Development of wearable multi-lead ECG measurement device using cubic flocked electrode | Scientific Reports - Nature.com

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Introduction

Vital motion monitoring utilizing wearable sensors enables wellness absorption successful regular life. For example, assorted wearable sensors person been reported for pulse rate^1,2,3, peripheral oxygen saturation (SpO₂)^4,5, assemblage temperature^6,7,8, humor flow^9,10, and electromyography measurements^11,12. In particular, the request for wearable measurement sensors for electrocardiogram (ECG) measurements^{13,14,15,16,17} is precocious due to the fact that bosom illness is among the astir prevalent causes of decease worldwide¹⁸. For example, the Asahi Kasei Zoll Medical Corporation is selling the “Life Vest”, which integrates an ECG measurement relation utilizing adust electrodes and an electrical daze relation into the vest¹⁹. When ventricular fibrillation occurs during sleep, the Life Vest tin prevention the patient's beingness by detecting the ventricular fibrillation and automatically administering an electrical shock. As described above, wearable ECG measurement devices are wide utilized successful wellness absorption applications and aesculapian applications.

To measurement ECG signals for aesculapian applications specified arsenic 12-lead ECG, Holter ECG monitoring, and Mason-Likar (ML) ECG, electrodes indispensable beryllium placed connected the patient’s thorax and torso. Therefore, a clothing-type wearable instrumentality is suitable for usage successful aesculapian applications. In addition, from the viewpoints of wearability and hygiene, the electrode should beryllium a adust benignant alternatively than a bedewed type^20,21,22,23. However, 1 of the astir important problems to beryllium flooded erstwhile performing ECG measurements with adust electrodes is question artifacts (MAs). MAs are fluctuations of the ECG awesome owed to assemblage movement. Because gels are not utilized with adust electrodes, the mechanical interaction betwixt the tegument and the electrode is unstable. Therefore, adjacent insignificant movements specified arsenic breathing tin origin changes successful the impedance and the resting imaginable betwixt the tegument and the electrodes. As a result, these electrical changes distort the baseline of the ECG. One mode to trim MAs is to summation the interaction unit acting betwixt the tegument and the electrodes. Inoue’s radical reported unchangeable ECG measurements wherever they improved the interaction unit by impregnating the sponge with conductive ink²⁴. In addition, Cardon’s radical reported adust electrodes formed into the signifier of an array of pillars that amended the section interaction pressure²⁵. However, MAs and diligent discomfort are successful a trade-off relationship. Therefore, interaction unit optimization is important.

The author’s radical has been processing a adust electrode utilizing electrostatic flocking technology^26,27 and wearable multi-lead ECG measurement devices²⁸. However, successful erstwhile reports, we improved the interaction unit by wrapping the wearer’s thorax with a corset implicit the compression wear. This method was precise uncomfortable for the wearer. Therefore, successful this study, we person developed a caller adust electrode called the “cubic flocked electrode (CFE)” that tin amended the interaction unit locally without the request for a corset. The CFE, successful which the aboveground of a urethane signifier is electrostatically flocked with Ag-plated fibers, is simply a adust electrode that offers interaction stableness and precocious flexibility. Therefore, precocious MA absorption tin beryllium expected erstwhile utilizing the CFE nether due interaction pressure.

In this paper, we archetypal picture the CFE fabrication method and the cardinal characteristics of this electrode. It is shown that the adust electrode worldly tin beryllium applied uniformly to a three-dimensional urethane signifier aboveground utilizing electrostatic flocking technology. Next, to estimation the interaction unit worth that tin alteration ECG measurements to beryllium performed without MAs, an MA reproduction and valuation experimentation was conducted utilizing a tegument phantom. In this experiment, we aimed to forestall MAs from occurring due to the fact that of assemblage movements caused by mean respiration. Based connected the interaction unit worth obtained from the MA reproduction experiment, we designed a wearable multi-lead ECG measurement instrumentality utilizing the CFE. This wearable multi-lead ECG measurement instrumentality was developed for measuring 12-lead ECG astatine location without a doctor. Since the measurement is assumed to instrumentality respective minutes successful a resting state, question artifacts owed to mean respiration are dominant. Therefore, we designed the instrumentality truthful that the interaction unit tin trim question artifacts caused by mean respiration.

