Expandable electrode set

Abstract

The present invention relates to an expandable electrode set, a method of using the expandable electrode set, an electrode set system, and a method of manufacturing the electrode set (100) described herein. Various examples of the electrode set (100) include nodes (102) that are physically connected to each other by connectors (104) having a shape that allows for deformation of the electrode set. The shape and material of the connectors (104) are designed to provide consistent deformation so that when an alignment mark is placed on a site of a body to be monitored, the nodes (102) end up in the correct position on the site of the body to take measurements. The electrode set (100) can include sensors, emitters, or both sensors and emitters in various configurations.

Description

Technical Field

[0001] This invention relates to the field of systems and methods for acquiring physiological signals from subjects. In particular, this invention relates to a set of electrodes for measuring electrophysiological signals. Background Technology

[0002] Acquiring electrophysiological signals is of great importance in current medical technology. Electrical activity of the heart (ECG), brain (EEG), nerves (EMG), or pregnant women (fetal ECG or fECG) or other electrical measurements (e.g., electrooculography for the eye, ERG for bowel activity, EEG for intestinal activity) are commonly recorded for diagnostic or monitoring purposes. Furthermore, stimulation via electrical signals or imaging based on impedance measurements of body parts (EIT: electrical impedance tomography) has rapidly spread in medical practice. Accurate measurement of electrophysiological signals requires precise positioning of the measuring electrodes. Proper placement of the electrodes used for stimulation or imaging is essential for accurate readings.

[0003] Similarly, in many medical cases, proper measurements are required to achieve the correct positional accuracy when a given pathology necessitates the deployment of electrodes (or other sensors) at specific locations along with other types of skin contact sensors (such as light-emitting diodes and photoreceptors) or sensors created using silicon integrated cells (MEMS). Summary of the Invention

[0004] Therefore, the present invention relates to an electrode assembly comprising:

[0005] - A first node and a second node, the first node including a first pad for receiving electromagnetic energy from a first portion of the site being studied, and the second node including a second pad;

[0006] - A connector connecting the first node to the second node, the connector being formed such that, when tension is applied to the first node or the second node, the shape provides a consistent deformation from a first distance between the first node and the second node to one or more second distances between the first node and the second node, wherein, in the undeformed state, the first node and the second node are planar, and in the deformed state, the first node and the second node are non-planar, wherein the length of the connector remains constant from the undeformed state to the deformed state;

[0007] - At least one alignment mark is fixed to the first node or the second node, the at least one alignment mark being removably fixed to a marker on the subject at the site of study, wherein the at least one alignment mark is configured to transfer tension to the first node or the second node when the alignment mark is fixed to the marker.

[0008] The term "connector formed by providing a shape that deforms uniformly" can also be understood as a connector configured to provide a shape that deforms uniformly. Advantageously, this electrode assembly is planar in its undeformed state, which allows for the compact storage of a large number of electrode assemblies. This aspect is particularly interesting, for example, for ambulances, as ambulances must store a large number of different medical systems / equipment for easy mobility.

[0009] According to one embodiment, the second pad is used to receive electromagnetic energy from a second portion of the site under study, or to send a signal to a first portion of the site under study.

[0010] According to one embodiment, the electrode assembly further includes a first wire within the connector, the first wire being electrically connected to a first pad of the first node and extending to a measurement lead.

[0011] According to one embodiment, the electrode assembly further includes a second wire within a connector, the second wire being electrically connected to a second pad of the second node and extending to a measurement lead, wherein the measurement lead terminates at a measurement connector to be inserted into a monitoring / input device.

[0012] According to one embodiment, the electrode assembly further includes a plurality of third nodes, at least a portion of which includes a pad for receiving electromagnetic energy from a plurality of third portions of the site under study; and a plurality of second connectors connecting at least one of the plurality of third nodes to a first node or a second node, the plurality of second connectors being formed such that, when tension is applied to the at least one alignment mark, the shape provides a consistent deformation from a first distance between at least a portion of the plurality of third nodes to one or more second distances between at least a portion of the plurality of third nodes, wherein, in an undeformed state, the plurality of third nodes are planar, and in a deformed state, the plurality of third nodes are nonplanar.

[0013] According to one embodiment, the electrode assembly further includes a plurality of second alignment marks fixed to one or more of the plurality of third nodes, the plurality of second alignment marks being removably fixed to a plurality of second landmarks on the subject at the site of study, wherein the plurality of second alignment marks are configured to transmit the tension to at least a portion of the plurality of third nodes when the plurality of second alignment marks are being fixed to the landmarks.

[0014] According to one embodiment, the electrode assembly further includes a pad reinforcement fixed to the first node, wherein the pad reinforcement ensures electrical connection between the pad and the first wire.

[0015] According to one embodiment, the connector includes a plastic substrate, polyimide, polyethylene, polyetheretherketone (PEEK), or a non-conductive polyester or polymer.

[0016] According to one embodiment, the shape includes a sinusoidal shape. This embodiment advantageously allows the spacing between nodes to change from a first distance to one or more second distances depending on the degree to which the connector is pulled.

[0017] According to one embodiment, the shape includes a spiral, a double helix, a horseshoe shape, or an angular shape.

[0018] According to one embodiment, the first pad and / or the second pad comprises a conductive or semiconductive material.

[0019] According to one embodiment, the first pad and / or the second pad comprises copper, aluminum, stainless steel, gold, silver, or alloys thereof.

