Manual actuation system for deployment of implant

• US 8,911,487 B2
• Filed: 09/22/2010
• Issued: 12/16/2014
• Est. Priority Date: 09/22/2009
• Status: Active Grant

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Bennett, Eric, Vitus, Erin, Vargas, Matt, Bose, Arani, Pons, Stephen, Tompkins, Ben, Barry, David
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): SHIPLEY, AMY R
• Application Number:
  US12/888,137
• Publication Number:
  US 20110238147A1
• Time in Patent Office: 1,546 Days
• Field of Search: 623 111- 112, 623/2.11, 606/108, 606/213, 606/215, 606/232, 606/103, 606/74, 606/1, 600/585, 294135-136
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A system for mechanically deploying intraluminal implants is disclosed. The system is used with an implant that is delivered and/or deployed via a pull wire and includes a handle having a funnel and receiving channel for receiving the pull wire, a slider having a thumb grip and a wedge, and a shuttle having a grabber for grasping the pull wire. The thumb grip is pulled proximally to retract the wedge to cause the grabber to grasp the wire and retract the shuttle but not the wire. An extension spring linked between the slider and the shuttle abruptly pulls the shuttle to retract the pull wire after the slider is fully retracted.

Claims

1. A system for deployment of an implant, the system comprising:

an implant;

a catheter having a catheter body, a proximal end and a distal end;

a pull wire having a proximal end and a distal end, the pull wire disposed within the catheter body and releasably engaging the implant at or near the distal end of the catheter; and

a handle for retracting the pull wire, said handle comprising;

a shell having a distal end, a proximal end, a stop element, and a receptacle for receiving the proximal end of the pull wire;

a trigger slidably mounted on an exterior of the shell;

a slider slidably disposed within the shell and coupled to move with the trigger, the slider comprising a trip; and

a shuttle having a latch member that is releasably retained by the stop element and releaseable by the trip, the shuttle slidably disposed within the shell and coupled to the slider by a first energy storage member, the shuttle further comprising a wire grabber;

wherein the shuttle remains stationary during proximal retraction of the trigger which draws the slider proximally, storing potential energy in the first energy storage member, until the trip engages the latch and releases the latch from the stop element thereby allowing the shuttle to be abruptly pulled proximally by the first energy storage member.

2. A system as in claim 1, wherein the slider opens the wire grabber to release the pull wire when the trigger is fully advanced in the distal direction.

3. A system as in claim 2, wherein proximal retraction of the trigger closes the wire grabber to engage the pull wire.

4. A system as in claim 3, wherein the wire grabber comprises a lever pivotally mounted on the shuttle and a surface which is engaged by a wedge on the slider to open the grabber when the trigger is fully advanced in the distal direction.

5. A system as in claim 1, wherein the first energy storage member comprises an elastic extension member mounted between the slider and the shuttle to elongate as the trigger is proximally retracted.

6. A system as in claim 1, further comprising a second energy storage member coupled between the slider and the shell, wherein proximal retraction of the trigger stores potential energy in the second energy storage member so that the slider is returned to its distal-most position when the trigger is released.

7. A system as in claim 6, wherein the second energy storage member is a coil compression spring.

8. A system as in claim 1, wherein the receptacle on the shell has a conical surface with a wire passage at its apex so that the catheter is retained by the receptacle while the wire passes through the passage to the wire grabber.

9. A system as in claim 1 further comprising:

a resting configuration;

a grasping configuration for grasping the pull wire; and

a deployed configuration.

10. A system as in claim 9, further comprising:

at least one priming phase configuration.

11. A method for retracting a pull wire in a catheter, said method comprising:

mating a proximal end of the catheter with a handle having a slider including a tripping element;

proximally retracting a trigger on the handle to proximally translate the slider to perform the following steps in sequence;

(1) cause a grabber disposed on a shuttle having a latch to capture a proximal end of the pull wire;

(2) store potential energy in a first energy storage device coupled between the slider and the shuttle; and

(3) cause the tripping element to press the latch in order to release the shuttle so that it will be pulled proximally by the energy storage device thus retracting the pull wire relative to the catheter.

12. A method as in claim 11, wherein the step of mating a proximal end of the catheter to a handle comprises aligning the proximal end of the catheter body in a conical receptacle at a distal end of the handle with the pull wire extending through an opening at an apex of the conical receptacle.

13. A method as in claim 11, wherein the grabber has to spring-loaded pivotally mounted lever which closes on the pull wire as a wedge on the slider retracts relative to the shuttle.

14. A method as in claim 13, wherein the first energy storage device comprises a tension spring which elongates as the slider is retracted relative to the shuttle.

15. A method as in claim 14, wherein the shuttle is initially held in place by a latch on the shuttle which engages a stop on the handle and is subsequently released by a trip on the slider which engages and dislodges the latch when the slider is retracted proximally by a preselected distance.

16. A method as in claim 15, wherein the slider and the shuttle are caused to return to the distal-most position by the release of energy from a second energy storage device disposed between the slider and the handle, wherein the second energy storage device stores potential energy as the trigger is proximally refracted.

17. A method as in claim 11, further comprising releasing the trigger so that the slider and shuttle return to their distal-most positions and the grabber releases the wire.

18. A method as in claim 11, wherein the catheter carries an implant and retracting the pull wire releases the implant from the catheter.

19. A method as in claim 11, further comprising removing a first catheter from the handle and mating a proximal end of a second catheter body with the handle.

20. A method of deploying an implant, the method comprising the steps of:

providing an implant;

providing an implant tool including a shaft having a lumen and a pull wire disposed in the lumen for releaseably retaining the implant near the distal end of the lumen;

providing a handle for receiving the pull wire, the handle comprising a slider having a trip and a shuttle having a latch, the slider and shuttle for gripping and retracting the pull wire;

coupling the implant and the pull wire near the distal end of the lumen;

advancing the implant tool and implant intravascularly to an implant site;

coupling the pull wire and the handle;

retracting the slider until the trip releases the latch so that the shuttle retracts the pull wire; and

removing the implant tool, leaving the implant at the implant site.

21. The method of claim 20 where the handle comprises a lumen and the shuttle comprises a wire gripper, and the step of coupling the pull wire and the handle comprises introducing the pull wire into the lumen and retracting the slider until the wire gripper grips the pull wire.

22. The method of claim 20 where the shuttle comprises a trip, and the step of retracting the slider until the shuttle retracts the pull wire comprises retracting the slider until the slider activates the trip.

23. The method of claim 20 where the handle further comprises a retraction spring biasing the shuttle to retract within the handle, and a stop for preventing the refraction of the shuttle, and the shuttle comprises a button for resting against the stop, where the step of retracting the slider until the shuttle retracts the pull wire comprises retracting the slider until the slider depresses the button out of resting engagement with the stop.

24. The method of claim 21 where the slider comprises a wedge and the wire gripper comprises gripper elements, and wedge nests between the gripper elements before retraction of the slider, where the step of retracting the slider until the wire gripper grips the wire comprises moving the slider until the wedge no longer nests between the gripper elements.