Method for treating benign prostatic hyperplasia with thermal therapy

• US 5,843,144 A
• Filed: 06/26/1995
• Issued: 12/01/1998
• Est. Priority Date: 06/26/1995
• Status: Expired due to Term

• Current Assignee: Auslo Research LLC
• Original Assignee: Urologix Inc.
• Inventors: Kluge, Stanley E., Norsted, Steven W., Dann, Mitchell, Kauphusman, James V., Reid, John M., Rudie, Eric N., Burgett, James E., Neilson, Bruce H.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/494,320
• Time in Patent Office: 1,254 Days
• Field of Search: 128/736, 128/772, 604/53, 604/95, 600/2, 606/27, 606/41, 606/28, 606/33, 607/101, 607/96, 607/102, 607/105, 607/113, 607/116, 607/156
• US Class Current: 607/101
• 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

Abstract

A method for treating an individual with diseased prostatic tissue, such as benign prostatic hyperplasia, includes inserting a catheter into a urethra to position a microwave antenna located within the catheter adjacent a prostatic region of the urethra. A microwave antenna is then driven within a power range for applying microwave energy substantially continuously to prostatic tissue to heat the prostatic tissue surrounding the microwave antenna at a temperature and for a time period sufficient to cause necrosis of the prostatic tissue.

Claims

1. A method for treating an individual with prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

heating a volume of tissue within the prostate, excluding tissue adjacent the rectal wall, with continuously applied microwave energy from the microwave antenna to temperatures of at least 45°

C. up to a distance of at least 2 centimeters from the wall of the urethra for a time period sufficient to destroy substantially the entire volume of tissue while cooling the urethra.

2. The method of claim 1 wherein the step of heating further comprises:

producing an asymmetrical radiation pattern within the prostate with the microwave energy.

3. The method of claim 2 wherein the producing step further comprises:

providing a greater amount of cooling on a first side of the prostate than on a second side of the prostate.

4. The method of claim 2 wherein the producing step further comprises:

locating the microwave antenna within the catheter nearer a first side of the catheter than a second side of the catheter, the first side of the catheter to be positioned adjacent the anterior and lateral portions of the prostate and the second side of the catheter to be positioned adjacent the posterior portion of the prostate.

5. The method of claim 1 and further including:

preventing a temperature of a rectum from exceeding 42°

C.

6. A method for treating an individual with prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

circulating a fluid within the catheter to cool the urethra; and

applying power to the microwave antenna continuously within a power range and for a time period sufficient to substantially destroy a volume of tissue within the prostate up to at least 1.8 centimeters from the wall of the urethra while cooling the urethra during the application of power and while maintaining a temperature of the rectum below 42°

C.

7. A method for treating an individual with prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

cooling the urethra with the catheter;

applying power in increasing levels to the microwave antenna until predetermined criteria are met while continuing to cool the urethra; and

maintaining power applied to the microwave antenna within a desired power range which causes heating within the prostate to a temperature of at least 45°

C. up to at least 2 centimeters from the wall of the urethra for a time sufficient to necrose prostatic tissue while continuing to cool the urethra to prevent necrosis of the urethra.

8. The method of claim 7 wherein the predetermined criteria are met when at least one of the following conditions exist:

(1) the catheter temperature reaches a first minimum temperature; and

(2) a temperature of a rectum reaches a second minimum temperature.

9. The method of claim 8 wherein the first minimum temperature is 35°

C., the second minimum temperature is 40°

C., and the minimum power level is 35 Watts.

10. The method of claim 8 wherein the predetermined criteria further includes the catheter temperature reaching a temperature within 1°

C. to 40°

C.

11. The method of claim 10 wherein the step of maintaining power further comprises maintaining the power level within the desired range to maintain a temperature of the rectum below 42°

C.

12. The method of claim 11 wherein maintaining the power level further comprises:

decreasing the power level in increments of 1 watt per minute if the temperature of the rectum reaches 42°

C. until the temperature of the rectum is below 42°

C.

