GUIDE SHIELDS FOR MULTIPLE COMPONENT PROSTHETIC HEART VALVE ASSEMBLIES AND APPARATUS AND METHODS FOR USING THEM

• US 20070260305A1
• Filed: 04/30/2007
• Published: 11/08/2007
• Est. Priority Date: 04/29/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Drews, Michael, Hong, James, Ino, Takashi, Gurskis, Donnell, Fitterer, Mimi
• Granted Patent: US 9,295,548 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2427 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0091 transparent or translucent

Abstract

A heart valve assembly includes an annular prosthesis and a plurality of guide shields removably attached around a circumference of the annular prosthesis. A plurality of elongate guide rails extend from the annular prosthesis, which are releasably retained by the guide shields. During use, the annular prosthesis is directed into a biological annulus, e.g., with the guide rails retained by the guide shields, and secured to tissue surrounding the biological annulus using fasteners. The guide rails are released from the guide shields, and a valve prosthesis is advanced over the leaders and through a passage defined by the guide shields towards the annular prosthesis. The guide rails may include retentions elements that secure the valve prosthesis to the annular prosthesis. The guide shields are removed from the annular prosthesis, the guide rails are separated from the annular prosthesis, and are removed from the biological annulus.

Claims

1. A heart valve assembly implantable within a biological annulus, comprising:

a first prosthesis comprising an annular member implantable within the biological annulus, and a sewing cuff extending outwardly from the annular member;

a second valve prosthesis comprising an annular frame and at least one valve element; and

one or more guide shields removably attached to the first prosthesis and extending upwardly therefrom, the one or more guide shields at least partially defining a passage through which the second prosthesis is directed towards the first prosthesis.

2. The heart valve assembly of claim 1, wherein the first prosthesis comprises a plurality of elongate leaders extending from one of the annular member and the sewing cuff, the leaders being receivable through the second prosthesis for guiding the second prosthesis towards the first prosthesis.

3. The heart valve assembly of claim 2, wherein the second prosthesis comprises a plurality of receptacles for slidably receiving respective leaders therethrough.

4. The heart valve assembly of claim 3, wherein the receptacles and the leaders comprises cooperating connectors for securing the second prosthesis to the first prosthesis.

5. The heart valve assembly of claim 4, wherein the cooperating connectors one or more retention elements on the leaders and one or more latches in the receptacle for engaging the retention elements when the leaders pass through the receptacles, thereby preventing subsequent removal of the second prosthesis away from the first prosthesis.

6. The heart valve assembly of claim 2, wherein the one or more guide shields comprise a plurality of guide shields disposed adjacent each of the plurality of leaders.

7. The heart valve assembly of claim 6, wherein the guide shields comprise upper ends, and wherein the upper ends include elements for releasably retaining the leaders to the guide shields to maintain the leaders away from the passage at least partially defined by the guide shields.

8. The heart valve assembly of claim 1, wherein each of the guide shields comprises a wide base extending partially around a circumference of the first prosthesis, and a narrow upper end.

9. The heart valve assembly of claim 8, wherein the base is removably attached to the first prosthesis by one or more sutures that may be severed to allow the base to separated from the first prosthesis.

10. The heart valve assembly of claim 1, wherein the one or more guide shields are slidably attached to the first prosthesis by one or more tethers such that each guide shield is disposed away from the first prosthesis and is directable against the first prosthesis to at least partially define the passage for guiding the second prosthesis towards the first prosthesis.

11. The heart valve assembly of claim 10, wherein each of the one or more guide shields is removable from the first prosthesis by pulling an upper end of the guide shield, the tethers sliding freely through the first prosthesis.

12. A prosthesis for implanting a valve prosthesis within a biological annulus, comprising:

an annular prosthesis comprising an annular member implantable within the biological annulus, the annular member being compressible radially inwardly from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition; and

a plurality of guide shields removably attached around a periphery of the annular prosthesis, the guide shields defining a passage through which the second prosthesis is directed towards the first prosthesis.

13. The prosthesis of claim 12, wherein each of the guide shields comprises a wide base extending partially around a circumference of the first prosthesis, and a narrow upper end.

