Therapeutic prostatic thermotherapy

• US 7,089,064 B2
• Filed: 08/30/2002
• Issued: 08/08/2006
• Est. Priority Date: 05/08/1998
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Turner, Paul F., Perlmutter, Aaron P., Sells, Dixie T., Manker, Charles F., Schaefermeyer, Theron N.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/232,062
• Publication Number:
  US 20030023238A1
• Time in Patent Office: 1,439 Days
• Field of Search: 606 27- 31, 606/34, 606/35, 606/41, 606/42, 607/101, 607/102
• US Class Current: 607/102
• 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 computer program product comprising a computer-usable medium having program logic for controlling an electromagnetic energy applicator in a urethral catheter, the computer program product comprising:

temperature setting program code for programming desired prostatic tissue temperature values, each of said values being lower than a subsequent value;

temperature determining program code for determining and measuring a temperature value of prostatic tissue;

temperature comparing program code for comparing the measured prostatic tissue temperature value to the programmed prostatic temperature values; and

control signal adjustment program code for adjusting a power control signal to vary prostatic tissue temperature in accordance with a relationship between the measured prostatic tissue temperature and the programmed prostatic tissue temperature values depending on the time the prostatic tissue has been at the measured prostatic tissue temperature, wherein the prostatic tissue temperature is first maintained at a first temperature value for a first set time period sufficient for acclimatizing the patient and is then increased to subsequent programmed temperature values for periods of time sufficient to achieve a therapeutic effect on the prostate.

2. The computer program product of claim 1 wherein the first desired prostatic tissue temperature value ranges from about 42°

C. to about 46°

C. and the second desired prostatic tissue temperature value ranges from about 49°

C. to about 60°

C.

3. The computer program product of claim 1 wherein the first and second set time periods are each no less than about thirty seconds.

4. A computer operatively connected to an apparatus for treating prostate tissue for benign prostatic hyperplasia or prostatitis in a patient having a urethra, said apparatus including a catheter for insertion into the urethra, and an applicator within the catheter and a connector for connecting the applicator to an energy source, wherein the computer embodies a program of instructions executable by the computer for performing the steps of:

establishing a value of power from said energy source to be applied by said applicator;

determining a value of temperature of the prostate tissue;

adjusting said power from said energy source in dependence on the time the prostate tissue has been at said prostate tissue temperature value; and

computing a value of thermal dosage of said prostate tissue that is a function of said prostate tissue temperature value and the time said prostate tissue has been at said prostate tissue temperature value.

5. The computer of claim 4 wherein said thermal dosage value computation step further comprises a function including the product of said prostate tissue temperature and the time said prostate tissue has been at said prostate tissue temperature value.

6. The computer of claim 4 wherein the program further comprises instructions executable by the computer for performing the step of computing a cumulative value of said thermal dosage corresponding to the sum of the values of said thermal dosage at a plurality of values of said prostate tissue temperature.

7. The computer of claim 4 wherein the program further comprises instructions executable by the computer for performing the step of determining a therapeutic effect on said prostate tissue in dependence on a value of said cumulative thermal dosage.

8. The computer of claim 7 wherein the program further comprises instructions executable by the computer for performing the step of correlating said therapeutic effect to a value of prostate tissue necrosis.

9. The computer of claim 6 wherein the program further comprises instructions executable by the computer for performing the steps of selecting said value of said cumulative thermal dosage to be a thermal dose of about 1500 equivalent 45°

C. minutes to about 30,000 equivalent 45°

C. minutes is applied to the prostate tissue proximate the applicator.

10. The computer of claim 4 wherein the program further comprises instructions executable by the computer for performing the steps of generating control signals for said applicator to apply to the prostate tissue proximate said applicator a thermal dose of about 1500 equivalent 45°

C. minutes to about 30,000 equivalent 45°

C. minutes.

11. The computer of claim 4 wherein the program further comprises instructions executable by the computer for performing the step of generating signals indicative of a distribution of said applied power in said tissue proximate to said applicator.

12. A computer operatively connected to an apparatus for treating prostate tissue for benign prostatic hyperplasia or prostatitis in a patient having a urethra, said apparatus including a catheter for insertion into the urethra, and an applicator within the catheter and a connector for connecting the applicator to an energy source, wherein the computer embodies a program of instructions executable by the computer for performing the steps of:

establishing a value of power from said energy source to be applied by said applicator;

determining a value of temperature of the prostate tissue;

adjusting said power from said energy source in dependence on the time the prostate tissue has been at said prostate tissue temperature value; and

generating signals corresponding to a distribution of energy delivered to the tissue proximate to the applicator radially away from and along a length of the applicator.

13. The computer of claim 12 wherein said energy distribution generation step further comprises the step of generating signals corresponding to a Specific Absorption Rate of power in said tissue.

14. A computer program product comprising a computer-usable medium having program logic for controlling an electromagnetic energy applicator in a urethral catheter, the computer program product comprising:

temperature setting program code for establishing a plurality of desired prostatic tissue temperature values building to a final desired temperature;

temperature determining program code for determining and measuring a temperature value of prostatic tissue surrounding a distal end of the catheter;

temperature comparing program code for comparing the measured prostatic tissue temperature value to each of the plurality of desired prostatic temperature values;

control signal adjustment program code for adjusting a power control signal to vary prostatic tissue temperature in accordance with a relationship between the measured prostatic tissue temperature and each of the plurality of desired prostatic tissue temperatures depending on the period of time the prostatic tissue has been at the measured prostatic tissue temperature;

wherein said control signal adjustment program code also controls the duration for which each of said plurality of desired prostatic tissue temperature values are maintained via said power control signal, prior to said measured prostatic tissue temperature value meeting said final desired temperature, wherein at least one of the plurality of desired prostatic tissue temperature values and the duration thereof is set for achieving a therapeutic effect on the prostate.

15. A computer program product comprising a computer-usable medium having program logic for controlling an electromagnetic energy applicator in a urethral catheter for prostatic thermotherapy, the computer program product comprising:

temperature setting program code for establishing a temperature range and a final temperature, said final temperature being outside and greater than the temperature range;

temperature comparing program code for comparing a measured prostatic tissue temperature value to the temperature range and to the final temperature;

control signal adjustment program code for adjusting a power control signal to the applicator in accordance with the comparison between the measured prostatic tissue temperature value and the temperature range and final temperature depending on the time the prostatic tissue has been at the measured prostatic tissue temperature value, wherein the measured prostatic tissue temperature value is first maintained within the temperature range for a first predetermined lime period sufficient to achieve a first therapeutic effect on the prostate and is then maintained at the final temperature for a second predetermined time period s sufficient to achieve a second therapeutic effect on the prostate.