EP3193702A1

EP3193702A1 - Dual electrode, garment, method and electrocardiogram device

Info

Publication number: EP3193702A1
Application number: EP15767088.6A
Authority: EP
Inventors: Markus Riemenschneider; Jürgen SAUERZAPF
Original assignee: Personal Medsystems GmbH
Current assignee: Personal Medsystems GmbH
Priority date: 2014-09-16
Filing date: 2015-09-14
Publication date: 2017-07-26
Also published as: WO2016041630A1; DE102014013708A1

Abstract

The invention relates to a dual electrode (10) for measuring an electrocardiogram of the heart of a patient (1), comprising: a first electrode portion (11a) for placement on a first body site (E, S, RA, LA) of the patient (1); and a second electrode portion (11b) for placement on a second body site (E, S, RA, LA) of the patient (1) which is different from the first body site (E, S, RA, LA); the first electrode portion (11a) and the second electrode portion (11b) being electrically separated from one another.

Description

DOUBLE ELECTRODE, CLOTHING, METHOD AND

electrocardiogram

FIELD OF THE INVENTION

The present invention generally relates to a double electrode, a garment with a double electrode, a method and an electrocardiogram device for measuring an electrocardiogram.

BACKGROUND OF THE INVENTION

Known electrocardiogram devices are used to create an electrocardiogram of the heart. In this case, electrodes that are placed at predetermined locations on the human or animal body are used to measure electrical potentials originating from the cardiac muscle fibers. Depending on the arrangement, number and placement of the electrodes on the body, different leads are defined, such as e.g. the derivation to Einthoven, Goldberger, Wilson, etc.

There is an endeavor to obtain a quick and effective diagnosis of the condition of the heart, even outside the clinical or medical environment. In addition to cardiac arrhythmias such as atrial fibrillation or extra ventricular beats, important diagnoses include life-threatening heart attacks.

In order to make a complete diagnosis of the heart rhythm and the blood flow of the heart, at least one 12-lead ECG with the leads to Einthofen (I, II, III), Goldberger (aVR, aVL, aVF) is known according to medical guidelines. and Wilson (V1 -V6) required. For certain diagnoses (eg posterior infarction), the posterior wall (V7-V9) or right-hand lead (VR3 - VR6) may also need to be written. These are also referred to below as "classical derivatives".

For this purpose, according to the prior art, the following delivery systems are known, which can measure at least one 12-channel ECG:

Einthoven / Goldberger / Wilson (9 electrodes on the extremities and thorax + ground electrode)

Frank (7 electrodes + ground electrode) EASI (4 electrodes + ground electrode)

It is known to omit the ground electrode in mobile ECG devices, so that in the simplest case of the EASI lead at least 4 electrodes are to be attached to the body of the patient.

In order to be able to carry out a quick diagnosis, even with an EASI lead with only 4 electrodes, it takes approximately 1 minute until the electrodes are attached to the body and the measurement can begin.

Accordingly, a number of devices are known in the art that measure only one channel to allow for even faster measurement. In these known methods, it is sufficient to derive an ECG via the fingers of both arms of the body. The measurement can already begin after a few seconds. However, with this method, only a rough statement about the heart rhythm can be made. A detailed statement according to the above-mentioned known guidelines for rhythm and blood flow of the heart is not possible due to the measurement with only one channel.

The object of the present invention is to improve the measurement of an electrocardiogram.

SUMMARY OF THE INVENTION

In a first aspect, the present invention provides a dual electrode for measuring an electrocardiogram of the heart of a patient, comprising: a first electrode portion for placement at a first body site of the patient; and a second electrode portion for placing at a second body site of the patient other than the first body site, wherein the first electrode portion and the second electrode portion are electrically separated from each other.

According to a second aspect, the present invention provides a garment with a double electrode according to the first aspect.

According to a third aspect, the present invention provides a method for measuring an electrocardiogram of the heart of a patient, comprising: applying a double electrode according to the first aspect and / or applying a hand according to the second aspect, on a hand of the patient so that the first electrode portion is placed on the surface of the patient's hand; Placing the second electrode portion at a body site of the patient; and measuring the electrocardiogram.

