Non-thermal ablation system for treating BPH and other growths

• US 9,211,155 B2
• Filed: 08/19/2009
• Issued: 12/15/2015
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: prostaCare Pty Ltd.
• Original Assignee: prostaCare Pty Ltd.
• Inventors: Fruland, Benjamin R., Kroll, Kai, Nelson, Tom A., Sundquist, Stephen K., Holtz, Michael C.
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US12/544,112
• Publication Number:
  US 20100049031A1
• Time in Patent Office: 2,309 Days
• Field of Search: 606/46, 606/48
• US Class Current: 1/1
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00148 with metal
• 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 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2018/1266 with DC current output
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 5/055 : involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61N 1/36071 : Pain

Abstract

Systems and methods for non-thermal ablation of tissue are provided. A non-implantable minimally invasive system for treatment of tissue in a body via direct current ablation is provided including a catheter, a plurality of electrodes for deployment through the catheter, a power source for applying power to the electrodes, and a fixation element for maintaining the catheter in a treatment position during treatment of the tissue. A minimally invasive method for treating tissue in a body via direct current ablation is provided including inserting a catheter into the body such that a portion of the catheter remains outside of the body, deploying a fixation element to fix the catheter in a treatment position, deploying a plurality of electrodes through the catheter, applying power to the plurality of electrodes, using the electrodes to apply a current to the tissue, and removing the catheter from the body.

Claims

1. A minimally invasive method for treating prostate tissue of a prostate in a body via direct current ablation from a urethra transecting the prostate, comprising:

inserting a catheter into the urethra, wherein a portion of the catheter remains outside of the body when the catheter is in a treatment position proximate the prostate;

deploying a fixation element associated with the catheter to fix the catheter in the treatment position;

deploying a plurality of electrodes through the catheter into the prostate, wherein at least one of the plurality of electrodes is deployed into at least one of a lateral posterior quadrant of the prostate tissue relative to the urethra, a lateral anterior quadrant of the prostate tissue relative to the urethra, or combinations of the prostate tissue relative to the urethra thereof, and wherein the electrodes are separated by an angular spacing;

determining input treatment parameters, wherein the input treatment parameters include a quantity of charge to the prostate tissue;

inputting the input treatment parameters into at least one of a power source and a processor;

using a power source to apply direct current between approximately 10 and 50 mA and a power of less than 3200 mW to each of the plurality of electrodes to deliver the quantity of charge, wherein the direct current applied is based on the input treatment parameters;

wherein upon application of the direct current, at least one of the plurality of electrodes imparts at least one of a high pH and a low pH in a treatment zone proximate to each electrode of the plurality of electrodes to create a necrotic zone in the treatment zone, wherein the application of the direct current is substantially non-thermal;

comparing a measured treatment parameter with at least one of the input treatment parameters; and

stopping the application of direct current to the treatment zone once the measured treatment parameter reaches the at least one input treatment parameter, wherein the at least one input treatment parameter is reached and the application of direct current to the plurality of electrodes is stopped between approximately 15 and 45 minutes with the catheter in the treatment position.

2. The minimally invasive method of claim 1, wherein the plurality of electrodes are the fixation element and deploying the fixation element and deploying the plurality of electrodes comprises one step of deploying the plurality of electrodes.

3. The minimally invasive method of claim 1, wherein the treatment zone is created between a bladder neck and a verumontanum of the prostate and wherein the minimally invasive method treats benign prostatic hyperplasia.

4. The minimally invasive method of claim 1, further comprising determining a prostate size to determine the input treatment parameters.

5. The minimally invasive method of claim 4, wherein an ultrasound, a cystoscopy, an MRI, a PET, or a CT is used to determine the prostate size.

6. The minimally invasive method of claim 4, further comprising determining a transverse width of the prostate to determine the input treatment parameters.

7. The minimally invasive method of claim 4, wherein the input treatment parameters include at least one of electrode insertion length, charge delivered, direct current magnitude, and treatment duration, and wherein determining the input treatment parameters comprises comparing information gathered from determining the prostate size against tabulated data.

8. The minimally invasive method of claim 1, wherein the input treatment parameters include at least one of electrode insertion length, charge delivered, direct current magnitude, and treatment duration.

9. The minimally invasive method of claim 1, wherein the fixation element is deployed in a urinary bladder and further comprising using ultrasound to verify positioning of the fixation element in the urinary bladder.

10. The minimally invasive method of claim 1, further comprising examining the body by cystoscopy or ultrasound to determine a number of electrodes of the plurality of electrodes to be deployed.

