阅读说明：本技术 用于患者监测系统的传感器组件 (Sensor assembly for patient monitoring system ) 是由 阿霍霍·奥比 N·C·施托费尔 史蒂文·M·福克 T·瓦伦特 M·凯尔 卡伦·斯塔尔 于 2020-03-06 设计创作，主要内容包括：所公开的传感器组件可用于患者监测系统中以监测患者的一个或多个生理参数。该传感器组件可包括衬底和一个或多个电极,该一个或多个电极可包括晶格结构以限制一个或多个电极与患者的皮肤之间的接触面积。该传感器组件可包括有利于一个或多个电极与数据采集单元之间的连接的连接器或连接器组件。该传感器组件可尤其用于具有敏感性皮肤的患者,诸如新生儿重症监护病房(NICU)中的婴儿。(The disclosed sensor assembly may be used in a patient monitoring system to monitor one or more physiological parameters of a patient. The sensor assembly may include a substrate and one or more electrodes, which may include a lattice structure to limit a contact area between the one or more electrodes and the skin of the patient. The sensor assembly may include a connector or connector assembly that facilitates connection between one or more electrodes and a data acquisition unit. The sensor assembly may be particularly useful for patients with sensitive skin, such as infants in Neonatal Intensive Care Units (NICUs).)

1. A sensor assembly, comprising:

a substrate; and

an electrode positioned on a first side of the substrate, wherein the electrode is configured to obtain data indicative of one or more physiological parameters of a patient, and the electrode comprises conductive portions arranged in a lattice structure.

2. The sensor assembly of claim 1, wherein the substrate comprises a textile fabric.

3. The sensor component of claim 1, wherein the lattice structure comprises a plurality of lattice cells having a rectangular, square, triangular, diamond, pentagonal, hexagonal, octagonal, or circular shape.

4. The sensor assembly of claim 1, wherein the conductive portion comprises a conductive ink printed onto the substrate or printed onto a film laminated to the substrate.

5. The sensor assembly of claim 1, wherein the conductive portion comprises a conductive wire woven into the substrate.

6. The sensor assembly of claim 1, wherein the conductive portion comprises a conductive fabric coupled to the substrate via an adhesive, a wire, or a fastener.

7. The sensor assembly of claim 1, comprising a first portion of a connector configured to electrically couple the electrode to a wire, wherein the first portion is coupled to the substrate and the electrode, and the first portion comprises an attachment portion configured to mate with a second portion of the connector coupled to the wire.

8. The sensor assembly of claim 7, wherein the first portion is oriented to expose the attachment portion on a second side of the substrate opposite the first side of the substrate.

9. The sensor assembly of claim 1, comprising a connector assembly configured to electrically couple the electrode to a lead, wherein the connector assembly comprises:

a conductor positioned on a second side of the substrate opposite the first side of the substrate;

a first connector electrically coupling the electrode to the conductor; and

a first portion of a second connector configured to electrically couple the conductor to the wire, wherein the first portion is coupled to the substrate and the conductor, the first portion includes an attachment portion configured to mate with a second portion of the second connector coupled to the wire, and the first portion is oriented to expose the attachment portion on the second side of the substrate.

10. The sensor assembly of claim 1, comprising one or more additional electrodes, wherein the electrode and the one or more additional electrodes each have a rectangular shape, have a length of between about 5 centimeters and 15 centimeters (cm), have a width of between about 0.5cm and 1cm, are arranged in parallel lines, and are spaced apart from each other by about 0.5 centimeters to 1.5 centimeters.

11. The sensor assembly of claim 1, wherein a first total area of the conductive portion of the electrode is less than or equal to about 90% of a second total area of the electrode.

12. The sensor assembly of claim 1, comprising a pressure sensor, a temperature sensor, an accelerometer, or any combination thereof coupled to the first side of the substrate.

13. The sensor assembly of claim 1, wherein the one or more physiological parameters include heart rate, respiration rate, or both.

14. The sensor assembly of claim 1, comprising one or more markings formed on the substrate to indicate proper placement of the patient's head, the patient's torso, or both relative to the electrode.

15. A sensor assembly, comprising:

a substrate comprising a textile;

an electrode positioned on a first side of the substrate, wherein the electrode is configured to obtain data indicative of one or more physiological parameters of a patient; and

an attachment portion configured to mate with a corresponding attachment portion of a wire to enable transmission of the data to a data acquisition unit, wherein the attachment portion is oriented relative to the substrate to be exposed on a second side of the substrate opposite the first side of the substrate.

16. The sensor assembly of claim 15, wherein the electrode comprises conductive portions arranged in a lattice structure.

17. The sensor assembly of claim 15, wherein the attachment portion comprises a key, a slot, or a magnet.

18. The sensor assembly of claim 15, wherein the attachment portion is part of a connector assembly, and the connector assembly comprises:

a conductor positioned on the second side of the substrate;

a first connector electrically coupling the electrode to the conductor; and

a first portion of a second connector electrically coupling the conductor to the wire, wherein the first portion includes the attachment portion and is coupled to the substrate and the conductor.

19. A method of manufacturing a sensor assembly, comprising:

forming an electrode on a first side of a substrate, wherein the substrate is a textile, the electrode is configured to obtain data indicative of one or more physiological parameters of a patient, and the electrode comprises conductive portions arranged in a lattice structure.

