Valve Delivery Tool

• US 20140330368A1
• Filed: 05/02/2014
• Published: 11/06/2014
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gloss, Michael, Groen, Timothy, Nadian, Behrooz, Rust, Matthew, Ryan, Timothy, Birmingham, Evelyn, Casley, Mark, Majkrzak, Carolyn, Weston, Matthew, Anderson, Marc, McGowan Smyth, Deirdre
• Granted Patent: US 9,629,718 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• 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 2250/0007 for adjusting length

Abstract

A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Claims

1. A system comprising:

a medical device for replacing a valve of a subject, the implantable medical device having a self-expanding frame; and

a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame,

wherein the holder comprises a first controllably constrictable and expandable loop, wherein the first loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

2. A system according to claim 1,

wherein the frame comprises an inflow region,

wherein the inflow region comprises an upper portion and a lower portion, and

wherein the first loop is disposed about at least a portion of the upper portion of the inflow region of the frame such that constriction or expansion of the first loop controls constriction or expansion of the upper portion of the inflow region of the frame.

3. A system according to claim 2, wherein the holder comprises a second controllably constrictable and expandable loop, wherein the second loop is disposed about at least a portion of the lower portion of the inflow region of the frame such that constriction or expansion of the second loop controls constriction or expansion of the lower portion of the inflow region of the frame.

4. A system according to claim 3, wherein the first and second loop are independently controllably constrictable and expandable.

5. A system according to claim 3, wherein the frame comprises an outflow region and wherein the holder comprises a third controllably constrictable and expandable loop, wherein the third loop is disposed about at least a portion of the outflow region of the frame such that constriction or expansion of the third loop controls constriction or expansion of at least a portion of the outflow region of the frame.

6. A system according to claim 5, wherein the first loop is independently controllably constrictable and expandable relative to the second and third loops.

7. A system according to claim 6, wherein the second and third loops are together controllably constrictable and expandable.

8. A system according to claim 6,

wherein the first loop is a portion of a first cord, wherein the second loop is a portion of a second cord, wherein the third loop is a portion of a third cord,

wherein the holder comprises a first extension member having a first opening, a second opening and a conduit between the first and second openings,

wherein the holder comprises a second extension member having a first opening, a second opening and a conduit between the first and second openings,

wherein a portion of the first cord extends through the conduit of the first extension member, and

wherein a portion of the second and third cords extend through the conduit of the second extension member.

9. A system according to claim 8, wherein the frame has a longitudinal axis and wherein the holder is configured such that the first and second extension members are offset from the longitudinal axis of the frame and are substantially parallel to the longitudinal axis of the frame when the holder constricts the frame or retains the frame in a constricted configuration.

10. A system according to claim 9, wherein the first and second extension members are positioned external to the frame when the holder constricts the frame or retains the frame in a constricted configuration.

11. A system according to claim 8, wherein the first cord comprises a suture forming the first loop and a tether attached to an end of the suture, wherein the second cord comprises a suture forming the second loop and a tether attached to an end of the suture, and wherein the third cord comprises a suture forming the third loop and a tether attached to an end of the suture.

12. A system according to claim 8,

wherein the holder comprises an adapter configured to cooperatively mate with a shaft, where the adaptor comprises first and second lumens extending through the adaptor, and

wherein a portion of the first cord extends through the first lumen such that an end of the first cord extends beyond the adaptor and wherein a portion of the second cord extends through the second lumen such that an end of the second cord extends beyond the adaptor.

13. A system according to claim 12, further comprising the shaft, wherein the shaft defines one or more lumens through the shaft, wherein the shaft is configured to couple to the adaptor of the holder, and wherein a portion of the first cord extends through one of the one or more lumens of the shaft such that an end of the first cord extends beyond the shaft and wherein a portion of the second cord extends through one of the one or more lumens of the shaft such that an end of the second cord extends beyond the adaptor, wherein the portions of the first and second cords extend through the same lumen or different lumens of the shaft.

14. A system according to claim 13, further comprising a handle operably coupled to, or operably couplable to, the shaft.

15. A system according to claim 14, wherein the handle comprises a first actuation element operably couplable to the end of the first cord such that constriction and expansion of the first loop is controllable via the first actuation element.

