Method and system for obtaining electrocardiogram signals of a patient via a non-adherent direct contact electrode device

Abstract

Various methods and systems for a fabric cover including a plurality of integrated electrodes for measuring electrocardiogram signals of a patient in direct contact with at least a subset of the plurality of integrated electrodes are provided. As one example, a fabric cover 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 cover adapted for 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 arranged between the topmost electrode and the bottommost electrode within the measurement region in a direction perpendicular to the width.

Description

TECHNICAL FIELD

[0001] Embodiments of the subject matter disclosed herein relate to a device comprising a plurality of electrodes adapted to have direct, but non-adherent, contact with a patient's electrocardiogram signal and measure the patient's electrocardiogram signal. BACKGROUND

[0002] An electrocardiogram (ECG) can provide a measurement of electrical signals of the heart. Standard methods for measuring electrical potential (e.g., bioelectric potential) of a patient and obtaining an ECG signal of the patient can include affixing electrodes directly to the patient's skin. For example, a plurality of electrodes can be attached to the patient's skin via adhesive. The obtained ECG signal can be used to diagnose a cardiac condition of the patient, as well as determine a 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 a neonate / infant), the ECG signal and / or heart rate can be needed during resuscitation and / or monitoring of the patient for additional interventions to be performed. SUMMARY

[0003] In one embodiment, a fabric cover 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 cover 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 arranged between the topmost electrode and the bottommost electrode within the measurement region in a direction perpendicular to the width.

[0004] It is to be understood that the above brief description is provided to introduce in simplified form a selection of concepts that are further described in the detailed description. This brief description does not identify key or essential features of the claimed subject matter nor does it limit the scope of the claimed subject matter to any particular implementation described in this Summary. Furthermore, the claimed subject matter is not limited to implementations that solve any or all disadvantages noted in the above Background or any part of this disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0005] The present application will be better understood by reading the following description of non-limiting embodiments, with reference to the appended drawings, in which:

[0006] Figure 1 An example of a neonatal or infant care environment is shown that includes a fabric cover having integrated sensors for direct contact with a patient.

[0007] Figure 2 An example block diagram of a system for measuring bioelectric potential of a patient is shown that includes a device having an array of sensors and signal processing circuitry.

[0008] Figure 3An example of a dynamic switching circuit is shown, which is used to control... Figure 2 The sensor array of the sensor.

[0009] Figure 4 A schematic diagram of an exemplary position of a patient on a fabric cover that includes multiple integrated sensors for measuring the patient’s bioelectric potential is shown.

[0010] Figure 5 A flowchart is shown of a method for dynamically switching the driving electrodes of a sensor array of a device in direct contact with a patient and for determining the patient’s electrocardiogram (ECG) signal and / or heart rate by means of signals acquired from multiple measuring electrodes of the sensor array.

[0011] Figures 6 to 10 An exemplary arrangement of electrodes suitable for placement in a fabric sleeve in direct contact with a patient is shown.

[0012] Figure 11 A schematic diagram of a fabric cover is shown, which is configured to facilitate skin-to-skin contact between the patient and care provider while measuring the patient's bioelectric potential. Detailed Implementation

[0013] The following describes various embodiments of a device (e.g., a fabric cover) comprising multiple electrodes for measuring electrocardiogram (ECG) signals of a patient in direct contact with at least a subset of multiple electrodes. For monitoring and caring for patients, such as newborns or infants, the patient's electrocardiogram (ECG) and / or heart rate signals can be acquired and displayed to a user (e.g., a medical professional). As mentioned above, standard electrodes for measuring a patient's ECG signals can be attached to the patient's skin. However, such electrodes adhered to the patient's skin can cause damage to the more delicate skin of a newborn or infant. Furthermore, medical professionals may require a considerable amount of time to attach all ECG leads (e.g., electrodes). However, the timing of ECG electrode attachment is often critical for administering necessary and life-saving care to a newborn or infant. In one example, after birth, a newborn or infant can be placed in a neonatal or infant care environment (which may include a cradle, incubator, or incubator) on top of a platform or mattress. Devices such as fabric covers (in some embodiments, which may be in the form of a blanket, sheet, or mattress cover) may include multiple electrodes (also referred to herein as sensors) attached to or integrated therein. The fabric sleeve, including the arrangement of electrodes, can 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 the patient is placed on the fabric sleeve in which the electrodes are embedded, the signal processing circuitry of the electrodes in the fabric sleeve (such as...) Figure 2 and Figure 3The signal processing circuit shown, or the signal processing circuit that electronically communicates with the electrodes of the fabric sleeve, can automatically and immediately begin acquiring the patient's biopotential signal. Although the electrodes of the fabric sleeve can be in direct contact with the patient's skin, they can be applied to the patient without physical attachment (e.g., adhesion). Therefore, as... Figure 4 As shown, the patient may be able to move across the surface of the electrodes and fabric sleeve, thereby changing which electrodes of the fabric sleeve are in direct contact with the patient's skin. The electrodes can be arranged in an array and include multiple measuring electrodes (suitable for measuring the patient's biopotential) and one or more dedicated driving electrodes (suitable for outputting a driving common-mode output signal adapted to reduce noise in the measured biopotential signal). The acquired biopotential signal can then be used to determine the patient's ECG signal and / or heart rate. Figure 5 The method demonstrates that which electrodes in the electrode array are being used as driving electrodes for data acquisition can be dynamically switched during operation based on which electrodes are determined to be in direct contact with the patient. Therefore, even when the patient moves around on top of or against the fabric cover, a more accurate ECG signal with reduced noise can be obtained (in one example, continuously). The system allows for minimal passive contact with the patient while still permitting direct contact with the patient's skin. Therefore, the impact on infants / newborns can be reduced.

[0014] Figure 1 An example of a neonatal or infant care environment is shown, which includes a fabric cover having integrated (e.g., in one embodiment, an integrated) sensor for direct contact with the patient. Specifically, Figure 1 A newborn or infant care environment 100 is shown. (Example) Figure 1 As shown, environment 100 may include a neonatal / infant radiant warmer 102, which may be referred to as an infant warmer, and the infant warmer may include a mattress 104 for supporting the patient 108 (newborn or infant). In an alternative embodiment, environment 100 may be an incubator. In an alternative embodiment, environment 100 may be a cradle. Incubators and / or warmers and / or cradles may be used in neonatal intensive care units (NICUs) and / or immediately after the delivery of the infant.

[0015] A device 110 with a sensor array is positioned between a mattress 104 and a patient 108. As used herein, the sensor array and the sensor may also be referred to as an electrode array and an electrode, respectively. Figure 1In the example shown, device 110 is a fabric cover 106 positioned on / above a mattress 104 such that the top surface 112 of the fabric cover 106 is in direct contact with the patient 108. The fabric cover 106 includes multiple electrodes (e.g., sensors) integrated therein for measuring the bioelectrical potential of the patient 108. As further described below, these electrodes may be arranged on the top surface 112 such that they are in direct contact with the skin of the patient 108. In one example, the fabric cover 106 may be a type of mattress or sheet. In one example, the fabric cover 106 may be a blanket.

[0016] As further described herein, device 110 can provide electrocardiogram (ECG) monitoring of a patient (such as a newborn or infant). Device 110 may consist of multiple sensors (e.g., electrodes) defining a sensor array integrated with the remainder of device 110 (e.g., integrated with or sewn into the fabric of fabric cover 106). Device 110 may be transportable and reusable (e.g., washable). Furthermore, device 110 can be inserted under a patient (such as a newborn or infant) and onto any surface (such as a blanket, mattress, etc.). Figure 1 (as shown) or the mother's chest or abdomen (such as) Figure 11 As shown above. For example, as shown Figure 11 As shown and further described below, device 110 can be integrated into kangaroo care / wearable skin-to-skin applications (such as slings, neck straps, braces, nursing tops, etc.). As further described below, device 110 may include electronics for direct contact measurement of bioelectric potentials (e.g., heart rate), signal conditioning and processing, and / or wired or wireless communication with additional electronics, processors, or control units. Even when the patient moves across the surface of device 110 (causing the patient to change which sensors / electrodes of device 110 are in direct contact with the patient), device 110 can be configured for rapid measurement of ECG signals. For example, device 110 can achieve ECG signal measurement via motion artifacts associated with the patient's movement on device 110 (e.g., on a sheet or blanket).

