Extendable electrode set

Abstract

The present invention relates to stretchable electrode sets, and methods of using stretchable electrode sets, electrode set systems, and methods of manufacturing electrode sets (100) are described herein. Various examples of electrode sets (100) include nodes (102) physically connected to each other by connectors (104) having shapes that allow deformation of the electrode set. The shape and material of the connectors (104) are designed to provide consistent deformation so that placement of alignment markers on the body part to be monitored will cause the nodes (102) to reach the correct location on the body part where measurements will be taken. The electrode sets (100) may include sensors, emitters, or sensors and emitters in various configurations.

Description

Technical Field

[0002] , , ,

[0004] , , , , , , , , ,

[0003]

[0001] The present invention relates to the field of systems and methods for acquiring physiological signals from a subject. In particular, the present invention relates to a set of electrodes for measuring electrophysiological signals.

Background Art

[0002] The acquisition of electrophysiological signals is very important in current medical technology. Electrical activities of the heart (electrocardiogram ECG), brain (electroencephalogram EEG), nerves (electromyogram EMG), or pregnant women (fetal electrocardiogram or fECG), and other electrical measurements (electrooculogram (EOG) related to the eyes, ERG EEG related to intestinal activities, etc.) are generally recorded for diagnostic or monitoring purposes. Also, imaging based on electrical signal stimulation or impedance measurement of a part of the subject's body (EIT: electrical impedance tomography) is rapidly spreading in medical practice. In order to achieve accurate measurement of electrophysiological signals, it is necessary to accurately place the measurement electrodes. Correct placement of the electrodes for stimulation or imaging is necessary for accurate reading.

[0003] Similarly, when, due to a given medical condition, an inter-arrangement between electrodes (or other sensors) in a specific arrangement and other types of skin-contact sensors such as sensors made using light-emitting diodes, photoreceptors, or silicon integrated cells (MEMS) is required, in many medical cases, accurate position accuracy needs to be achieved for correct measurement.

Summary of the Invention

[0004] Therefore, the present invention provides - a first node and a second node, wherein the first node comprises a first pad for receiving electromagnetic energy from a first part of a site under study, and the second node comprises a second pad, the first node and the second node; - A connector for connecting a first node to a second node, wherein the connector is formed from a shape that 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 when a tensile force is applied to the first node or the second node, wherein the first node and the second node are planar in the undeformed state and non-planar in the deformed state, and the length of the connector is constant from the undeformed state to the deformed state, - An alignment marker comprising at least one alignment marker fixed to either a first node or a second node, wherein the at least one alignment marker is removably fixed to a landmark on the subject at the site of study, and is configured to transmit a tensile force to either the first node or the second node when the at least one alignment marker is fixed to the landmark, This relates to an electrode set equipped with the following features. The expression "a connector formed from a shape that provides consistent deformation" may be understood as the connector having a shape configured to provide consistent deformation. Advantageously, the electrode sets of this disclosure are planar in their undeformed state, enabling compact storage of multiple electrode sets. This aspect is of particular interest, for example, for ambulances that must house numerous different medical systems / devices for transport.

[0005] According to one embodiment, the second pad is for receiving electromagnetic energy from a second portion of the area under study or for transmitting a signal to a first portion of the area under study.

[0006] According to one embodiment, the electrode set further comprises a first wire in a connector that is electrically connected to a first pad of a first node and extends to a measuring lead.

[0007] According to one embodiment, the electrode set further comprises a second wire in a connector which is electrically in communication with a second pad of a second node and extends to a measuring lead which terminates in a measuring connector inserted into a monitoring / input device.

[0008] According to one embodiment, the electrode set further comprises a plurality of third nodes, at least a portion of which are provided with third pads for receiving electromagnetic energy from a plurality of third portions of a site under study, and a plurality of second connectors for connecting at least one of the plurality of third nodes to either a first node or a second node, wherein the plurality of second connectors are formed from a shape that 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 when a tensile force is applied to at least one alignment marker, wherein the plurality of third nodes are planar in an undeformed state and nonplanar in a deformed state.

[0009] According to one embodiment, the electrode set further comprises a plurality of second alignment markers fixed to one or more of a plurality of third nodes, the plurality of second alignment markers being removably fixed to a plurality of second landmarks on the subject at the site of study, and the plurality of second alignment markers being configured to transmit tensile force to at least a portion of the plurality of third nodes once fixed to the landmarks.

[0010] According to one embodiment, the electrode set further comprises a first pad reinforcement fixed to a first node, the pad reinforcement ensuring an electrical connection between the pad and the first wire.

[0011] According to one embodiment, the connector comprises a plastic substrate, polyimide, polyethylene, polyetheretherketone (PEEK), or nonconductive polyester or polymer.

[0012] According to one embodiment, the shape is sinusoidal. This embodiment advantageously allows the spacing between nodes to be changed from a first distance to one or more second distances, depending on how much the connector is stretched.

[0013] According to one embodiment, the shape may be a spiral shape, a double spiral shape, a horseshoe shape, or an angular shape.

[0014] According to one embodiment, the first pad and / or the second pad comprises a conductive or semiconducting material.

[0015] According to one embodiment, the first pad and / or the second pad comprises copper, aluminum, stainless steel, gold, silver, or an alloy thereof.

