Intravascular ultrasonic catheter/probe and method for treating intravascular blockage

• US 4,870,953 A
• Filed: 11/13/1987
• Issued: 10/03/1989
• Est. Priority Date: 11/13/1987
• Status: Expired due to Term

• Current Assignee: Cybersonics, Inc, Don Michael International, LLC
• Original Assignee: Donmicheal T. Anthony, Eugene A. Decastro, Robert J. Siegel
• Inventors: DeCastro, Eugene A., Siegel, Robert J., DonMicheal, T. Anthony
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Pham, Huong Q.
• Application Number:
  US07/120,390
• Time in Patent Office: 690 Days
• Field of Search: 128/24 A, 128/24 R, 128/328, 128/786, 128/660.01
• US Class Current: 606/128
• 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 2017/00141 continuous, e.g. wave
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/320098 with transverse or torsional motion
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00035 with return means
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10

Abstract

Apparatus and method are disclosed for treating atherosclerotic plaque and thromboses by the application of ultrasonic energy to a site of intravascular blockage. The ultrasonic apparatus includes a solid wire probe having a bulbous tip at one end and coupled to an ultrasonic energy source at the other end, the probe being carried within a hollow catheter. The catheter and probe are inserted into a blood vessel and are advanced to the site of a stenosis, where the probe is extended from the catheter and caused to vibrate ultrasonically, resulting in the destruction of the arterial plaque. The ultrasonic apparatus includes a fitting for delivering a radiographic contrast solution to the probe tip by flowing the solution into the catheter, the contrast fluid being released into the blood vessel to assist in positioning the apparatus and determining the effectiveness of treatment. A physiologic solution may also be carried to the probe tip by flowing the solution through the catheter, thereby controlling the temperature of the probe tip during the procedure.

Claims

1. An ultrasonic apparatus for the treatment of a patient having blood vessels obstructed by deposits of atherosclerotic plaque or blood clots, comprising:

an ultrasonic energy source;

an elongated, solid, flexible probe having first and second ends and coupled at the first end to the ultrasonic energy source and having a tip at the second end, the probe length selected so as to provide both longitudinal and transverse motion of the probe tip, the probe tip having a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip;

a hollow catheter for internally carrying a portion of the probe, the catheter having first and second ends, the tip of the probe having a diameter less than the internal diameter of the hollow catheter; and

means adapted to slide the probe within the catheter to extend the probe from the second end of the catheter into a mass of atherosclerotic plaque or blood clots.

3. The ultrasonic apparatus of claim 1 wherein the probe tip is provided with a flexible extension approximately 2 cm in length along the longitudinal axis of the probe, the extension being flexible enough to fold back on itself when contacting the blood vessel wall.

20. Apparatus as defined in claim 1 wherein the probe tip has a bulbous shape such that the tip of the probe is rounded and has a diameter greater than the diameter of the remainder of the probe.

2. An ultrasonic apparatus for the treatment of a patient having blood vessels obstructed by deposits of atherosclerotic plaque or blood clots, comprising:

an ultrasonic energy source;

an elongated, solid, flexible probe having first and second ends and coupled at the first end to the ultrasonic energy source and having a tip at the second end, the probe length selected so as to provide both longitudinal and transverse motion of the probe tip, the probe tip having a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip; and

a hollow catheter having first and second ends, internally carrying a portion of the probe, the tip of the probe having a diameter less than the internal diameter of the hollow catheter, the second end of the probe adapted to be inserted into the blood vessel to be treated;

the catheter having an inflatable annular balloon around the outer circumference of the second end of the catheter.

4. The ultrasonic apparatus of claim 2 wherein the catheter has a plurality of internal passageways that extend along the length of the catheter.

5. The ultrasonic apparatus of claim 2 wherein the catheter has means for inflating the balloon after the second end of the catheter is in the blood vessel.

6. An apparatus for use with an ultrasonic energy source and capable of being advanced in a blood vessel to the site of a blockage due to atherosclerotic plaque or blood clot for the treatment of the blockage, comprising:

a flexible, elongated metal wire probe having one end adapted to be coupled to the ultrasonic energy source and having a tip at the other end, and the length of the probe being selected so that the probe length is an acoustical length of a whole number multiple of a one-half wavelength of the frequency of the ultrasonic energy source in the material of which the probe is constructed, with the tip of the probe located at an antinode of the probe length, the tip having a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip;

a hollow catheter comprised of a flexible material having an inside diameter sufficient to internally carry the blunt, rounded tip of the probe, adapted to be inserted into the blood vessel at one end, and having an inflatable cuff at the inserted end that may be inflated to axially center the catheter and probe in the blood vessel; and

means, coupled to the catheter, for introducing fluid into the blood vessel through the catheter.

