Inversion delivery device and method for a prosthesis

• US 9,999,504 B2
• Filed: 10/13/2015
• Issued: 06/19/2018
• Est. Priority Date: 10/13/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Czyscon, Joseph, Leingang, Evan
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US14/882,324
• Publication Number:
  US 20160100941A1
• Time in Patent Office: 980 Days
• 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 2002/9511 the retaining means being filaments or wires

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 method of acting on an implant during delivery comprising:

navigating an implant to a target delivery site using a delivery catheter, said implant being releasably connected to said delivery catheter by at least one tether;

activating a mechanism that alters a linear position of at least a portion of said implant relative to at least a component of said delivery catheter;

wherein continued activation of said mechanism automatically engages and disengages a component attached to said at least one tether such that said tether experiences tension when said component is engaged and a release of said tension when said component is disengaged, and such that said component slides within a handle assembly for only a portion of a range of said mechanism; and

,

wherein engagement and disengagement of said component is dependent on a position of said mechanism.

2. The method of claim 1 wherein navigating an implant to a target delivery site using a delivery catheter comprises navigating a prosthetic valve to the target delivery site.

3. The method of claim 1 wherein activating a mechanism that alters a linear position of at least a portion of said implant relative to at least a component of said delivery catheter comprises rotating a drive knob around a lead screw.

4. The method of claim 3 wherein continued activation of said mechanism comprises continued rotation of the drive knob in a single direction in order to cause the mechanism to engage and disengage the component attached to the at least one tether.

5. The method of claim 1 wherein said engagement and disengagement of said component is defined by positions of inflection points in a cam track.

6. The method of claim 1 said engagement and disengagement of said component is defined by positions of magnets fixed linearly relative to said mechanism that interact with magnets that are fixed relative to said component.

7. The method of claim 1 wherein said component comprises a carriage.

8. A medical implant delivery system comprising:

an implant;

a delivery catheter;

at least one tether within said delivery catheter and having a distal end and a proximal end, said distal end releasably attached to said implant;

a carriage attached to said proximal end of said at least one tether;

a handle assembly at a proximal end of said delivery catheter and slidably housing said carriage therein;

an activation mechanism that changes a linear position of said implant relative to said delivery catheter;

wherein operation of said activation mechanism automatically engages and disengages said carriage such that said carriage slides within said handle assembly for only a portion of a range of said activation mechanism.

9. The medical implant delivery system of claim 8 wherein said activation mechanism that changes a linear position of said implant relative to said delivery system comprises a follower engaged to a lead screw, said follower including follower arms that ride in a cam track, said cam track including inflection points that engage and disengage said carriage.

10. The medical implant delivery system of claim 8 wherein said activation mechanism that changes a linear position of said implant relative to said delivery system comprises a follower engaged to a lead screw, said follower including magnets.

11. The medical implant delivery system of claim 8 wherein said activation mechanism that changes a linear position of said implant relative to said delivery system comprises a follower engaged to a lead screw, said follower including a rack with partial teeth that engage a gear set associated with a carriage rack on said carriage.

12. The medical implant delivery system of claim 11 further comprising a cam lifter on said rack that lifts and lowers at least one lock that connects said carriage to said lead screw.

13. A medical implant delivery system comprising:

an implant;

a delivery catheter;

at least one tether within said delivery catheter and having a distal end and a proximal end, said distal end releasably attached to said implant;

a pusher catheter slidingly disposed within said delivery catheter;

an inversion mechanism that selectively associates and disassociates movement of said at least one tether with the relative movement between the delivery catheter and the pusher catheter, said inversion mechanism comprising;

a carriage attached to said proximal end of said at least one tether;

a handle assembly at a proximal end of said delivery catheter and slidably housing said carriage therein;

an activation mechanism that changes a linear position of said implant relative to said delivery catheter;

wherein operation of said activation mechanism automatically engages and disengages said carriage such that said carriage slides within said handle assembly for only a portion of a range of said activation mechanism.

14. The medical implant delivery system of claim 13 wherein said at least one tether comprises three tethers.

15. The medical implant delivery system of claim 13 wherein said pusher catheter comprises a plurality of lumens.

16. The medical implant delivery system of claim 13 wherein said activation mechanism comprises a lead screw.

17. The medical implant delivery system of claim 16 wherein said activation mechanism further comprises a follower that moves linearly when said lead screw is rotated.

18. The medical implant delivery system of claim 17 wherein said follower comprises at least one follower arm.

19. The medical implant delivery system of claim 18 wherein said at least one follower arm rides in a cam track that engages and disengages said at least one follower arm with said carriage.