Hypotube shaft with articulation mechanism

Patent metadata

Field	Value
Publication number	US-10213300-B2
Application number	US-201615004373-A
Country	US
Kind code	B2
Filing date	Jan 22, 2016
Priority date	May 4, 2012
Publication date	Feb 26, 2019
Grant date	Feb 26, 2019

Abstract

A delivery device for a prosthetic heart valve includes a shaft, a sheath, and a pull wire. The shaft has a proximal end, a distal end, and a longitudinal axis. The sheath is attached to the shaft and is rotatable about an axis transverse to the longitudinal axis of the shaft. The pull wire is mechanically coupled to the sheath such that movement of the pull wire rotates the sheath relative to the shaft. The sheath may be in a first position relative to the shaft when a distal end of the pull wire is in a first position and may be in a second position when the distal end of the pull wire is in a second position. Deflection of the sheath relative to the shaft enables a prosthetic valve to be axially aligned with the native valve annulus for deployment.

First claim

The invention claimed is:

1. A device for delivering a medical aid into a patient, the device comprising:
a hollow shaft having proximal and distal ends, a longitudinal axis, and flexible and rigid portions between the proximal and distal ends, the flexible portion being configured to bend away from the longitudinal axis and the hollow shaft distal end having an end face;
a guide bushing having a first lumen, an exterior surface, and a body defined between the first lumen and the exterior surface, a portion of the exterior surface of the guide bushing abutting the end face of the hollow shaft distal end;
a pull wire directly attached to and extending within the body of the guide bushing;
a flexible tube extending through the first lumen of the guide bushing; and
a sheath mechanically coupled to the flexible tube, the sheath surrounding a distal end of the flexible tube in a first position and being slidable to a second position to expose the distal end of the flexible tube,
wherein the guide bushing is in a first position when the pull wire is in a first position and the guide bushing is in a second position when the pull wire is in a second position.

2. The device of claim 1 , further comprising a resilient member extending through the flexible portion of the hollow shaft and attached to proximal and distal portions of the hollow shaft.

3. The device of claim 2 , wherein the resilient member is a spring having a flat surface such that movement of the resilient member is substantially within a plane perpendicular to the flat surface.

4. A device for delivering a medical aid into a patient, the device comprising:
a hollow shaft having a proximal portion including a proximal end, a distal portion including a distal end, and flexible and rigid portions between the proximal and distal ends, the hollow shaft proximal portion having a longitudinal axis and the flexible portion being configured to bend away from the longitudinal axis;
a pull wire mechanically coupled to the hollow shaft;
a flexible tube extending through the distal portion of the hollow shaft a guide bushing having a first lumen, an exterior surface, and a body defined between the first lumen and the exterior surface, the exterior surface of the guide bushing being sized to matingly engage an interior surface of the hollow shaft distal portion; and a sheath mechanically coupled to the flexible tube, the sheath surrounding a distal end of the flexible tube in a first position, and the sheath being slidable to a second position exposing the distal end of the flexible tube, wherein the hollow shaft distal portion is in a first position when the pull wire is in a first position and the hollow shaft distal portion is in a second position when the pull wire is in a second position, and wherein the pull wire extends within the body of the guide bushing.

5. The device of claim 4 , wherein the flexible tube is in a first position when the pull wire is in the first position and the flexible tube is in a second position when the pull wire is in the second position.

6. The device of claim 4 , wherein the hollow shaft distal portion has a central axis, the central axis and the longitudinal axis of the hollow shaft proximal portion being parallel when the hollow shaft distal portion is in the first position, and the central axis and the longitudinal axis of the hollow shaft proximal portion being transverse to each other when the hollow shaft distal portion is in the second position.

7. The device of claim 4 , further comprising an elastomeric sleeve that tightly covers the flexible portion of the hollow shaft to prevent blood leakage through the flexible portion.

8. The device of claim 4 , further comprising a valve assembled on the flexible tube, wherein the valve is in a first position when the pull wire is in the first position and the valve is in a second position when the pull wire is in the second position.

9. The device of claim 8 , further comprising a sheath slidable relative to the flexible tube between a first position in which the sheath surrounds the valve and holds the valve in a contained configuration and a second position in which the sheath exposes the valve for deployment.

10. The device of claim 4 , wherein the distal portion has an inner surface along a part of a length thereof defining an inner lumen having a smaller perimeter than a rest of the length of the inner surface of the hollow shaft.

11. The device of claim 4 , further comprising:
a spring attached to the proximal and distal portions of the hollow shaft and extending through the flexible portion of the hollow shaft, wherein the spring has a surface that defines a plane parallel to the longitudinal axis when the hollow shaft distal portion is in the first position such that movement of the spring is substantially within a plane perpendicular to the surface.

12. A device for delivering a medical aid into a patient, the device comprising: a hollow shaft having a proximal portion including a proximal end, a distal portion including a distal end, and flexible and rigid portions between the proximal and distal ends, the hollow shaft proximal portion having a longitudinal axis and the flexible portion being configured to bend away from the longitudinal axis; a pull wire mechanically coupled to the hollow shaft; a flexible tube extending through the distal portion of the hollow shaft; and a sheath mechanically coupled to the flexible tube, the sheath surrounding a distal end of the flexible tube in a first position, and the sheath being slidable to a second position exposing the distal end of the flexible tube, wherein the hollow shaft distal portion is in a first position when the pull wire is in a first position and the hollow shaft distal portion is in a second position when the pull wire is in a second position, and wherein the flexible portion is in a form of a coil.

13. The device of claim 12 , wherein the coiled flexible portion is formed by a continuous spiral cut along the hollow shaft.

14. The device of claim 12 , further comprising a guide bushing having a first lumen, an exterior surface, and a body defined between the first lumen and the exterior surface, the exterior surface of the guide bushing being sized to matingly engage an interior surface of the distal portion of the hollow shaft.

15. The device of claim 14 , wherein the pull wire extends within the body of the guide bushing.

16. A device for delivering a medical aid into a patient, the device comprising:
a hollow shaft having proximal and distal ends, a longitudinal axis, and flexible and rigid portions between the proximal and distal ends, the flexible portion being configured to bend away from the longitudinal axis;
a guide bushing having a first lumen, the guide bushing being sized to matingly engage the hollow shaft distal end;
a pull wire directly and fixedly attached to the guide bushing;
a flexible tube extending through the first lumen of the guide bushing; and
a sheath mechanically coupled to the flexible tube, the sheath surrounding a distal end of the flexible tube in a first position and the sheath being slidable to a second position exposing the distal end of the flexible tube,
wherein the guide bushing is in a first position when the pull wire is in a first position and the guide bushing is in a second position when the pull wire is in a second position.

17. The device of claim 16 , wherein the flexible tube is in a first position when the pull wire is in the first position and the flexible tube is in a second position when the pull wire is in the second position.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Klima Daniel J
• Laplante Jeffrey P

Classifications

• A61F2/2427

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

• A61M2025/015

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

• A61B2017/00318

  Steering mechanisms · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61M25/0147

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