Sensor assembly for a patient monitoring system

Abstract

The disclosed sensor assembly can be used in a patient monitoring system to monitor one or more physiological parameters of a patient. The sensor assembly can include a substrate and one or more electrodes that can include a lattice structure to limit the contact area between the one or more electrodes and the skin of the patient. The sensor assembly can include a connector or connector assembly that facilitates connection between the one or more electrodes and a data acquisition unit. The sensor assembly can be particularly useful for patients with sensitive skin, such as infants in a neonatal intensive care unit (NICU).

Description

Background Technology

[0001] The main topics discussed in this article relate to patient monitoring systems.

[0002] This section is intended to introduce the reader to various aspects of the technology that may relate to the aspects of the present technology described and / or claimed below. This discussion is believed to help provide the reader with background information to facilitate a better understanding of the various aspects of this disclosure. Therefore, it should be understood that these statements will be read for this purpose and not as an admission of prior art.

[0003] Various types of sensors can be used to monitor patients in medical settings, such as infants in neonatal intensive care units (NICUs). For example, patients can be monitored via one or more electrodes positioned (e.g., via adhesive) on their skin to generate an electrocardiogram (ECG) and / or monitor the patient's cardiac parameters. Summary of the Invention

[0004] The following outlines some 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 to provide only a brief overview of the possible forms of that disclosure. In practice, embodiments may include various forms that may be similar to or different from those described below.

[0005] In one embodiment, the sensor assembly includes a substrate and electrodes positioned on a first side of the substrate. The electrodes are configured to acquire data indicative of one or more physiological parameters of a patient, and the electrodes include conductive portions arranged in a lattice structure.

[0006] In one embodiment, the sensor assembly includes a substrate having a textile and electrodes positioned on a first side of the substrate, wherein the electrodes are configured to acquire data indicative of one or more physiological parameters of a patient. The sensor assembly also includes an attachment portion configured to engage with a corresponding attachment portion of a wire to enable data transmission to a data acquisition unit, wherein the attachment portion is oriented relative to the substrate to expose a second side of the substrate opposite the first side of the substrate.

[0007] 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 acquire data indicative of one or more physiological parameters of a patient, and the electrode includes conductive portions arranged in a lattice structure. Attached Figure Description

[0008] These and other features, aspects, and advantages of this disclosure will be better understood when the following detailed description is read with reference to the accompanying drawings, in which the same symbols denote the same parts throughout the drawings, wherein:

[0009] Figure 1 This is a block diagram of a patient monitoring system according to an embodiment of this disclosure;

[0010] Figure 2 It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of a sensor assembly for a patient monitoring system, wherein the sensor assembly includes a substrate and an electrode array on a first side of the substrate;

[0011] Figure 3 It is applicable to the embodiments of this disclosure. Figure 2 A cross-sectional side view of the connector of the sensor assembly, wherein the cross-section is in Figure 2 The line is cut within 3-3, and the connector is in a first orientation relative to the substrate of the sensor assembly;

[0012] Figure 4 It is applicable to the embodiments of this disclosure. Figure 2 A cross-sectional side view of the connector of the sensor assembly, wherein the connector is in a second orientation relative to the substrate of the sensor assembly;

[0013] Figure 5 It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of the first and second sides of the substrate of the sensor assembly of the patient monitoring system, wherein the connector assembly is positioned on the second side of the substrate;

[0014] Figure 6 It is according to an embodiment of the present invention. Figure 5 A schematic diagram of the first side of the sensor assembly;

[0015] Figure 7 It is applicable to embodiments of the present invention. Figure 5 and Figure 6 A cross-sectional side view of the first connector of the sensor assembly, wherein the cross-section is in Figure 6 Cut within line 7-7;

[0016] Figure 8 It is applicable to embodiments of the present invention. Figure 5 and Figure 6 A cross-sectional side view of the second connector of the sensor assembly, wherein the cross-section is in Figure 6 Cut within line 8-8;

[0017] Figure 9 It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of the sensor assembly of a patient monitoring system, wherein the sensor assembly includes a connector assembly arranged to position the connectors close to each other.

[0018] Figure 10It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of the sensor components of a patient monitoring system, wherein the sensor components include an electrode array for easy diagnostic monitoring;

[0019] Figure 11 It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of the sensor assembly of a patient monitoring system, wherein the sensor assembly includes an electrode array having multiple electrodes and conductive paths;

[0020] Figure 12 It is compatible with the implementation scheme of this disclosure. Figure 1 A schematic diagram of an electrode with a rectangular lattice structure used in a patient monitoring system;

[0021] Figure 13 It is compatible with the implementation scheme of this disclosure. Figure 1 A schematic diagram of an electrode with a square lattice structure used in a patient monitoring system;

[0022] Figure 14 It is compatible with the implementation scheme of this disclosure. Figure 1 A schematic diagram of an electrode with a triangular lattice structure used in a patient monitoring system;

[0023] Figure 15 It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of the sensor assembly of a patient monitoring system, wherein the sensor assembly includes a substrate and an electrode array, as well as various other sensors on a first side of the substrate; and

[0024] Figure 16 It is applicable to the embodiments of this disclosure. Figure 1 A schematic diagram of a patient monitoring system for placing a patient marker assembly relative to an electrode array of sensor components. Detailed Implementation

[0025] One or more specific embodiments of this disclosure will be described below. To provide a concise description of these embodiments, not all characteristics of an actual embodiment may be described in the specification. It should be understood that in the development of any such actual embodiment, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developer's specific objectives, such as complying with system-related and business-related constraints that may differ from implementation to implementation. Furthermore, it should be understood that such development efforts may be complex and time-consuming, but remain routine tasks of design, fabrication, and manufacturing for those skilled in the art who benefit from this disclosure.

