Electrode Patch and Connection System

Abstract

An electrode patch 100 for monitoring electrical activity generated by a subject is disclosed. The electrode patch includes a plurality of spatially arranged electrodes 102 for contacting an external surface of the subject's skin to sense and measure electrical potentials at the plurality of electrodes 102. The electrode patch 100 further comprises at least one connector portion 104 for connecting to a connector of a connector device. The connector portion 104 is spaced apart from and electrically connected to the electrodes 102. A connector device for connecting to such an electrode patch is also disclosed.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to electrode patches and connection systems, particularly, but not exclusively, to electrode patches suitable for use in monitoring gastrointestinal electrical activity and connection systems for such electrode patches. [Background technology]

[0002] Gastric rhythm disorders underlie or contribute to conditions such as gastroparesis, chronic nausea and vomiting, functional dyspepsia, and gastroesophageal reflux disease (GERD). Gastroparesis is a condition in which the stomach does not empty properly, typically after a meal, resulting in symptoms of early satiety, bloating, pain, nausea, vomiting, and malnutrition, and in severe cases, may be fatal. Medical guidelines suggest that the majority of patients suspected of having gastroparesis should undergo upper gastrointestinal (GI) endoscopy (a video-guided examination of the interior of the stomach). Chronic unexplained nausea and vomiting presents similar symptoms to gastroparesis, but gastric emptying studies are normal. Functional dyspepsia is a condition characterized by "chronic dyspepsia" symptoms that persist for at least several weeks to several months. Functional dyspepsia is further divided into epigastric pain syndrome, characterized by upper abdominal pain or burning, and postprandial distress syndrome, characterized by early satiety and postprandial heaviness. Other symptoms of functional dyspepsia include abdominal distension, nausea, and postprandial pain. While the cause of functional dyspepsia is poorly understood, gastric dysrhythmic activity has been clearly implicated, with some studies showing that up to 60% of adult dyspepsia patients have abnormal gastric electrical activity. Delayed gastric emptying occurs in 25–40% of cases of functional dyspepsia. Upper gastrointestinal endoscopy is a standard diagnostic tool for evaluating patients with dyspepsia and ruling out other pathologies. Delayed gastric emptying also affects an important subpopulation of patients with GERD, where gastric dysrhythmic activity has been implicated. Gastric electrical activity may also become disorganized after gastric surgery, resulting in delayed gastric emptying and / or the symptoms described above.

[0003] Gastrointestinal peristalsis is coordinated by propagating electrical activity called slow waves. GI slow waves are initiated and spread through a network of interstitial cells of Cajal (ICCs), which are connected to the smooth muscle layer of the GI wall. In the human stomach, slow waves originate at pacemaker sites of greater curvature and propagate toward the antrum at a usual frequency of approximately three cycles per minute.

[0004] Electrocardiography (ECG) is a routine diagnostic test for cardiac arrhythmias, using electrodes placed on the skin to record electrical activity in distant organs. Electrogastrography (EGG) involves the assessment of GI electrical activity via a small number of skin electrodes placed on the abdominal surface. EGG has been proposed as a diagnostic test for gastric disorders, but despite research efforts, it has not yet met clinical expectations. The primary reason EGG cannot reliably diagnose gastric dysfunction is that the test relies on measuring frequency and power, whereas modern spatial high-resolution mapping techniques have shown that gastric rhythm disorders often occur at frequencies within the normal range. Therefore, EGG may miss many abnormalities. Recent studies have shown that mapping the spatial pattern of gastric electrical activity is necessary to reliably distinguish and classify gastric electrical abnormalities. EGG is the sum of electrical activity occurring in the stomach and can provide accurate information about the normal or abnormal propagation of individual slow-wave cycles. Another reason for the unreliability of EGG is that the signal strength of GI electrical signals is very low, and noise can be mistaken for a signal. Furthermore, due to the small number of electrodes used, EGG electrodes often do not directly cover the stomach in many patients, meaning that gastric signals are less likely to be acquired.

[0005] Super Quantum Interference Devices (SQUIDs) can be used to measure the magnetic fields associated with GI electrical activity, but they are multi-million dollar devices that must be housed in magnetically shielded rooms, and analysis of the resulting signals is complex and has not yet been reliably achieved. Also, the resolution achieved via SQUIDs may not be optimal.

[0006] Roving electrodes placed in contiguous areas of the gastric mucosa, or a few electrodes placed linearly and attached to a nasogastric tube, can provide some indication of GI dysrhythmic activity, but they may not reliably provide information about the spatial propagation of gastric slow-wave activity and therefore cannot account for abnormal velocity, direction of propagation, or dysrhythmias. Gastric intubation is also a relatively invasive method for measuring gastric dysfunction, which may require sedation or may be poorly tolerated in some patients. Furthermore, these measures can only be performed in the fasting state, and patients often experience symptoms only after eating.