13. The method of claim 12 and further comprising:

increasing the power level in increments of one watt per minute after the temperature of the rectum returns to a temperature below 42°

C. until the catheter temperature is within 1°

C. of 40°

C.

14. The method of claim 7 wherein in the step of maintaining power, the desired power range is selected to cause the catheter temperature to be maintained at some determined temperature level within 1°

C. of 40°

C.

15. The method of claim 7 wherein in the step of maintaining power, the desired power range is selected to cause the catheter temperature to be maintained at a temperature within 1°

C. of 40°

C.

16. The method of claim 15 wherein the power is maintained within the desired range by adjusting the power level in one watt increments per minute.

17. The method of claim 7 wherein the step of applying increasing power levels further comprises:

applying a power level of ten watts for two minutes and then increasing the power level in increments of 5 watts every 2 minutes.

18. The method of claim 17 in the step of applying increasing power levels further comprises:

increasing the power level in increments of 1 watt per minute after the predetermined criteria are met until the catheter temperature is within 1°

C. of 40°

C.

19. The method of claim 7 wherein the first step of cooling the urethra further comprises:

circulating a fluid between the microwave antenna and the urethra at temperature of 10°

C. or less for up to 10 minutes prior to the step of applying power.

20. The method of claim 7 wherein the steps of applying power and maintaining power further comprise:

applying power at a frequency in the range of approximately 902 to 928 MHz to the microwave antenna to apply a MW emission to the portion of the prostate surrounding the catheter.

21. A method for treating an individual with benign prostatic hyperplasia, the method comprising:

inserting a catheter into a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

cooling the urethra with the catheter;

applying power in increasing levels to the microwave antenna until predetermined criteria are met while continuing to cool the urethra;

maintaining power applied to the microwave antenna within a range which causes substantially continuous heating of tissue within the prostate to a temperature of at least 45°

C. at a distance of at least 2 centimeters from the urethra while continuing to cool the urethra; and

cooling the urethra after discontinuing power.

22. A method for treating an individual with benign prostatic hyperplasia, the method comprising:

measuring a temperature of a rectum;

inserting a catheter into a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

cooling the urethra with the catheter to maintain the urethra at a non-necrotic temperature;

applying power in a microwave frequency range to the microwave antenna until an urethral catheter temperature is within a predetermined range so that a portion of the prostate surrounding the microwave antenna reaches a temperature of at least 45°

C. at a distance of up to 2 centimeters from the urethra;

adjusting the power level to continuously maintain the catheter temperature within the predetermined temperature range for a predetermined period of time and to maintain the rectal temperature below a predetermined temperature so that the portion of the prostate is maintained at a substantially continuous temperature of at least 45°

C. at a distance of up to 2 centimeters from the urethra for a time sufficient to necrose the portion of the prostate;

decreasing the power applied to the microwave antenna to zero watts; and

cooling the urethra with the catheter after decreasing the power.

23. The method of claim 22 wherein the predetermined temperature range of the catheter temperature is a temperature within 1°

C. of 40°

C.

24. The method of claim 22 wherein the predetermined temperature of the rectum is 42°

C.

25. The method of claim 22 wherein the power is adjusted by changing the power level in one watt increments per minute.

26. The method of claim 22 wherein the step of applying increasing power levels further comprises:

applying a power level of ten watts for two minutes and then increasing the power level in increments of 5 watts every 2 minutes.

27. The method of claim 26 in the step of applying increasing power levels further comprises:

increasing the power level in increments of 1 watt per minute.

28. The method of claim 22 wherein the first step of cooling the urethra further comprises:

circulating fluid between the microwave antenna and the urethra at temperature of 10°

C. or less for up to 10 minutes prior to the step of applying power.

29. The method of claim 22 wherein the steps of applying power and maintaining power further comprise:

applying power at a frequency in the range of approximately 902 to 928 MHz to the microwave antenna to apply a MW emission to the portion of the prostate surrounding the catheter.

