Device for diagnosis and induced regeneration in tissues by means of therapeutic percutaneous electrolysis and electro-stimulation targeted via bipolar needle

Abstract

A device for use in the medical and hospital sector for the diagnosis, induced regeneration of tissue by means of therapeutic percutaneous electrolysis and targeted electro-stimulation based on the use of at least one bipolar needle that includes within a very small area of two electrodes located at the exterior and interior conductor of said bipolar needle, limiting the tissue to be treated within the bevel area of the needle without affecting the surrounding healthy tissue in which said bipolar needle is applied the necessary electrical signals for diagnosing the degree of degeneration and to calculate the necessary electrical charge for treating the damaged tissue while controlling said current in a manner that eliminates the contraindications that currently exist.

Claims

1. A device for diagnosis and induced regeneration of tissues using therapeutic percutaneous electrolysis and electro-stimulation targeted through a bipolar needle, and configured to allow self-diagnosis targeted on the area of damaged tissue to be treated without affecting the surrounding healthy tissue, the device comprising: at least one AC voltage generator that comprises an oscillator configured to generate a clock signal for a direct digital synthesizer (DDS), a control logic configured to apply a sinusoidal signal through the at least one AC voltage generator; a D/A converter which performs a digital/analogue conversion on the sinusoidal signal received from the AC voltage generator; a programmable amplifier configured to amplify the signal resulting from the digital/analogue conversion; an impedance adaptor configured to minimize an output error of the programmable amplifier; an I-V converter configured to convert the current that runs through the tissue into voltage, wherein said voltage is amplified by the programmable amplifier with the impedance adaptor, an A/D converter with low-pass filter for processing the signal measured from the voltage amplified by the I-V converter; a direct current generator and a memory, said memory configured to be processed by the control logic for generating a dosage of electric charge of the bipolar needle by the at least one direct current generator; a module for generating the targeted electro-stimulation, comprising at least one direct current converter, at least one ammeter and at least two bipolar needles, each bipolar needle comprising a central conductor and an exterior conductor, wherein the direct current converter is configured to generate a bipolar pulse signal that is applied to the tissue by the at least two bipolar needles, whereby the central conductor of each needle acts as an electrode and its exterior conductor acts as shielding, and the module is adapted for detecting current leakages that run through each electrode based on the at least one ammeter along with the control logic, and wherein the module is also adapted for detecting a potential difference between two electrodes and an impedance between the two electrodes by at least one voltmeter along with the control logic, wherein the control logic limits a maximum and a minimum value that stop the treatment.

2. The device of claim 1, further comprising a Teflon coating on at least one bipolar needle and at least two isolated monopolar needles.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) To complement the description provided and for the purpose of helping to better understand the characteristics of the invention, said description is accompanied by the following figures for illustrative but not limiting purposes:

(2) FIG. 1 is the global block diagram of the invention, displaying: (1) Module or control logic (2) Electronic diagnostic module (3) Treatment module (4) Electro-stimulation module (5) Multiplexer selector for diagnosis/treatment (25) Bipolar needle for diagnosis/treatment (26) Bipolar needles for targeted electro-stimulation

(3) FIG. 2 is a profile view and section of a bipolar needle, indicating: (6) section of the bevel of a bipolar needle (7 and 8) Electrodes of a bipolar needle

(4) FIG. 3 represents the block diagram of the electronic diagnosis module, illustrating: (1) Module or control logic (9) Alternating voltage generator (10) Programmable amplifier (11) Impedance adapter (12) Multiplexer selector of bipolar needle or calibration (13) Known impedance for equipment calibration (14) I/V converter (15) Amplifier (16) A/D converter (17) Algorithm for estimating electrical bioimpedance (18) Bioimpedance comparer (25) Bipolar needle for diagnosis/treatment

(5) FIG. 4 illustrates the block diagram of the electrolysis treatment module, indicating: (1) Module or control logic (19) Source of direct current (20) Intensity meters (anode and cathode) (21) Voltage meter (25) Bipolar needle for diagnosis/treatment

