Endovascular devices and methods for exploiting intramural space

• US 20070093780A1
• Filed: 09/11/2006
• Published: 04/26/2007
• Est. Priority Date: 09/12/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Olson, Matthew, Atkinson, Robert, Kugler, Chad
• Granted Patent: US 8,083,727 B2
• Time in Patent Office: Days
• US Class Current: 604/510
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• 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 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• 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 2017/22034 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 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing a first intravascular device having a distal portion with a concave side, inserting the first device into the vascular lumen, positioning the distal portion in the vascular wall, and orienting the concave side of the distal portion toward the vascular lumen.

Claims

1. A method of facilitating vascular treatment via a vascular wall defining a vascular lumen having an occlusion disposed therein, the method comprising:

providing an intravascular device having a distal intramural portion;

inserting the intramural portion into the vascular lumen;

passing the intramural portion from the vascular lumen into the vascular wall proximal of the occlusion;

moving the intramural portion within the vascular wall in a longitudinal direction;

moving the intramural portion within the vascular wall in a circumferential direction such that the intramural portion has a concave side facing the vascular lumen;

providing a re-entry device having a tissue penetrating tip;

orienting the tip as a function of the concave side of the intramural portion such that the tip is pointed toward the vascular lumen;

causing the tip to penetrate tissue to pass from within the vascular wall to within the vascular lumen; and

passing the intramural portion from the vascular wall into the vascular lumen distal of the occlusion such that the intravascular device extends from the vascular lumen proximal of the occlusion, transmurally adjacent the occlusion, to the vascular lumen distal of the occlusion.

2. A method of facilitating vascular treatment by positioning a device intravascularly such that the device extends from a vascular lumen proximal of an occlusion, transmurally adjacent the occlusion, to the vascular lumen distal of the occlusion, wherein an intramural portion of the device has a concave side that facilitates orientation toward the vascular lumen.

3. A method of facilitating vascular treatment via a vascular wall defining a vascular lumen, the method comprising:

providing a first intravascular device having a distal intramural portion;

positioning the intramural portion in the vascular wall; and

moving the intramural portion within the vascular wall in a circumferential direction such that the intramural portion has a concave side facing the vascular lumen.

4. A method as in claim 3, further comprising:

providing a second intravascular device; and

positioning the second device, using radiographic visualization, in the vascular lumen as a function of the position of the intramural portion.

5. A method as in claim 3, further comprising:

providing a second intravascular device;

placing the second device in the vascular lumen adjacent the intramural portion in the vascular wall; and

moving the intramural portion in a circumferential direction a distance greater than the cross-sectional size of the distal end of the second device to form an intramural barrier that guards against perforation of the second device through the vascular wall as the second device is advanced distally.

6. A method as in claim 3, further comprising:

providing a re-entry device having a tissue penetrating tip;

orienting the tip as a function of the concave side of the intramural portion such that the tip is pointed toward the vascular lumen; and

causing the tip to penetrate tissue to pass from within the vascular wall to within the vascular lumen.

7. A method as in claim 3, further comprising:

moving the intramural portion in a circumferential direction such that the intramural portion circumferentially dissects an occlusion disposed in the vascular lumen; and

removing the occlusion.

8. A method as in claim 3, 4, 5, 6 or 7, wherein the intramural portion is disposed in the vascular wall between an inner surface and an outer surface thereof.

9. A method as in claim 3, 4, 5, 6 or 7, wherein an occlusion is disposed in the vascular lumen, and the intramural portion is disposed in the vascular wall adjacent the occlusion.

10. A method as in claim 3, 4, 5, 6 or 7, wherein a total occlusion is disposed in the vascular lumen, and the intramural portion is disposed in the vascular wall adjacent the total occlusion.

11. A method as in claim 3, 4, 5, 6 or 7, further comprising radiographically visualizing the intramural portion within the vascular wall.

12. A method as in claim 3, 4, 5, 6 or 7, wherein positioning the intramural portion comprises:

inserting the intramural portion into the vascular lumen; and

passing the intramural portion from the vascular lumen into the vascular wall.

13. A method as in claim 3, 4, 5, 6 or 7, wherein the intramural portion extends circumferentially around about 90°

or more of the vascular lumen.

14. A method as in claim 3, 4, 5, 6 or 7, wherein the intramural portion extends circumferentially around about 180°

or more of the vascular lumen.

15. A method as in claim 3, 4, 5, 6 or 7, wherein the intramural portion extends circumferentially around about 360°

or more of the vascular lumen.