[0016] According to one embodiment, the first wire and / or the second wire comprises copper, aluminum, stainless steel, gold, silver, or an alloy thereof.

[0017] According to one embodiment, the first pad is provided with a first through hole, and the second pad is provided with a second through hole, the first and second through holes being openings that allow for the injection of a conductive material to enhance electrical contact with the skin.

[0018] According to one embodiment, the electrode set further comprises a third node, the third node comprising a third pad for transmitting electromagnetic energy.

[0019] According to one embodiment, the electromagnetic energy is near-infrared light, infrared light, or visible light.

[0020] According to one embodiment, the electrode set further comprises a fourth node, the fourth node comprising a fourth pad for receiving electromagnetic energy generated by electromagnetic transmission from the third pad.

[0021] According to one embodiment, the electrode set further comprises a third node for receiving a sensor.

[0022] The present invention also relates to a method for measuring signals from a part of a subject, and the method is: - The electrode set is placed in close proximity to the area to be measured, and the electrode set is -A first node and a second node, wherein the first node comprises a first pad for receiving electromagnetic energy from a first part of the area under study, and the second node comprises a second pad for receiving electromagnetic energy from a second part of the area under study, - A connector for connecting a first node to a second node, wherein the connector is formed from a shape that 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 when a tensile force is applied to the first node or the second node, wherein the first node and the second node are planar in the undeformed state and non-planar in the deformed state, and the length of the connector is constant from the undeformed state to the deformed state, - An alignment marker comprising at least one alignment marker fixed to either a first node or a second node, wherein the at least one alignment marker is removably fixed to a landmark on the subject at the site of study, and the at least one alignment marker is configured to transmit a tensile force to either the first node or the second node when fixed to the landmark, -A first wire in the connector, the first wire is electrically in communication with the first pad of the first node and extends to the measuring lead, - A second wire within the connector, the second wire is electrically in communication with the second pad of the second node and extends to the measurement lead, the measurement lead terminates at the measurement connector inserted into the monitoring / input device, and the second wire The electrode set comprising the above is placed in close proximity to the area to be measured, · Fixing at least one alignment marker to a landmark, · Connecting a measurement lead to a monitoring / input device, · Instantiating a monitoring application in the monitoring / input device and starting measurement of an electrophysiological signal of a subject's site, and comprising.

[0023] According to one embodiment, the method further comprises injecting a conductive, acoustic, or light-transmissive material through a first through-hole of the first pad and a second through-hole of the second pad.

[0024] According to one embodiment, the connector comprises a plastic substrate, polyimide, polyethylene, polyether ether ketone (PEEK), or a non-conductive polyester or polymer.

[0025] According to one embodiment, the shape comprises a sine wave shape.

[0026] According to one embodiment, the shape comprises a spiral shape, a double spiral shape, a horseshoe shape, or an angular shape.

[0027] According to one embodiment, the first pad and / or the second pad comprise a conductive or semiconductive material.

[0028] According to one embodiment, the first pad and / or the second pad comprise copper, aluminum, stainless steel, gold, silver, or an alloy thereof.

[0029] Also, the present invention a sensor set (100) according to any one of the above-described embodiments, wherein the monitoring / input device is configured to receive data of an electrophysiological signal received from the first pad or the second pad, a monitoring service that communicates with the monitoring / input device to receive data of an electrophysiological signal or to transmit instructions to the monitoring / input device, This also relates to sensor set systems equipped with these features.

[0030] Detailed explanations are provided with reference to the attached drawings. In the drawings, the leftmost digit (singular or plural) of the reference number indicates the drawing in which that reference number first appears. The use of the same reference number in different drawings indicates similar or identical items or functions. [Brief explanation of the drawing]

[0031] [Figure 1] This disclosure shows some examples of expandable electrode sets in a non-extended state. [Figure 2] The following are examples of electrode sets in an unfolded state relating to some of the present disclosure. [Figure 3] The electrical wiring within a retractable electrode set, relating to some examples of the present disclosure, is shown. [Figure 4] This is an enlarged view of an example node used in a retractable electrode set, relating to some examples of the present disclosure. [Figure 5] This is a schematic diagram showing an electrode set system relating to some examples of the present disclosure. [Figure 6] This flowchart shows a method using a stretchable electrode set, relating to some examples of the present disclosure. [Figure 7] This flowchart shows a method for manufacturing a stretchable electrode set, relating to some examples of the present disclosure. [Figure 8] This is a component-level diagram of a monitoring / input device for use with the systems and methods described herein, relating to some examples of the present disclosure. [Modes for carrying out the invention]

[0032] Examples of this disclosure may include systems and methods for providing and using a retractable sensor set. When measuring three-dimensional body parts using conventional sensor sets, it is often difficult to properly position the sensors in the correct location on the patient's body (part) in order to obtain the most accurate readings possible. As a result, the use of conventional sensor sets is often limited to facilities such as hospitals that have technicians for installation. Because installation of conventional sensor sets requires specialists, and the cost and inconvenience of using conventional sensor sets are very high, the ability to utilize the data that can be obtained in many medical cases is limited. It should be noted that some of the drawings are described from the perspective of installation on a subject by a second person, but the subject matter of this disclosure is not limited to such methods, and various examples of the subject matter of this disclosure may be installed by the subject themselves.