[0017] Figure 2 An exemplary block diagram of a system 200 for measuring the bioelectric potential of a patient (e.g., a newborn or infant) is shown. The system includes a device 110 with a sensor array 201 and signal processing circuitry 212. The device 110 may be a fabric cover (such as...) Figure 1 The fabric cover 106 shown may, in some embodiments, be a sheet, mattress cover and / or blanket, or such as Figure 11The fabric cover 1110 can be a neck strap, suspension strap, loop, etc. Therefore, the device 110 may be or include a fabric base 203 in which multiple individual sensors or electrodes (202, 204, 206, and 208) of the sensor array 201 are integrated (e.g., embedded, sewn, bonded, or adhered in some way). Figure 2 As shown, sensor array 201 includes four individual sensors 202, 204, 206, and 208, all of which are spaced apart from each other via gaps (e.g., distances) 205 (e.g., not touching or in direct contact with each other). However, in an alternative embodiment, sensor array 201 may include more or fewer than four individual sensors (e.g., two, three, five, eight, ten, etc.). The individual sensors of 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... Figure 4 and Figures 6 to 10 As shown in the diagram. For all patterns, the individual sensors can be spaced apart from each other, such that a certain amount of fabric on the fabric base 203 electrically insulates adjacent sensors from each other. In this way, electrical signals are not transmitted between the sensors.

[0018] In one embodiment, each sensor of the sensor array 201 can be an electrode adapted to measure the bioelectric potential of the patient in direct contact with the surface of the sensor. The sensors (e.g., sensors 202, 204, 206, and 208) can 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 can include a plurality of measurement electrodes (e.g., that receive and measure ECG signals from the patient) and one or more dedicated drive electrodes (e.g., that output a drive common mode output signal to the patient). In some examples, each of the measurement electrodes can be switchable to a drive electrode (e.g., from receiving bioelectric potential signals from the patient to delivering a common mode output signal to the patient). However, all dedicated drive electrodes can remain as drive electrodes and can not be switchable to measurement electrodes. In this way, electrodes designated as dedicated drive electrodes can only be used to output a drive common mode output signal and can not be used to measure the bioelectric potential of the patient. As described further below, at any one time, one or more sensors can be selected to actively become a drive electrode and deliver a drive common mode output signal. In one embodiment, the first sensor 202, the second sensor 204, and the third sensor 206 can be measurement electrodes, and the fourth sensor 208 is a dedicated drive electrode. In another embodiment, the first sensor 202 and the second sensor 204 can be measurement electrodes, and the third sensor 206 and the 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 can be measurement sensors adapted to be individually switched to function 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 can be measurement sensors, and wherein the second sensor 204 and the third sensor 206 are each adapted to be switched to function as a drive electrode. In this way, different combinations of measurement electrodes and drive electrodes included in the sensor array 201 are possible.

[0019] 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 can be conductive wires woven or embedded within the fabric base 203. In this way, electrical signals can be passed back and forth between the individual sensors and the connector 210. For example, signals received by a measurement electrode from the patient can be transmitted to the connector 210 via the corresponding electrical connection 209, and a drive common mode output signal can be sent from the connector 210 to a drive electrode via the corresponding electrical connection 209. Figure 2A single connector 210 is shown in FIG. 2. However, in alternative embodiments, there can be multiple connectors (e.g., one for each individual sensor in the sensor array 201).

[0020] 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 select portions of the signal processing circuit 212 can be included within the device 110, and the processed signals can be transmitted via a wireless connection to additional processing electronics or a remote data acquisition and / or display apparatus. In this embodiment, the connector 210 can be omitted. Alternatively or additionally, the device 110 can include an integrated electronics layer 213 that is electrically coupled to (and / or included within) the connector 210 and adapted to perform measurements on the electrical signals received from the plurality of sensors. For example, the integrated electronics layer can include one or more components of the signal processing circuit 212 and / or the dynamic switching circuit 300 (described further below) in a single layer. In another embodiment, as shown in FIG. 3, all components of the signal processing circuit 212 can be positioned separately (e.g., remotely) from the device 110, such that the connector 210 and wired or wireless connection 211 can transmit electrical signals (acquired measurements and drive signals) between the device 110 and the signal processing circuit 212. In some embodiments, the connector 210 can include a wireless pod that includes a transmitter / receiver for transmitting wireless signals between the device 110 and the signal processing circuit 212. In another embodiment, the device 110 can include a separate wireless pod that is electrically coupled to the connector 210 or each individual sensor of the sensor array 201. In another embodiment, such as when the sensors and / or connector 210 are wirelessly connected to the signal processing circuit 212, the sensors can receive power via a battery 230 incorporated into the device 110 (e.g., incorporated into the fabric cover). Figure 3 Figure 2 Further described below) in a single layer. In another embodiment, as shown in FIG. 3, all components of the signal processing circuit 212 can be positioned separately (e.g., remotely) from the device 110, such that the connector 210 and wired or wireless connection 211 can transmit electrical signals (acquired measurements and drive signals) between the device 110 and the signal processing circuit 212. In some embodiments, the connector 210 can include a wireless pod that includes a transmitter / receiver for transmitting wireless signals between the device 110 and the signal processing circuit 212. In another embodiment, the device 110 can include a separate wireless pod that is electrically coupled to the connector 210 or each individual sensor of the sensor array 201. In another embodiment, such as when the sensors and / or connector 210 are wirelessly connected to the signal processing circuit 212, the sensors can receive power via a battery 230 incorporated into the device 110 (e.g., incorporated into the fabric cover).

[0021] ​In one embodiment, the signal processing circuit 212 can be based on a processor. In one embodiment, the signal processing circuit 212 can 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 bidirectional signal communication with the sensor array 201. The signal processing circuit 212 can 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 can 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 can define tangible computer-readable storage media of the signal processing circuit 212. The signal processing circuit 212 can also include a power source 224, which can be a battery-based power source to facilitate mobile operation of the signal processing circuit 212. In one embodiment, the one or more output devices 222 can be provided, for example, by one or more of a display with or without an associated touch screen and / or one or more audio output devices (e.g., speakers). In one embodiment, the devices 214, 216, 218, 220, 222, and 224 communicate via a system bus 226. The signal processing circuit 212 can output data via the output devices 222, which can include bus-connected output devices as shown in Figure 2

[0022] Figure 3 An example of a dynamic switching circuit 300 for controlling ECG sensors (e.g., sensors 202, 204, 206, and 208) of the device 110 is shown. In one embodiment, the dynamic switching circuit 300 can be part of the signal processing circuit 212, such as part of the CPU 216. In another embodiment, the dynamic switching circuit 300 can be included on / in the device 110, such as part of and / or in electrical connection with the connector 210 (e.g., via the integrated electronics layer 213).

[0023] The dynamic switching circuit 300 includes a sensor array 201 that includes a plurality of ECG sensors (e.g., electrodes). As referenced above with respect to the sensor array 201 and Figure 2 ​As discussed, at least one (and in some examples, at least two) of the ECG sensors of the sensor array 201 are dedicated, selectively outputting drive common mode output signals, and the drive electrodes of the plurality of ECG sensors are measurement electrodes adapted to measure the bioelectric potentials of the patient and output these signals for determining the ECG signal of the patient. The measurement electrodes can also be switched to selectively output the drive common mode output signal. Further, as described below, more than one of the switchable measurement electrodes can be selected to output the drive common mode signal at any one time. However, the dynamic switching circuit 300 can 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 the patient lying on the device 110.

