Method for cavitation-induced tissue healing with low intensity ultrasound

• US 7,429,249 B1
• Filed: 06/14/2000
• Issued: 09/30/2008
• Est. Priority Date: 06/14/1999
• Status: Expired due to Fees

• Current Assignee: Exogen Inc. (Bioventus LLC)
• Original Assignee: Exogen Inc. (Bioventus LLC)
• Inventors: Talish, Roger J., Winder, Alan A.
• Primary Examiner(s): Smith; Ruth S
• Application Number:
  US09/980,329
• Time in Patent Office: 3,030 Days
• Field of Search: 600/458, 600/437, 600/439, 601 2- 4, 604/22, 424 95- 952
• US Class Current: 601/2
• 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

A method and kit for therapeutically treating bone and tissue injuries using ultrasound. The method includes the steps of introducing an ultrasound contrast agent into the patient, preferably, the patient'"'"'s blood stream, and impinging ultrasonic waves in proximity to an injury. The ultrasound contrast agent facilitate in lowering the cavitation threshold, i.e., the energy required for the cavitation, to a level attainable by the ultrasonic waves to induce acoustic intracellular microstreaming to accelerate the healing process. The method further includes the steps of maintaining the resonance bubble frequency of the microbubbles of the ultrasound contrast agent from 0.5 MHz to 10 MHz; maintaining the acoustic transmit frequency of the ultrasound waves from 10 kHz to 10 MHz; and maintaining the acoustic spatial average-temporal average (SATA) intensity of the ultrasonic waves from 5 to 500 mW/cm². The kit of the invention includes at least one ergonomically constructed ultrasonic transducer (16) configured to cooperate with a placement module (14) for placement in proximity to an injury and a portable, ergonomically constructed main operating unit (12) constructed to fit within a pouch (18) worn by the patient.

Claims

1. A method for accelerating a healing process for an injury using ultrasound, the method comprising

introducing a capsule comprising a piezoelectric sensor and an ultrasound contrast agent into a patient, wherein the ultrasound contrast agent is adapted to accelerate a healing process for an injury upon application of ultrasound;

mounting an ultrasonic source to the patient;

transmitting an acoustic signal to the piezoelectric sensor instructing the capsule to release a portion of the ultrasound contrast agent, wherein the release of the ultrasound contrast agent is specifically targeted to the proximity of the injury; and

impinging ultrasonic waves in proximity to the injury, wherein the ultrasound contrast agent facilitates in lowering the cavitation threshold to an intensity level attainable by the ultrasonic waves.

2. The method according to claim 1, further comprising maintaining the acoustic spatial average-temporal average (SATA) intensity of the ultrasonic waves from about 5 to 500 mW/cm².

3. The method according to claim 1, wherein the ultrasound contrast agent is comprised of microbubbles having a radius from 0.1 to 10.0 um.

4. The method according to claim 3, further comprising maintaining the resonance bubble frequency of the microbubbles from 0.5 MHz to 10 MHz.

5. The method according to claim 3, wherein the radii of the microbubbles of the ultrasound contrast agent are less than 7.0 μ

m.

6. The method according to claim 1, further comprising maintaining the acoustic transmit frequency of the ultrasonic waves from 10 MHz to 10 MHz.

7. The method according to claim 1, further comprising terminating the impinging step after approximately thirty minutes.

8. The method according to claim 1, wherein introducing a capsule further comprises time-releasing the ultrasound contrast agent into the patient.

9. The method according to claim 1, wherein introducing a capsule further comprises using a syringe to intravaneously introduce the capsule comprising a piezoelectric sensor and an ultrasound contrast agent into the patient.

10. The method according to claim 1, wherein introducing a capsule further comprises using a capsule that is timed-release.

11. The method according to claim 1, wherein transmitting an acoustic signal to the piezoelectric sensor comprises instructing the capsule to release the ultrasound contrast agent in preset amounts at multiple predetermined time intervals.

12. A method for accelerating a healing process for an injury upon application of ultrasound, the method comprising the steps of:

providing a main operating unit having an internal power source coupled to an ultrasonic transducer assembly, the ultrasonic transducer assembly includes at least one ultrasonic transducer, an ultrasonic signal generator and signal generator circuitry therein, wherein the ultrasonic transducer assembly is adapted to be mounted to a patient'"'"'s body;

providing a placement module configured for receiving the ultrasonic transducer assembly and for placing the at least one ultrasonic transducer in proximity to the injury;

providing a syringe capable of introducing a capsule comprising a piezoelectric sensor and an ultrasound contrast agent into the patient;

introducing via the syringe a capsule comprising a piezoelectric sensor and an ultrasound contrast agent into the patient, wherein the ultrasound contrast agent is adapted to accelerate a healing process for an injury upon application of ultrasound, and the piezoelectric sensor is capable of receiving an acoustic signal to release at least some of the ultrasound contrast agent inside the patient;

transmitting an acoustic signal to the piezoelectric sensor instructing the capsule to release a portion of the ultrasound contrast agent in proximity to the injury; and

exciting the at least one ultrasonic transducer to impinge ultrasonic waves at or near the injury, wherein the ultrasound contrast agent facilitates in lowering the cavitation threshold to an intensity level attainable by the ultrasonic waves.