[0033] Figure 1 shows a top view of the retractable electrode set 100 in its un-deployed state. It should be noted that while some of the descriptions herein relate to “electrodes” or “electrode sets,” the descriptions using electrodes are merely typical and illustrative, and therefore the subject matter of this disclosure is not limited to electrodes. As used herein, “un-deployed” means that the electrode set 100 is not placed on a body part, and “deployed” means that the electrode set 100 is placed on a body part, either partially or entirely. Referring to Figure 2, the electrode set 100 is shown in its deployed state. In the un-deployed state shown in Figure 1, the electrode set 100 is substantially flat, meaning that when placed on a flat surface, all or almost all of the bottom surface of the electrode set 100 adjacent to the flat surface is in contact with that surface. In the deployed state shown in Figure 2, the electrode set 100 is partially deformed and wraps around a 3D body part of the patient or subject under study. In some examples, the deformation may be referred to as “flexion,” and the two terms are interchangeable. For example, in Figure 1, nodes 102H and 102I, connected by connector 104E, are shown to have a distance D1 between nodes 102I and 102H, whereas in Figure 2, the distance between nodes 102I and 102H is D2, which is greater than D1.

[0034] Referring again to Figure 1, the electrode set 100 includes nodes 102A to 102F (collectively referred to herein as “node 102”, and individually as “node 102A”, “node 102B”, etc.) and connectors 104A to 104E (collectively referred herein as “connector 104”, and individually as “connector 104A”, “connector 104B”, etc.). Note that Figure 1 includes additional nodes and connectors without labels, which are for illustrative purposes only. The internal structure of node 102 and connector 104 is described in more detail in Figures 3 and 4. In use, node 102 is used to sense (measure or detect) electrophysiological signals that are the result of electrical activity in a particular body part. Note that the shapes of the various components of electrode set 100 shown in Figure 1 are merely typical examples, and may have different shapes depending on the specific application. For example, node 102 may be circular as shown in Figure 1, but may also be elliptical, oval, square, rectangular, and / or polygonal, or a combination thereof. In some examples, node 102 may be used to pass an electric current through a subject being tested to measure impedance. These and other applications of node 102 as an electrical or electromagnetic device are considered to be within the scope of the subject matter of this disclosure.

[0035] The electrode set 100 further includes measuring leads 106A and 106B and measuring connectors 108A and 108B. The measuring leads 106A and 106B receive electrical signals from node 102 via connector 104. Inside each of the measuring leads 106A and 106B, there are wires from node 102 running from node 102 to the measuring leads 106A and 106B. The measuring leads 106A and 106B are connected to a device that measures the electrical signals from node 102 (shown in more detail in Figure 2).

[0036] As mentioned above, conventional electrode sets often require a technician or other qualified person to ensure proper placement of the electrode set on a body part. This is because the nodes that measure bodily electrical activity need to be placed at specific points on the body to obtain the most accurate readings possible. The electrode set 100 in Figure 1 provides various mechanisms that enable a variety of users, including untrained individuals, to properly place the electrode set 100 on a body part (e.g., the head or abdomen of a pregnant woman).

[0037] The first mechanism enabling the proper placement of the electrode set 100 to a body part is the alignment markers 110A to 110D (collectively referred to herein as “alignment markers 110”, and individually as “alignment marker 110A”, “alignment marker 110B”, etc.). The alignment markers 110 are used by the person installing the electrode set 100 to properly align the electrode set 100. The alignment markers 110 are configured to be placed in contact with predetermined anatomical landmarks of the human subject under study. The landmarks may be based on a variety of factors, including criteria defined by the medical community for positioning the node 102 to accurately record electrophysiological signals. Such systems exist for the positioning 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 may not require the use of specific landmarks, and other locations on the body may be used and may be considered within the scope of the subject matter of this disclosure. For example, the ear, nose, navel, or other landmarks may be used for proper placement of the electrode set 100. It should also be noted that the electrode set 100 is not limited to human use and may be used on non-human subjects. In the example shown in Figure 1, the alignment marker 110 is positioned according to the anatomical landmarks of the nasion, inion, and bilateral ear hairs in 10–20 international systems or their variations; however, as mentioned herein, other landmarks may be used and are considered to be within the scope of the subject matter of this disclosure.

[0038] The person installing the electrode set 100 places one or more alignment markers 110 at one or more locations (e.g., anatomical landmarks) and temporarily secures them (using tape or other adhesives suitable for use on the body). In the example shown in Figure 1, there are four alignment markers 110, but as mentioned above, there may be more or fewer than four depending on the specific configuration of the electrode set 100. When one of the alignment markers 110 is placed at an anatomical landmark, the placement of the alignment marker 110 is advantageous because it applies force to the node 102 closest to the alignment marker 110 via the marker connectors 112A to 112D (collectively referred to herein as "marker connector 112," and individually as "marker connector 112A," "marker connector 112B," etc.). In one favorable example, the placement of alignment marker 110C applies a tensile force to node 102B via marker connector 112C in a direction roughly aligned with force vector XE. Similarly, the placement of alignment marker 110A applies a force roughly aligned with force vector XN, the placement of alignment marker 110B applies a force roughly aligned with force vector XW, and the placement of alignment marker 110D applies a force roughly aligned with force vector XS.