[0020] According to one embodiment, the first conductor and / or the second conductor comprises copper, aluminum, stainless steel, gold, silver, or alloys thereof.

[0021] According to one embodiment, the first pad includes a first through-hole, and the second pad includes a second through-hole, the first and second through-holes being openings that allow the injection of a conductive material that enhances electrical contact with the skin.

[0022] According to one embodiment, the electrode assembly further includes a third node, wherein the third node includes a third pad for transmitting electromagnetic energy.

[0023] According to one embodiment, the electromagnetic energy is near-infrared light, infrared light, or visible light.

[0024] According to one embodiment, the electrode assembly further includes a fourth node, wherein the fourth node includes a fourth pad for receiving electromagnetic energy generated by electromagnetic transmission from the third pad.

[0025] According to one embodiment, the electrode assembly further includes a third node for receiving sensors.

[0026] The present invention also relates to a method for measuring signals at a site of a subject, the method comprising:

[0027] - Place the electrode assembly close to the area to be measured, the electrode assembly including...

[0028] - A first node and a second node, the first node including a first pad for receiving electromagnetic energy from a first portion of the site under study, and the second node including a second pad for receiving electromagnetic energy from a second portion of the site under study.

[0029] - A connector that connects a first node to a second node, the connector being formed such that, when tension is applied to the first or second node, the shape provides a consistent deformation from a first distance between the first and second nodes to one or more second distances between the first and second nodes, wherein, in an undeformed state, the first and second nodes are planar, and in a deformed state, the first and second nodes are non-planar, wherein the length of the connector remains constant from the undeformed state to the deformed state;

[0030] - At least one alignment mark is fixed to the first node or the second node, the at least one alignment mark being removably fixed to a marker on the subject at the site of study, wherein the at least one alignment mark is configured to transfer tension to the first node or the second node when the alignment mark is fixed to the marker;

[0031] - A first wire within the connector, the first wire being electrically connected to a first pad of the first node and extending to a measuring lead; and

[0032] - A second conductor within the connector, the second conductor being electrically connected to a second pad of the second node and extending to a measurement lead, wherein the measurement lead terminates at a measurement connector to be inserted into a monitoring / input device;

[0033] • Secure at least one alignment mark to the boundary marker;

[0034] Connect the measurement leads to the monitoring / input device; and

[0035] • Instantiate the monitoring application in the monitoring / input device to begin measuring the electrophysiological signals at the site of the subject.

[0036] According to one embodiment, the method further includes injecting a conductive, acoustic, or light-transmitting material through a first through-hole in the first pad and a second through-hole in the second pad.

[0037] According to one embodiment, the connector includes a plastic substrate, polyimide, polyethylene, polyetheretherketone (PEEK), or a non-conductive polyester or polymer.

[0038] According to one embodiment, the shape includes a sinusoidal shape.

[0039] According to one embodiment, the shape includes a spiral, a double helix, a horseshoe shape, or an angular shape.

[0040] According to one embodiment, the first pad and / or the second pad comprises a conductive or semiconductive material.

[0041] According to one embodiment, the first pad and / or the second pad comprises copper, aluminum, stainless steel, gold, silver, or alloys thereof.

[0042] The present invention also relates to a sensor array system, comprising:

[0043] - The sensor group (100) according to any one of the above embodiments, wherein the monitoring / input device is configured to receive data of electrophysiological signals received from the first pad or the second pad; and

[0044] - A monitoring service connected to the monitoring / input device, used to receive data from the electrophysiological signals or send instructions to the monitoring / input device. Attached Figure Description

[0045] Detailed description is provided with reference to the accompanying drawings. In the drawings, the leftmost number of the reference numerals indicates the figure in which the reference numeral first appears. The same reference numerals are used in different figures to indicate similar or identical items or features.

[0046] Figure 1 The scalable electrode array in a non-deployment state is shown as some examples according to this disclosure.

[0047] Figure 2 Electrode assemblies in a deployed state are shown as some examples according to this disclosure.

[0048] Figure 3 Electrical wiring in a scalable electrode group is shown in some examples according to this disclosure.

[0049] Figure 4 This is a close-up view of an example node used in a scalable electrode array, based on some examples of this disclosure.

[0050] Figure 5 This is a schematic diagram illustrating an electrode assembly system according to some examples of the present disclosure.

[0051] Figure 6 This is a flowchart illustrating a method of using a scalable electrode array according to some examples of this disclosure.

[0052] Figure 7 This is a flowchart illustrating a method for manufacturing a scalable electrode assembly according to some examples of this disclosure.

[0053] Figure 8 This is a component-level view of the monitoring / input device used in the systems and methods described herein, based on some examples of this disclosure. Detailed Implementation

[0054] Examples of this disclosure can include systems and methods for providing and using scalable sensor sets. When measuring three-dimensional body parts using conventional sensor sets, it is often difficult to correctly align the sensors on the patient's body (body part) to obtain the most accurate readings. This typically limits the use of conventional sensor sets to hospitals or other facilities available for installation by technicians. The cost and inconvenience of using conventional sensor sets can be very high due to the need for expert installation, which in turn limits the ability to utilize data available in many medical cases. It should be noted that while some figures are described based on installation on a subject by a second person, the subject matter of this disclosure is not limited to this manner, as various examples of the subject matter of this disclosure can be installed by the subject themselves.