[0026] When describing the elements of various embodiments of this disclosure, the terms “a,” “an,” “the,” and “the” are intended to refer to one or more of these elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that additional elements may be present in addition to the listed elements. One or more specific embodiments of the embodiments described herein will be described below. To provide a concise description of these embodiments, not all features of the actual embodiment may be described in the specification. It should be understood that in the development of any such actual embodiment, as in any engineering or design project, many implementation-specific decisions must be made to achieve the developer’s specific objectives, such as complying with system-related and business-related constraints that may differ from implementation to implementation. Furthermore, it should be understood that such development efforts may be complex and time-consuming, but remain routine tasks of design, fabrication, and manufacturing for those skilled in the art who benefit from this disclosure.

[0027] The embodiments of this disclosure relate generally to patient monitoring systems, and more specifically, 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 acquire data indicative of one or more physiological parameters of a patient (e.g., heart rate, respiratory 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, the one or more electrodes may be formed from conductive wires woven into (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., immersed in a cleaning fluid).

[0028] In some embodiments, neither the substrate nor one or more electrodes are adhered to the patient's skin by an adhesive. Instead, the substrate may wrap around the patient, or the patient may lie on the substrate to position one or more electrodes in direct contact with the patient's skin without the need for an adhesive or other contact-facilitating intermediate substrate or composition. One or more electrodes may include a lattice structure (e.g., an open structure, a non-solid structure, a discontinuous structure, or a frame) to limit the contact area between one or more electrodes and the patient's skin. Therefore, the disclosed systems and methods are particularly suitable for patients with sensitive skin, such as infants in the neonatal intensive care unit (NICU). While the disclosed embodiments are presented in the context of the NICU for the purpose of discussion, it should be understood that the disclosed embodiments are adaptable for use with a wide variety of patients in both medical and non-medical settings.

[0029] Considering the above, Figure 1This 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 having a first side 16 (e.g., a patient contact 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. Furthermore, the substrate may be a blanket, clothing article, diaper, and / or a cover for a mat or other patient support surface (e.g., a piece of fabric or a disposable paper cover). In some embodiments, the substrate 14 may be a patch configured to be coupled (e.g., temporarily coupled via adhesives and / or fasteners such as snaps, clamps, hook-and-loop fasteners) to another object. For example, the substrate 14 may be a piece of cloth or a sheet of paper configured to be coupled to a blanket, clothing article, diaper, mat, or other patient support surface cover or other object via fastener 19. As described above, the disclosed embodiments are particularly suitable for use with infants, and therefore it should be understood that the dimensions of the substrate 14 can be set for being configured to house an infant in an incubator in a NICU (e.g., the substrate may be a mating sheet for an incubator pad).

[0030] The sensor assembly 12 may also include an electrode array 20 having one or more electrodes 22 positioned (e.g., exposed) on a first side 16 of the substrate 14. The 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, the one or more electrodes 22 may be formed by printing conductive ink (e.g., silver-based ink) onto a film and then (e.g., via lamination) bonding the film to the substrate 14. In some embodiments, the one or more electrodes 22 may be formed by weaving conductive wires (e.g., silver-based wires) into the substrate 14 (e.g., braiding conductive wires to form the substrate 14 and / or embroidering conductive wires through the substrate 14). In some embodiments, the one or more electrodes 22 may be formed by coupling one or more pieces of conductive fabric (e.g., having a conductive coating or made of conductive wire) to the substrate 14 via stitching, adhesives, and / or fasteners (e.g., snaps, clamps). In some such embodiments, one or more sheets of conductive fabric may be etched to remove conductive portions (e.g., remove conductive coatings) thereby forming multiple individual electrodes 22 and / or providing a lattice structure for one or more electrodes 22, as discussed in more detail below.

[0031] During a monitoring session, the sensor assembly 12 can be positioned such that one or more electrodes 22 contact appropriate areas of the patient. For example, a substrate 14 can be positioned on a patient support surface (e.g., a mat or table), and the patient can lie on top of the substrate 14 with one or more electrodes 22 located under the patient's torso. As shown, one or more bumps 28 (e.g., protrusions, expansion bodies, or textured structures) can be positioned along a second side 18 of the substrate 14 to push one or more electrodes 22 into the patient's skin. One or more bumps 28 can be integrally formed with the substrate 14 (e.g., woven into the substrate 14) or can be a piece of fabric, elastomer, or other material coupled to the substrate 14 by stitching, adhesives, and / or fasteners (e.g., snaps, clamps, hook and loop fasteners).