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

providing a first intravascular device having a distal portion;

providing a re-entry device having a distal portion configured to penetrate the vascular wall toward the vascular lumen and configured to not penetrate the vascular wall thereafter;

inserting the first device into the vascular lumen;

positioning the distal portion of the first device in the vascular wall;

positioning the distal portion of the re-entry device in the distal portion of the first intravascular device; and

penetrating the vascular wall toward the vascular lumen.

17. The method of claim 16, wherein the distal portion of the first device has a bend with a radius of curvature approximating an inside curvature of the vascular lumen.

18. The method of claim 17, wherein penetrating the vascular wall includes extending the distal portion of the re-entry device beyond the first device, wherein the distal portion of the re-entry device has a bend with a radius of curvature less than a radius of curvature of the vascular lumen.

19. The method of claim 16, wherein the distal portion of the first device has a bend with a radius of curvature less than a radius of curvature of the vascular lumen.

20. The method of claim 16, wherein positioning the distal portion of the first device comprises traversing the occlusion with the distal portion of the first device, and penetrating the vascular wall includes penetrating the vascular wall with the re-entry device.

21. The method of claim 16, wherein positioning the distal portion of the re-entry device in the distal portion of the first intravascular device comprises inserting the re-entry device within an internal lumen of the first intravascular device such that curvature of the re-entry device self aligns with the curvature of the first intravascular device.

22. The method of claim 21, wherein the curvature of the re-entry device self aligns with the curvature of the first intravascular device such that when a concave side of the first intravascular device is oriented toward the vascular lumen, the concave side of the re-entry device will also be oriented toward the vascular lumen.

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

providing a first intravascular device having a distal portion with lateral projections;

inserting the first device into the vascular lumen;

positioning the distal portion in the vascular wall; and

directing the lateral projections in substantially equal and opposite directions within the vascular wall.

24. The method of claim 23, wherein the lateral projections comprise a collapsible lattice structure that is capable of expanding from a first collapsed configuration within a containment sheath to a second deployed configuration, and wherein directing the lateral projections comprises retraction of the sheath relative to the first intravascular device.

25. The method of claim 23, wherein the first intravascular device is contained in a sheath having a distal portion with a side port, and directing the lateral projections includes deploying the lateral projections from the side port.

26. The method of claim 23, wherein the first intravascular device includes an elastic wire configured to expand circumferentially within the vascular wall.

27. The method of claim 26, wherein the elastic wire forms a substantially sinusoidal pattern bent around a cylinder in a deployed configuration.

28. The method of claim 26, wherein the elastic wire forms a partial “

U”

shape in a deployed configuration.

29. The method of claim 26, wherein a distal end of the elastic wire is connected to a blunt tip at a distal end of the first intravascular device.

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

providing a first intravascular device having a distal portion with a concave side;

inserting the first device into the vascular lumen;

positioning the distal portion in the vascular wall; and

orienting the concave side of the distal portion toward the vascular lumen.

31. The method of claim 30, wherein the distal portion includes a radial curve having a radius of curvature that is less than a radius of curvature of the vascular lumen.

32. The method of claim 30, wherein the distal portion includes a radial curve having a radius of curvature approximating the curvature of the vascular lumen.

33. The method of claim 30, wherein distal portion includes a side port along the concave side.

34. The method of claim 30, wherein the elongate shaft defines open areas oriented along a surface of the shaft, and an actuation member extends along the shaft and has a distal end connected to a distal end of the shaft such that actuation of the actuation member results in closure of the open areas, thereby imparting a bend.

35. The method of claim 30, wherein the first intravascular device comprises an elongate shaft includes a plurality of spaced polymeric segments having greater flexibility than material of the shaft between the segments, and an actuation member extends along the shaft and has a distal end connected to a distal end of the shaft such that actuation of the actuation member imparts a bend.

36. The method of claim 35, wherein the segments are wedge shaped.

37. The method of claim 30, wherein the first intravascular device comprises an elongate shaft, the shaft exhibiting a first, relatively straight restrained configuration and a second resting configuration having a bend.

38. The method of claim 37, further comprising a sheath having a lumen configured to enclose a portion of the shaft such that the shaft assumes the relatively straight configuration when at least partially disposed within the sheath, and assumes the bend when not disposed within the sheath.