[0039] The electrode set 100 flexes or deforms due to a tensile force acting on it in the directions of two or more force vectors (e.g., XE, XN, XW, and XS). As used herein, “flexing” refers to a material deformed from a planar state (as shown in Figure 1) to a three-dimensional state (as shown by the example in Figure 2). The electrode set 100 is designed with a material that provides adequate elastic force to counteract tensile forces in order to correctly align the node 102 to one or more anatomical landmarks. For example, if the elastic force (i.e., the force generated when a deformed object tries to return to its original state) is too low, various nodes may be easily pulled in a particular direction. In this example, the structural stiffness of the electrode set 100 and its node 102 and connector 104 is insufficient to provide a controlled and specific deployment of the node 102 of the electrode set 100. In other cases, if the rigidity of the electrode set 100 is excessively large, i.e., if the elastic force is relatively large, among various disadvantages, the structure of the electrode set 100 may require a strong adhesive or bonding agent to maintain the alignment marker 110 in place, potentially placing an excessive burden on the material of the electrode set 100.

[0040] Therefore, the structure of the electrode set 100 and its components, particularly the connector 104, is designed to maintain a balance between rigidity and flexibility. In the example shown in Figure 1, a sinusoidal shape made of a specific material favorably achieves this balance. It should be understood that the shape and material are examples, and other shapes and materials may be used. For example, other shapes such as helical, double helix, horseshoe, or angular shapes may be used. The shape of the connector 104 of the electrode set is designed to allow a planar configuration when unfolded, while allowing a non-planar configuration during use.

[0041] Advantageously, the sinusoidal shape also allows the spacing between nodes 102 to be changed from a first distance to one or more second distances, depending on how much the connector 104 is stretched. One or more second distances can be used to allow the electrode set 100 to be deployed in various applications. In one embodiment, the ratio of the first distance between two nodes connected by a connector, such as nodes 102B and 102F connected by connector 104H, in the deployed configuration to the distance between the same two nodes connected by the same connector element in the undeployed configuration is greater than 1.05, and in some examples the ratio is between 1.05 and up to 2.0, although even larger ratios may be achievable depending on the specific material, dimensions, etc.

[0042] Furthermore, the sinusoidal shape with a predetermined elastic force provided by the connector 104 advantageously allows the electrode set 100 to be used on body parts of various sizes and shapes. For example, the electrode set 100 can be used on body parts of different shapes, including the skull or abdomen, as well as body parts of various cultures and ethnicities. When the electrode set 100 is placed on a body part, the sinusoidal shape and elastic force cause the electrode set 100 to deform in a predetermined manner. For example, as the electrode set 100 deforms to conform to the body part, the elastic force and sinusoidal shape cause the nodes 102 of the electrode set 100 to separate in the direction of the force vector, allowing the nodes 102 to be properly positioned at the location of the body part being measured. This means that when the electrode set 100 is placed, there are no areas of nodes 102 that remain bundled together at or near the pre-deformation distance, or other nodes 102 that are excessively spread out at or near the post-deformation distance. Consistent deformation across all force vectors makes the electrode set 100 usable on a variety of body sizes and shapes. During the transition from the undeformed state to the deformed state, the length of the connector 104 remains the same, meaning that the connector 104 does not stretch, but rather its shape changes from a sinusoidal shape to a linear shape.

[0043] In some examples, the connector 104 is constructed using polyimide, polyethylene, polyetheretherketone (PEEK), or other fully or partially insulating polymers. In some examples, the connector 104 (including any internal components such as copper tracks or wiring) preferably has a thickness in the range of 90 μm to 200 μm, a thickness in the range of 100 μm to 170 μm, and in more preferred configurations, a thickness range of 118 μm to 122 μm. In some examples, the thickness of the connector 104 is 120 μm with a tolerance of 20 percent (20%). It should be noted that the thickness of the connector 104 may vary depending on the specific material used to provide similar elastic force.

[0044] Referring again to Figure 2, the monitoring / input device 200 is also shown. In some examples, the monitoring / input device 200 provides power to enable node 102 to be used to detect electrophysiological signals generated by a human body part 202 under study, for example, the head, as shown as an example in Figure 2. In an example where node 102 is used to image the body part 202, the monitoring / input device 200 provides power via measurement leads 106A and 106B to enable imaging. As shown, the measurement leads 106A and 106B are connected to the monitoring / input device 200 by inserting measurement connectors 108A and 108B into the appropriate ports (not shown) on the monitoring / input device 202. The monitoring / input device 200 may record data for later transfer to a system for diagnosis / measurement and / or may have internal communication capabilities that enable the monitoring / input device 200 to transmit data for use (as described in more detail in Figure 5).

[0045] Figure 3 shows the electrical wiring within an electrode set 100 according to some examples of the present disclosure. Figure 3 shows a measuring lead 106A and a node 104. Within node 104 and measuring lead 106A (measuring lead 106B is configured similarly), there is a wire that electrically connects node 102 (for example, node 102J in Figure 3) to measuring lead 106A, as shown in more detail in Figure 4.

