Apparatus and method for treatment of benign prostatic hyperplasia

• US 20030060856A1
• Filed: 08/13/2002
• Published: 03/27/2003
• Est. Priority Date: 08/13/2001
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Ali Jaafar, Victor Chornenky
• Inventors: Jaafar, Ali, Chornenky, Victor
• Granted Patent: US 6,994,706 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• 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° C. to 55° C., while keeping the urinary tract at a temperature 15° C. to 20° 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. An apparatus for treatment of benign prostate hyperplasia of a male patient, comprising:

a) an applicator piece adapted for placing a set of conductive electrodes into the urethra and in the vicinity of the prostate gland, said electrodes shaped and positioned for creating a substantial electric field in the volume of benign hyperplasia, said electric field directed predominantly in the radial direction to the urethra;

b) a high voltage pulse generator connected to said electrodes and adapted for delivering high voltage pulses exceeding the upper limit of electroporation for neoplastic cells of the prostate and thus causing electroporation necrosis of the benign prostatic hyperplasia.

2. An apparatus of claim 1 comprising a urethral catheter with a sealed hollow passage inside, said passage connected to a cooling system adapted for cooling the urethra to a temperature 10 to 20 degree C.

3. An apparatus of claim 2 further including a radio frequency generator connected to the electrodes and delivering radio frequency power to the prostate to heat the benign prostate hyperplasia tissue to 45-50 degrees C. for a short period of time before application of the electroporation treatment.

4. An apparatus of claim 3 further including a set of temperature sensors placed in the vicinity of the conductive electrodes and used to control delivery of coolant to the urethra and radio frequency energy to the prostate for stabilization both the temperature of the urethra and the bulk of the prostate at predetermined levels.

5. An apparatus of claim 1 in which the high voltage generator includes a means for monitoring the electric current and resistance of the treated tissue before, during and after treatment.

7. An apparatus of the claim 1 in which a set of needles carrying conductive electrodes is introduced into the body of the prostate gland.

10. An apparatus of the claim 7 including a perineal needle template used for placement of conductive needle-type electrodes into the body of the prostate through the perineum under ultrasound guidance.

16. A method of claim 10 in which pulses generated by the high voltage pulse generator are rectangular, exponential, single or alternating polarity.

6. An apparatus for treatment of benign prostatic hyperplasia of a male patient, comprising:

a) a urethral catheter carrying conductive electrodes and having a proximal end, elongated member and a distal end, said proximal end positioned outside of the patient'"'"'s body, said elongated member being sized so that it can be introduced into the urethra, said distal end terminated with a balloon adapted for expansion in the patient'"'"'s bladder, said conductive electrodes being affixed to the elongated member adjacent to the transition zone of the prostate, to the distal balloon in the bladder and on the external surface of the patient'"'"'s body;

b) a high voltage pulse generator connected to said electrodes and adapted for delivering high voltage pulses exceeding the upper limit of electroporation for neoplastic cells and thus causing electroporation necrosis of the benign prostatic hyperplasia.

8. An apparatus for treatment of benign prostatic hyperplasia of a male patient, comprising:

a) an applicator including two spatially and electrically separated cylindrical electrodes secured on a flexible needle having a sharp tip, said needle placed into prostate through a urethral probe, said probe having a proximal end, elongated member and distal end, said proximal end positioned outside of the patient'"'"'s body and attached to a control handle piece, said control handle piece used for manipulation of angular and longitudinal positions of the probe in the urethra, said elongated member having a passageway extending from the proximal end to the distal end and adapted for accommodation of an endoscope, said elongated member having at least one additional passageway slidably carrying said flexible needle from the proximal end to a side port at the distal end of the probe, said side port positioned near the transition zone of the prostate, said control handle piece connected to a finger activated mechanism mounted between the needle and adapted for advancement or retraction of the needle, said flexible needle adapted for changing direction at the side port and penetrating the prostate gland under an angle to the urethra close to 90 degrees;

b) a high voltage pulse generator connected to said electrodes and adapted for delivering high voltage pulses exceeding the upper electroporation limit for the fibro muscular cells of benign prostate hyperplasia and thus causing electroporation necrosis of the benign prostate hyperplasia.

