Transurethral systems and methods for ablation treatment of prostate tissue

• US 8,880,195 B2
• Filed: 09/15/2008
• Issued: 11/04/2014
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: LaZure Scientific Inc.
• Original Assignee: Lazure Technologies, LLC
• Inventors: Azure, Larry
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US12/283,940
• Publication Number:
  US 20090076494A1
• Time in Patent Office: 2,241 Days
• Field of Search: 606/32, 606/34, 606 41- 44, 607/115, 607/116, 607/143, 607/148
• US Class Current: 607/143
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2576/00 Medical imaging apparatus involving image processing or analysis A61B1/00009, A61B6/52 and A61B8/52 take precedence; image processing per se G06T; details of algorithms for analysing medical images G06T7/0012

Abstract

Transurethral systems and methods for delivering electrical energy and controlled, mild heating to a prostate tissue of a patient for destruction of cancerous and/or hyperplastic tissue. A method includes positioning an elongate urethral probe having an expandable member with electrode elements at a target location in the patient'"'"'s urethra, and inflating or expanding at the target location. Secondary electrodes are positioned within or adjacent to the prostate tissue and spaced from the electrode elements of the expandable member, and an alternating electrical current flow is established between the electrode elements of the expandable member and the one or more secondary electrodes. Current delivery can be selected so as to destroy or ablate cancerous cells of the prostate tissue.

Claims

1. A method of delivering an electric field to destroy cancerous cells of a prostate tissue of a patient including positioning of an elongate urethral probe comprising a proximal end and a distal portion having an expandable member, and one or more conductive electrode elements disposed on an outer surface of the expandable member, the method comprising:

advancing the distal portion of the probe through the patient'"'"'s urethra so as to position the expandable member at a target location in the patient'"'"'s urethra;

expanding the expandable member at the target location so as to position the conductive electrode elements in contact with an inner surface of the patient'"'"'s urethra at the target location;

positioning one or more secondary electrodes such that a current transfer region of each of the one or more secondary electrodes is disposed within or adjacent to the prostate tissue and spaced from the electrode elements of the expandable member, thereby at least partially defining a treatment volume; and

establishing an alternating electrical current flow between the electrode elements of the expandable member and the one or more secondary electrodes by delivering electrical current from at least one of (a) at least one of the one or more conductive electrode elements and (b) at least one of the one or more current transfer regions, and through tissue of the treatment volume, so as to preferentially destroy cancerous cells of the prostate tissue in the treatment volume relative to non-cancerous cells in the treatment volume.

2. The method of claim 1, wherein electrical current flow is established so as to heat the target tissue to an average temperature of less than about 50 degrees C.

3. The method of claim 1, the alternating current flow comprising a frequency of less than about 300 kHz.

4. The method of claim 3, the alternating electrical current flow comprising a frequency from about 50 kHz to about 250 kHz.

5. The method of claim 3, the alternating electrical current flow comprising a frequency of about 100 kHz.

6. The method of claim 1, wherein the elongate urethral probe comprises one or more secondary electrodes deployable from a body of the elongate probe.

7. The method of claim 6, further comprising deploying one or more secondary electrodes from the body of the probe and through the urethral wall into the prostate tissue and spaced from the positioned expandable member, the deployed electrodes substantially defining an ablation volume with the expandable member positioned within the ablation volume;

and establishing an electrical current flow between the electrode elements of the expandable member and the one or more secondary electrodes so as to preferentially destroy cancerous cells of the prostate tissue.

8. The method of claim 1, wherein the secondary electrodes comprise elongate needle electrodes advanced through the perineum of the patient and into the prostate tissue.

9. The method of claim 8, further comprising establishing an electrical current flow between the electrode elements of the expandable member and the positioned needle.

10. The method of claim 1, wherein establishing the current flow comprises applying an electrical through a treatment volume so as to provide an electric field extending radially outward from a current flow center.

11. The method of claim 1, further comprising flowing a heated or cooled inflation media through the expandable member during energy delivery.

