Method for performing intraurethral radio-frequency urethral enlargement

• US 6,692,493 B2
• Filed: 08/26/2002
• Issued: 02/17/2004
• Est. Priority Date: 02/11/1998
• Status: Expired due to Fees

• Current Assignee: Cosman Company Incorporated, The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: Cosman Company Incorporated, The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Rittman, William J. III, Goldberg, S. Nahum, McGovern, Francis J., Cosman, Eric R.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US10/227,533
• Publication Number:
  US 20030060819A1
• Time in Patent Office: 540 Days
• Field of Search: 606/41, 606/49, 606/50, 607/98, 607/99, 607/105, 607/113
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

Relief of urethral obstruction is achieved by heat ablation of prostatic tissue by an ablation electrode passed within the urethra to a position in the prostate near the point of urethral obstruction. The electrode is coupled to a high frequency power supply to ablatively heat the urethra and the prostatic tissue near the urethra. Image guidance of the electrode placement is monitored by an imaging device. The temperature of the tissue is sensed at the electrode to control the high frequency heating energy and ablation process. The electrode has a blunt tip to help prevent piercing of the wall of the urethra during insertion of the electrode into the urethra through the penis and the positioning of the electrode tip near to the point of urethral obstruction. Several forms of electrodes, apparatus, and methods accommodate the specific objectives.

Claims

1. A method of alleviating urethral obstruction in a patient comprising:

inserting a distal portion of an elongate member into the urethra of the patient without piercing the wall of the urethra, the elongate member having a conductive element disposed on an outer surface of the distal portion of the elongate member; and

applying a high-frequency output through the conductive element for six minutes or less.

2. The method of claim 1, further comprising monitoring the position of a portion of the elongate member in the urethra using an ultrasonic image scanner.

3. The method of claim 1, further comprising generating image representations of a portion of the elongate member for guiding the elongate member in the urethra via CT or MR imaging scanner.

4. The method of claim 1, further comprising detecting a temperature level of the tissue proximate to the conductive element with a temperature sensor in the elongate member coupled to an external temperature monitor, the temperature being at least 50°

C.

5. The method of claim 1, further comprising:

inflating a balloon tip of the elongate member inside the bladder of the patient.

6. The method of claim 1, further comprising generating image representations of a portion of the elongate member in the urethra with an X-ray imaging apparatus.

7. The method of claim 1, wherein applying the high-frequency output includes forming a cavity such that the urethral passage is enlarged relative to a normal size of the urethral passage.

8. The method of claim 1, wherein the conductive element includes a ring electrode.

9. A method of altering tissue to relieve the symptoms of benign prostatic hyperplasia in a patient comprising:

inserting a distal portion of an elongate member into the urethra through the penis to a region of the prostate without piercing the wall of the urethra, the elongate member having an active ring electrode disposed on an outer surface of the distal portion;

connecting the electrode to a high-frequency generator; and

applying a high-frequency output through the electrode to elevate the temperature of a portion of the urethra in the region of the prostate to at least 50°

C.

10.The method of claim 9, further comprising generating an image representation of the position of a portion of the elongate member in the region of the prostate by utilizing an imaging apparatus.

13. The method of claim 9, further comprising inflating a balloon tip of the elongate member so that the elongate member is stably positioned in the urethra.

14. The method of claim 9, wherein applying the output includes enlarging the urethra relative to a normal size of the urethra.

15. The method of claim 9, wherein applying the output includes applying the output through the ring electrode to a return electrode.

16. The method of claim 9, wherein applying the output includes ablating urethral or prostate tissue.

10. The method of claim 10, where in generating the image comprises inserting an ultrasonic image scanner into the rectum of the patient to visualize the prostate and the position of a portion of the elongate member within the region of the prostate.

11. The method of claim 10, wherein generating the image comprises scanning the patient with a CT or MR image scanner to visualize the prostate and the position of a portion of the elongate member within the region of the prostate.

12. The method of claim 10, wherein generating the image comprises taking X-ray images to visualize the prostate and the position of a portion of the elongate member within the region of the prostate.

17. A method of altering tissue to relieve the symptoms of benign prostatic hyperplasia in a patient comprising:

placing a distal portion of an elongate member intraurethrally into the urethral passage, the elongate member having a conductive element, and

energizing the conductive element in the urethral passage with high frequency energy for six minutes or less.

18. The method of claim 18, wherein energizing the conductive element alleviates urethral obstruction.

20. The method of claim 18, wherein energizing the conductive element includes connecting the conductive element to a high frequency generator.

21. The method of claim 18, wherein energizing the conductive element includes forming the cavity such that the urethral passage is enlarged relative to a normal of the urethral passage.

22. The method of claim 18, wherein energizing the conductive element includes applying the high frequency energy through the conductive element to a return electrode.

23. The method of claim 18, further comprising imaging a portion of the elongate member to monitor the position of the elongate member.

19. The method of claim 19, wherein alleviating urethral obstruction includes forming a cavity in the urethral passage and adjacent prostate tissue having a diameter in the range of about 0.3 to 5 cm.

24. The method of claim 24, wherein imaging includes ultrasonic imaging.

26. The method of claim 24, wherein imaging includes CT imaging.

27. The method of claim 24, wherein imaging includes MR imaging.

25. The method of claim 25, wherein imaging includes inserting an ultrasonic scanner transrectally.

28. The method of claim 28, further comprising detecting a temperature level of tissue surrounding the conductive element.

29. The method of claim 28, wherein energizing the conductive element causes emission of current from the conductive element and dissipation of energy into tissue around the conductive element.

30. A method of treating the symptoms of urinary obstruction in a patient comprising:

inserting a distal portion of an elongate member into a urethral passage to a region of the prostate of the patient, the elongate member having a ring electrode disposed on an outer surface of the distal portion, and

energizing the ring electrode with high frequency energy to elevate the temperature of a portion of the urethra in the region of the prostate to at least 50°

C.

31. The method of claim 31, wherein said ring electrode comprises a metal ring, and wherein energizing the ring electrode comprises connecting the metal ring to a high frequency generator.

32. The method of claim 31, wherein the elongate member comprises a flexible catheter having an inflatable balloon on the distal portion, and inserting the distal portion comprises inflating the balloon in the bladder of the patient.

33. The method of claim 31, wherein energizing the ring electrode includes sustaining the energizing for sufficient time to alter tissue in the prostate by temperature elevation to relieve symptoms of urinary obstruction.