9. An apparatus of claim 8, in which the needle carrying conductive electrodes has a proximal end, an elongated member and a distal end, said proximal end terminated with at least two insulated wires connected to at least two cylindrical electrodes secured on the elongated member, said electrodes spatially separated and electrically insulated from each other and from the elongated member, said elongated member having a passage through it carrying said insulated wires, said distal end having a sharp solid tip, said insulated wires adapted to connection with the output of the high voltage pulse generator.

11. A method for treatment of benign prostatic hyperplasia of a male patient, comprising steps:

a) placing a set of conductive electrodes in the body of the patient in the vicinity of the prostate, said electrodes shaped and positioned to create a substantial radial to the urethra electric field in the region of benign prostatic hyperplasia,

b) delivering high voltage pulses with amplitude and duration exceeding the upper electroporation limit for the neoplastic cells and thus causing electroporation necrosis of the benign prostatic hyperplasia.

12. A method of claim 11 further including a step of cooling the urethra to a temperature 10 to 20 degree C.

13. A method of claim 11 further including a step of delivering radio frequency power to the electrodes to heat the benign prostate hyperplasia tissue to 45-50 degrees C. for a short period of time before application of the electroporation treatment.

14. A method of claim 12 further including a step of providing a set of temperature sensors placed in the vicinity of the conductive electrodes and used for control of delivery of coolant to the urethra and radio frequency energy to the prostate for stabilization of the temperature of the urethra and the prostate at predetermined levels.

15. A method of claim 11 further including monitoring of the electric current and resistance of the treated tissue during and after treatment, said monitoring used for determination of the end-point of the treatment.

17. A method of claim 11 in which the set of conductive needle-type electrodes is placed into the body of the prostate by using a perineal needle template under ultrasound guidance.

18. An apparatus for treatment of benign prostate hyperplasia of a male patient, comprising:

a) a urethral probe carrying a conductive electrode and having a proximal end, elongated member and a distal end, said proximal end positioned outside of the patient'"'"'s body and attached to a control handle piece, said elongated member being made of a rigid metal and sized so that it can be introduced into the urethra, said distal end terminated with a balloon adapted for expansion in the patient'"'"'s bladder, said conductive electrode electrically insulated from the elongated member and secured at its surface adjacent to the transition zone of the prostate;

a plurality of needle electrodes mounted in a rigid cartridge, slidably movable along a rail secured to the control handle piece, said movable cartridge having a travel between two extreme position, in the first of which the needles are hidden behind a protective cap for safety, in the second the needles are advanced forward through bores and introduced into the body of the prostate, said needle electrodes adapted to be placed in the transition zone, said urethral probe and rail shaped and spatially positioned relatively to each other in such a manner that the needles move parallel to the distal part of the urethra at predetermined distances and positions from each other and from the urethra electrode;

b) a high voltage pulse generator connected to the urethral electrode and needle electrodes delivering high voltage pulses with amplitude and duration exceeding the upper limit of electroporation for neoplastic cells and thus causing electroporation necrosis of the benign prostatic hyperplasia.

19. An apparatus of claim 18 in which the needle electrodes in the needle cartridge of the applicator are arranged in two or three rows circumferentially to the urethra, said electrodes parallel to each other and to the urethra, each needle in a said row positioned at the same distance from the urethra.

20. An apparatus of claim 19 in which the needle electrodes in each row are connected to each other and kept at the same potential during high voltage pulsing, resulting in generation of electric field with a predominantly radial direction.

21. An applicator for placement of electrodes into prostate of a male patient for delivery of variety of forms of electrical energy for treatment of the prostate, comprising:

a) a urethral probe carrying a conductive electrode and having a proximal end, elongated member and a distal end, said proximal end positioned outside of the patient'"'"'s body and attached to a control handle piece, said elongated member being made of a rigid material and sized so that it can be introduced into the urethra, said distal end terminated with a balloon adapted for expansion in the patient'"'"'s bladder, said conductive electrode secured at the surface of the elongated member adjacent to the prostate;

b) a plurality of needle electrodes mounted in a rigid cartridge, slidably movable along a rail secured to the control handle piece, said movable cartridge having a travel between two extreme position, in the first of which the needles are hidden behind a protective cap for safety, in the second the needles are advanced forward through holes in the protective cap and introduced into the body of the prostate, said needle electrodes adapted to be placed in a zone of the prostate to be treated, said urethral probe and rail shaped and spatially positioned relatively to each other in such a manner that the needles move parallel to the distal part of the urethra at predetermined distances and positions from each other and from the urethra electrode.