Methods and apparatus for performing diagnostic and therapeutic ultrasound simultaneously

• US 5,558,092 A
• Filed: 06/06/1995
• Issued: 09/24/1996
• Est. Priority Date: 06/06/1995
• Status: Expired due to Term

• Current Assignee: Cerevast Therapeutics, Inc.
• Original Assignee: Imarx Pharmaceutical Corp. (Sycamore Entertainment Group, Inc.)
• Inventors: Yellowhair, David W., Unger, Evan C.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/468,052
• Time in Patent Office: 476 Days
• Field of Search: 128/660.03, 128/662.03, 601/2, 607/97
• US Class Current: 600/439
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• CPC Class Codes: A61K 49/223 Microbubbles, hollow microspheres, free gas bubbles, gas microspheres
• 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
• CPC Class Codes: G01S 15/8925 the array being a two-dimensional transducer configuration, i.e. matrix or orthogonal linear arrays
• CPC Class Codes: G01S 15/899 Combination of imaging systems with ancillary equipment

Abstract

Methods and apparatus for performing diagnostic ultrasound simultaneously with the application of therapeutic ultrasonic waves are disclosed. The methods and apparatus are particularly advantageous in performing ultrasonic imaging of a region of a patient while simultaneously applying therapeutic ultrasonic waves to the region for the purpose of rupturing vesicles administered to that region for purposes such as enhanced cavitation or the targeted release of a bioactive agent into the region. An operator is able to monitor the rupture of vesicles in real time.

Claims

1. An ultrasonic transducer assembly for simultaneous application of diagnostic and therapeutic ultrasonic waves comprising:

a plurality of therapeutic transducer elements for generating therapeutic ultrasonic waves;

a plurality of diagnostic transducer elements for generating and receiving diagnostic ultrasonic waves; and

a platform having a substantially planar upper surface on which said pluralities of therapeutic and diagnostic transducer elements are arranged, said plurality of therapeutic transducer elements being disposed on said planar surface centrally of said plurality of diagnostic transducer elements.

2. The ultrasonic transducer assembly of claim 1 further comprising a first backing material disposed between said plurality of therapeutic transducer elements and the planar surface of said platform, and a second backing material disposed between said plurality of diagnostic transducer elements and the planar surface of said platform.

3. The ultrasonic transducer assembly of claim 2 wherein said first backing material has a lower acoustic impedance than said second backing material.

4. The ultrasonic transducer assembly of claim 2 wherein said first backing material has an acoustic impedance in the range of about 2×

10⁶ Kg/m² /s to 3×

10⁶ Kg/m² /s.

5. The ultrasonic transducer assembly of claim 2 wherein said second backing material has an acoustic impedance of about 7×

10⁶ Kg/m² /s.

6. The ultrasonic transducer assembly of claim 2 wherein said first and second backing materials are each formed of a polymer matrix material.

7. The ultrasonic transducer assembly of claim 2 wherein said first backing material comprises one of an epoxy with tungsten powder and air.

8. The ultrasonic transducer assembly of claim 2 wherein said second backing material comprises an epoxy with tungsten powder.

9. The ultrasonic transducer assembly of claim 1 wherein said plurality of therapeutic transducer elements are isolated from said plurality of diagnostic transducer elements on said planar surface by a material having a heavily damped acoustic impedance.

10. The ultrasonic transducer assembly of claim 9 wherein said acoustic insulating material comprises one of neoprene and air.

11. The ultrasonic transducer assembly of claim 1 wherein said plurality of therapeutic transducer elements comprises a linear array of therapeutic transducer elements, and wherein said plurality of diagnostic transducer elements comprises first and second linear arrays of diagnostic transducer elements disposed on opposite sides of said linear array of therapeutic transducer elements.

12. The ultrasonic transducer assembly of claim 1 wherein said plurality of therapeutic transducer elements comprises a multiplexed phased array of therapeutic transducer elements, and said plurality of diagnostic transducer elements comprises a multiplexed phased array of diagnostic transducer elements that surround the multiplexed phased array of therapeutic transducer elements on said planar surface.

13. The ultrasonic transducer assembly of claim 1 wherein said plurality of therapeutic transducer elements comprises an annular array of therapeutic transducer elements, and said plurality of diagnostic transducer elements comprises a multiplexed phased array of diagnostic transducer elements that surround the annular array of therapeutic transducer elements on said planar surface.

14. The ultrasonic transducer assembly of claim 1 further comprising a layer of an impedance matching material disposed in facing relation over said therapeutic and diagnostic transducer elements on a side opposite said platform.

15. A method for treating a patient comprising the steps of:

(i) administering to the patient a quantity of vesicles;

(ii) insonating the vesicles in a region of the patient with therapeutic ultrasonic waves at a frequency and energy to cause the vesicles to rupture; and

(iii) simultaneously receiving ultrasonic emissions from the insonated vesicles at a harmonic of the frequency of the therapeutic ultrasonic waves and generating an image of said region from the received ultrasonic emissions.

16. The method recited in claim 15 wherein the therapeutic ultrasonic waves comprise continuous-wave ultrasonic signals.

17. The method recited in claim 15 wherein the therapeutic ultrasonic waves are pulsed.

18. The method recited in claim 15 wherein the harmonic at which the ultrasonic emissions of said vesicles are received comprises a second harmonic of the frequency of said therapeutic ultrasonic waves.

19. The method recited in claim 15 wherein said image is generated in real-time.

20. The method recited in claim 15 further comprising the step of monitoring the vesicles using diagnostic ultrasonic waves to determined the presence of the vesicles in said region prior to said insonating step.

21. The method recited in claim 15 wherein the vesicles are administered intravenously.

22. The method recited in claim 15 wherein the vesicles are combined with a bioactive agent to form a vesicle formulation, rupture of the vesicles causing release of the bioactive agent into the region.

23. The method recited in claim 15 wherein said insonating step is performed using a plurality of therapeutic transducer elements, and said receiving step is performed simultaneously using a plurality of diagnostic transducer elements, wherein the plurality of therapeutic transducer elements are located centrally of the plurality of diagnostic transducer elements on a common platform.

24. The method recited in claim 15 wherein the frequency of the therapeutic ultrasonic waves is in the range of about 0.75 to about 3.0 MHz.

25. The method recited in claim 24 wherein the frequency of the therapeutic ultrasonic waves is in the range of about 1.0 to about 2.0 MHz.

26. The method recited in claim 15 wherein the energy of said therapeutic ultrasonic waves is in the range of about 0.05 W/cm² to about 5.0 W/cm².

27. The method recited in claim 26 wherein the energy of said therapeutic ultrasonic waves is in the range of about 0.2 W/cm² to about 2.5 W/cm².