[0032] In the illustrated embodiment, one or more electrodes 22 are communicatively coupled to a data acquisition unit 24 via one or more wires 26 (e.g., electrical wires or any suitable conductors). The one or more electrodes 22 can generate signals indicative of a patient's physiological parameters (e.g., heart rate, respiratory rate), and the one or more wires 26 can carry the signals to the data acquisition unit 24. The data acquisition unit 24 can process the signals using any suitable processing technique to calculate the patient's heart rate and / or respiratory rate. For example, in some embodiments, the data acquisition unit 24 can process the signals to generate an ECG waveform. In some such cases, the heart rate and / or respiratory rate can be derived from the ECG waveform. The respiratory rate can be obtained in a variety of other ways. For example, a low current can be supplied to electrodes positioned across the patient's chest and electrodes positioned across the patient's abdomen, and the change in resistance measured over time can indicate the respiratory rate (e.g., two-channel respiratory rate monitoring). In some such cases, the same electrodes 22 can 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.

[0033] As shown in the figure, the data acquisition unit 24 can be an electronic computing system having a communication device 30, a processor 32, a memory / storage device 34, and / or an output device 36. The memory / storage device 34 may include one or more tangible, non-transitory computer-readable media storing instructions executable by the processor 32 and / or data to be processed by the processor 32. For example, the memory / storage device 34 may include random access memory (RAM), read-only memory (ROM), rewritable non-volatile memory (such as flash memory), hard disk drive, optical disk, etc. Additionally, the processor 32 may include one or more general-purpose microprocessors, one or more application-specific integrated circuits (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, ECG waveforms, heart rate, and / or respiratory rate.

[0034] The communication device 30 enables the data acquisition unit 24 to communicate with the remote computing system 38 via various protocols, such as various wired or wireless communication protocols. In some embodiments, the data acquisition unit 24 may relay raw or processed data to the remote computing system 38. The remote computing system 38 may be an electronic computing system having the communication device 40, processor 42, memory / storage device 44, and / or 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, processor 32, memory / storage device 34, and / or output device 36 of the data acquisition unit 24. Therefore, the remote computing system 38 may process data (e.g., in the manner described above with respect to the data acquisition unit 24) and / or display data for visualization by, for example, medical professionals.

[0035] Figure 2This 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 a first side 16 of the substrate 14. In the illustrated embodiment, the electrodes 22 are physically spaced apart from each other, 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 cm (or between about 0.5 cm and 1.5 cm), and the electrodes 22 may have a length of about 10 cm (or between about 5 cm and 15 cm) and a width of about 1 cm (or between about 0.5 cm and 1.5 cm). 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, shapes, and configurations. Furthermore, multiple sensor assemblies 12 of substrates 14 with different characteristics (e.g., different sizes and / or configurations, such as patches, blankets, clothing, and / or coverings of various sizes) and / or electrodes 22 with different characteristics (e.g., different numbers, sizes, shapes, arrangements, and / or contact ratios) can be provided as kits to medical facilities for use with patients having different characteristics (e.g., medical needs, skin conditions, sizes). For example, for use with adults, electrodes 22 may be spaced about 4 cm apart (or between about 3.5 and 5.5 cm), and electrodes 22 may have a length of about 25 cm (or between about 15 and 50 cm) and a width of about 2 cm (or between about 1.5 and 3 cm).

[0036] As shown, a mark 48 (e.g., an indicator) may be provided on the substrate 14 to facilitate patient placement relative to the electrode 22. For example, mark 48 may indicate a position where the patient's head should be positioned to position the patient's torso on top of the electrode 22. In the illustrated embodiment, when the patient's head is placed on mark 48, the electrode 22 extends horizontally across the patient's torso (e.g., from the patient's left to right side). While the illustrated sensor assembly 12 may be configured for use with the electrode 22 extending horizontally across the patient's torso, it should be understood that the sensor assembly 12 may be configured for use with the electrode 22 extending vertically across the patient's torso (e.g., from the chest portion to the abdominal portion of the patient's torso).

[0037] In some embodiments, one or more electrodes in electrode 22 may include a lattice structure 50 (e.g., an open structure, a non-solid structure, a discontinuous structure, or a frame). Therefore, one or more electrodes in electrode 22 do not form a solid conductive surface in contact with the patient's skin; instead, the conductive portions are separated by non-conductive portions (e.g., conductive ink, wires, or fabrics are spaced apart from each other by non-conductive fabrics or films). Thus, the contact area between electrode 22 and the patient's skin is reduced compared to other types of electrodes with solid conductive surfaces.

