Endoluminal Laser Ablation Device and Method for Treating Veins

• US 20090240242A1
• Filed: 02/27/2009
• Published: 09/24/2009
• Est. Priority Date: 02/28/2008
• Status: Active Grant

• Current Assignee: Biolitec Unternehmensbeteiligungs II AG
• Original Assignee: CeramOptec Industries Incorporated (Biolitec AG)
• Inventors: Neuberger, Wolfgang
• Granted Patent: US 9,693,826 B2
• Time in Patent Office: Days
• US Class Current: 606/7
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence

Abstract

An improved method and device is provided for safe and efficient low power density endoluminal treatment of venous insufficiency. One such device emits pulsed or continuous energy radially through an optical fiber end with a conical shaped tip for 360° radial emission. In some embodiments, a conical reflective surface is distally spaced opposite to and faces the emitting tip for enhancing radial emission efficiency by reflecting out any designed or remnant forwardly transmitted energy in radial directions. Other devices include flat emitting faces sealed within protective, radiation transparent covers. Laser radiation is transmitted at a wavelength and power such that is it substantially entirely absorbed within the blood vessel wall to sufficiently damage the intravascular endothelium and, in turn, achieve blood vessel closure. Because the energy is substantially entirely absorbed within the blood vessel wall, the need for a local anesthetic along the treatment area of the blood vessel may be substantially avoided.

Claims

1. A device for endoluminal treatment of a blood vessel, comprising:

a flexible waveguide defining an elongated axis, a proximal end optically connectable to a source of radiation, and a distal end receivable within the blood vessel and including a radiation emitting surface that emits radiation from the radiation source laterally with respect to the elongated axis of the waveguide onto an angularly extending portion of the surrounding vessel wall.

2. A device as defined in claim 1, wherein the emitting surface is angled with respect to the elongated axis of the waveguide.

3. A device as defined in claim 2, wherein the emitting surface is oriented at an acute angle with respect to the elongated axis of the waveguide.

4. A device as defined in claim 3, wherein the emitting surface defines an arcuate surface contour.

5. A device as defined in claim 4, wherein the arcuate emitting surface extends throughout an angle of at least about 90°

.

6. A device as defined in claim 4, wherein the arcuate emitting surface extends throughout an angle within the range of about 90°

to about 360°

.

7. A device as defined in claim 4, wherein the emitting surface defines the distal tip of the waveguide.

8. A device as defined in claim 7, wherein the emitting surface is substantially conical shaped.

9. A device as defined in claim 8, wherein the emitting surface is either substantially convex shaped or is substantially concave shaped.

10. A device as defined in claim 1, further comprising a reflecting surface distally spaced relative to and facing the emitting surface for reflecting forwardly directed radiation laterally with respect to the elongated axis of the waveguide.

11. A device as defined in claim 10, wherein the emitting surface emits radiation substantially radially with respect to the elongated axis of the waveguide, and the reflecting surface reflects radiation substantially radially with respect to the elongated axis of the waveguide.

12. A device as defined in claim 10, wherein the reflecting surface defines an arcuate surface contour oriented at an acute angle with respect to the elongated axis of the waveguide.

13. A device as defined in claim 12, wherein the reflecting surface is substantially conical shaped.

14. A device as defined in claim 13, wherein the reflecting surface is either substantially convex shaped or is substantially concave shaped.

15. A device as defined in claim 1, further comprising a cover that is fixedly secured to the waveguide and sealed with respect thereto, that encloses the emitting surface therein, and that defines a gas-waveguide interface that refracts emitted radiation laterally with respect to the elongated axis of the waveguide onto the surrounding vessel wall.

16. A device as defined in claim 15, wherein the cover is a cap that is substantially transparent with respect to the emitted radiation.

17. A device as defined in claim 15, further comprising a radiation reflective surface enclosed within the cover, distally spaced relative to and facing the emitting surface, for reflecting forwardly directed radiation laterally with respect to the elongated axis of the waveguide.

18. A device as defined in claim 1, further comprising a lateral radiation emitting distal region defined by a plurality of radiation emitting surfaces axially spaced relative to each other along a distal region of the waveguide.

19. A device as defined in claim 18, further comprising a first radiation emitting surface formed at the distal tip of the waveguide, and a plurality of second radiation emitting surfaces proximally located with respect to the first radiation emitting surface and axially spaced relative to each other.

20. A device as defined in claim 19, wherein the first radiation emitting surface is substantially conical shaped, each second radiation emitting surface defines an arcuate surface contour angled with respect to the elongated axis of the waveguide, and each second radiation emitting surface laterally emits a portion of the radiation transmitted through the waveguide laterally with respect to the elongated axis onto a surrounding arcuate portion of the vessel wall and allows the remaining transmitted radiation to pass through the waveguide for lateral emission by any downstream second radiation emitting surfaces and the first radiation emitting surface.