According to a fourth aspect, in a shirt-like garment according to the present invention, the first electrode portion is disposed on the inner surface of the shirt-like garment contacting the upper body of the patient (and thus automatically contacts the surface of the patient at a predetermined position), and the second electrode portion is manually passed The patient is contactable arranged on the outer surface of the shirt.

According to a fifth aspect, the present invention provides an electrocardiogram apparatus for measuring an electrocardiogram of the heart of a patient, comprising: at least one double electrode according to the first aspect; and a controller electrically coupled to the dual electrode and configured to receive electrical electrode signals from the dual electrode and to receive an electrocardiogram.

Further aspects and features of the present invention will become apparent from the dependent claims, the accompanying drawings and the following description of preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWING

Embodiments of the invention will now be described by way of example and with reference to the accompanying drawings, in which:

Fig. 1 illustrates the known EASI delivery system;

Fig. 2 shows a modified ECG lead-off system according to an embodiment of the present invention;

Fig. 3 illustrates an embodiment of a double electrode;

Fig. 4a shows an embodiment of a glove with a double electrode in a plan view of the inside of the glove; Fig. 4b shows the glove in a cross-sectional view;

Fig. 5 shows an embodiment of an ECG device with two double electrodes; and

Fig. 6 illustrates an embodiment of a method for receiving an ECG.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In Fig. 3, an embodiment of a double electrode 10 is illustrated. Before describing in detail preferred embodiments, some general explanations follow for the embodiments of the present inventions.

As mentioned above, known electrocardiogram devices are used to generate an electrocardiogram of the heart, with electrodes placed at predetermined locations on the human body measuring electrical potentials originating from the cardiac muscle fibers. Depending on the arrangement, number and placement of the electrodes on the body, different leads are defined, such as e.g. the leads according to Einthoven, Goldberger, Wilson, etc. The electrodes, which are glued or otherwise attached to the body for the acquisition of the electrocardiogram, are typically, as mentioned, in each case connected via an electrode cable to the electrocardiogram device and depending on the derivative used, 12, 6, 4 or another number of electrodes with a corresponding number of electrode cables are used.

As also mentioned at the outset, there is also a desire to obtain a fast and effective diagnosis of the condition of the heart outside of the clinical or medical environment, which includes cardiac arrhythmias such as atrial fibrillation or ventricular extra beats as well as life-threatening heart attacks.

In order to make a complete diagnosis of the heart rhythm and blood flow to the heart, according to known medical guidelines, at least one 12-lead ECG with the Einthofen (I, II, III), Goldberger (aVR, aVL, aVF) and Wilson (V1 -V6) required. For certain diagnoses (eg posterior infarction), the posterior wall (V7-V9) or right-hand lead (VR3 - VR6) may also need to be written. These are also referred to below as "classical derivatives." In some embodiments, such classical derivations conditions for use.

For this purpose, e.g. The following derivation systems are known which can measure at least one 12-channel ECG:

Frank (7 electrodes + ground electrode)

EASI (4 electrodes + ground electrode)

It is also known to dispense with mobile electrocardiogram devices on the ground electrode, so that in some embodiments, in the simplest case of EASI lead at least 4 electrodes are to be attached to the body of the patient.

The lead-off system e.g. according to EASI requires the following electrode arrangement in a patient 1, as shown in Fig. 1:

E: Immediately below the breastbone in the middle of the ribcage A: Left middle axis line at the level of the lower border of the sternum S: Above the sternum

I: Right middle axis at the level of the lower border of the sternum

This electrode configuration biases a tetrahedron, which is indicated in Figure 1 by the dashed lines. The tetrahedron completely describes the electrical activity. All other classical derivatives, such as those mentioned above, can be calculated from these tetrahedral derivatives in some embodiments (see, for example, US 4850370 A).

It has now been recognized that the tentering points of the tetrahedron for e.g. the EASI derivative can be changed, as also illustrated in FIG. 2:

S: Above the sternum

E: Immediately below the breastbone in the middle of the rib cage RA: right arm LA: left arm

The position "I right middle axis" thus moves to the right arm "RA" and the position "A left middle axis" on the left arm "LA".

