Controlled high efficiency lesion formation using high intensity ultrasound

• US 7,470,241 B2
• Filed: 08/04/2003
• Issued: 12/30/2008
• Est. Priority Date: 11/26/1999
• Status: Expired due to Term

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Therus Corp. (Boston Scientific Corporation)
• Inventors: Zhang, Jimin, Perozek, David M., Weng, Lee
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Fernandez; Katherine L
• Application Number:
  US10/633,726
• Publication Number:
  US 20040030268A1
• Time in Patent Office: 1,975 Days
• Field of Search: 601 2- 4, 601/439, 600/407, 600/439, 600/437, 600/438, 606/111
• US Class Current: 601/3
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2090/378 using ultrasound
• 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 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/546 involving monitoring or regulation of device temperature
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• 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: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

An ultrasound system used for both imaging and delivery high intensity ultrasound energy therapy to treatment sites and a method for treating tumors and other undesired tissue within a patient'"'"'s body with an ultrasound device. The ultrasound device has an ultrasound transducer array disposed on a distal end of an elongate, relatively thin shaft. In one form of the invention, the transducer array is disposed within a liquid-filled elastomeric material that more effectively couples ultrasound energy into the tumor, that is directly contacted with the device. Using the device in a continuous wave mode, a necrotic zone of tissue having a desired size and shape (e.g., a necrotic volume selected to interrupt a blood supply to a tumor) can be created by controlling at least one of the f-number, duration, intensity, and direction of the ultrasound energy administered. This method speeds the therapy and avoids continuously pausing to enable intervening normal tissue to cool.

Claims

1. A method of ultrasonically cutting off the blood supply to a uterine fibroid without necrosing the entire fibroid, comprising the following steps of:

a) providing an ultrasonic transducer configured to emit focused high intensity ultrasound energy;

b) pre-selecting one or more tissue treatment sites located on the uterine fibroid wherein the one or more tissue treatment sites are selected such that necrosing the tissues at the one or more tissue treatment sites will decrease the blood supply to the uterine fibroid; and

c) applying the ultrasound energy to only the pre-selected tissue treatment sites.

2. An efficient heating method using high intensity ultrasound energy comprising the following steps:

a) providing an ultrasound transducer configured to emit focused high intensity ultrasound energy;

b) determining a tissue treatment zone; and

c) energizing the ultrasound transducer to cause pre-focal heating and necrosis of a substantial portion of tissue between the transducer and the transducer'"'"'s focal point, wherein the focal point is directed to the treatment zone.

3. The method of claim 2, wherein the pre-focal heating of the tissues causes temperature of the tissue to increase to about 50°

C.

4. The method of claim 2, wherein the tissue treatment zone is determined such that necrosis at the tissue treatment zone causes a decrease in blood supply to a tumor.

5. A method of treating a uterine fibroid, comprising:

applying high intensity focused ultrasound energy selectively to the uterine fibroid base; and

repeating the application of high intensity focused ultrasound to the uterine fibroid base from a plurality of angles around the circumference of the uterine fibroid, wherein high intensity focused ultrasound energy is directed only to the uterine fibroid base.

6. The method of claim 5, wherein each application of high intensity focused ultrasound causes heating of tissue in a pie shaped region.

7. The method of claim 5, wherein the repeated applications cause substantially the entire uterine fibroid base to be heated.