Medical implant deployment tool

• US 8,287,584 B2
• Filed: 11/14/2005
• Issued: 10/16/2012
• Est. Priority Date: 11/14/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Argento, Claudio, Morejohn, Dwight, Hildebrand, Daniel, Saul, Tom, Haug, Ulrich R.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US11/274,889
• Publication Number:
  US 20070112355A1
• Time in Patent Office: 2,528 Days
• Field of Search: 606/108, 623/1.11, 623/2.11, 623 22- 226, 623/1.26, 623/1.32, 623/1.24, 623/2.1, 623/2.14, 623 217- 218, 623 223- 232, 623/1.15, 623/1.2, 623/2.4, 623/900
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A medical implant deployment tool and deployment method are disclosed. One aspect of the invention provides an implant system including an implant adapted for endovascular delivery and deployment; and a deployment tool adapted to deploy the implant, with the deployment tool having an actuation controller; a plurality of actuation elements adapted to apply forces to one or more implant deployment mechanisms and each adapted to extend along an actuation element path within a patient'"'"'s vasculature; and an actuation element compensation mechanism adapted to compensate for differences in length between the actuation element paths. Another aspect of the invention provides a method of deploying an implant including the steps of endovascularly delivering an implant and implant deployment mechanisms to an implant site and applying an actuation force to the implant deployment mechanisms through actuation elements extending through the patient'"'"'s vasculature while compensating for differences in length between actuation element path lengths to deploy the implant.

Claims

1. An implant system comprising:

an implant adapted for endovascular delivery and deployment; and

a deployment tool adapted to deploy the implant, the deployment tool comprising;

an actuation controller;

a plurality of actuation elements adapted to apply forces to one or more implant deployment mechanisms comprising an anchor;

wherein the anchor has one or more posts attached thereto;

wherein the anchor has one or more buckles attached thereto and the implant deployment mechanism is adapted to shift the position of at least one of the one or more posts relative to at least one of the one or more buckles and each actuation element is adapted to extend along an actuation element path within a patient'"'"'s vasculature; and

an actuation element compensation mechanism adapted to compensate for differences in length between the actuation element paths.

2. The system of claim 1 further comprising a catheter, the actuation elements being disposed within the catheter, the actuation element compensation mechanism comprising portions of the actuation element paths extending in a spiral along at least a portion of the catheter.

3. The system of claim 1 wherein the actuation element compensation mechanism comprises a catheter comprising a plurality of actuation element lumens, at least one actuation element being disposed in each of the actuation element lumens.

4. The system of claim 1 wherein the actuation controller comprises the actuation element compensation mechanism.

5. The system of claim 4 wherein the actuation element compensation mechanism comprises a manifold fluid reservoir and a plurality of pistons, each piston being operatively connected to an actuation element and each having a surface exposed to fluid from the reservoir.

6. The system of claim 5 wherein the actuation element compensation mechanism further comprises a source of pressurized fluid communicating with the reservoir.

7. The system of claim 5 wherein the reservoir comprises a movable wall adapted to be moved to change the volume of the reservoir.

8. The system of claim 4 wherein the actuation element compensation mechanism comprises a movable mechanical linkage operatively connected to the actuation elements.

9. The system of claim 8 wherein the mechanical linkage comprises a pivoting element.

10. The system of claim 9 wherein the mechanical linkage comprises two pivoting elements.

11. The system of claim 8 wherein the mechanical linkage comprises a spring at the proximal end of each actuation element.

12. The system of claim 8 wherein the mechanical linkage comprises a pulley.

13. The system of claim 8 wherein the mechanical linkage comprises an actuation element operation mechanism adapted to permit each actuation element to be moved separately and in unison.

14. The system of claim 1 wherein the actuation element compensation mechanism comprises a catheter comprising at least two actuation element lumens, a first actuation element being disposed in a first lumen and a second actuation element being disposed in a second lumen.

15. The system of claim 14 wherein the catheter has a bent shape.

16. The system of claim 14 wherein the first actuation element is shorter than the second actuation element.

17. The system of claim 1 wherein the actuation element compensation mechanism comprises a catheter comprising an actuation element lumen, the actuation elements being disposed in the lumen.

18. The system of claim 17 wherein the actuation element lumen is parallel to and offset from a central axis of the catheter.

19. The system of claim 1 wherein the implant is a replacement heart valve.

20. A method of deploying an implant comprising:

endovascularly delivering an implant and implant deployment mechanisms including actuation elements extending through the patient'"'"'s vasculature along actuation element path lengths to an implant site;

wherein the implant includes an anchor;

wherein the anchor has one or more posts attached thereto;

wherein the anchor has one or more buckles attached thereto;

applying an actuation force to the implant deployment mechanisms through actuation elements extending through the patient'"'"'s vasculature while compensating for differences in length between actuation element path lengths to deploy the implant; and

wherein applying an actuation force to the implant deployment mechanism shifts the position of at least one of the one or more posts relative to at least one of the one or more buckles.

21. The method of claim 20 wherein the compensating step comprises moving a proximal end of one actuation element proximal to a proximal end of another actuation element.

22. The method of claim 21 wherein the moving step comprises applying fluid pressure to a piston surface operatively connected to each actuation element.

23. The method of claim 21 further comprising locking relative positions of the proximal ends of the actuation elements prior to the applying step.

24. The method of claim 20 wherein the compensating step comprises moving a proximal end of one actuation element distal to a proximal end of another actuation element.

25. The method of claim 24 wherein the moving step comprises applying fluid pressure to a piston surface operatively connected to each actuation element.

26. The method of claim 24 further comprising locking relative positions of the proximal ends of the actuation elements prior to the applying step.

27. The method of claim 20 wherein the applying step comprises moving a hinged mechanical linkage to which proximal ends of the actuation elements are operatively connected.

28. The method of claim 20 wherein the applying step comprises moving a mechanical linkage operatively connected to proximal ends of the actuation elements through a pulley.

29. The method of claim 20 wherein the applying step comprises moving a mechanical linkage operatively connected to proximal ends of the actuation elements through springs.

30. The method of claim 20 wherein the implant is a replacement heart valve.

31. The method of claim 20 wherein the applying step comprises applying an actuation force to the implant through the implant deployment mechanisms to deploy the implant.

32. The method of claim 20 wherein the applying step comprises applying an actuation force to the implant through the implant deployment mechanisms to foreshorten the implant.

33. A method for delivering an implant, the method comprising:

providing an implant, the implant comprising;

an anchor,

a post attached to the anchor,

an actuation element coupled to the post, and

a buckle attached to the anchor;

wherein the implant is configured to shift between a delivery configuration and a deployed configuration;

advancing the implant through the vasculature of a patient to a position adjacent to an area of interest;

applying an actuation force to the actuation element;

wherein applying an actuation force to the actuation element draws the post into the buckle and shifts the implant from the delivery configuration to the deployed configuration;

wherein the implant includes one or more additional actuation elements; and

wherein an actuation element compensation mechanism is associated with the actuation element and the one or more additional actuation elements.

34. The method of claim 33, wherein the implant further comprises one or more additional posts and one or more additional buckles corresponding to the one or more additional posts.

35. The method of claim 34, further comprising applying an actuation force to the one or more additional actuation elements to draw the one or more additional posts into the corresponding one or more additional buckles.

36. The method of claim 33, wherein the actuation element compensation mechanism includes a winding actuation element path.

37. The method of claim 33, wherein the actuation element compensation mechanism includes a pulley and one or more tackles.

38. The method of claim 33, wherein the implant includes a heart valve attached to the anchor.