[0046] Figure 4 is a magnified view of a node 102J used in an electrode set 100, relating to some examples of the present disclosure. The node shown in Figure 4 includes a pad 402, a pad stabilizer 404, and a pad reinforcement 406. The pad 402 may be made of a variety of conductive and semiconducting materials, including but not limited to copper, aluminum, and stainless steel. The active area of ​​the pad 402 (i.e., the area that is in contact with or in close proximity to a portion of the surface of a subject under study) may comprise silver, silver chloride, conductive silicon, conductive polymer, or plastic filled with a conductive material such as carbon. The pad 402 is illustrated as having a circular shape, but other shapes, such as helical, double helix, horseshoe, or angular shapes, may be used and are considered to be within the scope of the subject matter of the present disclosure. The pad 402 is stabilized by the pad stabilizer 404 and attached to the connector 104R. The pad stabilizer encloses at least a portion of the pad 402, but the surface of the pad 402, which is designed to be positioned in contact with the skin or other surface to be measured or detected, is preferably almost material-free. In other examples, one or more pads and the pads themselves may be composed of a magnetic conductor (such as carbon) which can be advantageously used in applications such as magnetic resonance imaging.

[0047] The pad reinforcement 406 is used to reinforce or secure the electrical connection between the pad 402 and the wire 302A. The wire 302B is used by other nodes 102. The wire 302A is used by the measuring device to detect the electrical activity of the subject under study (passive configuration) or, in an alternative configuration, to supply electrical energy (active configuration). For example, in a passive configuration, node 402 may be used to detect electrical activity from the subject under study. In an active configuration, node 402 may receive sufficient electrical energy from the wire 302A to enable imaging of a body part by stimulating the subject with an electrical signal. For example, a body part may be imaged by deploying node 102J, passing current through the wire 302A to the pad 402, recording the potential, and reconstructing an image from the potentials of node 102J and other nodes 102.

[0048] The pad 402 of node 102J further includes a through-hole 408. The through-hole 408 is an opening that penetrates 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 subject's skin when the pad 402 is in close proximity to the subject's skin. The type of conductive material may be a gel used with an EEG or ECG cup electrode, but other types of conductive materials may be used and are considered to be within the scope of the subject matter of this disclosure. This embodiment is particularly advantageous because it allows for the introduction of a conductive gel between the pad and the subject's skin, which is advantageous for improving signal quality. If the portion of the subject's skin is the head, the conductive gel may be able to bring contact between the pad and the subject's skin via the subject's hair. The pad 402 of node 102J further includes an orifice 410. The orifice 410 may be used, among various applications, to provide a means for attaching the node 102J, as well as the through-hole 408, or to allow air to escape when the node 102J is attached. The through-hole 408 may also be used to determine if sufficient gel or cream has been administered, as the cream or gel may leak through it once a sufficient amount has been used. The node 102J may contain more or fewer orifices 410 and more through-holes 408, or it may not contain any through-holes 408. In an alternative design, the through-hole 408 is absent, and the gel may be administered beneath 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. For example, a pad without conductive gel in contact with the subject's hair may collect a low or no signal, which may be further discarded by software operation.

[0049] Figure 5 is a schematic diagram showing an electrode set system 500 relating to some examples of the present disclosure. In various examples, the electrode set 100 may be used to monitor or measure a part of the human body 202. The electrode set 100 is electrically connected to a monitoring / input device 200. As shown in Figure 2, the electrode set 100 is connected to the monitoring / input device 200 by inserting the measurement leads 106A and 106B into the monitoring / input device 200. It should be noted that the subject matter of the present disclosure is not limited to removable measurement leads, and some configurations may include pre-installed measurement leads. These and other configurations are considered to be within the scope of the subject matter of the present disclosure.

[0050] The electrode set system 500 further includes a monitoring service 502 that is communicably connected to the monitoring / input device 200 via a network 504. The network 504 may be any type of network that communicably connects the monitoring / input device 200 to the monitoring service 502, including but not limited to a Wi-Fi network, a local area network, or a cellular network. Those skilled in the art will recognize that the systems and methods described herein can also be used with a variety of networks.

[0051] During use, the user of electrode set 100 attaches the electrode set to the body to be monitored and / or measured. Electrode set 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 further examples, monitoring / input device 200 transmits data to monitoring service 502 at any time during or after the use of electrode set 100. In yet another example, monitoring service 502 sends commands to monitoring / input device 200 to configure its operation. For example, while monitoring / input device 200 is detecting a body signal, monitoring service 502 may detect an anomaly. Monitoring service 502 sends a command to monitoring / input device 200 to change its configuration from measurement or detection mode to imaging mode and attempt to determine more information about the anomaly.

[0052] Figure 6 is a flowchart of process 600 using a retractable electrode set, relating to some examples of the present disclosure. Process 600 and other processes described herein are shown as flow graph examples, and each operation may represent a sequence of operations that may be implemented in hardware, software, or a combination thereof. In the context of software, an operation represents a computer executable instruction stored in one or more computer-readable storage media that performs the operation described, when executed by one or more processors. Generally, a computer executable instruction includes 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 constrained, and any number of described operations may be combined in any order and / or in parallel to perform the process.

[0053] Referring to Figure 6, process 600 initiates operation 602, in which the electrode set is positioned in close proximity to the part 202 of the human / animal / object under study. It should be understood that while various aspects of the subject matter of this disclosure are described in relation to human subjects, the subject matter of this disclosure is not limited to its application to human subjects.

