-direction steerable handles for steering catheters

Patent metadata

Field	Value
Publication number	US-12097337-B2
Application number	US-202117548971-A
Country	US
Kind code	B2
Filing date	Dec 13, 2021
Priority date	Mar 21, 2016
Publication date	Sep 24, 2024
Grant date	Sep 24, 2024

Abstract

Disclosed herein are steerable catheter assemblies that utilize various mechanisms to accomplish independent control of catheter flex magnitude and catheter flex direction to provide improved steerability of an attached catheter. Some embodiments include a catheter with two or more pull wires that flex the catheter and a control handle coupled to the catheter. The control handle can include a direction control coupled to the two or more pull wires such that adjustment of the direction control adjusts a direction of catheter flex by the two or more pull wires, and the control handle can include a magnitude control coupled to the two or more pull wires such that adjustment of the magnitude control adjusts the magnitude of catheter flex.

First claim

What is claimed is:

1. A delivery assembly for implanting a prosthetic device, comprising:
a catheter;
a prosthetic device deliverable through the catheter;
a control handle coupled to the catheter, the control handle including a gimbal mechanism comprising:
an outer gimbal member pivotal about a first axis perpendicular to a longitudinal axis of the control handle; and
an inner gimbal member pivotably coupled relative to the outer gimbal member to pivot about a second axis perpendicular to the first axis;

a plurality of pull wires coupled to the control handle such that the orientation of the gimbal mechanism controls tension on the plurality of pull wires to control movement of the prosthetic device; and
a control knob rotatable about the longitudinal axis of the control handle, wherein movement of the control knob controls movement of the gimbal mechanism.

2. The delivery assembly of claim 1 , wherein movement of the prosthetic device is controlled by flexing the distal end of the catheter.

3. The delivery assembly of claim 1 , wherein the plurality of pull wires are coupled to the gimbal mechanism.

4. The delivery assembly of claim 1 , wherein the plurality of pull wires comprises at least three pull wires.

5. The delivery assembly of claim 1 , wherein the outer gimbal member is annular and the inner gimbal member is pivotably coupled within the outer gimbal member.

6. The delivery assembly of claim 1 , wherein movement of the control knob controls movement of the inner gimbal member.

7. The delivery assembly of claim 1 , wherein rotational movement of the control knob controls tension in the plurality of pull wires.

8. The delivery assembly of claim 1 , wherein the control handle further comprises a central shaft and wherein at least a portion of the plurality of pull wires extend through the central shaft.

9. The delivery assembly of claim 3 , wherein the plurality of pull wires are coupled to the gimbal mechanism by passing through one or more apertures on the gimbal mechanism.

10. The delivery assembly of claim 3 , wherein a proximal end of each of the plurality of pull wires is attached to the gimbal mechanism.

11. The delivery assembly of claim 7 , wherein the control knob is configured to be manually rotated by a user of the delivery assembly.

12. The delivery assembly of claim 8 , wherein the central shaft extends through an opening in the inner gimbal member.

13. The delivery assembly of claim 8 , wherein each of the plurality of pull wires are coupled to the gimbal mechanism by passing through one or more apertures on the gimbal mechanism, extend proximally from the one or more apertures to a proximal end of the handle, and extend distally from the proximal end of the handle through the central shaft.

14. A delivery assembly for implanting a prosthetic device, comprising:
a catheter;
a prosthetic device deliverable through the catheter;
a control handle coupled to the catheter, the control handle including a gimbal mechanism comprising:
an outer gimbal member pivotal about a first axis perpendicular to a longitudinal axis of the control handle; and
an inner gimbal member pivotably coupled relative to the outer gimbal member to pivot about a second axis perpendicular to the first axis; and

a plurality of pull wires coupled to the control handle such that the orientation of the gimbal mechanism controls tension on the plurality of pull wires to control movement of the prosthetic device,
wherein the outer gimbal member is annular and the inner gimbal member is pivotably coupled within the outer gimbal member.

15. The delivery assembly of claim 14 , further comprising a control knob rotatable about the longitudinal axis of the control handle, wherein movement of the control knob controls movement of the gimbal mechanism.

16. The delivery assembly of claim 14 , wherein the control handle further comprises a central shaft extending through an opening in the inner gimbal member.

17. A delivery assembly for implanting a prosthetic device, comprising:
a catheter;
a prosthetic device deliverable through the catheter;
a control handle coupled to the catheter, the control handle including a gimbal mechanism comprising:
an outer gimbal member pivotal about a first axis perpendicular to a longitudinal axis of the control handle;
an inner gimbal member pivotably coupled relative to the outer gimbal member to pivot about a second axis perpendicular to the first axis;
a central shaft extending through an opening in the inner gimbal member; and

a plurality of pull wires coupled to the control handle such that the orientation of the gimbal mechanism controls tension on the plurality of pull wires to control movement of the prosthetic device; and wherein at least a portion of the plurality of pull wires extend through the central shaft.

18. The delivery assembly of claim 17 , wherein the outer gimbal member is annular and the inner gimbal member is pivotably coupled within the outer gimbal member.

19. The delivery assembly of claim 17 , further comprising a control knob rotatable about the longitudinal axis of the control handle, wherein movement of the control knob controls movement of the gimbal mechanism.

Assignees

• Edwards Lifesciences Corp

Inventors

• Khuu Bao
• Winston Matthew T
• Metchik Asher L
• Dixon Eric Robert

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61M25/0147

  with movable mechanical means, e.g. pull wires · 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

• A61F2/2427

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