Systems and methods for delivering a medical implant

• US 20070203503A1
• Filed: 02/14/2007
• Published: 08/30/2007
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Hildebrand, Daniel, Valencia, Hans, Argento, Claudio, Brandt, Brian, Salahieh, Amr, Dueri, Jean-Pierre, Saul, Tom, Morejohn, Dwight, Haug, Ulrich
• Granted Patent: US 7,988,724 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/2215 having an open distal end
• 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 2/2433 using balloon catheter
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter

Abstract

The present invention relates to apparatus and methods for endovascularly delivering and releasing a prosthesis, e.g., an aortic prosthesis, within and/or across a patient'"'"'s native heart valve, referred to hereinafter as replacing the patient'"'"'s heart valve. In some embodiments the delivery system comprises a plurality of first actuatable element adapted to engage a plurality of second elements in a first configuration to capture the implant within the delivery system, and wherein the plurality of first actuatable element are adapted to engage the plurality of second elements in a second configuration and to release the implant from the delivery system.

Claims

1. A delivery system adapted to deliver a medical implant through a body lumen and release the medical implant at a location within the body, the delivery system comprising:

a plurality of first actuatable elements adapted to engage a plurality of second elements in which the first and second elements are adapted to define a space with a fixed shape in which a portion of the implant is captured.

2. The system of claim 1 wherein the plurality of first actuatable elements and the plurality of second elements are adapted such that by actuating the plurality of first actuatable elements a portion of the implant is released from the plurality of second elements.

3. The system of claim 1 wherein the plurality of first actuatable elements and the plurality of second elements are adapted to engage to lock.

4. The system of claim 1 wherein the plurality of first actuatable elements are adapted to be actuated with a proximally directed force.

5. The system of claim 4 wherein the delivery system is adapted to deliver the proximally directed force from outside the body.

6. The system of claim 1 wherein the plurality of actuatable elements are rigid elements.

7. The system of claim 1 wherein the medical implant is an expandable anchor.

8. The system of claim 1 wherein the delivery system is adapted to be configured in a first delivery configuration and a second expanded configuration.

9. The system of claim 8 further comprising a restraining mechanism adapted to limit the expansion of the delivery system.

10. The system of claim 1 wherein neither the plurality of first actuatable elements nor the plurality of second elements are adapted to be coupled to the implant.

11. A capturing system adapted to releasably capture a medical implant in a delivery system wherein the delivery system is adapted to deliver the medical implant through a body lumen, the capturing system comprising:

a plurality of finger elements; and

a plurality of actuatable elements each configured to slidably interface with one of the plurality of finger elements;

wherein each of the plurality of actuatable elements is adapted to engage one of the plurality of finger elements in a first position so as to capture a portion of the medical implant, and each of the plurality of actuatable elements is adapted to engage one of the plurality of finger elements in a second position to release the portion of the medical implant from the coupling system.

12. The system of claim 11 wherein the plurality of finger elements and the plurality of actuatable elements are adapted to engage to lock together.

13. The system of claim 12 wherein the plurality of finger elements and the plurality of actuatable elements are adapted to engage to lock in the first position.

14. The system of claim 12 wherein the plurality of finger elements and the plurality of actuatable elements are adapted to engage to lock in the second position.

15. The system of claim 12 wherein the plurality of actuatable elements are adapted to be actuated by a proximally directed force.

16. The system of claim 12 wherein the plurality of actuatable elements are adapted to be actuated to be unlocked from the plurality of finger elements.

17. The system of claim 16 wherein the actuatable element comprises a lock element which is adapted to engage with the finger element to lock them together, the actuatable element further comprising a lock stop element adapted to prevent movement of the lock element after the actuatable element is unlocked from the first position.

18. The system of claim 17 wherein the lock element and lock stop element are shaped to mate.

19. The system of claim 16 wherein the plurality of actuatable elements are adapted to be actuated to be moved from the unlocked position to the second position.

20. The system of claim 19 wherein the actuatable elements are adapted to slide on the exterior surface of the plurality of finger elements.