21. Apparatus as defined in claim 6 wherein said tip has a bulbous, rounded form.

7. A method of treating a patient suffering from partial or total blood vessel blockage due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, the method comprising the steps of:

(a) providing an ultrasonic energy source;

an elongated, hollow catheter; and

an elongated, solid, flexible probe carried internally within the catheter;

(b) providing the probe with a blunt, rounded tip having a diameter less than the internal diameter of the hollow catheter and with a length that results in both longitudinal and transverse motion of the probe tip, the blunt, rounded tip being formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip;

(c) attaching a first end of the catheter and probe to the ultrasonic energy source such that a second end of the probe is coextensive with a second end of the catheter;

(d) making an incision in the outer skin of the patient down to a blood vessel;

(e) introducing the catheter carrying the probe into the blood vessel and advancing the catheter and probe to the site of blockage by viewing a real-time x-ray image of the catheter and probe in the blood vessel;

(f) extending the probe from the end of the catheter and thereby making contact with the fibrous or calcified plaque or blood clot at the site of blockage; and

(g) transmitting ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the blockage.

8. The method of claim 7 wherein the step (c) of advancing the catheter and probe to the site of an arterial blockage includes introducing a radiographic contrast fluid through the catheter and around the probe to the site of the blockage in the blood vessel and viewing the contrast fluid in real-time on an x-ray image.

9. The method of claim 8 further comprising the step of:

(f) viewing the flow of contrast fluid released from the catheter into the blood vessel after the transmission of ultrasonic energy to determine the extent of destruction of the arterial blockage.

10. The method of claim 7 further comprising the step of:

(f) supplying a physiologic fluid through the catheter to the site of arterial blockage to control the temperature of the probe tip while the ultrasonic energy is being applied.

11. The method of claim 7 further comprising the step of:

(f) removing plaque debris from the area of the treatment site by creating a suction through the catheter.

12. The method of claim 7 wherein the catheter has a plurality of internal passageways extending along its length, the method further comprising the step of:

(f) removing plaque debris from the area of the treatment site by creating a suction through one of the internal passageways.

13. The method of claim 7 wherein the catheter has an annular, inflatable cuff located around the outer circumference of the second end of the catheter;

and

the step (f) of the method further includes inflating the annular cuff, thereby blocking off the treatment site and centering the catheter in the blood vessel.

22. A method as defined in claim 7 wherein the tip has a bulbous, rounded form.

14. A method of treating a patient suffering from partial or total blockage of a blood vessel due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, the method comprising the steps of:

(a) providing an ultrasonic apparatus comprising an ultrasonic energy source;

an elongated, solid, flexible probe coupled at a first end to the ultrasonic energy source and having a tip at a second end;

a hollow catheter for internally carrying a portion of the probe such that the catheter is adapted to be coupled at a first end to means for introducing fluid into the catheter and inserted at a second end of the catheter into the blood vessel to be treated, and means to slide the probe within the catheter and to extend the probe from the second end of the catheter into a mass of atherosclerotic plaque or blood clot;

(b) providing the probe tip with a blunt, rounded shape having a diameter less than the internal diameter of the hollow catheter and formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip, and the probe is selected to have a length that results in both longitudinal and transverse motion at the tip;

(c) inserting the probe within the catheter and attaching the first end of the probe to the ultrasonic energy source such that the second end of the probe is coextensive with the second end of the catheter;

(d) making an incision in the outer skin of the patient down to a blood vessel and inserting a self-sealing sheath into the blood vessel;

(e) introducing the catheter carrying the probe through the self-sealing sheath and into the blood vessel, and advancing the catheter and probe to the site of blockage by viewing a real-time x-ray image of the catheter and probe in the blood vessel;

(f) extending the probe from the end of the catheter so that the probe tip makes contact with the fibrous or calcified plaque or blood clot at the site of arterial blockage; and

(g) transmitting ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the fibrous or calcified plaque or blood clot.

