Prosthetic vascular conduit and assembly method

• US 8,685,084 B2
• Filed: 12/28/2012
• Issued: 04/01/2014
• 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): Erezo, Darwin
• Assistant Examiner(s): SHIPLEY, AMY R
• Application Number:
  US13/729,636
• Publication Number:
  US 20130172991A1
• Time in Patent Office: 459 Days
• Field of Search: 623/2.1, 623/2.11, 623 124- 126, 623 111- 112, 623/1.23, 606/108, 606/149, 606/153, 600/36
• US Class Current: 623/2.11
• 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 kit for assembling a prosthetic vascular conduit, the kit comprising:

a prosthetic vascular conduit configured to be coupled to a prosthetic valve having an annular portion, the prosthetic vascular conduit including a terminal collar member adapted to receive the annular portion of the valve, the terminal collar member including a portion that is radially contractible to engage the annular portion of the valve to couple the valve to the 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 the prosthetic valve and an outer portion, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the conduit adjacent to the terminal collar member 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 conduit at a position corresponding to the receiving portion of the hub, wherein an inner surface of the sleeve member contacts the conduit and the terminal collar member is wrapped at least partially over and around the sleeve member such that the terminal collar member contacts an outer surface of the sleeve member;

wherein the sleeve member is removable from the hub so as to cause the terminal collar member to lose contact with the inner and outer surfaces of the sleeve member and be wrapped around the annular portion of the prosthetic valve when the prosthetic valve is housed within the inner portion of the receiving portion of the hub.

2. The kit of claim 1, wherein a cuff is located at or near an end portion of the terminal collar member.

3. The kit of claim 2, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof.

4. The kit of claim 2, wherein the terminal collar member of the conduit is anchored to the sleeve member via a first set of anchoring threads.

5. The kit of claim 4, wherein the first set of anchoring threads is passed through the cuff and wherein the sleeve member can be removed from the conduit once the anchoring threads of the first set are defeated.

6. The kit of claim 4, wherein the conduit is anchored to the holder device via a second set of anchoring threads.

7. The kit of claim 6, further including a ring member rigidly connected to the shaft, the anchoring threads of the second set being secured to the ring member.

8. The kit of claim 2, wherein the cuff is formed of a material permitting suturing of the annular portion of the prosthetic valve to the conduit.

9. The kit of claim 8, wherein the annular portion is a sewing ring of the prosthetic valve.

10. The kit of claim 1, wherein the shaft includes a handle provided at a distal portion thereof.

11. The kit of claim 10, further comprising a coupling mechanism for coupling the holder device to a base member, the coupling mechanism disposed at an end of the distal portion of the shaft.

12. The kit of claim 1, wherein the terminal collar member includes at least one angular marker for angularly referencing the prosthetic valve with respect to the terminal collar member.

13. The kit of claim 1, wherein the conduit includes a radially expandable portion adjacent the terminal collar member.

14. A kit for assembling a prosthetic vascular conduit, the kit comprising:

a prosthetic vascular conduit configured to be coupled to a prosthetic valve having an annular portion, the prosthetic vascular conduit including a terminal collar member adapted to receive the annular portion of the valve, the terminal collar member including a portion that is radially contractible to engage the annular portion of the valve to couple the valve to the 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 the prosthetic valve and an outer portion, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the conduit adjacent to the terminal collar member 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 conduit at a position corresponding to the receiving portion of the hub, wherein an inner surface of the sleeve member contacts the conduit and the terminal collar member is wrapped at least partially over and around the sleeve member such that the terminal collar member contacts an outer surface of the sleeve member, and wherein an inner diameter of the sleeve member is sized and dimensioned to accommodate the conduit and the terminal collar member;

wherein the sleeve member is removable from the hub so as to cause the terminal collar member to lose contact with the inner and outer surfaces of the sleeve member and be wrapped around the annular portion of the prosthetic valve once the prosthetic valve is housed within the inner portion of the receiving portion of the hub.

15. The kit of claim 14, wherein the inner diameter of the sleeve member exceeds an outer diameter of the terminal collar member by substantially twice a wall thickness of the conduit.

16. A kit for assembling a prosthetic vascular conduit, the kit comprising:

a prosthetic vascular conduit configured to be coupled to a prosthetic valve having an annular portion, the prosthetic vascular conduit including a terminal collar member adapted to receive the annular portion of the valve, the terminal collar member including a portion that is radially contractible to engage the annular portion of the valve to couple the valve to the conduit;

a holder assembly including a shaft comprising a distal portion and a proximal portion, and a hub located at an end of the proximal portion of the shaft, wherein the distal portion and proximal portions are separate and may be removably coupled, the distal portion includes a handle, the distal portion includes a coupling mechanism for being removably coupled to a base member in order to render the holder assembly self-standing, the hub including a receiving portion including an inner portion to house the prosthetic valve and an outer portion, wherein the prosthetic vascular conduit is fitted on the holder assembly so that at least a portion of the conduit adjacent to the terminal collar member 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 conduit at a position corresponding to the receiving portion of the hub, wherein an inner surface of the sleeve member contacts the conduit and the terminal collar member is wrapped at least partially over and around the sleeve member such that the terminal collar member contacts an outer surface of the sleeve member;

wherein the sleeve member is removable from the hub so as to cause the terminal collar member to lose contact with the inner and outer surfaces of the sleeve member and be wrapped around the annular portion of the prosthetic valve when the prosthetic valve is housed within the inner portion of the receiving portion of the hub.

17. The kit of claim 16, wherein the receiving portion of the hub includes at least one window.