[0038] In order to transmit the signal to the data acquisition unit 24 ( Figure 1 Each electrode in electrode 22 is electrically coupled to a wire in wire 26 via a corresponding connector 52. Each connector in connector 52 may be a conductive connector or a fastener, such as a snap-fit, clamp, or magnet. For example, each connector in connector 52 may include a first portion 54 (e.g., a first connector portion) coupled to the corresponding 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 the end portion of wire 26. When the first portion 54 and the second portion 56 mate (e.g., engage or interlock by securing the second portion 56 to the first portion 54, as indicated by arrow 58), a signal can be transmitted from electrode 22 to wire 26 through connector 52. In the illustrated embodiment, the first portion 54 of connector 52 is oriented such that when the first portion 54 and the second portion 56 mate, wire 26 is positioned on and extends along a first side 16 of substrate 14.

[0039] Connector 52 is merely exemplary, and the electrical connection between electrode 22 and wire 26 can be made in any of a variety of ways. For example, the connection can be made on a single layer (e.g., the first side 16 of substrate 14) by extending conductive pathways (e.g., conductive fabric, conductive wires) from electrode 22 to the edge of substrate 14 for connection to wire 26. The conductive pathways, wire 26, and / or any connector (e.g., connector 52) on the first side 16 of substrate 14 can be covered (e.g., covered 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 in contact with the patient can be covered to electrically isolate them from the patient.

[0040] Figure 3 In order to be in Figure 2The figure shows a cross-sectional side view of one of the connectors 52 taken within line 3-3. As shown, connector 52 includes a first portion 54 coupled to electrode 22 and substrate 14, and a second portion 56 positioned at the end portion of wire 26. The first portion 54 and the second portion 56 cooperate to electrically couple electrode 22 to wire 26. In the illustrated embodiment, connector 52 is a snap-fit ​​connector, and the first portion 54 includes a body 60 extending through electrode 22 and substrate 14. For example, body 60 may penetrate (e.g., pierce) electrode 22 and substrate 14, and may then be bent as indicated by arrow 64 by a tooth 62 extending from body 60 to secure the first portion 54 to electrode 22 and substrate 14. However, it should be understood that the first portion 54 may be coupled to electrode 22 by any suitable technique that positions the first portion 54 in contact with electrode 22 and exposes an attachment portion 66 (e.g., a key, slot, magnet) of the first portion 54 on a first side 16 of substrate 14 so that the first portion 54 and the second portion 56 can cooperate with each other. For example, the first portion 54 may not extend through the electrode 22 and the substrate 14. Instead, the first portion 54 may be positioned on the electrode 22 and secured to the electrode 22 and / or the substrate 14 by stitching. Although the attachment portion 66 of the first portion 54 is shown as a key (e.g., a protrusion) engaging a slot of the second portion 56, it should be understood that the attachment portion 66 may include other features such as a slot engaging a key of the second portion 56 or a magnet coupled to another magnet of the second portion 56.

[0041] As mentioned above, in Figure 2 and Figure 3 In this connector 52, the first portion 54 is oriented such that when the first portion 54 and the second portion 56 mate, the wire 26 is positioned on and extends along a first side 16 of the substrate 14. However, the first portion 54 of the connector 52 may be oriented such that when the first portion 54 and the second portion 56 mate, the wire 26 is positioned on and extends along a second side 18 of the substrate 14. Figure 4 This is a cross-sectional side view of one of the connectors in connector 52, wherein the first part 54 is oriented in this manner.

[0042] like Figure 4As shown, connector 52 includes a first portion 54 coupled to electrode 22 and substrate 14, and a second portion 56 positioned at the end portion of wire 26. Connector 52 is snap-fit, and the first portion 54 includes a body 60 extending through electrode 22 and substrate 14, and the body 60 is oriented to expose an attachment portion 66 of the first portion 54 on a second side 18 of substrate 14. The first portion 54 and the second portion 56 cooperate to electrically couple electrode 22 to wire 26. As described above, connector 52 can have various forms, and it should be understood that the first portion 54 can be coupled to electrode 22 via any suitable technique that positions the first portion 54 in contact with electrode 22 and exposes the attachment portion 66 of the first portion 54 on the second side 18 of substrate 14. Such a configuration prevents interference between wire 26 and other devices and / or between wire 26 and patient.

[0043] Figure 5 and Figure 6 This is a schematic diagram of an embodiment of the sensor assembly 12, showing an electrode array 20 on a first side 16 of substrate 14 and a plurality of connector assemblies 70 on a second side 18 of substrate 14. For ease of discussion, the first side 16 and the second side 18 of substrate 14 are... Figure 5 The electrodes are shown individually and side-by-side. 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 having any of a variety of sizes, shapes, and configurations (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more). The substrate 14 may include a marker 48, and / or one or more of the electrodes 22 may include a lattice structure 50.

[0044] In order to transmit the signal to the data acquisition unit 24 ( Figure 1 Each electrode in electrode 22 can be electrically coupled to a wire in wire 26 via one of the connector assemblies in connector assembly 70. Each connector assembly in connector assembly 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, grommets, pins, snaps, clamps, or threads, which contacts the electrode 22 positioned on a first side 16 of substrate 14 and the conductor 74 positioned on a second side 18 of substrate 14. The conductor 74 may be any of a variety of conductors (e.g., flexible circuits, wires, conductive inks, conductive fabrics, or threads) that can be coupled to the second side 18 of substrate 14 via printing, stitching, adhesives, lamination, and / or fasteners. The conductor 74 extends from the first connector 72 toward the edge 78 of substrate 14.