21. A device as defined in claim 18, further comprising an axially-extending cover that encloses the lateral radiation emitting distal region, forms a gas interface at each of the plurality of radiation emitting surfaces that is sealed with respect to the exterior of the waveguide, and cooperates with the angled arcuate surface contour of at least a plurality of the radiation emitting surfaces to deflect radiation laterally with respect to the elongated axis of the waveguide.

22. A device as defined in claim 21, wherein the cover is substantially transparent with respect to the emitted radiation and is sufficiently flexible to allow the waveguide to bend upon passage through a tortuous blood vessel.

23. A device as defined in claim 18, further comprising a sleeve slidably mounted over the waveguide and defining an internal radiation reflective surface for reflecting laterally emitted radiation inwardly and controlling the axial length of the lateral radiation emitting distal region.

24. A device as defined in claim 1, further comprising a radiation source, a temperature sensor thermally coupled to a distal region of the waveguide for monitoring a temperature within the blood vessel and transmitting signals indicative thereof, and a control module electrically coupled to the temperature sensor for regulating the power output of the radiation source based thereon.

25. A device as defined in claim 24, further comprising a pullback actuator drivingly coupled to the waveguide for controlling the pullback speed of the waveguide, and wherein the control module is electrically coupled to the pullback actuator for regulating the pullback speed of the waveguide based on the temperature at the distal region of the waveguide.

26. A device as defined in claim 1, further comprising a guide wire detachably coupled to the waveguide and including a distal portion extending distally beyond the distal tip of the waveguide for guiding the waveguide through the blood vessel.

27. A device as defined in claim 26, wherein the guide wire is mechanically connected to the waveguide, is not detachable from the waveguide by pushing distally on the guide wire, but is detachable from the waveguide by pulling proximally on the guide wire.

28. A device as defined in claim 1, further comprising a guide wire fixedly secured to the tip of the waveguide and extending distally therefrom.

29. A device as defined in claim 28, wherein the waveguide includes a cover enclosing the radiation emitting surface, the cover is sealed with respect to the waveguide and defines a gas interface that cooperates with the angle of the emitting surface to refract emitted radiation laterally with respect to the elongated axis of the waveguide, and the guide wire is fixedly secured to the cover and extends distally therefrom.

30. A device as defined in claim 1, wherein the radiation emitting surface is angled inwardly from the distal tip toward the elongated axis of the waveguide.

31. A device as defined in claim 30, wherein the radiation emitting surface defines a substantially concave, substantially conical shape.

32. A device as defined in claim 30, wherein the distal tip of the waveguide defines an expanded width in comparison to a portion of the waveguide extending proximally therefrom.

33. A device as defined in claim 32, wherein the distal tip is rounded to facilitate insertion of the waveguide through the blood vessel.

34. A device as defined in claim 1, wherein a distal region of the waveguide defines an enclosed space that is sealed with respect to the exterior of the waveguide and forms a gas interface at the radiation emitting surface for refracting emitted radiation laterally with respect to the elongated axis of the waveguide.

35. A device as defined in claim 34, wherein the radiation emitting surface is substantially conical shaped.

36. A device as defined in claim 1, wherein the waveguide is an optical fiber.

37. A device as defined in claim 1 for endoluminal laser ablation, further comprising at least one laser source that provides laser radiation of at least one of about 1470 nm and about 1950 nm, each ±

about 30 nm, at a power of less than or equal to about 10W, wherein the proximal end of the waveguide is optically coupled to the at least one laser source, and wherein the emitting surface of the waveguide emits radiation laterally with respect to the elongated axis of the waveguide in an axially-extending, annular pattern onto the surrounding vessel wall.

38. A device as defined in claim 37, further comprising an electric pullback device drivingly coupled to the waveguide and configured to pullback the waveguide through the blood vessel while delivering laser radiation at an energy delivery rate of less than about 30 J/cm on average to the blood vessel wall.

50. A device as defined in claim 38, further comprising means for pulling back the waveguide through the blood vessel while delivering laser radiation at an energy delivery rate of less than about 30 J/cm on average to the blood vessel wall.

39. A device for endoluminal treatment of a blood vessel, comprising:

a flexible waveguide defining an elongated axis, a proximal end optically connectable to a source of radiation, and a distal end receivable within the blood vessel and including means for emitting radiation from the radiation source laterally with respect to the elongated axis of the waveguide onto an angularly extending portion of the surrounding vessel wall.

40. A device as defined in claim 39, wherein the means for emitting includes a radiation emitting surface that is angled with respect to the elongated axis of the waveguide.

41. A device as defined in claim 39, wherein the emitting surface is one of substantially convex shaped and substantially concave shaped.

