阅读说明：本技术 用于经由非粘附性直接接触电极装置来获得患者的心电图信号的方法和系统 (Method and system for obtaining an electrocardiogram signal of a patient via a non-adhesive direct contact electrode arrangement ) 是由 T·瓦伦特 N·施托费尔 M·M·凯尔 S·福克 于 2020-03-04 设计创作，主要内容包括：本发明提供了用于织物套的各种方法和系统,该织物套包括用于测量与多个集成电极中的至少一个子集直接接触的患者的心电图信号的多个集成电极。作为一个示例,用于婴儿培养箱或保暖器的织物套包括：多个电极,该多个电极在适于与患者直接接触的该织物套的表面的测量区域内彼此间隔开,该多个电极包括横跨测量区域的整个宽度延伸的最顶部电极、横跨测量区域的整个宽度延伸的最底部电极和在垂直于宽度的方向上在测量区域内布置在最顶部电极与最底部电极之间的一组电极。(Various methods and systems are provided for a fabric sleeve including a plurality of integrated electrodes for measuring an electrocardiogram signal of a patient in direct contact with at least a subset of the plurality of integrated electrodes. As one example, a fabric sleeve for an infant incubator or warmer includes: a plurality of electrodes spaced apart from one another within a measurement region of a surface of the fabric sleeve adapted to be in direct contact with a patient, the plurality of electrodes including a topmost electrode extending across an entire width of the measurement region, a bottommost electrode extending across the entire width of the measurement region, and a set of electrodes disposed between the topmost electrode and the bottommost electrode within the measurement region in a direction perpendicular to the width.)

1. A fabric sleeve for an infant incubator or warmer, comprising:

a plurality of electrodes spaced apart from one another within a measurement region of a surface of the fabric sleeve adapted to be in direct contact with a patient, the plurality of electrodes including a topmost electrode extending across an entire width of the measurement region, a bottommost electrode extending across the entire width of the measurement region, and a set of electrodes disposed between the topmost electrode and the bottommost electrode within the measurement region in a direction perpendicular to the width.

2. The fabric sleeve of claim 1, wherein each electrode of the set of electrodes extends across a majority of the entire width of the measurement region.

3. The fabric sleeve of claim 1, wherein each electrode of the set of electrodes is disposed directly adjacent to two other electrodes of the set of electrodes and one of the topmost and bottommost electrodes.

4. The fabric sleeve of claim 1, wherein the topmost electrode and the bottommost electrode are dedicated drive electrodes, and wherein each electrode of the set of electrodes is a measurement electrode.

5. The fabric sleeve of claim 1, wherein each electrode of the plurality of electrodes and the fabric sleeve are porous.

6. The fabric sleeve of claim 1, further comprising at least one electrical connector and a plurality of electrical leads, each of the plurality of electrical leads insulated from the plurality of electrodes via a dielectric layer and extending between a respective electrode and the at least one electrical connector.

7. The fabric sleeve of claim 6 wherein said at least one electrical connector is wirelessly connected to signal processing circuitry via a wireless connection.

8. The fabric sleeve of claim 6, further comprising an integrated electronics layer electrically coupled to said at least one electrical connector and adapted to perform measurements on electrical signals received from said plurality of sensors.

9. The fabric sleeve of claim 8, wherein said integrated electronics layer includes a dynamic switching circuit including an input switch matrix and an output switch matrix adapted to switch which of said plurality of electrodes is driven to output a drive common mode output signal and which signals received from said plurality of electrodes are used to determine an electrocardiogram signal of said patient.

10. The fabric sleeve of claim 1 wherein said plurality of electrodes receive power via a battery incorporated into said fabric sleeve.

11. The fabric sleeve of claim 1, wherein each electrode of the plurality of electrodes is an electrode pad comprising a silver deposited electrode layer, and wherein each electrode and the corresponding electrical connections between the electrode and an electrical connector or measurement electronics are electrically conductive, while the remainder of the fabric sleeve is non-conductive.

12. A system for measuring biopotentials of a patient, comprising:

a plurality of electrodes spaced apart from one another along a surface adapted to be placed in direct contact with the patient; and

an electronic processor in electronic communication with each electrode of the plurality of electrodes and adapted to: obtaining signals output from at least two measurement electrodes of the plurality of electrodes in direct contact with the patient, and dynamically switching which of the plurality of electrodes is selected as a drive electrode while at least a portion of the surface is in contact with the patient.

13. The system of claim 12, wherein the plurality of electrodes comprises a first set of dedicated drive electrodes adapted to output only a drive common mode output signal and a second set of measurement electrodes adapted to measure biopotentials of the patient, wherein the drive electrodes are selected from the first set of dedicated drive electrodes and the two measurement electrodes are selected from the second set of measurement electrodes.

14. The system of claim 13, wherein the first set of dedicated drive electrodes comprises at least two electrodes, wherein a number of electrodes in the second set of measurement electrodes is greater than a number of electrodes in the first set of dedicated drive electrodes, and wherein the plurality of electrodes are spaced apart from each other via a gap comprising a material that insulates adjacent electrodes from each other.

15. The system of claim 12, wherein the electronic processor is further adapted to: determining which of the plurality of electrodes are in direct contact with the patient based on the individual skin impedance measurements received from each of the plurality of electrodes, and selecting the drive electrode as the electrode having the individual skin impedance measurement at a threshold level.

16. The system of claim 15, wherein the electronic processor is further adapted to determine an electrocardiogram signal of the patient from signals output by the at least two measurement electrodes determined to be in direct contact with the patient, wherein the electrodes having signals used to determine the electrocardiogram signal do not include the selected drive electrode.

17. The system of claim 16, wherein the electronic processor is further adapted to determine a heart rate of the patient from the determined electrocardiogram signal and display one or more of the determined heart rate and electrocardiogram signal via a display device.

18. A method, comprising:

while the patient is in direct contact with the fabric surface having the plurality of electrodes integrated therein:

receiving signals from the plurality of electrodes;

based on the received signals, selecting at least a first electrode of the plurality of electrodes as a measurement electrode and a second electrode of the plurality of electrodes as a drive electrode;

receiving and processing signals from at least the first electrode to determine and output an electrocardiogram signal of the patient with reduced noise; and

dynamically switching which of the plurality of electrodes is selected as the drive electrode in response to a change in which of the plurality of electrodes is in direct contact with the patient.

19. The method of claim 18, wherein the dynamic switching comprises: receiving a signal that the second electrode is no longer in direct contact with the patient; and selecting a different third electrode of the plurality of electrodes as the drive electrode; and while continuing to determine and output the electrocardiogram signal, switching to deliver a driving common mode output signal to the patient from the first electrode to the third electrode.

20. The method of claim 19, wherein selecting at least the first electrode of the plurality of electrodes as a measurement electrode comprises: receive signals from the plurality of electrodes, determine which signals indicate that corresponding ones of the plurality of electrodes are in direct contact with the patient, and process the signals of each corresponding electrode indicated as being in direct contact with the patient to determine the electrocardiogram signal, and further comprising displaying, via a display device, one or more of the determined electrocardiogram signal and a heart rate determined from the electrocardiogram signal.

Technical Field

Embodiments of the subject matter disclosed herein relate to devices including a plurality of electrodes adapted to have direct, but non-adhesive, contact with and measure an electrocardiogram signal of a patient.

Background

An Electrocardiogram (ECG) may provide a measurement of the electrical signals of the heart. Standard methods for measuring the patient's electrical potential (e.g., biopotentials) and obtaining the patient's ECG signal may include securing electrodes directly to the patient's skin. For example, the plurality of electrodes may be attached to the skin of the patient via an adhesive. The acquired ECG signals may be used to diagnose a cardiac condition of the patient, as well as to determine the heart rate of the patient. Heart rate can be used for patient monitoring and diagnosis. When used in neonatal or infant care applications (typically directly after delivery of the neonate/infant), an ECG signal and/or heart rate may be required during resuscitation and/or monitoring of the patient for additional intervention.

Disclosure of Invention

In one embodiment, a fabric sleeve for an infant incubator or warmer comprises: a plurality of electrodes spaced apart from one another within a measurement region of a surface of the fabric sleeve adapted to be in direct contact with a patient, the plurality of electrodes including a topmost electrode extending across an entire width of the measurement region, a bottommost electrode extending across the entire width of the measurement region, and a set of electrodes disposed between the topmost electrode and the bottommost electrode within the measurement region in a direction perpendicular to the width.

It should be appreciated that the brief description above is provided to introduce in simplified form a selection of concepts that are further described in the detailed description. It is not meant to identify key or essential features of the claimed subject matter, the scope of which is defined uniquely by the claims that follow the detailed description. Furthermore, the claimed subject matter is not limited to implementations that solve any disadvantages noted above or in any part of this disclosure.