[0045] The second connector 76 may be a conductive connector or fastener, such as a snap-fit, clamp, or magnet, configured to electrically couple conductor 74 to wire 26. For example, each connector in the second connector 76 may include a first portion 80 (e.g., a first connector portion) coupled to conductor 74 and 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 the end portion of wire 26. When the first portion 80 and the second portion 82 mate (e.g., engage or interlock by securing the second portion 82 to the first portion 80, as indicated by arrow 84), a signal can be transmitted from electrode 22 to wire 26 through connector assembly 70.

[0046] In the illustrated embodiment, the connector assembly 70 allows the wire 26 to be coupled at a second side 18 of the substrate 14, which prevents interference between the wire 26 and other devices and / or between the wire 26 and the patient. The connector assembly 70 also allows the electrode 22 to be positioned on the 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 allowing the wire 26 to connect adjacent to the edge 78 of the substrate 14. This configuration can limit the size of the electrode 22 to reduce patient discomfort and / or may facilitate coupling the wire 26 to other components of the sensor assembly 12 without interfering with, for example, a patient positioned on top of the electrode 22.

[0047] Figure 7 In order to be in Figure 6 The figure shows a cross-sectional side view of one of the first connectors 72 taken within line 7-7. As shown, the first connector 72 contacts an electrode 22 positioned on a first side 16 of the substrate 14 and a conductor 74 positioned on a 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 mentioned above, the first connector 72 can be any of a variety of connectors or fasteners, such as grommets, pins, snaps, clamps, and / or threads.

[0048] Figure 8 In order to be in Figure 6The figure shows a cross-sectional side view of one of the second connectors 76 taken within line 8-8. As shown, the second connector 76 electrically couples conductor 74 to wire 26. The second connector 52 includes a first portion 80 connected to conductor 74 and substrate 14 and a second portion 82 positioned at the end of wire 26. The first portion 80 and the second portion 82 cooperate to electrically couple conductor 74 and thus electrode 22 to wire 26. In the illustrated embodiment, the second connector 76 is a snap-fit ​​connector, and the first portion 80 includes a body 86 extending through conductor 74 and substrate 14. For example, the body 86 may penetrate (e.g., pierce) conductor 74 and substrate 14, and then prongs 88 extending from the body 86 may be bent as indicated by arrow 90 to secure the first portion 80 to conductor 74 and substrate 14. However, it should be understood that the first portion 80 can be coupled to the conductor 74 by any suitable technique that positions the first portion 80 in contact with the conductor 74 and exposes the attachment portion 92 (e.g., a bond, slot, magnet) of the first portion 80 on the second side 18 of the substrate 14 so that the first portion 80 and the second portion 82 can engage with each other. For example, the first portion 80 may not extend through the conductor 74 and the substrate 14. Instead, the first portion 80 may be positioned on 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 bond (e.g., a protrusion) engaging the slot of the second portion 82, it should be understood that the attachment portion 74 may include other features such as a slot engaging the bond of the second portion 82 or a magnet coupled to another magnet of the second portion 82.

[0049] As mentioned above, in Figures 5 to 8 In this configuration, the first portion 80 of the second connector 76 is oriented such that when the first portion 80 and the second portion 82 mate, the wire 26 is coupled to a second side 18 of the substrate 14. However, the first portion 80 of the second connector 76 may be oriented such that when the first portion 80 and the second portion 82 mate, the wire 26 is coupled to a first side 16 of the substrate 14. This configuration allows the size of the electrode 22 and conductive components on the first side 16 of the substrate 14 to be limited to reduce patient discomfort, while still allowing the wire 26 to be connected near the edge 78 of the substrate 14 to reduce, for example, interference and / or disturbance to the patient positioned on top of the electrode 22.

[0050] Various other arrangements of electrode 22 and / or connector assembly 70 are envisioned. For example, Figure 9This is a schematic diagram of an embodiment of sensor assembly 12, in which connector assembly 70 is arranged to position second connectors 76 close to each other. More specifically, in the illustrated embodiment, two conductors of conductor 74 have bends 100 (e.g., L-shaped) such that all four second connectors 76 are arranged in the central region 102 near the edge 78 of substrate 14. Therefore, not as... Figure 5 and Figure 6 As shown, the second connector 76 is arranged in a square pattern (e.g., at the four corners of the square) with single-line alignment. This configuration prevents interference, for example, between the wire 26 and other devices and / or between the wire 26 and the patient.

