Treatment of vascular occlusions using ultrasonic energy and microbubbles

• US 7,648,478 B2
• Filed: 03/11/2008
• Issued: 01/19/2010
• Est. Priority Date: 01/30/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Soltani, Azita, Hansmann, Douglas R.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US12/046,375
• Publication Number:
  US 20080208109A1
• Time in Patent Office: 679 Days
• Field of Search: 604 20- 22, 604/96.01, 604/49, 604/101.01, 604/101.02, 604/101.03, 604/101.05, 600/437, 600/466, 600/462, 600/467, 600/469, 600/470, 606 27- 28, 607/96, 607/97
• US Class Current: 604/22
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 2007/0039 using microbubbles
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

In one embodiment of the present invention, a method of treating a vascular occlusion located at a treatment site within a patient'"'"'s vasculature comprises positioning an ultrasound catheter at the treatment site. The method further comprises delivering a microbubble therapeutic compound from the ultrasound catheter to the vascular occlusion during a first treatment phase. The method further comprises pausing the delivery of the microbubble therapeutic compound and delivering ultrasonic energy from the ultrasound catheter to the vascular occlusion during a second treatment phase while the delivery of microbubble therapeutic compound remains paused.

Claims

1. A method of treating a vascular occlusion located at a treatment site within a patient'"'"'s vasculature, the method comprising:

positioning an ultrasound catheter at the treatment site;

delivering a microbubble therapeutic compound from the ultrasound catheter to the vascular occlusion during a first treatment phase; and

pausing the delivery of the microbubble therapeutic compound and delivering ultrasonic energy from the ultrasound catheter to the vascular occlusion during a second treatment phase while the delivery of microbubble therapeutic compound remains paused.

2. The method of claim 1, further comprising measuring a temperature at the treatment site during the second treatment phase, wherein a duration of the second treatment phase is at least partially dependent on the measured temperature.

3. The method of claim 1, wherein the first treatment phase has a duration between approximately one minute and approximately three minutes.

4. The method of claim 1, wherein the first treatment phase and the second treatment phase are approximately the same duration.

5. The method of claim 1, wherein the first treatment phase is longer than the second treatment phase.

6. The method of claim 1, wherein the first treatment phase is shorter than the second treatment phase.

7. The method of claim 1, further comprising repositioning the catheter after the first treatment phase and before the second treatment phase.

8. The method of claim 1, wherein the first and second treatment phases are alternately repeated a plurality of times.

9. The method of claim 1, wherein the microbubble therapeutic compound is infused from a catheter fluid delivery port positioned within the occlusion.

10. The method of claim 1, wherein the microbubble therapeutic compound is infused from a catheter fluid delivery port positioned external to the occlusion.

11. The method of claim 1, wherein the microbubble therapeutic compound includes between approximately 4×

10⁶ and approximately 4×

10⁸ microbubbles per milliliter.

12. The method of claim 1, wherein the microbubble therapeutic compound includes microbubbles having a diameter of between approximately 0.1 μ

m and approximately 100 μ

m.

13. A method of treating a vascular occlusion located at a treatment site within a patient'"'"'s vasculature, the method comprising:

passing an ultrasound catheter through the patient'"'"'s vasculature to the treatment site, wherein the ultrasound catheter includes at least one fluid delivery port;

positioning the ultrasound catheter at the treatment site such that the at least one fluid delivery port is positioned within the occlusion;

infusing a microbubble therapeutic compound from the ultrasound catheter into an internal portion of the occlusion;

pausing delivery of the microbubble therapeutic compound from the ultrasound catheter after a first quantity has been infused into the occlusion;

delivering ultrasonic energy from the ultrasound catheter into the infused microbubble therapeutic compound;

repositioning the ultrasound catheter at the treatment site; and

infusing a second quantity of microbubble therapeutic compound from the ultrasound catheter to the treatment site after the ultrasonic energy is delivered to the treatment site.

14. The method of claim 13, wherein the ultrasonic energy is delivered for between about one minute and about three minutes.

15. The method of claim 13, wherein the microbubble therapeutic compound is delivered to the treatment site for a period of time that is approximately equal to a period of time during which ultrasonic energy is delivered to the treatment site.

16. The method of claim 13, further comprising measuring a temperature at the treatment site, wherein the quantity of ultrasonic energy delivered into the infused microbubble therapeutic compound is at least partially dependent on the measured temperature.

17. The method of claim 13, wherein the microbubble therapeutic compound includes between approximately 4×

10⁶ and approximately 4×

10⁸ microbubbles per milliliter.

18. The method of claim 13, wherein the microbubble therapeutic compound includes microbubbles having a diameter of between approximately 0.1 μ

m and approximately 100 μ

m21.

19. The method of claim 13, wherein the ultrasound catheter includes a plurality of ultrasound radiating members.

20. The method of claim 13, wherein the ultrasound radiating member comprises an ultrasound radiating member having a hollow inner core, and wherein the microbubble therapeutic compound is passed through the hollow inner core before being infused at the treatment site.

21. An ultrasound catheter system comprising:

an elongate tubular body having an ultrasound radiating member and a fluid delivery lumen positioned therein;

a fluid reservoir that is hydraulically coupled to a proximal portion of the fluid delivery lumen, the fluid delivery reservoir containing a microbubble therapeutic compound;

an infusion pump configured to pump the microbubble therapeutic compound from the fluid reservoir into the fluid delivery lumen; and

control circuitry configured to send electrical activation power to the infusion pump and to the ultrasound radiating member, wherein the control circuitry is configured such that the infusion pump and the ultrasound radiating member are not activated simultaneously.

22. The ultrasound catheter system of claim 21, further comprising a temperature sensor, wherein the control circuitry sends electrical activation power to one of the infusion pump and the ultrasound radiating member based on a temperature signal received from the temperature sensor.

23. The ultrasound catheter system of claim 21, wherein a plurality of ultrasound radiating members are positioned within the elongate tubular body.

24. The ultrasound catheter system of claim 21, wherein a plurality of fluid delivery lumens are positioned within the elongate tubular body.

25. The ultrasound catheter system of claim 21, wherein the tubular body has an outer diameter between about 2 French and about 5 French.