15. The method of claim 14 wherein the step (c) of introducing the catheter carrying the probe into the blood vessel includes introducing a radiographic contrast fluid through the catheter to the site of the blockage in the blood vessel and viewing the contrast fluid in real-time on an x-ray image.

16. The method of claim 14 wherein the catheter has a plurality of internal passageways that extend along its length.

17. The method of claim 16 further including the step of:

(f) removing plaque debris from the area of the treatment site by creating a suction through one of the internal passageways of the catheter.

18. The method of claim 14 wherein the catheter has an annular balloon around its outer circumference at its second end and includes means for inflating the annular balloon;

and

the step (c) includes inflating the annular balloon so as to block off the treatment site and center the catheter in the blood vessel.

19. The method of claim 14 wherein the step (e) of transmitting ultrasonic energy along the probe includes pulsing the ultrasonic energy in 20 msec. cycles.

23. A method as defined in claim 14 wherein the probe tip has a bulbous shape such that the tip of the probe is rounded and has a diameter greater than that of the remainder of the probe.

24. An ultrasonic apparatus for the treatment of a patient having blood vessels obstructed by deposits of atherosclerotic plaque of blood clots, comprising:

an ultrasonic energy source;

an elongated, solid, flexible probe having first and second ends and coupled at the first end to the ultrasonic energy source and having a tip at the second end, the probe length selected so as to provide both longitudinal and transverse motion of the probe tip, the probe tip having a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip;

a hollow catheter for internally carrying a portion of the probe, the catheter having first and second ends; and

means adapted to slide the probe within the catheter and to extend the probe from the second end of the catheter into a mass of atherosclerotic plaque or blood clots, and means to reduce and control the temperature of said tip including means connected to said source for causing said source to supply pulsed ultrasonic energy to said probe.

29. The ultrasonic apparatus of claim 24 wherein the diameter of the probe tip is slightly less than the inside diameter of the catheter.

30. The ultrasonic apparatus of claim 24 wherein the probe tip is provided with a flexible extension approximately 2 cm in length along the longitudinal axis of the probe, the extension being flexible enough to fold back on itself when contacting the blood vessel wall.

25. An ultrasonic apparatus for the treatment of a patient having blood vessels obstructed by deposits of atherosclerotic plaque or blood clots, comprising:

an ultrasonic energy source;

an elongated, solid, flexible probe having first and second ends and coupled at the first end to the ultrasonic energy source and having a tip at the second end, the probe length selected so as to provide both longitudinal and transverse motion of the probe tip, the probe tip having a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip; and

a hollow catheter having first and second ends, internally carrying a portion of the probe, the second end of the probe adapted to be inserted into the blood vessel to be treated;

the catheter having an inflatable annular balloon around the outer circumference of the second end of the catheter, and means to reduce and control the temperature of said tip including means connected to said source for causing said source to supply pulsed ultrasonic energy to said probe.

31. The ultrasonic apparatus of claim 25 wherein the catheter has a plurality of internal passageways that extend along the length of the catheter.

32. The ultrasonic apparatus of claim 25 wherein the catheter has means for inflating the balloon after the second end of the catheter is in the blood vessel.

26. An ultrasonic apparatus for the treatment of a patient having blood vessels obstructed by deposits of atherosclerotic plaque or blood clots, comprising:

an ultrasonic energy source constituting means for producing pulsed ultrasonic vibrations;

a flexible, elongated metal wire probe having one end adapted to be coupled to the ultrasonic energy source and having a tip at the other end, and the length of the probe being selected so that the probe length is an acoustical length of a whole number multiple of a one-half wavelength of the frequency of the ultrasonic energy source in the material of which the probe is constructed, with the tip of the probe located at an antinode of the probe length, the tip having a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip;

a hollow catheter comprised of a flexible material having an inside diameter sufficient to internally carry the blunt, rounded tip of the probe, adapted to be inserted into the blood vessel at one end, and having an inflatable cuff at the inserted end that may be inflated to axially center the catheter and probe in the blood vessel; and

means, coupled to the catheter, for introducing fluid into the blood vessel through the catheter.

