Systems and Methods for Loading and Deploying an Intravascular Device

• US 20180055637A1
• Filed: 07/27/2017
• Published: 03/01/2018
• Est. Priority Date: 08/29/2016
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Randolf von Oepen
• Inventors: von Oepen, Randolf, McNiven, Sean A., Valencia, Francisco, Salvador, Ken C., Xie, Yongjin
• Granted Patent: US 11,109,967 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An intravascular device delivery system includes an elongated member with a distal end cap and a delivery disc that are longitudinally movable using a disc handle. A main body of the disc handle is configured to move the distal end cap and a movable body of the disc handle is configured to move the delivery disc. The movable body is movable relative to the main body, and the main body and movable body are movable together.

Claims

1. An intravascular device delivery system, the system comprising:

an elongated member having a distal end and a proximal end with a longitudinal axis extending therebetween, the elongated member including,

a coil,

a distal end cap longitudinally fixed to the coil,

a delivery catheter positioned longitudinally overlapping at least a portion of the coil, and

a delivery disc longitudinally fixed to the delivery catheter; and

a disc handle configured to move the distal end cap and delivery disc, the disc handle including,

a main body distal end cap configured to move the distal end cap, and

a movable body configured to move the delivery disc longitudinally relative to the distal end cap.

2. The system of claim 1, further comprising a distal cable configured to transmit tension from the main body to the distal end cap.

3. The system of claim 1, further comprising a proximal cable configured to transmit tension from the movable body to the distal end cap.

4. The system of claim 1, wherein the movable body is configured to be selectively fixed relative to the main body.

5. The system of claim 1, further comprising at least one tensioning element connected to the distal end cap or the delivery disc.

6. The system of claim 5, wherein the at least one tensioning element is a suture.

7. The system of claim 1, wherein the distal end cap or delivery disc further comprises a tensioning element release mechanism.

8. The system of claim 7, wherein the tensioning element release mechanism includes one or more electrically conductive elements.

9. An intravascular device delivery system, the system comprising:

an elongated member having a distal end and a proximal end with a longitudinal axis extending therebetween, the elongated member including,

an outer sleeve,

at least one steerable catheter;

a coil positioned longitudinally overlapping and radially within at least a portion of the outer sleeve,

a distal end cap longitudinally fixed to the coil,

a delivery catheter positioned longitudinally overlapping and radially within at least a portion of the coil, and

a delivery disc longitudinally fixed to the delivery catheter and positioned within the coil;

a disc handle configured to move the distal end cap and delivery disc, the disc handle including,

a main body configured to move the distal end cap longitudinally, and

a movable body configured to move the delivery disc longitudinally relative to the distal end cap; and

an intravascular device positioned adjacent the distal end cap.

10. The system of claim 9, wherein the distal end cap is selectively longitudinally fixed to the outer sleeve.

11. The system of claim 9, wherein the intravascular device is connected to the delivery disc with at least one tensioning element.

12. The system of claim 9, wherein the distal end cap or delivery disc further comprises a tensioning element release mechanism.

13. The system of claim 12, wherein the tensioning element release mechanism includes one or more electrically conductive elements.

14. The system of claim 13, wherein the delivery catheter is configured to provide electrical communication to the tensioning element release mechanism.

15. The system of claim 9, further comprising at least one tensioning element connecting the outer sleeve to the disc handle.

16. A method of deploying an intravascular device, the method comprising:

loading an intravascular device to a distal end of an intravascular device delivery system;

positioning the intravascular device at a target location;

partially deploying the intravascular device from the intravascular device delivery system;

repositioning the intravascular device; and

fully deploying the intravascular device from the intravascular device delivery system.

17. The method of claim 16, further comprising releasing at least one tensioning element connected to the intravascular device.

18. The method of claim 17, wherein releasing the at least one tensioning element includes heating at least one electrically conductive element.

19. The method of claim 16, wherein partially deploying the intravascular device further comprises advancing a distal end cap longitudinally to urge the intravascular device longitudinally relative to an outer sleeve.

20. The method of claim 16, wherein the intravascular device is a self-expanding device.

21. An intravascular device delivery system, the system comprising:

an elongated member having a distal end and a proximal end with a longitudinal axis extending therebetween, the elongated member including,

an outer sleeve having a proximal end and a distal end, a portion of the distal end being rotatably relative to a remainder of the outer sleeve.

22. The intravascular device delivery system of claim 21, wherein the portion rotates about a longitudinal axis of the outer sleeve.

23. The intravascular device delivery system of claim 22, wherein the portion has a length approximating a length of the intravascular device.

24. The intravascular device delivery system of claim 23, wherein the proximal end is configured to rotate relative to the portion.

25. The intravascular device delivery system of claim 21, further comprising a sealing member extending from the portion towards the proximal end of the elongated member.

26. The intravascular device delivery system of claim 25, wherein the sealing member seals a flexible region of the elongated member that extends from the portion to a location distal the proximal end of the elongated member.