20. The method of claim 19, comprising coupling an attachment portion to the substrate, wherein the attachment portion is configured to mate with a corresponding attachment portion of a wire to enable transmission of the data to a data acquisition unit, and the attachment portion is oriented relative to the substrate to be exposed on a second side of the substrate opposite the first side of the substrate.

Background

The subject matter disclosed herein relates generally to patient monitoring systems.

This section is intended to introduce the reader to various aspects of art, which may be related to various aspects of the present technology that are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

Various types of sensors may be used to monitor patients in a medical environment, such as infants in a Neonatal Intensive Care Unit (NICU). For example, the patient may be monitored via one or more electrodes positioned (e.g., via an adhesive) on the patient's skin to generate an Electrocardiogram (ECG) and/or to monitor cardiac parameters of the patient.

Disclosure of Invention

The following outlines certain embodiments commensurate with the scope of the originally claimed disclosure. These embodiments are not intended to limit the scope of the claimed disclosure, but rather these embodiments are intended only to provide a brief summary of possible forms of the disclosure. Indeed, embodiments may include forms that may be similar or different from the embodiments described below.

In one embodiment, a sensor assembly includes a substrate and an electrode positioned on a first side of the substrate. The electrode is configured to obtain data indicative of one or more physiological parameters of a patient, and the electrode includes conductive portions arranged in a lattice structure.

In one embodiment, a sensor assembly includes a substrate having a textile and an electrode positioned on a first side of the substrate, wherein the electrode is configured to obtain data indicative of one or more physiological parameters of a patient. The sensor assembly also includes an attachment portion configured to mate with a corresponding attachment portion of the lead to enable transmission of data to the data acquisition unit, wherein the attachment portion is oriented relative to the substrate to be exposed on a second side of the substrate opposite the first side of the substrate.

In one embodiment, a method of manufacturing a sensor assembly includes forming an electrode on a first side of a substrate, wherein the substrate is a textile, the electrode is configured to obtain data indicative of one or more physiological parameters of a patient, and the electrode includes conductive portions arranged in a lattice structure.

Drawings

These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:

fig. 1 is a block diagram of a patient monitoring system according to an embodiment of the present disclosure;

fig. 2 is a schematic diagram of a sensor assembly that may be used in the patient monitoring system of fig. 1, wherein the sensor assembly includes a substrate and an electrode array on a first side of the substrate, according to an embodiment of the present disclosure;

FIG. 3 is a cross-sectional side view of a connector that may be used with the sensor assembly of FIG. 2, where the cross-section is taken within line 3-3 of FIG. 2 and the connector is in a first orientation relative to a substrate of the sensor assembly, according to an embodiment of the present disclosure;

FIG. 4 is a cross-sectional side view of a connector that may be used with the sensor assembly of FIG. 2, wherein the connector is in a second orientation relative to the substrate of the sensor assembly, according to an embodiment of the present disclosure;

fig. 5 is a schematic illustration of a first side and a second side of a substrate of a sensor assembly that may be used in the patient monitoring system of fig. 1, with a connector assembly positioned on the second side of the substrate, according to an embodiment of the present disclosure;

FIG. 6 is a schematic view of a first side of the sensor assembly of FIG. 5, according to an embodiment of the present invention;

FIG. 7 is a cross-sectional side view of a first connector that may be used with the sensor assembly of FIGS. 5 and 6, wherein the cross-section is taken within line 7-7 of FIG. 6, in accordance with an embodiment of the present invention;

FIG. 8 is a cross-sectional side view of a second connector that may be used with the sensor assembly of FIGS. 5 and 6, wherein the cross-section is taken within line 8-8 of FIG. 6, in accordance with an embodiment of the present invention;

fig. 9 is a schematic diagram of a sensor assembly that may be used with the patient monitoring system of fig. 1, wherein the sensor assembly includes a connector assembly arranged to position connectors in proximity to one another, according to an embodiment of the present disclosure;

fig. 10 is a schematic diagram of a sensor assembly that may be used with the patient monitoring system of fig. 1, wherein the sensor assembly includes an electrode array that facilitates diagnostic monitoring, according to an embodiment of the present disclosure;

fig. 11 is a schematic diagram of a sensor assembly that may be used in the patient monitoring system of fig. 1, wherein the sensor assembly includes an electrode array having a plurality of electrodes and conductive pathways, according to an embodiment of the present disclosure;

fig. 12 is a schematic illustration of an electrode having a rectangular lattice structure that may be used with the patient monitoring system of fig. 1, according to an embodiment of the present disclosure;

fig. 13 is a schematic illustration of an electrode having a square lattice structure that may be used with the patient monitoring system of fig. 1, according to an embodiment of the present disclosure;

fig. 14 is a schematic illustration of an electrode having a triangular lattice structure that may be used with the patient monitoring system of fig. 1, according to an embodiment of the present disclosure;

fig. 15 is a schematic diagram of a sensor assembly that may be used in the patient monitoring system of fig. 1, wherein the sensor assembly includes a substrate and an electrode array and various other sensors on a first side of the substrate, according to an embodiment of the present disclosure; and is

Fig. 16 is a schematic illustration of a marker assembly that may be used in the patient monitoring system of fig. 1 to facilitate placement of a patient relative to an electrode array of a sensor assembly, according to an embodiment of the present disclosure.