12. The method of claim 1, wherein the method comprises treatment of benign prostate hyperplasia (BPH).

13. A method of delivering an electric field to destroy cancerous cells of a prostate tissue of a patient including positioning of an elongate urethral probe comprising a proximal end and a distal portion having an expandable member, the expandable member comprising one or more conductive electrode elements, the method comprising:

advancing the distal portion of the probe through the patient'"'"'s urethra to position the expandable member of the urethral probe at a target location in the patient'"'"'s urethra;

expanding the expandable member of the urethral probe at the target location so as to position the conductive electrode elements in contact with an inner surface of the patient'"'"'s urethra at the target location;

positioning a second probe in a rectal cavity of the patient, the second probe comprising one or more conductive electrode elements disposed on a surface of an expandable member, the second probe positioned such that the conductive electrode elements of the expandable member contact an inner surface of the patient'"'"'s rectal wall near the prostate; and

establishing an alternating electrical current flow between the conductive electrode elements of the urethral probe and the conductive electrode elements of the second probe by delivering electrical current from at least one of (a) at least one of the one or more conductive elements of the urethral probe and (b) at least one of the one or more conductive elements of the second probe so as to preferentially destroy cancerous cells of the prostate tissue relative to non-cancerous cells of the tissue disposed between the urethral probe expandable member and the second probe expandable member.

14. The method of claim 13, wherein electrical current flow is established so as to heat the target tissue to an average temperature of 40 degrees C. to 48 degrees C.

15. The method of claim 14, the electrical current flow comprising a frequency of about 50 kHz to about 300 kHz.

16. The method of claim 15, the alternating electrical current flow comprising a frequency of about 100 kHz.

17. The method of claim 13, further comprising flowing a heated or cooled inflation media through the expandable member of the urethral probe, the rectal probe, or both, during energy delivery.

18. A method of delivering an electric field to destroy cancerous cells or hyperplastic cells of a prostate tissue of a patient including positioning of an elongate urethral probe comprising a proximal end and a distal portion having one or more conductive electrode elements deployable therefrom, the method comprising:

advancing the distal portion of the probe through the patient'"'"'s urethra to position the distal portion of the urethral probe at a target location in the patient'"'"'s urethra;

deploying one or more electrodes from the distal portion of the probe so as to penetrate through the urethral wall and into the prostate tissue such that a current transfer region of each of the deployed electrodes is spaced laterally from the urethral probe distal portion so as to at least partially define a treatment volume; and

establishing an alternating electrical current flow between the deployed electrode elements of the urethral probe by delivering electrical current from at least one of the one or more current transfer regions so as to preferentially destroy cancerous cells of the prostate tissue of the treatment volume disposed between the electrodes relative to non-cancerous cells of the treatment volume.

19. The method of claim 18, wherein the alternating electrical current flow comprises a frequency of about 50 kHz to about 300 kHz.

20. A method of delivering an electric field to destroy cancerous cells of a target tissue of a patient including positioning of an elongate probe in a body lumen of the patient, the probe comprising a proximal end and a distal portion having an expandable member, and one or more conductive electrode elements disposed on an outer surface of the expandable member, the method comprising:

advancing the distal portion of the probe through the patient'"'"'s body lumen so as to position the expandable member at a target location in the lumen;

expanding the expandable member at the target location so as to position the conductive electrode elements in contact with an inner surface of the patient'"'"'s lumen at the target location;

positioning one or more secondary electrodes such that a current transfer region of each of the one or more secondary electrodes is disposed within or adjacent to the target tissue and spaced laterally from the electrode elements of the expandable member so as to at least partially define a treatment volume; and

establishing an alternating electrical current flow between the electrode elements of the expandable member and the one or more secondary electrodes by delivering electrical current from at least one of (a) at least one of the one or more conductive electrode elements and (b) at least one of the one or more current transfer regions so as to preferentially destroy cancerous cells of the target tissue within the treatment volume relative to non-cancerous cells within the treatment volume.

21. The method of claim 20, wherein the alternating electrical current flow comprises a frequency of about 50 kHz to about 300 kHz.