Urethral inserted applicator prostate hyperthermia

• US 5,344,435 A
• Filed: 11/05/1990
• Issued: 09/06/1994
• Est. Priority Date: 07/28/1988
• Status: Expired due to Term

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: BSD Medical Corporation
• Inventors: Terry, Philip A., Tumeh, Amer M., Turner, Paul F., Schaefermeyer, Theron N.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/609,372
• Time in Patent Office: 1,401 Days
• Field of Search: 128/784-786, 128/804, 128/736, 128/401, 607/101, 607/102, 607/97, 607/105, 607/154, 607/156, 607/113, 607/116
• US Class Current: 607/101
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• 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 2017/00057 Light
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2018/00035 with return means
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61N 2005/007 for cooling the patient
• CPC Class Codes: A61N 2005/061 Bladder and/or urethra
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A method for the treatment of the prostate gland which heats the tissues which would otherwise be surgically removed with a trans-urethral resection of the prostate. This method is accomplished by combining a radiating energy device integrated with a urinary drainage Foley type catheter, which is modified to provide cooling along the urethra surfaces. The radiating device also serves as a means to measure the tissue radiated thermal energy for the control or monitoring of temperature of the prostate tissues being heated. A urethral inserted applicator for prostate hyperthermia includes a multi-tube, balloon type catheter. The catheter includes a fluid dry tube for an energy radiator antenna applicator which also serves as a radiometric temperature sensor for measuring the temperature of the prostate tissue, and an open fluid receiving tube. An electromagnetic energy generator supplies electromagnetic energy to the applicator. A comparator is connected to the temperature output of the radiometer, and a temperature reference potentiometer for comparing the actual tissue temperature level with a desired temperature level and outputting control signals to the electromagnetic generator for controlling the output to the applicator. The microwave operated applicator is preferably an elongated coil having the tip end connected to the center conductor of a coaxial cable and the opposite end connected to the outer conductor of the coaxial cable. A sheet or sheath of insulation material covers the microwave coil antenna for insulating the coil from the tissue and the thickness of the sheet may be varied to provide uniform tissue heating along the length of the coil. The ultrasound operated applicator is preferably one or more ultrasound crystal cylinders to radiate energy into the tissue and convert tissue thermal ultrasonic energy into electrical energy for measurement by a radiometer, The balloon of the catheter engages the body'"'"'s bladder to position the applicator properly during the treatment.

Claims

1. An energy radiation applicator apparatus for treatment of benign hyperplasia, comprising:

a catheter means for insertion into and through a urethra of a body needing treatment so an end of the catheter means extends into the bladder of the body, said catheter means including a urine drainage passage extending through the catheter means for draining urine from the bladder;

applicator means carried by the catheter means, said applicator means including an applicator and a connector means for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue to be treated to a preselected temperature and for maintaining the preselected temperature during treatment;

fluid receiving means surrounding the applicator so as to be positioned between the applicator and the tissue to be heated;

a cooling fluid inlet passage extending through the catheter means to communicate with the fluid receiving means through a fluid inlet;

a cooling fluid outlet passage opening into the urine drainage passage and communicating with the fluid receiving means through a fluid outlet, both the fluid inlet passage and the urine drainage passage opening from the catheter means outside the body when the catheter means is inserted into the urethra;

means for supplying cooling fluid to the fluid inlet passage during heating of the tissue; and

positioning means for positioning and maintaining the positioning of the catheter means in the urethra so that the applicator means attached to the catheter means is and remains positioned adjacent to prostate tissue to be treated for as long as desired by the user.

2. An energy radiation applicator apparatus according to claim 1, wherein the cooling fluid outlet passage connects to the urine drainage passage intermediate its length through the catheter means.

3. An energy radiation applicator apparatus according to claim 2, wherein a source of vacuum communicates with the urine drainage passage opening from the catheter means outside a body in which the catheter means is inserted to draw cooling fluid and urine from the urine drainage passage.

4. An energy radiation applicator apparatus according to claim 2, including a cooling fluid reservoir outside the body and in communication with the cooling fluid inlet passage, and wherein the cooling fluid reservoir is positioned to cause flow of fluid into the fluid receiving means to fill the fluid receiving means with cooling fluid.

5. An energy radiation applicator apparatus according to claim 4, additionally including means for measuring the temperature of the cooling fluid entering the inlet passage, and means for measuring the temperature of the cooling fluid leaving the fluid receiving means, the difference in temperature being a function of the temperature of the tissue being heated.

6. An energy radiation applicator apparatus according to claim 5, including means for measuring the flow of cooling fluid through the fluid receiving means.

