Non-thermal ablation system for treating tissue

• US 9,597,145 B2
• Filed: 08/19/2009
• Issued: 03/21/2017
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: prostaCare Pty Ltd.
• Original Assignee: prostaCare Pty Ltd.
• Inventors: Nelson, Tom A., Kroll, Kai, Fruland, Benjamin R., Holtz, Michael C., Sundquist, Stephen K.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US12/544,134
• Publication Number:
  US 20100049188A1
• Time in Patent Office: 2,771 Days
• Field of Search: 606/34, 606/41, 606/48, 606/49
• 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 tissue in a body via direct current ablation comprising:

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

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

determining a treatment zone shape adjacent to the treatment position;

deploying a plurality of electrodes through the catheter into the tissue proximate the catheter and corresponding to the treatment shape;

determining treatment parameters for each of the deployed catheters extending from the treatment position, the treatment parameters including both dose (Coulomb/electrode) and time at a predetermined current level to deliver the dose, wherein the treatment parameters are determined to ablate the treatment zone shape based on direct current ablation by the electrodes;

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

applying current between about 10 and 100 mA of direct current per electrode and power having less than 3200 mW per electrode to deliver a charge to each of the plurality of electrodes using the power source, wherein the direct current applied is based on the 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 application of the direct current is substantially non-thermal; and

stopping the application of the direct current to the treatment zone once the necrotic zone corresponds to the treatment zone shape.

2. The minimally invasive method of claim 1, wherein the treatment zone shape corresponds to a lesion or a targeted area in the body.

3. The minimally invasive method of claim 2, wherein the treatment parameters further includes an electrode insertion length.

4. The minimally invasive method of claim 2, wherein an ultrasound, an endoscopy, an MRI, a PET, or a CT is used to determine the targeted area in the body.

5. The minimally invasive method of claim 1, further comprising visualizing the catheter, the fixation element, and the electrodes during deployment or treatment using magnetic resonance, ultrasound, or fluoroscopy.

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

7. The minimally invasive method of claim 1, wherein the treatment imparts a temperature increase in the tissue of less than that required to cause thermal damage to the tissue.

8. The minimally invasive method of claim 1, wherein a charge of 15 to 90 coulombs is delivered to each electrode of the plurality of electrodes.

9. The minimally invasive method of claim 1, wherein inserting the catheter into the body comprises inserting the catheter into a body lumen, and wherein deploying the plurality of electrodes includes deploying the plurality of electrodes in the tissue on both lateral sides of the catheter.

10. The minimally invasive method of claim 1, wherein inserting the catheter into the body comprises inserting the catheter into a body lumen, and wherein deploying the plurality of electrodes includes deploying the plurality of electrodes in the tissue on one side of the catheter.

11. The minimally invasive method of claim 1, wherein each of the electrodes forms a corresponding necrotic zone simultaneously.

12. The minimally invasive method of claim 1, wherein the dose corresponding to each one of the plurality of electrodes can be equal to or different than the dose corresponding to any other one of plurality the of electrodes.

13. The minimally invasive method of claim 1, wherein the treatment parameters further include a maximum current, and wherein the method further includes stopping the application of direct current if the maximum current is exceeded at any electrode.

14. The minimally invasive method of claim 1, wherein the predetermined current level and treatment position are selected such that the necrotic zone corresponds to the treatment zone shape after between 8 and 100 minutes.