Detailed Description

One or more specific embodiments of the present disclosure will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

When introducing elements of various embodiments of the present disclosure, the articles "a," "an," "the," and "said" are intended to mean that there are one or more of the elements. The terms "comprising," "including," and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. One or more specific embodiments among the present embodiments described herein will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

Embodiments of the present disclosure relate generally to patient monitoring systems and, more particularly, to sensor assemblies for patient monitoring systems. The sensor assembly may include a substrate and an electrode array, and the electrode array may include one or more electrodes configured to obtain data indicative of one or more physiological parameters of the patient (e.g., heart rate, respiration rate). The substrate may be a textile and the one or more electrodes may be coupled to or integrally formed with the substrate. For example, one or more electrodes may be formed from conductive threads woven into a substrate (e.g., embroidered onto the substrate). The one or more electrodes may be stretchable and biocompatible, and the sensor assembly may be disposable and/or capable of being sterilized (e.g., submerged in a cleaning fluid).

In some embodiments, neither the substrate nor the one or more electrodes are adhered to the skin of the patient by the adhesive. Instead, the substrate may be wrapped around the patient, or the patient may lie on the substrate to place one or more electrodes in direct contact with the patient's skin, without the need for adhesives or other intermediate substrates or compositions to facilitate contact. The one or more electrodes may include a lattice structure (e.g., an open cell structure, a non-solid structure, a non-continuous structure, or a frame) to limit the contact area between the one or more electrodes and the patient's skin. Thus, the disclosed systems and methods may be particularly useful for patients with sensitive skin, such as infants in Neonatal Intensive Care Units (NICUs). While the disclosed embodiments are presented in the context of an NICU to facilitate discussion, it should be understood that the disclosed embodiments may be adapted for use with a variety of different types of patients in both medical and non-medical environments.

With the above in mind, fig. 1 is a block diagram of a patient monitoring system 10. As shown, the patient monitoring system 10 may include a sensor assembly 12 having a substrate 14 with a first side 16 (e.g., a patient contacting side; a first surface) and a second side 18 (e.g., a second surface) opposite the first side 16. The substrate 14 may be a textile, which may be a flexible material formed from a network of natural or synthetic fibers. As used herein, the term textile may include any of a variety of fabric and/or paper materials. Further, the substrate may be a blanket, an article of clothing, a diaper, and/or a covering for a cushion or other patient-supporting surface (e.g., a piece of fabric or a disposable paper covering). In some embodiments, the substrate 14 may be a patch configured to be coupled (e.g., temporarily coupled via an adhesive and/or a fastener such as a snap, a clamp, a hook and loop fastener) to another object. For example, substrate 14 may be a piece of cloth or a piece of paper configured to be coupled to a blanket, article of clothing, a diaper, a cushion, or other covering of a patient support surface or other object via fasteners 19. As noted above, the disclosed embodiments may be particularly useful for infants, and thus, it should be understood that the substrate 14 may be sized for use in an incubator configured to accommodate an infant in the NICU (e.g., the substrate may be a mating piece for an incubator cushion).

The sensor assembly 12 may also include an electrode array 20 having one or more electrodes 22 positioned on (e.g., exposed at) the first side 16 of the substrate 14. One or more electrodes 22 may be positioned on the first side 16 of the substrate 14 via any of a variety of techniques. For example, one or more electrodes 22 may be formed by printing a conductive ink (e.g., a silver-based ink) onto a film, which is then bonded (e.g., via lamination) to substrate 14. In some implementations, the one or more electrodes 22 can be formed by weaving conductive threads (e.g., silver-based threads) into the substrate 14 (e.g., weaving the conductive threads to form the substrate 14 and/or embroidering the conductive threads through the substrate 14). In some embodiments, one or more electrodes 22 may be formed by coupling one or more pieces of conductive fabric (e.g., with a conductive coating or made with conductive wires) onto substrate 14, such as via stitching, adhesives, and/or fasteners (e.g., snaps, clips). In some such embodiments, one or more pieces of conductive fabric may be etched to remove conductive portions (e.g., remove a conductive coating) to form a plurality of individual electrodes 22 and/or to provide a lattice structure for one or more electrodes 22, as discussed in more detail below.

During the monitoring session, the sensor assembly 12 may be positioned such that the one or more electrodes 22 contact the appropriate area of the patient. For example, the substrate 14 may be positioned on a patient support surface (e.g., a mattress or table) and the patient may lie on top of the substrate 14 with the one or more electrodes 22 positioned below the torso of the patient. As shown, one or more bumps 28 (e.g., protrusions, dilators, relief structures) may be positioned along the second side 18 of the substrate 14 to push the one or more electrodes 22 into the skin of the patient. The one or more tabs 28 may be integrally formed with the substrate 14 (e.g., woven as part of the substrate 14), or may be a piece of fabric, elastomer, or other material that is coupled to the substrate 14 by stitching, adhesives, and/or fasteners (e.g., snaps, clips, hook-and-loop fasteners).