11. The minimally invasive method of claim 1, wherein the plurality of electrodes are deployed a distance of 14 to 22 mm into the prostate.

12. The minimally invasive method of claim 1, wherein the plurality of electrodes comprises between 2 and 12 electrodes.

13. The minimally invasive method of claim 1, wherein the plurality of electrodes comprises between 4 and 8 electrodes.

14. The minimally invasive method of claim 1, further comprising visualizing at least one of the catheter, the plurality of electrodes, and the fixation element during deployment or treatment and wherein visualizing is done by at least one of magnetic resonance, fluoroscopy, and ultrasound imaging.

15. The minimally invasive method of claim 1, further comprising increasing or decreasing the direct current delivered by the plurality of electrodes at a controlled ramp rate.

16. The minimally invasive method of claim 15, wherein the controlled ramp rate is between approximately 0.1 mA/sec and 10 mA/sec.

17. The minimally invasive method of claim 1, wherein the direct current is kept constant throughout the application of direct current by using voltage compliance to adjust for changing impedance between the plurality of electrodes during treatment.

18. The minimally invasive method of claim 1, wherein deploying the fixation element comprises inflating a balloon.

19. The minimally invasive method of claim 18, wherein inflating the balloon comprises inflating the balloon in a bladder.

20. The minimally invasive method of claim 1, wherein the necrotic zone is created with a temperature increase in the prostate of less than 8 degrees.

21. The minimally invasive method of claim 1, wherein the necrotic zone is created with a temperature increase in the prostate of less than that required to cause thermal damage to the prostate tissue.

22. The minimally invasive method of claim 1, further comprising using an indifferent electrode outside the body to complete a treatment circuit with the plurality of electrodes.

23. The minimally invasive method of claim 1, wherein the quantity of charge is between approximately 15 and 72 coulombs to each electrode of the plurality of electrodes.

24. The minimally invasive method of claim 1, wherein the quantity of charge is between approximately 24 and 48 coulombs to each electrode of the plurality of electrodes.

25. The minimally invasive method of claim 1, further comprising testing impedance of the plurality of electrodes in the prostate tissue to verify adequate contact.

26. A minimally invasive method for treating at least one treatment zone of prostate tissue of a prostate in a body via direct current ablation from a urethra transecting the prostate, comprising:

inserting a catheter into the urethra, wherein a portion of the catheter remains outside of the body when the catheter is in a treatment position proximate the prostate;

deploying a fixation element in a urinary bladder, the fixation element being operably coupled to the catheter and operating to fix the catheter in the treatment position;

deploying between approximately 4 and 8 electrodes a distance of approximately 14 to 22 mm into both lateral lobes of the prostate, wherein at least one of the between approximately 4 and 8 electrodes is deployed into at least one of a lateral posterior quadrant of the prostate tissue relative to the urethra, a lateral anterior quadrant of the prostate tissue relative to the urethra, or combinations of the prostate tissue relative to the urethra thereof, and wherein electrode pairs each consist of a subset of the between approximately 4 and 8 electrodes are separated from one another by an angular spacing;

determining input treatment parameters including a quantity of charge to be delivered to the at least one treatment zone;

inputting the input treatment parameters into at least one of a power source and a processor;

using a power source to apply a direct current between approximately 10 and 50 mA, a power of less than 3200 mW and the quantity of charge of between approximately 15 and 72 coulombs to each of the electrode pairs of the between 4 and 7 electrodes, wherein the direct current applied is based on the input treatment parameters;

wherein upon application of the direct current, at least one electrode of the between approximately 4 and 8 electrodes imparts at least one of a high pH and a low pH in a treatment zone proximate to the at least one electrode of the between approximately 4 and 8 electrodes to create a necrotic zone in the treatment zone, wherein the application of the direct current is substantially non-thermal;

comparing a measured treatment parameter with at least one of the input treatment parameters; and

stopping the application of the direct current to the treatment zone once the measured treatment parameter reaches the at least one input treatment parameter, wherein the at least one input treatment parameter is reached and the application of the direct current to the between approximately 4 and 8 of electrodes is done in approximately 15 to approximately 45 minutes with the catheter in the treatment position.

27. The minimally invasive method of claim 26, wherein Benign Prostatic Hyperplasia is treated between a bladder neck and a verumontanum of the prostate.

28. The minimally invasive method of claim 26, wherein determining the input treatment parameters includes determining prostate size.

29. The minimally invasive method of claim 26, wherein the method imparts a temperature increase in the prostate of less than 8 degrees.