[0051] Figure 10 This is a schematic diagram of an embodiment of sensor assembly 12, in which, in another configuration, electrode array 20 has six electrodes 22. As shown, electrode array 20 includes first end electrodes 22, 110, second end electrodes 22, 112, and four center electrodes 22, 114 positioned between the first end electrodes 22, 110 and the second end electrodes 22, 112. The electrodes 22 are physically separated from each other and can be accessed via any of the techniques disclosed herein (e.g., Figures 2 to 4 Connector 52, Figures 5 to 9 The connector assembly 70) is coupled to the wire. Additionally, the substrate 14 may include marker 48 and / or one or more of the electrodes 110, 112, 114. The electrodes may include a lattice structure 50. The sensor assembly 12 shown may be used for diagnostic monitoring (e.g., providing more detailed and / or reliable data indicative of cardiac function and / or respiratory rate) and / or may enable two-channel respiratory rate monitoring.

[0052] Figure 11 This is a schematic diagram of an embodiment of sensor assembly 12, in which, in another configuration, electrode array 20 has a plurality of electrodes 22. The electrodes 22 are physically separated from each other and can be accessed via any of the techniques disclosed herein (e.g., Figures 2 to 4 Connector 52, Figures 5 to 9 The connector assembly 70) is coupled to the wire. In the illustrated embodiment, the connection includes a conductive path 116 (e.g., conductor, conductive fabric, conductive wire) extending from the electrode 22 toward the edge of the substrate 14 (or at least away from the area configured to be positioned below or otherwise in contact with the patient) for connection to the wire. The conductive path 116, the wire, and / or any connector (e.g., connector 52) used on the first side 16 of the substrate 14 may be covered (e.g., covered by a non-conductive material such as a printed dielectric or a second substrate material), or at least the portion of these structures that may be in contact with the patient may be covered to electrically isolate them from the patient. For clarity, in Figure 11 Only some of the electrodes 22 and conductive paths 116 are numbered.

[0053] like Figure 11 As shown, substrate 14 may include marker 48 and / or one or more of electrodes 22 may include lattice structure 50. The sensor assembly 12 shown may be used for diagnostic monitoring (e.g., providing more detailed and / or reliable data indicative of cardiac function and / or respiratory rate) and / or may enable two-channel respiratory rate monitoring.

[0054] Figures 12 to 14 Various lattice structures 50 that can be used to form the electrode 22 disclosed herein are shown. Specifically, Figure 12 An electrode 22 with a lattice structure 50 is shown, the lattice structure having conductive portions 120 (e.g., conductive trusses or lines) arranged to form rectangular lattice units and defining non-conductive portions 122 (e.g., gaps). Figure 13 An electrode 22 with a lattice structure 50 is shown, the lattice structure having a conductive portion 120 arranged to form a square lattice unit and defining a non-conductive portion 122. Figure 14 A portion of an electrode 22 with a lattice structure 50 is shown, the lattice structure having a conductive portion 120 arranged to form triangular lattice units and defining a non-conductive portion 122.

[0055] like Figures 12 to 14 As shown, 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 the 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, refer to... Figure 12 The contact ratio can be defined as (L*Wa*b*N) / (L*W), where L is the length of electrode 22, W is the width of electrode, a is the length of each segment of non-conductive portion 122, b is the width of each segment of non-conductive portion 122, and N is the number of segments of non-conductive portion 122.

[0056] The contact ratio can be adjusted according to the patient's skin condition (e.g., different sensor assemblies 12 can be adapted for use with different patients). For example, relatively low contact ratios (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%) are suitable for patients with sensitive skin (e.g., premature infants, the elderly, burn patients), while relatively high contact ratios (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%) are suitable for patients without specific skin sensitivities (e.g., full-term infants). As described above, multiple sensor assemblies 12 with substrates 14 and / or electrodes 22 having different properties (including different contact ratios) can be provided as a kit to a medical facility. Therefore, medical professionals can select the appropriate sensor component 12 for the patient to balance the signal-to-noise ratio of the signal generated by the electrode 22 with the patient's skin sensitivity.

[0057] Furthermore, the conductive portion 120 can have various orientations. For example, in Figure 12 In this configuration, 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... Figure 13 In this configuration, the segment of the conductive portion 120 forms an angle with respect to the horizontal edge 124 and 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 units can have various cross-sectional shapes, such as rectangular (e.g., non-square), square, triangular, rhomboid, pentagonal, hexagonal, octagonal, or circular. In some embodiments, the lattice structure 50 can have lattice units with a variety of different cross-sectional shapes (e.g., both hexagonal and square).

[0058] Various methods for manufacturing and using the sensor assembly 12 are envisioned. For example, the sensor assembly 12 may be manufactured by forming one or more electrodes 22 having a lattice structure 50 on a substrate 14. As described above, one or more electrodes 22 may be formed by printing conductive ink onto a film, and then bonding the film (e.g., via lamination) to the substrate 14. One or more electrodes 22 may be formed by weaving conductive wires into the substrate 14, or one or more electrodes 22 may be formed by coupling one or more sheets of conductive fabric to the substrate 14. In some such embodiments, one or more sheets of conductive fabric may be etched to remove conductive portions. Next, a first portion 54 of the connector 52 or suitable components of the connector assembly 70 (e.g., the first connector 72, the conductor 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 patient's torso or placed under the patient's torso. 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.

