METHODS AND APPARATUS FOR LOADING A PROSTHESIS ONTO A DELIVERY SYSTEM

• US 20140155990A1
• Filed: 05/29/2013
• Published: 06/05/2014
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Incorporated
• Inventors: Nyuli, Colin A., Lane, Randy Matthew
• Granted Patent: US 9,345,573 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall

Abstract

A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.

Claims

1. A device for loading a prosthesis onto a delivery system, said device comprising:

a first housing comprising a first inlet, a first outlet, and a first central bore extending therebetween, and wherein the first housing has one or more actuators configured to actuate radially inward or outward, the one or more actuators adapted to selectively compress a discrete portion of the prosthesis radially inward when the prosthesis is disposed in the first central bore and while adjacent portions of the prosthesis remain uncompressed by the one or more actuators.

2. The device of claim 1, wherein the first central bore comprises a constant diameter region.

3. The device of claim 1, wherein the first central bore comprises a first tapered region adapted to radially collapse the prosthesis from a first initial diameter to a smaller diameter when the prosthesis is passed therethrough.

4. The device of claim 1, wherein the one or more actuators comprise three actuators circumferentially disposed around the first housing about every 120 degrees.

5. The device of claim 1, wherein the one or more actuators are operably coupled together such that the one or more actuators are actuated simultaneously.

6. The device of claim 1, further comprising a collar threadably engaged with the first housing and wherein rotating the collar actuates the one or more actuators.

7. The device of claim 1, wherein the one or more actuators comprise spring loaded actuators biased to return to a position disposed radially outward from the first central bore.

8. The device of claim 1, wherein the first housing further comprises a plurality of engagement elements for engaging an adjacent housing.

9. The device of claim 1, further comprising an inner support element releasably engaged with the first housing, the inner support element configured to support an inner surface of the prosthesis.

10. The device of claim 1, further comprises a second housing coupleable end-to-end with the first housing, wherein the second housing comprising a second inlet, a second outlet, and a second central bore extending therebetween, the second central bore having a second tapered region adapted to radially collapse the prosthesis from a second initial diameter to a second smaller diameter as the prosthesis is advanced through the second central bore.

11. The device of claim 10, wherein the second central bore further comprises a second constant diameter region in communication with the first central bore and proximal thereof

12. The device of claim 11, wherein the second central bore further comprises a filleted region disposed between the second tapered region and the second constant diameter region.

13. The device of claim 10, wherein the second central bore is at least partially cylindrically shaped.

14. The device of claim 10, wherein the second housing comprises a plurality of engagement elements for releasably engaging the second housing with an adjacent housing.

15. The device of claim 10, wherein the second housing comprises a plurality of engagement receptacles for receiving engagement elements on an adjacent housing.

16. The device of claim 14, wherein the plurality of engagement elements comprise three engagement tabs arranged circumferentially around the first housing approximately every 120 degrees.

17. The device of claim 10, wherein passage of the prosthesis through the second central bore shapes the prosthesis to have a circular cross-section.

18. The device of claim 1, further comprising a third housing coupleable end-to-end with the first or the second housing, the third housing comprising a third inlet, a third outlet, and a third central bore extending therebetween and in communication with the first central bore or the second central bore, the third central bore having a third tapered region adapted to radially collapse the prosthesis from a third diameter to a diameter smaller than the third diameter as the prosthesis is advanced through the third central bore.

19. The device of claim 18, wherein the third central bore further comprises a third constant diameter region in communication with the third tapered region and distal thereto.

20. The device of claim 19, wherein the third central bore further comprises a filleted region disposed between the third tapered region and the third constant diameter region.

21. The device of claim 18, wherein the third central bore is at least partially cylindrically shaped.

22. The device of claim 18, wherein the third housing comprises a plurality of engagement elements for releasably engaging an adjacent housing.

23. The device of claim 18, wherein the third housing comprises a plurality of engagement receptacles for receiving engagement elements on an adjacent housing.

24. The device of claim 22, wherein the plurality of engagement elements comprise three engagement tabs arranged circumferentially around the first housing approximately every 120 degrees.