42. A device as defined in claim 41, wherein the emitting surface is substantially conical shaped.

43. A device as defined in claim 40, further comprising means for reflecting forwardly directed radiation laterally with respect to the elongated axis of the waveguide.

44. A device as defined in claim 43, wherein the means for reflecting includes a reflective surface distally spaced relative to and facing the means for emitting.

45. A device as defined in claim 39, further comprising means for enclosing the emitting means and forming a gas interface for deflecting emitted radiation laterally with respect to the elongated axis of the waveguide.

46. A device as defined in claim 39, further comprising means for emitting diffuse radiation laterally with respect to the elongated axis of the waveguide along an axially-extending region of the waveguide.

47. A device as defined in claim 46, wherein the means for emitting diffuse radiation includes a plurality of radiation emitting surfaces proximally located with respect to said means for emitting and axially spaced relative to each other.

48. A device as defined in claim 46, further comprising means for adjusting the length of the means for emitting diffuse radiation.

49. A device as defined in claim 48, wherein the means for adjusting includes a sleeve slidably mounted on the waveguide.

51. A method for endoluminal treatment of a blood vessel, comprising the following steps:

(i) introducing a waveguide defining an elongated axis into the blood vessel;

(ii) transmitting radiation through the waveguide; and

(iii) emitting radiation laterally with respect to the elongated axis of the waveguide onto an angularly extending portion of the surrounding vessel wall.

52. A method as defined in claim 51, wherein the emitting step includes laterally emitting radiation onto a region of the surrounding vessel wall extending throughout an angle of at least about 90°

.

53. A method as defined in claim 52, wherein the emitting step includes laterally emitting radiation onto a region of the surrounding vessel wall extending throughout an angle within the range of about 90°

to about 360°

.

54. A method as defined in claim 53, further comprising laterally emitting radiation at a power of less than about 10 W.

55. A method as defined in claim 54, further comprising laterally emitting radiation at a power of less than about 5 W.

56. A method as defined in claim 53, further comprising the step of emitting radiation substantially radially with respect to the elongated axis of the waveguide in a substantially annular pattern onto the surrounding vessel wall.

57. A method as defined in claim 56, further comprising the step of reflecting forwardly emitted radiation laterally with respect to the elongated axis in a substantially annular pattern onto the surrounding vessel wall.

58. A method as defined in claim 56, further comprising the step of transmitting the radiation at a power of less then about 10 W at a wavelength within the range of about 980 nm to about 1900 nm.

59. A method as defined in claim 58, wherein the wavelength is within the range of at least one of (i) about 950 nm to about 1110 nm, (ii) about 1440 nm to about 1500 nm, and (iii) about 1870 nm to about 1930 nm.

60. A method as defined in claim 53, further comprising the step of withdrawing the waveguide through the blood vessel during step (iii).

61. A method as defined in claim 53, further comprising the step of applying a local infiltrate anesthetic at an access site prior to introducing the waveguide through the access site and into the blood vessel.

62. A method as defined in claim 61, further comprising the step of applying a local infiltrate anesthetic during step (iii), or interrupting step (iii) and applying a local infiltrate anesthetic, to a localized region of tissue to relieve any pain or discomfort at the localized region.

63. A method as defined in claim 60, further comprising performing the entire endoluminal treatment procedure without the use of local tumescent anesthesia or general anesthesia.

64. A method as defined in claim 63, further comprising the step of emitting radiation that is within the range of at least one of (i) about 1440 nm to about 1500 nm and (ii) about 1870 nm to about 1930 nm, at a power of less than about 10 W;

applying the emitted radiation substantially radially with respect to the elongated axis of the waveguide in a substantially annular pattern onto the surrounding vessel wall; and

withdrawing the waveguide through the blood vessel during the applying step.

65. A method as defined in claim 64, further comprising the step of emitting radiation at a power within the range of about 1 W to about 3 W and withdrawing the waveguide through the blood vessel at a rate sufficient to thermally damage and close the blood vessel.

66. A method as defined in claim 51, wherein the emitting step includes emitting diffuse radiation along an axially-extending region of the waveguide laterally into the surrounding vessel wall.

67. A method as defined in claim 66, wherein the emitting step includes emitting the radiation substantially radially with respect to the elongated axis of the waveguide in a substantially annular pattern onto the surrounding vessel wall.

68. A method as defined in claim 51, further comprising the step of introducing a cold saline solution into the vessel lumen prior to or during the emitting step.

69. A method as defined in claim 51, further comprising the step of vibrating at least one of the waveguide and the distal tip thereof to facilitate at least one of (i) relatively smooth pullback of the waveguide through the blood vessel and (ii) pullback through the blood vessel at a substantially constant rate.