[0059] Figure 15 This is a schematic diagram of a 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) for detecting patient movement, one or more temperature sensors 132 (e.g., thermocouples) for detecting patient body temperature, and / or one or more motion sensors 134 (e.g., accelerometers) for detecting movement of the substrate 14. The substrate 14 may include markings 48. Furthermore, one or more electrodes in the electrodes 22 and / or one or more sensors in the other sensors may include a lattice structure 50 (… Figures 12 to 14 ).

[0060] Each of one or more electrodes 22 and other sensors may be coupled to the data acquisition unit 24 via a corresponding wire 26, and one or more electrodes 22 and / or one or more other sensors may be coupled via any of the techniques disclosed herein (e.g., Figures 2 to 4 Connector 52, Figures 5 to 9The connector assembly 70) is coupled to the wire 26. During a monitoring session, the sensor assembly 12 can be positioned such that one or more electrodes 22 and other sensors contact appropriate areas of the patient. For example, a substrate 14 can be positioned on a patient support surface (e.g., a mat or table), and the patient can lie on top of the substrate 14, with one or more electrodes 22 and other sensors located under the patient's torso. One or more electrodes 22 and other sensors can generate signals indicative of various physiological parameters of the patient, and one or more wires 26 can carry the signals to a data acquisition unit 24 for processing. It should be understood that the data acquisition unit 24 can process the signals and (e.g., via...) Figure 1 The output device 36) provides an output indicating physiological parameters and / or can transmit signals (e.g., raw or processed signals) to a remote computing system 38. Figure 1 When calculating the patient's physiological parameters, signals from motion sensor 134 (or from any other motion sensor 134 positioned on or supporting the patient on the bed) can be processed and used to compensate for noise caused by motion.

[0061] Figure 16 This is a schematic diagram of an embodiment of sensor assembly 12, which has a marking 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) on a first side 16 of substrate 14 or otherwise formed (e.g., woven) to be visible on the first side 16 of substrate 14. As shown, the marking assembly 148 may include first markings 48, 150 indicating proper placement of the patient's head relative to electrodes 12, second markings 48, 152 indicating proper placement of the patient's torso relative to electrodes 22, and / or additional markings 48, 154 indicating proper placement of the patient's arm relative to electrodes 22. In the illustrated embodiment, the marking assembly 148 is designed to resemble a bumblebee, with the first markings 48, 150 indicating proper placement of the patient's head shown as the bumblebee's head, the second markings 48, 152 indicating proper placement of the patient's torso shown as the bumblebee's torso, and the additional markings 48, 154 indicating proper placement of the patient's arm shown as the bumblebee's wing. However, the marker component 48 can be any of a variety of shape combinations and / or can represent any of a variety of animals or people (e.g., cartoon characters). For example, the marker component 48 can be designed to resemble a turtle, with the first marker 48, 150 indicating proper placement of the patient's head being the turtle's head, and the second marker 48, 152 indicating proper placement of the patient's torso being the turtle's shell. It should be understood that the marker component 148 can be used in any of the sensor components of the sensor component 12 disclosed herein, such as... Figure 2 , Figure 5 , Figures 9 to 11 or Figure 15 Sensor component 12.

[0062] Technical advantages include providing sensor assemblies having a substrate (e.g., a textile substrate) and an electrode array. Sensor assemblies can improve patient monitoring technology by avoiding the use of adhesives, reducing the contact area between one or more electrodes and the patient's skin via a lattice structure, and / or by providing various connectors that allow one or more electrodes to be coupled to a data acquisition unit with limited interference from the patient.

[0063] This written description uses examples to disclose embodiments, including best practices, and also enables those skilled in the art to practice the embodiments, including making and using any device or system and performing any included methods. The scope of this disclosure is defined by the claims and may include other examples that would 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 that are not indistinguishable from the literal language of the claims, or if they include equivalent structural elements that have minor differences from the literal language of the claims. It should be understood that, relative to… Figures 1 to 14 The various features discussed can be combined in any suitable manner. For example, Figure 1 The fastener 19 and / or one or more protrusions 28 shown can be coupled to Figure 2 , Figure 5 , Figures 9 to 11 or Figure 15 In the sensor assembly 12.

Claims

1. A sensor assembly, comprising: Substrate, wherein the substrate includes textiles; and A plurality of electrodes are positioned on a first side of the substrate, wherein the plurality of electrodes are configured to acquire data indicative of one or more physiological parameters of a patient, each of the plurality of electrodes is configured to be electrically coupled to a data acquisition unit such that the data can be transmitted to the data acquisition unit, and each of the plurality of electrodes includes a conductive portion arranged in a lattice structure; wherein the conductive portion includes: conductive ink printed onto the substrate or onto a film laminated to the substrate; or conductive wire woven into the substrate; or conductive fabric coupled to the substrate via an adhesive, wire, or fastener; and Multiple protrusions are positioned on a second side of the substrate, the second side of the substrate being opposite to a first side of the substrate, wherein the multiple protrusions are configured to push the multiple electrodes into the patient's skin when the patient is placed on the first side of the sensor assembly, and wherein the multiple protrusions are integrally formed with the substrate.