In the illustrated embodiment, one or more electrodes 22 are communicatively coupled to a data acquisition unit 24 via one or more leads 26 (e.g., wires or any suitable conductor). One or more electrodes 22 may generate signals indicative of physiological parameters of the patient (e.g., heart rate, respiration rate), and one or more leads 26 may carry the signals to a data acquisition unit 24. The data acquisition unit 24 may process the signals by any suitable processing technique to calculate the patient's heart rate and/or the patient's breathing rate. For example, in some embodiments, data acquisition unit 24 may process the signals to generate an ECG waveform. In some such cases, the heart rate and/or respiration rate may be derived from the ECG waveform. The respiration rate may be obtained in various other ways. For example, low currents may be provided to electrodes positioned across the chest of the patient and electrodes positioned across the abdomen of the patient, and the change in resistance measured over time may be indicative of the respiration rate (e.g., two-channel respiration rate monitoring). In some such cases, the same electrodes 22 may be used for both heart rate monitoring and respiratory rate monitoring (e.g., alternating between heart rate monitoring and respiratory rate monitoring over time). Alternatively, the sensor assembly 12 may include some electrodes 22 for heart rate monitoring and other electrodes 22 for respiratory rate monitoring.

As shown, the data acquisition unit 24 may be an electronic computing system having a communication device 30, a processor 32, a memory/storage device 34, and/or an output device 36. Memory/storage 34 may include one or more tangible, non-transitory computer-readable media that store instructions capable of being executed by processor 32 and/or data to be processed by processor 32. For example, memory/storage 34 may include Random Access Memory (RAM), Read Only Memory (ROM), rewritable non-volatile memory (such as flash memory), a hard disk drive, an optical disk, and so forth. Additionally, processor 32 may include one or more general purpose microprocessors, one or more application specific processors (ASICs), one or more Field Programmable Gate Arrays (FPGAs), or any combination thereof. The processor 32 may instruct the output device 36 to display, for example, an ECG waveform, a heart rate, and/or a respiration rate.

Communication device 30 may enable data acquisition unit 24 to communicate with remote computing system 38 via various protocols, such as various wired or wireless communication protocols. In some embodiments, data acquisition unit 24 may relay the raw data or processed data to remote computing system 38. The remote computing system 38 may be an electronic computing system having a communication device 40, a processor 42, a memory/storage device 44, and/or an output device 46. These components of the remote computing system 38 may have any of the features discussed above with respect to the communication device 30, the processor 32, the memory/storage device 34, and/or the output device 36 of the data acquisition unit 24. Accordingly, remote computing system 38 may process the data (e.g., in the manner described above with respect to data acquisition unit 24) and/or display the data for visualization by, for example, a medical professional.

Fig. 2 is a schematic diagram of an embodiment of a sensor assembly 12 having a substrate 14 and an electrode array 20. As shown, the electrode array 20 includes four electrodes 22 on the first side 16 of the substrate 14. In the illustrated embodiment, the electrodes 22 are physically spaced apart from one another, arranged in parallel lines, and each of the electrodes 22 has a rectangular shape. For use with an infant, the electrodes 22 may be spaced apart from each other by about 1 centimeter (or between about 0.5 and 1.5 centimeters), and the electrodes 22 may have a length of about 10 centimeters (or between about 5 and 15 centimeters) and a width of about 1 centimeter (or between about 0.5 and 1.5 centimeters). However, it should be understood that the sensor assembly 12 may include any number of electrodes 22 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more) having any of a variety of sizes, any of a variety of shapes, and any of a variety of configurations. Further, multiple sensor assemblies 12 having substrates 14 of different characteristics (e.g., different sizes and/or configurations, such as patches, blankets, garments, and/or coverings of various sizes) and/or having electrodes 22 of different characteristics (e.g., different numbers, sizes, shapes, arrangements, and/or contact ratios) may be provided as a kit to a medical facility for patients having different characteristics (e.g., medical needs, skin conditions, sizes). For example, for use with adults, the electrodes 22 may be spaced apart by about 4 centimeters (or between about 3.5 and 5.5 centimeters), and the electrodes 22 may have a length of about 25 centimeters (or between about 15 and 50 centimeters) and a width of about 2 centimeters (or between about 1.5 and 3 centimeters).

As shown, indicia 48 (e.g., indicators) may be provided on the substrate 14 to facilitate placement of the patient relative to the electrodes 22. For example, the markers 48 may indicate locations where the patient's head should be placed to position the patient's torso on top of the electrodes 22. In the illustrated embodiment, the electrodes 22 extend horizontally across the torso of the patient (e.g., from the left side to the right side of the patient) when the patient's head is placed on the marker 48. While the illustrated sensor assembly 12 may be configured for use with electrodes 22 that extend horizontally across the torso of a patient, it should be understood that the sensor assembly 12 may be configured for use with electrodes 22 that extend vertically across the torso of a patient (e.g., from the chest portion to the abdomen portion of the torso of a patient).

In some embodiments, one or more of the electrodes 22 may include a lattice structure 50 (e.g., an open cell structure, a non-solid structure, a non-continuous structure, or a framework). Thus, one or more of the electrodes 22 do not form a solid conductive surface that contacts the patient's skin, but rather, the conductive portions are separated by non-conductive portions (e.g., conductive ink, wires, or fabrics are spaced apart from one another by non-conductive fabrics or films). Thus, the contact area between the electrode 22 and the patient's skin is reduced compared to other types of electrodes having solid conductive surfaces.

