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

• US 6,454,757 B1
• Filed: 09/02/1999
• Issued: 09/24/2002
• Est. Priority Date: 01/11/1991
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Mills, Timothy C., Nita, Henry
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/388,794
• Time in Patent Office: 1,118 Days
• Field of Search: 604/21, 604/22, 604/517, 604/500, 604/515, 604/73, 604/113, 604/523, 606/159, 606/193, 606/169-171, 601/2
• US Class Current: 604/517
• 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

A method for treating obstructions of tubular anatomical passageways of the urinary tract, including the urethra and fallopian tubes, provides inserting an ultrasonic catheter device into an anatomical passageway, passing ultrasound to the distal end of the catheter and infusing liquid infusate to the distal end of the catheter to expel it through lateral fluid outflow apertures at a rate which will cause fluidic dilation of the anatomical passageway.

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. a distal head member at least partially inserted into the distal end of the lumen of the catheter body, said distal head member having a lateral surface and a frontal surface and a plurality of fluid passageways and fluid outflow apertures formed at spaced locations about the lateral surface of said distal head member and positioned to expel fluid in outward directions generally perpendicular to the longitudinal axis of said catheter body;

iii. 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 in contact with the distal head member;

iv. at least one fluid infusion lumen extending longitudinally through said catheter body in fluid communication with said fluid passageways;

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 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, through said fluid passageways and out of said fluid 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 paint 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 further utilized to treat an obstruction of a fallopian tube part of the urogenital tract, wherein step b) of said method comprises:

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

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

infusing a liquid infusate through said infusion lumen, through said fluid passageways and out of said fluid outflow apertures at a rate which will cause fluidic, radial dilation of the tubular anatomical passageway in which said catheter is inserted.

6. The method of claim 1 wherein said distal head member further includes at least one fluid passageway opening through at least one fluid outflow aperture formed at the frontal surface of the distal head member which 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 through said fluid passageways and out of said fluid outflow apertures.

8. The method claim 1 wherein stop 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 cater to thereby cause ultrasound induced smooth muscle relaxation and resultant dilation of the anatomical passageway.

9. The method of claim 1 wherein the fluid infusion lumen further comprises a central fluid passageway extending longitudinally within the distal head member and interconnecting the plurality of fluid passageways.

10. 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 a plurality of fluid outflow apertures formed at the distal end of said catheter body and positioned to expel fluid in lateral directions generally perpendicular to the longitudinal axis of said elongate 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 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 fluid outflow apertures at a rate which will cause fluidic, radial dilation of the tubular anatomical passageway in which said catheter is inserted.

11. The method of claim 10 further comprising a distal head member at least partially inserted into the distal end of the catheter body, said distal head member having a lateral surface and a frontal surface and a plurality of fluid passageways and wherein said fluid outflow apertures are formed at spaced locations about the lateral surface of said distal head member.

12. The method of claim 10 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.

13. The method of claim 10 further comprising a distal head member at least partially inserted into the distal end of the catheter body, said distal head member having a central fluid passageway extending longitudinally therein to and fluidly communicative with the lumen of said catheter, said central passageway leading to a plurality of secondary passageways which lead to said plurality of fluid outflow apertures, respectively.

14. 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. a distal head member at least partially inserted into the distal end of the lumen of the catheter body, said distal head member having a central fluid passageway extending longitudinally therein to and fluidly communicative with the lumen of said catheter, said central passageway leading to a plurality of secondary 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;

iii. 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;

iv. 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;

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 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.

15. The method of claim 14 wherein said distal head member further comprises a lateral surface and wherein said fluid outflow apertures are formed at spaced locations about the lateral surface of said distal head member and positioned to expel fluid in lateral directions generally perpendicular to the longitudinal axis of said elongate catheter body.

16. The method of claim 15 wherein step d) further comprises:

infusing a liquid infusate through said infusion lumen and out of said fluid outflow apertures at a rate which will cause fluidic, radial dilation of the tubular anatomical passageway in which said catheter is inserted.

17. The method of claim 14 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.