16. A system according to claim 15, wherein the handle comprises a second actuation element operably couplable to the end of the second cord such that constriction and expansion of the second loop is controllable via the second actuation element.

17. A system according to claim 16, wherein the second actuation element is operably couplable to the end of the third cord such that constriction and expansion of the third loop is controllable via the second actuation element.

18. A system according to claim 15, further comprises a control unit tethered to the handle, wherein the control until comprises an actuation element operably couplable to the end of the second cord such that constriction and expansion of the second loop is controllable via the control unit actuation element.

19. A system according to claim 14, further comprising a control unit operably coupled to the handle, wherein the control unit comprises a first actuation element operably couplable to the end of the first cord such that constriction and expansion of the first loop is controllable via the first actuation element.

20. A system according to claim 19, wherein the control unit comprises a second actuation element operably couplable to the end of the second cord such that constriction and expansion of the second loop is controllable via the second actuation element.

21. A system according to claim 20, wherein the second actuation element is operably couplable to the end of the third cord such that constriction and expansion of the third loop is controllable via the second actuation element.

22. A system according to claim 1, wherein the holder further comprises a second controllably constrictable and expandable loop, wherein the second loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

23. A system according to claim 22, wherein the holder further comprises a third controllably constrictable and expandable loop, wherein the third loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

24. A system according to claim 23, wherein the first, second, and third loops together are disposed about a circumference of the frame.

25. A system according to claim 23, wherein constriction and expansion of the first, second and third loops are independently controllable.

26. A system according to claim 23, wherein constriction and expansion of the first loop is independently controllable relative to the second and third loops, wherein constriction and expansion of the second and third loops are controlled together.

27. A system according to claim 22,

wherein the first loop is a portion of a first cord,

wherein the second loop is a portion of a second cord, and

wherein the holder comprises a first extension member having a first opening, a second opening and a conduit between the first and second openings

wherein the holder comprises a second extension member having a first opening, a second opening and a conduit between the first and second openings,

wherein a portion of the first cord extends through the conduit of the first extension member, and

wherein a portion of the second cord extend through the conduit of second extension member.

28. A system according to claim 27, wherein the frame has a longitudinal axis and wherein the holder is configured such that the first and second extension members are offset from the longitudinal axis of the frame and are substantially parallel to the longitudinal axis of the frame when the holder constricts the frame or retains the frame in a constricted configuration.

29. A system according to claim 28, wherein the first and second extension members are positioned external to the frame when the holder constricts the frame or retains the frame in a constricted configuration.

30. A system according to claim 23,

wherein the first loop is a portion of a first cord, wherein the second loop is a portion of a second cord, wherein the third loop is a portion of a third cord,

wherein the holder comprises a first extension member having a first opening, a second opening, and a conduit between the first and second openings,

wherein the holder comprises a second extension member having a first opening, a second opening, and a conduit between the first and second openings,

wherein the holder comprises a third extension member having a first opening, a second opening, and a conduit between the first opening and the second opening, and

wherein a portion of the first cord extends through the conduit of the first extension member, a portion of the second cord extends through the conduit of the second extension member, and a portion of the third cord extend through the conduit of third extension member.

31. A system according to claim 30, wherein the frame has a longitudinal axis and wherein the holder is configured such that the first, second, and third members extend into a central opening of the frame at an angle relative to the longitudinal axis of the frame when the frame is expanded.

32. A system according to claim 1,

wherein the frame has a longitudinal axis,

wherein the holder further comprises an extension member having a first opening, a second opening, and a conduit between the first and second openings,

wherein the first loop is part of a first cord and wherein a portion of the first cord extends through the conduit of the extension member, and

wherein the holder is configured such that the extension member is offset from the longitudinal axis of the frame and is substantially parallel to the longitudinal axis of the frame when the holder constricts the frame or retains the frame in a constricted configuration.

33. A system according to claim 32, wherein the holder is configured such that the extension member is positioned external to the frame when the holder constricts the frame or retains the frame in a constricted configuration.