(6) FIG. 5 represents the block diagram of the electro-stimulation module, illustrating: (1) Module or control logic (22) Source of direct current (23) Intensity meters (24) Voltage meter (26) Bipolar needles for electro-stimulation

DESCRIPTION OF A PREFERRED IMPLEMENTATION MODE

(7) Describing by way of example a preferred form of implementation of the electro-medical device destined for the treatment of degenerated tissues of the neuromusculoskeletal system, the purpose of the invention being independent from the materials used for manufacturing the device, as well as the methods of application and all accessories that may be presented, provided they do not affect its essential nature.

(8) This invention uses at least one bipolar needle that comprises in a very small area, the bevel (6), two electrodes (7 and 8) located at the exterior and interior conductor of said bipolar needle, FIG. 2, limited to the bevel area that allows to target the area comprising the damaged tissue to be treated without affecting the healthy tissue. Also the fact that the healthy tissue does not interfere in measuring the electrical bioimpedance, allows to obtain lower values for said electrical bioimpedance, given that the electrical bioimpedance of the healthy tissue is not added and thus, avoiding the need for applying high voltages for generating the necessary electrical charge for treating the damaged tissue.

(9) This is why there are means for performing a self-diagnosis (2) of the degree of degeneration of the tissue and to subsequently calculate the treatment (3) by electrolysis, where said means are based, by means of at least one control logic (1) in the analysis of electrical bioimpedance shown by the tissue upon applying a sinusoidal signal of variable frequency by means of at least one alternating voltage generator (9) that comprises an oscillator that generates a clock signal towards a direct digital synthesizer (DDS) and a D/A converter for converting said digital signal into analogue; a programmable amplifier stage (10) responsible for amplifying the signal resulting from the digital/analogue conversion and an impedance adaptor (11) for minimising the output error of the programmable amplifier stage; an I/V converter (14) for converting into voltage the current running through the tissue to be diagnosed. Upon applying said sinusoidal signal from the alternating voltage generator (9) through a bipolar needle (25), this provides a more accurate action on the damaged area of the tissue, without affecting the healthy tissue surrounding the damaged area, given that said bipolar needle (25) comprises on the same bevel (6) two electrodes (7 and 8) limiting the tissue to be examined in the area close-by said bevel (6).

(10) Upon applying said sinusoidal signal through the bipolar needle (25) to the tissue to be diagnosed, an electrical current runs through the tissue that is located between the two electrodes (7 and 8) located at the bevel (6) of the bipolar needle (25), where the intensity will depend on the electrical bioimpedance of the tissue that is examined. The electrical bioimpedance may vary depending on the excitation frequency, on the different types of tissue and their condition. Said induced current which flows between the two electrodes (7 and 8) of the bipolar needle (25) is measured allowing to calculate the complex electrical bioimpedance of the examined tissue and its dissipation factor by means of Ohm's law.

(11) $\begin{array}{cc}\mathrm{Generator}\text{:}& V=V_O*\mathrm{sen}\left(2\mathrm{ft}\right)\\ \mathrm{Current}\text{:}& I=I_O*\mathrm{sen}\left(2\mathrm{ft}+\right)\\ \mathrm{Impedance}\text{:}& Z=\frac{V}{I}={}_e+j{\mathrm{��}}_m\\ \mathrm{Dissipation}\mathrm{factor}\text{:}& D=\frac{{}_e}{{\mathrm{��}}_m}\end{array}$

(12) The voltage obtained by means of the I/V converter (14) is amplified by a programmable amplifier stage (15) with impedance adapter and an A/D converter (16) with low-pass filter for processing the signal. As of said processed signal, an algorithm (17) is applied which allows to calculate the complex impedance and the dissipation factor of the diagnosed tissue where the results are stored on at least one memory device for subsequent comparison (18) with the values obtained for a sample of healthy tissue from the same patient, control sample, or with values obtained from several clinical trials for calculating the degree of degeneration of the measured tissue and the electrical charge required for determining the treatment module (3) using electrolysis for stimulating the regeneration of the damaged tissue through the same bipolar needle (25) managing to apply it only to the damaged area of the patient's tissue without affecting the healthy tissue surrounding the damaged tissue as described.