[0024] Referring to Figure 3 The dynamic switching circuit 300 includes the ECG sensors of the sensor array 201 in bidirectional electronic communication with a defibrillator protection circuit 302. The defibrillator protection circuit 302 can include a plurality of resistors and / or additional circuit elements that absorb repeated defibrillation and other high-energy pulses (e.g., electrostatic discharge) to protect the dynamic switching circuit 300 and / or more sensitive electronic circuit elements in the device 110. The defibrillator protection circuit 302 is electrically coupled to one or more input filters 304 via the bidirectional electronic communication. As one example, the one or more input filters 304 can include one or more filters (e.g., bandpass filters, adaptive filters, etc.) that filter out noise in the signals measured by the measurement electrodes (and that are used to determine the ECG signal of the patient) such as common motion / movement noise from the patient moving over / across the ECG electrodes. If one or more adaptive filters are used to filter out common motion noise, at least two input channels can be needed, each including at least 2 contact points between the ECG sensors and the skin of the patient, and one drive electrode. For example, in such a case, at least two of the ECG sensors of the sensor array 201 that are determined to be in direct contact with the skin of the patient (e.g., at least a threshold portion of the sensors are in direct contact with the patient, as explained further below) can be selected as the measurement electrodes, and a different (third) one of the ECG sensors of the sensor array 201 that is also determined to be in direct contact with the skin of the patient can be selected as the drive electrode. The adaptive filters can adjust the frequency range of the signals received from the patient, and can be executed by the CPU 216.

[0025] The filtered signals from the input filter 304 are electrically transmitted to one or more ECG differential amplifiers 306 for amplification of the measured signals from the patient. The amplified signals are then electrically transmitted to an input switch matrix 308. In one example, the input switch matrix 308 can determine which of the measurement electrodes of the ECG sensors are in contact with the patient’s skin and select the signals received from those contact 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 way, the input switch matrix 308 can 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 can include receiving a signal from each of the ECG sensors, which can include a measurement of the skin impedance of the patient’s skin, and determining which of the ECG sensors are in contact with the patient’s skin based on which of the skin impedance measurements meet a threshold level (indicating that the sensor providing that signal has a threshold amount of contact with the patient’s skin and thus can provide a strong enough signal for measuring the patient’s ECG signal). The signals from the ECG sensors determined to be in contact with the patient’s skin (and thus be the measurement electrodes) are transmitted to the ADC 310 for further processing and determination of the patient’s ECG signal and heart rate. The measurement electrodes can each be connected to the ADC 310 and the input switch matrix 308 can determine which of the measurement electrodes are in contact with the patient and thus can be used to provide the drive common mode signal back to the patient.

[0026] The ADC 310 converts the filtered and amplified analog signals from the selected measurement electrodes (ECG sensors) into digital signals for further processing and output. For example, the converted digital signals from the ADC 310 can be processed via additional electronics of the signal processing circuit 212 to determine the patient’s ECG signal and the patient’s corresponding heart rate. These determined ECG signals and / or heart rates can then be output to the user via one or more output devices (e.g., output devices 222 of the patient monitor 200). Figure 2 As one example, the output device can be an electronic display device.

[0027] Based on determining which ECG sensors are in sufficient contact with the patient’s skin to provide a low impedance and thus be considered contact sensors, the input switch matrix 308 can also select which of the measurement electrodes of the ECG sensors should be used as drive electrodes for delivering the drive common mode output signal. For example, the input switch matrix 308 can determine which of the input measurement electrodes will be used to feed the amplifier 312. For example, at least one input measurement electrode can be selected by the input switch matrix 308. In another example, all of the input measurement electrodes can be used to feed the amplifier 312 or any subset thereof.

[0028] The input switch matrix 308 then routes the selected ECG sensors to the drive electrode signal sources, and those signal sources to a drive common mode output amplifier 312 that can generate a drive common mode output signal. The drive common mode output signal and selection of drive electrodes are then electronically routed to an output switch matrix 314. The output switch matrix 314 functions to switch which ECG contacts are delivering the drive common mode output signal to the patient and to deliver the drive common mode output signal to the selected ECG sensors. In this way, a determination of which measurement electrodes are selected to be switched and used for drive output is made by the output switch matrix 314.

[0029] In this way, signals generated and measured using one or more of the direct contact ECG sensors of the sensor array 201 can be digitally sampled and combined to form an ECG signal of the patient, and a heart rate of the patient determined from the ECG signal. As discussed above, selection of contact ECG sensors for determining an ECG signal can include, at the input switch matrix 308, selecting signals from at least two contact ECG sensors (e.g., two contact points) for a measurement signal, and selecting one contact ECG sensor as a drive electrode. In another example, the input switch matrix 308 can select signals from more than two contact ECG sensors for a measurement signal, if it is determined that more than two ECG sensors are contacting the patient, for determining an ECG signal and heart rate of the patient.

[0030] Turning now to Figure 4 , a schematic diagram showing an example position of a patient 424 on a fabric wrap 410 is shown. The fabric wrap 410 can be similar to the device 110 and / or fabric wrap 106 discussed above with reference to Figures 1 to 3 . As discussed above, the fabric wrap 410 includes a plurality of integrated ECG sensors 412, 414, 416, 418, 420, and 422, which can be referred to herein as electrodes or electrode pads. Each of the ECG sensors are spaced apart from one another such that they are electrically insulated from one another via intervening fabric of the fabric wrap 410 (and thus cannot pass signals between one another, reducing signal interference between the ECG sensors). Figure 4 The example arrangement of ECG sensors on a surface of the fabric wrap 410 is not intended to be limiting, and other arrangements of ECG sensors are possible. As Figure 4ECG sensors include a top-most ECG sensor 412, a top-left ECG sensor 414, a bottom-left ECG sensor 416, a bottom-most ECG sensor 418, a bottom-right ECG sensor 422, and a top-right ECG sensor 420. The patient 424 can be smaller than the fabric sleeve 410, and thus can move around the top of the surface of the fabric sleeve 410 and across the surface of the fabric sleeve 410. As such, at different points in time, the patient’s skin can be in contact with different ECG sensors of the fabric sleeve 410. Accordingly, a dynamic switching circuit of a signal processing circuit included in or electrically coupled with the fabric sleeve 410, such as the dynamic switching circuit 300 of Figure 3 FIG. 3, can switch which ECG sensors are selected as measurement electrodes and drive electrodes in real-time (e.g., dynamically) to produce an ECG signal of the patient and determine a heart rate of the patient based on the location of the patient on the fabric sleeve 410 as determined according to the methods described herein with reference to Figure 3 and Figure 5

[0031] In particular, Figure 4 ​A first view 400 of a patient (e.g., a neonate or infant) 424 in a first position (e.g., top left corner) on a fabric wrap 410 is shown. In this first position, the patient 424 is in contact with the top-most ECG sensor 412, the left upper ECG sensor 414, and the left lower ECG sensor 416. While a small portion of the patient’s arm can be contacting the right upper sensor 420, there can not be sufficient skin-to-electrode contact to produce a strong enough skin impedance and measurement signal. Accordingly, the dynamic switching circuitry of the fabric wrap 410 can select the ECG sensors 412, 414, and 416 as contact sensors (e.g., ECG sensors in direct coplanar contact with a portion of the patient’s 424 skin). One of the contact ECG sensors 412, 414, and 416 can 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) determined to be non-contact ECG sensors can be discarded (or not acquired) and not used to determine the patient’s ECG signal and heart rate. In one embodiment, the ECG sensors 416 and 422 can be dedicated drive electrodes. Accordingly, the dynamic switching circuitry can automatically select the left lower ECG sensor 416 to deliver a drive common mode output signal. In alternative embodiments, different one or more of the ECG sensors of the fabric wrap 410 can be dedicated drive electrodes. In yet another embodiment, all of the ECG sensors of the fabric wrap 410 can be measurement electrodes adapted to switch between being a measurement electrode and a drive electrode (e.g., none dedicated to being driven only) as determined and selected by the dynamic switching circuitry. However, by including some dedicated drive electrodes and some switchable measurement electrodes, if all measurement electrodes are available to capture an ECG signal (e.g., because the measurement electrodes have good patient contact), there is always an electrode surface area that can 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. Further, more ECG channels can improve adaptive filtering results while using measurement electrodes for providing drive outputs reduces the number of channels available for post-digitalization signal processing, so it can be desirable to provide dedicated drive electrodes so that all possible channels are available for ECG signal acquisition.