The possibilities of calculating the classical derivatives from this tetrahedron are preserved and run analogously to the known calculations. As one skilled in the art is aware, only factors for calculation are to be changed.

In the arrangement of the electrodes shown in Fig. 2, the arms act electrically like a cable, so that based on the EASI-derivative of Fig. 1, the electrical contact points "I" and "A" only about 20 cm up in Move the direction of the transition between upper arm and upper body when the electrodes are attached to the positions shown in Fig. 2 "RA" and "LA" in the left and right hand. Where the electrodes are attached to the patient's arms is therefore largely irrelevant in some embodiments, especially when these points of contact move in the region of the hand.

The abutment points on the arms can be freely determined in some embodiments, e.g. Forearm, wrist area, hand itself (inner surface, one of the fingers, thumb ball, etc.). Overall, it should be noted at this point that the particular locations described here on the body of a patient, where the electrodes are to be arranged, are ultimately exemplary.

Different measuring arrangements can be used to calculate the classical derivatives, the reference electrode in each case being located at the various contact points "E", "S", "LA", "RA", as shown in FIG. 2. Accordingly, the reference electrode may be freely selected in some embodiments. This results in 4 measuring arrangements with different voltage vectors U (MV1), U (MV2) and U (MV3):

Reference electrode at position "E":

U (MV1, E) = U (E) -U (RA), U (MV2, E) = U (E) -U (LA), and U (MV3, E) = U (E) -U (S )

Reference electrode at position "S":

U (MV1, S) = U (S) -U (RA), U (MV2, S) = U (S) -U (LA), and U (MV3, S) = U (S) -U (E ) Reference electrode at position "RA":

U (MV1, RA) = U (RA) -U (E), U (MV2, RA) = U (RA) -U (LA), and U (MV3, RA) = U (RA) -U (S )

Reference electrodes at position "LA":

U (MV1, LA) = U (LA) -U (RA), U (MV2, LA) = U (LA) -U (E), and U (MV3, LA) = U (LA) -U (S )

In some embodiments, the calculation possibilities are not limited to the abovementioned classical derivatives, but all other possible derivatives which result from the linear combination of the measured vectors can also be calculated.

In addition, mention should be made of the above: In Fig. 2 illustrated embodiment of the invention, the boundary conditions for the choice of the 2 investment points next to "LA" and "RA": 3 resulting voltage vectors must be linearly independent and the contact points must be chosen so that a tetrahedron results (ie an attachment point can also be located, for example, in the neck / back / etc. of a patient).

It has now been further recognized that the use of one or more double electrodes may be expedient for the electrode arrangement of FIG. 2 and also for other derivatives.

Accordingly, some embodiments relate to a dual electrode for measuring an electrocardiogram of the heart of a patient comprising a first electrode portion for placement at a first body site of the patient and a second electrode segment for placement at a second body site of the patient other than the first body site , The first electrode portion and the second electrode portion are electrically separated from each other. The first and second electrode sections each form an electrode for receiving electrical potentials of the heart. The first and second body location could be a position at which one of the known classical derivatives is measured. In particular, the first and second body locations are one of the positions "E", "S", "LA" and "RA" as discussed in connection with FIG. 2. "Placing an electrode section at a body site of the patient" also includes the case - as in the exemplary embodiment according to the invention described herein in the context of a shirt-like garment - that an electrode portion is not always in contact with the patient, but for example, briefly keyed / gripped to allow a potential measurement.

The electrode sections of the double electrode may be formed of a conductive material, such as metal, a metallic and / or other electrically conductive coating, which is, for example, arranged on a plastic body, etc. Basically, the two electrode sections may be arranged arbitrarily. In some embodiments, however, they are oppositely disposed, with an electrical insulation layer being sandwiched between the electrode sections. In addition, the double electrode can each have an electrical line for an associated electrode section. The electrode sections may be flat, flat or otherwise designed.