14. The prosthesis of claim 13, wherein the base is removably attached to the annular prosthesis by one or more sutures that may be severed to allow the base to separated from the annular prosthesis.

15. The prosthesis of claim 14, wherein the one or more sutures are arranged through holes in the guide shields and the annular prosthesis such that each of the guide shields is removable from the annular prosthesis by cutting only a single cut through the respective one or more sutures.

16. The prosthesis of claim 14, wherein the annular prosthesis comprises one or more anchoring loops for receiving the sutures therethrough such that the sutures are slidable through the anchoring loops when the sutures are severed.

17. The prosthesis of claim 12, wherein the guide shields are slidably attached to the annular prosthesis by one or more tethers such that the guide shields are disposed away from the annular prosthesis and is directable against the annular prosthesis to at least partially define the passage for guiding a valve prosthesis towards the annular prosthesis.

18. The prosthesis of claim 12, further comprising a delivery tool comprising an elongate shaft including a proximal end, a distal end sized for introduction into the biological annulus, and an actuator for deforming the annular member from the relaxed condition to the contracted condition.

19. The prosthesis of claim 12, wherein the relaxed condition comprises a generally circular shape, and the contracted condition comprises a multiple lobular shape.

20. The prosthesis of claim 12, further comprising a plurality of elongate leaders extending from the annular prosthesis for guiding a valve prosthesis towards the annular prosthesis.

21. The prosthesis of claim 20, further comprising a valve prosthesis, the leaders being receivable through the valve prosthesis for guiding the valve prosthesis towards the annular prosthesis.

22. The prosthesis of claim 21, wherein the valve prosthesis comprises a plurality of receptacles for slidably receiving respective leaders therethrough.

23. The prosthesis of claim 22, wherein the receptacles and the leaders comprises cooperating connectors for securing the valve prosthesis to the annular prosthesis.

24. The prosthesis of claim 20, wherein the guide shields comprise upper ends, and wherein the upper ends include elements for releasably retaining the leaders to the guide shields to maintain the leaders away from the passage at least partially defined by the guide shields.

25. The prosthesis of claim 24, wherein the elements comprise a slot in the upper end of the guide shields.

26. A method for implanting a heart valve assembly in a biological annulus, the method comprising:

introducing a first prosthesis into the biological annulus, the first prosthesis including a plurality of guide shields at least partially defining a passage therebetween;

advancing a second valve prosthesis through the passage at least partially defined by the guide shields and into the biological annulus;

securing the second prosthesis to the first prosthesis; and

removing the guide shields from the first prosthesis.

27. The method of claim 26, wherein introducing the first prosthesis comprises:

introducing the first prosthesis into the biological annulus in a contracted condition;

deploying the first prosthesis in the biological annulus such that the first prosthesis expands to an enlarged condition; and

securing the first prosthesis to tissue surrounding the biological annulus.

28. The method of claim 26, wherein removing the guide shields comprises:

cutting one or more sutures attaching the guide shields to the first prosthesis, thereby releasing the guide shields; and

withdrawing the guide shields and sutures from the biological annulus.

29. The method of claim 26, wherein a single cut releases each of the guide shields from the first prosthesis.

30. The method of claim 26, wherein the first prosthesis comprises a plurality of elongate leaders extending therefrom, the leaders extending out of the biological annulus when the first prosthesis is introduced into the biological annulus, and wherein the second prosthesis is advanced through the passage along the leaders.

31. The method of claim 30, wherein the second prosthesis is secured to the first prosthesis using retention elements on the leaders.

32. The method of claim 31, further comprising severing the leaders above the retention elements after securing the second prosthesis to the first prosthesis to remove severed portions of the leaders from the biological annulus.

33. The method of claim 30, wherein the leaders are at least partially retained by the guide shields away from the passage when the first prosthesis is introduced into the biological annulus, and where the leaders are released from the guide shields before the second prosthesis is advanced along the leaders.

34. The method of claim 26, wherein the guide shields are removed after the second prosthesis is secured to the first prosthesis.