34. A delivery system for implanting a medical device having a self-expanding frame in a valve of a subject, the delivery system comprising:

a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame, the holder comprising a first controllably constrictable and expandable loop configured to be disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

35. A system according to claim 34, wherein the holder comprises a second controllably constrictable and expandable loop configured to be disposed about at least a portion of the self-expanding frame such that constriction or expansion of the second loop controls constriction or expansion of the lower portion of the inflow region of the frame.

36. A system according to claim 35, wherein the first and second loop are independently controllably constrictable and expandable.

37. A system according to claim 35,

wherein the first loop is a portion of a first cord, wherein the second loop is a portion of a second cord,

wherein the holder comprises a first extension member having a first opening, a second opening, and a conduit between the first and second openings,

wherein the holder comprises a second extension member having a first opening, a second opening, and a conduit between the first and second openings,

wherein a portion of the first cord extends through the conduit of the first extension member and wherein a portion of the second and third cords extend through the conduit of the second extension member.

38. A system according to claim 37, wherein the first and second extension members are configured to be offset from a longitudinal axis of the frame and are configured to be substantially parallel to the longitudinal axis of the frame when the holder constricts the frame or retains the frame in a constricted configuration.

39. A system according to claim 38, wherein the first and second extension members are positioned external to the frame when the holder constricts the frame or retains the frame in a constricted configuration.

40. A system according to claim 37, wherein the holder is configured such that first, second, and third members are configured to extend into a central opening of the frame at an angle relative to a longitudinal axis of the frame when the frame is expanded.

41. A system according to claim 37,

wherein the holder comprises an adapter configured to cooperatively mate with a shaft, where the adaptor comprises first and second lumens extending through the adaptor, and

wherein a portion of the first cord extends through the first lumen such that an end of the first cord extends beyond the adaptor and wherein a portion of the second cord extends through the second lumen such that an end of the second cord extends beyond the adaptor.

42. A system according to claim 41, further comprising the shaft, wherein the shaft defines one or more lumens through the shaft, wherein the shaft is configured to couple to the adaptor of the holder, and wherein a portion of the first cord extends through one of the one or more lumens of the shaft such that an end of the first cord extends beyond the shaft and wherein a portion of the second cord extends through one of the one or more lumens of the shaft such that an end of the second cord extends beyond the adaptor, wherein the portions of the first and second cords extend through the same lumen or different lumens of the shaft.

43. A system according to claim 42, further comprising a handle operably coupled to, or operably couplable to, the shaft.

44. A system according to claim 43, wherein the handle comprises a first actuation element operably couplable to the end of the first cord such that constriction and expansion of the first loop is controllable via the first actuation element.

45. A system according to claim 44, wherein the handle comprises a second actuation element operably couplable to the end of the second cord such that constriction and expansion of the second loop is controllable via the second actuation element.

46. A system according to claim 43, further comprising a control unit operably coupled to the handle, wherein the control unit comprises a first actuation element operably couplable to the end of the first cord such that constriction and expansion of the first loop is controllable via the first actuation element.

47. A system according to claim 34,

wherein the holder further comprises an extension member having a first opening, a second opening, and a conduit between the first and second openings,

wherein the first loop is part of a first cord and wherein a portion of the first cord extends through the conduit of the extension member, and

wherein the holder is configured such that the extension member is offset from a longitudinal axis of the frame and is substantially parallel to the longitudinal axis of the frame when the holder constricts the frame or retains the frame in a constricted configuration.

48. A system according to claim 47, wherein the holder is configured such that the extension member is positioned external to the frame when the holder constricts the frame or retains the frame in a constricted configuration.

49. A method for implanting a medical device having a self-expanding frame in a valve of a patient, comprising:

inserting the device into the valve of the patient, wherein the frame is in a constricted configuration; and

expanding a loop disposed around at least a portion of the frame to allow the frame to expand to cause at least a portion of the device to engage at least a portion of the valve.

50. A method according to claim 49, wherein the device is a prosthetic heart valve and wherein the self-expandable frame comprises an inflow region of the prosthetic heart valve, wherein the inflow region comprises an upper portion and a lower portion, and wherein the loop is disposed about at least a portion of the upper portion of the inflow region of the frame such that expansion of the loop allows the upper portion of the inflow region of the frame to expand.

51. A method according to claim 49, wherein the loop is in the form of a cinch suture.