[0032] Figure 4A second view 402 of the patient 424 in a second position (e.g., upper right corner) on the fabric sleeve 410 is also shown. In one example, the patient 424 can have moved from the first position (in the first view 400) to the second position (in the second view 402), changing which of the ECG sensors the patient 424 is in direct physical contact with (and thus changing the contact points of the fabric sleeve 410). In this second position, the patient 424 is in contact with the top-most ECG sensor 412, the upper right ECG sensor 420, and the lower right ECG sensor 422. Thus, the patient 424 is no longer in contact with the ECG sensors 414 and 416, and is newly in contact with the ECG sensors 420 and 422. Accordingly, in one example, the dynamic switching circuit can switch the drive electrode to the lower right ECG sensor 422 (switching from the lower left ECG sensor 416 in the first view 400) in response to the moved position of the patient on the fabric sleeve 410 and which ECG sensors are changing contact with the sensor. Further, the dynamic switching circuit can continue to use the top-most ECG sensor 412 as one measurement electrode, and switch to using the upper right ECG sensor 420 (rather than the lower right ECG sensor 416, as used in the first view 400) as the second measurement electrode.

[0033] In Figure 4 A third view 404 of the patient 424 in a third position (e.g., middle lower region) on the fabric sleeve 410 is shown. In one example, the patient 424 can 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 contact points 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 is no longer in contact with the top-most ECG sensor 412, remains in contact with the ECG sensors 420 and 422, and is newly in contact with the ECG sensors 414, 416, and 418 (compared to the second view 402). Accordingly, in one example, the dynamic switching circuit can maintain 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 can continue to use the upper right ECG sensor 420 as one measurement electrode, and switch to using the upper left ECG sensor 414 and the bottom-most ECG sensor 418 as additional measurement electrodes. In the case where the lower left ECG sensor 416 is a dedicated drive electrode, this lower left ECG sensor can also be used to apply the drive common-mode output signal in addition to the lower right ECG sensor 422, which is currently selected as the drive electrode.

[0034] InFigure 4 In the fourth view 406, the patient 424 is in a fourth position (e.g., lower left) on the fabric wrap 410. In one example, the patient 424 can 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 contact points of the fabric wrap 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 as contacting the sensor 422, not enough of the patient’s skin is in contact with the sensor 422 for the measured skin impedance of that sensor to be below the threshold level) and remains in contact with the ECG sensors 414, 416, and 418 (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 (switching from the lower right ECG sensor 422). Further, the dynamic switching circuit can continue to use the upper left ECG sensor 414 and the bottom-most ECG sensor 418 as the measurement electrodes.

[0035] In all of the views, Figure 4 In all of the views, at least two of the contact ECG sensors are selected as measurement electrodes, and a different one of the contact ECG sensors is selected as the drive electrode. From the acquired signals, an ECG signal of the patient with reduced noise (e.g., reduced noise from motion of the patient) can be obtained. As Figure 4ECG sensors used as measurement electrodes and drive electrodes can be selected based on which sensors are determined to be in direct contact with the patient's skin and dynamically switch at least under some conditions as the patient moves across the fabric wrap to different contact locations. For example, a dedicated drive electrode is fixed via a wired or wireless connection 211 in terms of connection to signal processing circuitry 212. The dedicated drive electrode is always enabled and driven. If impedance measurements are used, the system can select which measurement electrodes will be used for the drive output signal if a drive electrode is sensed to not be in contact with the patient. Which sensors are selected and used as drive electrodes and measurement (e.g., input) electrodes can be switched at any time during operation of the fabric wrap (e.g., while the patient is on and / or in contact with the fabric wrap). For example, the switching of measurement electrodes and drive electrodes can be performed prior to (from the measurement electrodes) initial acquisition of ECG signals. In another embodiment, the switching of measurement electrodes and drive electrodes can occur during ECG acquisition (e.g., while measurement signals are acquired from the measurement electrodes) in response to determining that the contact ECG sensors have changed (e.g., the ECG sensors currently used to determine ECG signals are no longer in contact with the patient and need to switch to other sensors that are in contact with the patient).

[0036] As shown in Figure 4 , multiple contacts between the patient and the ECG sensor pads are made immediately upon application of the patient (e.g., infant / newborn) to the surface of the fabric wrap. While the multiple contacts are direct points of contact between the patient's skin and the ECG sensor pads, none of the ECG sensor pads are adhered or physically attached to the patient's skin (e.g., via adhesive), thereby reducing damage and irritation to the delicate skin of the infant / newborn. Also as shown in the different views of Figure 4 , the patient is free to move over the surface of the fabric wrap and the sensor array. As such, the patient's position on the sensor array can change, and thus which electrodes are in contact with the patient's skin can also change during operation / data collection. As discussed above and further discussed below, the measurement electrodes and drive electrodes of the sensor array can be selected and switched in accordance with this movement and change of the contact sensors.

[0037] Figure 5 A flowchart of a method 500 for dynamically switching drive electrodes of a sensor array of a device that are in direct contact with a patient and determining an ECG signal and / or heart rate of the patient from signals acquired from multiple measurement electrodes of the sensor array is shown. In one example, the device can be the device 110 shown in Figure 1 and Figure 2 . And / or can be a fabric wrap, such as the fabric wrap described herein with reference to Figure 1 , Figure 4 and Figures 6 to 11One or more of the disclosed fabric wraps. For example, a fabric wrap can include one or more aspects of the fabric wrap shown in Figure 1 , Figure 4 and Figures 6 to 11 As disclosed herein, a device or fabric wrap can include a sensor array having a plurality of sensors (e.g., electrodes) spaced apart from one another across a surface of the fabric wrap. The fabric wrap and sensor array are adapted for direct contact with a patient's skin (e.g., a neonate or infant can be placed directly on top of the sensor array of the fabric wrap). However, the patient can move freely across the surface of the fabric wrap, thereby changing their position on the wrap. Thus, not all of the sensors of the sensor array can be in contact with the patient (via direct contact) at any one time, and which sensors are in contact with the patient can change as the patient moves / changes position on the wrap. As used herein, a "contact sensor" of the sensor array can be defined as a sensor that is determined to be in direct contact with the patient's skin such that it is able to acquire a signal (e.g., a bioelectric potential) from the patient. Additionally, as used herein, "direct contact" means that the electrode is in contact with the patient's skin without an intervening component disposed therebetween. In this manner, the electrode of the patient and the skin can be coplanarly in contact.

[0038] The method 500 begins, at 502, by receiving signals from a plurality of sensors (e.g., electrodes) of a sensor array of a fabric wrap as a patient (e.g., an infant or neonate) is placed in contact with the sensor array of the fabric wrap. For example, the method at 502 can include receiving (or acquiring) a signal from each sensor included in the sensor array. The received signals can be a measurable bioelectric potential of the patient, and can have varying strengths (e.g., magnitudes). In some embodiments, if one or more of the sensors is not in direct contact with the patient (e.g., not in contact with the patient at all), the received signal can be zero or below a lower threshold level, or the measured impedance can be above a threshold level. Once the patient is placed in contact with the sensor array, the signals from the sensors can be acquired automatically and immediately by signal processing circuitry of the fabric wrap or signal processing circuitry in electrical communication with the fabric wrap.