Results

Cubic flocked electrode

Figure 1a shows the CFE fabrication process utilizing electrostatic flocking technology, wherever Ag-plated fibers were formed connected the aboveground of a urethane form. The fibers were charged astatine 50 kV. Therefore, the fibers basal vertically against the urethane signifier surface, arsenic shown successful Fig. 1b. The CFE has dimensions of 20 mm × 20 mm and is 12 mm thick. The hardness of the CFE is 20° (SRIS 0101/Asker C). The flocking process is described successful item successful the “Methods” section.

First, we evaluated the cardinal characteristics of the CFE. Because the CFE is flexible, it tin beryllium deformed greatly by compression. The effect of this deformation connected the absorption worth of the CFE itself was truthful evaluated. Figure 1c shows the changes successful the absorption worth erstwhile the CFE is compressed successful the 3 axial (x, y, and z) directions. The compression complaint ranged from 10 to 50%. The absorption worth fluctuation is the largest on the z-axis (from 14.1 Ω astatine 100% to 8.0 Ω astatine 50%). The absorption fluctuations on the x and y axes were smaller than those on the z-axis (less than 10 Ω). However, erstwhile compared with the skin-electrode impedance, which is astir a fewer megaohms, the absorption alteration was tiny capable to beryllium negligible. Therefore, large-scale deformation of the CFE itself does not impact the ECG measurements.

Figure 1d shows the skin-electrode impedance characteristics of the CFE, a poly(3,4-ethylene dioxythiophene) polystyrene sulfonate (PEDOT: PSS) electrode (C3fit IN-pulse, Goldwin Inc., Japan), and an Ag/AgCl electrode (Red Dot, 3M, USA) with gel. The measurement frequence scope for the impedance is from 1 Hz to 10 kHz and the measurement presumption was astatine the forearm, arsenic shown successful the figure²⁹. Because the impedance is babelike connected the interaction pressure²⁸, the interaction unit betwixt the tegument and the electrode was fixed astatine 200 Pa. From this result, the impedance of the CFE was higher than that of the Ag/AgCl electrode with gel. However, erstwhile compared with the PEDOT: PSS electrode, which is an concern product, the impedance was astatine the aforesaid level for some electrodes. This effect shows that the impedance is tiny capable to let the CFE to beryllium applied to ECG measurements.

MA reproduction experiment

To measure the MA durability of the CFE, an MA reproduction experimentation was conducted utilizing a tegument phantom. The intent of this experimentation is besides to get the due interaction unit betwixt the tegument and the CFE for the plan of the wearable multi-lead ECG measurement design. The magnitude of the question artifact V_ma is fixed by the pursuing equation³⁰.

$${\mathrm{V}}_{\mathrm{ma}}=2\left[\Delta {\mathrm{V}}_{\mathrm{dc}-\mathrm{offset}}+\Delta {\mathrm{Z}}_{\mathrm{skin}-\mathrm{electrode}} \left(\frac{\left(\frac{{\mathrm{V}}_{\mathrm{ECG}}}{2}\right)+{\mathrm{V}}_{\mathrm{dc}-\mathrm{offset}}}{{\mathrm{Z}}_{\mathrm{in}}}+{\mathrm{I}}_{\mathrm{bias}}\right)\right]$$

(1)

V_dc-offset, Z_{skin-electrode}, V_ecg, and I_bias are the offset voltage generated astatine the skin-electrode interface, the impedance betwixt the tegument and the electrode, the ECG awesome voltage, and the input bias existent of the amplifier, respectively. ΔV_dc-offset and ΔZ_{skin-electrode} are large causes of MAs. The intent of this insubstantial is to trim some ΔV_dc-offset and ΔZ_{skin-electrode}, and to amusement experimentally the benignant of unit and conditions nether which V_ma tin beryllium reduced by utilizing a raised electrode.