[0054] Process 600 follows operation 604, in which the alignment marker 110 is fixed to a landmark at site 202 or another location of the subject under study. Depending on the specific configuration of the electrode set 100, there may be one or more alignment markers 110. When the alignment marker 110 is positioned at a specific landmark, the connector 104 is pulled, causing a flexure of at least a portion of the electrode set 100. This flexure allows the electrode set 100 to deform from an unfolded planar (or flat) configuration to an unfolded three-dimensional configuration, which can then conform to the overall shape of the site 202 being monitored / imaged.

[0055] Process 600 follows operation 606, in which the measurement connector 108 is connected to the monitoring / input device 200. In some examples, the monitoring / input device 200 may run a monitoring application or an imaging application (which will be described in more detail below in Figure 8).

[0056] Process 600 continues with operation 608, after which monitoring or imaging of site 202 begins. Process 600 then terminates with operation 610.

[0057] Figure 7 is a flowchart of a process 700 for manufacturing an electrode set 100, relating to some examples of the present disclosure.

[0058] Process 700 begins with operation 702, in which a mold for the electrode set 100 is made. The mold can be made using various processes with various materials. The mold is the shape of the electrode set 100 structure. For example in Figure 1, the mold includes shapes related to the connector 104, alignment marker 110, etc. In one example, the mold is cut from a planar layer of a substrate, such as polyimide. The substrate layer may be an insulating or partially conductive layer on which other materials may be placed. In some examples, the mold comprises a single sheet of material, and in other examples, the mold consists of two or more individual pieces of material. In some examples, the mold may be a multilayer material. It should be noted that operation 702 is not performed first, but may be performed after or before various other operations of process 700.

[0059] Process 700 follows operation 704, in which the wire 302 is plated onto the mold (or substrate, if performed before operation 702). The wire 302 connects individual nodes 102 to the monitoring / input device 200 via measuring leads 106A and 106B. The wire 302 can be formed using various plating or deposition techniques. The wire 302 can be formed from various conductive or semiconducting materials, such as copper, aluminum, gold, silver, and their alloys, but not limited to these. The thickness of the wire 302 can vary, but in some examples it is 0.3–0.5 μm.

[0060] Process 700 follows operation 706, in which node 104 is fixed to the mold. The node may be a pre-formed metal disk of various conductive or semiconducting materials, such as copper, aluminum, gold, silver, and their alloys, but not limited to these.

[0061] Process 700 is followed by operation 708, in which node 104 is fixed to wire 302 via pad reinforcement 406 relating to each node 102. The pad reinforcement 406 may be formed from a variety of materials, including polyimide or other polymers, which provide sufficient structural support for the connection between wire 302 and pad 402.

[0062] Process 700 terminates with operation 710.

[0063] Figure 8 shows a monitoring / input device for use with the systems and methods described herein, relating to some examples of the present disclosure. Figure 8 shows, as an example, the monitoring / input device 200 of Figures 2 and 5. The monitoring / input device 200 may be any computing component capable of communicating on or with a cellular network, an internet multimedia subsystem, and / or an IP network. 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 tablet computers, desktops, servers, and other network-connected devices.

[0064] The monitoring / input device 200 may comprise several components for performing various functions described above. The monitoring / input device 200 may comprise memory containing an operating system (OS) 804 and one or more standard applications 806. The standard applications 806 may comprise applications for controlling various components of the monitoring / input device 200. In this example, the standard applications 806 may also comprise a monitoring application 830 and an imaging application 832. The monitoring application 830 may be instantiated to control the operation of the monitoring / input device 200 for detecting signals emanating from a body. The control may include determining which node receives which signals and storing that data. The imaging application 832 may be instantiated to configure the monitoring / input device 200 to function as an imaging device, thereby energizing one or more nodes to receive electrical energy. For example, once instantiated, the imaging application 832 may cause the monitoring / input device 200 to apply current to one or more nodes, record the potentials of nodes that are not receiving current, and construct an image from the potentials.

[0065] In this method, the monitoring / input device 200 or monitoring service 502 (or other device) defines a subset of nodes 102 to which current is applied. The monitoring / input device 200 then records the potentials at nodes 102 that do not receive current. Optionally, several subsets of nodes 102 with different patterns are successively defined, and the resulting potentials are successively recorded. In other words, the set of nodes 102 is changed, and the application of current is repeated at different nodes 102. The monitoring / input device 200 or monitoring service 502 determines images of parts 202 of the subject's body, for example, by an image reconstruction algorithm. Such a method is suitable for non-invasive imaging such as electrical impedance tomography (EIT) in absolute (a-EIT), time-difference (td-EIT), or multi-frequency (MF-EIT) modes. Various body parts can be imaged using this method, particularly the lungs, muscles, chest, neck, brain, bladder, or limbs. This method can be used, in particular, to image volume changes of body parts under blood flow or perfusion.

