Therapeutic prostatic thermotherapy

• US 6,216,703 B1
• Filed: 08/06/1998
• Issued: 04/17/2001
• Est. Priority Date: 05/08/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: TherMatrx, Inc. (Endo International PLC)
• Inventors: Turner, Paul F., Schaefermeyer, Theron N., Perlmutter, Aaron P., Sells, Dixie T., Manker, Charles F.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/130,708
• Time in Patent Office: 985 Days
• Field of Search: 606/27-31, 607/96, 607/98-105, 607/156, 604/114, 604/22, 128/898
• US Class Current: 128/898
• 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 2017/00084 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 2018/00547 Prostate

Abstract

The present invention provides a method of treating a prostate in a patient in need thereof and a heating catheter, or an electromagnetic radiation applicator, system suitable for effecting the present inventive method. The present inventive method provides for substantial unexpected improvement in patient outcome by providing, inter alia, a preferred therapeutic temperature for thermotherapy of the prostate and a method of decreasing a patient'"'"'s intolerance due to pain. The present inventive system provides for, inter alia, automatic implementation of the present inventive method.

Claims

1. A method of treating a prostate for benign prostatic hyperplasia or prostatitis in a patient having a urethra, comprising elevating the temperature of the prostate to a destination temperature and for a time sufficient to achieve a therapeutic effect on the prostate, the energy being applied with a catheter system comprising

a non-cooled catheter for insertion into the urethra,

a heat applicator attached to the catheter. and a connector for connecting the applicator to an energy source, the method comprising

a first heating step of warming tissue proximal to the applicator up to an initial temperature, the initial temperature being in the range of about 42°

C. to about 46°

C.,

followed by a second heating step, the second heating step comprising gradually increasing the temperature of the tissue proximal to the applicator to the destination temperature in the range of from 49°

C. to about 57°

C. such that the mean rate of increase in temperature is from about 0.5 minute/°

C. to about 15 minute/°

C.

2. The method of claim 1, wherein the mean rate of increase in temperature, during the second step, is from about 1.0 minute/°

C. to about 10 minute/°

C.

3. The method of claim 2, wherein the mean rate of increase in temperature, during the second step, is selected such that from about 15 minutes to about 2 hours separate the time points when the tissue surrounding the applicator rises from the initial temperature to the destination temperature.

4. The method of claim 3, wherein the mean rate of increase in temperature is selected such that from about 15 minutes to about 45 minutes separate the time points when the tissue surrounding the applicator rises from the initial temperature to the destination temperature.

5. The method of claim 1, wherein the second heating step is controlled by a microcontroller, such that the second step occurs independent of direct human intervention after the initiation of the second step.

6. The method of claim 1, wherein the method is tolerable to the patient such that it is not necessary to administer a narcotic analgesic to the patient.

7. A method of treating a prostate for benign prostatic hyperplasia or prostatitis in a patient comprising applying energy to the prostate to elevate the temperature of the prostate to a therapeutic temperature and for a time sufficient to achieve a therapeutic effect on the prostate, the energy being applied such that the temperature of the prostate tissue is raised from an initial temperature of below the therapeutic temperature to a destination temperature in the range of from 49°

C. to about 57°

C., the method further comprising

a first heating step of warming the prostate up to critical maximum temperature, the critical maximum temperature being in the range of about 42°

C. to about 46°

C.,

followed by a second heating step, the second heating step comprising gradually increasing the maximum temperature of the prostate to the destination temperature such that the mean rate of increase in temperature is from about 0.5 minute/°

C. to about 15 minute/°

C.

8. The method of claim 7, wherein the mean rate of increase in temperature, during the second step, is from about 1.0 minute/°

C. to about 10 minute/°

C.

9. The method of claim 8, wherein the method does not comprise the administration of a narcotic analgesic to the patient.

10. The method of claim 7, the method further comprising, applying energy to the prostate to elevate the temperature of the prostate to a therapeutic temperature and for a time sufficient to achieve a therapeutic effect on the prostate, the energy being applied with a heated catheter system comprising

a non-cooled catheter for insertion into the urethra,

a heat applicator attached to the catheter, and a connector for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue surrounding the applicator to the therapeutic temperature and for maintaining the therapeutic temperature for a time sufficient to effect therapy of the prostate, and

the energy being applied such that a thermal dose of about 1500 equivalent 45° C. minutes to about 30,000 equivalent 45°

C. minutes is applied to the tissue surrounding the applicator.

11. The method of claim 10, wherein a thermal dose of from about 2000 equivalent 45°

C. minutes to about 30,000 equivalent 45°

C. minutes is applied to the tissue surrounding the applicator.

12. The method of claim 11, wherein the heated catheter is a hot water recirculating catheter.

13. The method of claim 11, wherein the source of energy is hot water.

14. The method of claim 11, wherein the source of energy is microwave.

15. The method of claim 11, wherein the source of energy is ultrasonic or RF.

16. The method of claim 11, wherein the method comprises first heating the applicator to a temperature in the range of from about 42°

C. to about 46°

C., followed by gradually increasing the temperature of the applicator to the therapeutic temperature such that the mean rate of increase in temperature after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 0.5 minute/°

C. to about 15 minute/°

C.

