The invention relates to a method of measuring physiological parameters on humans or animals based on the application of electrodes including electrodes for contact with the skin surface.

The invention moreover relates to an apparatus for measuring of physiological parameters on humans or animals based on the application of electrodes including electrodes for contact with the skin surface.

It is known to measure physiological parameters by using electrodes including the use of measuring impedance. The known technique includes the use of electrodes, which are attached to the skin surface around the measuring object, where the electrodes afterwards are connected with wires to the actual measuring apparatus.

The background for using impedance measurements is that all tissue and all organs have a characteristic impedance, measurement of impedance in a given object being measured can therefore give information about the composition of the tissue in the object being measured. At the same time the measurement is sensitive towards physiological changes in the object being measured, which means, that measurement of impedance often, with advantage, can be used in detecting such changes.

One of the major advantages of using measurements of impedance based on electrodes, which are attached to the surface of the skin, is that the measurements are non-invasive and are only making the people or animals being measured feel discomfort to a very small extent.

It has been found, however, that there are some drawbacks associated with the known technique.

The procedure with application of loose electrodes, which are being attached to the skin surface and after that being connected with wires to the actual measuring apparatus gives as an example the drawback that the measurements are hard to reproduce given that the mutual location of the electrodes only with much difficulty can be recreated with high precision.

Due to the use of loose electrodes the geometry between the electrodes will vary from measurement to measurement, which means, that the uncertainty of the individual measurement is relatively high.

The measurement is in addition complicated due to the use of wires which, besides being awkward to handle, easily can break or give periodic poor contact and thus give a cause for erroneous measurement.

It is as well a drawback that the equipment due to the use of loose electrodes, which are attached to the measuring apparatus with wires, becomes unmanageable and troublesome to transport, as the whole of the measuring apparatus consists of many separate parts.

Accordingly, an object of the invention is to improve the known procedure and the known apparatus.

The object of the invention is achieved by a method of the in the introduction to claim 1 stated type, which is characteristic by that the electrodes are mutually retained in a fixed geometry.

Hereby, it is thus possible to get a high precision on every single measurement, in that the geometry of measuring always is known and always is the same, as well as it gets easier to reproduce measurements.

In claim 2 is stated that it is as well a distinctive feature of the invention that the electrodes are integrated in a measuring device, which can be hand- held or fastened to the point of measurement such as by using a band or an adhesive substance.

When the electrodes are integrated in the measuring apparatus, the wires, which are normally used for connecting the electrodes with the measuring apparatus, are removed, and thus the number of potential errors decrease by which the quality of measurement is increased, as well as the equipment is easily operated hand-held. If the whole apparatus is attached to the object being measured, a person can as an example be monitored continuous in one's everyday life, which opens op for entirely new possibilities of measuring-and application methods. v As stated in claim 3 it is moreover a distinctive feature of the invention that the electrodes are used for measurement of impedance, where one or more, preferably two, are used for signal-generation, and where one or more, preferably two, are used for signal detection.

Hereby it is achieved that the measurement of impedance can be executed with high precision and a high extent of reproducibility, which totally gives measured data with relatively low uncertainty and thus a high extent of practical applicability.

Further preferred embodiments of the method of the invention are defined in claims 4 to 8.

As mentioned the invention also relates to an apparatus.

This apparatus or instrument is characteristic in that it can be operated hand-held or attached to the point of measurement with a band such as a

so called velcro band or with an adhesive substance, and is supplied with two or more integrated electrodes for contact with the skin surface and can be programmable and can be provided with indicators or a display for visualization of the measured physiological parameters and means for storage of data and data communication with external digital units such as computers.

Hereby it becomes possible, simple and effective, to measure physiological parameters, including impedance based, with high precision and reproducibility, which results in large practical, including clinical, applicability. Simultaneously it becomes possible to long-term monitor people or animals in their usual surrounding environment.

Further expedient embodiments are defined in claim 10.

The invention will now be explained more fully with reference to the drawings, in which: Fig. 1 shows an elementary sketch of a measurement of impedance for determination of physiological parameters.

Fig. 2 shows a hand-held apparatus for measurement of physiological parameters on a object under measurement in the form of a forearm.

Fig. 3 shows the transducerhead from the measurement equipment shown in fig. 1.