(13) There are plans to provide means for calibrating the device to avoid errors when taking the bioimpedance readings by means of a multiplexer (5) controlled from the control logic (1) that will allow to select performing the diagnosis via the bipolar needle (25) or performing the calibration via at least one known value calibration impedance (13) that would allow to know the impedance error present in the device, which will be compensated during the measurement of the bioimpedance of the examined tissue.

(14) There are means for treatment via electrolysis, selected by means of a multiplexer (5) from the control logic (1), which applies the electrical charge calculated for generating the electrolysis targeted on the affected tissue without affecting the surrounding healthy tissue and avoiding the need for applying high voltages, where said means comprise at least one source of direct current (19) that applies the calculated electrical charge to the damaged tissue via the electrodes (7 and 8), anode and cathode, which are located in the bevel area (6) of a bipolar needle (25). The means are provided for controlling said electrical charge based on at least one ammeter (20) that, along with the control logic (1), is responsible for limiting the electrical charge provided and for detecting a current leakage controlling the current that runs through each electrode (7 and 8), anode and cathode, located at the bevel (6) of said bipolar needle (25). This allows to compare both currents to determine whether they exceed a safety level threshold established by the control logic (1) and for the treatment (3) to be stopped. There is also at least one voltmeter (21) that, along with the control logic (1), detects the difference in potential between the two electrodes (7 and 8), calculating the impedance there is between both electrodes during the treatment, so if the calculated impedance exceeds the maximum or minimum levels established by the control logic (1) the treatment (3) will be stopped, eliminating existing contraindications in patients with endoprosthesis and osteosynthesis, patients with pacemakers or any electronic implant, patients with heart problems, pregnant women, patients with malignant tumours and/or patients with thrombophlebitis due to the improved focusing of the treatment and the control of possible current leakages.

(15) Due to using the bipolar needle (25) and the safety means mentioned above, the tissues affected by the electrical charge are limited to the area close to the bevel (6) of the bipolar needle (25), completely limiting said electrical charge via the damaged tissue, without affecting the surrounding healthy tissue, avoiding the need for applying high voltages and eliminating the contraindications present in current devices.

(16) It has means to generate the targeted electro-stimulation (4) aimed at stimulating the sensory nerve fibres of the affected tissue which are applied from the control logic (1) to pulsed bipolar signals through at least two bipolar needles (26), working these in a unipolar manner using the central conductor of each needle as an electrode and the exterior conductor as shielding.

(17) Said pulsed signals are generated by at least one direct current generator (22) that generates a current signal pattern formed by pulses of equal amplitude and duration, but out of synch by 180 for the average value of the signal to be null and avoid the occurrence of any phenomena of electrolysis. It also has means based on at least one ammeter (23) and a voltmeter (24) which, along with the control logic (1), controls said pulsed signal based on the measurement of the current running through each electrode and on the detection of a current leakage by measuring the current that runs through each electrode located in the central conductor of each needle in a manner that allows to compare both currents to determine whether a safety level threshold established by the control logic (1) is exceeded and stops the electro-stimulation (4), and also in detecting the difference in potential between the two electrodes and thus calculate the impedance present between both electrodes during the stimulation, so if the calculated impedance exceeds certain maximum or minimum levels established by the control logic, the electro-stimulation (4) is stopped and this eliminates the contraindications in patients described above.

(18) Also having foreseen the use of at least two bipolar needles and/or for at least two isolated monopolar needles, with a Teflon coating, for diagnosis, treatment and electro-stimulation.