The present invention relates to an apparatus for applying electrical stimulation to a human or animal body. The apparatus is also capable of measuring the impedance of the human or animal body.
For a variety of therapeutic applications, several treatment modalities are currently known in the art including electrical stimulation, heat therapy and thermostimulation.
Electrical stimulation involves the application of an electrical current to a single muscle or a group of muscles through one or more stimulation pads that are temporarily attached to the skin. The resulting muscle contraction can produce a variety of effects from strengthening injured muscles and reducing oedema to relieving pain and promoting healing. The pads are usually quite small and typically powered with a battery. This results in the application of a small amount of power and a low treatment depth of the resulting electric field. The shallow depth of the electric field generated by conventional electrical stimulation systems limits performance and patient benefit. Some systems have attempted to address this limitation by applying more current, often from a line or mains supply source. However, the small size of conventional electrical stimulation pads is such that on the application of larger amounts of power, i.e. the use of higher currents, patients often report the experience of pain or discomfort.
Heat therapy involves the application of heat to the body. Heat therapy is very useful as it has a number of effects such as relaxation of muscle spasm and increased blood flow that promotes healing. However, combination therapy, i.e. the synergistic use of other modalities such as massage, ultrasound and/or electrical stimulation has been found to be more effective than heat therapy alone.
Thermostimulation is one such combination therapy that involves the use of heat therapy and electrical stimulation simultaneously. With thermostimulation, the healing benefits of heat are provided along with the strengthening, toning, pain relieving and healing benefits of electrical stimulation. Moreover, the application of heat has been found effective in that it allows the patient to tolerate higher currents. This yields higher electric field strengths, greater depths of penetration and, therefore, more positive results than could be achieved with electrical stimulation without heat. Thermostimulation can be performed using pads that are temporarily attached to the skin.
The inventors have identified a need to provide improved apparatuses for electrical stimulation or thermostimulation.
In accordance with the invention, there is provided an apparatus comprising: means for applying electrical stimulation to a human or animal body via a pair of electrodes; and means for measuring impedance of the body between the pair of electrodes.
Using the same pair of electrodes to apply electrical stimulation and to measure impedance of the body results in an apparatus that is compact and simple to manufacture. Furthermore, this also results in a stimulation pad that is compact and simple to manufacture. Yet further, this simplifies use of the apparatus, by avoiding the need to apply separate sets of electrodes to the body to enable electrical stimulation and impedance measurement.
The apparatus preferably comprises means for controlling the electrical stimulation based upon the impedance measured by the means for measuring impedance. Using the same pair of electrodes to apply electrical stimulation and to measure impedance of the body allows the electrical stimulation to be controlled based upon the local impedance at precisely the region of the body to which stimulation is applied. Preferably, the means for controlling the electrical stimulation is operable to adjust the amplitude of the electrical stimulation applied to the body. More preferably, the means for controlling the electrical stimulation is operable to adjust the amplitude of the electrical stimulation applied to the body to compensate for variations in the impedance measured by the means for measuring impedance. Preferably, the means for controlling the electrical stimulation is operable to stop electrical stimulation being applied to the body if the impedance measured by the means for measuring impedance is less than a first threshold impedance value or greater than a second threshold impedance value.
The apparatus preferably further comprises a pad for placement on the body, wherein the pad comprises the pair of electrodes. Providing the pair of electrodes in a single pad simplifies use of the stimulation apparatus, since only the pad needs to be placed on the body in order to apply electrical stimulation and measure impedance. Hence, the need to apply to the body a separate device specifically for the purpose of measuring impedance is avoided.
