Ultrasonic catheter power control

• US 8,226,629 B1
• Filed: 03/31/2009
• Issued: 07/24/2012
• Est. Priority Date: 04/01/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Keilman, George, Hansmann, Douglas R., Soltani, Azita, Wilson, Richard R.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/415,965
• Time in Patent Office: 1,211 Days
• Field of Search: 604 20- 22, 604/500, 604/501
• US Class Current: 604/500
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A method of treating an occlusion at a treatment site within a patient'"'"'s vasculature comprises providing an ultrasonic catheter. The ultrasonic catheter has a distal region, a proximal region opposite the distal region, a fluid delivery lumen having at least one opening in the distal region, and an ultrasound radiating member positioned within the distal region. The method further comprises positioning the ultrasonic catheter at the treatment site, such that at least a portion of the distal region is within the occlusion. The ultrasonic catheter further comprises passing a therapeutic compound through the fluid delivery lumen such that the therapeutic compound is delivered to the treatment site. The ultrasonic catheter further comprises emitting ultrasonic energy from the ultrasound radiating member. The emitted ultrasonic energy has an amplitude that is periodically varied between a low amplitude and a high amplitude.

Claims

1. A method of treating an occlusion at a treatment site within a patient'"'"'s vasculature comprising:

providing an ultrasonic catheter having a distal region, a proximal region opposite the distal region, a fluid delivery lumen having at least one opening in the distal region, and an ultrasound radiating member positioned within the distal region;

positioning the ultrasonic catheter at the treatment site, such that at least a portion of the distal region is within the occlusion;

passing a therapeutic compound through the fluid delivery lumen such that the therapeutic compound is delivered to the treatment site; and

emitting ultrasonic energy from the ultrasound radiating member operating at a frequency of between 500 kHz and about 20 MHz, wherein the emitted ultrasonic energy has

an amplitude that is periodically varied between a low amplitude and a high amplitude,

a pulse average power exclusive of the low amplitude periods of between approximately 0.01 watts and approximately 20 watts,

a high amplitude pulse duration of between approximately 1 millisecond and approximately 50 milliseconds,

a high amplitude pulse repetition rate of between approximately 5 hertz and approximately 150 hertz, and

an in situ intensity at an energy radiating surface of between approximately 20 watts in<sup>−

2</sup> and approximately 90 watts in<sup>−

2</sup>.

2. The method of claim 1, wherein the emitted ultrasonic energy has an in situ intensity at the energy radiating surface of between approximately 30 watts in⁻

2 and approximately 65 watts in<sup>−

2</sup>.

3. The method of claim 1, wherein the emitted ultrasonic energy has a time average power inclusive of the low amplitude and the high amplitude periods of between approximately 0.1 watts and approximately 2.0 watts.

4. The method of claim 3, wherein the emitted ultrasonic energy has a time average power inclusive of the low amplitude and the high amplitude periods of between approximately 0.6 watts and approximately 1.2 watts.

5. The method of claim 1, wherein the emitted ultrasonic energy has a pulse average power exclusive of the low amplitude periods of between approximately 8 watts and approximately 16 watts.

6. The method of claim 1, wherein the emitted ultrasonic energy has a duty cycle of between approximately 1% and approximately 50%.

7. The method of claim 6, wherein the emitted ultrasonic energy has a duty cycle of between approximately 7.5% and approximately 15%.

8. The method of claim 1, wherein the emitted ultrasonic energy has a high amplitude pulse duration of between approximately 2.5 milliseconds and approximately 5 milliseconds.

9. The method of claim 1, wherein the ultrasound radiating member is a PZT transducer.

10. The method of claim 1, further comprising monitoring a temperature at the treatment site.

11. The method of claim 10, further comprising adjusting a time average power inclusive of the low amplitude and the high amplitude periods in response to the temperature measured at the treatment site.