Device for verifying the electrical output of a microcurrent therapy device

A device and method verifies the electrical output of a microcurrent therapy device. The current and/or voltage of an electrical pulse, being supplied to an electrode adapted to contact tissue, is measured by a control unit. The current and/or voltage is supplied by the control unit according to a predefined waveform. Any difference in the current or voltage of the electrical pulse being supplied with respect to the current or voltage of the predefined waveform is detected.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the U.S. national stage application of International Application PCT/GB2009/002728, filed Nov. 20, 2009, which international application was published on May 27, 2010, as International Publication WO2010/058184 in the English language. The International Application claims priority of Application No. GB0821280.5, filed Nov. 20, 2008.

FIELD OF THE INVENTION

The present invention relates to a method and device for verifying the electrical output of a microcurrent therapy device, in particular for verifying that the electrical output is being correctly supplied.

BACKGROUND OF THE INVENTION

Microcurrent therapy devices are well known in the prior art. Such devices are used in the treatment of animal or human tissue, for example damaged skin tissue which might have wounds or muscle tissue that might be torn. Typically, such devices comprise a control unit which is connected to electrodes. The control unit supplies a current, typically in the range of 0 to 1000 μA through electrodes which are in contact with the damaged tissue or overlaying tissue. There may be two electrodes, namely a positive and a negative electrode, and the control unit comprises a current generator which supplies current at a particular level from one electrode to the other electrode. The current that is being supplied has a particular predefined waveform, for example an analogue alternating current (AC) waveform or a square-tooth pulse waveform, having both positive and negative components at particular times in a cycle. The current generator attempts to regulate current at a level demanded by the predefined waveform, which may be user-selected. This is done by controlling the voltage across the electrodes. The voltage is varied because the resistance to current flow through tissue varies according to a number of factors, for example tissue thickness, distance between the electrodes, resistance to electrical current and contact between the electrodes and tissue.

The present applicant has previously applied for and been granted United Kingdom patent nos. 2406519, 2432323, 2432320, 2432321 and 2432322 relating to devices having control units which output various forms of waveforms. These waveforms have been determined to be significant in the repair of damaged tissue through the supply of microcurrent through the tissue. The disclosure in the aforementioned patents is incorporated herein by reference.

The control unit and electrodes are normally supplied and packaged as separate components; the control unit must be connected to electrodes prior to use. In this regard, the electrodes must be placed into good electrical contact with the tissue to ensure effective treatment. These tasks are often undertaken by the individual requiring treatment or another unskilled operator of the device, for example someone that is not a medical practitioner. This often means that the device may not end up being correctly connected to the electrodes or the electrodes may not end up being placed in good contact with the tissue to provide effective treatment.

SUMMARY OF THE INVENTION

The present invention, as defined in the appending claims, aims to solve the aforementioned problems. The present invention provides an indication via the control unit as to whether the device has been correctly connected to electrodes and placed into contact with tissue for effective treatment to take place.

In the first aspect of the present invention, there is provided a microcurrent therapy device, comprising:a control unit adapted to output an electrical signal to an electrode adapted to contact tissue, the current and/or voltage of the electrical signal being supplied according to a predefined waveform,wherein the control unit is further adapted to measure the current and/or voltage of the electrical signal being supplied and detect a difference in the current or voltage of the electrical pulse being supplied with respect to the current or voltage of the predefined waveform.

Thus, any variation in the voltage or current supplied to tissue can be detected and used to indicate an error in the device and/or electrode configuration.

In a second aspect of the present invention, there is provided a method for verifying the electrical output of a microcurrent therapy device, comprising:measuring the current and/or voltage of an electrical pulse being supplied to an electrode adapted to contact tissue, the current and/or voltage being supplied according to a predefined waveform;detecting a difference in the current or voltage of the electrical pulse being supplied with respect to the current or voltage of the predefined waveform.