Figure 2a,b amusement the experimental system. The tegument imaginable of the close limb (RA) position, which was generated utilizing an ECG simulator (ProSim8, Fluke Corp., USA), was connected to the tegument phantom (HXBNXTB858510MX, Wet Lab Inc., Japan). The CFE was attached to the aboveground of the tegument phantom and was past connected to an ECG amplifier (Analog Devices, USA). The CFE was glued to a textile (MCM3749, Under Armour, USA), which is the aforesaid worldly that is utilized for the wearable multi-lead ECG measurement instrumentality described aboriginal successful the paper. The borderline of the textile was fixed to a jig. The interaction unit betwixt the electrode and the tegument phantom was measured utilizing a unit gauge. Additionally, the tegument imaginable of the near limb (LL) was connected to the amplifier directly. The ECG awesome was recorded utilizing an oscilloscope arsenic the output ECG signal. The tegument phantom was attached to an x, z, and θ axial automatic stage. This automatic signifier moved successful a circular travel specified that displacement occurred betwixt the electrodes and the tegument phantom. As a result, an MA was reproduced. Note that the halfway of the axis of rotation of θ is the interaction constituent betwixt the tegument phantom and the electrode.

Two samples were prepared to comparison their ECG awesome prime levels. Sample A is simply a flocked electrode that was formed connected the textile directly. Sample B is the CFE attached to the textile, arsenic shown successful Fig. 2c. These samples were placed successful interaction with the tegument phantom specified that the fixed portion of the cloth was aligned with the aboveground of the tegument phantom. This interaction authorities is simply a reproduction of the interaction authorities of the existent wearable instrumentality itself. The interaction pressures measured utilizing the flocked electrode illustration and the CFE illustration were 57.3 Pa and 495.2 Pa, respectively, arsenic calculated utilizing the output of a unit gauge. The ECG awesome was measured erstwhile the automatic signifier reciprocated connected the x-axis (Δx = 500 µm, 1000 µm, 1500 µm), the z-axis (Δz = 500 µm, 1000 µm, 1500 µm), and the θ-axis (Δθ = 0.5°, 1.0°, 1.5°). These displacement values were calculated based connected the thorax enlargement complaint during respiration³¹. The frequence of the signifier question was 14 circular trips/min, which was equivalent to the mean quality breathing frequency. The measurement clip was 20 s.

About the results for Sample A, the largest MA was observed erstwhile the signifier moved on the x-axis. The MA is confirmed, adjacent astatine Δx = 500 μm. This is due to the fact that of the occurrence of slippage. Because the archetypal interaction unit was 57.3 Pa, the flocked electrode could not travel the x-axis displacement, and the tegument phantom-electrode interface slipped arsenic a result. For the z-axis and the θ-axis, the MA was suppressed due to the fact that the textile absorbed the displacement, which meant that the MA was smaller than the x-axis displacement. In contrast, successful the Sample B results, MAs were hardly observed connected the x-axis, the z-axis, and the θ-axis. It is believed that this effect was caused by the accrued interaction unit erstwhile making the cubic signifier of the urethane form. This means that the slippage was suppressed by the shear deformation of the urethane form. The results supra amusement that the occurrence of MAs tin beryllium reduced by utilizing the CFE. Furthermore, we obtained a plan indicator that interaction unit of 500 Pa oregon much tin trim the fig of MAs being caused by respiration.

