Methods of implanting an implantation device

• US 8,579,965 B2
• Filed: 11/01/2011
• Issued: 11/12/2013
• Est. Priority Date: 08/03/2001
• Status: Expired due to Term

• Current Assignee: JenaValve Technology, Inc., Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: JenaValve Technology, Inc., Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Bonhoeffer, Philipp, Boudjemline, Younes
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US13/286,459
• Publication Number:
  US 20120283823A1
• Time in Patent Office: 742 Days
• Field of Search: 606/108, 606/200, 623/1.11, 623/1.12, 623/1.23, 623/1.24, 623/1.26, 623/1.36, 623/2.11, 623/23.68
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

The implant implantation unit (2), at a determined position in the tubular element (51) with a wall comprising a cavity (50), is pushed there by a catheter (60) and the unit comprises deformable feelers (31) to, under the control of remote activation elements (42), change from a stowed form to a deployed functional form, to detect the cavity (50) and position itself there with reference to the position of the cavity.

Claims

1. A method of implanting an implantation device for a valve prosthesis relative to a native heart valve, the method comprising:

advancing an implantation device in a collapsed configuration to a position proximate a native valve having native valve leaflets, wherein the implantation device comprises a carrier element, a valve prosthesis supported by the carrier element, three feeler elements connected to and expandable radially outwardly relative to the carrier element;

allowing the feeler elements to radially expand relative to the carrier element while the carrier element remains in the collapsed configuration;

inserting each of the radially expanded feeler elements into a cavity defined by respective native valve leaflets and a wall of a blood vessel to which the native valve leaflets are attached;

positioning the carrier element in the collapsed configuration in a space substantially surrounded by the native valve leaflets; and

allowing the carrier element to radially expand and exert an outward radial force against the wall of the blood vessel, thereby anchoring the implantation device in position relative to the native heart valve.

2. The method of claim 1, wherein advancing the implantation device in a collapsed configuration comprises advancing the implantation device via a catheter comprising an outer sleeve and an inner sleeve, and wherein allowing the feeler elements to radially expand comprises releasing the feeler elements from the outer sleeve and allowing the carrier element to radially expand comprises releasing the carrier element from the inner sleeve.

3. The method of claim 1, wherein the native valve is an aortic valve.

4. A method of implanting an implantation device for a valve prosthesis relative to a native valve, the method comprising:

maintaining an implantation device formed from a shape memory material in a collapsed configuration via a catheter;

positioning the implantation device in the collapsed configuration relative to a native valve;

releasing at least one element of the implantation device to radially expand the at least one element relative to a remainder of the implantation device;

engaging the released at least one element with a native valve leaflet; and

radially confining the remainder of the implantation device via the catheter to remain in the collapsed configuration during the releasing and engaging of the at least one element.

5. The method of claim 4, wherein the at least one element comprises at least one arm having a free end, the method further comprising positioning the free end within a cavity defined by the native valve leaflet and a wall of a blood vessel to which the native valve leaflet is attached.

6. The method of claim 5, further comprising releasing the remainder of the implantation device to radially expand the remainder of the implantation device.

7. The method of claim 6, wherein releasing the remainder of the implantation device engages the native valve leaflet between the remainder of the implantation device and the at least one element.

8. The method of claim 4, wherein the at least one element of the implantation device comprises three arms disposed substantially 120 degrees apart from each other, and wherein the method further comprises positioning each arm within an aortic sinus.

9. The method of claim 4, radially confining the remainder of the implantation device via the catheter comprises radially confining a carrier element configured to support a valve prosthesis, wherein the at least one element is connected to the carrier element.

10. A method of implanting an implantation device relative to a native valve, the method comprising:

advancing an implantation device comprising a carrier element and at least one feeler element connected to the carrier element to a position proximate a native valve having native valve leaflets;

inserting the at least one feeler element into a cavity defined by one of the native valve leaflets and a wall of a blood vessel to which the native valve leaflet is connected; and

positioning the carrier element in a space substantially surrounded by the native valve leaflets.

