Treatment of vascular occlusions using ultrasonic energy and microbubbles

• US 20050192556A1
• Filed: 01/28/2005
• Published: 09/01/2005
• 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.
• Granted Patent: US 7,341,569 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 compound and delivering ultrasonic energy from the ultrasound catheter in combination with other therapeutic compounds 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:

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 without applying ultrasound energy to the site; and

delivering ultrasonic energy from the ultrasound catheter into the infused microbubble therapeutic compound after the vascular occlusion has been infused with the microbubble compound.

2. The method of claim 1, further comprising delivering a fluid to the treatment site through the ultrasound catheter while delivering ultrasound energy from the ultrasound catheter.

3. The method of claim 1, further comprising delivery a therapeutic compound to the treatment site through the ultrasound catheter while delivering ultrasound energy from the ultrasound catheter.

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

10⁵ and approximately 4×

10⁸ microbubbles per milliliter.

5. The method of claim 1, wherein the microbubble therapeutic compound includes microbubbles having a diameter of between approximately 0.01 μ

m and approximately 100 μ

m.

6. The method of claim 1, wherein the ultrasound catheter includes a plurality of ultrasound radiating members.

7. The method of claim 1, 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.

8. The method of claim 1, wherein delivering ultrasonic energy from the ultrasound catheter comprises activating an ultrasound transducer positioned within the treatment site.

9. 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 ultrasound from the ultrasound catheter to the vascular occlusion during a second treatment phase while the delivery of microbubble therapeutic compound remains paused.

10. The method of claim 9, further comprising delivering a fluid to the treatment site through the ultrasound catheter while delivering ultrasound energy from the ultrasound catheter.

11. The method of claim 9, further comprising delivery a therapeutic compound to the treatment site through the ultrasound catheter while delivering ultrasound energy from the ultrasound catheter.

12. The method of claim 9, 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.

13. The method of claim 12, wherein the first and second treatment phases are alternately repeated a plurality of times.

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

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

16. The method of claim 9, wherein the microbubble therapeutic compound includes between approximately 4×

10⁵ and approximately 4×

10⁸ microbubbles per milliliter.

17. The method of claim 9, wherein the microbubble therapeutic compound includes microbubbles having a diameter of between approximately 0.01 μ

m and approximately 100 μ

m.

18. The method of claim 9, wherein delivering ultrasonic energy from the ultrasound catheter comprises activating an ultrasound transducer positioned within the treatment site.

19. 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; and

alternately infusing a microbubble therapeutic compound from the ultrasound catheter into an internal portion of the occlusion and delivering ultrasonic energy from the ultrasound catheter and other therapeutic compounds to the occlusion.