[0066] In other examples, one or more of the pads 402 of node 102 may be replaced with other types of electromagnetic energy emitters, such as infrared, visible light, or near-infrared light-emitting diodes (LEDs). In some examples, as described above, node 102 may be an emitter, a sensor, or an emitter / sensor combination. For example, a combined emitter / sensor may be used to acquire a signal in the case of a non-self-emitting physiological signal. A near-infrared emitter may be used in processes such as near-infrared spectroscopy or optical coherence tomography. Standard application 806 may also include one or more functions or operations as described in Figures 1-8 above. In some further examples, one or more of node 102 may be a combined ultrasonic transducer for use in applications such as echocardiography. As used herein, an ultrasonic transducer may be a transmitter, receiver, and / or transceiver.

[0067] The monitoring / input device 200 may also include one or more processors 812, and one or more removable storage 814, non-removable storage 816, transceiver(s) 818, output device(s) 820, and input device(s) 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), or any combination of the two. The memory 802 may be used to store various data received from the electrode set 100 and / or data received from the monitoring service 502 via the network 504.

[0068] Memory 802 may also include OS 804. OS 804 includes modules and software that support basic functions such as task scheduling, application execution, and peripheral device control. In some examples, OS 804 may enable the monitoring application 830, the imaging application 832, and provide other functions as described above via the transceiver(s) 818. OS 804 may also enable the monitoring / input device 200, transmit and retrieve other data, and perform other functions. It should be noted that one or more functions of the subject matter of this disclosure may be performed by a system other than OS 804, such as firmware / FPGA / ASIC.

[0069] The monitoring / input device 200 may also include one or more processors 812. In some implementations, the processor(s) 812 may be, but not limited to, 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). The monitoring / input device 200 may also include additional data storage devices (removable and / or non-removable), such as magnetic disks, optical disks, or tapes. Such additional storage is shown in Figure 8 by removable storage 814 and non-removable storage 816.

[0070] Non-temporary computer-readable media may include volatile and non-volatile, removable and non-removable tangible physical media implemented with technology for storing information, such as computer-readable instructions, data structures, program modules, or other data. Memory 802, removable storage 814, and non-removable storage 816 are all examples of non-temporary computer-readable media. Non-temporary computer-readable media include, but are not limited to, RAM, ROM, electronically erasable programmable ROM (EEPROM), flash memory or other memory technologies, compact disk ROM (CD-ROM), digital versatile disk (DVD) or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other tangible physical media that can be used to store desired information and are accessible by the monitoring / input device 200. Any such non-temporary computer-readable media may be part of the monitoring / input device 200, or may be a separate database, data bank, remote server, or cloud-based server.

[0071] In some implementations, the transceiver(s) 818 includes any transceiver known in the art. In some examples, the transceiver(s) 818 may include a wireless modem(s) to facilitate wireless connectivity with other components (e.g., between the monitoring / input device 200 and the network 504), the internet, and / or an intranet, as well as network adapters and other compatible devices.

[0072] The transceiver(s) 818 may include one or more wireless transceivers that perform the function of sending and receiving radio frequency communications via an antenna (e.g., Wi-Fi or Bluetooth®). In other examples, the transceiver(s) 818 may include wired communication components, such as a wired modem or Ethernet port, for communication over one or more wired networks. The transceiver(s) 818 may enable the monitoring / input device 200 to download files, access web applications, and provide other communications related to the systems and methods described above.

[0073] In some implementations, the output device(s) 820 may include 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. Thus, the output device(s) may include a screen or display. The output device(s) 820 may also include a speaker or similar device for playing sound or ringtones when receiving voice or video calls. The output device(s) 820 may also include ports for one or more peripheral devices, such as headphones, peripheral speakers, or peripheral displays.

[0074] In various implementations, the input device(s) 822 includes any input device known in the art. For example, the input device(s) 822 may include one or more components of the electrode set 100. In other examples, the input device(s) 822 may include a camera, a microphone, or a keyboard / keypad. The input device(s) 822 may include a touch-sensitive display or keyboard to enable the user to input data, make requests and receive responses via a web application (e.g., within a web browser), make voice and video calls, and use standard application 806. For example, the monitoring / input device 200 may be a mobile phone having an input port capable of receiving data from the electrode set 100. The touch-sensitive display or keyboard / keypad may be a standard push-button alphanumeric multi-key keyboard (e.g., a conventional QWERTY keyboard), a virtual control device on a touchscreen, or one or more other types of keys or buttons, and may also include joysticks, wheels, and / or designated navigation buttons.

[0075] The examples in this disclosure are intended to be illustrative and non-limiting in all respects. The scope of this disclosure is indicated by the appended claims rather than the foregoing description, and all modifications that fall under the meaning and scope of equivalents are intended to be incorporated herein.