[0039] At 504, the method includes determining which sensors of the sensor array are in direct contact with the patient based on the individual skin impedance measurements. For example, the signals received from the sensors at 502 can be used to determine individual skin impedance measurements corresponding to each sensor. Then, at 504, the method includes determining, for each sensor of the sensor array, 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 for that sensor being above a threshold level. In one example, the threshold level can be a non-zero impedance value that indicates that the sensor (which can be a sensor pad, as discussed herein) has a large enough portion of its entire surface area in contact with the patient's skin in order to obtain a measurable biopotential signal for use in determining the patient's ECG signal (and heart rate). If the individual skin impedance measurement for a sensor is not below the threshold level, then the method at 504 can include determining that the sensor is not in contact with the patient (and thus any signals received from the contact are not to be used in determining the patient's ECG signal).

[0040] At 506, the method includes selecting a sensor from all of the sensors of the sensor array to function as a drive electrode based on which sensors are determined to be in contact with the sensor (e.g., in contact with the patient, as determined at 504), and outputting a drive common mode output signal via the selected sensor. As one example, the drive common mode output signal can be a voltage having a magnitude 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 frequency, etc. As discussed above, in one embodiment, all of the sensors of the sensor array can be measurement sensors adapted to receive and measure bioelectric potential signals from the patient for processing into an ECG signal for the patient. Each of these measurement sensors can be individually switched to function as a drive electrode by outputting the drive common mode output signal. If the measurement sensors are determined to be in direct contact with the patient at 504, any one of the measurement sensors can be selected as the drive electrode. In another embodiment, the sensor array can be divided into a first group of sensors that are measurement sensors that can also function as drive electrodes, and a second group of sensors that are dedicated drive electrodes. The dedicated drive electrodes can be used only to deliver the common mode output signal, and can not be used to acquire signals from the patient for determining an ECG signal for the patient. In one example, the number of dedicated drive electrodes (sensors) can be less than the number of measurement sensors. In this embodiment, the common mode output signal can be delivered to the drive electrodes for delivering 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 can be selected as the drive electrode. Alternatively, if more than one dedicated drive sensor is in contact with the patient, the processor can 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 can select a predetermined dedicated drive sensor (e.g., stored in a memory of the signal processing circuit) to be 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 can select all of the dedicated drive electrodes and output the drive common mode output signal. If none of the dedicated drive sensors are in direct contact with the patient, the processor can select one of the measurement sensors that are in direct contact with the patient to be the drive electrode, and switch the selected measurement electrode from measuring bioelectric potential of the patient to outputting the drive common mode output signal. An example of selecting a sensor to function as a drive electrode based on the location of the patient is shown in FIG. 6 as discussed above. Figure 4

[0041] ​The method 500 then continues to 508 to receive (or continue to receive) signals from contact measurement sensors (e.g., measurement sensors in contact with the patient). In one example, only measurement sensors in direct contact with the patient can acquire signals from the patient and transmit those signals to the signal processing circuit. In another example, the signal processing circuit can 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 a low contact impedance below a threshold can be used to determine an ECG signal, as further described below.

[0042] At 510, the method includes filtering the signals received from the measurement sensors. As described above with reference to Figure 3 the filters can include one or more different types of filters, such as adaptive filters, bandpass filters, etc. The method then continues to 512 to use the filtered signals from the measurement sensors determined to be in contact (e.g., direct contact) with the patient to determine an ECG signal for the patient and determine a heart rate for the patient from the determined ECG signal. For example, a dynamic switching circuit of the signal processing circuit can 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 the input switch matrix 308 shown in Figure 3 the filtered signals can then be determined from only these selected filtered signals to determine an ECG signal for the patient. The heart rate for the patient can then be determined directly from the determined ECG signal.

[0043] 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 can be a display device in electronic communication with the signal processing circuit. The user can be a medical provider, such as a technician, physician, or nurse. The method 500 can be continuously run such that the ECG signal and / or the heart rate are continuously determined and updated, and the display device can continuously display the updated signals while signals are acquired from the patient via the sensor array of the fabric suit. In this way, the user can monitor the condition of the patient while the patient is in contact with the fabric suit with minimal intervention (e.g., without adhesive electrodes adhered to the skin of the patient).

[0044] Continuing to 516, the method includes determining whether the contact sensors have changed. For example, the method at 516 can include determining whether a sensor previously (or most recently) selected as a drive electrode is no longer in contact with the patient. In this case, the currently selected drive sensor can be unable to deliver a drive common mode output signal for noise reduction. If the contact sensors have not changed, the method continues to 518 to continue acquiring signals from the measurement sensors and using the same (previously selected) sensors as the drive sensors. If any of the contact measurement sensors have changed, the method can also 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 only signals from sensors that are in direct contact with the patient).

[0045] 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 can 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, Figure 4 Examples of such switching of which sensor is used as a drive electrode are shown in FIGS. 5B and 5C. Dynamically switching which sensor is used as a drive electrode can include switching which sensor outputs the drive common mode output signal in real-time as signals are continuously acquired from the measurement sensors and as the patient moves (and changes position) across the surface of the sensor array. The switching at 520 can also include switching which measurement sensors are used to determine the ECG signal if one or more of the measurement sensors is no longer in contact with the patient.

[0046] Figures 6 to 10 An example arrangement of electrodes of a fabric sleeve, such as one of the fabric sleeves discussed herein, is shown. In particular, the fabric sleeve can be similar to the devices 110 and / or fabric sleeves 106 and 410 described above with reference to Figures 1 to 4 The devices 110 and / or fabric sleeves 106 and 410. Thus, the following discussion refers to the devices 110 and / or fabric sleeves 106 and 410. Figures 6 to 10The fabric cover under discussion can include similar components, including a sensor array comprising a plurality of sensors integrated with the rest of the fabric cover. In some embodiments, the fabric cover can be a bed sheet, a mattress cover, a blanket, or a wearable article such as a sling or a bandage. The plurality of sensors can be in the form of electrode pads and can be adapted to function as measurement electrodes and / or drive electrodes, as discussed herein. In one embodiment, both the fabric base of the fabric cover and the electrode pads can be porous so as to interact with the skin and allow exchange of moisture and gases therethrough, while still being able to take measurements from the electrode pads. The size of the array of electrode pads on the surface of the fabric cover can be set to include a selected number of electrode pads to accommodate a range of sizes of patients from a neonate to a larger infant to an adult.

[0047] Reference is made below to Figures 6 to 10 The fabric cover under discussion can be optimized to maximize the separation distance (e.g., gap) between adjacently arranged electrodes (e.g., electrode pads), to maximize the number of electrodes within the electrode array, to maximize the electrode separation distance, and to maximize the surface area of each electrode. For example, within a set area of the electrode array, referred to as a measurement area, as explained further below, by having an increased number of potential contact points, with each electrode pad being considered a contact point, while maximizing the surface area of each contact point, an increased number of sensor signals for determining ECG signals can be acquired, even as the patient changes position on the fabric cover, increasing the accuracy of the ECG signals and reducing signal noise. Maximizing the separation distance between electrodes allows for stronger signal peak-to-peak voltage to be acquired. Reference is made below to Figures 6 to 10 The various embodiments under discussion aim to achieve such an arrangement of electrode pads.

[0048] Turning first to Figure 6 A first embodiment of a fabric cover 600 is shown having a fabric base 602 with a plurality of electrode pads integrated therein. The electrode pads include semi-circular electrode pads 604 arranged at the top-most and bottom-most locations of a measurement area 608 of the 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 can have different shapes, such as square, circular, semi-circular, oval, hexagonal, etc.

