Apparatus and method for treatment of benign prostatic hyperplasia

• US 7,765,010 B2
• Filed: 02/06/2006
• Issued: 07/27/2010
• Est. Priority Date: 08/13/2001
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Jaafar, Ali, Chornenky, Victor I.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/347,965
• Publication Number:
  US 20060217703A1
• Time in Patent Office: 1,632 Days
• Field of Search: 606 27- 31, 606/41, 606 48- 50, 607/101, 607/102, 607/143, 604 21- 22, 435/173.1, 435/173.6, 435/285.2, 435/461
• US Class Current: 607/101
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

An apparatus and a method for treatment of benign prostatic hyperplasia are disclosed. The apparatus includes an applicator piece carrying a set of electrodes shaped and positioned to create a substantial electric field in the volume of hyperplasia and a pulse generator adapted for delivery of electrical pulses above the upper electroporation limit for the neoplastic cells. The amplitude, duration and number of the electrical pulses are generally selected to cause necrosis of a significant fraction of the volume of benign prostatic hyperplasia. The apparatus may include a high frequency system for heating the prostatic tissue and a cooling system for cooling the urethra. The combined action of heating and cooling may increase the temperature of the prostate cells to 45 degrees C. to 55 degrees C., while keeping the urinary tract at a temperature 15 degrees C. to 20 degrees C. This temperature distribution can increase the selectivity of the treatment by increasing susceptibility of the neoplastic cells to the electroporation treatment and decreasing it for the normal urethral tissues.

Claims

1. A method for treating benign prostatic hyperplasia (BPH) of a prostate, comprising:

placing a set of electrically conductive electrodes in the body of a patient near a BPH tissue to be treated; and

applying, through the placed electrodes, a plurality of electric pulses in an amount sufficient to irreversibly open pores in the membranes of the BPH tissue so as to cause irreversible electroporation necrosis of the BPH tissue.

2. The method of claim 1, further comprising cooling a urethra to a temperature in the range of 10 to 20 degrees Celsius.

3. The method of claim 1, further comprising heating the BPH tissue to a temperature in the range of 45 to 50 degrees Celsius before applying the electric pulses.

4. The method of claim 1, further comprising providing at least one temperature sensor to be placed in the vicinity of the electrodes for use in monitoring the temperature of the prostate.

5. The method of claim 1, further comprising monitoring the resistance of the treated BPH tissue after treatment for use in determining an end-point of the treatment.

6. The method of claim 1, wherein the step of applying includes applying a plurality of rectangular pulses.

7. The method of claim 1, wherein the step of placing includes placing the set of electrodes using a perineal needle template under ultrasound guidance.

8. The method of claim 1, wherein the step of applying includes applying each pulse with a duration of at least 10 microseconds.

9. The method of claim 1, wherein the step of applying includes applying each pulse with a duration of at least 10 microseconds and with an amplitude of at least 1000 Volts/cm.

10. The method of claim 1, further comprising injecting a cytotoxic drug into the BPH tissue.

11. The method of claim 1, wherein the step of applying includes applying the plurality of pulses through a switch circuit to commutate the electric pulses between the set of electrodes.

12. The method of claim 11, wherein the step of applying further includes applying the plurality of pulses with each pulse having a duration of at least 10 microseconds and having an amplitude of at least 1000 volts/cm.

13. A method for treating benign prostatic hyperplasia (BPH) of a prostate, comprising:

piercing a perineum to place a set of electrically conductive electrodes in the body of a patient near a BPH tissue to be treated; and

applying, through the placed electrodes, a plurality of electric pulses with each pulse having a duration of at least 10 microseconds and having an amplitude of at least 1000 volts/cm to irreversibly open pores in the membranes of the BPH tissue so as to cause irreversible electroporation necrosis of the BPH tissue.

14. The method of claim 13, wherein the step of applying includes applying the plurality of pulses through a switch circuit to commutate the electric pulses between the set of electrodes.

15. The method of claim 13, wherein the set of electrodes are placed using a perineal needle template under ultrasound guidance.

16. The method of claim 13, further comprising injecting a cytotoxic drug into the BPH tissue.

17. The method of claim 13, further comprising monitoring the resistance of the treated BPH tissue after treatment for use in determining an end-point of the treatment.