Fig. 4 shows a practical measuring setup where a hand-held measurement device is used for measuring physiological parameters on by way of example the forearm of a human.

Fig. 5 shows, seen from the side, a hand-held measuring apparatus supplied with integrated electrodes in the bottom and control buttons and display in the top.

Fig. 6 shows, seen from the bottom, the same measurement device as fig.

5.

Fig. 7 shows, seen from above, the same measurement device as fig. 5 and fig. 6.

Fig. 8 shows, seen from the bottom, a hand-held measurement device with numerous rows of integrated electrodes, which can be used for impedance tomography.

Fig. 9 shows, seen from the side, the same measurement device as fig. 8.

Fig. 10 shows a measurement device with electrodes integrated in the lateral surfaces of the apparatus.

Fig. 11 shows, seen from the bottom, an apparatus with two integrated electrodes for fixing to a surface of skin.

Fig. 12 shows, seen from the top, the same apparatus as shown on fig. 11.

In fig. 1,1 indicates a cross section of a measurement device, e. g. in form of a segment of a humane forearm, which is penetrated by an artery 2.

On the surface of the object of measurement, which, in the example, is the surface of the persons skin, electrodes are placed 3,4, 7 and 8.

The electrodes 4 and 7 are connected to a signal detection circuit 5, while electrodes 3 and 8 are connected to a signal generation circuit 6.

In practice the signal generation circuit 6 is a source of electrical current, where alternating current is preferred, while the signal detection circuit is a voltage detector.

During a measurement, the signal, being the alternating current, which from 6 is penetrating the measurement object 1, as well as the resulting voltage, which is registered in the detection circuit 5 is known. With knowledge of the current through, as well as the voltage across the object of measurement the impedance can simply be derived based on the formula R=V/I, where: R is the impedance in the volume of measurement, which is covered by the measurement setup, V is the voltage, which is measured in 5 and I is the current, which is generated from 6.

The cubical content, which is defined by the measuring set-up is primarily dependant of the mutual location of the electrodes and their physical extent.

As a result of the person's heartbeat the blood will be pumped through the veins of the body and thus result in pulsation of the artery 2, whereby the shown cross-sectional area will change as a function of the heartbeats.

Due to the fact that the blood, which flows through the artery, has got another characteristic impedance than the nearby tissue, the artery pulsation can be registered in the signal detector 5.

By using a simple signal algorithm, the heart rate can thereby relatively easily be derived from the signal detector 5. From the heart rate signal additional parameters such as HRV (Heart Rate Variability), including short- time measurement of HRV (short-term HRV) can as well be derived.

In fig. 2 an apparatus consisting of a measuring probe 9 is shown, which can be one-hand operated and thus it can be defined as hand-held, which is supplied with a display 10 for presentation of the measured and/or derived physiological parameters such as the pulse rate of the heart or HRV. The measuring probe 9 is supplied with a probehead 11, which contains electrodes for generation of signals and signal detection, whereby impedance based physiological parameters can be derived from an object of measurement, e. g. by way of a humane forearm 1.

Fig. 3 shows, seen from the bottom and in an enlarged illustration, the probehead 11 from the measuring probe 10 shown in fig. 2.

The probehead is provided with two electrodes 13, which are being used for emitting current in the object of measurement, and two electrodes 12, which are being used to detect the voltage, which is created as a function of the current in the object of measurement.

In advance of a measurement, the probehead 11 is placed on the skin over the area of measurement, such that the electrodes 12 and 13 are in direct contact with the surface of the skin.

In fig. 4 an example is shown of a practical measurement of physiological parameters such as heart rate and HRV from the forearm of a humane object under measurement 1, by application of a measurement probe 10, which is operated with a hand 14 by the user.

The registered and/or derived physiological parameters are shown on the display of the probe 10.

Another example of a preferred embodiment of the present invention is shown in fig. 5. The measurement device 15 can be operated with one hand and is at the top provided with operating buttons and a display for data visualization, and at the bottom provided with integrated electrodes 17.

The device 15 is shown seen from the bottom in fig. 6 and seen from above in fig. 7.

As it will appear from figures 5 to 7, the device 15 is characterized by, that the electrodes 17 are integrated in the product and therefore mutually placed in a fixed geometry. By this the geometry of measurement is always well-defined and the measurement results can therefore be defined and reproduced with high precision. The reproducibility is of crucial significance in many applications, as an example in case the measured or derived physiological parameters are going to be used in clinical applications.