Wearable multi-lead ECG measurement device

Figure 3a shows the wearable multi-lead ECG measurement instrumentality that we developed successful this work. The presumption is from the rear broadside of the device. Compression deterioration (MCM3749, Under Armour) was utilized arsenic a substrate textile to summation the interaction unit betwixt the tegument and the CFE. On the compression deterioration surface, 18 CFEs were attached astir the thorax area, and 4 CFEs were attached to the limbs utilizing adhesive paste. The positions of these electrodes were designed to measurement the V1–V6 signals of the Mason-Likar (ML) pb ECG signals, which are equivalent to the V1–V6 signals of the 12-lead ECG signals³². The 18 electrodes located astir the thorax tin beryllium divided into six precocious electrodes, six mediate electrodes, and six little electrodes. The crushed for this part process is to trim the power of electrode positioning errors owed to differences successful the mode that idiosyncratic patients deterioration the device. These electrodes were connected to the pads successful the tummy presumption utilizing conductive thread (AGposs, Mitsufuji Corp., Japan) and were sewn successful presumption utilizing a sewing machine. The pads were besides fabricated utilizing the electrostatic flocking exertion and were connected to corresponding pads connected the beforehand broadside by through-wiring. The conductive threads were protected and covered with a movie to forestall the threads from attaching to the patient’s tegument straight due to the fact that nonstop attachment tin origin sound connected the ECG signals. The measurement strategy is described successful item successful the “Methods” section. Figure 3b shows the valuation of the interaction unit betwixt the CFE aboveground and the tegument of a torso (CPLM, TOMANE CO., LTD., Japan). The interaction unit was measured by the insertion of a balloon that was connected to an aerial unit measurement strategy (AMI3037-2, AMI Tec Inc., JAPAN). To optimize the interaction unit according to the MA valuation experiment, the CFE’s tallness was designed by checking respective interaction pressures successful bid up to much than 500 Pa. Finally, the heights of the CFEs were determined arsenic shown successful Fig. 3b. The mean interaction pressures with the optimized CFE astatine positions V1–V6 were 0.6 kPa, 0.53 kPa, 0.53 kPa, 1.83 kPa, 0.37 kPa, and 0.73 kPa, respectively. These results amusement that the interaction pressures are astir each much than 500 Pa, which was indicated successful the MA valuation results.

Figure 4a shows a photograph of the ECG measurement experimentation with the wearable multi-lead ECG measurement device. The experimental protocol was arsenic follows.

1)
Put connected the wearable instrumentality without gel.
2)
Measure the multi-lead ECG awesome successful the spine presumption portion breathing freely (2 min).
3)
Take disconnected the wearable device.
4)
Measure the 12-lead ECG awesome utilizing a aesculapian merchandise (Smart ECG, ECG Lab Corp., Japan) successful the spine presumption portion breathing freely (2 min). The electrodes were placed by a aesculapian doctor. The fig of subjects for this experimentation was 10.

Figure 4b shows the ECG signals acquired successful 2 min astatine the V3 presumption of the mediate six electrodes. Both signals with MAs and signals without MAs tin beryllium observed from the ECG signals of this 2 min period. In a awesome without MAs, the P, Q, R, S, and T waveforms tin beryllium observed clearly. In contrast, the awesome with the largest MA successful this experimentation was detected arsenic shown successful the precocious close country of this figure. From this signal, portion the R waveform is the exception, the P, Q, S, and T waveforms could not beryllium observed due to the fact that of the fluctuations successful the baseline. However, these fluctuations occurred lone six times successful 2 min (marked by reddish triangles). Furthermore, the fluctuations occurred for lone a fewer seconds and soon disappeared. This effect indicates that the origin of the baseline fluctuation was a flimsy question of the quality assemblage alternatively than breathing.

Figure 5 shows the ECG signals measured by the wearable multi-lead ECG measurement instrumentality (18 electrodes) and by aesculapian products (six electrodes). Figure 5a shows the ECG waveform of a taxable who succeeded successful producing a unchangeable measurement. About the 18 pb ECG signals, we successfully acquired waveforms of sufficiently bully prime to let the P, Q, R, S, and T waves to beryllium identified successful each leads. In addition, the ECG awesome waveforms for each pb are akin to those of the six-lead ECG awesome obtained utilizing the aesculapian product. This confirms that the projected ECG offers the aforesaid prime arsenic the aesculapian product. In contrast, Fig. 5b shows the ECG waveform for a taxable whose measurements were not stable. Fluctuations of the baseline and sound are observed successful signals V1, V2, and V6. Signal V1 of the precocious electrode cannot beryllium confirmed, adjacent with the R waveform. In contrast, successful signals V3 to V5, we person achieved unchangeable ECG awesome measurements to immoderate extent. Because the taxable was slender (chest circumference: 86.0 cm) erstwhile compared with the different subjects (average thorax circumference: 92.2 cm), it is considered that unchangeable ECG measurements are possible, adjacent successful the V1, V2, and V6 awesome areas, by designing wearable multi-lead ECG devices to beryllium a circumstantial size. The results of the objection experimentation supra amusement that it is imaginable to measurement an ECG astatine the aforesaid level arsenic a aesculapian merchandise with the diligent successful a resting authorities by utilizing the projected wearable multi-lead ECG measurement instrumentality with the CFE.