11. The method of claim 10, further comprising positioning the carrier element and the at least one feeler element such that the one of the native valve leaflets is between the carrier element and the at least one feeler element.

12. The method of claim 10, further comprising deploying the carrier element to anchor the implantation device relative to the native valve.

13. The method of claim 12, wherein deploying the carrier element comprises expanding the carrier element.

14. The method of claim 13, wherein expanding the carrier element comprises expanding the carrier element via a balloon.

15. The method of claim 13, wherein expanding the carrier element comprises allowing the carrier element to self-expand.

16. The method of claim 13, wherein expanding the carrier element comprises radially dilating a valve prosthesis carried by the carrier element.

17. The method of claim 12, wherein deploying the carrier element comprises deploying the carrier element such that the carrier element exerts a radial force on the native valve leaflets and the wall of the blood vessel to which the native valve leaflets are attached.

18. The method of claim 17, wherein the radial force is sufficient to anchor the carrier element relative to the native valve.

19. The method of claim 10, further comprising deploying at least part of the at least one feeler element radially outwardly relative to the carrier element prior to inserting the at least one feeler element.

20. The method of claim 19, wherein deploying the at least one feeler element comprises deploying the at least one feeler element independently of deploying the carrier element.

21. The method of claim 20, wherein deploying the at least one feeler element comprises removing a sleeve within which the at least one feeler element is received during advancing of the implantation device.

22. The method of claim 10, wherein advancing the implantation device comprises advancing an implantation device comprising a valve prosthesis carried by the carrier element.

23. The method of claim 10, further comprising advancing a valve prosthesis to be carried by the carrier element to the carrier element positioned in the space.

24. The method of claim 10, wherein advancing the implantation device comprises advancing an implantation device comprising a carrier element and a plurality of feeler elements disposed about the carrier element at spaced angular positions.

25. The method of claim 24, wherein inserting the plurality of feeler elements comprises inserting each of the plurality of feeler elements into respective cavities defined by respective valve leaflets and the wall of the blood vessel to which the valve leaflets are attached.

26. The method of claim 10, wherein inserting the at least one feeler element comprises inserting the at least one feeler element such that a free end of the at least one feeler element moves along an inclined base of the cavity and causes rotation of the implantation device.

27. The method of claim 10, wherein inserting the at least one feeler element comprises inserting the at least one feeler element such that a free end of the at least one feeler element moves along an inclined base of the cavity and causes automatic positioning of the implantation device.

28. The method of claim 10, wherein inserting the at least one feeler element comprises rotating the implantation device.

29. The method of claim 10, wherein advancing the implantation device comprises advancing the implantation device to a position proximate an aortic valve.

30. The method of claim 10, wherein advancing the implantation device comprises advancing the implantation device to a position proximate a native heart valve.

31. The method of claim 10, wherein advancing the implantation device comprises advancing the implantation device with the at least one feeler element folded toward the carrier element.

32. The method of claim 10, further comprising containing the carrier element within an inner sleeve and containing the at least one feeler element within an outer sleeve positioned concentrically about the inner sleeve during the advancing of the implantation device.

33. The method of claim 32, further comprising sequentially deploying the at least one feeler element and the carrier element by sequentially removing the at least one feeler element from the outer sleeve and the carrier element from the inner sleeve.

34. The method of claim 10, wherein inserting the at least one feeler element comprises inserting the at least one feeler element until a free end of the at least one feeler element substantially reaches a base of the cavity and provides a sensation permitting detection of a location of the implantation device.

35. The method of claim 10, wherein advancing the implantation device comprises advancing the implantation device within a lumen of the blood vessel.

36. The method of claim 10, wherein the carrier element comprises a tubular mesh structure, and the method further comprises expanding the tubular mesh structure after the positioning.

37. The method of claim 10, wherein inserting the at least one feeler element comprises inserting exactly three feeler elements into respective cavities defined by respective native valve leaflets and the wall of the blood vessel.

38. The method of claim 10, wherein inserting the at least one feeler element further comprises inserting at least one feeler element that extends in an axial direction and radially outwardly relative to the carrier element.