GB2374533A

GB2374533A - Arthritis Electro-therapy device

Info

Publication number: GB2374533A
Application number: GB0109300A
Authority: GB
Inventors: Jo Joynt
Original assignee: SUPERBLUE Ltd
Current assignee: SUPERBLUE Ltd
Priority date: 2001-04-17
Filing date: 2001-04-17
Publication date: 2002-10-23
Also published as: AU2002249422A1; GB0109300D0; WO2002083235A3; WO2002083235A2

Abstract

A device for treating inflammatory diseases such as rheumatoid arthritis comprise a single phase (DC) micro-current applied to the surface of the body of the patient in the vicinity of the symptoms of the inflammatory disease. More particularly, a direct current of approximately 10 žA to 100 žA having a frequency of between 100 and 500 Hz is applied to the area of the patient's body being treated. As a result of the application of this micro-current, it is postulated that this particular micro-current treatment enhances the secretion of transforming growth factor - Beta in the cells of the patient, especially in the area being treated. The device may be controlled by a microprocessor and a treatment session may be programmed for a 20 minute period. If a high resitance is detected between the treatment electrodes of the device, a warning beeper alarm sounds.

Description

MICRO-CURRENT DEVICE FOR TREATING INFLAMMATORY DISEASES AND CONDITIONS The present invention relates to electrotherapy and, more particularly through the application of a micro-current, to treat inflammatory conditions such as rheumatoid arthritis in humans.

Humans and animals have been treated with electrical stimulation in the past. One form of electrical stimulation has entailed applying multistages or multi-phases of micro-currents to a patient where each stage includes a different range of microcurrents and frequencies. See, for example the disclosure found in U. S. Patent No. 5,935, 156. While such multi-stage micro-current treatments may be effective for certain illnesses and conditions, it has been determined that such multi-stage micro-current treatments are not effective for other medical conditions.

One such condition that appears to be unaffected by multi-stages of micro-current treatment is inflammatory diseases and conditions such as rheumatoid arthritis and osteoarthritis. These are, of course, painful and debilitating diseases that affect millions of people all over the world. While the pharmaceutical industry has, itself, made significant strides in the developing medications that are effective against inflammatory diseases and conditions, these conditions still persist among a significant portion of our population, and it is clear that medicines alone are not totally effective for some patients with inflammatory diseases such as rheumatoid arthritis.

The present invention entails a micro-current device for treating inflammatory diseases and conditions such as rheumatoid arthritis and osteoarthritis. The device produces a single stage micro-current to the patient. In the case of the present invention, the single stage micro-current includes the application of a current of approximately 10 pA-100 pA at a frequency of approximately 100- 500 Hz. The period of application can vary but it is contemplated that the period of treatment be for approximately twenty minutes, once or twice daily.

It is postulated that this single stage application of a micro-current to the patient's body will significantly enhance the secretion of transforming growth factor-Beta (TGF-P). TGF-P is an important regulator of cell-medicated inflammation and tissue regeneration [Derynck R, in: A. Thomson (ed), The Cytokine Handbook, Academic Press, 1994, pp. 319- 342]. Accordingly, it is contemplated that the enhanced secretion of TGF-ss in the cells of the patient, especially in the area of the body affected by the inflammatory disease or condition, significantly contributes to rectifying the conditions that give rise to such inflammatory disease and conditions.

Other objects and advantages of the present invention will become apparent and obvious from a study of the following description.

Figure 1 is a schematic illustration of the micro-current device of the present invention.

As noted above, the present invention entails a

micro-current therapy for treating inflammatory diseases and conditions such as rheumatoid arthritis and osteoarthritis. Essentially the method of treatment entails directing electrical signals to the body of a patient via a pair of electrodes. In the case of rheumatoid arthritis, the electrode pair would preferably be placed in close vicinity to the area of the body experiencing symptoms of rheumatoid arthritis. For example, for treating a rheumatoid arthritic joint, the pair of electrodes could be placed on opposite sides of the affected joint.

Thereafter, the micro-current is directed to the joint via the electrode pair.

It is important to appreciate that the present treatment for inflammatory diseases and conditions is a single stage or single phase process or treatment.