In some embodiments, the two electrode sections are arranged "back-to-back" in a housing and electrically separated from one another Such a double electrode offers two electrical contacts which, as mentioned, can serve as electrodes for an electrocardiogram derivation (hereinafter also "ECG"). Derivative or just called "derivative").

The double electrode can, for. B. be designed as an adhesive electrode (eg., Wet gel, dry gel), have a possibility for contacting an adhesive electrode (eg., Wet gel, dry gel) and / or designed as a suction electrode.

For example, the double electrode can be clamped between the hands in order to measure a so-called 1-channel ECG ("ECG" = electrocardiogram), as is generally known to the person skilled in the art, but the double electrode can also be attached to one of the two thumb pads of a patient Where the skin resistance is low and thus the signal quality is good, the prior art usually uses the fingertip for the contacting, which, however, typically has a high contact resistance and thus results in a poorer signal quality.

In addition, in some embodiments, two or more twin electrodes may be used. For the derivation of a tetrahedral ECG, as described above in 2 described in some embodiments, two double electrodes, for example, arranged as follows:

The first double electrode is placed with its first electrode portion at the position "RA", for example, index finger, middle finger, palm, or the like of the patient's right hand and right arm, respectively.

The first double electrode is brought with its second electrode portion by lifting the arm to the position "S", i.e. above the sternum of the patient.

The second double electrode is placed with its first electrode portion at the position "LA", for example, left index finger, middle finger, palm, or the like of the patient's left hand and left arm, respectively.

The second double electrode is brought with its second electrode portion by lifting the arm to the position "E", i.e. below the breastbone of the patient.

Of course, also the second electrode portion of the first double electrode can be brought to the position "E" and the second electrode portion of the second double electrode to the position "S".

In this way, a patient can derive a full-fledged ECG by contacting two double electrodes, one on each hand, each with two different body locations (for example position "E" and "S") with a corresponding ECG device. Therefore, in some embodiments, by using the double electrode, the ECG can be recorded as quickly or even faster than with known 1-channel ECG recorders, but with the difference that, depending on the embodiment, the diagnostic capabilities of the classical leads are available.

In some embodiments, the dual electrode or the first and / or the second electrode portion is adapted to a shape of the first and / or second body location, for example to a finger, fingertip, forearm portion, wrist, thorax portion, etc. In some embodiments, the first one is and / or the second electrode portion cup-shaped for placement on a ball of the thumb. In this case, the first and / or the second electrode section can also be designed as contact shells for the ball of the thumb so that they additionally act as a Can serve packaging for the electrode cable, which contacts the electrode sections.

Some embodiments relate to a glove having one (or more) double electrode as described above.

The first electrode portion may be disposed inside the glove for contacting a handball or other portion of the hand (e.g., fingertip) and the second electrode portion may be attached to the surface, e.g. the inside, the glove be arranged. With the second electrode portion, e.g. contacting a site of the breast (e.g., the "E" or "S" position). Thus, a 1-channel ECG lead can be recorded with a glove and an EKG lead can be taken as explained in connection with FIG. 2 when two such gloves are used.

ECG delivery via the glove makes it possible for persons, such as athletes (for example racing cyclists), to dispense with a chest strap for heart rate measurement and, in addition to the heart rate, also to measure a 1-channel ECG. In this case, the second electrode portion on the outside of the glove z. B. lie on a fingertip.

The same measuring principle above with the aid of a glove according to the invention can also be realized with the aid of a shirt-like piece of clothing. In this case, the first electrode portion (in different possible embodiment) is arranged on the inner surface of the shirt-like garment contacting the upper body of the patient; the second electrode portion, however, according to the invention separated from the first electrode portion is arranged on the outer surface of the shirt-like garment, so that it can be easily touched by the hand of the patient wearing the shirt-like garment. In the case of touch then the measurement / imaging, etc. takes place.

Some embodiments also relate to a method for measuring an electrocardiogram of the heart of a patient, as has already been partially explained above. First, the method comprises applying at least one double electrode as described above and / or applying a glove having a double electrode as described above to an arm Hand of the patient, so that the first electrode portion is placed on the surface of the arm or the hand of the patient. The method further includes placing the second electrode portion at a body site of the patient, such as the "E" or "S" position. Finally, the electrocardiogram is measured, eg with an ECG device.

