Opto-acoustic recanilization delivery system

• US 6,368,318 B1
• Filed: 01/23/1998
• Issued: 04/09/2002
• Est. Priority Date: 01/23/1998
• Status: Expired due to Fees

• Current Assignee: Lawrence Livermore National Security LLC (Government of the United States of America), Selva Medical, Inc. (W.L. Gore and Associates), W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Esch, Victor, Benett, William, London, Richard A., Broughton, Kathryn, Da Silva, Luiz B., Visuri, Steven R., Celliers, Peter M.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/012,379
• Time in Patent Office: 1,537 Days
• Field of Search: 606/7, 606/10, 606/11, 606/12, 606/15, 606/16, 606/17
• US Class Current: 606/7
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/2211 Plurality of fibres

Abstract

Fiber delivered laser pulses emulsify thrombus by mechanical stresses that include a combination of pressure, tension and shear stress. Laser radiation is delivered to the locality of a thrombus and the radiation is absorbed by blood, blood dot, or other present materials. The combination of a leading pressure wave and subsequent vapor bubble cause efficient, emulsification of thrombus. Operating the laser in a low average power mode alleviates potential thermal complications. The laser is operated in a high repetition rate mode to take advantage of ultrasound frequency effects of thrombus dissolution as well as to decrease the total procedure time. Specific parameter ranges for operation are described. The device includes optical fibers surrounding a lumen intended for flow of a cooling agent. The fibers may be arranged concentrically around the lumen to deliver radiation and heat over as large an area as possible. An alternative design approach incorporates the optical fibers into the wall of the guiding catheter and utilizes the catheter lumen as the cooling channel. An eccentric tip enables rotation of the device to address all parts of the vasculature. The eccentricity can be provided via a variety of means: spring dip, balloon, protrusion, etc.

Claims

1. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed away from said lumen to target areas other than directly forward looking.

2. The opto-acoustic recanilization delivery system of claim 1, wherein said lumen comprises a flexible tubing.

3. The opto-acoustic recanilization delivery system of claim 1, wherein said plurality of optical fibers are arranged concentrically around said lumen to deliver radiation and heat over as large an area as possible.

4. The opto-acoustic recanilization delivery system of claim 1, wherein said flexible tubing comprises a catheter.

5. The opto-acoustic recanilization delivery system of claim 1, wherein each said distal end is beveled or angled to aim the effect (primarily the shock wave) to produce a lateral deviation is said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

6. The opto-acoustic recanilization delivery system of claim 1, wherein said lumen comprises a cooling tip at said second end, wherein said cooling tip comprises a nozzle to allow coolant to jet in particular patterns or directions.

7. The opto-acoustic recanilization delivery system of claim 1, further comprising a second flexible tubing covering said flexible tubing, wherein said plurality of fiber optics, said flexible tubing and said lumen are recessed within said second flexible tubing to form a shrouded tip to prevent said plurality of optical fibers from coming into contact with the wall of said vasculature yet enable light propagated through said plurality of fiber optics to interact with blood or thrombus.

8. The opto-acoustic recanilization delivery system of claim 1, further comprising means for forming an eccentric tip at said second end of said flexible tubing.

9. The opto-acoustic recanilization delivery system of claim 8, wherein said means for forming an eccentric tip at said second end of said flexible tubing are selected from a group consisting of a spring clip, balloon and a protrusion.

10. The opto-acoustic recanilization delivery system of claim 1, further comprising a second flexible tubing covering said flexible tubing, further comprising a spring affixed to the outer wall of said flexible tubing at said second end, wherein said spring is held collapsed within said second flexible tubing, wherein said spring pops up when flexible tubing is extended away from said second flexible tubing to form an eccentric tip.

11. The opto-acoustic recanilization delivery system of claim 1, further comprising a second flexible tubing covering said flexible tubing, further comprising an inflatable bladder affixed to the outer wall of said flexible tubing at said second end, wherein said flexible tubing further comprises at least one leak path between said lumen and said inflatable bladder to present an unobstructed path between said lumen and said bladder, wherein when no cooling flow or other flow is passed though said lumen, said bladder remains deflated, wherein when cooling flow or other flow is passed though said lumen, it passes through said at least one leak path and induces pressure within said bladder causing it to inflate to an eccentric tip.

12. The opto-acoustic recanilization delivery system of claim 1, wherein said plurality of fiber optics comprise an array, wherein said lumen and said array are offset with respect to a central axis of said flexible tubing, to provide an asymmetric construction of said array and said lumen which together forms an eccentric tip.

13. The opto-acoustic recanilization delivery system of claim 11, wherein a corner of said lumen and said flexible tubing are trimmed at an angle, wherein when said cooling agent flows through said lumen, said cooling agent forces said delivery system to move laterally with respect to said central axis of said flexible tubing.

14.The opto-acoustic recanilization delivery system of claim 1, wherein each said proximal end is embedded within said flexible tubing near said first end.