By single stage or single phase, it is meant that the treatment essentially entails one particular microcurrent range being applied to the body for a particular time period. This should be contrasted with multi-stage treatment processes such as that disclosed in U. S. Patent No. 5,935, 156. The disclosure of this patent is expressly incorporated herein by reference.

The single stage process contemplated by the present invention entails directing a direct current of approximately 10 pA to 100 pA at a frequency between 100 and 500 Hz. Again, this micro-current is directed to the skin of the patient and is directed to the body area that suffers from the inflammatory disease or conditions. While the micro-current may vary within this range, it is believed that a preferable current treatment would entail applying

approximately 30 pA at approximately 300 Hz.

The particular waveform of the applied microcurrent may vary. However, one waveform for this single stage treatment process may be a modified square wave. In this regard, the square wave may be characterised by a rapid rise to a high current level, followed by a holding period at that high current level. The other portion of the modified square wave entails a gradual decay from the high current level to a level near zero. The waveform then repeats for the next period. In one embodiment, the first portion of the waveform could occur for approximately one-third of the period, and the second portion of the waveform could occur during the remaining two-thirds of the period. Again, it must be emphasized that the abovedescribed modified square wave is simply one waveform that may be utilised in directing the single stage micro-current therapy discussed above. In other words, other waveforms may be suitable.

The particular periods for treatment may vary from patient to patient depending on the particular inflammatory disease or condition being treated, how severe the disease or condition is determined to be, and the particular treatment stage that the patient finds himself or herself in at the time. Generally, the single stage treatment referred to above is conducted for a period of twenty minutes. This treatment can be repeated periodically, again depending on the condition of the patient and the stage that one finds the inflammatory disease or condition in at the time. However, in many cases, the single stage treatment discussed above would be applied for twenty minutes at a time, twice daily.

Patients suffering from rheumatoid arthritis and osteoarthritis reported numerous benefits from using the single stage micro-current therapy described above. Among the benefits found in treating both rheumatoid arthritis and osteoarthritis were that the patients were able to reduce use of prescribed drugs for the respective inflammatory diseases. Further, the single stage micro-current therapy was effective in reducing swelling, improving mobility, and improving the overall quality of life of the patient.

It is postulated that this single stage microcurrent treatment results in the enhanced secretion of cytokines and, particularly, transforming growth factor-Beta. (TGF-P). TGF-P is known to be an important regulator of cell-medicated inflammation and tissue regeneration.

An investigation was conducted with respect to the production of TGF-ss by the human monocytic cellline U937 where the cell-line was exposed to various micro-currents. In particular, the test, or investigation, looked at the effects of three different micro-currents on the secretion or production of TGF-ss. The three different microcurrents were considered in the context of three stages or phases. The first phase micro-current constituted 30 pA at a frequency of 300 Hz. The phase two micro-current was a nonpulsed direct galvanic current of 300 pA. Finally, the third phase constituted a square waveform having a current of 40 pA at a frequency of 3 Hz.

The U937 cell-line used in the test is a human monoblastic, promonocytic cell-line, originally

derived from a patient with histiocytic lymphoma.

U937 cells were maintained at 3-9 x 105 cells/ml in RPMI-1640 medium supplemented with 2mM L-glutamine, 100 units/ml penicillin, 100 ug/ml streptomycin and 0. 01M HEPES (Life Technologies Limited, Paisley, UK) containing 10% fetal calf serum (FCS) (referred to as 'complete medium'). U937 cells were induced to differentiate in the monocytic lineage by treatment with phorbol myristate acetate (PMA). The cells were incubated for 48-60 hours at 3 x 105/ml in complete medium containing 10% FCS and 15ng/ml PMA.