21. The system of claim 19 wherein the plurality of actuatable elements are adapted to be locked in the second position by releasing an actuation force on the plurality of actuatable elements.

22. The system of claim 21 wherein the plurality of actuatable elements are adapted to be locked in the second position by releasing a proximally directed actuation force.

23. The system of claim 11 further comprising a plurality of release actuators, wherein the plurality of actuatable elements are adapted to be actuated by the plurality of release actuators.

24. The system of claim 23 wherein the plurality of release actuators comprises a plurality of release actuator arrays.

25. The system of claim 11 wherein the plurality of finger elements comprise an implant interface, and wherein the implant engages with the implant interface in the first position.

26. The system of claim 25, wherein the implant interface is disposed near the distal end of the plurality of finger elements.

27. The system of claim 25 wherein the implant interface comprises a cavity in the finger element adapted to receive the portion of the implant.

28. The system of claim 11 wherein neither the plurality of actuatable elements nor the plurality of finger elements are adapted to be coupled to the portion of the implant.

29. The system of claim 11 wherein the portion of the implant is released from the capturing system as the actuatable element is moved from the first position to the second position.

30. The system of claim 29 wherein the actuatable elements comprise an ejection element adapted to eject the portion of the implant from the finger element while the actuatable element is being moved from the first position to the second position, thus releasing the portion of the implant from the capturing system.

31. The system of claim 30 wherein the ejection element is disposed substantially at the distal end of the actuatable element.

32. The system of claim 11 wherein the capturing system is adapted to assume a first collapsed delivery configuration and a second expanded configuration.

33. The system of claim 32 wherein the plurality of finger elements comprise a restraining device adapted to limit expansion of the capturing system.

34. The system of claim 33 wherein the restraining device passes through each of a set of holes in the plurality of finger elements, thereby coupling the plurality of finger elements and limiting the expansion of the plurality of finger elements.

35. The system of claim 11 wherein the medical implant comprises an expandable braid.

36. A method of endovascularly delivering and releasing a medical implant near a heart valve of a patient, the method comprising:

endovascularly delivering the medical implant to a location near or within a heart valve in a delivery configuration with a delivery system;

preventing the implant from being released from the delivery system, wherein the delivery system comprises a plurality of first actuatable elements engaging a plurality of finger elements in a first configuration;

actuating the plurality of first actuatable elements such that the plurality of first actuatable elements engage the plurality of finger elements in a second configuration, thereby releasing the medical implant from the delivery system.

37. The method of claim 36 wherein delivery of the medical implant comprises expanding the delivery system from the delivery configuration to an expanded configuration.

38. The method of claim 37 further comprising limiting the expansion of the delivery system.

39. The method of claim 36 wherein preventing the implant from being released comprises capturing at least a portion of the medical implant in a space between the finger element and the actuatable element.

40. The method of claim 36 wherein actuating the plurality of first actuatable elements comprises unlocking the plurality of actuatable elements from the plurality of finger elements.

41. The method of claim 40 wherein unlocking the plurality of actuatable elements from the plurality of finger elements comprises applying a proximally directed force on the plurality of actuatable elements.

42. The method of claim 36 wherein actuating the plurality of first actuatable elements comprises sliding the plurality of actuatable elements on the exterior face of the finger elements.

43. The method of claim 42 wherein the sliding comprising applying a proximally directed force to the plurality of actuatable elements.

44. The method of claim 36, wherein releasing the medical implant from the delivery system comprises ejecting the implant from the delivery system.

45. The method of claim 44 wherein ejecting the implant comprises ejecting the implant from the delivery system as the plurality of actuatable elements move from the first configuration to the second configuration.

46. The method of claim 44 wherein ejecting the medical implant comprises engaging a distal end of the actuatable element with at least a portion of the medical implant to release the medical implant from the finger element.

47. The method of claim 40 further comprising releasing a proximally directed force applied to the plurality of actuatable elements, wherein releasing the proximally directed force relocks the plurality of actuatable elements with the plurality of finger elements.