In some embodiments, the method further comprises applying a second double electrode and / or applying a second glove so that the first electrode portion of the second double electrode is placed on the surface of the other arm or the other hand of the patient. In addition, the method includes placing the second electrode portion at a second body site of the patient, e.g. also the "E" or "S" position that is not yet occupied. This makes it possible, as stated above, to quickly record an ECG, from which the classical derivatives can be calculated.

Some embodiments relate to an electrocardiogram device for measuring an electrocardiogram of the heart of a patient, the electrocardiogram device comprising at least one dual electrode as described above, and a controller electrically coupled to the double electrode and configured to receive electrical electrode signals from the double electrode and an electrocardiogram take.

In some embodiments, the electrocardiogram device includes at least two double electrodes, and the controller is further configured to calculate a derivative of electrode signals located on the patient's left arm, right arm, above the breastbone, and below the sternum of the patient, that is, the position discussed above "E", "S", "RA", "LA" are picked up by the first and second double electrodes. The controller may be configured to perform the calculations discussed above in connection with FIG. 2, in particular, it may be configured to calculate the voltage vectors as set forth above.

In addition, the controller may be submitted to compute a classical derivative, such as a derivative to Einthofen, Goldberger, Wilson, Nehb, Frank, and / or Dower. In some embodiments, the electrocardiogram device is designed to be portable.

Returning to FIG. 3, there is illustrated an embodiment of a dual electrode 10. It has a first electrode portion which is formed by a first electrode 1 1 a, and a second electrode portion which is formed by a second electrode 1 1 b, wherein the first 1 1 a and the second electrode 12b are arranged symmetrically opposite each other. The two electrodes 1 1 a and 1 b are formed of metal and thus electrically conductive. They are separated by an insulating body 12 which is formed of plastic and on which they are fixed, electrically separated from each other.

A first electrical line 13a is coupled to the first electrode 11a, and a second electrical line 13b is coupled to the second electrode 11b. The two electrical leads 13a and 13b are formed as wires in a cable which is guided in the insulating body 12.

An embodiment of a glove 20 according to the invention with such a double electrode 10 is illustrated in FIGS. 4a and 4b. The double electrode 10 is arranged to contact the heel of the hand when a user puts on the glove 20. The first electrode 1 1 a is disposed on the inside of the glove 20 and contacts the palm. The second electrode 1 1 b is disposed on the surface of the glove 20 and may be attached to another body site, such as e.g. position "E" or "S". The insulating body 12 of the double electrode 10 is connected to the material of the glove 20, so that the double electrode 10 is fixedly connected to the glove 20. Of course, in the context of the garment "glove 20" previously described disclosure includes all garments that can wear such a double electrode 10 on the one hand, but at the same time be adapted to the body topography of the patient (such as stocking-like and / or stretchable devices) to the stationary Position of the electrodes 11 a, 11 b for the purpose of measurement on the patient to ensure.

In other embodiments, the first and / or the second electrode may also be configured as electrically conductive strips on the glove itself or, for example, of electrically conductive threads (metal threads or the like) in the glove material, etc. The material of the glove or the shirt-like garment is not limited to a particular material and the glove may be made of any suitable material, such as leather, fabric, plastic, etc.

An embodiment of an ECG device 30, which correspond to two double electrodes 10 'and 10 ", which correspond to the double electrode 10 described in connection with FIG. 3, is illustrated in FIG. 5.

The ECG device 30 has a controller 35, which has a processor 31 and a memory 34. In addition, the ECG device 30 has a speaker 32 for outputting beeps and a display 33 for displaying an ECG, cardiac parameters, and other information.

The two double electrodes 10 'and 10 "are each connected via a line pair 35'a, 35'b or 35" a, 35 "b to the controller 35 or its processor 31.