[0055] Figure 1 A top view of the expandable electrode assembly 100 in its non-deployed state is shown. It should be noted that although some descriptions herein use the terms "electrode" or "electrode assembly," the subject matter disclosed herein is not limited to electrodes, as the use of electrodes in the description is merely exemplary and illustrative. As used herein, "non-deployed" means that the electrode assembly 100 is not mounted on a body part, while "deployed" means that the electrode assembly 100 is partially or wholly mounted on a body part. References Figure 2 The electrode assembly 100 is shown in its deployed state. Figure 1 In the non-deployed state shown, the electrode assembly 100 is substantially flat, meaning that when placed on a flat surface, all or substantially all of the bottom surfaces of the electrode assembly 100 that are close to the flat surface will be in contact with that surface. Figure 2 In the deployment configuration shown, electrode assembly 100 partially deforms to surround a 3D body part of the patient or subject being studied. In some examples, the deformation may be referred to as "twisting," where the two terms are interchangeable. For example, nodes 102H and 102I connected by connector 104E in... Figure 1 The diagram shows a distance of D1 between nodes 102I and 102H, while... Figure 2 In the diagram, the distance between nodes 102I and 102H is shown as D2, which is greater than D1.

[0056] Return to reference Figure 1 Electrode assembly 100 includes nodes 102A-102F (collectively referred to as "node 102" in this document, and individually as "node 102A", "node 102B", etc.) and connectors 104A-104E (collectively referred to as "connector 104" in this document, and individually as "connector 104A" and "connector 104B", etc.). Note that... Figure 1 This includes unlabeled additional nodes and connectors, which are for illustrative purposes only. The internal structure of node 102 and connector 104 is shown in [the diagram]. Figure 3 and4 This is described in more detail below. In use, node 102 is used to sense (measure or detect) electrophysiological signals as a result of electrical activity in a specific body part. Note that... Figure 1 The shapes of the various components of the electrode assembly 100 shown are merely exemplary and may vary depending on the specific application. For example, node 102 may be circular, such as... Figure 1 As shown, it can also be elliptical, egg-shaped, square, rectangular, and / or polygonal, or a combination thereof. In some examples, node 102 can be used to apply a current to the subject being measured to measure impedance. These and other uses of node 102 as an electrical or electromagnetic device are considered to be within the scope of the currently disclosed subject matter.

[0057] Electrode assembly 100 also includes measurement leads 106A and 106B and measurement connectors 108A and 108B. Measurement leads 106A and 106B receive electrical signals from node 102 via connector 104. Measurement leads 106A and 106B have internal conductors extending from each of nodes 102 to measurement leads 106A and 106B. Measurement leads 106A and 106B are connected to a device for measuring electrical signals from node 102 (in... Figure 2 (This is shown in more detail below).

[0058] As mentioned above, in conventional electrode sets, technicians or other qualified personnel are typically required to ensure the electrodes are correctly positioned on the body parts. This is because the nodes for measuring the body's electrical activity need to be placed at specific points on the body to obtain the most accurate readings possible. Figure 1 The electrode assembly 100 provides various mechanisms that allow a variety of users, including untrained individuals, to properly place the electrode assembly 100 on the body (e.g., the head or abdomen of a pregnant woman).

[0059] The first mechanism that allows for the proper placement of electrode assembly 100 on a body site is alignment marks 110A-110D (collectively referred to herein as "alignment marks 110", and individually as "alignment marks 110A", "alignment marks 110B", etc.). The person installing electrode assembly 100 uses alignment marks 110 to properly align electrode assembly 100. Alignment marks 110 are configured to contact predefined anatomical landmarks on the person being studied. Landmarks can be positioned based on various factors, including standards defined by the medical community, to ensure proper recording of electrophysiological signals. Such systems are used for the placement of ECG, EEG, EMG, and / or fECG or other electrophysiological signals, as well as other sensor sources for other measurement techniques. However, the subject matter of this disclosure does not require the use of specific landmarks, as other locations on the body can be used and are considered within the scope of this disclosure. For example, the ear, nose, navel, or other landmarks can be used for the proper placement of electrode assembly 100. It should also be noted that electrode assembly 100 is not limited to human use, as it can be used on non-human subjects. Figure 1 In the example shown, alignment mark 110 is located according to the anatomical landmarks of the nasal root, inner ear, and bilateral tragus in the International 10-20 system or its variants, although other landmarks may be used as described herein and are considered to be within the scope of the subject matter currently disclosed.

[0060] The person installing the electrode assembly 100 places and temporarily secures one or more alignment marks 110 (using tape or other adhesive suitable for use on the body) at one or more locations (i.e., anatomical landmarks). Figure 1 In the example shown, there are four alignment marks 110, although, as mentioned above, there may be more or fewer than four alignment marks 110 depending on the specific configuration of the electrode assembly 100. When one of the alignment marks 110 is placed on the anatomical landmark, the placement of the alignment mark 110 advantageously applies a force to the node 102 closest to the alignment mark 110 via the marking connectors 112A-112D (collectively referred to herein as “marker 112”, individually as “marker 112A”, “marker 112B”, etc.). In an advantageous example, the placement of the alignment mark 110C applies a tensile force to the node 102B in a direction generally aligned with the force vector XE via the marking connector 112C. Similarly, the placement of the alignment mark 110A applies a force generally aligned with the force vector XN, the placement of the alignment mark 110B applies a force generally aligned with the force vector XW, and the placement of the alignment mark 110D applies a force generally aligned with the force vector XS.

