Method and apparatus for thermal therapy of tumors

• US 5,620,479 A
• Filed: 01/31/1995
• Issued: 04/15/1997
• Est. Priority Date: 11/13/1992
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Diederich, Chris J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/383,472
• Time in Patent Office: 805 Days
• Field of Search: 604/53, 604/113, 604/28, 607/101, 607/102, 607/97, 607/104, 607/105, 607/154, 607/156, 607/113, 607/116, 607/22
• US Class Current: 601/3
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61N 5/045 specially adapted for treatment inside the body
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

An ultrasound applicator for thermal therapy, having a multi-element array of plastic or rubber coated piezoceramic tubular transducers, each with separate power control and supported by a coaxially disposed semi-flexible central tube, which can be placed directly within the tumor or target region, or within a body lumen such as a blood vessel or body cavity such as the urethra, or within a separate delivery catheter or system. Thermocouple sensors embedded in the coating over each transducer can be used for continuous monitoring of the tissue/applicator interface temperatures for feedback control of the power applied to each transducer. The transducers are resonant across the wall thickness and radiate energy in the radial direction. The applicator provides an air-cooling system which can control the temperature of the transducers and thereby improve heating characteristics. In the primary configuration, the central tube is a catheter which is compatible with remote afterloaders and standard brachytherapy technology, and facilitates the delivery of interstitial thermal therapy in conjunction with simultaneous brachytherapy or radiotherapy from within the applicator. For alternate forms of therapy or when the radiation source is not in the catheter, the central catheter can be used to circulate temperature regulated air or water to control the surface temperature of the applicator, or to infuse drugs. Further, the applicator can be placed within a thin-walled implant catheter and flushed with temperature controlled circulating coupling fluid to control the temperature of the catheter/tissue interface, or used in conjunction with other conventional delivery systems, instead of being used interstitially.

Claims

1. An apparatus for applying thermal therapy to tissue, comprising:

(a) a tubular ultrasound transducer;

(b) a cylindrical support member, said support member extending coaxially through said transducer;

(c) a power lead, said power lead electrically connected to said transducer;

(d) a sealant coating over said transducer; and

(e) an outer cover over said sealant coating, wherein said sealant coating is disposed between and in contact with said transducer and said outer cover, and wherein said transducer is thereby directly implantable in a patient.

2. An apparatus as recited in claim 1, wherein said support member comprises tube means for receiving a source of radiation.

3. An apparatus as recited in claim 1, where said support member comprises tube means for infusing a drug into said patient.

4. An apparatus as recited in claim 1, further comprising

(a) a second tubular ultrasound transducer, said support member extending through said second transducer, said outer cover and sealant coating covering said second transducer, said transducers being spaced apart and electrically isolated;

and

(b) a second power lead, said second power lead electrically connected to said second transducer, wherein each said transducer can be powered independently through its corresponding power lead.

5. An apparatus as recited in claim 4, further comprising:

(a) a plurality of temperature sensors, each said temperature sensor positioned between a corresponding one of said transducers and said outer cover; and

(b) a plurality of temperature sensor leads, each said temperature sensor lead electrically connected to a corresponding one of said temperature sensors.

6. An apparatus as recited in claim 5, further comprising means for controlling the amount of power to each said transducer independently in response to temperature measured by said temperature sensors.

13. A method of heating tissue in a patient for ultrasound thermal therapy using an apparatus as recited in claim 1, comprising the steps of:

(a) inserting said apparatus directly within a target region in said tissue of said patient and directly contacting tissue with said outer cover

(b) applying RF power to said power lead; and

(c) heating said tissue with said apparatus.

14. A method as recited in claim 13, further comprising the step of inserting a source of radiation into said support member.

15. A method as recited in claim 13, further comprising the step of circulating a coolant through said support member.

16. A method as recited in claim 13, further comprising the step of infusing a drug into said tissue through said support member.

17. A method as recited in claim 13, further comprising the step of circulating a coolant between said support member and said transducer.

18. A method as recited in claim 13, further comprising the step of controlling heating penetration by varying the frequency of said RF power to vary acoustic efficiency which varies the ratio of acoustic to conductive heating.

19. A method for thermal therapy of tissue in a patient using an apparatus as recited in claim 6, comprising the steps of:

(a) inserting said apparatus within a target region in said tissue of said patient;

(b) applying RF power to said power leads; and

(c) controlling the tissue temperature profile along the length of the apparatus by controlling the power to each said transducer independently.