The means for measuring impedance preferably comprises a first means for measuring voltage, the first means for measuring voltage being operable to measure the voltage between the pair of electrodes. The means for measuring impedance preferably further comprises a means for measuring current, the means for measuring current being operable to measure the current through the electrodes. The means for measuring current comprises: a resistor arranged to be connected in series with the electrodes; and a second means for measuring voltage, the second means for measuring voltage being operable to measure the voltage across the resistor. The means for measuring impedance preferably further comprises means for calculating impedance using the voltages measured by the first and second means for measuring voltage. The means for measuring current is preferably operable to measure current through the electrodes whilst the means for applying electrical stimulation is applying electrical stimulation to the body. The means for measuring impedance preferably comprises means for applying a measurement signal to the body, the means for measuring impedance being operable to measure impedance of the body whilst the measurement signal is being applied. Preferably, the amplitude of the measurement signal is chosen to prevent muscle contraction.
Preferred features of the invention will now be described, purely by way of example, with reference to the accompanying drawings, wherein like elements are indicated using like reference signs, and in which:
In addition to applying electrical stimulation to the body via the stimulation circuit 40, the stimulation system 10 may also be able to apply heat to the body. That is, the stimulation system 10 can be a thermostimulation system. Such a thermostimulation system is preferably operable to apply heat and electrical stimulation to the body simultaneously or independently of each other.
For the sake of simplicity, the invention will be described with reference to an example of a stimulation pad 30 that comprises two electrodes 50. An example of a suitable stimulation pad is disclosed in the applicant's earlier patent application, WO 2011/064527, the entire contents of which are incorporated by reference herein. WO 2011/064527 describes a stimulation pad having two elongate substantially parallel electrodes for electrical stimulation, each preferably moulded from carbon loaded silicone. The electrodes are then over-moulded, to hold the electrodes in position relative to one another, thereby providing a single moulded assembly. A heating element is positioned on the moulded assembly and held in place with a layer of silicone.
Another example of a suitable pad is the novel pad described below, with reference to
Electrical conductors 511, 512 are patterned on each surface 52, 53 of the substrate 500 to form electrical connections between the components of the circuit 51. As used herein, the term “patterned” is preferably understood to describe the result of a process whereby an electrically conducting region having a predefined shape is formed upon a surface of the substrate 500. The conductors are illustrated by the grey shaded areas in
The electronic components 502, 505, 507, 510, conductors 511, 512 and electrodes 514 are provided on both surfaces 52, 53 of the substrate 500. The electrodes 514 are formed on the first surface 53, whilst the heating element 502 is formed on the second surface 52. In use, the heating element 502 faces away from the skin of the user and the electrodes 514 face towards the skin. The temperature sensor 510, visual indicator 505 and connector 507 are also preferably provided on the second surface 52. Since electronic components 502, 505, 507, 510, conductors 511, 512 and electrodes 514 are provided on both surfaces of the substrate 500, the substrate 500 should have electrically insulating properties in order to prevent unwanted electrical conduction between components and conductors on different surfaces.
The circuit 51 comprises a connector 507 to allow the circuit to be electrically connected to the cable 60 (shown in
The heating element 502 preferably comprises a plurality of resistors 503 and one or more conductors 512. The resistors 503 are distributed across the second surface 52 of the substrate 500. For the sake of clarity, only three resistors 503 are labelled in
When a voltage is applied across the resistors 503, power is dissipated as heat. The positive and negative supply voltages are supplied to the resistors 503 by the pins labelled ‘Heat+’ and ‘Heat−’ respectively in the connector 507. The resistors 503 are soldered to the conductors 512, and are thereby electrically connected to the connector 507. The power dissipated by each resistor 503 is defined as:
P=I2R (1)
where P is the power dissipated (measured in watts), I is the current through the resistor (measured in amperes), and R is the resistance of the resistor (measured in ohms).
In an example, thirty resistors 503 are distributed over the area of the second surface 52.