Discussion

In this paper, the cardinal diagnostic valuation of the CFE, the quantitative valuation of the MAs, the compression plan for the wearable multi-lead ECG measurement instrumentality utilizing the CFE, and the results of objection tests performed successful a infirmary are described.

About the interior absorption fluctuations that occurred erstwhile the CFE was greatly deformed, the absorption alteration was respective ohms, adjacent astatine a compression complaint of 50% successful x, y, and z axial compression. As mentioned successful a erstwhile report²⁸, the electrostatic flocking-based electrode has characteristics of some precocious elasticity and precocious conductivity. Therefore, the alteration successful absorption of the CFE tin beryllium reduced adjacent nether precocious compression complaint conditions.

Next, astir the results of the MA reproduction experiment, ECG measurements were performed erstwhile the tegument phantom and the electrode were displaced connected the x, z, and θ axes. In particular, the power of the x-axial displacement was the largest among the displacements connected these 3 axes. As mentioned earlier, this displacement is owed to a gaffe astatine the tegument phantom-electrode interface. This gaffe is babelike connected the archetypal interaction unit and the magnitude of the silver-plated fiber. During tiny movements of the assemblage specified arsenic breathing, MAs did not hap successful the illustration erstwhile utilizing the CFE. However, MAs tin hap during larger movements specified arsenic walking and exercise. However, expanding the interaction unit is not the preferred solution successful presumption of some wearability and diligent comfort. Therefore, it is important to plan a nonslip adust electrode. In aboriginal work, we volition analyse the narration betwixt the magnitude of the silver-plated fibers and the slippage, and the MAs caused by this slippage.

Next, the ECG measurement results for 2 subjects from a full of 10 subjects are besides presented (Fig. 5). About the results of the 1 taxable who succeeded successful producing unchangeable ECG measurements, it is probable that each electrodes were successful unchangeable interaction with the taxable due to the fact that the size of the wearable multi-lead ECG measurement instrumentality was fitted well. These results were besides successful bully statement with those from a aesculapian merchandise for 18-lead ECG. Generally, successful a 12-lead ECG, the highest of the R question decreases erstwhile the electrode presumption connected the thorax rises. Additionally, the highest of the R question increases erstwhile the electrode presumption connected the thorax falls³³. This inclination was besides confirmed successful the experiments successful this work. These results confirmed that we successfully measured the ECG, with results that are accordant with accepted aesculapian findings.

In contrast, astir the results of the taxable who did not execute unchangeable ECG measurements, the origin of the instability is the size mismatch that was described above. In particular, the ECG was unstable successful the epigastrium (V1, V2) and the axilla (V6). It is believed that this instability was not owed to the electrode tallness of the CFE but occurred due to the fact that the pressing unit of the covering itself that was holding the electrode was weak. The existent tallness of the CFE was 12 mm astatine the epigastrium and 7 mm astatine the armpit (and 4 mm for V3 to V5). The interaction was astir apt unstable contempt these electrode heights due to the fact that the pressing unit of the covering acting connected the backmost of the CFE was low. This effect illustrates that it is important to plan the CFE and the wearable instrumentality to suit the wearer's assemblage shape.

Finally, we sermon the specification comparisons betwixt antithetic adust electrodes for 12-lead ECG measurement arsenic shown successful Table 1. The novelty of the projected electrode is that unchangeable ECG tin beryllium measured with debased interaction pressure. Conventional adust electrodes request a interaction unit of astir 2.0 kPa oregon much to stably measurement ECG. Also, galore papers bash not notation interaction pressure. Even with non-contact adust electrodes, determination is simply a cloth betwixt the electrode and the skin, truthful the interaction unit betwixt the cloth and the tegument is an important factor. On the different hand, with CFE, unchangeable ECGs tin beryllium measured astatine 0.5 kPa successful tegument phantom experiments and 0.77 kPa (average) successful objection tests. We judge that debased interaction unit is an important diagnostic and accomplishment of CFE due to the fact that debased interaction unit brings comfortableness to the wearer.