17. The method of claim 16, wherein the mean rate of temperature increase after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 1 minute/°

C. to about 10 minute/°

C.

18. The method of claim 16, wherein the mean rate of temperature increase after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 1 minute/°

C. to about 10 minute/°

C.

19. The method of claim 10, wherein a thermal dose of from about 1500 equivalent 45°

C. minutes to about 20,000 equivalent 45°

C. minutes is applied to the tissue surrounding the applicator.

20. The method of claim 19, wherein the heated catheter is a hot water recirculating catheter.

21. The method of claim 19, wherein the source of energy is hot water.

22. The method of claim 19, wherein the source of energy is microwave.

23. The method of claim 19, wherein the source of energy is ultrasonic or RF.

24. The method of claim 19, wherein the method comprises first heating the applicator to a temperature in the range of from about 42°

C. to about 46°

C., followed by gradually increasing the temperature of the applicator to the therapeutic temperature such that the mean rate of increase in temperature after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 0.5 minute/°

C. to about 15 minute/°

C.

25. The method of claim 10, wherein a thermal dose of from about 1500 equivalent 45°

C. minutes to about 7000 equivalent 45°

C. minutes is applied to the tissue surrounding the applicator.

26. The method of claim 25, wherein the heated catheter is a hot water recirculating catheter.

27. The method of claim 25, wherein the source of energy is hot water.

28. The method of claim 25, wherein the source of energy is microwave.

29. The method of claim 25, wherein the source of energy is ultrasonic or RF.

30. The method of claim 25, wherein the method comprises first heating the applicator to a temperature in the range of from about 42°

C. to about 46°

C., followed by gradually increasing the temperature of the applicator to the therapeutic temperature such that the mean rate of increase in temperature after the temperature range of about 42°

C. to 46°

C. has been achieved is from about 0.5 minute/°

C. to about 15 minute/°

C.

31. The method of claim 30, wherein the mean rate of temperature increase after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 1 minute/°

C. to about 10 minute/°

C.

32. The method of claim 10, wherein the heated catheter is a hot water recirculating catheter.

33. The method of claim 10, wherein the source of energy is hot water.

34. The method of claim 10, wherein the source of energy is microwave.

35. The method of claim 10, wherein the source of energy is ultrasonic or RF.

36. A method of treating a prostate for benign prostatic hyperplasia or prostatitis in a patient having a prostate and a urethra comprising applying energy to the prostate to elevate the temperature of the prostate to a therapeutic temperature and for a time sufficient to achieve a therapeutic effect on the prostate, the energy being applied with a heated catheter system comprising

a non-cooled catheter for insertion into the urethra,

a heat applicator attached to the catheter, and a connector for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue surrounding the applicator to the therapeutic temperature and for maintaining the therapeutic temperature for a time sufficient to effect therapy of the prostate, and, wherein the method further comprises first heating the applicator to a temperature in the range of from about 42°

C. to about 46°

C., followed by gradually increasing the temperature of the applicator to the therapeutic temperature such that the mean rate of increase in temperature after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 0.5 minute/°

C. to about 15 minute/°

C. the energy being applied such that a thermal dose of about 1500 equivalent 45°

C. minutes to about 30,000 equivalent 45°

C. minutes is applied to the tissue surrounding the applicator.

37. The method of claim 36, wherein the mean rate of temperature increase after the temperature range of about 42°

C. to about 46°

C. has been achieved is from about 1 minute/°

C. to about 10 minute/°

C.

38. A method of treating a prostate for benign prostatic hyperplasia or prostatitis in a patient having a prostate and a urethra, comprising applying energy to the prostate to elevate the temperature of the prostate to a therapeutic temperature and for a time sufficient to achieve a therapeutic effect on the prostate, the energy being applied with a heated catheter system comprising

a non-cooled catheter for insertion into the urethra,

a heat applicator attached to the catheter, and a connector for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue surrounding the applicator to the therapeutic temperature and for maintaining the therapeutic temperature for a time sufficient to effect therapy of the prostate, and

the energy being applied such that a thermal dose of about 1500 equivalent 45°

C. minutes to about 30,000 equivalent 45°

C. minutes is applied to the tissue surrounding the applicator, wherein the tissue surrounding the applicator is heated according to protocol A, B, C, D, E, F, or G set forth in Table 1.

39. The method claim 38, wherein the tissue surrounding the applicator is heated according to protocol A, B, C, D, or E set forth in Table 1.