[0061] Pulling the electrode assembly 100 in the directions of two or more force vectors (e.g., XE, XN, XW, and XS) causes the electrode assembly 100 to twist or deform. As used herein, "twisting" refers to the movement of the electrode assembly 100 from a planar state (e.g., Figure 1 As shown) deformed into a three-dimensional state (such as through Figure 2 The material used in designing electrode assembly 100 provides adequate tensile strength to counteract tension, allowing node 102 to be correctly aligned with one or more anatomical landmarks. For example, insufficient elastic strength (i.e., the force that occurs when a deformed object attempts to restore its original shape) may cause various nodes to be pulled too easily in a particular direction. In this example, the rigidity of the structure of electrode assembly 100, its nodes 102, and connector 104 is insufficient to provide controlled and specific deployment of the nodes 102 of electrode assembly 100. In another example, if the structure of electrode assembly 100 is too rigid, meaning relatively large elastic strength, the structure of electrode assembly 100 may require heavy-duty glue or adhesive to hold alignment marks 110 in place, and may impose excessive stress on the electrode assembly 100 material, among other disadvantages.

[0062] Therefore, the electrode assembly 100 and its components, particularly the connector 104, are designed to provide a balance between rigidity and flexibility. Figure 1 In the example shown, the sinusoidal shape constructed from a specific material advantageously achieves this balance. It should be understood that the shape and material are examples, as other shapes and materials can be used. For instance, other shapes such as spirals, double helices, horseshoes, or angular shapes can be used. The shape of the connector 104 of the electrode assembly is designed to allow a planar configuration when not deployed, and a non-planar configuration during use.

[0063] Advantageously, the sinusoidal shape also allows the spacing between nodes 102 to change from a first distance to one or more second distances depending on the degree to which connector 104 is pulled. These one or more second distances can be used to allow electrode assembly 100 to be deployed for various purposes. In one embodiment, the ratio of the first distance between two nodes linked by a connector in a deployed configuration (e.g., nodes 102B and 102F connected by connector 104H) to the distance between two identical nodes linked by the same connector element in a non-deployed configuration is greater than 1.05, and in some examples greater than 1.05 (and up to 2.0), although larger ratios can be achieved depending on the specific material, size, and the like.

[0064] Furthermore, the sinusoidal shape, along with the predetermined elastic force provided by connector 104, advantageously allows electrode assembly 100 to be used on body parts of various sizes and shapes. For example, electrode assembly 100 can be used on the skull or abdomen, as well as body parts of different shapes, including those of people from various cultures and ethnicities. When electrode assembly 100 is mounted on a body part, the sinusoidal shape and elastic force cause electrode assembly 100 to deform in a predetermined manner. For example, when electrode assembly 100 is deformed to fit on a body part, the elastic force and sinusoidal shape cause the nodes 102 of electrode assembly 100 to be spaced apart at a distance in the direction of the force vector, which allows the nodes 102 to be properly positioned at the location of the body part to be measured. This means that when electrode assembly 100 is mounted, electrode assembly 100 will not have areas where nodes 102 remain clustered together in the vicinity of the pre-deformation distance or post-deformation distance, or other nodes 102 that are too far apart in the vicinity of the post-deformation distance or pre-deformation distance. Consistent deformation across all force vectors allows electrode assembly 100 to be used on various body sizes and shapes. During the transition from the undeformed state to the deformed state, the length of connector 104 remains unchanged, which means that connector 104 is not stretched, but rather their shape changes from a sinusoidal shape to a linear shape.

[0065] In some examples, connector 104 is constructed using polyimide, polyethylene, polyetheretherketone (PEEK), or other fully or partially insulating polymers. In some examples, the thickness of connector 104 (including any internal components, such as copper rails or wiring) is preferably in the range of 90 μm to 200 μm, 100 μm to 170 μm, and in a more preferred configuration, 118 μm to 122 μm. In some examples, connector 104 has a thickness of 120 μm with a tolerance of twenty percent (20%). It should be noted that the thickness of connector 104 can vary depending on the specific material used to provide similar resilience.

[0066] Return to reference Figure 2 The diagram also shows a monitoring / input device 200. In some examples, the monitoring / input device 200 provides electrical power to allow node 102 to detect the location 202 of the person being studied (e.g., Figure 2 The electrophysiological signals generated (exemplarily shown in the head) are analyzed. In an example of imaging site 202 using node 102, monitoring / input device 200 is powered via measurement leads 106A and 106B to allow imaging. As shown, measurement leads 106A and 106B are connected to monitoring / input device 200 by inserting measurement connectors 108A and 108B into appropriate ports (not shown) of monitoring / input device 202. Monitoring / input device 200 may record data for later transmission to a system for diagnostic / measurement purposes, and / or may have internal communication capabilities that allow monitoring / input device 200 to send data for use (in... Figure 5 (More details will be provided below).

[0067] Figure 3 Electrical wiring in an electrode assembly 100 according to some examples of this disclosure is shown. Figure 3 Measurement lead 106A and node 104 are shown. Within node 104 and measurement lead 106A (measurement lead 106B is similarly constructed) is node 102 (e.g., Figure 3 The wire that is electrically connected to node 102J and measuring lead 106A, such as Figure 4 This is shown in more detail below.