17. The opto-acoustic recanilization delivery system of claim 1, wherein said plurality of optical fiber “

float”

freely within said lumen throughout said lumen until said plurality of fiber optics reach said second end where each said distal end of said plurality of fiber optics is embedded within said flexible tubing.

18. The opto-acoustic recanilization delivery system of claim 1, further comprising a laser for coupling laser light into each said proximal end, wherein said laser light has (i) a pulse frequency within the range of 1 kHz to 100 kHz, (ii) a wavelength within the range of 200 nm to 3000 nm, (iii) a fluence within the range of 0.1 J/cm² to 300 J/cm² and (iv) a pulse duration within the range of 1 ns to 1000 ns, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

19. The opto-acoustic recanilization delivery system of claim 1, further comprising a laser for coupling laser light into each said proximal end, wherein said laser light has (i) a pulse duration within the range of 1 ns to 1000 ns, (ii) an energy per pulse within the range of 10 μ

J to 1 mJ, (iii) a wavelength within the range of 200 nm to 3000 nm, (iv) a spot size within the range of 10 μ

m to 200 μ

m and (v) a repetition rate within the range of 1 kHz to 50 kHz, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

40. The opto-acoustic recanilization delivery system of claim 1, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

14. The opto-acoustic recanilization delivery system of claim 14, wherein said plurality of optical fibers is braided near said proximal end to provide strength in said delivery system.

15. The opto-acoustic recanilization delivery system of claim 14, wherein said plurality of optical fibers is straight to provide flexibility in said delivery system.

16. The opto-acoustic recanilization delivery system of claim 14, wherein said plurality of optical fibers is braided near said proximal end and wherein said plurality of optical fibers is straight near said distal end to provide flexibility in said delivery system.

20. A method of opto-acoustic recanilization, comprising:

inserting an opto-acoustic recanilization delivery system into the vasculature to a point near an occlusion, wherein said opto-acoustic recanilization delivery system comprises a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed away from said lumen to target areas other than directly forward looking; and

coupling laser light into said proximal end, wherein said laser light has (i) a pulse frequency within the range of 1 kHz to 100 kHz, (ii) a wavelength within the range of 200 nm to 3000 nm, (iii) a fluence within the range of 0.1 J/cm² to 300 J/cm² and (iv) a pulse duration within the range of 1 ns to 1000 ns, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

21. A method of opto-acoustic recanilization, comprising:

inserting an opto-acoustic recanilization delivery system into the vasculature to a point near an occlusion, wherein said opto-acoustic recanilization delivery system comprises a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed away from said lumen to target areas other than directly forward looking; and

coupling laser light into said proximal end, wherein said laser light has (i) a pulse duration within the range of 1 ns to 1000 ns, (ii) an energy per pulse within the range of 10 μ

J to 1 mJ, (iii) a wavelength within the range of 200 nm to 3000 nm, (iv) a spot size within the range of 10 μ

m to 200 μ

m and (v) a repetition rate within the range of 1 kHz to 50 kHz, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

22. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

23. An op to-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking, wherein said lumen comprises a cooling tip at said second end, wherein said cooling tip comprises a nozzle to allow coolant to jet in particular patterns or directions.

24. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

a second flexible tubing covering said flexible tubing, wherein said plurality of fiber optics, said flexible tubing and said lumen are recessed within said second flexible tubing to form a shrouded tip to prevent said plurality of optical fibers from coming into contact with the wall of said vasculature yet enable light propagated through said plurality of fiber optics to interact with blood or thrombus.

25. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking, further comprising means for forming an eccentric tip at said second end of said flexible tubing.

26. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

a second flexible tubing covering said flexible tubing, further comprising a spring affixed to the outer wall of said flexible tubing at said second end, wherein said spring is held collapsed within said second flexible tubing, wherein said spring pops up when said flexible tubing is extended away from said second flexible tubing to form an eccentric tip.

41. The opto-acoustic recanilization delivery system of claim 26, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

47. The opto-acoustic recanilization delivery system of claim 41, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

27. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

a second flexible tubing covering said flexible tubing, further comprising an inflatable bladder affixed to the outer wall of said flexible tubing at said second end, wherein said flexible tubing further comprises at least one leak path between said lumen and said inflatable bladder to present an unobstructed path between said lumen and said bladder, wherein when no cooling flow or other flow is passed though said lumen, said bladder remains deflated, wherein when cooling flow or other flow is passed though said lumen, it passes through said at least one leak path and induces pressure within said bladder causing it to inflate to an eccentric tip.

42. The opto-acoustic recanilization delivery system of claim 27, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

28. The opto-acoustic recanilization delivery system of claim 28, wherein a corner of said lumen and said flexible tubing are trimmed at an angle, wherein when said cooling agent flows through said lumen, said cooling agent forces said delivery system to move laterally with respect to said central axis of said flexible tubing.

29. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said proximal end is embedded within said flexible tubing near said first end;

wherein each said distal end is embedded within said flexible tubing near said second end;

wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking wherein said plurality of optical fiber “

float”

freely within said lumen throughout said lumen until said plurality of fiber optics reach said second end where each said distal end of said plurality of fiber optics is embedded within said flexible tubing.

30. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

a laser for coupling laser light into each said proximal end, wherein said laser light has (i) a pulse frequency within the range of 1 kHz to 100 kHz, (ii) a wavelength within the range of 200 nm to 3000 nm, (iii) a fluence within the range of 0.1 J/cm² to 300 J/cm² and (iv) a pulse duration within the range of 1 ns to 1000 ns, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

31. An opto-acoustic recanilization delivery system comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

a laser for coupling laser light into each said proximal end, wherein said laser light has (i) a pulse duration within the range of 1 ns to 1000 ns, (ii) an energy per pulse within the range of 10 μ

J to 1 mJ, (iii) a wavelength within the range of 200 nm to 3000 nm, (iv) a spot size within the range of 10 μ

m to 200 μ

m and (v) a repetition rate within the range of 1 kHz to 50 kHz, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

32. A method of opto-acoustic recanilization, comprising:

inserting an opto-acoustic recanilization delivery system into the vasculature to a point near an occlusion, wherein said opto-acoustic recanilization delivery system comprises a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

coupling laser light into said proximal end, wherein said laser light has (i) a pulse frequency within the range of 1 kHz to 100 kHz, (ii) a wavelength within the range of 200 nm to 3000 nm, (iii) a fluence within the range of 0.1 J/cm² to 300 J/cm² and (iv) a pulse duration within the range of 1 ns to 1000 ns, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

44. The opto-acoustic recanilization delivery system of claim 32, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

33. A method of opto-acoustic recanilization, comprising:

inserting an opto-acoustic recanilization delivery system into the vasculature to a point near an occlusion, wherein said opto-acoustic recanilization delivery system comprises a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein at least one fiber of said plurality of optical fibers at said distal end is pointed towards said lumen to target areas other than directly forward looking; and

coupling laser light into said proximal end, wherein said laser light has (i) a pulse duration within the range of 1 ns to 1000 ns, (ii) an energy per pulse within the range of 10 μ

J to 1 mJ, (iii) a wavelength within the range of 200 nm to 3000 nm, (iv) a spot size within the range of 10 μ

m to 200 μ

m and (v) a repetition rate within the range of 1 kHz to 50 kHz, wherein said laser light emerges from said distal end to generate an acoustic radiation field in a liquid ambient medium.

34. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

35. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end further comprising a second flexible tubing covering said flexible tubing; and

a spring affixed to the outer wall of said flexible tubing at said second end, wherein said spring is held collapsed within said second flexible tubing, wherein said spring pops up when said flexible tubing is extended away from said second flexible tubing to form an eccentric tip.

36. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent;

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end further comprising a second flexible tubing covering said flexible tubing; and

a second flexible tubing covering said flexible tubing, further comprising an inflatable bladder affixed to the outer wall of said flexible tubing at said second end, wherein said flexible tubing further comprises at least one leak path between said lumen and said inflatable bladder to present an unobstructed path between said lumen and said bladder, wherein when no cooling flow or other flow is passed though said lumen, said bladder remains deflated, wherein when cooling flow or other flow is passed though said lumen, it passes through said at least one leak path and induces pressure within said bladder causing it to inflate to an eccentric tip.

43. The opto-acoustic recanilization delivery system of claim 36, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

45. The opto-acoustic recanilization delivery system of claim 36, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.

37. The opto-acoustic recanilization delivery system of claims 37, wherein a corner of said lumen and said flexible tubing are trimmed at an angle, wherein when said cooling agent flows through said lumen, said cooling agent forces said delivery system to move laterally with respect to said central axis of said flexible tubing.

38. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein each said proximal end is embedded within said flexible tubing near said first end and wherein said plurality of optical fibers is braided near said proximal ends and wherein said plurality of optical fibers is straight near said distal ends to provide flexibility in said delivery system.

39. An opto-acoustic recanilization delivery system, comprising:

a flexible tubing comprising a first end and a second end, wherein said flexible tubing is suitable for insertion into the vasculature and comprises a lumen for flowing a cooling agent; and

a plurality of optical fibers, wherein each fiber of said plurality of optical fibers comprises a proximal end and a distal end, wherein each said distal end is embedded within said flexible tubing near said second end and wherein said plurality of optical fiber “

float”

freely within said lumen throughout said lumen until said plurality of fiber optics reach said second end where each said distal end of said plurality of fiber optics is embedded within said flexible tubing.

46. The opto-acoustic recanilization delivery system of claim 39, wherein each said distal end aims the effect to produce a lateral deviation of said second end upon delivery of laser radiation, or promote a fluid jetting directional phenomena.