Method for performing intraurethral radio-frequency urethral enlargement

• US 6,440,127 B2
• Filed: 02/11/1998
• Issued: 08/27/2002
• Est. Priority Date: 02/11/1998
• Status: Expired due to Fees

• Current Assignee: Cosman Company Incorporated, Massachusetts General Hospital (Mass General Brigham, Inc.)
• Original Assignee: Cosman Company Incorporated, The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Cosman, Eric R., Rittman, William J. III, Goldberg, S. Nahum, McGovern, Francis J.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/021,802
• Publication Number:
  US 20010018585A1
• Time in Patent Office: 1,658 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 inducing a urethral enlargement at the prostate in an operative field in a patient, which includes a periurethral region of the prostate, comprising the steps of:

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

applying an appropriate level of a high-frequency output from a high-frequency generator through the electrode to elevate the temperature of the urethra to at least 50°

C. to induce heat ablation of at least a portion of the urethra wall and at least a portion of the periurethral tissue within the operative field, thereby inducing formation of a cavity to enlarge a passageway within the urethra.

2. The method of claim 1, further comprising the step of monitoring the position of the electrode in the urethra within the operative field by an ultrasonic scanner inserted in the patient'"'"'s rectum.

3. The method of claim 1, further comprising the step of generating image representations of the electrode for guiding the electrode in the urethra into the region of the prostate in the operative field via a CT or MR imaging scanner.

4. The method of claim 1, and further comprising the step of detecting a temperature level of the tissue proximate to the electrode with a temperature sensor in the electrode coupled to an external temperature monitor.

5. The method of claim 1, wherein the elongate member comprises a catheter with a balloon tip, and the inserting step comprises the steps of:

inserting of the catheter into the urethra so that the balloon tip is inside the bladder of the patient; and

inflating the balloon tip so that the catheter is stably positioned in the urethra and that an exposed conductive portion of the electrode is in a fixed position in the urethra proximate to the region of the prostate.

6. The method of claim 1, further comprising the step of generating image representations of the electrode in the region of the prostate with an X-ray imaging apparatus.

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

8. The method of claim 1 wherein applying the high-frequency output includes applying the high-frequency output through the ring electrode to a return electrode.

9. A method of inducing a urethral enlargement at the prostate within an operative field of a patient, comprising the steps of:

inserting a distal portion of an elongate member into the urethra through the penis to a region of the prostate in the operative field 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 located external to the operative field; and

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

C. to induce ablation of at least a portion of the urethra wall and at least a portion of the periurethral tissue within the operative field, thereby inducing formation of a cavity to enlarge a passageway within the urethra.

10. The method of claim 9, further comprising the step of generating an image representation of the position of the electrode in the region of the prostate by utilizing an imaging apparatus.

11. The method of claim 10, wherein the generating step comprises inserting an ultrasonic image scanner into the rectum of the patient to visualize the prostate and the position of the electrode within the region of the prostate in the operative field.

12. The method of claim 10, wherein the generating step comprises scanning the patient with a CT or MR image scanner to visualize the prostate and the position of the electrode within the region of the prostate in the operative field.

13. The method of claim 10, wherein the generating step comprises taking X-ray images to visualize the prostate and the position of the electrode within the region of the prostate.

14. The method of claim 9, wherein the elongate member comprises a catheter having a balloon tip, and wherein the inserting step comprises the steps of:

inserting the catheter into the urethra so that the balloon tip is inside the bladder of the patient; and

inflating the balloon tip so that the catheter is stably positioned in the urethra.

15. The method of claim 9 wherein applying the output includes enlarging the passageway relative to a normal size of the urethral passage.

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

17. A method of treating the urethral passage, comprising:

placing a distal portion of an elongate member intraurethrally into the urethral passage, the elongate member having an active ring electrode disposed on an outer surface of the distal portion of the elongate member, and

energizing the electrode with high frequency energy to elevate a temperature of a wall defining the urethral passage and adjacent prostate tissue to about 50 to 100°

C. to ablate tissue of the wall and the adjacent prostate tissue to form a cavity communicating with the urethral passage.