In a third aspect of the present invention, there is provided a tissue dressing comprising the aforementioned microcurrent therapy device. Thus, any variation in the voltage or current supplied to tissue can be detected and used to indicate an error in the integrated device/tissue configuration.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1shows a microcurrent therapy device1according to the present invention. A control unit100is connected via first and second output wires101a,101bto first and second input wires102a,102bof first and second electrodes103a,103bvia connector104.FIG. 2shows a schematic representation of the internal components of the control unit100ofFIG. 1.

Electrical current is output by the control unit100to pass along a first output wire101athrough a first connector104a, along a first input wire102ato the first electrode103a, through tissue located against the electrodes103a,103band into the second electrode103b, along the second input wire102b, through a second connector104b, along the second output wire101band into the control unit100. The direction of current flow can be in either direction and, depending upon the direction of current flow, one of the electrodes103a,103bwill be a source electrode from which current is output into tissue, whilst the other electrode will be a receiving electrode into which current is received from the tissue. The control unit100is configured to pass the current at a predefined current level from the first electrode103ato the second electrode103bby controlling the voltage so that the supplied current is set at the predefined level. The predefined levels of current are set according to predefine current levels stored in treatment programs contained in memory in the control unit100. The control unit100and electrodes103a,103bmay be integrated into a single integrated unit, for example into a dressing which can be applied to tissue.

A microcontroller202is supplied with electrical power from a battery205with supply voltage Vs via a power supply204. The microcontroller202is connected to a current generator206to control the current level that is output to the electrodes103a,103b. The current generator206is also connected directly to the power supply204to receive electrical current at the output voltage of the power supply204. The current generator206outputs a particular level of current between the electrodes103a,103bto the microcontroller202. A push button switch208is connected to the power supply204and microcontroller202to control the on/off status of the control unit100. A light emitting diode (LED)210is also connected to and controlled by the microcontroller202to provide visual feedback to a user of the therapy device1.

The current generator206is configured to output electrical current between the electrodes103a,103bat a level demanded of it by the microcontroller202. The microcontroller202comprises memory stored with pre-defined programs of waveforms which have been deemed to be effective in treating damaged tissue. Thus, the microcontroller202demands a particular current level to be output from the current generator206according to the pre-defined programs which are stored within the microcontroller202. Examples of programs which are effective in treating damaged tissue are described in the present applicant's co-pending United Kingdom patent nos. 2406519, 2432323, 2432320, 2432321 and 2432322, which are herein incorporated by reference.

FIG. 3shows simplified waveforms of an idealised demanded current waveform301and an actual supplied current waveform302which passes between the electrodes103a,103b. As shown inFIG. 3, the idealised waveform301is a square-tooth waveform having a particular amplitude X and frequency f of pulse P. Thus, the duration of the supplied current over a particular time period is fixed for a particular level of current being supplied. As mentioned above, the actual current that passes between the electrodes is measured by the current generator206and this information is passed to the microcontroller202. The current generator206comprises a feedback loop to vary the voltage supplied across the electrodes to keep the current at the demanded level for the particular time period.

The impedance presented by tissue and electrodes103a,103bis approximated to have resistive and capacitive components. Providing good electrical contact is made between the electrodes and the tissue, the electrodes103a,103bwill be able to promote efficient ion creation in the tissue and the current generator206can maintain current according to the idealised waveform. However, if the electrodes103a,103bare not properly connected to the current generator206or the electrodes103a,103bare not in effective contact with the tissue, the impedance presented by the electrodes103a,103band tissue combination will be higher than expected and the current generator206will attempt to increase the voltage across the electrodes103a,103bto keep the current at the pre-defined level.

The supply voltage Vsfrom the battery205is fed to the power supply204. The supply voltage has a maximum level VS. The power supply204may (or may not) boost the supply voltage Vsto a higher level. The power supply therefore has a maximum level of output voltage (which may be higher than the supply voltage Vs) to be output to the current generator206. This maximum level of output voltage cannot be exceeded. Thus, if the resistance of the tissue and electrode combination exceeds a particular level, the current generator will no longer be able to increase the voltage across the electrodes beyond the maximum level and the current passing between the electrodes103a,103bwill fall towards the end of a pulse. This is shown as a current drop in the current pulse P of the actual waveform302depicted inFIG. 3. Prior to point A, the capacitive nature of the tissue and electrodes103a,103bmeans that, despite the tissue and electrode resistance being too high, the predefined level of current can still be achieved. However, as shown by the drop in the actual waveform302, between points A and B, the current gradually falls until it reaches a lower resistively limited value at point B. The current falls because the current generator206cannot increase the voltage across the electrodes103a,103bany higher than the maximum level after time A, so the capacitive potential presented by the charge stored in the electrodes103a,103band tissue gradually drops as the charge passes our of the tissue through the electrodes103a,103b.