To transmit signals to data acquisition unit 24 (fig. 1), each of electrodes 22 is electrically coupled to one of leads 26 via a respective connector 52. Each of the connectors 52 may be a conductive connector or a fastener, such as a snap, clamp, or magnet. For example, each of the connectors 52 may include a first portion 54 (e.g., a first connector portion) coupled to the respective electrode 22 and substrate 14 (e.g., via riveting or stitching) and configured to mate with a second portion 56 (e.g., a second connector portion) positioned at an end portion of the lead 26. When the first portion 54 and the second portion 56 are mated (e.g., joined or interlocked by securing the second portion 56 to the first portion 54, as indicated by arrow 58), a signal may be transmitted from the electrode 22 to the lead 26 through the connector 52. In the illustrated embodiment, the first portion 54 of the connector 52 is oriented such that the wires 26 are positioned on and extend along the first side 16 of the substrate 14 when the first portion 54 and the second portion 56 are mated.

Connector 52 is merely exemplary, and the electrical connection between electrode 22 and lead 26 may be made in any of a variety of ways. For example, connections may be made on a single layer (e.g., the first side 16 of the substrate 14) by extending conductive pathways (e.g., conductive fabric, conductive wires) from the electrodes 22 to the edges of the substrate 14 for connection to the leads 26. The conductive pathways, wires 26, and/or any connectors (e.g., connector 52) on the first side 16 of the substrate 14 may be covered (e.g., by a non-conductive material such as a printed dielectric or a second substrate material), or at least portions of these structures that may be contacted by the patient may be covered to electrically isolate the patient.

Fig. 3 is a cross-sectional side view of one of the connectors 52 taken within line 3-3 of fig. 2. As shown, the connector 52 includes a first portion 54 coupled to the electrode 22 and the substrate 14 and a second portion 56 positioned at an end portion of the lead 26. The first portion 54 and the second portion 56 cooperate to electrically couple the electrode 22 to the lead 26. In the illustrated embodiment, the connector 52 is a snap and the first portion 54 includes a body 60 that extends through the electrode 22 and the substrate 14. For example, the body 60 may penetrate (e.g., pierce) the electrode 22 and the substrate 14, and then the prongs 62 extending from the body 60 may be bent as indicated by arrows 64 to secure the first portion 54 to the electrode 22 and the substrate 14. However, it should be understood that first portion 54 may be coupled to electrode 22 by any suitable technique that places first portion 54 in contact with electrode 22 and exposes attachment portion 66 (e.g., key, slot, magnet) of first portion 54 on first side 16 of substrate 14 to enable first portion 54 and second portion 56 to mate with one another. For example, the first portion 54 may not extend through the electrode 22 and the substrate 14. Rather, the first portion 54 may be positioned over the electrode 22 and secured to the electrode 22 and/or the substrate 14 by stitching. While the attachment portion 66 of the first portion 54 is shown as a key (e.g., a protrusion) that engages a slot of the second portion 56, it should be understood that the attachment portion 66 may include other features, such as a slot that engages a key of the second portion 56 or a magnet coupled to another magnet of the second portion 56.

As described above, in fig. 2 and 3, the first portion 54 of the connector 52 is oriented such that the wires 26 are positioned on and extend along the first side 16 of the substrate 14 when the first portion 54 and the second portion 56 are mated. However, the first portion 54 of the connector 52 may be oriented such that the wires 26 are positioned on and extend along the second side 18 of the substrate 14 when the first portion 54 and the second portion 56 are mated. Fig. 4 is a cross-sectional side view of one of the connectors 52 with the first portion 54 oriented in this manner.

As shown in fig. 4, connector 52 includes a first portion 54 coupled to electrode 22 and substrate 14 and a second portion 56 positioned at an end portion of lead 26. Connector 52 is a snap and first portion 54 includes a body 60 extending through electrode 22 and substrate 14, and body 60 is oriented to expose an attachment portion 66 of first portion 54 at second side 18 of substrate 14. The first portion 54 and the second portion 56 cooperate to electrically couple the electrode 22 to the lead 26. As described above, the connector 52 can have various forms, and it should be understood that the first portion 54 can be coupled to the electrode 22 via any suitable technique that places the first portion 54 in contact with the electrode 22 and exposes the attachment portion 66 of the first portion 54 on the second side 18 of the substrate 14. Such a configuration may prevent interference between lead 26 and other devices and/or between lead 26 and the patient.

Fig. 5 and 6 are schematic diagrams of embodiments of the sensor assembly 12 showing the electrode array 20 on the first side 16 of the substrate 14 and a plurality of connector assemblies 70 on the second side 18 of the substrate 14. For ease of discussion, the first side 16 of the substrate 14 and the second side 18 of the substrate 14 are shown separately and side-by-side in fig. 5. In the illustrated embodiment, the electrode array 20 includes four electrodes 22 having a rectangular shape, arranged in parallel lines, and physically spaced apart from each other. However, it should be understood that the sensor assembly 12 may include any number of electrodes 22 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more) having any of a variety of sizes, any of a variety of shapes, and any of a variety of configurations. Substrate 14 may include indicia 48 and/or one or more of electrodes 22 may include lattice structure 50.