[0068] Figure 4 This is a close-up view of node 102J used in electrode assembly 100 according to some examples of this disclosure. Figure 4 The nodes shown include pad 402, pad stabilizer 404, and pad reinforcement 406. Pad 402 can be made of various conductive and semiconductive materials, including but not limited to copper, aluminum, stainless steel, and the like. The active area of ​​pad 402 (i.e., the area of ​​the surface placed to contact or approach the subject being studied) can include silver, silver chloride, conductive silicone, conductive polymer, or plastic loaded with a conductive material (e.g., carbon). Pad 402 is shown as circular, but other shapes can be used, such as, but not limited to, spiral, double helix, horseshoe, or angular, and these shapes are considered to be within the scope of the currently disclosed subject matter. Pad 402 is stabilized and attached to connector 104R by pad stabilizer 404. Although the surface of pad 402, designed to contact skin or other surfaces to be measured or detected, preferably has little or no material, the pad stabilizer encapsulates at least a portion of pad 402. In another example, one or more of the pads and the pad itself can be made of a magnetic conductor (e.g., carbon), which can be advantageously used in applications such as magnetic resonance imaging.

[0069] Pad reinforcement 406 is used to reinforce or secure the electrical connection between pad 402 and wire 302A. Wire 302B is used by another node 102. The measuring device uses wire 302A to detect the electrical activity of the subject being studied (passive configuration), or, in an alternative configuration, to transfer electrical energy (active configuration). For example, in a passive configuration, node 402 can be used to detect electrical activity from the subject being studied. In an active configuration, node 402 can receive sufficient electrical energy from wire 302A to allow imaging of body parts by stimulating the subject with electrical signals. For example, body parts can be imaged by deploying node 102J, applying current to pad 402 through wire 302A, recording the potential, and reconstructing an image from the potentials of node 102J and other nodes 102.

[0070] The pad 402 of node 102J also includes a through-hole 408. The through-hole 408 is an opening through the pad 402 and is advantageously used to allow injection through the through-hole 408 to introduce a layer of conductive material between the active area of ​​the pad 402 and a portion of the skin of the subject being studied, while the pad 402 is close to the skin of the subject being studied. One type of conductive material may be a gel used with EEG or ECG cup electrodes, but other types of conductive materials may also be used and are considered to be within the scope of the currently disclosed subject matter. This embodiment is particularly advantageous because it allows the introduction of a conductive gel between the pad and the subject's skin, which improves signal quality. Notably, when the site of study is the head, the conductive gel allows contact to be established between the pad and the tested skin through the subject's hair. The pad 402 of node 102J also includes a hole 410. The hole 410 may be used to provide a means for securing node 102J in a manner similar to the through-hole 408, or to allow air to escape when securing node 102J, among other uses. The via 408 can also be used to determine whether sufficient gel or emulsion has been dispensed, as the emulsion or gel may leak through the via 408 when a sufficient amount is used. It should be noted that node 102J may include more or fewer holes 410 and more vias 408, or may not include vias 408. In an alternative design, the via 408 is absent, and the gel can be dispensed below the electrode by lifting the electrode to inject the gel. According to one embodiment, the user can select which nodes to use as electrodes by applying conductive gel only to the pads 402 of those nodes. Pads without conductive gel (e.g., in contact with the subject's hair) will collect low or no signals, which may be further discarded by software manipulation.

[0071] Figure 5 This is a schematic diagram illustrating an electrode assembly system 500 according to some examples of this disclosure. In various examples, the electrode assembly 100 can be used to monitor or measure a part 202 of the human body. The electrode assembly 100 is electrically connected to a monitoring / input device 200. Figure 2 As shown, electrode assembly 100 is connected to monitoring / output device 200 by inserting measurement leads 106A and 106B into monitoring / input device 200. Note that the subject matter disclosed herein is not limited to removable measurement leads, as some configurations may include pre-installed measurement leads. These and other configurations are considered to be within the scope of the subject matter disclosed herein.

[0072] The electrode assembly system 500 also includes a monitoring service 502 that is communicatively connected to the monitoring / input device 200 via a network 504. The network 504 can be any type of network that communicatively connects the monitoring / input device 200 to the monitoring service 502, including but not limited to Wi-Fi networks, local area networks, or cellular networks. Those skilled in the art will recognize that the systems and methods described herein can also be used with a variety of networks.

[0073] During use, the user of electrode assembly 100 attaches the electrode assembly to the body to be monitored and / or measured. Electrode assembly 100 is connected to monitoring / input device 200. Monitoring / input device 200 is connected to monitoring service 502. In some examples, monitoring / input device 200 stores data locally during use. In another example, monitoring / input device 200 sends data to monitoring service 502 while electrode assembly 100 is in use or at any time thereafter. In yet another example, monitoring service 502 sends instructions to monitoring / input device 200 to configure its operation. For example, while monitoring / input device 200 is detecting bodily signals, monitoring service 502 may detect an anomaly. Monitoring service 502 may send instructions to monitoring / input device 200 to change its configuration from measurement or detection mode to imaging mode to attempt to determine more information about the anomaly.