Claims

1. An electrode set (100), wherein the electrode set (100) is A plurality of nodes (102) comprising a plurality of first nodes (102) and a plurality of second nodes (102), wherein each of the plurality of first nodes (102) is provided with a first pad (402) for receiving electromagnetic energy from a first part of the part under study, and each of the plurality of second nodes (102) is provided with a second pad (402) for receiving electromagnetic energy from a second part of the part under study or for transmitting a signal to the first part of the part under study, A plurality of connectors (104) each connect one of the plurality of first nodes (102) to one of the plurality of second nodes (102), A first wire (302) in the connector (104), wherein the first wire (302) is electrically in communication with the first pad (402) of the first node (102) and extends to the measuring lead (106), A second wire (302) within the connector (104), the second wire (302) is electrically in communication with the second pad (402) of the second node (102) and extends to the measurement lead (106), the measurement lead (106) terminates at the measurement connector (104) inserted into the monitoring / input device, and the second wire (302) is connected to the second wire (302), Equipped with, The electrode set (100) further comprises a plurality of alignment markers (110) each fixed to one of the first node (102) and the second node (102), each of the plurality of alignment markers (110) being removably fixed to a landmark on the subject at the site of study, and configured to transmit a tensile force to either the first node (102) or the second node (102) when the alignment marker (110) is fixed to the landmark. Each of the plurality of connectors (104) is formed from a shape that provides a consistent 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 the tensile force is applied to the first node (102) or the second node (102), and the consistent deformation is such that the first node (102) and the second node (104) are at the location of the body part being measured. 2) To enable the arrangement, the first node (102) and the second node (102) are spaced apart in the direction of the tensile force vector, the first node (102) and the second node (102) are planar in the undeformed state, the first node (102) and the second node (102) are nonplanar in the deformed state, and the length of the connector (104) remains constant from the undeformed state to the deformed state, the electrode set (100).

2. A plurality of third nodes (102), wherein at least a portion of the plurality of third nodes (102) are equipped with third pads (402) for receiving electromagnetic energy from a plurality of third parts of the area under study, A plurality of second connectors (104) connecting at least one of the plurality of third nodes (102) to either the first node (102) or the second node (102), wherein the plurality of second connectors (104) are formed from a shape that, when a tensile force is applied to the at least one alignment marker (110), provides a consistent deformation from a first distance between at least some of the plurality of third nodes (102) to one or more second distances between at least some of the plurality of third nodes (102), wherein in the undeformed state the plurality of third nodes (102) are planar, and in the deformed state the plurality of third nodes (102) are nonplanar, The electrode set according to claim 1, further comprising the following:

3. The electrode set according to claim 2, further comprising a plurality of second alignment markers (110) fixed to one or more of the plurality of third nodes (102), wherein the plurality of second alignment markers (110) are removably fixed to a plurality of second landmarks on the subject at the site of study, and the plurality of second alignment markers (110) are configured to transmit the tensile force to at least a portion of the plurality of third nodes (102) when fixed to the landmarks.

4. The electrode set according to claim 2 or 3, further comprising a fourth node (102), the fourth node (102) comprising a fourth pad (402) for receiving electromagnetic energy generated by electromagnetic transmission from the third pad (402).

5. The electrode set according to any one of claims 2 to 4, wherein at least one third node (102) is configured to receive a sensor.

6. The electrode set according to any one of claims 1 to 5, further comprising a first pad reinforcement (406) fixed to the first node (102), wherein the first pad reinforcement (406) ensures an electrical connection between the first pad (402) and the first wire (302).

7. The electrode set according to any one of claims 1 to 6, wherein the at least one connector (104) comprises a plastic substrate, polyimide, polyethylene, polyetheretherketone (PEEK), or a nonconductive polyester or polymer.

8. The electrode set according to any one of claims 1 to 7, wherein the shape is a sinusoidal shape.

9. The electrode set according to any one of claims 1 to 8, wherein the shape comprises a spiral shape, a double spiral shape, a horseshoe shape, or an angular shape.

10. The electrode set according to any one of claims 1 to 9, wherein the pad (402) is made of a conductive or semiconducting material.

11. The electrode set according to any one of claims 1 to 10, wherein the first pad (402) and / or the second pad (402) comprises copper, aluminum, stainless steel, gold, silver, or an alloy thereof.

12. The electrode set according to any one of claims 1 to 11, wherein the first wire (302) and / or the second wire (302) comprises copper, aluminum, stainless steel, gold, silver, or an alloy thereof.

13. The electrode set according to any one of claims 1 to 12, wherein the first pad (402) comprises a first through hole (408), and the second pad (402) comprises a second through hole (408), and the first through hole (408) and the second through hole (408) are openings that allow injection of a conductive material to enhance electrical contact with the skin.

14. The electrode set according to any one of claims 1 to 13, wherein the electromagnetic energy is near-infrared light, infrared light, or visible light.

15. A method for measuring electrophysiological signals at a site of a subject, wherein the method is: The electrode set (100) according to any one of claims 1 to 14 is placed in close proximity to the area to be measured, The plurality of alignment markers (110) are fixed to a plurality of landmarks on the subject at the site of study, wherein each of the plurality of alignment markers (110) transmits a tensile force in the direction of the force vector to either the first node (102) or the second node (102), each of the plurality of connectors (104) provides a consistent 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), and the first node (102) and the second node (102) are spaced apart in the direction of the force vector to allow the placement of the first node (102) and the second node (102) at the location of the body part to be measured. Connect the measurement lead (106) to the monitoring / input device, The monitoring application is instantiated in the monitoring / input device, and the measurement of electrophysiological signals from the subject's body part is initiated. A method that includes [a certain feature].

16. The method according to claim 15, further comprising injecting a conductive 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 set system (500), - The monitoring / input device is configured to receive electrophysiological signal data received from the first pad or the second pad, the electrode set (100) according to any one of claims 1 to 14, - A monitoring service that communicates with the monitoring / input device in order to receive the electrophysiological signal data or to send commands to the monitoring / input device, A sensor set system (500) equipped with the following.

Images