The temperature sensor 510 is mounted on the second surface 52 of the substrate 500, using surface-mount technology. The temperature sensor 510 is preferably mounted at the point equidistant between the electrodes 514a, 514b. This is to give an indication of the temperature near the region where electrical stimulation is applied, although the temperature sensor 510 could be placed at any other suitable point on the second surface 52. The positive and negative supply voltages for the temperature sensor 510 are supplied by the pins labelled ‘Temp+’ and ‘Temp−’ respectively in the connector 507. The temperature sensor 510 is coupled to the connector 507 by the conductors 511 patterned on the first surface 53 of the substrate 500. Vias through the substrate 500 connect the conductors 511 on the first surface 53 to the temperature sensor 510 and connector 507 that are mounted on the second surface 52. The temperature sensor 510 can be a resistance thermometer or a thermocouple. The temperature sensor is preferably a platinum resistance thermometer (PRT), and is more preferably a Pt1000 element. A Pt1000 element is preferable due to its high accuracy.
An electrical stimulation current is delivered from the console 20 to the electrodes 514a, 514b by the pins of the connector 507 labelled ‘EM1’ and ‘EM2’ respectively. The electrodes 514 are coupled to the connector 507 by the conductors 511 patterned on the first surface 53. Vias through the substrate 500 connect the conductors 511 on the first surface 53 to the connector 507 that is mounted on the second surface 52.
Other electronic components could be mounted on the substrate 500 and, preferably, mounted on the second surface 52 of the substrate. For example, logic components such as a programmable logic device, microprocessor or microcontroller could be mounted on the substrate 500. Such logic components could be used to control the heat and/or electrical stimulation that is applied to a user. As another example, one or more sensors could be mounted on the substrate 500, in addition to the temperature sensor 510. As shown in
As mentioned previously, in use, the heating element 502 faces away from the skin of the user and the electrodes 514 face towards the skin. Thus, heat generated in the heating element 502 on the second surface 52 is conducted through the substrate 500 to the first surface 53, and is subsequently conducted to the body of a user through the casing body 100 of the stimulation pad 30.
The example of a stimulation pad 30 that is described above with reference to
The signal generator 402 can comprise an amplifier 403 and a filter 404.
Returning to
The first means for measuring voltage 410 is connected to the terminals 412a and 412b. The first means for measuring voltage 410 is thereby operable to measure the voltage (i.e. the potential difference) between electrode 50a and electrode 50b.
The means for measuring current 406 comprises a resistor 407 and a second means for measuring voltage 408. The resistance of the resistor 407 is accurately known. The resistor 407 is connected in series between the output of the signal generator 402 and a first terminal 412a. Hence, the resistor 407 is in series with the electrodes 50. In use, the resistor 407 is in series with a human or animal body to which the electrodes 50 are connected. The second means for measuring voltage 408 is operable to measure the voltage across the resistor 407. When the signal generator 402 generates an output signal 416, an electrical current 422, 424 flows through the resistor 407, electrodes 50 and the body. The current through the resistor 407 is defined by Ohm's law:
I=V/R (2)
where I is the current (measured in amperes), V is the voltage across the resistor 407 (measured in volts) and R is the known resistance of the resistor 407 (measured in ohms). Thus, the means for measuring current is operable to measure the current through the resistor 407 using a measurement of the voltage across the resistor 407 and the known resistance. Since the resistor 407 is connected in series with the electrodes 50 and the body, the current through the resistor 407 is equal to the current through the body.
The first and second means for measuring voltage 408, 410 each preferably comprise a respective analogue-to-digital converter (ADC). Each analogue-to-digital converter is operable to convert an analogue input voltage to a digital value suitable to be input to the controller 400. Thus, the first means for measuring voltage 410 is operable to provide a first digital value to the controller 400, the first digital value being representative of the voltage between electrode 50a and electrode 50b. The second means for measuring voltage 418 is operable to provide a second digital value to the controller 400, the second digital value being representative of the current through the electrodes 50a, 50b. By using two analogue-to-digital converters, current and voltage can be measured simultaneously. The first and second means for measuring voltage 410, 408 are connected to the controller 400 by a respective bus 418, 420. Alternatively, each analogue-to-digital converter and the controller 400 can be provided in a single integrated circuit.