PMA-treated U937 cells were washed and transferred to six-well tissue culture plates (Nunclon, Life Technologies Limited) at 3 x 105 cells/ml of complete medium, with 3 ml/well. An electrode plate was manufactured to fit onto a sixwell plate with two cadmium-coated nickel/bronze electrodes inserted into each well, with the electrode tips immersed 1mm in to the culture medium. The positive and negative leads from a micro-current source were connected to the insert electrodes, and current applied. The cells in different wells were exposed to different phases of micro-current, either alone or sequentially, for either 5 minutes or 10 minutes per phase. (The negative controls were wells containing cells that were not exposed to microcurrents, and wells containing complete medium but no cells). Following electrical stimulation, the electrode plate was replaced with the lid of the tissue culture plate and the cells incubated at 370C in 5% carbon dioxide. One ml aliquots of the cultures were removed after 24 48 and 72 hours for determination of cell numbers and viability (by trypan blue exclusion). The supernatants of these aliquots

were stored at-20 C for subsequent analysis of cytokine content.

Transforming growth factor beta-1 (TGF-ssl) was assayed in the U937 culture supernatants using DuoSet ELISA Development System kits (R & D Systems). For the detection of TGF-ssl, the culture supernatants were diluted 1/10 in phosphate buffered saline to reduce the contribution of the TGF-ssl, in the 10% FCS in the culture medium. Latent TGF-ss was activated by treatment with IN HCl followed by neutralisation with 1.2N NaOH/HEPES. The assays were performed according to the manufacturer's instructions. The results were recorded as optical densities at 450nm. Statistical comparisons were performed using the Wilcoxon matched pairs test.

U937 cells, which had been pre-treated with PMA to induce monocytic differentiation, were electrically stimulated by all three micro-current phases generated by the micro-current source and culture supernatant collected after a further 48 hours of culture. This did not appear to have a significant effect on cell numbers or viability. Culture supernatants of PMA pre-treated, non-electrically stimulated U937 cells served as controls, since PMA treatment itself induces some expression of TGF-ss.

Five minutes of only phase one (30 pA at a frequency of 300Hz) treatment induced significant enhancement of TGF-ss secreted by the U937 cells (median 124. 5% of control, p=0.03). There was no significant effect on TGF-ss secretion by treatment with phase two micro-current alone (median 95.7% of control, p=0.81) ; phase three (40 pA at a frequency of

3Hz) alone (median 79. 5% of control, p=0.81) ; or phases one, two and three applied consecutively for 5 minutes each (median 83% of control, p=0.47). Phase one treatment also induced the highest secretion of TGF-ss by PMA pre-treated U937 cells into culture supernatants collected 24 hours after either 5 or 10 minutes of electrical stimulation.

The results presented here indicate a single stage micro-current treatment can stimulate the secretion of certain cytokines by human cells of the monocyte/macrophage lineage. In particular, 5 minutes exposure to the phase one micro-current generated by the micro-current source (Medeor waveform, 30 pA 300 Hz) significantly enhanced the secretion of TGF-P by U937 cells. The sequential application of the other two micro-current phases did not enhance TGF-ss secretion.

Now turning to the drawing, Figure 1 shows a micro-current device that includes a primary channel 30. It is appreciated that the micro-current device and its components would be enclosed in a housing.

Figure 1 shows the basic electronic operating configuration of the primary channel 30. The primary channel includes a primary electrode port 27, a microprocessor 32, LEDs 34, a beeper 36, and a waveform generator 40. Connected to the primary channel is an on/off switch 22 as well as the primary electrodes 50, and a power supply 60. The on/off switch 26 is preferably a push button type and resistor multiplexed into an analog to digital port of the processor 32. The primary electrodes 50 can be of any type known in the art and the particular details

of the electrodes 50 are not dealt with here in detail because such is not per se material to the present invention.

Power supply 60 supplies the microprocessor 32 and the primary channel 30 with power. Power supply 60 includes a primary battery 62 and an optional or secondary battery 64. The primary battery 62 supplies power to the primary channel 30. The secondary battery 64 may provide power to other channels that might be incorporated into the device of the present invention. The actuation of the device via the on/off switch 22 activates the power supply 60, which in turn controls the on/off state of the battery 62. In a preferred embodiment the power supply 60 converts the battery voltage to a supply logic level of 5 volts.

The microprocessor 32 controls and/or monitors voltage, the input switch 26, status of the LEDs 34, beeper 36 and the waveform generator 40. The waveform generator receives signals from the microprocessor 32 and transforms the signals into an appropriate microcurrent waveform, and supplies the waveform to the primary electrode port 27. From the primary electrodeport 27, the primary electrode 50 direct a microcurrent from the device to a part of a patient's body that is to be treated for rheumatoid arthritis or osteoarthritis.