[0074] Figure 6 This is a flowchart illustrating process 600 using a scalable electrode array according to some examples of this disclosure. Process 600 and other processes described herein are shown as example flowcharts, each of which may represent a series of operations that can be implemented in hardware, software, or a combination thereof. In the context of software, an operation represents computer-executable instructions stored on one or more computer-readable storage media that, when executed by one or more processors, perform the operation. Typically, computer-executable instructions include routines, programs, objects, components, data structures, etc., that perform a particular function or implement a particular abstract data type. The order in which the operations are described is not intended to be construed as limiting, and any number of the described operations may be combined in any order and / or in parallel to implement the process.

[0075] refer to Figure 6 Process 600 begins operation 602, in which the electrode assembly is placed near site 202 of the person / animal / subject to be studied. It should be understood that various aspects of the currently disclosed subject matter are described based on human subjects, although it should be understood that the currently disclosed subject matter is not limited to use on human subjects.

[0076] Process 600 continues to operation 604, where alignment marks 110 are secured to a landmark on site 202 or another location on the subject being studied. Depending on the specific configuration of electrode assembly 100, one or more alignment marks 110 may be present. When an alignment mark 110 is placed on a particular landmark, connector 104 is pulled to cause a twist in at least a portion of electrode assembly 100. This twist allows for three-dimensional confirmation of the deployment of electrode assembly 100 from a non-deployed planar (or flat) configuration to conform to the overall shape of the monitored / imaged site 202.

[0077] Process 600 continues to operation 606, where measurement connector 108 is connected to monitoring / input device 200. In some examples, monitoring / input device 200 can perform monitoring applications or imaging applications (see below). Figure 8 (More details will be provided in the text).

[0078] Process 600 continues to operation 608, in which monitoring or imaging of part 202 begins. Process 600 then ends at operation 610.

[0079] Figure 7 This is a flowchart illustrating a process 700 using an expandable electrode array according to some examples of this disclosure.

[0080] Process 700 begins with operation 702, in which a template for the electrode assembly 100 is created. This template can be prepared using various processes employing various materials. The template is the shape of the electrode assembly 100 structure. For example, in... Figure 1 In this process, the template includes shapes associated with connector 104, alignment mark 110, and the like. In one example, the template is cut from a planar layer of a substrate such as polyimide. The substrate can be an insulating or partially conductive layer of material on which other materials can be placed. In some examples, the template comprises a single sheet of material, while in other examples, the template consists of two or more separate sheets of material. In some examples, the template can be a multilayer material. It should be noted that instead of performing operation 702 at the beginning, operation 702 can be performed after or before various other operations of process 700.

[0081] Process 700 continues at operation 704, where wire 302 is plated onto a template (or, if performed prior to operation 702, onto a substrate). Wire 302 connects individual nodes 102 to monitoring / input devices 200 via measurement leads 106A and 106B. Various electroplating or deposition techniques can be used to form wire 302. Wire 302 can be formed from various conductive or semiconductive materials, such as, but not limited to, copper, aluminum, gold, silver, and their alloys. The thickness of wire 302 can vary, but in some examples is 0.3 to 0.5 μm.

[0082] Process 700 continues to operation 706, in which node 104 is fixed to the template. The node can be a pre-formed metal disc of various conductive or semi-conductive materials, such as, but not limited to, copper, aluminum, gold, silver and their alloys.

[0083] Process 700 continues to operation 708, in which node 104 is secured to wire 302 by pad reinforcement 406 at each node 102. Pad reinforcement 406 may be formed of various materials, including polyimide or other polymers that provide sufficient structural support for the connection between wire 302 and pad 402.

[0084] Process 700 ends at operation 710.

[0085] Figure 8 These are monitoring / input devices for the systems and methods described herein, based on some examples of this disclosure. Figure 8 It is shown in the form of an example. Figure 2 and Figure 5 The monitoring / input device 200 can be any computing component capable of communicating with cellular networks, Internet multimedia subsystems, and / or IP networks. Those skilled in the art will recognize that the systems and methods described herein can also be used with a variety of electronic devices, such as tablets, desktops, servers, and other network-connected devices.

[0086] The monitoring / input device 200 can include several components to perform various of the aforementioned functions. The monitoring / input device 200 can include a memory 802, which includes an operating system (OS) 804 and one or more standard applications 806. The standard applications 806 can include applications for controlling various components of the monitoring / input device 200. In this case, the standard application 806 can also include a monitoring application 830 and an imaging application 832. The monitoring application 830 can be instantiated to control the operation of the monitoring / input device 200 for detecting signals generated from the body. This control can also include determining which nodes receive what signals and storing the data. The imaging application 832 can be instantiated to configure the monitoring / input device 200 to act as an imaging device, whereby one or more nodes are energized to input electrical energy. For example, if instantiated, the imaging application 832 can cause the monitoring / input device 200 to apply current to one or more nodes, record the potential of nodes that do not receive current, and construct an image based on the potential.

[0087] In this method, a monitoring / input device 200 or monitoring service 502 (or another device) defines a subset of nodes 102 to which current is applied. The monitoring / input device 200 then records the potential on the nodes 102 that do not receive current. Optionally, several subsets of nodes 102 with different patterns are defined sequentially, and the resulting potentials are recorded sequentially. In other words, the set of nodes 102 is changed, and current is repeatedly applied to different nodes 102. The monitoring / input device 200 or monitoring service 502 may, for example, use an image reconstruction algorithm to determine an image of a body part 202 of the subject. This method is suitable for non-invasive imaging, such as electrical impedance tomography (EIT), absolute (a-EIT), time difference (td-ET), or multi-frequency (MF-EIT) modes. This method can be used to image various parts of the body, particularly the lungs, muscles, breasts, cervix, brain, bladder, or limbs. This method can be used to image volume changes in body parts, particularly under blood flow or perfusion.