Drawings

The invention will be better understood by reading the following description of non-limiting embodiments with reference to the attached drawings, in which:

fig. 1 shows an example of a neonatal or infant care environment comprising a fabric sleeve with integrated sensors for direct contact with a patient.

Fig. 2 shows an exemplary block diagram of a system for measuring biopotentials of a patient, including an apparatus having a sensor array and signal processing circuitry.

FIG. 3 shows an example of a dynamic switching circuit for controlling the sensors of the sensor array of FIG. 2.

Fig. 4 shows a schematic diagram of an exemplary position of a patient on a fabric sleeve including a plurality of integrated sensors for measuring biopotentials of the patient.

Fig. 5 shows a flow chart of a method for dynamically switching drive electrodes of a sensor array of a device in direct contact with a patient and determining an Electrocardiogram (ECG) signal and/or heart rate of the patient by means of signals acquired from a plurality of measurement electrodes of the sensor array.

Fig. 6-10 illustrate exemplary arrangements of electrodes of a fabric sleeve adapted to be placed in direct contact with a patient.

FIG. 11 shows a schematic diagram of a fabric sleeve configured to facilitate inter-dermal contact between a patient and a care provider while measuring a biopotential of the patient.

Detailed Description

The following description relates to various embodiments of an apparatus (e.g., a fabric sleeve) including a plurality of electrodes for measuring electrocardiogram signals of a patient in direct contact with at least a subset of the plurality of electrodes. To monitor and care for a patient, such as a neonate or infant, an Electrocardiogram (ECG) and/or heart rate signal of the patient may be acquired and displayed to a user (e.g., a medical professional). As described above, standard electrodes for measuring the ECG signal of a patient may be attached to the skin of the patient. However, such electrodes that adhere to the skin of a patient can cause damage to the more delicate skin of a neonate or infant. Furthermore, a medical professional may need a period of time to attach all ECG leads (e.g., electrodes). However, the time at which the ECG electrodes are attached is often critical for administering the necessary and life-saving care to the neonate or infant. In one example, after birth, a neonate or infant may be placed in a neonate or infant care environment (which may include a bassinet, warmer, or incubator), on top of a platform or mattress. Devices such as fabric sleeves (which may be in the form of blankets, sheets, or mattress covers in some embodiments) may include a plurality of electrodes (also referred to herein as sensors) attached or integrated therein. The fabric sleeve including the arrangement of electrodes may then be positioned in direct contact with the patient (e.g., placed on top of a mattress, with the patient lying directly on the fabric sleeve). For example, when a patient is placed on a fabric cover having electrodes embedded therein, signal processing circuitry of the electrodes of the fabric cover (such as the signal processing circuitry shown in fig. 2 and 3) or signal processing circuitry in electronic communication with the electrodes of the fabric cover may automatically and immediately begin acquiring biopotential signals of the patient. While the electrodes of the fabric sleeve may be in direct contact with the patient's skin, they may not be physically attached (e.g., adhered) to the patient. Thus, as shown in fig. 4, the patient may be able to move around across the surfaces of the electrodes and the fabric sleeve, thereby changing which electrodes of the fabric sleeve are in direct contact with the patient's skin. The electrodes may be arranged in an array and comprise a plurality of measurement electrodes (adapted to measure biopotentials of a patient) and one or more dedicated drive electrodes (adapted to output a drive common mode output signal adapted to reduce noise of the measured biopotential signals). The acquired biopotential signals may then be used to determine the ECG signal and/or heart rate of the patient. As shown in the method of fig. 5, which of the electrodes are being used as drive electrodes for data acquisition may be dynamically switched during operation based on which electrodes are determined to be in direct contact with the patient. Thus, a more accurate ECG signal with reduced noise can be obtained (in one example, continuously) even when the patient is moving around at the top of or against the fabric sleeve. The system may have minimal passive contact with the patient while still allowing direct contact with the patient's skin. Thus, the impact on the infant/neonate may be reduced.

Fig. 1 shows an example of a neonatal or infant care environment including a fabric sleeve with an incorporated (e.g., integrated in one embodiment) sensor for direct contact with a patient. In particular, fig. 1 shows a neonatal or infant care environment 100. As shown in fig. 1, the environment 100 may include a neonatal/infant radiant warmer 102, which may be referred to as an infant warmer, which may include a mattress 104 for supporting a patient 108 (a neonate or infant). In an alternative embodiment, environment 100 may be an incubator. In an alternative embodiment, the environment 100 may be a bassinet. The incubator and/or warmer and/or cradle may be used in a Neonatal Intensive Care Unit (NICU) and/or immediately after delivery of the infant.

A device 110 having a sensor array is positioned between the mattress 104 and the patient 108. As used herein, sensor arrays and sensors may also be referred to as electrode arrays and electrodes, respectively. In the example shown in fig. 1, the device 110 is a fabric sleeve 106 that is positioned on/over the mattress 104 such that a top surface 112 of the fabric sleeve 106 is in direct contact with the patient 108. The fabric sleeve 106 includes a plurality of electrodes (e.g., sensors) integrated therein for measuring biopotentials of the patient 108. As described further below, the plurality of electrodes may be disposed on the top surface 112 such that they may be in direct contact with the skin of the patient 108. In one example, the fabric sleeve 106 may be a type of mattress or bed sheet. In one example, the fabric sleeve 106 may be a blanket.

As further described herein, the device 110 may provide Electrocardiographic (ECG) monitoring of a patient, such as a neonate or infant. The device 110 may be comprised of a plurality of sensors (e.g., electrodes) defining a sensor array integrated with the remainder of the device 110 (e.g., integrated with or sewn into the fabric of the fabric sleeve 106). The device 110 may be transportable and reusable (e.g., washable). In addition, the device 110 may be inserted under a patient, such as a neonate or infant, and on any surface, such as a blanket, mattress (as shown in fig. 1), or mother's chest or abdomen (as shown in fig. 11). For example, as shown in fig. 11 and as further described below, the device 110 may be integrated into a kangaroo care/wearable inter-skin application (such as a sling, neck strap, band loop, nursing coat, etc.). As described further below, the apparatus 110 may include electronics for: direct contact measurement of biopotentials (e.g., heart rate), signal conditioning and processing, and/or wired or wireless communication with additional electronics, processors, or control units. The device 110 can be configured for rapid measurement of ECG signals even in the event that the patient moves across the surface of the device 110 (such that the patient changes which sensors/electrodes of the device 110 are in direct contact with the patient). For example, device 110 may enable measurement of ECG signals through motion artifacts associated with patient movement on device 110 (e.g., on a bed sheet or blanket).

Fig. 2 shows an exemplary block diagram of a system 200 for measuring biopotentials of a patient (e.g., a neonate or infant), including an apparatus 110 having a sensor array 201 and a signal processing circuit 212. The device 110 may be a fabric sleeve (such as the fabric sleeve 106 shown in fig. 1, which may be a sheet, mattress cover, and/or blanket in some embodiments, or a fabric sleeve 1110, such as fig. 11, which may be a neck strap, sling, band, etc.). Thus, the device 110 may be or include a fabric base 203 in which a plurality of individual sensors or electrodes (202, 204, 206, and 208) of the sensor array 201 are integrated (e.g., embedded, stitched, bonded, or adhered in some manner). As shown in fig. 2, the sensor array 201 includes four individual sensors 202, 204, 206, and 208, all spaced apart from each other (e.g., not touching or directly contacting each other) via a gap (e.g., distance) 205. However, in alternative embodiments, the sensor array 201 can include more or less than four individual sensors (e.g., two, three, five, eight, ten, etc.). The individual sensors of the sensor array 201 may be arranged in a pattern. Examples of different patterns of sensors for the sensor array of device 110 are shown in fig. 4 and 6-10. For all patterns, the individual sensors may be spaced apart from each other such that a certain amount of fabric of the fabric base 203 electrically insulates adjacent sensors from each other. In this way, electrical signals are not transmitted between the sensors.

