Shock-Wave Generating Device, Such as for the Treatment of Calcific Aortic Stenosis

• US 20090227992A1
• Filed: 02/01/2007
• Published: 09/10/2009
• Est. Priority Date: 02/02/2006
• Status: Abandoned Application

• Current Assignee: Hitachi Kokusai Electric Incorporated (Hitachi, Ltd.), ReLeaf Medical Ltd.
• Original Assignee: ReLeaf Medical Ltd.
• Inventors: Flugelman, Moshe Y., Nir, Yael
• Application Number:
  US12/223,458
• Publication Number:
  US 20090227992A1
• Time in Patent Office: Days
• US Class Current: 606/7
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2018/263 the conversion of laser energy into mechanical shockwaves taking place in a liquid
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre

Abstract

Disclosed is a method for removing deposits from an in vivo tissue, such as removing calcified plaque from a calcified aortic valve by removing the deposits with the help of shock waves produced by a light-source such as a laser in an aqueous liquid in proximity of the tissue as well as a shock-wave generating device useful in implementing the method. Disclosed is a minimally invasive valve-sparing treatment of calcific aortic stenosis.

Claims

1. A shock-wave generating device for invivo removal of deposits from tissue, comprising:

a) a probe with a proximal end and a distal end, said distal end having a distal tip, said probe comprises;

i) a light-guide configured to guide shock wave-generating light to the distal end of said probe;

b) a light-source directing light into said light-guide, said light-source configured to generate a pulse train which comprises at least one pulse of light, each said pulse of light of a duration of less than 300 ns, which generates a shock wave in an aqueous liquid wherein at least one wavelength of said light is a wavelength having a water absorption coefficient of no less than about 10³ cm<sup>−

1</sup>.

2. The device of claim 1 wherein said wavelength is between 2.8 μ

m and 3.5 μ

m.

3. The device of claim 1, wherein said duration of said pulse of light is 15 ns or less.

4. The device of claim 1, wherein said pulse train consists of not less than two pulses of light at a frequency of not lower than 2 Hz.

8. The device of claim 1, wherein said probe is an aortic catheter.

12. The device of claim 1, said probe further comprising:

an irrigation fluid conduit, configured to provide a fluid passage from a proximal end of said probe out through a fluid outlet positioned at a distal end of said probe.

14. The device of claim 1, said probe further comprises:

iii) an aspiration fluid conduit configured to provide a fluid passage from a fluid inlet positioned at a distal end of said probe to a proximal end of said probe.

16. The device of claim 1, further comprising:

e) an illumination component configured to project light out of a projecting port at proximity of said distal end of said probe; and

f) an observation component configured to acquire, light produced by said illumination component and received at the observation component from an object and produce an image of the object.

19. The device of claim 1, said probe further comprising:

vi) a cutting tool configured to cut tissue.

20. The device of claim 19, wherein said cutting tool comprises a cutting light-source light guide configured to guide light between said proximal end of said probe and said distal end of said probe.

21. The device of claim 1, further comprising:

i) a heart beat monitor with an output;

and wherein

said light-source comprises a trigger functionally associated with said heart beat monitor.

45. The device of claim 1, wherein said catheter has a distal tip which protrudes a distance from at least one of the following:

a distal tip of said light-guide;

said fluid outlet of said irrigation fluid conduit;

said fluid inlet of said aspiration fluid conduit;

said projecting port;

where said observation component acquires light.

46. The device of claim 45, wherein said distance is between 0.3 and 2 mm.

47. The device of claim 45, wherein the surface area of the protruding distal tip of said light-guide is not less than about 0.008 mm².

5-7. -7. (canceled)

9-11. -11. (canceled)

13. (canceled)

15. (canceled)

17-18. -18. (canceled)

22. A method of dislodging plaque from an aortic valve, the method comprising:

a) providing a cardiac catheter having a distal end and a distal tip, which comprises a light-guide, a distal tip of said light-guide in proximity of a distal end of said catheter;

b) placing said distal tip of said light-guide at a distance from a calcified area of said aortic valve;

c) guiding a pulse train which comprises at least one pulse of light, each pulse of light of an energy, of a duration and including at least one wavelength of light such as to generate a shock wave in said aqueous liquid at an interface between said distal tip of said light-guide and said aqueous liquid, said pulse train sufficient to dislodge at least some plaque coating from said area,

wherein at least one said wavelength is a wavelength having a water absorption coefficient of no less than about 10³ cm<sup>−

1</sup> and

wherein said duration is less than about 300 ns.

23. The method of claim 22, wherein said heart is beating.

24. The method of claim 23, wherein generation of said pulse train of light is coordinated with said beating of said heart.

25. The method of claim 22, wherein said distal tip of said catheter protrudes substantially said distance from said distal tip of said light-guide and said placing said distal tip of said light-guide at a distance from said area comprises contacting said distal tip of said catheter against said aortic valve in proximity of said area.

28. The method of claim 22, wherein said distance is not greater than about 2 mm.

29. The method of claim 22, wherein said distance is not less than about 0.3 mm.

30. The method of claim 22, wherein substantially all wavelengths of light guided through said light-guide have a water absorption coefficient of no less than about 10³ cm⁻

1.

31. The method of claim 22, wherein said duration of said pulse of light is less than 15 ns.

34. The method of claim 22, wherein said frequency is not lower than about 5 Hz.

35. The method claim 22, wherein said frequency is not higher than about 1000 Hz.

36. The method of claim 22, further comprising:

iv) prior to guiding a pulse train, observing said area.

37. The method of claim 36, wherein said observing said area comprises optically observing said area.

38. The method of claim 37, further comprising, during said optical observation, illuminating said area with at least one wavelength of light substantially not absorbed by said aqueous liquid.

39. The method of claim 37, further comprising:

v) prior to said optical observing, irrigating said area with a substantially transparent liquid so as to displace said aqueous liquid to allow clearer said observation of said area.

40. The method of claim 22, further comprising:

vi) aspirating at least some of said dislodged deposits.

41. The method of claim 40, wherein said aspiration is intermittent.

42. The method of claim 40, wherein said aspiration occurs during said guiding of said pulse train of said light.

43. The method of claim 22, further comprising:

d) cutting commissural fusion of said calcified aortic valve.

44. The method of claim 43, wherein said cutting is with light projected through a light guide associated with said catheter.

26-27. -27. (canceled)

32-33. -33. (canceled)