Endovascular devices and methods for exploiting intramural space

• US 20080228171A1
• Filed: 11/20/2007
• Published: 09/18/2008
• Est. Priority Date: 11/21/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad J., Atkinson, Robert E., Olson, Matthew J., Olson, Ross A.
• Granted Patent: US 10,888,354 B2
• Time in Patent Office: Days
• US Class Current: 604/529
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy

Abstract

Devices and methods for exploiting intramural (e.g., subintimal) space of a vascular wall to facilitate the treatment of vascular disease, particularly total occlusions. For example, the devices and methods disclosed herein may be used to visually define the vessel wall boundary, protect the vessel wall boundary from perforation, bypass an occlusion, and/or remove an occlusion.

Claims

1. A medical method, comprising:

advancing a catheter, with distal lateral projections in a collapsed configuration, through an intramural space; and

articulating a distal opening of the catheter, with distal lateral projections in an expanded configuration, toward a true lumen distal of an occlusion.

2. A medical method, comprising:

advancing a catheter through an intramural space; and

passing a re-entry device having a cork-screw tip through a distal articulated opening in the catheter, though an intimal layer and into a true lumen distal of an occlusion.

3. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the device terminating at a distal tip configured for controlled deflection;

a first actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the first actuation member;

an orienting element having a first collapsed configuration and a second expanded, substantially planar configuration; and

a second actuation member connected to a portion of the planar orienting element and extending to a proximal end of the shaft for causing expansion of the orienting element upon actuation of the second actuation member.

4. The system of claim 3, wherein the orienting element is biased toward the collapsed configuration.

5. The system of claim 3, wherein the elongate shaft includes an inner layer and an outer layer.

6. The system of claim 3, wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

7. The system of claim 6, wherein a distal end of the second actuation member is connected to either the proximal collar or the distal collar.

8. The system of claim 6, wherein the orienting element exhibits the second expanded configuration upon moving the distal collar and the proximal collar closer together.

9. The system of claim 6, wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

10. The system of claim 6, wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

11. The system of claim 3, wherein the orienting element includes a pair of wings that extend along opposing sides of the device, each wing having a distal end and a proximal end.

12. The system of claim 11, wherein the wings exhibit the second expanded configuration upon moving the distal wing ends and the proximal wing ends closer together.

13. The system of claim 11, further comprising radiopaque markers designating the distal and proximal wing ends.

14. The system of claim 13, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

15. The system of claim 11, further comprising radiopaque markers designating an intermediate location along each wing.

16. The system of claim 15, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

17. The system of claim 3, wherein the substantially planar configuration is slightly curved to conform to the shape of a vascular lumen.

18. The system of claim 3, wherein the distal tip is configured to deflect only in a plane substantially perpendicular to the plane of the expanded orienting element.

19. The system of claim 3, wherein the first actuation member comprises a tension member.

20. The system of claim 3, wherein the first actuation member comprises a push member.

21. The system of claim 3, wherein the first actuation member includes two actuation members formed along opposing surfaces of the distal tip for causing deflection of the distal tip in two substantially orthogonal directions each substantially perpendicular to the plane of the expanded orienting element.

22. The system of claim 3, wherein the distal tip includes a pattern of rings formed with opposing longitudinal spines formed in the inner layer of the elongate shaft arranged to allow deflection only in a plane substantially perpendicular to the plane of the expanded orienting element.

23. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the shaft including an inner layer and an outer layer;

an orienting element at a distal end of the device including a pair of wings that extend along opposing sides of the device, the wings having a first collapsed configuration and a second expanded, substantially planar configuration; and

each wing having a distal end and a proximal end, and wherein the wings exhibit the second expanded configuration upon moving the distal wing ends and the proximal wing ends closer together.

24. The system of claim 23, further comprising radiopaque markers designating the distal and proximal wing ends.

25. The system of claim 24, wherein:

the radiopaque markers are separated by a first distance when the wings are assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the wings are assuming the second expanded, substantially planar configuration; and

the second distance is smaller than the first distance.

26. The system of claim 23, further comprising radiopaque markers designating an intermediate location along each wing.

27. The system of claim 26, wherein:

the radiopaque markers are separated by a first distance when the wings are assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the wings are assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

28. The system of claim 23, wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

29. The system of claim 28, wherein a distal end of an actuation member is connected to either the proximal collar or the distal collar.

30. The system of claim 28, wherein the orienting element exhibits the second expanded configuration upon moving the distal collar and the proximal collar closer together.

