Methods and apparatus for focused ultrasound application

• US 8,388,535 B2
• Filed: 01/21/2011
• Issued: 03/05/2013
• Est. Priority Date: 10/25/1999
• Status: Active Grant

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Kona Medical, Inc.
• Inventors: Weng, Lee, Perozek, David M., Zhang, Jimin
• Primary Examiner(s): KISH, JAMES M
• Application Number:
  US13/011,533
• Publication Number:
  US 20110118602A1
• Time in Patent Office: 774 Days
• Field of Search: 600/437, 600/439, 601/2
• US Class Current: 600/439
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00504 Tissue welding
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: G10K 11/32 characterised by the shape of the source
• CPC Class Codes: G10K 11/346 using phase variation

Abstract

An ultrasonic applicator unit (2) is used diagnostically to locate a puncture wound (316) in an artery and then therapeutically to seal the puncture wound with high intensity focused ultrasound (HIFU). A control unit (6) coupled to the applicator unit includes a processor (74) that automates the procedure, controlling various parameters of the diagnostic and therapeutic modes, including the intensity and duration of the ultrasonic energy emitted by the applicator unit. A protective, sterile acoustic shell (4), which is intended to be used with a single patient and then discarded, is slipped over the applicator unit to protect against direct contact between the applicator unit and the patient and to maintain a sterile field at the site of the puncture. The apparatus and method are particularly applicable to sealing a puncture made when inserting a catheter into an artery or other vessel. Several different procedures are described for locating the puncture wound, including imaging the vessel in which the puncture is disposed and use of a locator rod to determine the disposition of the puncture along the longitudinal axis of the artery.

Claims

1. A method for determining exposure parameters for a high intensity focused ultrasound system used to noninvasively target a blood vessel in a patient with a high intensity focused ultrasound beam, the method comprising:

providing the high intensity focused ultrasound system including at least one ultrasound transducer having a plurality of transducer elements

imaging the blood vessel to be treated with the high intensity focused ultrasound beam;

identifying tissue along an ultrasound energy path through which there will be a subsequent application of ultrasound energy between the blood vessel and the at least one ultrasound transducer;

estimating high intensity ultrasound energy intensities at the blood vessel and non-zero ultrasound energy intensities at the tissue for a subsequent application of high intensity focused ultrasound through the tissue to the blood vessel along the ultrasound energy path between the blood vessel and the at least one ultrasound transducer based at least in part on the relative position between the transducer(s) and the blood vessel and the relative position between the transducer(s) and the tissue along the ultrasound energy path between the blood vessel and the at least one ultrasound transducer; and

determining exposure parameters for the high intensity focused ultrasound beam that cause the estimated energy intensity delivered to the blood vessel to remain above a first level while the estimated energy intensity at the tissue along the ultrasound energy path between the blood vessel and the at least one ultrasound transducer remains below a second level, wherein the second level is less than the first level but greater than zero, wherein the exposure parameters include at least one of ultrasound intensity level, exposure interval, and scan geometry, and wherein the exposure parameters are determined to ensure that the second level will not result in irreversible damage to the tissue along the ultrasound energy path between the blood vessel and the at least one ultrasound transducer.

2. The method of claim 1, wherein the first level is sufficient to raise a temperature of the blood vessel to between about 60 and about 100 degrees Celsius.

3. The method of claim 1, further comprising treating the blood vessel with the high intensity focused ultrasound beam.

4. The method of claim 1, wherein the ultrasound transducer comprises a phased array of transducers.

5. A method for determining one or more operational parameters of a high intensity focused ultrasound system for a noninvasive therapeutic application of a high intensity focused ultrasound beam to a patient, the method comprising:

providing the high intensity focused ultrasound system including at least one transducer element;

imaging a blood vessel to be exposed with the high intensity focused ultrasound beam emitted from the high intensity focused ultrasound system;

estimating an acoustic path length between the transducer element(s) and the blood vessel;

estimating an acoustic attenuation value of the high intensity focused ultrasound beam propagated from a position external to the patient based at least in part on the acoustic path length and a look up table of attenuation values; and

determining one or more operational parameters of the high intensity focused ultrasound system based at least in part on the acoustic attenuation value, wherein the parameters ensure that a dose of high intensity therapeutic energy is delivered from the high intensity focused ultrasound system to the blood vessel while assuring that interpath tissue is not exposed to an energy intensity that will result in tissue damage, wherein the operational parameters include at least one of ultrasound intensity level, exposure interval, and scan geometry.

6. The method of claim 5, wherein the dose of high intensity therapeutic energy causes a collagen layer in the blood vessel to reach a temperature of between about 60 degrees Celsius and about 100 degrees Celsius.

7. The method of claim 5, wherein the estimating an acoustic attenuation value based at least in part on the acoustic path length step comprises employment of A-mode attenuation measurements.

8. The method of claim 5, wherein the estimating an acoustic attenuation value based at least in part on the acoustic path length step comprises the use of a look table based on predetermined empirical measurements.

9. The method of claim 5, wherein the blood vessel is identified through detecting a Doppler signal.

10. The method of claim 5, further comprising an over-scan of the blood vessel to compensate for targeting ambiguity.

11. The method of claim 5, wherein the blood vessel comprises collagen overlaying a vascular target.

12. The method of claim 5, wherein the estimating an acoustic attenuation value based at least in part on the acoustic path length step is further based at least in part on patient weight.

13. The method of claim 5, wherein pulse-echo lines of interrogation are utilized to assist in the identification of the target tissue.

14. The method of claim 5, wherein the dose of high intensity therapeutic energy is sufficient to raise a temperature of the blood vessel to between about 60 and about 100 degrees Celsius.

15. The method of claim 5, further comprising treating the blood vessel with the high intensity focused ultrasound beam.

16. The method of claim 5, wherein the transducer element comprises a phased array of transducers.

17. A method for determining one or more operational parameters of a high intensity focused ultrasound system for a noninvasive therapeutic application of a high intensity focused ultrasound beam to a vascular target, the method comprising:

providing the high intensity focused ultrasound system including at least one transducer element;

utilizing imaging to identify the vascular target to be exposed with the high intensity focused ultrasound beam emitted from at least one of the transducer element(s);

estimating an acoustic path length between at least one of the transducer element(s) and the vascular target;

estimating an acoustic attenuation value of the high intensity focused ultrasound beam propagated from a position external to the patient based at least in part on the acoustic path length and a look up table of attenuation values; and

determining one or more operational parameters of the high intensity focused ultrasound system based at least in part on the acoustic attenuation value, wherein the parameters ensure that a dose of high intensity therapeutic energy is delivered from the high intensity focused ultrasound system to the vascular target while assuring that interpath tissue is not exposed to an energy intensity that will result in tissue damage, wherein the operational parameters include at least one of ultrasound intensity level, exposure interval, and scan geometry.

18. The method of claim 17, wherein the imaging comprises Doppler imaging.

19. The method of claim 17, wherein the imaging comprises pulse-echo lines of interrogation.

20. The method of claim 17, wherein the high intensity focused ultrasound system comprises an imaging transducer and a therapy transducer.

21. The method of claim 20, wherein the imaging transducer is the same as the therapy transducer.

22. The method of claim 17, wherein the dose of high intensity therapeutic energy is sufficient to raise a temperature of the vascular to between about 60 and about 100 degrees Celsius.

23. The method of claim 17, further comprising treating the vascular target with the high intensity focused ultrasound beam.

24. The method of claim 17, wherein the transducer element comprises a phased array of transducers.