The controller is configured to receive ECG signals from the two double electrodes 10 'and 10 "and to determine an ECG therefrom and, if necessary, to calculate one or more of the abovementioned classical derivatives. as explained in connection with Fig. 2. The program necessary for this purpose is, for example, stored in the memory 34 and contains corresponding code which causes the processor 31 to execute the program.

A method 40 for measuring an ECG using, for example, the ECG device of FIG. 5 is illustrated in FIG.

First, at 41 one or both of the double electrodes 10 'and 10 "of the ECG device 30 are respectively applied to the left and right hands of the patient and placed at 42 on the palm of the left and right hands so that there is a corresponding one Contact is made.

Then the other two electrodes of the double electrodes 10 'and 10 "are placed on the body, eg at the positions" E "and" S ", respectively, so that at each of the positions" E "," S "," RA "and" LA " As shown in Fig. 2 and explained in connection with this, an electrode is applied, for which purpose the patient only has to move his hands with the correspondingly arranged double electrodes 1 β 'and 10 "to the position" S "above and place "E" below the breastbone.

Next, at 44, an ECG is measured by the ECG device 30 and output on the display 33, for example.

Claims

A dual electrode (10) for measuring an electrocardiogram of the heart of a patient (1) comprising: a first electrode portion (11a) for placement at a first body site (E, S, RA, LA) of the patient (1); and a second electrode portion (1 1 b) for placing at a second body site (E, S, RA, LA) of the patient (1) different from the first body site (E, S, RA, LA); wherein the first electrode portion (1 a) and the second electrode portion (11 b) are electrically separated from each other.

2. Double electrode according to claim 1, wherein the first (1 1 a) and / or the second (1 1 b) electrode portion is adapted to a shape of the first or second body location (E, S, RA, LA).

3. Double electrode according to claim 2, wherein the first (11 a) and / or the second (1 1 b) electrode portion is cup-shaped for placement on a ball of the thumb.

4. garment (20) with a double electrode (10) according to any one of the preceding claims.

5. A garment according to claim 4, wherein the garment is a glove (20) and the first electrode portion (11) is disposed inside the glove (20) for contacting a handball and the second electrode portion (11b) is disposed on the surface of the glove (20) is arranged.

The garment of claim 4 wherein the garment is a shirt and the first electrode portion is disposed on the inner surface of the shirt contacting the upper body of the patient and the second electrode portion is disposed on the outer surface of the shirt to be contacted by the patient's hands to be able to.

7. Method for measuring an electrocardiogram of the heart of a patient comprising:

The application (41) of a double electrode (10) according to any one of claims 1 to 3 and / or application (41) of a glove (20) according to any one of claims 4 and 5 on a hand of the patient (1), so that the first electrode portion on the Surface of the patient's hand (1) is placed;

Placing (43) the second electrode portion (11b) at a body site (E, S, RA, LA) of the patient (1); and

Measuring (44) the electrocardiogram.

8. The method of claim 7, further comprising applying (41) a second double electrode (10) according to any one of claims 1 to 3 and / or applying (41) a second glove (20) according to any one of claims 4 and 5 on one hand the patient (1) comprising, so that the first electrode portion (1 1 a) of the second double electrode (10) on the surface of the other hand of the patient (1) is placed; and placing the second electrode portion (11b) at a second body site (E, S, RA, LA) of the patient (1).

An electrocardiogram device for measuring an electrocardiogram of the heart of a patient, comprising: at least one double electrode (10 ', 10 ") according to any one of claims 1 to 3; and a controller (35) connected to the double electrode (10', 10") is electrically coupled and adapted to receive electrical electrode signals from the dual electrode (10 ', 10 ") and to receive an electrocardiogram.

An electrocardiogram device comprising at least two double electrodes (10 ', 10 ") according to any one of claims 1 to 3, and wherein the controller (35) is further adapted to calculate a derivative of electrode signals present on the left arm (LA). , on the right arm (RA), above the sternum (S) and below the breastbone (E) of the patient (1) through the first (10 ') and the second (10 ") double electrode.

1 1. Electrocardiogram device according to claim 9 or 10, in which the discharge is a derivative to Einthofen, Goldberger, Wilson, Nehb, Frank or Dower.