Treatment of vascular occlusions using ultrasonic energy and microbubbles

• US 9,192,566 B2
• Filed: 04/17/2014
• Issued: 11/24/2015
• Est. Priority Date: 02/17/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Soltani, Azita, Hansmann, Douglas R.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/255,834
• Publication Number:
  US 20140316329A1
• Time in Patent Office: 586 Days
• Field of Search: 604/22
• US Class Current: 1/1
• 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 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61N 2007/0039 using microbubbles
• CPC Class Codes: A61N 7/022 intracavitary

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.

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 assembly at the treatment site;

delivering a diluted microbubble-therapeutic compound from the ultrasound assembly to the vascular occlusion, wherein the diluted microbubble-therapeutic compound has;

(1) an initial microbubble concentration of between 500,000-1,000,000 microbubble/mL;

or

(2) an effective microbubble concentration of between 5,000-10,000 microbubble/mL; and

delivering ultrasonic energy from the ultrasound assembly to the vascular occlusion concurrently.

2. The method of claim 1, wherein the dilute microbubble-therapeutic compound comprises biological or synthetic-shelled microbubbles.

3. The method of claim 2, wherein the biological or synthetic-shelled microbubbles are less than or equal to approximately 10 micrometers in diameter.

4. The method of claim 1, wherein the diluted microbubble-therapeutic compound and/or ultrasonic energy are delivered concurrently and continuously.

5. The method of claim 1, wherein the ultrasonic energy has a peak rarefaction acoustic pressure less or equal to approximately 5.0 MPa.

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

passing an ultrasound assembly through the patient'"'"'s vasculature to the treatment site, wherein the ultrasound assembly comprises at least one distal fluid delivery port and at least one ultrasound radiating member;

delivering a microbubble-therapeutic compound having an initial microbubble concentration to the proximal end of the at least one distal fluid delivery port to the vascular occlusion, wherein the initial microbubble concentration is diluted to between 500,000-1,000,000 microbubble/mL, and the microbubble-therapeutic compound has a final concentration at the point of delivery to the vascular occlusion that is further reduced to 0.01% of the initial microbubble concentration; and

delivering ultrasonic energy from the ultrasound assembly to the vascular occlusion concurrent to delivering the microbubble-therapeutic compound.

7. The method of claim 6, wherein the microbubble-therapeutic compound comprises biological or synthetic-shelled microbubbles.

8. The method of claim 7, wherein the biological or synthetic-shelled microbubbles are less than or equal to approximately 10 micrometers in diameter.

9. The method of claim 6, wherein the microbubble-therapeutic compound and/or ultrasonic energy are delivered continuously and concurrently.

10. The method of claim 6, wherein the ultrasonic energy has a peak rarefaction acoustic pressure less or equal to approximately 5.0 MPa.