Hand Unit to Release a Self-Expanding Implant

• US 20140107757A1
• Filed: 10/17/2013
• Published: 04/17/2014
• Est. Priority Date: 10/17/2012
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Dorn, Jurgen, Hoffman, Martina
• Granted Patent: US 9,687,372 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

An elongate hand unit for deploying an elongate implant from the distal end of a delivery catheter. The hand unit has a distal end and a proximal end separated by a hand unit length. The hand unit may include a pull component and a push component. The pull component may include a pull grip sliding on the push component to deploy the implant. The push component may be operatively connected to the push element and include at its proximal end a push surface to receive during deployment of the implant a force that pushes on the push element shaft to resist proximal movement of the implant during deployment. The push component may provide a guide rail that defines a guide path for the pull grip, whereby proximal movement of the pull grip along the guide path deploys the implant.

Claims

1. An elongate hand unit for deploying an elongate implant from a distal end of a delivery catheter, the catheter having a shaft between the distal end carrying the implant and a proximal end to which the hand unit may be coupled, the shaft comprising a push element to maintain the position of the implant during deployment and a pull element to be pulled proximally relative to the push element, by a release distance sufficient to deploy the implant, wherein the elongate hand unit comprises:

a distal end and a proximal end separated by a hand unit length;

a pull component and a push component, wherein;

the pull component includes a pull grip, to be gripped and pulled proximally by the release distance, sliding on the push component, thereby to pull the pull element proximally, thereby to deploy the implant; and

the push component is operatively connected to the push element of the catheter shaft and includes at its proximal end a push surface to receive during deployment of the implant a force that pushes on the push element shaft to resist proximal movement of the implant during deployment, the push component providing a guide rail that defines a guide path for the pull grip, with a guide path length along which the pull grip can slide proximally, from a distal to a proximal end of the guide rail whereby the proximal movement of the pull grip along the guide path deploys the implant; and

a guide path extender that is movable from a compact disposition in which the push surface is a first distance from the distal end of the hand unit to an extended disposition in which the push surface is a second distance, greater than the first distance, from the distal end of the hand unit, the guide path extender making available to the pull grip an increased guide path length.

2. The elongate hand unit according to claim 1, wherein the push component comprises a telescopic tube arrangement that provides the guide path extender.

3. The elongate hand unit according to claim 2, wherein the telescopic tube arrangement includes first and second telescopically arranged tubes and a latch between them that permits the telescopic arrangement to increase in length but resists length reductions.

4. The elongate hand unit according to claim 3, wherein the guide rail is on the radially outer of the first and second telescopically arranged tubes and not on the radially inner of the first and second tubes.

5. The elongate hand unit according to claim 1, wherein the push component comprises a first and a second guide rail portion, which can couple together thereby to deliver an aggregate guide path length greater than that provided by each of the first and second portions individually, the first and second portions thereby providing the guide path extender.

6. The elongate hand unit according to claim 1, wherein the push surface is on a push hub.

7. The elongate hand unit according to claim 6, wherein the push hub can receive a guide wire.

8. The elongate hand unit according to claim 6, wherein the push hub includes a coupling for a flushing liquid.

9. The elongate hand unit according to claim 1, wherein the pull grip is a pull hub and the guide rail is tubular.

10. The elongate hand unit according to claim 9, wherein the pull hub includes a coupling for a flushing liquid.

11. The elongate hand unit according to claim 1, further comprising a tether that sets a maximum distance separating the push surface and the pull grip.

12. The elongate hand unit according to claim 1, further comprising a removable spacer that sets a minimum distance separating the push surface and the pull grip.

13. The elongate hand unit according to claim 1, wherein the catheter includes a rolling membrane at the distal end thereof that extends proximally as far as the pull component.

14. A method of deploying an elongate implant with a delivery catheter system that incorporates a shaft carrying an implant at a distal end, the shaft having a push element to maintain the position of the implant during deployment and a pull element to be pulled proximally relative to the push element, by a release distance sufficient to deploy the implant, the delivery catheter system further incorporating at a proximal end an elongate hand unit comprising a pull component having a pull grip, the hand unit further comprising a push component operatively connected to the push element, the push component providing a guide rail that defines a guide path for the pull grip, with a guide path length along which the pull grip can slide proximally, from a distal to a proximal end of the guide rail whereby the proximal movement of the pull grip along the guide path deploys the implant, the hand unit further comprising a guide path extender for increasing the length of the guide path, the method comprising:

advancing the distal end of the catheter delivery system along a bodily lumen to a position in which the implant is to be deployed;

extending the guide path extender; and

deploying the elongate implant by moving proximally the pull grip while holding the push component to prevent proximal movement of the push component.

15. The method according to claim 14, wherein the step of extending the guide path extender is performed after a first deploying step that deploys a distal part of the length of the implant and before a second deploying step that deploys a proximal part of the length of the implant.