Catheter delivery system for stent valve

• US 9,675,485 B2
• Filed: 09/09/2011
• Issued: 06/13/2017
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Essinger, Jacques, Delaloye, Stephane, Hefti, Jean-Luc, Mantanus, Luc
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US13/821,434
• Publication Number:
  US 20130231736A1
• Time in Patent Office: 2,104 Days
• Field of Search: 294209-210, 811771, 81489-491, 161101
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 90/08 Accessories or related features not otherwise provided for
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A delivery catheter for a stent. The delivery catheter may comprise a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further comprises a handle at its proximal end and at least one sheath which may at least partially circumferentially cover said stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on said handle portion.

Claims

1. A delivery catheter for delivery of a valve stent, comprising:

a proximal end comprising a handle portion;

an actuator comprising a threaded element fitting within the handle portion and a manual rotary control fitting outside the handle portion, the threaded element and the rotary control being rotatable together around a longitudinal axis of the catheter for rotating the threaded element within the handle portion when the rotary control is turned;

a distal end including a stent attachment region adapted to receive a self-expanding stent;

at least one sheath configured to at least partially circumferentially cover said stent such as to retain said stent in a collapsed configuration, said sheath being coupled at its proximal end to the actuator such as to be moved along said stent;

a pin fixed to the handle portion;

wherein;

the threaded element engages the pin such that rotary movement of the threaded element within the handle portion generates axial movement of the threaded element with respect to the handle portion, the axial movement being transmitted to the sheath and to the rotary control such that the rotary control translates axially as it is turned, and

the rotary control includes an elongate generally cylindrical outer shape and overlaps at least partly a proximal region of the handle portion, said region bearing an indicator which is progressively exposed or covered according to the linear position of the rotary control and is configured to indicate an extent of displacement of the sheath at the distal end.

2. The delivery catheter according to claim 1, wherein the rotary control is configured such that the linear translation of the rotary control is the same linear translation as the sheath.

3. A delivery catheter according to claim 1, wherein the valve stent comprises first and second portions configured for engagement, in use, with opposite sides of a native aortic valve annulus;

and wherein the handle portion further comprising indicia for indicating sheath displacement with respect to a first step for deploying the first stent portion and a second step for deploying the second stent portion.

4. A delivery catheter according to claim 1, wherein the actuator is arranged such as to move the sheath in the distal and/or proximal direction(s) along an operative range of movement in response to rotation of the rotary control through about three turns or less around the longitudinal axis of the catheter.

5. The delivery catheter according to claim 4, further comprising a friction member for frictionally resisting rotation of the rotary control.

6. A delivery catheter according to claim 1, wherein the rotary control has a longitudinal length of at least 4 cm.

7. A delivery according to claim 1, wherein the handle portion further comprises an indicator rotatable about the longitudinal axis of the catheter, the indicator being positionable to indicate a rotational orientation of a stent with respect to the handle.

8. The delivery catheter of claim 7, wherein the indicator is manually settable.

9. The delivery catheter of claim 7, wherein valve stent comprises a valve having valve leaflets and associated peripheral commissures, and wherein the indicator comprises indicia for indicating the rotational orientation of at least one of the commissures.

10. A delivery catheter according to claim 1, wherein the handle portion comprises a bulbous portion intermediate distal and proximal ends of the handle portion, the bulbous portion providing a tactile positioning guide for an operators hand.

11. The delivery catheter of claim 10, wherein the bulbous portion is one or more selected from:

(i) rounded;

(ii) frusto-spherical;

(iii) distinct from the actuator.

12. The delivery catheter of claim 10, wherein the bulbous portion has one or more dimensions selected from:

(i) a radial height compared to at least one adjacent surface of at least 5 mm;

(ii) an axial extent of at least 20 mm;

(iii) a radius of curvature of at least 15 mm;

(iv) a radius of curvature not greater than 60 mm.

13. A delivery catheter according to claim 1, wherein said delivery catheter further comprises one or more gears configured for at least two different transmission ratios between the movement of the actuator and the movement of the sheath depending on the position of the distal end of the sheath along said stent.