Methods and apparatus for loading a prosthesis onto a delivery system

• US 10,016,275 B2
• Filed: 04/20/2016
• Issued: 07/10/2018
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Nyuli, Colin A., Lane, Randy Matthew
• Primary Examiner(s): Salone, Bayan
• Application Number:
  US15/134,164
• Publication Number:
  US 20160228251A1
• Time in Patent Office: 811 Days
• Field of Search: 29515, 29516, 29505, 29508, 29509
• 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, when the prosthesis is disposed in the first central bore, to selectively deflect locating features at a discrete portion of the prosthesis radially inward while adjacent portions of the prosthesis are not displaced by the one or more actuators, in order to enable the deflected locating features to mate with the delivery system;

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; and

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,

wherein the third housing comprises a plurality of engagement elements for releasably engaging three engagement tabs arranged circumferentially around the first housing approximately every 120 degrees.

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, wherein the second central bore further comprises a second constant diameter region in communication with the first central bore and proximal thereof.

11. The device of claim 10, wherein the second central bore further comprises a filleted region disposed between the second tapered region and the second constant diameter region.

12. The device of claim 1, wherein the second central bore is at least partially cylindrically shaped.

13. The device of claim 1, wherein the second housing comprises a plurality of engagement elements for releasably engaging the second housing with an adjacent housing.

14. The device of claim 1, wherein the second housing comprises a plurality of engagement receptacles for receiving engagement elements on an adjacent housing.

15. The device of claim 1, wherein the second housing comprises a plurality of engagement elements for releasably engaging three engagement tabs arranged circumferentially around the first housing approximately every 120 degrees.

16. The device of claim 1, wherein passage of the prosthesis through the second central bore shapes the prosthesis to have a circular cross-section.

17. The device of claim 1, wherein the third central bore further comprises a third constant diameter region in communication with the third tapered region and distal thereto.

18. The device of claim 17, wherein the third central bore further comprises a filleted region disposed between the third tapered region and the third constant diameter region.

19. The device of claim 1, wherein the third central bore is at least partially cylindrically shaped.

20. The device of claim 1, wherein the third housing comprises a plurality of engagement elements for releasably engaging an adjacent housing.

21. The device of claim 1, wherein the third housing comprises a plurality of engagement receptacles for receiving engagement elements on an adjacent housing.

22. The device of claim 1, wherein passage of the prosthesis through the third central bore shapes the prosthesis to have a circular cross-section.

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

24. 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.

25. The device of claim 24, wherein the plurality of anchoring tabs are adapted to be releasably engaged with retaining features on a delivery catheter.

26. The device of claim 24, wherein the prosthesis comprises a prosthetic heart valve and the plurality of anchoring tabs comprise commissure posts of the prosthetic heart valve.

27. 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.