To transmit signals to data acquisition unit 24 (fig. 1), each of electrodes 22 may be electrically coupled to one of leads 26 via one of connector assemblies 70. Each of the connector assemblies 70 may include a first connector 72, a conductor 74 (e.g., a conductive path), and a second connector 76. The first connector 72 may be a conductive connector or fastener, such as a rivet, grommet, pin, snap, clamp, thread, that contacts the electrode 22 positioned on the first side 16 of the substrate 14 and the conductor 74 positioned on the second side 18 of the substrate 14. The conductor 74 may be any of a variety of conductors (e.g., flex circuit, wire, conductive ink, conductive fabric, wire) that may be coupled to the second side 18 of the substrate 14 (e.g., via printing, stitching, adhesive, lamination, and/or fasteners). The conductor 74 extends from the first connector 72 toward an edge 78 of the substrate 14.

The second connector 76 may be a conductive connector or fastener, such as a snap, clamp, or magnet, configured to electrically couple the conductor 74 to the wire 26. For example, each of the second connectors 76 may include a first portion 80 (e.g., a first connector portion) coupled to the conductor 74 and the substrate 14 (e.g., via riveting or stitching) and configured to mate with a second portion 82 (e.g., a second connector portion) positioned at an end portion of the wire 26. When the first portion 80 and the second portion 82 are mated (e.g., joined or interlocked by securing the second portion 82 to the first portion 80, as indicated by arrow 84), a signal may be transmitted from the electrode 22 to the lead 26 through the connector assembly 70.

In the illustrated embodiment, the connector assembly 70 enables the wires 26 to be coupled at the second side 18 of the substrate 14, which may prevent interference between the wires 26 and other devices and/or between the wires 26 and the patient. The connector assembly 70 may also enable the electrode 22 to be positioned on a central portion of the substrate 14 without extending along the first side 16 of the substrate 14 to the edge 78 of the substrate 14, while still enabling the lead 26 to be connected adjacent the edge 78 of the substrate 14. Such a configuration may limit the size of the electrode 22 to reduce patient discomfort and/or may facilitate coupling of the lead 26 to other components of the sensor assembly 12 without interfering with, for example, a patient positioned on top of the electrode 22.

Fig. 7 is a cross-sectional side view of one of the first connectors 72 taken within line 7-7 of fig. 6. As shown, the first connector 72 is in contact with the electrode 22 positioned on the first side 16 of the substrate 14 and the conductor 74 positioned on the second side 18 of the substrate 14. In the illustrated embodiment, the first connector 72 is a rivet that can penetrate (e.g., pierce) the electrode 22 to secure the first connector 72 to the electrode 22, the substrate 14, and the conductor 74. However, as noted above, the first connector 72 may be any of a variety of connectors or fasteners, such as grommets, pins, snaps, clamps, and/or threads.

Fig. 8 is a cross-sectional side view of one of the second connectors 76 taken within line 8-8 of fig. 6. As shown, the second connector 76 electrically couples the conductor 74 to the wire 26. The second connector 52 includes a first portion 80 connected to the conductor 74 and the substrate 14 and a second portion 82 positioned at an end of the wire 26. The first portion 80 and the second portion 82 cooperate to electrically couple the conductor 74, and thus the electrode 22, to the lead 26. In the illustrated embodiment, the second connector 76 is a snap and the first portion 80 includes a body 86 that extends through the conductor 74 and the substrate 14. For example, the body 86 may penetrate (e.g., pierce) the conductor 74 and the substrate 14, and then the gear teeth 88 extending from the body 86 may be bent as indicated by arrow 90 to secure the first portion 80 to the conductor 74 and the substrate 14. However, it should be understood that the first portion 80 may be coupled to the conductor 74 by any suitable technique that places the first portion 80 in contact with the conductor 74 and exposes an attachment portion 92 (e.g., key, slot, magnet) of the first portion 80 on the second side 18 of the substrate 14 to enable the first portion 80 and the second portion 82 to mate with one another. For example, the first portion 80 may not extend through the conductor 74 and the substrate 14. Rather, the first portion 80 may be positioned over the conductor 74 and secured to the conductor 74 and/or the substrate 14 by stitching. While the attachment portion 74 of the first portion 80 is shown as a key (e.g., a protrusion) that engages a slot of the second portion 82, it should be understood that the attachment portion 74 may include other features, such as a slot that engages a key of the second portion 82 or a magnet coupled to another magnet of the second portion 82.

As described above, in fig. 5-8, the first portion 80 of the second connector 76 is oriented such that the wires 26 are coupled at the second side 18 of the substrate 14 when the first portion 80 and the second portion 82 are mated. However, the first portion 80 of the second connector 76 may be oriented such that the wires 26 are coupled at the first side 16 of the substrate 14 when the first portion 80 and the second portion 82 are mated. Such a configuration may enable the dimensions of the electrodes 22 and conductive components on the first side 16 of the substrate 14 to be limited to reduce discomfort to the patient, while still enabling connection to the leads 26 near the edge 78 of the substrate 14 to reduce interference and/or disturbance, for example, to a patient positioned on top of the electrodes 22.

Various other arrangements of the electrodes 22 and/or the connector assembly 70 are contemplated. For example, fig. 9 is a schematic view of an embodiment of the sensor assembly 12 in which the connector assembly 70 is arranged to position the second connectors 76 in proximity to each other. More specifically, in the illustrated embodiment, two of the conductors 74 have bends 100 (e.g., L-shaped) such that all four of the second connectors 76 are disposed in a central region 102 near the edge 78 of the substrate 14. Thus, rather than being aligned in a single line as shown in fig. 5 and 6, the second connectors 76 are arranged in a square pattern (e.g., located at the four corners of a square). Such a configuration may prevent interference between, for example, lead 26 and other devices and/or between lead 26 and the patient.