2. The sensor assembly according to claim 1, wherein the lattice structure comprises a plurality of lattice units having rectangular, square, triangular, rhomboid, pentagonal, hexagonal, octagonal or circular shapes.

3. The sensor assembly of claim 1, the sensor assembly comprising a plurality of connectors, wherein each of the plurality of connectors includes a first portion and a second portion, wherein the first portion of each of the plurality of connectors is configured to electrically couple a respective electrode of the plurality of electrodes to a respective wire, wherein the first portion is coupled to the substrate and the respective electrode, and the first portion includes an attachment portion configured to engage with a second portion coupled to the respective wire.

4. The sensor assembly of claim 3, wherein the first portion is oriented to expose the attachment portion on a second side of the substrate opposite to the first side of the substrate.

5. The sensor assembly of claim 1, wherein the sensor assembly comprises a plurality of connector assemblies, each of the plurality of connector assemblies being configured to electrically couple a respective electrode of the plurality of electrodes to a respective wire, wherein each of the plurality of connector assemblies comprises: A conductor, the conductor being positioned on a second side of the substrate opposite to the first side of the substrate; A first connector electrically couples the respective electrodes to the conductor; and A first portion of a second connector is configured to electrically couple the conductor to the respective wires, 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 respective wires, and the first portion is oriented to expose the attachment portion on a second side of the substrate.

6. The sensor assembly of claim 1, wherein each of the plurality of electrodes has a rectangular shape, a length between 5 cm and 15 cm, a width between 0.5 cm and 1 cm, is arranged in parallel lines, and is spaced apart from each other by 0.5 cm to 1.5 cm.

7. The sensor assembly of claim 1, wherein the first total area of ​​the conductive portion of the respective electrodes of the plurality of electrodes is less than or equal to approximately 90% of the second total area of ​​the respective electrodes.

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

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

10. The sensor assembly of claim 1, wherein the sensor assembly includes one or more markers formed on the substrate to indicate proper placement of the patient’s head, the patient’s torso, or both relative to the electrodes.

11. A sensor assembly, comprising: Substrate, said substrate including textiles; A plurality of electrodes are positioned on a first side of the substrate, wherein respective conductive portions of the plurality of electrodes are configured to acquire data indicative of one or more physiological parameters of a patient, wherein each of the plurality of electrodes is configured to be electrically coupled to a data acquisition unit such that the data can be transmitted to the data acquisition unit; wherein the conductive portions include: conductive ink printed onto the substrate or onto a film laminated to the substrate; or conductive wires woven into the substrate; or conductive fabric coupled to the substrate via adhesives, wires, or fasteners; and A plurality of first attachment portions, each of the plurality of first attachment portions being coupled to a respective electrode of the plurality of electrodes and configured to cooperate with a respective second attachment portion of a respective wire to enable data transmission to the data acquisition unit, wherein each of the plurality of first attachment portions is oriented relative to the substrate to expose a second side of the substrate opposite to a first side of the substrate; and Multiple protrusions are positioned on a second side of the substrate, wherein the multiple protrusions are configured to push the multiple electrodes into the patient's skin when the patient is placed on a first side of the sensor assembly.

12. The sensor assembly of claim 11, wherein the conductive portion of each of the plurality of electrodes is arranged in a lattice structure.

13. The sensor assembly of claim 11, wherein the plurality of first attachment portions comprise a key, a slot, or a magnet.

14. The sensor assembly of claim 11, wherein the plurality of first attachment portions are part of a connector assembly, and the connector assembly comprises: A conductor, the conductor being positioned on the second side of the substrate; A first connector electrically couples the respective electrodes to the conductor; and A first portion of a second connector electrically couples the conductor to the respective wires, wherein the first portion includes the plurality of first attachment portions and is coupled to the substrate and the conductor.

15. A method of manufacturing a sensor assembly, comprising: A plurality of electrodes are formed on a first side of a substrate, wherein the substrate is a textile, the plurality of electrodes are configured to acquire data indicative of one or more physiological parameters of a patient, and each of the plurality of electrodes is configured to be electrically coupled to a data acquisition unit such that the data can be transmitted to the data acquisition unit, and each of the plurality of electrodes includes a conductive portion arranged in a lattice structure, the conductive portion being in direct contact with the patient, wherein the conductive portion includes: conductive ink printed on the substrate or printed on a film laminated to the substrate; or conductive wire woven into the substrate; or conductive fabric coupled to the substrate via an adhesive, wire or fastener; The method includes coupling respective first attachment portions to the substrate and respective electrodes of the plurality of electrodes, wherein the respective first attachment portions are configured to engage with respective second attachment portions of respective wires to enable data transmission to a data acquisition unit, and the respective first attachment portions are oriented relative to the substrate to expose a second side of the substrate opposite to a first side of the substrate. It also includes positioning a plurality of protrusions on a second side of the substrate, wherein the plurality of protrusions are configured to push the plurality of electrodes into the patient’s skin when the patient is placed on a first side of the substrate.

Images