31. The system of claim 30, wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

32. The system of claim 30, wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

33. The system of claim 23, wherein the device terminates at a distal tip configured for controlled deflection.

34. The system of claim 33, wherein the distal tip is configured to deflect only in a plane substantially perpendicular to the plane of the expanded orienting element.

35. The system of claim 33, further comprising at least one actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the actuation member.

36. The system of claim 33, further comprising two actuation members formed along opposing surfaces of the distal tip for causing deflection of the distal tip in two substantially orthogonal directions each substantially perpendicular to the plane of the expanded orienting element.

37. The system of 33, wherein the distal tip includes a pattern of rings formed with opposing longitudinal spines formed in the inner layer of the elongate shaft arranged to allow deflection only in a plane substantially perpendicular to the plane of the expanded orienting element.

38. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening,

an orienting element provided along the shaft and having a first collapsed configuration and a second expanded, substantially planar configuration;

a bearing surface mounted to a portion of the elongate shaft along the orienting element;

a first actuation member connected to the orienting element, extending distally around the bearing surface, and then proximally to a proximal end of the device; and

a second actuation member connected to the orienting element and extending proximally to the proximal end of the device;

wherein actuating the first actuation member causes controlled expansion of the orienting element, and actuating the second actuation member causes controlled collapse of the orienting element.

39. The system of claim 38, wherein the first and second actuation members are connected so as to form an integral member.

40. The system of claim 38, wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

41. The system of claim 40, wherein both the first and second actuation members are connected to the proximal collar.

42. The system of claim 40, wherein the bearing surface is located distally of the proximal collar.

43. The system of claim 40, wherein the orienting element comprises a first radiopaque marker and a second radiopaque marker.

44. The system of claim 43, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is smaller than the first distance.

45. The system of claim 43, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

46. The system of claim 40, wherein the orienting element exhibits the second expanded configuration upon moving the distal collar and the proximal collar closer together.

47. The system of claim 46, wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

48. The system of claim 46, wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

49. The system of claim 38, wherein the device terminates at a distal tip configured for controlled deflection.

50. The system of claim 49, wherein the distal tip is configured to allow deflect only in a plane substantially perpendicular to the plane of the expanded orienting element.

51. The system of claim 49, further comprising a third actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the third actuation member.

52. The system of claim 49, further comprising two actuation members formed along opposing surfaces of the distal tip for causing deflection of the distal tip in two substantially orthogonal directions substantially perpendicular to the plane of the expanded orienting element.

53. The system of claim 49, wherein the distal tip includes a pattern of rings formed with opposing longitudinal spines formed in the inner layer of the elongate shaft arranged to allow deflection only in a plane substantially perpendicular to the plane of the expanded orienting element.

54. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

providing an intramural orienting device having an elongate shaft with a lumen extending therethrough to a distal opening, the device terminating at a distal tip configured for controlled deflection,

providing an actuation member connected to the distal tip and extending to a proximal end of the shaft;

providing an orienting element along the shaft having a first collapsed configuration and a second expanded, substantially planar configuration;

inserting the orienting device into the vascular lumen;

positioning at least the orienting element of the orienting device in the vascular wall;

expanding the orienting element to achieve the planar configuration; and

actuating the actuation member to deflect the distal tip in a plane substantially perpendicular to the plane of the expanded orienting element such that the tip is oriented either toward the vascular lumen or away from the vascular lumen.

55. The method of claim 54, further comprising determining if the tip is oriented either toward the vascular lumen or away from the vascular lumen.

56. The method of claim 54, further comprising re-deflecting the tip approximately 180 degrees relative to a first deflected direction if the tip is oriented away from the vascular lumen such that the tip is oriented toward the vascular lumen.

57. The method of claim 54, further comprising:

providing a re-entry device having a distal tip configured to penetrate vascular tissue;

inserting the re-entry device into the lumen of the orienting device; and

advancing at least the distal tip of the re-entry device out of the shaft lumen and into the vascular wall such that it is directed toward the vascular lumen.

58. The method of claim 54, further comprising using radiographic visualization to confirm that the tip is oriented toward the vascular lumen.

59. The method of claim 54, wherein providing an orienting element includes providing a pair of wings that extend along opposing sides of the device, each wing having a distal end and a proximal end.

60. The method of claim 59, wherein expanding the orienting element comprises moving the distal wing ends and the proximal wing ends closer together.

61. The method of claim 54, wherein the distal tip deflects only in the plane substantially perpendicular to the plane of the expanded orienting element.

62. The method of claim 54, wherein actuating the actuation member comprises pulling the actuation member proximally.

63. The method of claim 54, wherein actuating the actuation member comprises pushing the actuation member distally.