Fig. 10 is a schematic diagram of an embodiment of the sensor assembly 12, wherein the electrode array 20 has six electrodes 22 in another configuration. As shown, the electrode array 20 includes a first end electrode 22, 110, a second end electrode 22, 112, and four center electrodes 22, 114 positioned between the first end electrode 22, 110 and the second end electrode 22, 112. The electrodes 22 are physically separated from each other and may be coupled to the leads via any of the techniques disclosed herein (e.g., the connector 52 of fig. 2-4, the connector assembly 70 of fig. 5-9). Further, the substrate 14 may include the indicia 48 and/or one or more of the electrodes 110, 112, 114 may include the lattice structure 50. The illustrated sensor assembly 12 may be used for diagnostic monitoring (e.g., may provide more detailed and/or reliable data indicative of cardiac function and/or respiration rate) and/or may enable two-channel respiration rate monitoring.

Fig. 11 is a schematic diagram of an embodiment of a sensor assembly 12 in which an electrode array 20 has a plurality of electrodes 22 in another configuration. The electrodes 22 are physically separated from each other and may be coupled to the leads via any of the techniques disclosed herein (e.g., the connector 52 of fig. 2-4, the connector assembly 70 of fig. 5-9). In the illustrated embodiment, the connection includes a conductive pathway 116 (e.g., a conductor, a conductive fabric, a conductive wire) extending from the electrode 22 toward an edge of the substrate 14 (or at least away from an area configured to be positioned under or otherwise contact the patient) for connection to a lead. The conductive pathways 116, wires, and/or any connectors (e.g., connector 52) used on the first side 16 of the substrate 14 may be covered (e.g., by a non-conductive material such as a printed dielectric or a second substrate material), or at least portions of these structures that may be contacted by the patient may be covered to electrically isolate them from the patient. For clarity, only some of the electrodes 22 and conductive vias 116 are numbered in fig. 11.

As shown in fig. 11, substrate 14 may include indicia 48 and/or one or more of electrodes 22 may include lattice structure 50. The illustrated sensor assembly 12 may be used for diagnostic monitoring (e.g., may provide more detailed and/or reliable data indicative of cardiac function and/or respiration rate) and/or may enable two-channel respiration rate monitoring.

Fig. 12-14 illustrate various lattice structures 50 that may be used to form the electrodes 22 disclosed herein. In particular, fig. 12 shows one electrode 22 having a lattice structure 50 with conductive portions 120 (e.g., conductive trusses or wires) arranged to form rectangular lattice cells and defining non-conductive portions 122 (e.g., gaps). Fig. 13 shows one electrode 22 having a lattice structure 50 with conductive portions 120 arranged to form square lattice cells and defining non-conductive portions 122. Fig. 14 shows a portion of one electrode 22 having a lattice structure 50 with conductive portions 120 arranged to form triangular lattice cells and defining non-conductive portions 122.

As shown in fig. 12-14, the non-conductive portion 122 may be occupied (e.g., filled) by the substrate 14. However, in some embodiments, the non-conductive portion 122 may additionally be occupied by, for example, a film or other material on which the conductive portion 120 is printed or coated. The lattice structure 50 may have a contact ratio, which may be defined as a ratio of a first total area of the conductive portion 120 of the electrode 22 to a second total area of the electrode 22. For example, referring to fig. 12, the contact ratio may be defined as (L W-a b N)/(L W), where L is the length of the electrode 22, W is the width of the electrode, a is the length of each section of the non-conductive portion 122, b is the width of each section of the non-conductive portion 122, and N is the number of sections of the non-conductive portion 122.

The contact ratio may be adjusted according to the skin condition of the patient (e.g., different sensor assemblies 12 may be adapted for use with different patients). For example, a relatively low contact ratio (e.g., less than or equal to about 50%, 40%, 30%, or 20%, or between about 10% and 50%, 20% and 40%, or 25% and 35%) may be appropriate for patients with sensitive skin (e.g., premature infants, elderly, burn patients), while a relatively high contact ratio (e.g., greater than or equal to about 50%, 60%, 70%, 80%, or 90%, or between about 50% and 95%, 70% and 90%, or 75% and 85%) may be appropriate for patients without specific skin sensitivity (e.g., term infants). As described above, multiple sensor assemblies 12 having substrates 14 of different characteristics and/or electrodes 22 of different characteristics (including different contact ratios) may be provided as a kit to a medical facility. Accordingly, a medical professional may select an appropriate sensor assembly 12 for a patient to balance the signal-to-noise ratio of the signal generated by electrode 22 with the skin sensitivity of the patient.

Further, the conductive portion 120 may have various orientations. For example, in fig. 12, the conductive portion 120 includes a section parallel to the horizontal edge 124 of the electrode 22 and a section parallel to the vertical edge 126 of the electrode 22. However, in fig. 13, the sections of the conductive portion 120 are angled relative to the horizontal edge 124 of the electrode 22 and relative to the vertical edge 126 of the electrode 22. It should also be understood that the lattice structure 50 can have any of a variety of forms. For example, the lattice cells can have various cross-sectional shapes, such as rectangular (e.g., non-square), square, triangular, diamond, pentagonal, hexagonal, octagonal, or circular. In some embodiments, lattice structure 50 may have lattice cells of a variety of different cross-sectional shapes (e.g., both hexagonal and square).