20. A method as recited in claim 19, wherein said apparatus includes a sealant coating over said transducers and an outer cover over said sealant coating, and further comprising the steps of inserting said apparatus into said tissue and directly contacting tissue with said outer cover.

21. A method as recited in claim 19, further comprising the step of inserting a source of radiation into said support member.

22. A method as recited in claim 19, further comprising the step of circulating a coolant through said support member.

23. A method as recited in claim 19, further comprising the step of infusing a drug into said tissue through said support member.

24. A method as recited in claim 19, further comprising the step of circulating a coolant between said support member and said transducer.

25. A method as recited in claim 19, further comprising the step of placing said applicator in a catheter inserted into said tissue.

26. A method as recited in claim 25, further comprising the step of circulating a coolant between said applicator and said catheter.

27. A method as recited in claim 19, further comprising the step of controlling heating penetration by varying frequency of said RF power to vary acoustic efficiency which varies the ratio of acoustic to conductive heating.

7. An apparatus tier applying controlled thermal therapy to a tumor, comprising,

(a) a support member;

(b) a plurality of electrically isolated spaced-apart tubular ultrasound transducers received over said support member; and

(c) a plurality of power leads, each said power lead electrically connected to a corresponding one of said transducers wherein each said transducer can be powered independently through its corresponding power lead.

8. An apparatus as recited in claim 7, where said support member comprises tube means for infusing a drug into said patient.

9. An apparatus as recited in claim 7, further comprising

(a) a sealant coating over said transducers;

and

(b) an outer cover over said sealant coating, wherein said sealant coating is disposed between and in contact with said transducer and said outer cover, and wherein said transducer is thereby directly implantable in a patient.

10. An apparatus as recited in claim 7, wherein said support member comprises tube means for receiving a source of radiation.

11. An apparatus as recited in claim 7, further comprising:

(a) a plurality of temperature sensors, each said temperature sensor positioned adjacent to a corresponding one of said transducers; and

(b) a plurality of temperature sensor leads, each said temperature sensor lead electrically connected to a corresponding one of said temperature sensors.

12. An apparatus as recited in claim 11, further comprising means for controlling the amount of power to each said transducer independently in response to temperature measured by said temperature sensors.

28. A method of heating tissue in a patient for ultrasound thermal therapy, comprising the steps of:

(a) inserting an ultrasound applicator within a target region in said tissue of said patient, said ultrasound applicator comprising a support member extending coaxially through an ultrasound transducer and a power lead electrically connected to said transducer;

(b) applying RF power to said power lead;

(c) heating said tissue with said applicator; and

(d) infusing a drug into said tissue through said support member.

29. A method for thermal therapy of tissue in a patient, comprising the steps of:

(a) inserting an ultrasound applicator within a target region in said tissue of said patient, said ultrasound applicator comprising a cylindrical support member extending coaxially through a plurality of spaced-apart tubular ultrasound transducers and a plurality of power leads, each said power lead electrically connected to a said one of said transducers;

(b) applying RF power to said power leads;

(c) heating said tissue with said applicator; and

(d) infusing a drug into said tissue through said support member.

30. A directly implantable applicator for thermal therapy of tumors, comprising:

(a) a plurality of electrically isolated spaced-apart tubular ultrasound transducers;

(b) a support member extending through said transducers;

(c) a plurality of power leads, each said power lead electrically connected to a corresponding one of said transducers wherein each said transducer can be powered independently through its corresponding power lead;

(d) a plurality of temperature sensors, each said temperature sensor positioned adjacent to a corresponding one of said transducers;

(e) a plurality of temperature sensor leads, each said temperature sensor lead electrically connected to a corresponding one of said temperature sensors;

(f) a sealant coating over said transducer; and

(g) an outer cover over said sealant coating, wherein said sealant coating is disposed between and in contact with said transducer and said outer cover, and wherein said transducer is thereby directly implantable in a patient.

31. An apparatus as recited in claim 30, further comprising means for controlling the amount of power to each said transducer independently in response to temperature measured by said temperature sensors.

32. An apparatus as recited in claim 30, wherein said support member comprises tube means for receiving a source of radiation.

33. An apparatus as recited in claim 30, where said support member comprises tube means for infusing a drug into said patient.