In one embodiment, each sensor of the sensor array 201 may be an electrode adapted to measure a biopotential of the patient in direct contact with the surface of the sensor. The sensors (e.g., sensors 202, 204, 206, and 208) may also be referred to herein as ECG sensors because they are adapted to measure Electrocardiogram (ECG) signals from the patient and determine the heart rate of the patient based on the measured signals. The sensor array 201 may include a plurality of measurement electrodes (e.g., that receive and measure ECG signals from a patient) and one or more dedicated drive electrodes (e.g., that output drive common mode output signals to the patient). In some examples, each of the measurement electrodes may be switched to be a drive electrode (e.g., from receiving biopotential signals from the patient to delivering a common mode output signal to the patient). However, all dedicated drive electrodes may remain as drive electrodes and may not be switched to measurement electrodes. In this way, the electrodes designated as dedicated drive electrodes may be used only to output a drive common mode output signal and may not be used to measure the biopotential of the patient. At any one time, one or more sensors may be selected to actively become drive electrodes and deliver a drive common mode output signal, as described further below. In one embodiment, first sensor 202, second sensor 204, and third sensor 206 may be measurement electrodes, while fourth sensor 208 is a dedicated drive electrode. In another embodiment, first sensor 202 and second sensor 204 may be measurement electrodes, while third sensor 206 and fourth sensor 208 are dedicated drive electrodes. In yet another embodiment, each of the first sensor 202, the second sensor 204, the third sensor 206, and the fourth sensor 208 may be a measurement sensor adapted to be individually switched to act as a drive electrode. In yet another embodiment, each of the first sensor 202, the second sensor 204, the third sensor 206, and the fourth sensor 208 may be a measurement sensor, and wherein the second sensor 204 and the third sensor 206 are adapted to be switched to act as drive electrodes. In this way, different combinations of measurement electrodes and drive electrodes comprised in the sensor array 201 are possible.

Each individual sensor (202, 204, 206, and 208) is electrically coupled to an electrical connector 210 via a different electrical connection 209. In one embodiment, the electrical connections 209 may be conductive wires woven or embedded within the fabric base 203. In this manner, electrical signals may be communicated back and forth between the various sensors and the connector 210. For example, signals received by the measurement electrodes from the patient may be transmitted to the connector 210 via the corresponding electrical connections 209, and drive common mode output signals may be sent from the connector 210 to the drive electrodes via the corresponding electrical connections 209. A single connector 210 is shown in fig. 2. However, in alternative embodiments, there may be multiple connectors (e.g., one for each individual sensor in sensor array 201).

The signal processing circuit 212 of the system 200 is electrically coupled to the connector 210 (or connectors) via a wired or wireless connection 211. In one embodiment, all or selected portions of the signal processing circuitry 212 may be included within the apparatus 110, and the processed signals may be transmitted to additional processing electronics or a remote data acquisition and/or display device via a wireless connection. In this embodiment, the connector 210 may be omitted. Alternatively or in addition, device 110 may include an integrated electronics layer 213 electrically coupled to (and/or included within) connector 210 and adapted to perform measurements on electrical signals received from a plurality of sensors. For example, the integrated electronics layer may include one or more components of the signal processing circuit 212 and/or the dynamic switching circuit 300 (as further described below with reference to fig. 3). In another embodiment, as shown in fig. 2, all components of signal processing circuitry 212 may be located separately (e.g., remotely) from device 110, so connector 210 and wired or wireless connection 211 may transmit electrical signals (acquired measurements and drive signals) between device 110 and signal processing circuitry 212. In some embodiments, the connector 210 may include a wireless pod including a transmitter/receiver for transmitting wireless signals between the device 110 and the signal processing circuit 212. In another embodiment, the device 110 may include a separate wireless pod electrically coupled to the connector 210 or each separate sensor of the sensor array 201. In another embodiment, the sensor may receive power via a battery 230 incorporated into the device 110 (e.g., into the fabric sleeve), such as when the sensor and/or connector 210 is wirelessly connected to the signal processing circuit 212.

In one implementation, the signal processing circuit 212 may be processor-based. In one embodiment, the signal processing circuitry 212 may include one or more input/output interface devices 214 for communicating with, for example, the sensors 202, 204, 206, and 208 of the sensor array 201 and/or one or more external processing circuits. The one or more input/output interface devices 214 can include associated analog-to-digital and/or digital-to-analog circuitry for facilitating bi-directional signal communication with the sensor array 201. The signal processing circuitry 212 may also include one or more Central Processing Units (CPUs) 216, one or more memory devices 218 (e.g., Random Access Memory (RAM) and/or cache memory, which may be volatile), one or more storage devices (e.g., non-volatile storage devices) 220, and one or more output devices 222. The one or more memory devices 218 and/or the one or more storage devices 220 may define a tangible computer-readable storage medium for the signal processing circuit 212. The signal processing circuit 212 may also include a power source 224, which may be a battery-based power source to facilitate mobile operation of the signal processing circuit 212. In one implementation, the one or more output devices 222 may be provided, for example, by one or more of a display and/or one or more audio output devices (e.g., speakers) with or without an associated touch screen. In one embodiment, devices 214, 216, 218, 220, 222, and 224 communicate via a system bus 226. The signal processing circuitry 212 may output data via an output device 222, which may comprise a bus-connected output device as shown in fig. 2, and/or an output device that outputs data to the apparatus 110, which is provided as an output device that communicates with the signal processing circuitry 212 via an input/output interface device 214.

Fig. 3 shows an example of a dynamic switching circuit 300 for controlling ECG sensors (e.g., sensors 202, 204, 206, and 208) of device 110. In one embodiment, the dynamic switching circuit 300 may be part of the signal processing circuit 212, such as part of the CPU 216. In another embodiment, dynamic switching circuitry 300 may be included on/within device 110, such as part of and/or electrically connected to connector 210 (e.g., via integrated electronics layer 213).

The dynamic switching circuit 300 includes a sensor array 201 that includes a plurality of ECG sensors (e.g., electrodes). As discussed above with reference to sensor array 201 and fig. 2, at least one (and in some examples at least two) of the ECG sensors of sensor array 201 are dedicated, the drive electrodes selectively outputting the drive common mode output signal and the plurality of ECG sensors are measurement electrodes adapted to measure biopotentials of the patient and output these signals for use in determining the ECG signal of the patient. The measurement electrodes may also be switched to selectively output a drive common mode output signal. Further, more than one of the switchable measurement electrodes may be selected at any one time to output a driving common mode signal, as described below. However, the dynamic switching circuit 300 may dynamically switch which of the available electrodes outputs the drive common mode signal based on which sensor is in direct contact with the skin of a patient lying on the device 110.

Referring to fig. 3, the dynamic switching circuit 300 includes an ECG sensor of the sensor array 201 in bi-directional electronic communication with the defibrillator protection circuit 302. The defibrillator protection circuit 302 may include a plurality of resistors and/or additional circuit elements that absorb repetitive defibrillation and other high-energy pulses (e.g., electrostatic discharge) to protect the more sensitive electronic circuit elements in the dynamic switching circuit 300 and/or the device 110. The defibrillator protection circuit 302 is electrically coupled to one or more input filters 304 via bi-directional electronic communication. As one example, the one or more input filters 304 may include one or more filters (e.g., band pass filters, adaptive filters, etc.) that filter out noise (such as common motion/movement noise from a patient moving over/across ECG electrodes) in a signal measured by a measurement electrode (and which is used to determine the ECG signal of the patient). If one or more adaptive filters are used to filter out common motion noise, at least two input channels, each comprising at least 2 contact points between the ECG sensor and the patient's skin, and one drive electrode may be required. For example, in this case, at least two of the ECG sensors in the sensor array 201 that are determined to be in direct contact with the patient's skin (e.g., at least a threshold portion of the sensors are in direct contact with the patient, as explained further below) may be selected as measurement electrodes, and a different (third) one of the ECG sensors in the sensor array 201 that is also determined to be in direct contact with the patient's skin may be selected as drive electrodes. The adaptive filter may adjust the frequency range of the signal received from the patient and may be executed by the CPU 216.

The filtered signals from the input filter 304 are electrically transmitted to one or more ECG differential amplifiers 306 for amplifying the measured signals from the patient. The amplified signals are then electrically transmitted to the input switch matrix 308. In one example, the input switch matrix 308 may determine which of the measurement electrodes of the ECG sensor are in contact with the patient's skin and select the signals received from those contacting measurement electrodes for transmission to an analog-to-digital converter (ADC)310 for further processing and determination of the patient's ECG signal and/or heart rate. In this manner, the input switch matrix 308 may selectively switch which measurement electrodes are used to obtain signals for determining the patient's ECG signal and/or heart rate. Determining which ECG sensors are in contact with the patient's skin may include: receiving signals from each of the ECG sensors, which may include measurements of skin impedance of the patient's skin; and determining which of the ECG sensors is in contact with the patient's skin based on which of the skin impedance measurements satisfies the threshold level (thereby indicating that the sensor providing the signal has a threshold amount of contact with the patient's skin and therefore can provide a strong enough signal for measuring the patient's ECG signal). The signal from the ECG sensor (and the sensor is thus a measurement electrode) that determines contact with the patient's skin is transmitted to the ADC310 for further processing and determination of the patient's ECG signal and heart rate. The measurement electrodes may each be connected to an ADC310, and the input switch matrix 308 may determine which measurement electrodes are in contact with the patient and thus may be used to provide a driving common mode signal back to the patient.