27. The intravascular device delivery system of claim 21, wherein a first end of a sealing member is mounted to the portion and a second end of a sealing member is mounted to a location proximal a flexible region of the elongated member.

28. The intravascular device delivery system of claim 21, wherein an intermediate portion of a sealing member mounted to at least the portion is freely movable relative to the elongate member.

29. The intravascular device delivery system of claim 21, further comprising at least one steerable catheter positionable within at least a portion of the outer sleeve.

30. The intravascular device delivery system of claim 21, further comprising a coil positioned longitudinally overlapping and radially within at least a portion of the outer sleeve.

31. The intravascular device delivery system of claim 25, further comprising:

a distal end cap longitudinally fixed to the coil,

a delivery catheter positioned longitudinally overlapping and radially within at least a portion of the coil, and

a delivery disc longitudinally fixed to the delivery catheter and positioned within the coil.

32. The intravascular device delivery system of claim 26, further comprising a disc handle configured to move the distal end cap and delivery disc, the disc handle comprising:

a main body configured to move the distal end cap longitudinally, and

a movable body configured to move the delivery disc longitudinally relative to the distal end cap.

33. A loading assembly for aiding with loading an intravascular device into an intravascular device delivery system, the loading assembly comprising:

a fixture to support a proximal end of the intravascular device delivery system;

another fixture to support a distal end of the intravascular device delivery system; and

a reservoir to receive a portion of the intravascular device delivery system and an unloaded intravascular device.

34. The loading assembly of claim 33, wherein the another fixture comprises an angularly orientated support and a member extending into the reservoir.

35. The loading assembly of claim 33, wherein the another fixture comprises a base member from which the member extends, the member being configured to transmit forces to the base member.

36. The loading assembly of claim 33, further comprising a support extending from an angularly orientated support of the another fixture.

37. The loading assembly of claim 36, further comprising another support extending form the base member.

38. The loading assembly of claim 33, wherein the fixture comprises a base member and a sliding support selectively movable along at least a portion of the base member.

39. The loading assembly of claim 38, further comprising a locking mechanism to receive a stabilizer that supports the proximal end of the intravascular device delivery system.

40. A stabilizer for supporting an intravascular device delivery system, the stabilizer comprising:

a base; and

a plurality of mounts to receive a proximal end of the intravascular device delivery system, the plurality of mounts being selectively movable relative to the stabilizer base.

41. The stabilizer of claim 40, wherein the base comprises a stabilizer base and a sliding member mountable to a sliding mechanism.

42. The stabilizer of claim 41, wherein the stabilizer base is pivotally mounted to the sliding member.

43. The stabilizer of claim 42, where the base comprises a stabilizer base with at least one mount of the plurality of mounts extends from the stabilizer base.

44. The stabilizer of claim 43, further comprising a micro adjustor to move at least one mount of the plurality of mounts relative to a base.

45. The stabilizer of claim 43, further comprising at macro adjustor to move at least one mount of the plurality of mounts relative to a base.

46. The stabilizer of claim 43, further comprising a combination micro and macro adjustor.

47. The stabilizer of claim 43, further comprising a secondary sliding member disposed at a proximal end of the stabilizer.

48. The stabilizer of claim 47, wherein one of the plurality of mounts is supported by the secondary sliding member.

49. A method for delivering an intravascular device to a target location, comprising one or more of the following:

preparing an intravascular device for loading into an intravascular device delivery system;

moving the intravascular device into a cover;

advancing the intravascular device delivery system towards a target location;

unsheathing at least a portion of the intravascular device from the cover; and

disconnecting the intravascular device from the intravascular device delivery system.

50. A method of claim 49 further comprising one or more of the following:

mounting a distal tip of the intravascular device delivery system to a guidewire tubular member;

mounting the distal tip to the cover;

releasing a tension on a portion of the intravascular device delivery system;

flushing the intravascular device delivery system;

advancing the intravascular device delivery system through a septum;

positioning the intravascular device near a mitral annulus;

advancing the intravascular device through at least a portion of the mitral annulus; and

tensioning a tensioning element connecting the intravascular device to the intravascular device delivery system.

51. The method of claim 50, further comprising flushing portions of intravascular device delivery system.

52. The method of claim 51, wherein unsheathing at least the portion of the intravascular device delivery system further comprises:

unsheathing an arterial disk of the intravascular device while maintaining a remainder of the intravascular device within the cover.

53. The method of claim 52, further comprising preventing the intravascular device to move distally during unsheathing of the at least the portion of the intravascular device.

54. The method of claim 53, further comprising moving one or more mounts of a plurality of mounts of a fixture supporting the intravascular device delivery system to selectively move one or more of the cover, the intravascular device, a distal tip, a guidewire tube, a delivery catheter, and a compression element.

55. The method of claim 53, further comprising moving one or more mounts of a plurality of mounts of a fixture supporting the intravascular device delivery system to selectively move one or more of the cover, the intravascular device, a distal tip, a guidewire lumen, a tension member, and a compression member.