The primary channel output from the device is to the electrodes 50. The electrodes 50 are supplied electrical signals from the waveform generator 40 via the primary electrode port 27. The status of the device is indicated by LEDs 34 which are controlled by the microprocessor 32. Also the device then includes

a warning beeper 36 which is controlled by the microprocessor 32. The warning beeper 36 is activated when the device detects high resistance between the electrode 50 of an electrode pair, indicating that the electrodes 50 are making proper contact to a portion of the patient's body to be treated. Such a situation is called a"pad open condition".

To activate the device, the on/off switch 22 is placed in the "on" position. Once energised, the microprocessor 32 is operative to produce an output according to pre-programming. Essentially, the microprocessor 32 sends the appropriate signals to the waveform generator 40 to cause the appropriate signals to be sent to the electrodes 50. Microprocessor 32 also instructs the LED 34 and the beeper 36 to indicate the appropriate status of the device. Once the rheumatoid arthritis or osteoarthritis treatment is completed, the device is turned off.

In the present case, the device is preprogrammed to provide a treatment that is particularly designed to treat rheumatoid arthritis and osteoarthritis. In particular, the microprocessor is programmed to provide a single stage micro-current treatment to a particular area of the body. Essentially, the device is preprogrammed to output a direct current between 10 pA and 100 pA having a frequency of between 100 and 500 Hz. The duration of the treatment can also be preprogrammed into the microprocessor 32. For example, the device may be provided with buttons or switches that are operative to actuate the device for a certain time period. In this regard, the microprocessor 32 can be preprogrammed to provide one or more micro-current levels within a single stage

micro-current treatment. For example, by means of a switch or button the user can select a particular micro-current level as well as a particular frequency. frequency. For example, the device may be provided with a button or switch that permits the device to provide an output of approximately 30 pA at a frequency of approximately 300 Hz.

The particular waveform of the micro-current can vary. For example, the waveform may assume the form of a modified square wave, or a waveform that includes a non-repeating ramp period, followed by a level period, or a square wave of a particular duty cycle.

From the foregoing discussion, it is seen that the use of a single phase or single stage microcurrent treatment can have a therapeutic value in treating inflammatory diseases such as rheumatoid arthritis and osteoarthritis. As noted above, it is postulated that by directing a single phase or single stage micro-current to the area of the human body exhibiting inflammatory symptoms results in relieving pain and reducing swelling while improving a patient's mobility.

The present invention may, of course, be carried out in other specific ways than those herein set forth without departing from the scope and the essential characteristics of the invention. The present embodiments are therefore to be construed in all aspects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.

Claims

CLAIMS 1. A micro-current device for treating rheumatoid arthritis comprising: a power source; and a micro-current generating system for generating a micro-current and directing the micro-current to an area of the body that lies in the vicinity of the rheumatoid arthritis symptoms and wherein the microcurrent treatment applied to the body area includes a direct current between 10 pA and 100 pA having a frequency between 100 and 500 Hz.
2. The micro-current device of claim 1 wherein the micro-current generated by the device and applied to the body area enhances the secretion of transforming growth factor-Beta (TGF-P).
3. The micro-current device of claim 2 wherein the micro-current generating system includes a microprocessor programmed to produce a micro-current of approximately 30 pA at a frequency of approximately 300 Hz to the area of the patient's body.
4. The micro-current device of claim 1 wherein the micro-current generating system includes a microprocessor programmed to direct the micro-current treatment to the body area for a period of approximately 20 minutes.
5. The micro-current device of claim 1 wherein the micro-current generating system includes a microprocessor that is programmed to produce a single stage micro-current treatment to the body where the micro-current produced along with the frequency of the

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micro-current is generally constant for a selected treating period.
6. The micro-current device of claim 1 wherein the device is further effective to produce a micro-current for treating osteoarthritis.
7. The method of treating a patient of claim 6 wherein the applied micro-current enhances the secretion of transforming growth factor-Beta (TGF-p).