The ADC310 converts the filtered and amplified analog signal from the selected measurement electrode (ECG sensor) to a digital signal for further processing and output. For example, the converted digital signals from the ADC310 may be processed via additional electronics of the signal processing circuit 212 to determine a patient's ECG signal and the patient's corresponding heart rate. These determined ECG signals and/or heart rate may then be output to the user via one or more output devices (e.g., output device 222 of fig. 2). As one example, the output device may be an electronic display device.

The input switch matrix 308 may also select which of the ECG sensor's measurement electrodes should be used as drive electrodes for delivering a drive common mode output signal based on determining which ECG sensors are in sufficient contact with the patient's skin to provide a low electrical impedance, and thus are considered contact sensors. For example, the input switch matrix 308 may determine which input measurement electrodes are to be used to feed the amplifier 312. For example, at least one input measurement electrode may be selected by input switch matrix 308. In another example, all of the input measurement electrodes may be used to feed the amplifier 312 or any subset thereof.

The input switch matrix 308 then sends the selected ECG sensors to the drive electrode signal sources and delivers those signal sources to a drive common mode output amplifier 312, which can generate a drive common mode output signal. The drive common mode output signal and the selection of drive electrodes are then electronically sent to the output switch matrix 314. The output switch matrix 314 functions as follows: switching which ECG contact is delivering a driving common mode output signal to the patient and delivering the driving common mode output signal to the selected ECG sensor. In this manner, the selection of which measurement electrodes are to be switched and used to drive the output is determined by the output switch matrix 314.

In this manner, signals generated and measured using one or more direct contact ECG sensors of the sensor array 201 may be digitally sampled and combined to form an ECG signal of the patient, and the heart rate of the patient determined from the ECG signal. As described above, selecting contact ECG sensors for determining an ECG signal may include: at the input switch matrix 308, signals are selected from at least two contact ECG sensors (e.g., two contact points) for the measurement signal, and one contact ECG sensor is selected as a drive electrode. In another example, for measuring signals, the input switch matrix 308 may select signals from more than two contact ECG sensors (if it is determined that more than two ECG sensors are contacting the patient) for determining the ECG signals and heart rate of the patient.

Turning now to fig. 4, a schematic illustration of an exemplary position of a patient 424 on a fabric sleeve 410 is shown. Fabric sleeve 410 may be similar to device 110 and/or fabric sleeve 106 discussed above with reference to fig. 1-3. As discussed above, the fabric sleeve 410 includes a plurality of integrated ECG sensors 412, 414, 416, 418, 420, and 422, which may be referred to herein as electrodes or electrode pads. Each of the ECG sensors are spaced apart from each other such that they are electrically insulated from each other (and thus unable to pass signals between each other, thereby reducing signal interference between the ECG sensors) via the intervening fabric of the fabric sleeve 410. Fig. 4 shows an exemplary arrangement of ECG sensors on the surface of the fabric sleeve 410, which is not intended to be limiting and other arrangements of ECG sensors are possible. As shown in the example of fig. 4, the ECG sensors include a topmost ECG sensor 412, an upper left ECG sensor 414, a lower left ECG sensor 416, a bottommost ECG sensor 418, a lower right ECG sensor 422, and an upper right ECG sensor 420. The patient 424 may be smaller than the fabric sleeve 410 and thus may move around on top of and across the surface of the fabric sleeve 410. Thus, at different points in time, the patient's skin may be in contact with different ECG sensors of the fabric sleeve 410. Accordingly, a dynamic switching circuit (such as dynamic switching circuit 300 of fig. 3) that includes signal processing circuitry in or electrically coupled to the fabric sleeve 410 may switch in real-time (e.g., dynamically) which ECG sensors are selected as measurement electrodes and drive electrodes for generating an ECG signal of the patient and determining the heart rate of the patient based on the patient's position on the fabric sleeve 410 (as determined according to the methods described herein with reference to fig. 3 and 5).

In particular, fig. 4 shows a first view 400 of a patient (e.g., a neonate or infant) 424 in a first position (e.g., upper left corner) on a fabric sleeve 410. In this first position, patient 424 is in contact with topmost ECG sensor 412, upper left ECG sensor 414, and lower left ECG sensor 416. While a small portion of the patient's arm may be contacting the upper right sensor 420, there may not be enough skin-to-electrode contact to produce a strong enough skin impedance and measurement signal. Thus, the dynamically switched circuitry of the fabric sleeve 410 may select the ECG sensors 412, 414, and 416 to be contact sensors (e.g., ECG sensors that are in direct coplanar contact with a portion of the skin of the patient 424). One of the contact ECG sensors 412, 414, and 416 may be selected as a drive electrode (sensor), while the remaining two are selected as measurement electrodes. Signals from the remaining ECG sensors (418, 420, 422) that are determined to be contactless ECG sensors may be discarded (or not acquired) and not used to determine the ECG signal and heart rate of the patient. In one embodiment, the ECG sensors 416 and 422 can be dedicated drive electrodes. Thus, the dynamic switching circuit may automatically select the lower left ECG sensor 416 to deliver a driving common mode output signal. In an alternative embodiment, different one or more of the ECG sensors of the fabric sleeve 410 may be dedicated drive electrodes. In yet another embodiment, all ECG sensors of fabric sleeve 410 may be measurement electrodes (e.g., none dedicated to being driven only) adapted to switch (as determined and selected by the dynamic switching circuitry) between being measurement electrodes and being drive electrodes. However, by including some dedicated drive electrodes and some switchable measurement electrodes, if all measurement electrodes can be used to capture the ECG signal (e.g. because the measurement electrodes have good patient contact), electrode surface area is provided which can always be used to reduce common mode noise, which can improve signal processing results to mitigate motion and noise artifacts using adaptive filtering by the CPU. Furthermore, more ECG channels may improve the adaptive filtering results while using measurement electrodes for providing drive outputs reduces the number of channels available for post-digitization signal processing, so it may be desirable to provide dedicated drive electrodes so that all possible channels are available for ECG signal acquisition.

Fig. 4 also shows a second view 402 of a patient 424 in a second position (e.g., upper right corner) on the fabric sleeve 410. In one example, the patient 424 may have moved from a first position (in the first view 400) to a second position (in the second view 402), changing which of the ECG sensors the patient 424 is in direct physical contact with (thus changing the point of contact of the fabric sleeve 410). In this second position, the patient 424 is in contact with the topmost ECG sensor 412, the upper right ECG sensor 420, and the lower right ECG sensor 422. Thus, the patient 424 no longer contacts the ECG sensors 414 and 416, and has just contacted the ECG sensors 420 and 422. Thus, in one example, the dynamic switching circuitry can switch the drive electrodes to the lower right ECG sensor 422 (from the lower left ECG sensor 416 in the first view 400) in response to the patient's moving position on the fabric sleeve 410 and changing which ECG sensors are contacting the sensors. Further, the dynamic switching circuit may continue to use the topmost ECG sensor 412 as one measurement electrode and switch to using the upper right ECG sensor 420 (instead of the lower right ECG sensor 416, as used in the first view 400) as a second measurement electrode.

In the third view 404 of fig. 4, the patient 424 is in a third position (e.g., the mid-lower region) on the fabric sleeve 410. In one example, the patient 424 may have moved from the second position (in the second view 402) to the third position (in the third view 404), changing which of the ECG sensors the patient 424 is in direct physical contact with (and thus changing the point of contact of the fabric sleeve 410). In this third position, the patient 424 is in contact with the upper left ECG sensor 414, the lower left ECG sensor 416, the bottom most ECG sensor 418, the lower right ECG sensor 422, and the upper right ECG sensor 420. Thus, the patient 424 no longer contacts the topmost ECG sensor 412, remains in contact with the ECG sensors 420 and 422, and has just contacted the ECG sensors 414, 416, and 418 (as compared to the second view 402). Thus, in one example, the dynamic switching circuit may hold the drive electrode as the lower right ECG sensor 422 and not switch the drive electrode to a different ECG sensor. Further, the dynamic switching circuit may continue to use the top right ECG sensor 420 as one measurement electrode and switch to using the top left ECG sensor 414 and the bottom most ECG sensor 418 as additional measurement electrodes. Where the lower left ECG sensor 416 is a dedicated drive electrode, it may be used to apply a drive common mode output signal in addition to the lower right ECG sensor 422 currently selected as the drive electrode.

In the fourth view 406 of fig. 4, the patient 424 is in a fourth position (e.g., bottom left) on the fabric sleeve 410. In one example, the patient 424 may have moved from the third position (in the third view 404) to the fourth position (in the fourth view 406), changing which of the ECG sensors the patient 424 is in direct physical contact with (and thus changing the point of contact of the fabric sleeve 410). In this fourth position, the patient 424 is in contact with the upper left ECG sensor 414, the lower left ECG sensor 416, and the bottom-most ECG sensor 418. Thus, the patient 424 is no longer in contact with the upper right ECG sensor 420 and the lower right ECG sensor 422 (e.g., even though a small portion of the patient 424 is shown in contact with the sensor 422, there is not enough of the patient's skin in contact with the sensor 422 so the measured skin impedance of the sensor is below the threshold level) and remains in contact with the ECG sensors 414, 416, and 418 (as compared to the third view 404). Thus, in one example, the dynamic switching circuit can switch the drive electrode to the lower left ECG sensor 416 (from the lower right ECG sensor 422). Further, the dynamic switching circuitry may continue to use the top left ECG sensor 414 and the bottom-most ECG sensor 418 as measurement electrodes.

