Ultrasonic devices and methods for ablating and removing obstructive matter from anatomical passageways and blood vessels

• US 20030009125A1
• Filed: 06/27/2002
• Published: 01/09/2003
• Est. Priority Date: 01/11/1991
• Status: Active Grant

• Current Assignee: Henry Nita, Timothy C. Mills
• Original Assignee: Henry Nita, Timothy C. Mills
• Inventors: Nita, Henry, Mills, Timothy C.
• Granted Patent: US 6,929,632 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• 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 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

Disclosed are methods and devices for removing obstructive matter from anatomical passageways, including the removal of obstructive matter from the cerebral vasculature, prostatic obstructions from the urinary tract and/or obstructive matter from the fallopian tubes.

Claims

1. A method of treating an obstruction of a tubular anatomical passageway of the urogenital tract, said method comprising the steps of:

a) providing an ultrasound catheter having a proximal end, and a distal end, said catheter comprising;

i. an elongate flexible catheter body having a proximal end, a distal end, and a longitudinal axis extending longitudinally therethrough;

ii. at least one ultrasound transmission member extending longitudinally through said catheter body, and coupleable to an ultrasound source, said ultrasound transmission member having a distal end which is substantially coterminous with the distal end of said catheter body;

iii. At least one fluid infusion lumen extending longitudinally through said catheter body and opening through at east one fluid outflow aperture formed at the distal end of said catheter body.

b) inserting said catheter, distal end first, into the urogenital tract and advancing said catheter to a point where the distal end of said catheter is adjacent the obstruction to be retreated;

c) coupling said ultrasound transmission member to an ultrasound source and utilizing said ultrasound source to pass ultrasound through said ultrasound transmission member to the distal end of said catheter;

d) infusing a liquid infusate through said infusion lumen and out of said distal outflow aperture.

2. The method of claim 1 wherein step b) further comprises:

providing a guidewire having a proximal end and a distal end;

initially inserting said guidewire, distal end first, into the urogenital tract and advancing said guidewire to a point where the distal end of said guidewire is adjacent the obstruction to be treated;

subsequently advancing said catheter over said guidewire to a point where the distal end of said catheter is adjacent the obstruction to be treated.

3. The method of claim 1 utilized to treat an obstruction of a fallopian tube, wherein step b) of said method further comprises:

inserting said catheter device, distal end first, into said obstructed fallopian tube and advancing said catheter to a poin where the distal end of said catheter is adjacent the fallopian tube obstruction to be treated.

4. The method of claim 1 for treating a prostatic obstruction of the urethra, wherein step b) of said method further comprises:

inserting said catheter device, distal end first, into the urethra and advancing said catheter to a point where the distal end of said catheter is adjacent the prostatic obstruction to be treated.

5. The method of claim 1 wherein said at least one fluid outflow aperture of said catheter device comprises a plurality of lateral outflow apertures positioned to expel fluid in lateral directions generally perpendicular to the longitudinal axis of said elongate catheter body and wherein step d) further comprises:

infusing a liquid infusate through said infusion lumen and out of said distal outflow apertures so as to cause radial dilation of the tubular anatomical passageway in which said catheter is inserted.

6. The method of claim 1 wherein said fluid outflow aperture of said ultrasound catheter device is configured and positioned to expel fluid in the distal direction, parallel to the longitudinal axis of said catheter and wherein step d) further comprises:

infusing said fluid at a rate which will cause said fluid to be expelled in the distal direction parallel to the longitudinal axis of said catheter and into impingement with said obstruction.

7. The method of claim 1 wherein step d) further comprises infusing said liquid infusate through said infusion lumen such that said liquid infusate comes in contact with said ultrasound transmission member so as to remove excess heat from said ultrasound transmission member and subsequently passes out of said distal outflow aperture.

8. The method claim 1 wherein step c) further comprises:

utilizing said ultrasound source to pass ultrasound within the frequency range of 20 kHz to 1 MHz through said ultrasound transmission member to the distal end of said catheter to thereby cause ultrasound induced smooth muscle relaxation and resultant dilation of the anatomical passageway.

9. A method of ultrasonically treating an obstruction of a blood vessel, said method comprising the steps of:

a) providing an ultrasound catheter having a proximal end and a distal end, said catheter comprising;

i) an elongate flexible catheter body having a proximal end, a distal end and a longitudinal axis extending longitudinally therethrough;

ii) at least one ultrasound transmission member extending longitudinally through said catheter body and coupleable to an ultrasound source, said ultrasound transmission member having a distal end which is substantially coterminous with the distal end of said catheter body;

iii) at least one fluid infusion lumen extending longitudinally through said catheter body and opening through at least one fluid outflow aperture formed at the distal end of said catheter body;

iv) at least one aspiration lumen extending longitudinally through said catheter body and opening through at least one aspiration port formed in the distal-most centimeter of said catheter body;

b) inserting said catheter device, distal end first, into the vasculature and advancing said catheter to a point where the distal end of said catheter is adjacent the obstruction to be treated;

c) coupling said ultrasound transmission member to an ultrasound source and utilizing said ultrasound source to pass ultrasound through said ultrasound transmission member to the distal end of said catheter;

d) infusing a liquid infusate through said infusion lumen and out of said distal outflow aperture;

e) applying suction to said aspiration lumen to draw matter into said distal aspiration port and through said aspiration lumen of said catheter.

10. The method of claim 9 utilized to treat a cerebral vascular obstruction, wherein step b) of said method further comprises:

inserting said catheter, distal end first, into the vasculature and advancing said catheter to a point where the distal end of said catheter is positioned in an intracranial or extracranial cerebral blood vessel, adjacent the obstruction to be treated.