[0049] The measurement area 608 is defined as the area of the fabric cover that includes all of the electrode pads of the sensor array of the fabric cover. There can be no electrode pads (e.g., electrodes) arranged outside the perimeter of the measurement area 608. As Figure 6As shown, both of the semi-circular 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 extend across the entire width of the measurement region, it is more likely that a contact point will be obtained at either end of the patient. For example, both of the semi-circular electrode pads 604 can be dedicated drive electrodes, and the extent and shape of the semi-circular electrode pads can optimize contact with the patient’s head if the patient is rolling or moving relative to the fabric sleeve.

[0050] Each of the rectangular electrode pads 606 is arranged directly adjacent to two other of the rectangular electrode pads 606 and one of the semi-circular electrode pads 604. The spacing, arrangement, and / or shape of the rectangular electrode pads 606 can optimize contact with the patient’s torso region for ECG signal acquisition. Gaps 612 are arranged between adjacently arranged electrode pads. The gaps 612 can have different sizes. In one example, the gaps 612 can be less than a threshold distance, such as half an inch. However, in alternative examples, the gaps 612 can be between 0.25 inches and 0.5 inches or between 0.4 inches and 0.6 inches. The greater the gap between two signal electrodes, the higher the skin impedance between them, and thus the greater the amplitude of the measured ECG signal. The material within the gaps 612, between the electrode pads, is the fabric material of the fabric base 602, and can be insulating so that electrical signals do not transfer between adjacent electrode pads.

[0051] Figure 7 A second embodiment of a fabric sleeve 700 is shown having a fabric base 602 with a plurality of electrode pads integrated therein. In this embodiment, the electrode pads include semi-circular electrode pads 702 arranged at the topmost and bottommost locations of the measurement region 608. The semi-circular electrode pads 702 have a smaller height (direction perpendicular to the width 610) than the semi-circular electrode pads 604 of Figure 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 of the electrode pads can extend across the entire width 610. Further, in some embodiments, the rectangular electrode pads 704 can have alternative shapes, such as an oval, a rectangle with semi-circular ends, a semi-circle, etc. As shown, adjacent electrode pads are separated by gaps 612, which can vary between different pairs of electrode pads or can be the same for each adjacent pair of electrode pads. Figure 6

[0052] ​The fabric sheath disclosed herein may be made of fabric materials (including one or more of cotton, nylon, rayon, spandex, etc.). Electrodes (electrode pads) and electrical connections between the electrode pads and connectors or connecting elements, as well as connectors (or leads), may be made of conductive deposition materials (such as silver). For example, the electrode pads and electrical connections and / or connectors may be silver-deposited electrode layers on a fabric base comprising one or more fabric materials listed above. Masking or etching processes may be used to define active electrode regions and their corresponding conductive electrical connections (e.g., signal paths to connectors). This contrasts with the non-conductive or insulating areas of the fabric base of the fabric sheath. Using silver for the electrodes and / or signal paths allows for electrical signal transmission while providing antimicrobial properties with increased biocompatibility. The signal wiring path (electrical connection) from each electrode pad to the connector or measurement point at the electronic interface of the fabric sheath can be insulated by adding a dielectric layer to avoid undesirable contact with the patient's skin. Electrical contacts or connectors (such as...) for measuring or receiving signals from each electrode pad... Figure 2 The connector 210 shown can be a simple connector with elastic contact pads of sufficient pitch density on a fabric base, enabling the connection to transmit biopotential signals to a data acquisition front-end device (e.g., which may be part of a signal processing unit). This transmission can be either via a wired cable from the connector or directly to an integrated electronic layer that performs measurements on the fabric cover and wirelessly transmits the data to a monitoring station.

[0053] Fabric covers may be designed for single use or reuse. For example, fabric covers may be washed between uses (e.g., between patients). However, fabric covers may have a limited number of uses because the electrical contacts and / or electrode pads may deteriorate over time due to contact with water during washing.

[0054] Turn now Figures 8 to 10 The illustration shows the arrangement of electrode pads in a fabric sleeve and an additional embodiment of the electrical connection (e.g., signal path) from each electrode pad to a measurement point (which, in one example, may include a connector). Specifically, Figure 8 It shows having with Figure 7 A first fabric sleeve 800 with a similar arrangement of electrode pads. For example, the fabric sleeve 800 includes topmost and bottommost semicircular electrode pads 802 and a plurality of elongated electrode pads 804 arranged therebetween. Each electrode pad is coupled to a separate measurement point 806 via an electrical connector 808. Each measurement point 806 may be coupled to or include its own connector (e.g., similar to...). Figure 2the same side of the fabric sleeve can 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 can be included on or off (e.g., remote from) the fabric sleeve.

[0055] Figure 9 A second fabric sleeve 900 is shown having a different arrangement of electrode pads including topmost and bottommost semi-circular electrode pads 902 and a plurality of hexagonal electrode pads 904 arranged therebetween. Some of the hexagonal electrode pads 904 can be partial (e.g., cut in half) hexagons in order to accommodate a honeycomb-like arrangement of the hexagonal electrode pads (e.g., adjacent hexagons offset in an alternating pattern), as shown. Each of the hexagonal electrode pads 904 are spaced apart from one another and from the semi-circular electrode pads 904. In alternative embodiments, the hexagonal electrode pads 904 can have an alternative polygonal shape, such as pentagonal, heptagonal, octagonal, decagonal, etc. Similar to the above with reference to Figure 9 each of the electrode pads of the fabric sleeve 900 are coupled to separate measurement points 906 by electrical connections 908. Figure 8 Figure 9 each of the electrode pads of the fabric sleeve 900 are coupled to separate measurement points 906 by electrical connections 908.

[0056] Figure 10 A third fabric sleeve 1000 is shown having yet another arrangement of electrode pads including topmost and bottommost semi-circular electrode pads 1002, a plurality of elongate electrode pads 1006, and a plurality of rectangular electrode pads 1004. In particular, Figure 10 two rows of rectangular electrode pads 1004 separated from one another via two elongate electrode pads 1006 that are spaced apart from one another and from a row of rectangular electrode pads 1004 arranged adjacent thereto, and an elongate electrode pad 1006 positioned between each row of rectangular electrode pads 1004 and one of the semi-circular electrode pads 1002. However, in alternative embodiments, the third fabric sleeve 1000 can include additional or fewer rows of rectangular electrode pads 1004, and more or fewer elongate electrode pads 1006 spaced apart between multiple rows of adjacent rectangular electrode pads 1004 and / or between a row of rectangular electrode pads 1004 and the semi-circular electrode pads 1002. Similar to the above with reference to Figure 8 each of the electrode pads of the fabric sleeve 1000 are coupled to separate measurement points 1008 by electrical connections 1010. Figure 10 each of the electrode pads of the fabric sleeve 1000 are coupled to separate measurement points 1008 by electrical connections 1010.

[0057] Figure 11 A schematic view 1100 of a patient 1124 positioned on a caregiver 1102 and held in place using a fabric sleeve 1110 is shown. The fabric sleeve 1110 can be similar to the above with reference to​Figures 1 to 3 The device 110 and / or the fabric wrap 106 are discussed. However, as Figure 11 shown, the fabric wrap 1110 can be in the form of a wearable article configured to facilitate skin-to-skin contact between the patient 1124 and the caregiver 1102, which can be a parent or other caregiver of the patient. Thus, the fabric wrap 1110 can be in the form of a band, a sling, a carrier, a nursing top, or other wearable article. As shown, the patient 1124 is positioned between the caregiver 1102 and the fabric wrap 1110 such that the patient 1124 is in direct skin-to-skin contact with the caregiver 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 wrap 1110 (e.g., via a second, opposite side of the patient).