27. A method of treating a patient suffering from partial or total blood vessel blockage due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, the method comprising the steps of:

(a) providing an ultrasonic energy source;

an elongated, hollow catheter; and

an elongated, solid, flexible probe carried internally within the catheter;

(b) providing the probe with a blunt, rounded tip having a length that results in both longitudinal and transverse motion of the probe tip, the blunt, rounded tip being formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip;

(c) attaching a first end of the catheter and probe to the ultrasonic energy source such that a second end of the probe is coextensive with a second end of the catheter;

(d) making an incision in the outer skin of the patient down to a blood vessel;

(e) angiographically introducing the catheter carrying the probe into the blood vessel and advancing the catheter and probe to the site of blockage by viewing a real-time image of the catheter and probe in the blood vessel;

(f) extending the probe from the end of the catheter and thereby making contact with the fibrous or calcified plaque or blood clot at the site of blockage; and

(g) transmitting pulsed ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the blockage without overheating the probe tip.

35. The method of claim 27 further comprising the step of:

(h) supplying a physiologic fluid through the catheter to the site of arterial blockage to control the temperature of the probe tip while the ultrasonic energy is being applied.

36. The method of claim 27 further comprising the step of:

(h) removing plaque debris from the area of the treatment site by creating a suction through the catheter.

37. The method of claim 27 wherein the catheter has a plurality of internal passageways extending along its length, the method further comprising the step of:

(h) removing plaque debris from the area of the treatment site by creating a suction through one of the internal passageways.

38. The method of claim 27 wherein the catheter has an annular, inflatable cuff located around the outer circumference of the second end of the catheter;

and

the step (f) of the method further includes inflating the annular cuff, thereby blocking off the treatment site and centering the catheter in the blood vessel.

28. A method of treating a patient suffering from partial or total blockage of a blood vessel due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, the method comprising the steps of:

(a) providing an ultrasonic apparatus comprising an ultrasonic energy source;

an elongated, solid, flexible probe coupled at a first end to the ultrasonic energy source and having a tip at a second end;

a hollow catheter for internally carrying a portion of the probe such that the catheter is adapted to be coupled at a first end to means for introducing fluid into the catheter and inserted at a second end of the catheter into the blood vessel to be treated, and means to slide the probe within the catheter and to extend the probe from the second end of the catheter into a mass of atherosclerotic plaque or blood clot;

(b) providing the probe tip with a blunt, rounded shape formed to be substantially free of any tendency to perforate a blood vessel and the probe having a degree of flexibility selected to prevent perforation of the blood vessel upon contact with the probe tip, and the probe is selected to have a length that results in both longitudinal and transverse motion at the blunt, rounded tip;

(c) inserting the probe within the catheter and attaching the first end of the probe to the ultrasonic energy source such that the second end of the probe is coextensive with the second end of the catheter;

(d) mixing an incision in the outer skin of the patient down to a blood vessel and angiographically inserting a self-sealing sheath into the blood vessel;

(e) introducing the catheter carrying the probe through the self-sealing sheath and into the blood vessel, and advancing the catheter and probe to the site of blockage by viewing a real-time image of the catheter and probe in the blood vessel;

(f) extending the probe from the end of the catheter so that the probe tip makes contact with the fibrous or calcified plaque or blood clot at the site of arterial blockage; and

(g) transmitting pulsed ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the fibrous or calcified plaque or blood clot without overheating the probe tip.

33. The method of claim 28 wherein the step (e) of advancing the catheter and probe to the site of an arterial blockage includes introducing a radiographic contrast fluid through the catheter and around the probe to the site of the blockage in the blood vessel and viewing the contrast fluid in real-time on an x-ray image.

34. The method of claim 33 further comprising the step of:

(h) viewing the flow of contrast fluid released from the catheter into the blood vessel after the transmission of ultrasonic energy to determine the extent of destruction of the arterial blockage.

39. The method of claim 28 wherein the step (e) of introducing the catheter carrying the probe into the blood vessel includes introducing a radiographic contrast fluid through the catheter to the site of the blockage in the blood vessel and viewing the contrast fluid in real-time on an x-ray image.

40. The method of claim 28 wherein the catheter has a plurality of internal passageways that extend along its length.

41. The method of claim 40 further including the step of:

(h) removing plaque debris from the area of the treatment site by creating a suction through one of the internal passageways of the catheter.

42. The method of claim 28 wherein the catheter has an annular balloon around its outer circumference at its second end and includes means for inflating the annular balloon;

and

the step (e) includes inflating the annular balloon so as to block off the treatment site and center the catheter in the blood vessel.

43. The method of claim 28 wherein the step (g) of transmitting pulsed ultrasonic energy along the probe includes pulsing the ultrasonic energy in 20 msec. cycles.