Various methods of manufacture and use of the sensor assembly 12 are contemplated. For example, the sensor assembly 12 may be fabricated by forming one or more electrodes 22 having a lattice structure 50 on the substrate 14. As described above, one or more electrodes 22 may be formed by printing a conductive ink onto the film, and then bonding the film (e.g., via lamination) to substrate 14. One or more electrodes 22 may be formed by weaving conductive wires into substrate 14, or one or more electrodes 22 may be formed by coupling one or more pieces of conductive fabric onto substrate 14. In some such implementations, one or more pieces of conductive fabric may be etched to remove the conductive portions. Next, the first portion 54 of the connector 52 or the appropriate components of the connector assembly 70 (e.g., the first connector 72, the conductors 74, the first portion 80 of the second connector 82) may be assembled onto the substrate 14. During use, the sensor assembly 12 may be wrapped around the torso of a patient, or the sensor assembly 12 may be placed under the torso of a patient. Signals from one or more electrodes 22 may be transmitted (e.g., via connector 52 and/or connector assembly 70 and one or more wires 26) to data acquisition unit 24, which may then relay the data to remote computing system 38.

FIG. 15 is a schematic diagram of sensor assembly 12 having one or more electrodes 22 and various other sensors. For example, other sensors may include one or more pressure sensors 130 (e.g., strain gauges) that detect movement of the patient, one or more temperature sensors 132 (e.g., thermocouples) that detect the patient's body temperature, and/or one or more motion sensors 134 (e.g., accelerometers) that detect movement of the substrate 14. Substrate 14 may include indicia 48. Further, one or more of the electrodes 22 and/or one or more of the other sensors may include a lattice structure 50 (fig. 12-14).

Each of the one or more electrodes 22 and other sensors may be coupled to the data acquisition unit 24 via a respective lead 26, and one or more of the one or more electrodes 22 and/or other sensors may be coupled to the lead 26 via any of the techniques disclosed herein (e.g., the connector 52 of fig. 2-4, the connector assembly 70 of fig. 5-9). During the monitoring session, the sensor assembly 12 may be positioned such that the one or more electrodes 22 and other sensors contact the appropriate area of the patient. For example, the substrate 14 may be positioned on a patient support surface (e.g., a mattress or table) and the patient may lie on top of the substrate 14 with the one or more electrodes 22 and other sensors located below the torso of the patient. One or more electrodes 22 and other sensors may generate signals indicative of various physiological parameters of the patient, and one or more leads 26 may carry the signals to a data acquisition unit 24 for processing. It should be understood that the data acquisition unit 24 may process the signals and provide an output indicative of the physiological parameter (e.g., via the output device 36 in fig. 1) and/or may transmit the signals (e.g., raw signals or processed signals) to a remote computing system 38 (fig. 1). When calculating physiological parameters of a patient, signals from the motion sensor 134 (or from any other motion sensor 134 positioned on the patient or on a bed supporting the patient) may be processed and used to compensate for noise due to motion.

Fig. 16 is a schematic diagram of an embodiment of sensor assembly 12 having a marker assembly 148 to facilitate patient placement relative to electrodes 22 of electrode array 20. The marking assembly 148 may be printed (e.g., screen printed) or otherwise formed (e.g., woven) on the first side 16 of the substrate 14 to be visible on the first side 16 of the substrate 14. As shown, the marker assembly 148 may include first markers 48, 150 indicating proper placement of the patient's head relative to the electrode 12, second markers 48, 152 indicating proper placement of the patient's torso relative to the electrode 22, and/or additional markers 48, 154 indicating proper placement of the patient's arms relative to the electrode 22. In the illustrated embodiment, the marker assembly 148 is designed to look like a bumblebee, the first markers 48, 150 indicating proper placement of the patient's head are shown as the bumblebee's head, the second markers 48, 152 indicating proper placement of the patient's torso are shown as the bumblebee's torso, and the additional markers 48, 154 indicating proper placement of the patient's arms are shown as the bumblebee's wings. However, marker assembly 48 may be any of a variety of combinations of shapes and/or may represent any of a variety of animal or human beings (e.g., cartoon characters). For example, the marker assembly 48 may be designed to look like a turtle, the first marker 48, 150 indicating proper placement of the patient's head may be the head of the turtle, and the second marker 48, 152 indicating proper placement of the patient's torso may be the shell of the turtle. It should be understood that the marker assembly 148 may be used with any of the sensor assemblies 12 disclosed herein, such as the sensor assembly 12 of fig. 2, 5, 9-11, or 15.

Technical effects include providing a sensor assembly having a substrate (e.g., a textile substrate) and an electrode array. The sensor assembly may improve patient monitoring techniques by avoiding the use of adhesives, reducing the contact area between the one or more electrodes and the patient's skin via the lattice structure, and/or by providing various connectors that enable the one or more electrodes to be coupled to the data acquisition unit with limited interference with the patient.

This written description uses examples to disclose embodiments, including the best mode, and also to enable any person skilled in the art to practice embodiments, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the disclosure is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims. It should be appreciated that the various features discussed with respect to fig. 1-14 may be combined in any suitable manner. For example, the fastener 19 and/or one or more tabs 28 shown in fig. 1 may be incorporated into the sensor assembly 12 of fig. 2, 5, 9-11, or 15.