Inversion delivery device and method for a prosthesis

• US 9,566,154 B2
• Filed: 05/05/2014
• Issued: 02/14/2017
• Est. Priority Date: 05/16/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Czyscon, Joseph S., Leingang, Evan M., Wilson, Robert Foster, Gainor, John P.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US14/270,274
• Publication Number:
  US 20140243960A1
• Time in Patent Office: 1,016 Days
• Field of Search: 606/108, 606/194, 606/200, 623/1.11, 623/2.1, 623/2.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A delivery device usable to deliver an inverting implant is provided that includes a positioning mechanism that automatically initiates the inversion process once a predetermined length of the implant has exited a delivery catheter. The positioning mechanism allows the implant to be safely and accurately deployed with reduced operator experience and in a greater variety of target locations.

Claims

1. A delivery device for a medical implant comprising:

a handle;

a catheter extending from a distal end of said handle, said catheter including a delivery catheter and a pusher catheter slidingly disposed within said delivery catheter, wherein said delivery catheter is fixed relative to said distal end of said handle and said pusher catheter has a plurality of lumens;

a pusher catheter control moveably attached to said handle and operably coupled to said pusher catheter such that axial movement of said pusher catheter control relative to said handle causes said pusher catheter to move axially within said delivery catheter, wherein said pusher catheter control is operably coupled to said pusher catheter through a slot in said handle.

2. The delivery device of claim 1 further comprising a locking mechanism operable to prevent movement of said pusher catheter within said delivery catheter.

3. The delivery device of claim 2 wherein said pusher catheter control comprises a ring surrounding said handle.

4. The delivery device of claim 3 wherein said locking mechanism is operable by rotating said ring around said handle.

5. The delivery device of claim 1 wherein said pusher catheter comprises a non-cylindrical outer surface.

6. The delivery device of claim 1 wherein said pusher catheter comprises an outer surface defining at least one longitudinal indentation sized to contain a control wire between said outer surface and an inner surface of said delivery catheter.

7. A method of delivering an implant to a target location comprising:

advancing a delivery catheter through a vasculature to a target location, said delivery catheter connected to a handle, said delivery catheter containing a pusher catheter slidably disposed therein and an implant;

unsheathing said implant from said delivery catheter by retracting said delivery catheter relative to said pusher catheter, which is accomplished by holding said handle with a first hand while rotating a delivery catheter drive mechanism with a second hand;

retracting said pusher catheter by sliding a control in a proximal direction on an outside surface of said handle.

8. The method of claim 7 wherein unsheathing said implant from said delivery catheter further comprises:

deploying said implant in said target location;

observing said implant operably function in said target location; and

,

releasing said implant.

9. The method of claim 7 further comprising locking said pusher catheter relative to said delivery catheter.

10. The method of claim 9 wherein locking said pusher catheter relative to said delivery catheter comprises operating a locking mechanism.

11. The method of claim 10 wherein operating a locking mechanism comprises rotating said control.

12. The method of claim 7 wherein advancing a delivery catheter through a vasculature to a target location comprises advancing said delivery catheter over a guidewire that leads to the target location.

13. The method of claim 7 wherein rotating a delivery catheter drive mechanism causes said delivery catheter to retract proximally over said pusher catheter.

14. A pusher catheter for a delivery device having a handle comprising:

at least one lumen;

at least one longitudinal groove on an outside surface of said pusher catheter, and extending at least from said handle to a distal end of the pusher catheter, said groove forming a passage for a control wire when said pusher catheter is placed within a delivery catheter;

a control distal of a proximal end of said pusher catheter, said control arranged on an outside surface of, and extending through said handle, thereby allowing a user to advance or retract said pusher catheter within a delivery catheter.

15. The pusher catheter of claim 14 wherein said at least one longitudinal groove comprises a plurality of longitudinal grooves.

16. The pusher catheter of claim 14 wherein said at least one lumen comprises a plurality of lumens.