Table 1 The specification comparisons betwixt antithetic adust electrodes for 12-lead ECG measurement.

In summary, we person reported the improvement of a wearable multi-lead ECG measurement instrumentality utilizing CFEs. In aboriginal work, we purpose to recognize a adust electrode that tin execute unchangeable ECG measurements without MAs not lone during breathing but besides portion the diligent is walking and taking exercise.

Methods

Fabrication of cubic flocked electrode

(1st step) The cubic urethane signifier was 20 mm × 20 mm successful size and 10 mm thick. The hardness of the urethane signifier was 20° (SRIS 0101/Asker C). (2nd step) Adhesive paste (UNIBINDER NU-84, Co., Ltd., Japan) was sprayed astir the urethane form. (3rd step) Subsequently, Ag-plated fibers (AGposs chopped fibre 1.7T, 0.5 mm; Mitsufuji Corporation, Japan) were formed astir the urethane signifier utilizing electrostatic flocking technology. The fibers were 500 µm agelong and person a diameter of 18 µm. The fibers were charged up to 50 kV and past sprayed connected the urethane form. Therefore, the fibers basal vertically against the aboveground of the urethane form. (4th step) Finally, the urethane signifier was dried successful a furnace astatine 100 °C for 30 min.

Fabrication of wearable multi-lead ECG measurement device

The multi-lead ECG deterioration and measurement strategy is shown successful Fig. 6. The signals measured by the CFE astatine each presumption were connected to the flexible printed circuit (FPC) via drawback buttons connected the wearable device. Therefore, the wearable instrumentality and the FPC tin beryllium attached and detached some mechanically and electrically. The FPC is connected to a awesome processing committee with amplifiers (AD8232, Analog Devices) and a microcontroller portion (MCU; MSP430F55281YFF, Texas Instruments, USA). Eighteen amplifiers are included to measurement the V1–V6 signals astatine the precocious six electrodes, the mediate six electrodes, and the little six electrodes. These signals are past transmitted to a smartphone oregon idiosyncratic machine (PC) via wires and the signals tin frankincense beryllium measured. The smartphone oregon PC supplies the powerfulness to the awesome processing board.

Demonstration test

The authors state that the Ag-plated fibre developed successful this enactment does not person skin-irritating properties, arsenic confirmed by the results of a superior tegument irritation trial (MTT assay). Additionally, the experimental protocols successful this insubstantial were approved by the IRB of Ethics successful Applied Biomedical Engineering and Technology (71120030-A-20181002-001) successful the National Institute of Advanced Industrial Science and Technology (AIST). Furthermore, the authors state that each experiments were carried retired portion pursuing the applicable guidelines and regulations. All volunteers provided informed signed consent to enactment successful the study. There were nary unpaid complaints including tegument itching oregon rashes successful the objection test.

Data availability

The datasets generated during and/or analyzed during the existent survey are disposable from the corresponding writer upon tenable request.

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Acknowledgements

This enactment was supported by the New Energy and Industrial Technology Development Organization (NEDO) task called “Development of Basic Technology for Next-Generation Printed Electronics Materials and Process Technology Project”, and by JSPS KAKENHI nether Grant Number JP20278610.

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Authors and Affiliations

Sensing System Research Center, National Institute of Advanced Industrial Science and Technology (AIST), Tsukuba, 305-8564, Japan
Toshihiro Takeshita, Manabu Yoshida, Yusuke Takei, Atsushi Ouchi & Takeshi Kobayashi
Graduate School of Medicine, Nagoya University, Nagoya, 466−8550, Japan
Akinari Hinoki & Hiroo Uchida

Contributions

T.T., M.Y., Y.T., A.H., H.U., and T.K. conceived the experiments; T.T., Y.T., and A.O. conducted the experiments; and T.T. and A.H. analyzed the results. All authors reviewed the manuscript.

Corresponding author

Correspondence to Toshihiro Takeshita.

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Takeshita, T., Yoshida, M., Takei, Y. et al. Development of wearable multi-lead ECG measurement instrumentality utilizing cubic flocked electrode. Sci Rep 12, 19308 (2022). https://doi.org/10.1038/s41598-022-24043-6

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