Method of cryoablating benign prostate hyperplasia

• US 6,179,831 B1
• Filed: 04/29/1999
• Issued: 01/30/2001
• Est. Priority Date: 04/29/1999
• Status: Expired due to Fees

• Current Assignee: Galil Medical Ltd. (Boston Scientific Corporation)
• Original Assignee: Galil Medical Ltd. (Boston Scientific Corporation)
• Inventors: Bliweis, Mordechai
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/301,576
• Time in Patent Office: 642 Days
• Field of Search: 606/20-28
• US Class Current: 606/21
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/0268 with restriction of flow
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/378 using ultrasound

Abstract

A method for treating benign prostate hyperplasia is provided. The method is effected by (a) inserting a cystoscope into a prostatic urethra portion of a urethra of a patient having benign prostate hyperplasia; (b) guiding a probe of a cryoprobe having an operating tip through a channel of the cystoscope to an portion of the prostatic urethra; (c) navigating the operating tip through a wall of the prostatic urethra into at least one location at a time of a prostate of the patient; and (d) operating the cryoprobe thereby cooling the operating tip and producing an ice-ball of prostate tissue around the operating tip, so as to locally freeze a portion of the prostate, yet substantially avoid freezing the prostatic urethra.

Claims

1. A method for treating benign prostate hyperplasia, the method comprising the steps of:

(a) inserting a cystoscope into a prostatic urethra portion of a urethra of a patient having benign prostate hyperplasia;

(b) guiding a probe of a cryoprobe having an operating tip through a channel of said cystoscope to a portion of said prostatic urethra;

(c) navigating said operating tip through a wall of said prostatic urethra into at least one location at a time of a prostate of said patient; and

(d) operating said cryoprobe thereby cooling said operating tip and producing an ice-ball of prostate tissue around said operating tip, so as to locally freeze a portion of said prostate, yet substantially avoid freezing said prostatic urethra.

2. The method of claim 1, further comprising the step of:

(e) retracting said probe from said channel of said cystoscope.

3. The method of claim 2, further comprising the step of:

(f) retracting said cystoscope from said urethra.

4. The method of claim 1, wherein said step of inserting said cystoscope into said prostatic urethra portion of said urethra of said patient having benign prostate hyperplasia is aided using an optical probe inserted through an optical channel of said cystoscope.

5. The method of claim 1, wherein said step of navigating said operating tip through said wall of said prostatic urethra into at least one location at a time of said prostate of said patient is aided using an optical probe inserted through an additional channel of said cystoscope.

6. The method of claim 1, wherein said step of navigating said operating tip through said wall of said prostatic urethra into at least one location at a time of said prostate of said patient is aided using a built-in optical channel of said cystoscope.

7. The method of claim 1, wherein said step of navigating said operating tip through said wall of said prostatic urethra into at least one location at a time of said prostate of said patient is aided using ultrasound monitoring.

8. The method of claim 1, wherein said step of navigating said operating tip through said wall of said prostatic urethra into at least one location at a time of said prostate of said patient is aided using an optical channel of said cystoscope and ultrasound monitoring.

9. The method of claim 1, further comprising the step of:

(e) prior to executing said step of inserting said cystoscope into said prostatic urethra portion of said urethra of said patient having benign prostate hyperplasia, providing said patient with local anesthesia.

10. The method of claim 1, further comprising the step of:

(e) heating said operating tip so as to melt at least an inner portion of said ice ball and navigating said operative away from said portion of said prostate.

11. The method of claim 1, wherein said cystoscope has a navigation mechanism operative therewith, said navigation mechanism serves to effect said step of navigating said operating tip through said wall of said prostatic urethra into at least one location at a time of said prostate of said patient.

12. The method of claim 1, wherein said operating tip of said probe is formed with a sharp end so as to minimize the wound formed in said wall of said prostatic urethra when effecting said step of navigating said operating tip through said wall of said prostatic urethra into at least one location at a time of said prostate of said patient.

13. The method of claim 1, wherein said probe is flexible at least at a portion thereof adjacent said operating tip.

14. The method of claim 1, wherein said probe of said cryoprobe includes a heat exchanger coupled to an orifice, the orifice opening into a jacket;

said jacket forming a reservoir capable of housing a fluid in contact with said at least one location, at a time, of said prostate of said patient;

said cryoprobe further includes two gas sources providing two gases, each of said two gas sources being independently connected to said heat exchanger of said probe, and a mechanism for allowing and stopping a flow of each of said two gases through said orifice.

15. The method of claim 14, wherein said gas sources are pressurized, pressurized gas sources are gas reservoirs containing gas under pressure.

16. The method of claim 14, wherein said gas sources include one or more compressors, which draw gas from a reservoir containing gas at a lower pressure than desired.

17. The method of claim 14, wherein said heat exchanger is a thin tube or a porous matrix heat exchanger.

18. The method of claim 1, wherein said probe of said cryoprobe includes (i) a heat exchanger coupled to an orifice, the orifice opening into a jacket;

and (ii) the jacket which is in contact with the surface to be heated and cooled, the jacket forming a reservoir capable of housing a fluid in contact with a surface to be heated and cooled;

said cryoprobe further includes

(a) two independent connections for pressurized gas sources, connected to the heat exchanger;

(b) temperature generation mechanism, coupled to the probe, including;

(i) two independent pressurized gas sources, connected to the probe through the two independent connections;

(ii) controllable gas flow valves to permit or preclude a flow of each of gases from the independent pressurized gas sources into the probe; and

(c) processing mechanism for controlling the controllable gas flow rate valves according to predetermined operating conditions.

19. The method of claim 18, wherein said cryoprobe further includes a data input mechanism, to provide operation data to said processing mechanism.

20. The method of claim 19, wherein said data input mechanism includes a keyboard.

21. The method of claim 20, wherein said cryoprobe further includes display mechanism to display data written to, or read from, said processing mechanism.

22. The method of claim 19, wherein said data input mechanism includes a communication port.

23. The method of claim 22, wherein said communication port is an RS232 port.

24. The method of claim 19, wherein said data input mechanism includes a magnetic or optical reading mechanism, to read pre-prepared data.

25. The method of claim 24, wherein said cryoprobe further includes a temperature-reading mechanism located at or near said operating tip, which temperature-reading mechanism provides temperature readings to said processing mechanism.

26. The method of claim 25, wherein said temperature-reading mechanism includes one or more thermocouples.

27. The method of claim 26, wherein said cryoprobe further includes a pressure-reading mechanism located between the pressurized gas source and said probe, to provide to said processing mechanism readings corresponding to pressure supplied by each of said pressurized gas sources.