25. The device of claim 18, wherein passage of the prosthesis through the third central bore shapes the prosthesis to have a circular cross-section.

26. The device of claim 1, wherein the prosthesis comprises a prosthetic heart valve.

27. The device of claim 1, wherein the prosthesis comprises a plurality of anchoring tabs, and wherein actuation of the one or more actuators is adapted to move the plurality of anchoring tabs radially inward.

28. The device of claim 27, wherein the plurality of anchoring tabs are adapted to be releasably engaged with retaining features on the delivery catheter.

29. The device of claim 27, wherein the prosthesis comprises a prosthetic heart valve and the plurality of anchoring tabs comprise commissure posts of the prosthetic heart valve.

30. A system for loading a prosthesis onto a delivery system, said system comprising:

the device of claim 1;

a prosthetic cardiac valve; and

a delivery device.

31. A method for loading a prosthesis onto a delivery system, said method comprising:

providing a prosthetic valve having a plurality of commissure posts coupled thereto, wherein the prosthetic valve comprises an unbiased diameter;

reducing the unbiased diameter of the prosthetic valve in selected discrete regions, the selected discrete regions comprising the commissure posts; and

loading the reduced diameter prosthetic valve onto a delivery device.

32. The method of claim 31, wherein reducing the unbiased diameter of the prosthetic valve comprises actuating one or more actuators on a first housing, the one or more actuators selectively engaging discrete regions of the prosethetic valve.

33. The method of claim 32, further comprising passing the prosthetic valve through a constant diameter portion of a central channel in the first housing.

34. The method of claim 32, wherein actuating the one or more actuators comprises depressing one or more pins or fingers radially inward to engage the discrete regions of the prosthetic valve, the discrete regions moving radially inward into a reduced profile.

35. The method of claim 34, wherein depressing comprises simultaneously depressing the one or more pins or fingers.

36. The method of claim 31, further comprising reducing diameter of the prosthetic valve from the unbiased diameter to a first diameter less than the unbiased diameter.

37. The method of claim 36, wherein reducing diameter of the prosthetic valve from the unbiased diameter to the first diameter comprises passing the prosthetic valve through a tapered central channel.

38. The method of claim 37, wherein passing the prosthetic valve through the tapered central channel comprises pushing or pulling the prosthetic valve therethrough.

39. The method of claim 37, wherein passing the prosthetic valve through the tapered central channel comprises shaping the prosthetic valve to have a circular cross-section.

40. The method of claim 36, further comprising reducing diameter of the prosthetic valve from the first diameter to a second diameter less than the first diameter.

41. The method of claim 40, wherein reducing diameter of the prosthetic valve from the first diameter to the second diameter comprises passing the prosthetic valve through a second tapered central channel.

42. The method of claim 41, wherein passing the prosthetic valve through the second tapered central channel comprises pushing or pulling the prosthetic valve therethrough.

43. The method of claim 31, wherein the delivery device comprises an inner shaft and an outer shaft slidably disposed thereover, and wherein loading the reduced diameter prosthetic valve comprises disposing the prosthetic valve between the inner shaft and outer shafts.

44. The method of claim 31, wherein loading the reduced diameter prosthetic valve comprises releasably engaging the commissure posts with the delivery device.

45. The method of claim 31, wherein the prosthetic valve is fabricated from a nickel titanium alloy, and the method further comprises cooling the prosthetic valve to a temperature less than or equal to the austenitic finish temperature of the prosthetic valve.

46. The method of claim 45, wherein cooling the prosthetic valve comprises cooling the prosthetic valve in chilled saline.

47. The method of claim 40, wherein the diameter of the prosthetic valve is reduced from the unbiased diameter to the first diameter in a first housing, and wherein the diameter of the prosthetic valve is reduced from the first diameter to the second diameter in a second housing, and wherein the method further comprises coupling the first housing with the second housing.

48. The method of claim 47, further comprising uncoupling the first housing from the second housing after the diameter has been reduced to the first diameter.

49. The method of claim 31, further comprising supporting an inner surface of the prosthesis with a support element.