Portable device to initiate and monitor treatment of stroke victims in the field

• US 9,457,201 B2
• Filed: 05/10/2013
• Issued: 10/04/2016
• Est. Priority Date: 05/11/2012
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Hoelscher, Thilo, Voie, Arne
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US13/892,187
• Publication Number:
  US 20140155788A1
• Time in Patent Office: 1,243 Days
• Field of Search: 601/2
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• 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: A61H 2201/0176 By stopping operation
• CPC Class Codes: A61H 2201/018 By limiting the applied torque or force
• CPC Class Codes: A61H 2201/105 with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 2201/1604 Head
• CPC Class Codes: A61H 2201/5002 Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5058 Sensors or detectors
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 2205/02 Head
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 2007/0039 using microbubbles
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• 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

Methods and apparatuses are provided for initiating stroke treatment “in the field” and/or during the transport of the patient to a care facility. The capability is provided to adjust automatically to the individual “therapeutic window” for each single patient, which is crucial because of the significant differences in skull morphology between humans of different age, gender and race. Further, the methods and apparatuses are based on the use of non-invasive application of ultrasound, as well as the non-invasive application of ultrasound in combination with an acoustically active agent, such as microbubbles, where stable cavitation of the microbubbles caused by the ultrasound may be relied upon as an underlying mechanism for both the therapeutic application as well as its control.

Claims

1. A method, comprising:

non-invasively applying ultrasound energy to a cranium of a patient via first and second ultrasound transducers attached at disparate locations about the cranium of the patient;

intravenously administering an acoustically active agent to the patient;

exciting the acoustically active agent by the ultrasound energy to cause stable cavitation, controlling application of the ultrasound energy such that the first and second ultrasound transducers alternately apply the ultrasound energy in pulses to the cranium of the patient;

during a time in which either the first or second ultrasound transducer is not applying ultrasound energy, detecting a state of cavitation of the acoustically active agent using the respective first or second ultrasound transducer, determining a type of cavitation from the detected state, and

if the type of cavitation is inertial, whereby the application of the ultrasound energy has exceeded a level commensurate with a therapeutic window, then reducing an output power of the ultrasound energy until stable cavitation is detected; and

if the type of cavitation is stable, then maintaining the output power of the ultrasound energy such that stable cavitation is maintained;

wherein the non-invasive application of the ultrasound energy occurs at the site of an emergency and/or during transport to a care facility.

2. The method of claim 1, wherein the disparate locations about the cranium of the patient comprise temporal bone regions forward of the ears of the patient.

3. The method of claim 1, wherein the acoustically active agent comprises microbubbles.

4. The method of claim 1, wherein the stable cavitation triggers a plurality of biophysical effects in the patient.

5. The method of claim 4, wherein the controlling of the application of the ultrasound energy is performed automatically.

6. The method of claim 5, wherein performing the automatic control further comprises automatically controlling the application of the ultrasound energy in accordance with at least one of patient-specific characteristics.

7. The method of claim 6, wherein the at least one of the patient-specific characteristics comprises at least one of age, gender, race, skull bone characteristics, and morphology.

8. The method of claim 1, further comprising, performing the non-invasive application of the ultrasound energy and the controlling of the application of the ultrasound energy to counteract effects of at least one of myocardial infarction, deep vein thrombosis, and a cerebrovascular accident due to ischemia.

9. The method of claim 1, wherein each of the first and second ultrasound transducers are connected via cables to a portable, battery-operated power and control device, and wherein the first and second ultrasound transducers comprise single-use ultrasound transducers.

10. The method of claim 9, wherein the first and second ultrasound transducer comprise single-use ultrasound transducers comprising disk-shaped piezo-electric elements.

11. The method of claim 9, wherein the first and second ultrasound transducers comprise single-use ultrasound transducers, wherein the single-use ultrasound transducers transmit at either a frequency of 200 kHz or in a band of frequencies centered about 200 kHz, and wherein the single-use ultrasound transducers receive acoustic signals in a minimum bandwidth between 100 to 300 kHz.