Prosthetic vascular conduit and assembly method

• US 9,138,314 B2
• Filed: 02/10/2014
• Issued: 09/22/2015
• Est. Priority Date: 12/29/2011
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Rolando, Giovanni, Gaschino, Paolo, Achiluzzi, Monica, Carlino, Felice Giuseppe
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US14/176,533
• Publication Number:
  US 20140188217A1
• Time in Patent Office: 589 Days
• Field of Search: 623/2.11, 623 236- 238, 623/2.4, 623 111- 112, 606/153, 606/108, 600/36
• US Class Current: 1/1
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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: Y10T 29/49412 with assembly, disassembly or composite article making

Abstract

A kit for implanting a prosthetic vascular conduit includes a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion. The conduit includes a terminal collar member for receiving the valve. The kit further includes a holder including a shaft and a hub including a receiving portion configured for housing a prosthetic valve. The conduit is fitted on the holder so that at least a portion of the conduit wraps over the receiving portion of the hub. A sleeve member fitted onto the conduit in a position corresponding to the receiving portion of the hub, and a portion of the collar member is wrapped or folded over the sleeve member. The sleeve member is slidable away from the hub to unwrap the collar member such that it is disposed around the annular portion of a prosthetic valve.

Claims

1. A method of assembling a prosthetic valved conduit, comprising:

providing a kit including;

a prosthetic heart valve having an annular portion;

a prosthetic vascular conduit having a terminal collar member to receive the annular portion of the prosthetic heart valve, the terminal collar member including a cuff that is radially contractible to engage the annular portion of the prosthetic heart valve to couple the prosthetic heart valve to the prosthetic vascular conduit;

a holder device including a shaft and a hub located at an end of a proximal portion of the shaft, the hub including a receiving portion to house the prosthetic heart valve, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the conduit adjacent to the cuff wraps around the receiving portion of the hub; and

a sleeve member fitted onto the prosthetic vascular conduit at a position corresponding to the receiving portion of the hub, wherein the cuff is wrapped at least partially over the sleeve member;

advancing the prosthetic heart valve into the receiving portion of the hub until the annular portion of the prosthetic heart valve contacts the receiving portion;

sliding the sleeve member away from the hub to cause the cuff of the prosthetic vascular conduit to wrap around the annular portion of the prosthetic heart valve; and

securing the cuff of the prosthetic vascular conduit around the annular portion of the prosthetic heart valve by radially contracting the cuff.

2. The method of claim 1, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof, and wrapping the cuff comprises pulling the drawstring.

3. The method of claim 1, further comprising anchoring the terminal collar member of the prosthetic vascular conduit to the sleeve member by passing a first set of anchoring threads through the cuff.

4. The method of claim 1, further comprising anchoring the prosthetic vascular conduit to the holder device via a second set of anchoring threads.

5. The method of claim 1, further comprising coupling the holder device to a base member to hold the holder device in a vertical orientation.

6. The method of claim 1, further comprising subsequently implanting the prosthetic valved conduit.

7. The method of claim 6, wherein implanting the prosthetic valved conduit comprises:

placing suture threads through an aortic annulus;

passing the suture threads through the cuff, a sewing ring and again through the cuff;

parachuting the prosthetic valved conduit along the suture threads to the aortic annulus;

securing the prosthetic valved conduit to the aortic annulus by tying the suture threads;

cutting the suture threads securing the prosthetic vascular conduit to the holder device; and

removing the holder device.

8. A method of assembling a prosthetic valved conduit, comprising:

providing a kit including;

a prosthetic heart valve having an annular portion;

a prosthetic vascular conduit having a terminal collar member to receive the annular portion of the prosthetic heart valve, the terminal collar member including a cuff that is radially contractible to engage the annular portion of the prosthetic heart valve to couple the prosthetic heart valve to the prosthetic vascular conduit;

a holder device including a shaft and a hub located at an end of a proximal portion of the shaft, the hub including a receiving portion including an inner portion to house a prosthetic heart valve and an outer portion, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the prosthetic vascular conduit adjacent to the cuff surrounds the receiving portion of the hub and contacts the outer portion of the receiving portion; and

a sleeve member fitted onto and surrounding the prosthetic vascular conduit at a position corresponding to the receiving portion of the hub, wherein an inner surface of the sleeve member contacts the prosthetic vascular conduit and the cuff is wrapped at least partially over and around the sleeve member such that the cuff contacts an outer surface of the sleeve member;

advancing the prosthetic heart valve into the receiving portion of the hub until the annular portion of the prosthetic heart valve contacts the receiving portion;

removing the sleeve member from the hub to cause the cuff of the prosthetic vascular conduit to lose contact with the inner and outer surfaces of the sleeve member and be wrapped around the annular portion of the prosthetic heart valve; and

securing the cuff of the prosthetic vascular conduit around the annular portion of the prosthetic heart valve by radially contracting the cuff.

9. The method of claim 8, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof, and wrapping the cuff comprises pulling the drawstring.

10. The method of claim 8, further comprising anchoring the terminal collar member of the prosthetic vascular conduit to the sleeve member by passing a first set of anchoring threads through the cuff.

11. The method of claim 8, further comprising anchoring the prosthetic vascular conduit to the holder device via a second set of anchoring threads.

12. The method of claim 8, further comprising coupling the holder device to a base member to hold the holder device in a vertical orientation.

13. The method of claim 8, further comprising subsequently implanting the prosthetic valved conduit.

14. The method of claim 13, wherein implanting the prosthetic valved conduit comprises:

placing suture threads through an aortic annulus;

passing the suture threads through the cuff, a sewing ring and again through the cuff;

parachuting the prosthetic valved conduit along the suture threads to the aortic annulus;

securing the prosthetic valved conduit to the aortic annulus by tying the suture threads;

cutting the suture threads securing the prosthetic vascular conduit to the holder device; and

removing the holder device.