[0088] In another example, one or more of the pads 402 of node 102 can be replaced by other types of electromagnetic energy emitters, such as infrared, visible, or near-infrared light-emitting diodes (LEDs). In some examples, as described above, node 102 can be an emitter, a sensor, or a coupler of emitter / sensor. For example, in cases where non-self-emitted physiological signals are present, a coupled emitter / sensor can be used to acquire the signal. Near-infrared emitters can be used in procedures such as near-infrared spectroscopy or optical coherence tomography. Standard application 806 can also include one or more functions or operations (such as...) Figure 1-8 (As shown). In some other examples, one or more nodes 102 may be ultrasonic transducers coupled for use in applications such as echography. As used herein, an ultrasonic transducer may be a transmitter, receiver, and / or transceiver.

[0089] The monitoring / input device 200 may also include one or more processors 812 and one or more of a removable memory 814, a non-removable memory 816, a transceiver 818, an output device 820, and an input device 822. In various implementations, the memory 802 may be volatile (e.g., random access memory (RAM)), non-volatile (e.g., read-only memory (ROM), flash memory, etc.), or some combination of both. The memory 802 may be used to store various data received from the electrode group 100 and / or data received from the monitoring service 502 via the network 504.

[0090] The memory 802 may also include an OS 804. The OS 804 contains modules and software supporting basic functions, such as task scheduling, application execution, and control of peripheral devices. In some examples, the OS 804 may enable monitoring application 830, imaging application 832, and, as described above, provide other functions via transceiver 818. The OS 804 may also enable monitoring / input device 200 to send and retrieve additional data and perform other functions. It should be noted that one or more functions of the currently disclosed subject matter may be performed by other systems besides the OS 804, such as firmware / FFPGA / ASIC.

[0091] The monitoring / input device 200 may also include one or more processors 812. In some implementations, the processor 812 may be a central processing unit (CPU), a graphics processing unit (GPU), both a CPU and a GPU, or any other processing unit, such as an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA), by way of example and not limitation. The monitoring / input device 200 may also include additional data storage devices (removable and / or non-removable), such as a hard disk, optical disk, or magnetic tape. This additional storage... Figure 8 The image is shown in the form of a removable memory 814 and a non-removable memory 816.

[0092] Non-transitory computer-readable media can include tangible physical media that are volatile and non-volatile, removable and non-removable, implemented with technologies for storing information, such as computer-readable instructions, data structures, program modules, or other data. Memory 802, removable memory 814, and non-removable memory 816 are examples of non-transitory computer-readable media. Non-transitory computer-readable media include, but are not limited to, RAM, ROM, electrically erasable programmable ROM (EEPROM), flash memory or other memory technologies, optical disc ROM (CD-ROM), digital versatile disc (DVD) or other optical storage, magnetic tape cassettes, magnetic tape, disk storage or other magnetic storage devices, or any other tangible physical media capable of storing desired information and accessible by monitoring / input device 200. Any such non-transitory computer-readable media may be part of monitoring / input device 200, or may be a separate database, database, remote server, or cloud-based server.

[0093] In some implementations, transceiver 818 includes any transceiver known in the art. In some examples, transceiver 818 may include a wireless modem to facilitate wireless connectivity with other components (e.g., between monitoring / input device 200 and network 504), the Internet and / or intranets, and wireless network adapters or other capable devices.

[0094] Transceiver 818 may also include one or more radio transceivers that perform operations via an antenna (e.g., Wi-Fi or...). The transceiver 818 provides the functionality to send and receive radio frequency communications. In other examples, the transceiver 818 may include wired communication components, such as a wired modem or Ethernet port, for communication via one or more wired networks. The transceiver 818 enables the monitoring / input device 200 to download files, access web applications, and provide other communications associated with the systems and methods described above.

[0095] In some embodiments, output device 820 includes any output device known in the art, such as a display (e.g., a liquid crystal or thin-film transistor (TFT) display), a touchscreen, a speaker, a vibration mechanism, or a haptic feedback mechanism. Therefore, the output device can include a screen or display. Output device 820 can also include a speaker or similar device to play sound or a ringtone upon receiving an audio or video call. Output device 820 can also include ports for one or more peripheral devices, such as headphones, peripheral speakers, or peripheral displays.

[0096] In various embodiments, input device 822 includes any input device known in the art. For example, input device 822 may include one or more components of electrode assembly 100. In another example, input device 822 may include a camera, microphone, or keyboard / keyboard. Input device 822 can include a touch-sensitive display or keyboard to enable a user to input data and make requests and receive responses via a web application (e.g., in a web browser), make audio and video calls, and use standard application 806, etc. For example, monitoring / input device 200 may be a cellular phone with an input port capable of receiving data from electrode assembly 100. The touch-sensitive display or keyboard / keyboard may be a standard alphanumeric keypad (e.g., a conventional QWERTY keyboard), virtual controls on a touchscreen, or one or more other types of keys or buttons, and may also include joysticks, scroll wheels, and / or designated navigation buttons, etc.