It is in addition seen that the device 15 is easy to operate, easy to clean and easy to transport. Because the electrodes 17 are integrated in the product there are no wires, which must be connected between the electrodes and the device, and thus the quantity of potential sources of error are reduced significantly.

Apparatus, as the shown example 15, can, depending of the number of electrodes 17 and the mutual geometrical position of these, be optimized for measuring of different types of physiological parameters derived in a well-defined including limited volume such as determination of mass of fatty tissue, determination of degree of ischaemia, determination of absorption of liquid and fluid in tissue and determination of stage or degree of wound

healing.

In case there is being measured across a vein as shown schematic in fig. 1 in form of an artery, there can, as previously mentioned, be derived data about heart rate and HRV, as well as it is possible to derive information about the blood flow in the vein and the respiration of the person on basis of the measured signals.

In fig. 8 an apparatus 20 is shown, seen from the bottom, which is provided with an array 19 of electrodes. By using an array of electrodes it is possible to get a three-dimensional tomographic identification of the tissue defined by the measurement apparatus 20.

In a preferred embodiment of a impedance tomographic measurement device 20 the marked outer rows of electrodes 19 are the source of current, while the intermediate electrodes are used for signal detection.

With a construction as the one shown in fig. 8 of a device 20 it is possible to detect form, size and location of an underlying vein such as an artery. In fig.

9 such an impedance tomographic device 20 is shown, which is provided with one or more sources of light 21, which can be used to mark, with a spot of light on the surface of the skin, e. g. the centre of an underlying artery. Such a mark can later be used as a target point for inserting a hypodermic needle into the artery.

In fig. 10 another preferred embodiment of the present invention is shown consisting of a device 24, which is provided with two integrated electrodes 24 and 25, which can be used for registering the self induced or natural electrical voltage of a object of measurement, as an example in form of a human, generates in response to the electrocardiographical (ECG) signal, which controls the contraction of the heart.

Measurement of impedance performed with the same electrodes, which record the ECG signal, can be used to determine if the device is in touch with an individual, which e. g. can be used to determine the beginning as well as the ending of an ECG measurement.

If a person with each hand holds on to respectively electrode 24 and electrode 25, the ECG signal can easily be detected, whereby physiological parameters such as heart rate and HRV including short-time HRV can easily be derived and presented on the built-in display 23.

Fig. 11 shows an example of a device 26 carried out in pursuant to the invention. The device is seen from the bottom where the device is provided with two integrated electrodes 27. The device 26 is in fig. 12 shown from above, where it is provided with a unit 28, which can typically contain electronics, battery and e. g. light-emitting diodes.

As it will appear from fig. 11 and fig. 12 the device is thin in relation to the length and width. In practice the device can be made of a flexible thin material and can be applied with a self-adhesive substance, thus the whole device 26 can be attached to the skin surface of a person.

If the device is placed above a surface wound, the electrodes 27 can be used partially for emitting current through the wound, which can often have a positive effect on the wound healing, as well as the electrodes can be shaped so they can also measure the impedance in the area of the wound.

The impedance in the area of the wound will be a function of the wound healing stage, which thus can be shown on 28, e. g. by one or more indicators such as light-emitting diodes. If light-emitting diodes are used the colour of these could e. g. change, in such a way that an open wound would

give a red light, while a healing wound would be shown in yellow towards green colours dependant of the stage of the wound healing.

It is thus a part of the present invention that the electrode based device can be used for measuring of physiological parameters as well as for emitting current with regard to e. g. advance wound healing processes or to stimulate muscles.

It is also a part of the present invention that the device is hand-held or can be attached to the object of measurement as an example by using band, such as velcro, tape or self-adhensive material.

All the devices can be sterilized and manufactured by skin-and environmentally friendly materials.

All the shown examples of devices can be programmable, typically by use of a microprocessor or-controller, and all the devices can be provided with communication circuits, so that data can be exchanged e. g. wireless with external units such as computers.

The invention is not limited to the forms of construction, which are directly described and/or shown in the figures, but also covers all forms of construction, which can indirectly be derived from the present text or the present figures.