18. The method of claim 17 wherein energizing the electrode forms a cavity in the wall and adjacent prostate tissue having a diameter in the range of about 0.3 to 5 cm.

19. The method of claim 17 wherein energizing the electrode includes elevating the temperature for about 6 minutes.

20. The method of claim 17 wherein energizing the electrode includes connecting the electrode to a high frequency generator.

21. The method of claim 17 wherein energizing the electrode includes forming the cavity such that the urethral passage is enlarged relative to a normal size of the urethral passage.

22. The method of claim 17 wherein energizing the electrode includes applying the high frequency energy through the electrode to a return electrode.

23. The method of claim 17 further comprising imaging the electrode to monitor the position of the electrode.

24. The method of claim 23 wherein imaging includes ultrasonic imaging.

25. The method of claim 24 wherein imaging includes inserting an ultrasonic scanner transrectally.

26. The method of claim 23 wherein imaging includes CT imaging.

27. The method of claim 23 wherein imaging includes MR imaging.

28. The method of claim 17 further comprising detecting a temperature level of tissue surrounding the electrode.

29. The method of claim 17 wherein energizing the electrode causes emission of current from the electrode and dissipation of energy into tissue around the electrode.

30. A method of treating the urethral passage, comprising:

placing a distal portion of an elongate member intraurethrally into the urethral passage, the elongate member having multiple circumferential electrodes disposed on an outer surface of the distal portion of the elongate member, and

energizing at least one of the electrodes with high frequency energy to elevate a temperature of a wall defining the urethral passage and adjacent prostate tissue to about 50 to 100°

C. to ablate tissue of the wall and the adjacent prostate tissue to form a cavity communicating with the urethral passage.

31. The method of claim 30 wherein energizing the electrode forms a cavity in the wall and adjacent prostate tissue having a diameter in the range of about 0.3 to 5 cm.

32. The method of claim 30 wherein energizing the electrode includes elevating the temperature for about 6 minutes.

33. The method of claim 30 wherein energizing the electrode includes connecting the electrode to a high frequency generator.

34. The method of claim 30 wherein energizing the electrode includes forming the cavity such that the urethral passage is enlarged relative to a normal size of the urethral passage.

35. The method of claim 30 wherein energizing the electrode includes energizing multiple electrodes.

36. The method of claim 30 further comprising imaging the electrode to monitor the position of the electrode.

37. The method of claim 36 wherein imaging includes ultrasonic imaging.

38. The method of claim 37 wherein imaging includes inserting an ultrasonic scanner transrectally.

39. The method of claim 36 wherein imaging includes CT imaging.

40. The method of claim 36 wherein imaging includes MR imaging.

41. The method of claim 30 further comprising detecting a temperature level of tissue surrounding the electrode.

42. The method of claim 30 wherein placing the distal portion includes the elongate member having multiple ring electrodes at the distal portion.

43. The method of claim 30 further comprising selecting one or more electrodes to be energized to grade a size of ablation.

44. A method of treating a urethral passage comprising:

inserting a distal portion of an elongate member into the urethra, the elongate member having an active ring electrode disposed on an outer surface of the distal portion;

applying an appropriate level of a high-frequency output from the high-frequency generator through the electrode to elevate the temperature of a portion of the urethra to at least 50°

C. to induce ablation of at least a portion of the urethra wall and at least a portion of the periurethral tissue; and

maintaining the urethra wall at a temperature of at least 50°

C. for a period of time sufficient to kill the tissue.

45. The method of claim 44, wherein the period of time is six minutes or less.

46. The method of claim 44, wherein the electrode is a non-cooled electrode.

47. The method of claim 44, wherein the elongate member has multiple ring electrodes disposed on the outer surface of the distal portion.

48. The method of claim 47, wherein each electrode is a non-cooled electrode.

49. The method of claim 48, wherein the period of time is six minutes or less.