Method for treating benign prostate hyperplasia

• US 9,486,625 B2
• Filed: 02/23/2015
• Issued: 11/08/2016
• Est. Priority Date: 08/08/2011
• Status: Active Grant

• Current Assignee: Medamp Electronics LLC
• Original Assignee: Medamp Electronics LLC
• Inventors: Ruse, Richard B., Crawford, E. David, Nabors, William L. Sr., Bohanan, Scott J.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): AVIGAN, ADAM JOSEPH
• Application Number:
  US14/628,613
• Publication Number:
  US 20150196351A1
• Time in Patent Office: 624 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• 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 2090/3925 ultrasonic
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02

Abstract

A method and apparatus for treating a condition in a patient such as BPH, irretractable infection, cyst, fibroid, or any mass such as prostate or breast cancer, skin cancer, melanoma, or any other soft tissue cancerous or benign mass, employs a unique, three-dimensional software-controlled electronic amplifier array using arbitrary waveforms that dynamically and proportionally steer electrical currents by using two or more current vector paths, sequentially or simultaneously, through a defined area containing electrically-conductive ionic solutions so as to obtain 100% thermal heating or hyperthermia through the defined area. The condition is treated or a mass is destroyed with a minimally-invasive treatment which requires no radiation or chemotherapy which could be harmful to the patient.

Claims

1. A method of treating benign prostate hyperplasia (BPH) within a patient'"'"'s body, which comprises

positioning three or more electrode shafts comprising at least two electrode bands on each shaft in or around a patient'"'"'s prostate gland to create a defined area;

delivering signals that are DC arbitrary waveforms or AC arbitrary waveforms of a frequency of up to about 1 KHz to the electrode bands; and

proportionately varying voltage amplitude and pulse-widths between the three or more electrode shafts to dynamically steer and focus ionic current vectors to the defined area to create and steer a hot zone in three dimensions within the defined area to resistively heat the defined area to alleviate BPH.

2. The method of claim 1, wherein three electrode shafts are used and each shaft has three electrode bands.

3. The method of claim 1, wherein the defined area is heated sufficiently to kill or inactivate cells within the defined area.

4. The method of claim 1, wherein the current vectors create a hot zone within the defined area which is the summation of intersecting current vectors to induce hyperthermia.

5. The method of claim 1, wherein the current vectors substantially and uniformly elevate the defined area to a temperature of from about 48°

C. to about 50°

C.

6. The method of claim 1, wherein the defined area and percentage of volume within the prostate is treated using 3 or 4 electrode shafts that define an energy field whereby the entire volume of tissue within the energy field defined by the electrodes is heated to systematically define an area to destroy or inactivate the cells contained within the defined area, thereby causing the area to scar down or atrophy or otherwise soften or lose its high tensile tone, which in turn reduces pressure on the urethra to alleviate symptoms of BPH.

7. The method of claim 6, wherein scarring down, atrophy, softening, or loss of high tensile tone of the prostate and alleviation of symptoms of BPH is accomplished without prescription drugs or surgery.

8. The method of claim 1 which comprises use of three or more electrode shafts, each electrode shaft having two or more platinum bands or contact points and each electrode having a thermal sensor.

9. The method of claim 1, wherein voltage amplitude and pulse-widths between electrodes can be proportionately varied to dynamically shift or steer current vectors anywhere in the defined area in three dimensions, without moving the electrodes, to ensure proper resistive heating.

10. The method of claim 1, wherein the ionic current vectors intersect to generate controlled and focused hyperthermia.

11. The method of claim 1, wherein ionic current vectors are electronically steered to uniformly elevate areas of the mass to a temperature of from about 48°

C. to about 50°

C.

12. The method of claim 1, wherein three or more electrode shafts with electrode bands will be capable of being inserted into holes within a grid block as a mechanical guide while an ultrasound image is viewed simultaneously, to treat the defined area.

13. The method of claim 1, wherein a processor-controlled electronic amplifier array generates signals to dynamically and proportionally steer current vectors under software control using a computer.

14. The method of claim 1, wherein each electrode shaft has at least one thermal sensor to provide feedback to the processor.

15. The method of claim 14, wherein the processor samples and analyzes thermal data from the thermal sensors and manages the energy delivered by adjusting voltage amplitudes and pulse-widths of waveforms delivered to the electrode bands.

16. The method of claim 1, wherein the signals delivered are instructive signals generated by a processor, are received in a differentially driven amplifier array configured to receive such signals, and are delivered to the electrode bands, and

wherein the processor is configured to control the amplifier array to proportionately vary the voltage amplitude of signals to the electrode bands to dynamically steer and focus ionic current vectors to create and steer a hot zone anywhere in three dimensions within the defined area.