7. An energy radiation applicator apparatus according to claim 1, additionally including means for measuring a parameter indicative of the temperature of the heated tissue surrounding the applicator.

8. An energy radiation applicator apparatus according to claim 7, wherein the means for measuring a parameter indicative of the temperature of the tissue measures a parameter indicative of the energy applied to the tissue surrounding the applicator.

9. An energy radiation applicator apparatus according to claim 1, wherein the applicator is adapted to radiate ultrasonic energy and includes a plurality of piezoelectric elements.

10. An energy radiation applicator apparatus according to claim 1, wherein the applicator is adapted to radiate electromagnetic energy and includes a helical coil antenna.

12. An energy radiation applicator apparatus according to claim 1, wherein the means for circulating cooling fluid through the fluid receiving means includes a fluid inlet through which cooling fluid is supplied to the fluid receiving means and a fluid outlet through which fluid flows from the fluid receiving means, said fluid inlet and fluid outlet being positioned with respect to the fluid receiving means so that fluid flowing from the inlet to the outlet will flow substantially through the fluid receiving means.

13. An energy radiation applicator apparatus according to claim 12, wherein the catheter means includes a cooling fluid inlet passage extending through the catheter means to communicate with the fluid inlet, and a cooling fluid outlet passage extending through the catheter means to communicate with the fluid outlet, both the fluid inlet passage and the outlet passage opening from the catheter means outside the body when the catheter means is inserted into the urethra.

14. An energy radiation applicator apparatus according to claim 13, wherein the fluid outlet is smaller than the fluid inlet [opening]to cause fluid pressure build up in the fluid receiving means to thereby insure the presence of fluid in the fluid receiving means when fluid is provided to the fluid inlet.

11. An energy radiation applicator apparatus for treatment of benign hyperplasia, comprising:

a catheter means for insertion into a urethra of a body needing treatment;

applicator means carried by the catheter means, said applicator means including an applicator and a connector means for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue to be treated to a preselected temperature and for maintaining the preselected temperature during treatment;

fluid receiving means surrounding the applicator so as to be positioned between the applicator and the tissue to be heated;

means for circulating cooling fluid through the fluid receiving means during heating of the tissue;

positioning means for positioning and maintaining the positioning of the catheter means in the urethra so that the applicator means attached to the catheter means is and remains positioned adjacent to prostate tissue to be treated for as long as desired by the user;

means for measuring the temperature of cooling fluid prior to being circulated through the fluid receiving means; and

means for measuring the temperature of the cooling fluid after being circulated through the fluid receiving means, the difference in temperature being a function of the temperature of the tissue being heated.

15. An energy radiation applicator apparatus according to claim 11, including means for measuring the flow of cooling fluid through the fluid receiving means.

16. An energy radiation applicator apparatus according to claim 11, wherein the applicator is adapted to radiate ultrasonic energy and includes a plurality of piezo-electric elements.

17. An energy radiation applicator apparatus according to claim 11, wherein the applicator is adapted to radiate electromagnetic energy and includes a helical coil antenna.

18. An energy radiation applicator apparatus according to claim 11, wherein the means for circulating cooling fluid through the fluid receiving means includes a cooling fluid reservoir outside the body and in communication with the fluid receiving means, and wherein the cooling fluid reservoir is positioned to allow flow of fluid into the fluid receiving means to fill the fluid receiving means with cooling fluid.

19. An energy radiation applicator apparatus for treatment of benign hyperplasia, comprising:

a catheter means for insertion into a urethra of a body needing treatment;

applicator means carried by the catheter means, said applicator means including an applicator and a connector means extending through the catheter means to outside the body for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue to be treated to a preselected temperature and for maintaining the preselected temperature during treatment;

fluid receiving means surrounding the applicator so as to be positioned between the applicator and the tissue to be heated;

means for circulating cooling fluid through the fluid receiving means during heating of a tissue; and

means for measuring properties of the cooling fluid indicative of the temperature of the tissue being heated to thereby obtain an estimate of the temperature of the tissue being heated.

20. An energy radiation applicator apparatus according to claim 19, additionally including

energy measurements means;

and

means for selectively coupling the connector means to either a source of energy sufficient to elevate the temperature of tissue surrounding the applicator to a preselected temperature and for maintaining the preselected temperature during treatment, or to the energy measurement means whereby energy received by the applicator from tissue surrounding the applicator is connected to the energy measurement means and is measured, the energy measured being indicative of the temperature of the tissue being heated and serving as a second measurement of such temperature.