[0097] The examples disclosed herein are to be considered illustrative rather than limiting in all respects. The scope of this disclosure is indicated by the appended claims rather than the foregoing description, and all changes in the meaning and scope of their equivalents are intended to be included therein.

Claims

1. An electrode assembly (100), the electrode assembly (100) comprising: Multiple nodes (102), including at least one first node (102) and one second node (102), the first node (102) including a first pad (402) for receiving electromagnetic energy from a first part of the site under study, and the second node (102) including a second pad (402) for receiving electromagnetic energy from a second part of the site under study or for sending a signal to the first part of the site under study; At least one connector (104) connecting the first node (102) to the second node (102), the connector (104) being formed in a shape that provides a uniform deformation from a first distance between the first node (102) and the second node (102) to one or more second distances between the first node (102) and the second node (102) when a tensile force is applied to the first node (102) or the second node (102), wherein, in an undeformed state, the first node (102) and the second node (102) are planar, and in a deformed state, the first node (102) and the second node (102) are non-planar, wherein the length of the connector (104) remains constant from the undeformed state to the deformed state; At least one alignment mark (110) is fixed to the first node (102) or the second node (102), the at least one alignment mark (110) being removably fixed to a marker on the subject at the site of study, wherein the at least one alignment mark (110) is configured to transmit tension to the first node (102) or the second node (102) when the alignment mark (110) is fixed to the marker; The first wire (302) within the connector (104) is electrically connected to the first pad (402) of the first node (102) and extends to the measuring lead (106); and The second conductor (302) within the connector (104) is electrically connected to the second pad (402) of the second node (102) and extends to the measurement lead (106), wherein the measurement lead (106) terminates at the measurement connector (104) to be inserted into the monitoring / input device.

2. The electrode assembly according to claim 1, further comprising: A plurality of third nodes (102), at least a portion of which includes a third pad (402) for receiving electromagnetic energy from a plurality of third portions of the site under investigation; and A plurality of second connectors (104) connecting at least one of a plurality of third nodes (102) to a first node (102) or a second node (102), the plurality of second connectors (104) being formed of a shape that, when tension is applied to the at least one alignment mark (110), provides a uniform deformation from a first distance between at least a portion of the plurality of third nodes (102) to one or more second distances between at least a portion of the plurality of third nodes (102), wherein, in an undeformed state, the plurality of third nodes (102) are planar, and in a deformed state, the plurality of third nodes (102) are nonplanar.

3. The electrode assembly according to claim 2 further includes a plurality of second alignment marks (110) fixed to one or more of the plurality of third nodes (102), the plurality of second alignment marks (110) being removably fixed to a plurality of second landmarks on the subject at the site of study, wherein, The plurality of second alignment marks (110) are configured to transfer the tension to at least a portion of the plurality of third nodes (102) while the plurality of second alignment marks (110) are being fixed to the landmark.

4. The electrode assembly according to claim 1 further includes a first pad reinforcement (406) fixed to the first node (102), wherein, The first pad reinforcement (406) ensures the electrical connection between the first pad (402) and the first wire (302).

5. The electrode assembly according to claim 1, wherein, The at least one connector (104) comprises a plastic substrate, polyimide, polyethylene, polyetheretherketone (PEEK), or a non-conductive polyester or polymer.

6. The electrode assembly according to claim 1, wherein, The shape includes a sinusoidal shape.

7. The electrode assembly according to claim 1, wherein, The shape includes spiral, double spiral, horseshoe, or angular.

8. The electrode assembly according to claim 1, wherein, The pad (402) comprises a conductive or semi-conductive material.

9. The electrode assembly according to claim 1, wherein, The first pad (402) and / or the second pad (402) include copper, aluminum, stainless steel, gold, silver or alloys thereof.

10. The electrode assembly according to claim 1, wherein, The first conductor (302) and / or the second conductor (302) may be made of copper, aluminum, stainless steel, gold, silver or alloys thereof.

11. The electrode assembly according to claim 1, wherein, The first pad (402) includes a first through-hole (408), and the second pad (402) includes a second through-hole (408), the first through-hole (408) and the second through-hole (408) being openings that allow the injection of a conductive material that enhances electrical contact with the skin.

12. The electrode assembly according to claim 1, wherein, The electromagnetic energy is near-infrared light, infrared light, or visible light.

13. The electrode assembly according to claim 2, further comprising a fourth node (102), wherein, The fourth node (102) includes a fourth pad (402) for receiving electromagnetic energy generated by electromagnetic transmission from the third pad (402).

14. The electrode assembly according to claim 2, wherein, At least one third node (102) is configured to receive sensors.

15. A method for measuring electrophysiological signals at a site of a subject, the method comprising: Place the electrode assembly (100) according to claim 1 close to the part to be measured. At least one alignment mark (110) is attached to a marker on the subject at the site of study; Connect the measurement lead (106) to the monitoring / input device; and A monitoring application is instantiated in the monitoring / input device to begin measuring the electrophysiological signals at the site of the subject.

16. The method of claim 15, further comprising injecting a conductive, acoustic, or light-transmitting material through a first through-hole (408) of the first pad (402) and a second through-hole of the second pad (402).

17. A sensor array system (500), comprising: - The sensor array (100) according to claim 1, wherein the monitoring / input device is configured to receive data of electrophysiological signals received from the first pad or the second pad; and - A monitoring service connected to the monitoring / input device, used to receive data from the electrophysiological signals or send instructions to the monitoring / input device.

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