Methods and apparatus for loading a prosthesis onto a delivery system

• US 9,345,573 B2
• Filed: 05/29/2013
• Issued: 05/24/2016
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Original Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Inventors: Nyuli, Colin A., Lane, Randy Matthew
• Primary Examiner(s): Wilensky, Moshe
• Assistant Examiner(s): Salone, Bayan
• Application Number:
  US13/904,827
• Publication Number:
  US 20140155990A1
• Time in Patent Office: 1,091 Days
• Field of Search: 295/15, 295/05, 295/08, 295/09, 295/16
• US Class Current: 1/1
• 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 method for loading a prosthesis onto a delivery system, said method comprising:

providing a housing, the housing comprising one or more actuators that move radially inward or radially outward;

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

passing the prosthetic valve through the housing thereby reducing a diameter at a first end of the prosthetic valve to a first diameter;

actuating the one or more actuators thereby moving the plurality of commissure posts at the first end radially inward to a diameter smaller than the first diameter; and

coupling the plurality of commissure posts in the smaller diameter configuration to a delivery device.

2. The method of claim 1, wherein passing the prosthesis through the housing comprises passing the prosthetic valve through a constant diameter portion of a central channel in the first housing.

3. The method of claim 1, wherein actuating the one or more actuators comprises depressing one or more pins or fingers radially inward to engage the plurality of commissure posts, the plurality of commissure moving radially inward into the diameter smaller than the first diameter, the one or more pins or fingers passing through a wall of the housing.

4. The method of claim 3, wherein depressing comprises simultaneously depressing the one or more pins or fingers.

5. The method of claim 1, wherein reducing the diameter of the prosthetic valve at the first end comprises passing the prosthetic valve through a tapered central channel in the housing.

6. The method of claim 5, wherein passing the prosthetic valve through the tapered central channel comprises pushing or pulling the prosthetic valve therethrough.

7. The method of claim 5, wherein passing the prosthetic valve through the tapered central channel comprises shaping the prosthetic valve to have a circular cross-section.

8. The method of claim 1, further comprising further reducing diameter of the prosthetic valve at the first end from the first diameter to a second diameter less than the first diameter.

9. The method of claim 8, wherein reducing diameter of the prosthetic valve at the first end from the first diameter to the second diameter comprises passing the prosthetic valve through a second tapered central channel in the housing.

10. The method of claim 9, wherein passing the prosthetic valve through the second tapered central channel comprises pushing or pulling the prosthetic valve therethrough.

11. The method of claim 1, wherein the delivery device comprises an inner shaft and an outer shaft slidably disposed thereover, and wherein coupling the plurality of commissure posts in the smaller diameter configuration comprises disposing the plurality of commissure posts between the inner shaft and outer shafts.

12. The method of claim 1, wherein coupling the plurality of commissure posts comprises releasably engaging the commissure posts with the delivery device.

13. The method of claim 1, 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.

14. The method of claim 13, wherein cooling the prosthetic valve comprises cooling the prosthetic valve in chilled saline.

15. The method of claim 8, wherein the diameter of the prosthetic valve is reduced 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.

16. The method of claim 15, further comprising uncoupling the first housing from the second housing after the diameter has been reduced to the first diameter.

17. The method of claim 1, further comprising supporting an inner surface of the prosthesis with a support element.