The microcontroller202is configured to detect any drop in the actual supplied current before the end of the current pulse via measurement of the current and voltage regulated by the current generator206and passed back to the microprocessor202via feedback line212. The microcontroller202comprises an analogue to digital converter (ADC) to sample analogue current feedback and voltage feedback. When the actual current therefore falls below a threshold VTdefined with respect to the demanded current beyond a particular point in time T1of the current pulse P in the actual waveform302, a fault counter has a one value added to it. The counter is implemented as a register in the microcontroller202. When the actual supplied current is above the threshold defined with respect to the idealised waveform for a predefined time period, then a one valve is subtracted from the fault counter (only if the fault counter is greater than zero). The microcontroller202is configured to check whether the fault counter exceeds a particular value (for example a value of 5). If the fault counter exceeds a fault threshold value, then the LED210is activated and/or its flash rate is changed by the microcontroller202to give a visual indication to a user of the therapy device1that there is a problem with passing current through the tissue. For example, this problem might be as a result of a bad connection between the control unit and the electrodes or between the electrodes and tissue. The function of the fault counter is to prevent activation of the visual indicator for a one-off fault, for example as a result of an occasional glitch in the electrode/tissue connection.

The counter provides a form of filtering on the fault indicator to ensure that faulty trips of the fault indicator do not occur. Of course, it will be appreciated that for an analogue current waveform, the current level may be negative, i.e. the current is passing in an opposite direction between the electrodes103a,103b. This will mean that a fault is indicated by a rise from a minimum level of the actual supplied current. The change in actual supplied current can be detected for both positive and negative parts of the current waveform at a particular point in the current pulse P, i.e. towards the end of a pulse.

Examples of detection levels used when there is a positive current pulse might be:—a demanded current target of 40 μA might have a threshold of 25 μA;a demanded current of 50 μA might have a threshold of 40 μA; anda demanded current of 100 μA might have a threshold of 90 μA.

The aforementioned levels would be negative if a negative current pulse was being supplied to the electrodes103a,103b.

In an alternative embodiment of the invention, the microprocessor202averages the current or voltage difference with respect to the idealised waveform over a predefined time period at the end of the pulse to give a variable value corresponding to the quality of the signal output. Thus, rather than a single bi-polar indication of the electrical signal quality, a variable value is used to give a graduated indication of the signal quality, for example via a plurality of LEDs or an LCD display (either a displayed value or level indicator).

A drop in the current with respect to the idealised waveform can be for a number of reasons, for example: battery charge becoming low, incorrect placement of electrodes (e.g. too large a separation or insufficient tissue contact) and inadequate connection between the electrodes and the control unit etc.

The microcontroller202is also configured to detect the voltage being supplied to the current generator206and provide an indication when the voltage to the current generator206is at its maximum towards the end of a current pulse, thereby indicating that no further current can be supplied and that there is a fault with the connection of the control unit100to the electrodes103a,103b.

A further fault is detected by the microcontroller202detecting a sudden drop in the voltage supplied to the current generator206at anytime during the current pulse. This might indicate a shorting of the electrodes. In this scenario, the demanded current would be set at a particular level, but, in an attempt to supply this current when there is a short between the electrodes, the voltage level demanded by the current generator206would drop to a very low level and this is detected as falling below a particular threshold voltage, thereby indicating to the microcontroller202that there is a short between the electrodes103a,103b.

It will be understood that the present invention has been described purely by way of example and modifications of detail can be made within the scope of the invention as defined by the appendent claims.