11. The method of claim 10 wherein the obstruction to be treated is in a carotid artery and wherein the distal head of said catheter is positioned within said carotid artery adjacent the obstruction to be treated.

12. The method of claim 10 wherein the obstruction to be treated is in a vertebral artery and wherein step b) further comprises positioning the distal end of said catheter within said vertebral artery adjacent the obstruction to be treated.

13. The method of claim 10 wherein the obstruction to be treated is in a basilar artery and wherein step b) further comprises positioning the distal end of said catheter within said basilar artery adjacent the obstruction to be treated.

14. The method of claim 10 wherein the obstruction to be treated is in a anterior cerebral artery and wherein step b) further comprises positioning the distal end of said catheter within said anterior cerebral artery adjacent the obstruction to be treated

15. The method of claim 10 wherein the obstruction to be treated is in a middle cerebral artery and wherein step b) further comprises positioning the distal end of said catheter within said middle cerebral artery adjacent the obstruction to be treated.

16. The method of claim 10 wherein the obstruction to be treated is in a posterior cerebral artery and wherein step b) further comprises positioning the distal end of said catheter within said posterior cerebral artery adjacent the obstruction to be treated.

17. The method of claim 10 wherein said method further comprises the step of:

maintaining the rate of infusion through said infusion lumen and maintaining the rate of aspiration through said aspiration lumen such that said rates of infusion and aspiration are substantially equivalent.

18. The method of claim 9 wherein step d) further comprises infusing said liquid infusate through said infusion lumen such that said liquid infusate comes in contact with said ultrasound transmission member so as to remove excess heat from said ultrasound transmission member and subsequently passes out of said distal outflow aperture.

19. The method claim 9 wherein step c) further comprises:

utilizing said ultrasound source to pass ultrasound within the frefuency range of 20 kHz to 1 MHz through said ultrasound transmission member to the distal end of said catheter to thereby cause ultrasound induced smooth muscle relaxation and resultant dilation of the anatomical passageway.

20. An ultrasound catheter device for delivering ultrasound from an external ultrasound source to a location inside a mammalian body, said device comprising:

a) a tubular catheter body having a proximal end, a distal end, at least one lumen extending longitudinally therethrough and a longitudinal axis;

b) a distal head member comprising a plug at least partially inserted into the distal end of the lumen of the catheter body, said distal head member having at least one fluid passageway extending therethrough and terminating in at least one fluid outflow aperture said fluid passageway being configured to carry fluid from said catheter lumen, through said fluid passageway and out of said fluid outflow aperture;

c) a proximal connector assembly on the proximal end of said catheter body, said proximal connector assembly having at least one bore extending longitudinally therethrough in fluid connection with the lumen of said catheter body, and at least one fluid infusion port to permit infusion of fluid;

d) an ultrasound transmission member having a proximal end and a distal end, said ultrasound transmission member extending longitudinally through the lumen of said catheter body and into the bore of said proximal connector assembly, the distal end of said ultrasound transmission member being in contact with said distal head member and the proximal end of said ultrasound transmission member being coupleable, by way of said proximal connector assembly, to said external ultrasound source;

e) said catheter device being thereby constructed to concomitantly deliver;

i) ultrasonic vibration from said ultrasound source to the distal head member of said catheter; and

ii) a flow of infusion/dilation fluid through said catheter body and out of said at least one fluid outflow aperture.

21. The catheter device of claim 20 further comprising:

an aspiration passageway formed in said distal head member and terminating in at least one aspiration port on the outer surface of said distal head member;

at least one aspiration tube extending longitudinally through said catheter body and having a distal end opening through an aspiration port formed in said distal head member, said aspiration tube having a proximal end which is connectable to a suction source so as to draw matter into said aspiration port and through said aspiration tube, in the proximal direction.

22. The catheter device of claim 20 wherein said distal head member has a lateral sidewall and a frontal surface and wherein said at least one distal outflow aperture comprises:

a plurality of apertures formed at spaced locations about the lateral surface of said distal head member to expel fluid in outward directions generally perpendicular to the longitudinal axis of said catheter body.

23. The device of claim 20 wherein said at least one fluid outflow aperture comprises a plurality of fluid outflow apertures formed at spaced locations about said distal head member such that expulsion of fluid out of said outflow apertures will cause radial dilation of a surrounding anatomical passageway.

24. The vice of claim 20 wherein said at least one fluid outflow aperture comprises:

at least one bore extending longitudinally through said distal head member such that expulsion of fluid from said outflow aperture will flow forward from said distal head member in a direction generally parallel to the longitudinal axis of said catheter body.

25. The device of claim 20 wherein said distal head member comprises a generally cylindrical plug having a cylindrical lateral outer surface which is substantially continuous with the adjacent outer surface of said catheter body.

26. The device of claim 20 wherein said distal head member has a frontal surface of blunt radiused configuration.

27. The device of claim 20 said distal head member has a central fluid passageway extending longitudinally therein to and fluidly communicative with the lumen of said catheter, said central fluid passageway leading to a plurality of secondary fluid passageways which lead to a plurality of fluid outflow apertures, respectively, so as to carry infusion fluid from the lumen of said catheter, through said distal head member and out of said plurality of fluid outflow apertures.

28. The device of claim 20 wherein said catheter is an over-the-wire type of catheter which further comprises:

a guidewire lumen extending longitudinally through said catheter and having a guidewire passageway extending longitudinally through said distal head and opening through the distal surface thereof.

29. The device of claim 20 wherein said catheter is a monorail type of catheter which further comprises:

a monorail guidewire passage lumen extending through a distal portion of said catheter, from a distal guidewire aperture formed in the distal surface of said distal head member to a sidewall guidewire passage aperture formed in the sidewall of said catheter at a location between the proximal and distal ends of said catheter.