[0058] As discussed above, the fabric wrap 1110 includes a plurality of integrated ECG sensors 1112, 1114, 1116, 1118, 1120, and 1122, which can be referred to herein as electrodes or electrode pads. Each of the ECG sensors is spaced apart from one another such that they are electrically insulated from one another via intervening fabric of the fabric wrap 1110 (and thus cannot pass signals between one another, reducing signal interference between the ECG sensors). Figure 11 An exemplary arrangement of the ECG sensors on the fabric wrap 1110 is shown, which is not intended to be limiting, and other arrangements of the ECG sensors are possible. Further, the ECG sensors on the fabric wrap 1110 can be positioned on a patient-facing surface of the fabric wrap 1110 such that the electrodes can be in direct contact with the patient 1124, while an insulating layer (not shown in Figure 11 for visual purposes) can form an outward-facing surface of the fabric wrap 1110.

[0059] As shown in the example of Figure 11 the ECG sensors include a top-most ECG sensor 1112, a left upper ECG sensor 1114, a left lower ECG sensor 1116, a bottom-most ECG sensor 1118, a right lower ECG sensor 1122, and a right upper ECG sensor 1120. The patient 1124 can be smaller than the fabric wrap 1110, and thus can move about across the patient-facing surface of the fabric wrap 1110. As such, at different points in time, the patient’s skin can be in contact with different ECG sensors of the fabric wrap 1110. Thus, a dynamic switching circuit of a signal processing circuit included in or electrically coupled with the fabric wrap 1110, such as the dynamic switching circuit 300 of Figure 3 may switch, in real-time (e.g., dynamically), which ECG sensors are selected as measurement and drive electrodes for use in measuring ECG signals based on the patient’s position on the fabric wrap 1110, as per the teachings of Figure 3And Figure 5 The method determines) to generate an ECG signal of the patient and determine a heart rate of the patient.

[0060] The fabric wrap 1110 can be similar to the fabric wraps described above, and thus can be constructed of a fabric material including one or more of cotton, nylon, rayon, spandex, etc. The electrodes can be similar to the electrodes described above, and thus the electrodes (electrode pads) and electrical connections between the electrode pads and the connectors or connecting elements, as well as the connectors (or leads) can be constructed of an electrically conductive deposited material such as silver, for example a silver deposited electrode layer on a fabric base that includes one or more of the fabric materials listed above.

[0061] The fabric wrap 1110 can be configured to maximize contact of the electrodes with the patient 1124 while minimizing contact of the electrodes with the caregiver 1102. Thus, in areas of the fabric wrap 1110 that are positioned to preferentially contact the patient, the electrodes integrated in the fabric wrap 1110 can be positioned on the fabric wrap 1110. The fabric wrap can include straps, fasteners, or Figure 11 other features not shown in FIG. 11 A to facilitate secure positioning of the patient 1124 relative to the caregiver 1102 while also ensuring maximum contact between the patient 1124 and the electrodes. The fabric wrap 1110 can include an insulating layer on the outward facing surface of the fabric wrap 1110 (opposite the patient facing surface), as well as integrated electrodes that can prevent contact between the caregiver 1102 and the electrodes.

[0062] However, given the likelihood of patient movement and the small size of the patient relative to the caregiver 1102, and also given the desire to maximize patient contact with the electrodes even as the patient moves (and thus the electrodes extend widely / longitudinally across the fabric wrap), it can not be possible to prevent accidental contact between one or more of the electrodes and the caregiver, or otherwise shield the caregiver from interfering with the patient’s ECG signal under all conditions. Thus, at least in some examples, a diagnostic routine can be performed prior to and / or during patient ECG signal acquisition to determine whether the caregiver is interfering with the ECG signal being acquired by the system. If the caregiver is interfering with the ECG signal, acquisition of the ECG signal can be paused until the caregiver is no longer interfering with the ECG signal, or the effects of the caregiver on the ECG signal can be filtered out.

[0063] Figure 1 And Figures 6 to 10Exemplary configurations are shown with relative positioning of various components. In at least one example, elements shown as being in direct contact or direct coupling with one another can be referred to as being in direct contact or direct coupling, respectively. Similarly, in at least one example, elements that are abutting or adjacent to one another can be referred to as abutting or adjacent to one another, respectively. For example, components disposed in coplanar contact with one another can be referred to as being in coplanar contact. As another example, in at least one example, elements positioned apart from one another with only space therebetween and no other components can be described as such. As yet another example, elements shown as being above / below one another, on opposite sides of one another, or between left / right sides of one another can be described with respect to one another as such. Further, as shown in the figures, in at least one example, the topmost element or point of an element can be referred to as the "top" of the component, and the bottommost element or point of an element can be referred to as the "bottom" of the component. As used herein, top / bottom, upper / lower, above / below can be with respect to a vertical axis of the figure, and can be used to describe the positioning of elements with respect to one another in the figures. Thus, in one example, an element shown as being above another element is positioned vertically above the other element. As another example, the shape of an element shown in the figures can be referred to as having those shapes (e.g., such as rounded, flat, planar, curved, rounded, chamfered, angled, etc.). Further, in at least one example, elements shown as intersecting one another can be referred to as intersecting elements or as intersecting one another. Additionally, in one example, an element shown as being within another element or shown as being outside of another element can be described as such.

[0064] In this manner, the fabric sleeve can include a plurality of electrodes arranged on a surface of the fabric sleeve in order to measure and ECG signal and / or a heart rate of a patient. The surface of the fabric sleeve is adapted to be in direct contact with a patient (e.g., a patient can be placed on top of and / or against the fabric sleeve). However, the electrodes can not be physically attached to the patient (via adhesive or other method), and can allow the patient to move freely across the surface of the fabric sleeve. As such, the signal processing circuitry of the fabric sleeve can determine which of the plurality of electrodes are in direct contact with the skin of the patient, 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 an ECG signal of the patient during acquisition of signals via the electrodes. Thus, a more accurate ECG signal and heart rate of a patient with reduced noise can be acquired and used for diagnosis and intervention even as the patient moves across the fabric sleeve and changes position on the fabric sleeve. The technical effects 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; 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 based on the received signals; receiving and processing signals from the at least 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 are to more quickly obtain a more accurate ECG signal and heart rate with reduced noise while also reducing irritation to the skin of the patient. As such, patient treatment based on the ECG signal and / or heart rate can be more quickly and effectively delivered in situations where time to intervene or treat the patient is more critical (for post-delivery infants or newborns).

[0065] As an embodiment, a fabric cover for an infant incubator or warmer includes a plurality of electrodes spaced apart from one another within a measurement area of a surface of the fabric cover adapted for direct contact with a patient, the plurality of electrodes including a topmost electrode extending across an entire width of the measurement area, a bottommost electrode extending across the entire width of the measurement area, and a set of electrodes arranged between the topmost electrode and the bottommost electrode within the measurement area in a direction perpendicular to the width. In a first example of the fabric cover, each electrode of the set of electrodes extends across a substantial portion of the entire width of the measurement area. In a second example of the fabric cover, optionally including the first example, each electrode of the set of electrodes is arranged directly adjacent to two other electrodes of the set of electrodes and one of the topmost electrode and the bottommost electrode. In a third example of the fabric cover, optionally including one or both of the first example and the second example, 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 cover, optionally including one or more or each of the first example through the third example, each electrode of the plurality of electrodes and the fabric cover are porous. In a fifth example of the fabric cover, optionally including one or more or each of the first example through the fourth example, the fabric cover further includes at least one electrical connector and a plurality of electrical leads, each electrical lead of the plurality of electrical leads being insulated from the plurality of electrodes via a dielectric layer and extending between a 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 example through the fifth example, the at least one electrical connector is wirelessly connected to signal processing circuitry via a wireless electrical connection. In a seventh example of the fabric cover, optionally including one or more or each of the first example through the sixth example, the fabric cover further includes 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 example through the seventh example, the integrated electronics layer includes dynamic switching circuitry including an input switch matrix and an output switch matrix adapted to switch which electrode 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 an electrocardiogram signal of the patient. In a ninth example of the fabric cover, optionally including one or more or each of the first example through the eighth example, the plurality of electrodes receive electrical power via a battery incorporated into the fabric cover. In a tenth example of the fabric cover, optionally including one or more or each of the first example through the ninth example, each electrode of the plurality of electrodes is an electrode pad including a silver-deposited electrode layer, and wherein each electrode and the corresponding electrical connection between the electrode and the electrical connector or measurement electronics is electrically conductive, while the remainder of the fabric cover is non-conductive.