39. The method of claim 37, wherein the bend is a compound bend.

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

providing a first intravascular device having a distal portion with a keying element;

providing a re-entry device having a keyed distal portion;

inserting the first device into the vascular lumen;

positioning the distal portion of the first device in the vascular wall;

orienting the distal portion of the first device toward the vascular lumen; and

orienting the keyed distal portion of the re-entry device with respect to the keying element of the first device such that the re-entry device is oriented toward the vascular lumen.

41. The method of claim 40, wherein the distal portion of the first device includes a radial curve having a radius of curvature that is less than a radius of curvature of the vascular lumen.

42. The method of claim 40, wherein the distal portion of the first intravascular device includes a radial curve having a radius of curvature approximating the curvature of the vascular lumen.

43. The method of claim 41, wherein the keyed distal portion of the re-entry device includes a radial curve having a radius of curvature less than a radius of curvature of the vascular lumen.

44. The method of claim 40, wherein positioning the distal portion of the first device comprises traversing the occlusion with the distal portion of the first device, and further comprising penetrating the vascular wall with the re-entry device toward the vascular lumen.

45. The method of claim 40, wherein the keyed distal portion of the re-entry device includes external surface features configured for engagement with surfaces along an internal lumen of the keying element.

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

providing a first intravascular device having a distal portion with a concave side;

providing a re-entry device having a curved distal portion;

inserting the first device into the vascular lumen;

positioning the distal portion of the first device in the vascular wall;

orienting the concave side of the distal portion of the first device toward the vascular lumen; and

orienting the curved distal portion of the re-entry device with respect to the concave side of the distal portion of the first device such that the re-entry device is oriented toward the vascular lumen.

47. The method of claim 46, wherein the distal portion of the first device includes a radial curve having a radius of curvature that is less than a radius of curvature of the vascular lumen.

48. The method of claim 46, wherein the distal portion of the first intravascular device includes a radial curve having a radius of curvature approximating the curvature of the vascular lumen.

49. The method of claim 46, wherein positioning the distal portion of the first device comprises traversing the occlusion with the distal portion of the first device, and further comprising penetrating the vascular wall with the re-entry device toward the vascular lumen.

50. The method of claim 46, wherein positioning the distal portion of the re-entry device in the distal portion of the first intravascular device comprises inserting the re-entry device within an internal lumen of the first intravascular device such that curvature of the re-entry device self aligns with the curvature of the first intravascular device.

51. The method of claim 50, wherein the curvature of the re-entry device self aligns with the curvature of the first intravascular device such that when a concave side of the first intravascular device is oriented toward the vascular lumen, the concave side of the re-entry device will also be oriented toward the vascular lumen.

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

providing a first intravascular device having a distal portion;

providing a re-entry device having a rotational cutting distal portion;

inserting the first device into the vascular lumen;

positioning the distal portion of the first device in the vascular wall; and

positioning the rotational cutting distal portion of the re-entry device in the distal portion of the first device.

53. The method of claim 52, further comprising penetrating the vascular wall by rotating the cutting portion relative to the first device.

54. The method of claim 52, wherein providing a re-entry device having a rotational cutting distal portion comprises providing an abrasive coating to the cutting portion.

55. The method of claim 52, wherein providing a re-entry device having a rotational cutting distal portion comprises providing external threads along the cutting portion.

56. A device for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the device comprising an elongate shaft having a distal portion sized and configured to be deployed in the vascular wall, the distal portion having a bend in a longitudinal direction and in a radial direction.

57. The device of claim 56, wherein the bend exhibits a radius of curvature that is less than a radius of curvature of the vascular lumen.

58. The device of claim 56, wherein the bend includes a radial curve having a radius of curvature approximating the curvature of the vascular lumen.

59. The device of claim 56, wherein the elongate shaft defines open areas oriented along a surface of the shaft, and an actuation member extends along the shaft and has a distal end connected to a distal end of the shaft such that actuation of the actuation member results in closure of the open areas, thereby imparting the bend.

60. The device of claim 56, wherein the elongate shaft includes a plurality of spaced polymeric segments having greater flexibility than material of the shaft between the segments, and an actuation member extends along the shaft and has a distal end connected to a distal end of the shaft such that actuation of the actuation member imparts the bend.

61. The device of claim 60, wherein the segments are wedge shaped.

62. The device of claim 56, wherein the shaft exhibits a first, relatively straight restrained configuration and a second resting configuration having the bend.

63. The device of claim 62, further comprising a sheath having a lumen configured to enclose a portion of the shaft such that the shaft assumes the relatively straight configuration when at least partially disposed within the sheath, and assumes the bend when not disposed within the sheath.