In all views of fig. 4, at least two contact ECG sensors are selected as measuring electrodes and a different one is selected as driving electrode. Thus, an ECG signal of the patient with reduced noise (e.g., reduced noise from motion of the patient) may be obtained from the acquired signals. As shown in the example of fig. 4, the ECG sensor used as the measurement electrode and the drive electrode may be selected based on the following conditions: which sensors are determined to be directly contacting the patient's skin and, at least under some conditions, dynamically switch as the patient moves across the fabric sleeve to different contact locations. For example, a dedicated drive electrode is fixed via a wired or wireless connection 211 depending on the connection to the signal processing circuit 212. The dedicated drive electrode is always enabled and driven. If impedance measurements are used, then it is sensed that the drive electrodes are not in contact with the patient, and the system can select which of the measurement electrodes will be used to drive the output signal. Which sensors are selected and used as drive electrodes and measurement (e.g., input) electrodes may be switched at any time during operation of the fabric sleeve (e.g., while the patient is on and/or in contact with the fabric sleeve). For example, the switching of the measurement electrodes and the drive electrodes may be performed prior to initial acquisition of the ECG signal (from the measurement electrodes). In another embodiment, the switching of the measurement electrodes and drive electrodes may occur during ECG acquisition (e.g., while the measurement signals are being acquired from the measurement electrodes) in response to determining that the contact ECG sensor has changed (e.g., the ECG sensor currently used to determine the ECG signals is no longer in contact with the patient and needs to switch to other sensors in contact with the patient).

As shown in fig. 4, multiple contacts between the patient (e.g., infant/neonate) and the ECG sensor board are made immediately upon application of the patient to the surface of the fabric sleeve. While the multiple contacts are direct points of contact between the patient's skin and the ECG sensor board, none of the ECG sensor board adheres or physically adheres to the patient's skin (e.g., via an adhesive), thereby reducing damage and irritation to the delicate skin of the infant/neonate. As also shown in the different views of fig. 4, the patient is free to move over the surface of the fabric sleeve and over the sensor array. Thus, the position of the patient on the sensor array can be changed, and therefore which electrodes are in contact with the patient's skin can also be changed during operation/data collection. As discussed above and further discussed below, the measurement electrodes and drive electrodes of the sensor array may be selected and switched according to this movement and variation of the contact sensor.

Fig. 5 shows a flow chart of a method 500 for dynamically switching drive electrodes of a sensor array of a device in direct contact with a patient and determining an ECG signal and/or heart rate of the patient by means of signals acquired from a plurality of measurement electrodes of the sensor array. In one example, the apparatus may be the apparatus 110 shown in fig. 1 and 2. And/or may be a fabric sleeve, such as one or more of the fabric sleeves disclosed herein with reference to fig. 1, 4, and 6-11. For example, the fabric sleeve may include one or more aspects of the fabric sleeve shown in fig. 1, 4, and 6-11. As disclosed herein, a device or fabric sleeve may include a sensor array having a plurality of sensors (e.g., electrodes) spaced apart from one another across a surface of the fabric sleeve. The fabric sleeve and sensor array are adapted to be in direct contact with the patient's skin (e.g., a neonate or infant may be placed directly on top of the sensor array of the fabric sleeve). However, the patient is free to move across the surface of the fabric sleeve, thereby changing its position on the sleeve. Thus, not all sensors of the sensor array may contact the patient at any one time (via direct contact), and which sensors are in contact with the patient may change as the patient moves/changes position on the sleeve. As used herein, a "contact sensor" of a sensor array may be defined as a sensor that is determined to be in direct contact with the skin of a patient so as to be able to acquire a signal (e.g., a biopotential) from the patient. Additionally, as used herein, "direct contact" refers to the electrode contacting the patient's skin without an intervening component disposed therebetween. In this way, the patient's electrodes may be in coplanar contact with the skin.

The method 500 begins at 502 by: when a patient (e.g., an infant or neonate) is placed in contact with a sensor array of a fabric sleeve, signals are received from a plurality of sensors (e.g., electrodes) of the sensor array. For example, the method at 502 may include: a signal is received (or acquired) from each sensor included in the sensor array. The received signal may be a measurable biopotential of the patient, and may have varying intensities (e.g., magnitudes). In some embodiments, if one or more of the sensors are not in direct contact with the patient (e.g., are not in contact with the patient at all), the received signal may be zero or below a lower threshold level, or the measured impedance may be above a threshold level. Once the patient is placed in contact with the sensor array, the signals from the sensors may be automatically and immediately acquired by the signal processing circuitry of the fabric sleeve or in electrical communication with the fabric sleeve.

At 504, the method includes determining which sensors of the sensor array are in direct contact with the patient based on the respective skin impedance measurements. For example, the signals received from the sensors at 502 may be used to determine individual skin impedance measurements corresponding to each sensor. Then, the method at 504 includes, for each sensor of the sensor array, determining that the individual sensor is in direct contact with the patient (and thus is a contact sensor) in response to the individual skin impedance measurement of the sensor being above a threshold level. In one example, the threshold level may be a non-zero impedance value, indicating that the sensor (which may be a sensor pad, as discussed herein) has a sufficiently large portion of its entire surface area in contact with the patient's skin in order to obtain a measurable biopotential signal for determining the patient's ECG signal (and heart rate). If the individual skin impedance measurements of the sensor are not below the threshold level, the method at 504 may include determining that the sensor is not in contact with the patient (and thus any signal received from that contact is not applied to determine the patient's ECG signal).

At 506, the method includes: based on which sensors are determined to be contact sensors (e.g., in contact with the patient, as determined at 504), sensors are selected from all of the sensors of the sensor array to be used as drive electrodes, and a drive common mode output signal is output via the selected sensors. As one example, the drive common mode output signal may be a voltage having a magnitude that is continuously applied to the patient via the selected drive sensor in order to cancel electromagnetic interference due to patient movement/motion and other environmental artifacts (such as power line frequencies, etc.). As described above, in one embodiment, all sensors of the sensor array may be measurement sensors adapted to receive and measure biopotential signals from the patient for processing into an ECG signal for the patient. Each of these measurement sensors may be individually switched to act as a drive electrode by outputting a drive common mode output signal. If it is determined at 504 that the measurement sensors are in direct contact with the patient, any of the measurement sensors may be selected as the drive electrode. In another embodiment, the sensor array may be divided into a first group of sensors, which are measurement sensors that may also be used as drive electrodes, and a second group of sensors, which are dedicated drive electrodes. The dedicated drive electrodes may be used only to deliver the common mode output signal and may not be used to acquire signals from the patient for determining the patient's ECG signal. In one example, the number of dedicated drive electrodes (sensors) may be less than the number of measurement sensors. In this embodiment, the common mode output signal may be delivered to the drive electrodes for delivery of the common mode output signal to the patient. If more than one dedicated drive sensor is in contact with the patient, the sensor that outputs the highest skin impedance measurement may be selected as the drive electrode. Alternatively, if more than one dedicated drive sensor is in contact with the patient, the processor may randomly select one of the contacted dedicated drive sensors to be the drive electrode. In yet another example, if more than one dedicated drive sensor is in contact with the patient, the processor may select a predetermined dedicated drive sensor (e.g., stored in a memory of the signal processing circuit) as the drive electrode and output the drive common mode output signal. In yet another example, if more than one dedicated drive sensor is in contact with the patient, the processor may select all dedicated drive electrodes and output a drive common mode output signal. If none of the dedicated drive sensors is in direct contact with the patient, the processor may select one of the measurement sensors in direct contact with the patient as a drive electrode and switch the selected measurement electrode from measuring the biopotential of the patient to outputting a drive common mode output signal. An example of selecting a sensor to use as a drive electrode based on the patient's position is shown in fig. 4, discussed above.

Method 500 then proceeds to 508 to receive (or continue to receive) a signal from a contact measurement sensor (e.g., a measurement sensor in contact with a patient). In one example, only measurement sensors in direct contact with the patient may acquire signals from the patient and transmit these signals to the signal processing circuitry. In another example, the signal processing circuit may receive signals from each individual measurement sensor even if the sensor is not in contact with the patient, and then only the received signals from sensors with low contact impedance below a threshold may be used to determine the ECG signal, as described further below.