30. A method for treating an individual with benign prostatic hyperplasia, the method comprising:

inserting a thermal sensing device into a rectum of the patient measuring a rectal temperature;

inserting a catheter into a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

circulating a fluid within the catheter between the microwave antenna and the urethra wherein the fluid stabilizes at a temperature of less than 10°

C. to maintain the urethra adjacent the antenna at a temperature below 45°

C.;

measuring a temperature of the urethral catheter with a thermosensing device positioned within the urethral catheter adjacent the prostate;

driving the microwave antenna at a signal in the range of 902 to 928 MHz and a power of 10 watts to apply a MW emission to a portion of the prostate surrounding the urethral catheter, the MW emission causing molecular excitation of the portion of the prostate surrounding the microwave antenna;

increasing the drive signal applied to the microwave antenna in increments of five watts every two minutes until at least one of the following conditions is achieved;

the urethral catheter temperature is at least 35°

C.; and

the rectal catheter temperature is about 40°

C.;

increasing the drive signal in increments of 1 watts per minute until the urethral catheter temperature is within 1°

C. of 40°

C. so that the portion of the prostate surrounding the microwave antenna reaches a temperature of at least 45°

C.;

adjusting the drive signal in one watt increments per minute to maintain the urethral catheter temperature within 1°

C. of 40°

C. and maintaining the drive signal at this level for at least 45°

C. up to 60 minutes from the time the urethral catheter temperature first reaches 37°

C. so that the portion of the prostate is necrosed by being maintained continuously at a temperature of at least 45°

C. at distances of at least 2 centimeters from the urethra within the prostate along the length of the microwave antenna;

decreasing the drive signal in increments of one watt per minute if the rectal temperature reaches 42°

C. until the rectal temperature is less than 42°

C. and then increasing the drive signal in increments of one watt per minute until the urethral catheter temperature is within 1°

C. of 40°

C. and the rectal catheter temperature is less than 42°

C.;

decreasing the drive signal to a power level of zero watts; and

maintaining circulation of fluid within the urethral catheter between the microwave antenna and the urethra at a temperature of 10°

C. or less for at least ten minutes after discontinuing power applied to the microwave antenna.

31. A method for treating an individual with prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

circulating a fluid within the catheter to cool the urethra; and

applying power to the microwave antenna within a power range without discontinuing power and for a time period sufficient to cause necrosis of tissue within the prostate at a distance of at least 1.8 centimeters from the urethra while preventing necrosis of the urethra by cooling the urethra during the application of power.

32. A method for treating prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a energy producing source within the catheter adjacent to a prostate surrounding the urethra;

heating a volume of tissue within the prostate, excluding tissue adjacent the rectal wall, with continuously applied energy from the energy producing source to temperatures of at least 45°

C. up to at least 2 centimeters from a wall of the urethra for a time sufficient to destroy substantially the entire volume of tissue while cooling the urethra.

33. The method of claim 32 wherein the energy producing source is a microwave antenna.

34. A method for treating an individual with prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

circulating a fluid between the microwave antenna and the urethra; and

applying power continuously to the microwave antenna within a power range and for a time period sufficient to destroy substantially an entire volume of tissue within the prostate up to a distance of at least 1.8 centimeters from a wall of the urethra while cooling the urethra during the application of power.

35. A method for treating a target tissue comprising:

inserting a probe within a body conduit to position an energy producing source within the probe adjacent to a target tissue located adjacent the body conduit;

heating a volume of the target tissue with continuously applied energy from the energy producing source to temperatures of at least 45°

C. up to at least 2 centimeters from a wall of the body conduit for a time sufficient to destroy substantially the entire volume of targeted tissue while cooling the body conduit.

36. A method for treating an individual with prostatic tissue disease, the method comprising:

inserting a catheter within a urethra to position a microwave antenna located within the catheter adjacent to a prostate surrounding the urethra;

heating tissue within the prostate with continuously applied microwave energy from the microwave antenna to temperatures of at least 45°

C. at a distance of at least 2 centimeters from a wall of the urethra for a time sufficient to cause necrosis within the prostate without causing necrosis of tissue outside the prostate while cooling the urethra.