Preferably the controller 400 comprises a suitably programmed microprocessor or microcontroller. Alternatively, the controller 400 could be implemented using programmable logic, discrete logic gates or even a suitable analogue circuit. The controller 400 is operable to calculate the impedance of the body between the electrodes 50 when the stimulation pad 30 is in use.
The operation of the stimulation circuit 40 to measure impedance will now be described. In the following, it is assumed that the electrodes 50a, 50b of the stimulation pad 30 are electrically connected to a body. An input signal 405 is supplied to the signal generator 402 by the controller 400. In response to the input signal 405, the signal generator 402 generates an output signal 416. The output signal 416 causes a current (which is referred to herein as a “measurement current” 422) to flow. The measurement current 422 starts at the signal generator 402, flows through the resistor 407, then through the electrode 50a, then through the body, then through the electrode 50b and finally returns to the signal generator 402.
The current through the body is measured by the means for measuring current 406. More specifically, the current through the body is measured by measuring the voltage across the resistor 407 with the second means for measuring voltage 408, and dividing that voltage by the known resistance of the resistor 407 to provide a current measurement in accordance with equation (2). The voltage of the body between the electrodes 50 is measured by the first means for measuring voltage 410. The controller 400 calculates the impedance of the body in the region of the electrodes 50 using the measured current and voltage.
The equations used by the controller 400 to calculate impedance will now be described. The measurement current 422 can be either an alternating current or a direct current signal. If alternating current is used, the impedance is defined as:
Z=|V/I*e
j(ø
−ø
) (3)
where Z is the impedance of the body between the electrodes 50a, 50b (measured in ohms), V is the voltage across the electrodes 50a, 50b (measured in volts), I is the current through the body (measured in amperes), øI is the phase of the current, øV is the phase of the voltage, j is an imaginary number, and |x| denotes the amplitude of a variable x. Hence, the controller 400 can calculate the impedance of the body using a measurement of the current through the body, a measurement of the voltage of the body between the electrodes 50, a measurement of the phase difference between the current and voltage, and the relationship defined in equation (3).
If direct current is used, øI and øV are equal to zero and hence the impedance is equivalent to the resistance defined by Ohm's law:
R=V/I (4)
where R is the resistance of the human or animal body between the electrodes 50a, 50b (measured in ohms), V is the voltage across the electrodes 50a, 50b (measured in volts) and I is the current through the body (measured in amperes). Hence, the controller 400 can calculate the impedance of the body using a measurement of the current through the body, a measurement of the voltage of the body between the electrodes 50, and the relationship defined in equation (4).
The impedance measurement represents the impedance of the region of the body that is local to the electrodes 50. Hence, the impedance measurement provides information on the conditions in the region local to the electrodes, but not on the body as a whole. If necessary, the overall impedance of the body can be estimated by combining local impedance measurements taken at several body locations.
The operation of the stimulation circuit 40 to apply electrical stimulation will now be described. In the following, it is assumed that the electrodes 50a, 50b of the stimulation pad 30 are electrically connected to a body. An input signal 405 is supplied to the signal generator 402 by the controller 400. In response to the input signal 405, the signal generator 402 generates an output signal 416. The output signal 416 causes a current (which is referred to herein as a “stimulation current” 424) to flow. The stimulation current 424 starts at the signal generator 402, flows through the resistor 407, then through the electrode 50a, then through the body, then through the electrode 50b and finally returns to the signal generator 402.
When applying electrical stimulation to the body, the controller 400 is preferably operable to control the output signal 416 based upon the measured impedance of the body. For example, by controlling the amplitude and/or the duration of the input signal 405, the controller 400 can control the amplitude and/or duration of the output signal 416. The controller 400 can also stop supplying an input signal 405 to the signal generator 402, so as to stop the output signal 416 being generated and thereby stop electrical stimulation being applied to the body.