At 510, the method includes filtering a signal received from a measurement sensor. As described above with reference to fig. 3, the filter may include one or more different types of filters, such as adaptive filters, band pass filters, and so forth. The method then proceeds to 512 to use the filtered signal from the measurement sensor determined to be in contact (e.g., direct contact) with the patient to determine an ECG signal of the patient and to determine a heart rate of the patient from the determined ECG signal. For example, the dynamic switching circuitry of the signal processing circuitry may be adapted to select filtered signals only from measurement sensors determined to be in direct contact with the patient (e.g., via an input switch matrix, such as input switch matrix 308 shown in fig. 3), and then determine the patient's ECG signal only from these selected filtered signals. The heart rate of the patient can then be determined directly from the determined ECG signal.

At 514, the method includes outputting the ECG signal and/or the heart rate to a user via an output device. In one example, the output device may be a display device in electronic communication with the signal processing circuit. The user may be a medical provider such as a technician, physician, or nurse. The method 500 may run continuously such that the ECG signal and/or heart rate is continuously determined and updated, and the display device may continuously display the updated signal while acquiring signals from the patient via the sensor array of the fabric sleeve. In this manner, the user may monitor the condition of the patient while the patient is in contact with the fabric sleeve with minimal intervention (e.g., no adhesive electrode is adhered to the patient's skin).

Continuing to 516, the method includes determining whether the contact sensor has changed. For example, the method at 516 may include determining whether the sensor previously (or most recently) selected as the drive electrode is no longer in contact with the patient. In this case, the currently selected drive sensor may not be able to deliver a drive common mode output signal for noise reduction. If the touch sensor has not changed, the method proceeds to 518 to continue acquiring signals from the measurement sensor and using the same (previously selected) sensor as the drive sensor. If any of the contact measurement sensors has changed, the method may further include continuing to acquire signals from the measurement sensors, but switching which measurement sensor signals are used to determine the ECG signal (e.g., via selecting signals from only sensors that are in direct contact with the patient).

If the contact sensors have changed, the method continues to 520 to dynamically switch which sensor is used as a drive sensor (e.g., electrode), while continuing to acquire signals from the contact measurement sensors if the currently selected drive sensor is no longer in contact with the patient. For example, the method at 520 may include switching from outputting a drive common mode output signal from a first sensor (determined to no longer be in direct contact with the patient) to outputting a drive common mode output signal from a second sensor (determined to be in direct contact with the patient). As described above, an example of which sensor is used as such switching of the drive electrode is shown in fig. 4. Dynamically switching which sensor is used as the drive electrode may include: as signals are continuously acquired from the measurement sensors and as the patient moves across the surface of the sensor array (and changes position), which sensor output drives the common mode output signal is switched in real time. Switching at 520 may also include switching which measurement sensors to use for determining the ECG signal if one or more measurement sensors are no longer in contact with the patient.

Fig. 6-10 illustrate exemplary arrangements of electrodes of a fabric sleeve, such as one of the fabric sleeves discussed herein. In particular, the fabric sleeve may be similar to device 110 and/or fabric sleeves 106 and 410 described above with reference to fig. 1-4. Thus, the fabric sleeve discussed below with reference to fig. 6-10 may include similar components, including a sensor array including a plurality of sensors integrated with the remainder of the fabric sleeve. In some embodiments, the fabric sleeve may be a sheet, mattress cover, blanket, or wearable article (such as a sling or wrap). The plurality of sensors may be in the form of electrode pads and may be adapted to act as measurement electrodes and/or drive electrodes, as discussed herein. In one embodiment, both the fabric base of the fabric sleeve and the electrode pad may be porous to interact with the skin and allow moisture and gas to be exchanged through them while still enabling measurements to be taken from the electrode pad. The electrode pad array on the surface of the fabric sleeve may be sized to include a selected number of electrode pads to accommodate a range of sizes of patients from newborns to older infants to adults.

The fabric sleeves discussed below with reference to fig. 6-10 may be optimized to maximize the separation distance (e.g., gap) between adjacently disposed electrodes (e.g., electrode pads), maximize the plurality of electrodes within an electrode array, maximize the electrode separation distance, and maximize the surface area of each electrode. For example, by having an increased number of potential contact points (where each electrode pad is considered a contact point) within a set area of the electrode array (referred to as a measurement area, as explained further below) while maximizing the surface area of each contact point, sensor signals for determining an increased number of ECG signals can be acquired even as the patient changes position on the fabric sleeve, thereby increasing the accuracy of the ECG signals and reducing signal noise. Maximizing the separation distance between the electrodes allows stronger signal peak-to-peak voltages to be obtained. Various embodiments discussed below with reference to fig. 6-10 are directed to achieving such an arrangement of electrode pads.

Turning first to fig. 6, a first embodiment of a fabric sleeve 600 is shown having a fabric base 602 with a plurality of electrode pads integrated therein. The electrode pads include semicircular electrode pads 604 arranged at the topmost and bottommost positions of a measurement region 608 of a fabric base 603 of the fabric cover 600 with a plurality of rectangular electrode pads 606 arranged therebetween. In alternative embodiments, the electrode pads 606 may have different shapes, such as square, circular, semi-circular, oval, hexagonal, and the like.

The measurement area 608 is defined as the area of the fabric sleeve that includes all of the electrode pads of the sensor array of the fabric sleeve. There may be no electrode pads (e.g., electrodes) disposed outside the perimeter of the measurement region 608. As shown in fig. 6, both semicircular electrode pads 604 extend across the entire width 610 of the measurement region 608, and each of the rectangular electrode pads extends across only a portion of the width 610. By having the topmost and bottommost electrode pads extending across the entire width of the measurement region, contact points are more likely to be obtained at either end of the patient. For example, both semicircular electrode pads 604 may be dedicated drive electrodes, and the extent and shape of the semicircular electrode pads may optimize contact with the patient's head if the patient is rolling or moving relative to the fabric sleeve.

Each of the rectangular electrode pads 606 is disposed directly adjacent to two other of the rectangular electrode pads 606 and one of the semicircular electrode pads 604. The spacing, arrangement, and/or shape of the rectangular electrode pads 606 may optimize contact with the torso region of the patient for ECG signal acquisition. Gaps 612 are disposed between the adjacently disposed electrode pads. The gaps 612 may have different sizes. In one example, the gap 612 may be less than a threshold distance, such as one-half inch. However, in alternative examples, the gap 612 may be between 0.25 inches and 0.5 inches or between 0.4 inches and 0.6 inches. The larger the gap between the two signal electrodes, the higher the skin impedance between them and thus the larger the amplitude of the measured ECG signal. The material within the gap 612 between the electrode pads is the fabric material of the fabric base 602 and may be insulating so that electrical signals are not transmitted between adjacent electrode pads.

Fig. 7 shows a second embodiment of a fabric sleeve 700 having a fabric base 602 with a plurality of electrode pads integrated therein. In this embodiment, the electrode pads include semicircular electrode pads 702 disposed at a topmost position and a bottommost position of the measurement region 608. The semicircular electrode pad 702 has a smaller height (direction perpendicular to the width 610) than the semicircular electrode pad 604 of fig. 6. The electrode pads also include rectangular electrode pads 704 that each extend across a majority of the entire width 610 of the measurement region 608. In alternative embodiments, each of the electrode pads 704 or a portion thereof may extend across the entire width 610. Further, in some embodiments, the rectangular electrode pad 704 may have alternative shapes, such as an oval shape, a rectangle with semi-circular ends, a semi-circle, and the like. As shown in fig. 6, adjacent electrode pads are separated by a gap 612, which may vary between different electrode pad pairs or may be the same for each adjacent electrode pad pair.

The fabric sleeves disclosed herein may be constructed from a fabric material (including one or more of cotton, nylon, rayon, spandex, and the like). The electrodes (electrode pads) and the electrical connections between the electrode pads and the connector or connecting element, as well as the connector (or lead) may be comprised of a conductive deposition material, such as silver. For example, the electrode pads and electrical connections and/or connectors may be silver deposited electrode layers on a textile substrate comprising one or more of the textile materials listed above. A masking or etching process may be used to define the active electrode areas and their corresponding conductive electrical connections (e.g., signal paths to connectors). This is in contrast to the non-conductive or insulating areas of the fabric base of the fabric sleeve. The use of silver material for the electrodes and/or signal paths may allow electrical signal transmission while providing antimicrobial properties with increased biocompatibility. The signal wiring paths (electrical connections) from each electrode pad to the connectors or measurement points at the electronic interface of the fabric sleeve can be insulated by adding a dielectric layer, avoiding undesired contact with the patient's skin. The electrical contacts or connectors (such as connector 210 shown in fig. 2) that measure or receive the signals from each electrode pad may be simple connectors with a sufficient pitch density of resilient contact pads on the fabric base to enable the connection to communicate biopotential signals to a data acquisition front-end device (which may be part of a signal processing unit, for example), either via a wired cable from the connector, or directly to an integrated electronics layer that performs the measurements on the fabric sleeve and wirelessly transmits the data to a monitoring station.