[0066] As another embodiment, a system for measuring bioelectric potentials 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: obtain signals output from at least two measurement electrodes of the plurality of electrodes in direct contact with the patient, and dynamically switch 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. In a first example of the system, the plurality of electrodes includes 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 bioelectric potentials of the patient, wherein the drive electrode is 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, the first set of dedicated drive electrodes includes 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 one another via a gap including a material that insulates adjacent electrodes from one another. In a third example of the system, optionally including one or both of the first and second examples, the electronic processor is further adapted to: determine which of the plurality of electrodes are in direct contact with the patient based on individual skin impedance measurements received from each of the plurality of electrodes, and select the drive electrode as the electrode having an individual skin impedance measurement at a threshold level. In a fourth example of the system, optionally including 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 the 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. In a fifth example of the system, optionally including one or more or each of the first through fourth examples, 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 the electrocardiogram signal via a display device.

[0067] As yet another embodiment, a method includes, while a patient is in direct contact with a fabric surface having a 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 the at least first electrode to determine and output an electrocardiogram signal of the patient having reduced noise; and dynamically switching which electrode of the plurality of electrodes is selected as the drive electrode in response to changes in which electrodes of the plurality of electrodes are in direct contact with the patient. In a first example of the method, the dynamically switching includes: 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 switching to deliver a drive common-mode output signal to the patient from the first electrode to the third electrode while continuing to determine and output the electrocardiogram signal. In a second example of the method, which optionally includes the first example, the selecting at least the first electrode of the plurality of electrodes as the measurement electrode includes: receiving signals from the plurality of electrodes, determining which signals are indicative of a corresponding electrode of the plurality of electrodes being in direct contact with the patient, and processing the signals of each corresponding electrode that is indicated as being in direct contact with the patient to determine the electrocardiogram signal, and further includes displaying one or more of the determined electrocardiogram signal and a heart rate determined from the electrocardiogram signal via a display device.

[0068] As used herein, an element or step recited in the singular and preceded with the word "a" or "an" should be understood as not excluding plural of said elements or steps, unless explicitly stated that such exclusion applies. Also, as used herein, "one" or "another" version of an item should be understood as one or more of the items, unless explicitly stated that such exclusion applies. Moreover, embodiments "comprising", "including", or "having" an element or a plurality of elements can include additional such elements not expressly mentioned, unless explicitly stated otherwise. The terms "comprising", "including", and "having" are used as open-ended language not excluding additional elements or steps. The terms "including" and "in which" are used as the plain language equivalents of the respective terms "comprising" and "wherein". Also, the terms "first", "second", or "third" and the like, merely denote different instances of an element, without necessarily requiring or implying any particular order or sequence.

[0069] This written description uses examples to disclose the application, including the best mode, and also to enable any person skilled in the art to practice the application, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the application is defined by the claims, and can include other examples that occur to those skilled in the art. Such other examples are intended to fall within the scope of the claims if they have structural elements in common with the words recited in the claims or if they do not differ from the recited literal language of the claims by insubstantial differences.

Claims

1. A fabric cover for an infant incubator or warmer, comprising: a plurality of electrodes spaced apart from one another within a measurement area of a surface of the fabric cover adapted to be placed in direct contact with a patient, the plurality of electrodes including a topmost electrode extending across an entire width of the measurement area, a bottommost electrode extending across the entire width of the measurement area, and a set of electrodes arranged between the topmost electrode and the bottommost electrode within the measurement area in a direction perpendicular to the width; an integrated electronics layer including dynamic switching circuitry including an input switch matrix and an output switch matrix adapted to switch which of the plurality of electrodes is driven to output a driven common mode output signal and which signals received from the plurality of electrodes are used to determine an electrocardiogram signal of the patient, wherein the dynamic switching circuitry is adapted to switch based on a location of the patient on the fabric cover.

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

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

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

6. The fabric cover of claim 1, further comprising at least one electrical connector and a plurality of electrical leads, each of the plurality of electrical leads being 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 cover of claim 6, wherein the at least one electrical connector is wirelessly connected to signal processing circuitry via a wireless electrical connection.

8. The fabric cover of claim 6, the integrated electronics layer being electrically coupled to the at least one electrical connector and adapted to perform measurements on electrical signals received from the plurality of electrodes.

9. The fabric cover of claim 1, wherein the plurality of electrodes receive electrical power via a battery incorporated into the fabric cover.

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

11. A system for measuring bioelectric potentials 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 integrated electronics layer including dynamic switching circuitry including an input switch matrix and an output switch matrix adapted to switch which of the plurality of electrodes is driven to output a driven common mode output signal and which signals received from the plurality of electrodes are used to determine an electrocardiogram signal of the patient, wherein the dynamic switching circuitry is adapted to switch based on a location of the patient on the fabric cover. an electronic processor in electronic communication with each of the plurality of electrodes and adapted to: obtain signals output from at least two measurement electrodes of the plurality of electrodes in direct contact with the patient, and dynamically switch 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, wherein the drive electrode is used to output a drive common mode output signal, wherein the dynamically switching is based on a location of the patient on the surface.

12. The system of claim 11, wherein the plurality of electrodes includes 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 bioelectric potentials of the patient, wherein the drive electrode is selected from the first set of dedicated drive electrodes and the two measurement electrodes are selected from the second set of measurement electrodes.

13. The system of claim 12, wherein the first set of dedicated drive electrodes includes 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, the gap including a material that insulates adjacent electrodes from each other.

14. The system of claim 11, wherein the electronic processor is further adapted to: determine which of the plurality of electrodes are in direct contact with the patient based on individual skin impedance measurements received from each of the plurality of electrodes, and select the drive electrode as the electrode having an individual skin impedance measurement at a threshold level.

15. The system of claim 14, wherein the electronic processor is further adapted to determine an electrocardiogram signal of the patient from the 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.

16. The system of claim 15, 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.

17. A method comprising: while a patient is in direct contact with a fabric surface having a 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, wherein the drive electrode is used to output a drive common mode output signal; receiving and processing signals from at least the first electrode to determine and output an electrocardiogram signal of the patient having reduced noise; and in response to a change in which of the plurality of electrodes is in direct contact with the patient, dynamically switching which of the plurality of electrodes is selected as the drive electrode, wherein the dynamically switching is based on a location of the patient on the fabric surface.

18. The method of claim 17, wherein said dynamically 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 switching to delivering a drive common mode output signal to the patient from the first electrode to the third electrode while continuing to determine and output the electrocardiogram signal.

19. The method of claim 18, wherein selecting at least the first electrode of the plurality of electrodes as a measurement electrode comprises: receiving signals from the plurality of electrodes, determining which signals indicate that a corresponding electrode of the plurality of electrodes is in direct contact with the patient, and processing the signals of each corresponding electrode indicated to be in direct contact with the patient to determine the electrocardiogram signal, and further comprising displaying one or more of the determined electrocardiogram signal and a heart rate determined from the electrocardiogram signal via a display device. and selecting a different, third electrode of the plurality of electrodes as the drive electrode; and switching to delivering a drive common mode output signal to the patient from the first electrode to the third electrode while continuing to determine and output the electrocardiogram signal. receiving signals from the plurality of electrodes, determining which signals indicate that a corresponding electrode of the plurality of electrodes is in direct contact with the patient, and processing the signals of each corresponding electrode indicated to be in direct contact with the patient to determine the electrocardiogram signal, and further comprising displaying one or more of the determined electrocardiogram signal and a heart rate determined from the electrocardiogram signal via a display device.

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