The measured impedance may vary due to perspiration and/or improper placement of the pad 30. The presence of perspiration can create a low-impedance conducting path across the surface of the user's skin, which will cause the measured impedance to decrease. Improper placement of the pad 30 can result in poor electrical contact between the electrodes 50 of the pad 30 and the body, which will cause the measured impedance to increase. Physiological effects, such as an increase in the blood volume of muscles, may also cause small changes in the measured impedance. The controller 400 can adjust the amplitude of the electrical stimulation to compensate for changes in the measured impedance. For example, the controller 400 can increase or decrease the amplitude of the voltage of the output signal 416 (or the amplitude of the stimulation current 424) to ensure that the level of electrical stimulation that is actually delivered to the body remains constant.
The main reason for measuring the impedance of the body is to ensure the safety of the user during electrical stimulation. For example, if perspiration were to cause the impedance between the electrodes 50 of the pad to decrease whilst the voltage of the output signal 416 remained constant, the stimulation current 424 applied to the body would increase. To prevent the stimulation current 424 increasing to a level that could be harmful to the user, the controller 400 can stop the output signal 416 being generated if the impedance of the body decreases below a first threshold value. As another example, to avoid electrical stimulation being applied in the event of poor electrical contact between the electrodes 50 and the body, the controller 400 can stop the output signal 416 being generated if the impedance of the body increases above a second threshold value. The controller 400 can also generate an alert (such as an audible alert and/or a visible alert) if the impedance decreases below the first threshold value or increases above the second threshold value.
When the impedance of the body is being measured, the amplitude of the output signal 416 is chosen so as to be too small to cause nerve stimulation. This prevents muscle contraction whilst impedance is being measured, and thereby improves the accuracy of the impedance measurement. A suitable amplitude for the output signal 416 can be empirically determined. Thus, as shown in
As described above, electrical stimulation is applied to a body using the same electrodes 50 that are used to measure impedance of the body. The shared use of a single pair of electrodes 50 is advantageous because it allows impedance to be measured at the region of the body to which electrical stimulation is applied. In particular, this allows the detection of undesirable low-impedance conducting paths caused by perspiration, and allows action to be taken to prevent those conducting paths causing unsafe levels of electrical stimulation being applied to the body. The shared use of a single pair of electrodes also allows the quality of electrical contact between the electrodes and the body to be determined, and allows action to be taken if the quality of electrical contact is poor. The shared use of a single pair of electrodes also allows the electrical stimulation to be controlled based upon the local impedance at precisely the region of the body to which stimulation is applied. Additionally, the shared used of a single pair of electrodes 50 eliminates the need for separate sets of electrodes to measure impedance and to apply electrical stimulation. This simplifies the stimulation circuit 40 and results in a stimulation pad 30 that is compact and simple to manufacture. Furthermore, the shared use of a single pair of electrodes makes the stimulation system easier to use, by avoiding the need to apply separate sets of electrodes to the body in order to perform electrical stimulation and impedance measurement.
If the pad 30 comprises a heating element, the controller can preferably control the temperature of the heating element based upon the measured impedance of the body. This also has the advantage of allowing the therapeutic treatment to be adapted based upon how the user's body is responding to the therapy. The temperature of the heating element can be increased, decreased or maintained at its current level based upon the measured impedance.
Whilst the stimulation circuit 40 is described above as being a component of console 20, it is also possible to include some or all of the functionality of the stimulation circuit 40 in the stimulation pad 30. For example, the stimulation pad 30 could comprise the means for measuring current 406, the first means for measuring voltage 410 and a means for calculating impedance. In this example, the stimulation pad 30 could communicate a digital or analogue value representative of the impedance of the body to the console 20 via the cable 60. The present invention preferably encompasses arrangements in which some or all of the functionality of the stimulation circuit 40 is implemented in the stimulation pad 30.
It will be understood that the invention has been described above purely by way of example, and that modifications of detail can be made within the scope of the invention.
Number | Date | Country | Kind |
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1119608.6 | Nov 2011 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2012/072621 | 11/14/2012 | WO | 00 | 5/9/2014 |