The fabric sleeve may be intended for single use or repeated use. For example, the fabric sleeve may be washed between uses (e.g., between patients). However, the fabric sleeve may have a limited number of uses, as the electrical contacts and/or electrode pads may deteriorate over time due to contact with water during washing.

Turning now to fig. 8-10, additional embodiments of the arrangement of the electrode pads of the fabric sleeve and the electrical connections (e.g., signal paths) from each electrode pad to a measurement point (which may include a connector in one example) are shown. In particular, fig. 8 shows a first textile sleeve 800 having a similar arrangement of electrode pads as fig. 7. For example, the fabric sleeve 800 includes top-most and bottom-most semicircular electrode pads 802 and a plurality of elongated electrode pads 804 disposed therebetween. Each electrode pad is coupled to a separate measurement point 806 by an electrical connection 808. Each measurement point 806 may be coupled to or include its own connector (e.g., similar to connector 210 of fig. 2), or all measurement points on the same side of the fabric sleeve may be coupled to a common connector that is in electronic communication with additional signal processing electronics via a wired or wireless connection. All or a portion of the additional signal processing electronics may be included on or off (e.g., remote from) the fabric sleeve.

Fig. 9 shows a second textile sleeve 900 having a different arrangement of electrode pads, including top-most and bottom-most semicircular electrode pads 902 and a plurality of hexagonal electrode pads 904 arranged therebetween. Some of the hexagonal electrode pads 904 may be partial (e.g., half-cut) hexagons in order to accommodate a honeycomb-like arrangement of hexagonal electrode pads (e.g., adjacent hexagons offset in an alternating pattern), as shown in fig. 9. Each of the hexagonal electrode pads 904 is spaced apart from each other and from the semicircular electrode pad 904. In alternative embodiments, the hexagonal electrode pad 904 may have alternative polygonal shapes, such as pentagonal, heptagonal, octagonal, decagonal, and the like. Similar to that described above with reference to fig. 8, each electrode pad of fig. 9 is coupled to a separate measurement point 906 by an electrical connection 908.

Fig. 10 shows a third fabric sleeve 1000 having yet another arrangement of electrode pads including a top-most and bottom-most semi-circular electrode pad 1002, a plurality of elongated electrode pads 1006, and a plurality of rectangular electrode pads 1004. In particular, fig. 10 shows two rows of rectangular electrode pads 1004 separated from each other via two elongated electrode pads 1006 (which are spaced apart from each other and from a row of rectangular electrode pads 1004 arranged adjacently), and an elongated electrode pad 1006 positioned between each row of rectangular electrode pads 1004 and one of the semicircular electrode pads 1002. However, in alternative embodiments, the third textile sleeve 1000 may include additional or fewer rows of rectangular electrode pads 1004 and more or fewer elongated electrode pads 1006 spaced between adjacent rows of rectangular electrode pads 1004 and/or between a row of rectangular electrode pads 1004 and a semi-circular electrode pad 1002. Similar to that described above with reference to fig. 8, each electrode pad of fig. 10 is coupled to a separate measurement point 1008 by an electrical connection 1010.

Fig. 11 shows a schematic view 1100 of a patient 1124 positioned on a care provider 1102 and held in place using a fabric sleeve 1110. The fabric sleeve 1110 may be similar to the device 110 and/or fabric sleeve 106 discussed above with reference to fig. 1-3. However, as shown in fig. 11, the fabric sleeve 1110 may be in the form of a wearable article configured to facilitate inter-dermal contact between the patient 1124 and a care provider 1102 (which may be the patient's parent or other care provider). Thus, the fabric sleeve 1110 may be in the form of a band, sling, carrier, nursing coat, or other wearable article. As shown, the patient 1124 is positioned between the care provider 1102 and the fabric sleeve 1110 such that the patient 1124 is in direct inter-dermal contact with the care provider 1102 (e.g., via a first side of the patient), and the patient 1124 is in direct skin-to-fabric and/or electrode contact with the fabric sleeve 1110 (e.g., via a second, opposite side of the patient).

As discussed above, the fabric sleeve 1110 includes a plurality of integrated ECG sensors 1112, 1114, 1116, 1118, 1120, and 1122, which may be referred to herein as electrodes or electrode pads. Each of the ECG sensors are spaced apart from each other such that they are electrically insulated from each other (and thus unable to pass signals between each other, thereby reducing signal interference between the ECG sensors) via the intervening fabric of the fabric sleeve 1110. Fig. 11 shows an exemplary arrangement of ECG sensors on a fabric sleeve 1110, which is not intended to be limiting and other arrangements of ECG sensors are possible. Further, the ECG sensors on the fabric cover 1110 may be positioned on the patient-facing surface of the fabric cover 1110 such that the electrodes may make direct contact with the patient 1124, while an insulating layer (not shown in fig. 11 for visual purposes) may form the outward-facing surface of the fabric cover 1110.

As shown in the example of fig. 11, the ECG sensors include a topmost ECG sensor 1112, an upper left ECG sensor 1114, a lower left ECG sensor 1116, a bottommost ECG sensor 1118, a lower right ECG sensor 1122, and an upper right ECG sensor 1120. The patient 1124 may be smaller than the fabric sleeve 1110 and therefore may move around across the patient-facing surface of the fabric sleeve 1110. Thus, at different points in time, the patient's skin may be in contact with different ECG sensors of the fabric sleeve 1110. Accordingly, a dynamic switching circuit (such as dynamic switching circuit 300 of fig. 3) including signal processing circuitry in or electrically coupled to the fabric sleeve 1110 may switch in real-time (e.g., dynamically) which ECG sensors are selected as measurement electrodes and drive electrodes for generating an ECG signal of a patient and determining a heart rate of the patient based on the patient's position on the fabric sleeve 1110 (as determined according to the methods described herein with reference to fig. 3 and 5).

The fabric sleeve 1110 may be similar to the fabric sleeves described above, and thus may be constructed from a fabric material (including one or more of cotton, nylon, rayon, spandex, and the like). The electrodes may be similar to the electrodes described above, so the electrodes (electrode pads) and the electrical connections between the electrode pads and the connector or connecting element, and the connector (or lead) may be comprised of a conductive deposition material, such as silver, for example a silver deposition electrode layer on a textile base comprising one or more of the textile materials listed above.

The fabric sleeve 1110 can be configured to maximize electrode contact with the patient 1124 while minimizing electrode contact with the care provider 1102. Thus, in a measurement region that is positioned to preferentially contact the patient, electrodes integrated in the fabric cover 1110 may be positioned on the fabric cover 1110. The fabric sleeve may include straps, fasteners, or other features not shown in fig. 11 to facilitate secure positioning of the patient 1124 with respect to the care provider 1102 while also ensuring maximum contact between the patient 1124 and the electrodes. The fabric sleeve 1110 can include an insulating layer on the outward facing surface of the fabric sleeve 1110 (opposite the patient facing surface), and an integrated electrode that can prevent contact between the care provider 1102 and the electrode.

However, given the high likelihood of patient motion and the small size of the patient relative to the care provider 1102, and also given the desire to maximize patient-to-electrode contact even as the patient moves (and thus the electrode's wide/long extension across the fabric sleeve), under all conditions, accidental contact between one or more of the electrodes and the care provider may not be prevented, or otherwise the care provider is spared from interfering with the patient's ECG signal. Thus, in at least some examples, before and/or during patient ECG signal acquisition, a diagnostic routine may be executed to determine whether a caregiver is affecting the ECG signals acquired by the system. If the caregiver is affecting the ECG signal, the acquisition of the ECG signal may be suspended until the caregiver no longer affects the ECG signal or the effect on the ECG signal from the caregiver may be filtered.

Fig. 1 and 6-10 illustrate exemplary configurations with relative positioning of various components. In at least one example, such elements may be referred to as being in direct contact or directly coupled to each other, if shown as being in direct contact or directly coupled, respectively. Similarly, elements that abut or are adjacent to each other may, at least in one example, abut or be adjacent to each other, respectively. For example, components disposed in coplanar contact with each other may be referred to as coplanar contacts. As another example, in at least one example, elements that are positioned spaced apart from one another and have only space therebetween without other components may be referenced as so described. As another example, elements shown as being above/below one another, on opposite sides of one another, or between left/right sides of one another may be so described with reference to one another. Further, as shown, in at least one example, a topmost element or point of an element can be referred to as a "top" of a component, and a bottommost element or point of an element can be referred to as a "bottom" of the component. As used herein, top/bottom, upper/lower, above/below may be with respect to the vertical axis of the figure, and may be used to describe the positioning of elements in the figure with respect to each other. Thus, in one example, an element shown as being above another element is positioned vertically above the other element. As another example, the shapes of elements shown in the figures may be referred to as having these shapes (e.g., such as being circular, straight, planar, curved, rounded, chamfered, angled, etc.). Further, in at least one example, elements that are shown as intersecting one another can be referred to as intersecting elements or intersecting one another. Additionally, in one example, an element shown as being within another element or shown as being outside another element may be referred to as being so described.

In this way, the fabric sleeve may comprise a plurality of electrodes arranged on the surface of the fabric sleeve in order to measure and ECG signals and/or the heart rate of the patient. The surface of the fabric sleeve is adapted to be in direct contact with the patient (e.g., the patient may be placed on top of and/or against the fabric sleeve). However, the electrodes may not be physically attached to the patient (via adhesive or other means) and the patient may be allowed to move freely across the surface of the fabric sleeve. Thus, the signal processing circuitry of the fabric sleeve may determine which of the plurality of electrodes are in direct contact with the patient's skin and dynamically switch which of the plurality of electrodes is used to output a drive common mode output signal and which electrode signal is used to determine the patient's ECG signal during acquisition of the signal via the electrodes. Thus, even as the patient moves across the fabric sleeve and changes position on the fabric sleeve, a more accurate ECG signal and heart rate of the patient with reduced noise can be acquired and used for diagnosis and intervention. A technical effect of receiving signals from a plurality of electrodes while a patient is in direct contact with a fabric surface having the plurality of electrodes integrated therein; based on the received signals, selecting at least a first electrode of the plurality of electrodes as a measurement electrode and a second electrode of the plurality of electrodes as a drive electrode; receiving and processing signals from at least a first electrode to determine and output an electrocardiogram signal of the patient with reduced noise; and dynamically switching which of the plurality of electrodes is selected as the drive electrode in response to changes in which of the plurality of electrodes is in direct contact with the patient in order to more quickly obtain a more accurate ECG signal and heart rate with reduced noise while also reducing stimulation of the patient's skin. Thus, in situations where time to intervene or treat the patient is more critical (for post-partum infants or neonates), patient treatment based on ECG signals and/or heart rate can be delivered more quickly and efficiently.

As one embodiment, a fabric sleeve for an infant incubator or warmer comprises: a plurality of electrodes spaced apart from one another within a measurement region of a surface of the fabric sleeve adapted to be in direct contact with a patient, the plurality of electrodes including a topmost electrode extending across an entire width of the measurement region, a bottommost electrode extending across the entire width of the measurement region, and a set of electrodes disposed between the topmost electrode and the bottommost electrode within the measurement region in a direction perpendicular to the width. In a first example of a textile sleeve, each electrode of the set of electrodes extends across a majority of the entire width of the measurement area. In a second example of the textile sleeve, optionally including the first example therein, each electrode of the set of electrodes is arranged directly adjacent to two other electrodes of the set of electrodes and one of a topmost electrode and a bottommost electrode. In a third example of the fabric sleeve, optionally including one or both of the first and second examples, the topmost electrode and the bottommost electrode are dedicated drive electrodes, and wherein each electrode of the set of electrodes is a measurement electrode. In a fourth example of the fabric sleeve, optionally including one or more or each of the first through third examples therein, each electrode of the plurality of electrodes and the fabric sleeve are porous. In a fifth example of the fabric sleeve, optionally including one or more or each of the first through fourth examples therein, the fabric sleeve further comprises at least one electrical connector and a plurality of electrical leads, each of the plurality of electrical leads insulated from the plurality of electrodes via the dielectric layer and extending between the respective electrode and the at least one electrical connector. In a sixth example of the fabric cover, optionally including one or more or each of the first through fifth examples, wherein the at least one electrical connector is wirelessly connected to the signal processing circuitry via a wireless connection. In a seventh example of the fabric sleeve, optionally including one or more or each of the first through sixth examples therein, the fabric sleeve further comprises an integrated electronics layer electrically coupled to the at least one electrical connector and adapted to perform measurements on electrical signals received from the plurality of sensors. In an eighth example of the fabric cover, optionally including one or more or each of the first through seventh examples, the integrated electronics layer comprises a dynamic switching circuit comprising an input switch matrix and an output switch matrix adapted to switch which of the plurality of electrodes is driven to output a drive common mode output signal and which signals received from the plurality of electrodes are used to determine the electrocardiogram signal of the patient. In a ninth example of the fabric sleeve, optionally including one or more or each of the first through eighth examples, the plurality of electrodes receive power via a battery incorporated into the fabric sleeve. In a tenth example of the textile sleeve, optionally including one or more or each of the first through ninth examples, each electrode of the plurality of electrodes is an electrode pad comprising a silver deposited electrode layer, and wherein each electrode and the corresponding electrical connections between the electrodes and the electrical connector or measurement electronics are electrically conductive, while the remainder of the textile sleeve is non-conductive.

As another embodiment, a system for measuring biopotentials of a patient includes a plurality of electrodes spaced apart from one another along a surface adapted to be placed in direct contact with the patient; and an electronic processor in electronic communication with each of the plurality of electrodes and adapted to: signals output from at least two measurement electrodes of a plurality of electrodes in direct contact with the patient are obtained, and which of the plurality of electrodes is selected as a drive electrode is dynamically switched while at least a portion of the surface is in contact with the patient. In a first example of the system, the plurality of electrodes comprises a first set of dedicated drive electrodes adapted to output only the drive common mode output signal and a second set of measurement electrodes adapted to measure biopotentials of the patient, wherein the drive electrodes are selected from the first set of dedicated drive electrodes and the two measurement electrodes are selected from the second set of measurement electrodes. In a second example of the system, optionally including the first example therein, the first set of dedicated drive electrodes comprises at least two electrodes, wherein the number of electrodes in the second set of measurement electrodes is greater than the number of electrodes in the first set of dedicated drive electrodes, and wherein the plurality of electrodes are spaced apart from each other via a gap comprising a material that insulates adjacent electrodes from each other. In a third example of the system, optionally including one or both of the first example and the second example, the electronic processor is further adapted to: determining which of the plurality of electrodes are in direct contact with the patient based on the individual skin impedance measurements received from each of the plurality of electrodes, and selecting the drive electrode as the electrode having the individual skin impedance measurement at the threshold level. In a fourth example of the system, which optionally includes one or more or each of the first through third examples, the electronic processor is further adapted to determine an electrocardiogram signal of the patient from signals output by at least two measurement electrodes determined to be in direct contact with the patient, wherein the electrodes having signals used to determine the electrocardiogram signal do not include the selected drive electrodes. In a fifth example of the system, optionally including one or more or each of the first to fourth examples, the electronic processor is further adapted to determine a heart rate of the patient from the determined electrocardiogram signal and display, via the display device, one or more of the determined heart rate and the electrocardiogram signal.

As yet another embodiment, the method includes, while the patient is in direct contact with the fabric surface having the plurality of electrodes integrated therein: receiving signals from a plurality of electrodes; based on the received signals, selecting at least a first electrode of the plurality of electrodes as a measurement electrode and a second electrode of the plurality of electrodes as a drive electrode; receiving and processing signals from at least a first electrode to determine and output an electrocardiogram signal of the patient with reduced noise; and dynamically switching which of the plurality of electrodes is selected as the drive electrode in response to a change in which of the plurality of electrodes is in direct contact with the patient. In a first example of the method, the dynamic switching comprises: receiving a signal that the second electrode is no longer in direct contact with the patient; and selecting a third electrode of the different, plurality of electrodes as a drive electrode; and while continuing to determine and output the electrocardiogram signal, switching to deliver a driving common mode output signal to the patient from the first electrode to the third electrode. In a second example of the method, which optionally includes the first example, selecting at least a first electrode of the plurality of electrodes as the measurement electrode comprises: the method further includes receiving signals from the plurality of electrodes, determining which signals indicate that corresponding electrodes of the plurality of electrodes are in direct contact with the patient, and processing the signals of each corresponding electrode indicated as being in direct contact with the patient to determine an electrocardiogram signal, and further including displaying, via a display device, one or more of the determined electrocardiogram signal and a heart rate determined from the electrocardiogram signal.

As used herein, an element or step recited in the singular and proceeded with the word "a" or "an" should be understood as not excluding plural said elements or steps, unless such exclusion is explicitly recited. Furthermore, references to "one embodiment" of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Moreover, unless explicitly stated to the contrary, embodiments "comprising," "including," or "having" an element or a plurality of elements having a particular property may include additional such elements not having that property. The terms "including" and "in … are used as shorthand, language equivalents of the respective terms" comprising "and" wherein ". Furthermore, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements or a particular positional order on their objects.

This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the relevant art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.