[0007] High-resolution mapping of GI electrical activity by measurements at the serosal surface requires invasive surgical access and is therefore not suitable for clinical use in the majority of patients with gastrointestinal symptoms.

[0008] Inserting a catheter or similar device into a subject's body during minimally invasive surgery or endoscopy can be difficult and often requires a highly skilled medical practitioner to perform the test. Furthermore, such invasive tests can cause discomfort to the subject and expose the subject to the risk of infection or other complications, which is clearly undesirable. Some patients may take a long time to fully recover after undergoing an invasive test. Furthermore, such invasive tests generally require a visit to a hospital, clinic, or similar facility to perform the test, which can be inconvenient and expensive.

[0009] Prior art systems and scientific research papers have attempted to achieve non-invasive monitoring of GI activity, such as by using arrays of skin surface electrodes.

[0010] For example, International Publication No. 2017201538 discloses a device, system, and method for monitoring physiological function from a surface electrophysiological sensor. It discloses a device including an electrophysiological sensor structure including an array of electrodes spatially arranged on a substrate and operable to acquire electrophysiological signals and obtain serial data. It discloses the use of a data processing unit to process spatially resolved time-series data based on the electrophysiological signals to determine wave propagation parameters.

[0011] Similarly, U.S. Patent No. 9,474,482 B2 discloses an apparatus and method for diagnosing motility disorders of the body's gastrointestinal tract, which discloses measuring electrical signals from the GI tract while a patient is engaged in normal daily activities, recording the measured signals transmitted by the body with a portable electronic device, recording one or more symptoms of the body in real time by the patient, and analyzing characteristics of the recorded electrical signals for diagnosing the body's GI disorder.

[0012] However, conventional / known devices do not provide features to enable a simple yet reliable connection between the electrode patch and a connector device, such as a portable electronic device (e.g., a data acquisition device) worn by the user. If the connection mechanism between the electrode patch and such a connector device is unreliable or not adequate / robust, accidental disconnection between the electrode patch and the connector device is likely to occur, defeating the purpose of enabling real-time electrophysiological monitoring. Furthermore, such known devices fail to provide a mechanism to enable the device to be comfortably worn by the subject while the subject engages in normal daily activities. Furthermore, due to its weight, the connector device can easily disconnect / detach from the electrode patch or even fall off the subject's body. This can not only damage the connector device but also cause confusion, frustration, and poor treatment compliance. Conventional devices fail to address this issue.

[0013] Furthermore, to monitor GI electrical activity, due to the small amplitude of the signal, electrodes may need to be placed on the abdominal surface to be close to the gastrointestinal organs of interest. Because the skin on the abdominal surface typically undergoes significant deformation from normal body movement, the electrode patch may need to be embedded in a conformal material that can appropriately deform with the skin. If rigid electrodes or incompatible materials are used, the electrode patch or electrode may peel off from the skin, leading to unreliable signal quality. Conventional / previously known devices cannot or do not adequately address this issue.

[0014] Additionally, distortion of the electrode patch when attached to the connector device can result in connection failure and crosstalk.

[0015] Furthermore, conventional electrode patches do not focus on designs that allow for optimal packaging of the electrode patch's contact pads within a minimal area, which means that conventional electrode patches are bulkier and can be uncomfortable to wear, especially on the abdomen.

[0016] Providing the minimum width of conductors required for screen printing while at the same time providing a suitable physical layout to fit all electrodes with a common connector portion for mating with the connector of a connector device can be difficult, meaning that conventional electrode patches become even bulkier.

[0017] Conventional / previously known connector devices may require cables or wires to connect the electrode patches to the connector device. Cables containing numerous electrodes can be cumbersome to wear, difficult or expensive to manufacture, and are a common point of failure, further reducing the wearability of the electrophysiological monitoring device. [Object of the Invention]

[0018] It is an object of the present invention to provide an electrode patch that overcomes or at least partially ameliorates some of the drawbacks and risks mentioned above, or at least provides people with a useful choice.

[0019] Alternatively or additionally, it is an object of the present invention to provide a connection system for electrode patches that overcomes or at least partially ameliorates some of the above-mentioned disadvantages and risks, or at least provides people with a useful choice. Summary of the Invention

[0020] In a first aspect, the present invention provides an electrode patch for monitoring electrical activity generated by a subject, comprising: a plurality of spatially arranged electrodes for contacting an exterior surface of the subject's skin for sensing and measuring electrical potentials at the plurality of electrodes; and The electrode patch includes at least one connector portion for connecting to a connector of the connector device, the at least one connector portion being spaced apart from the electrodes and electrically connected to the electrodes via electrical conductors extending as conductive tracks between the electrodes.

[0021] In one embodiment, at least one tongue is formed on the electrode patch that extends from the remainder of the electrode patch, and at least one connector portion is disposed on the at least one tongue.

[0022] In some embodiments, at least one tang is flush with the remainder of the electrode patch.

[0023] In some embodiments, the electrode patch is flexible and stretchable.

[0024] In some embodiments, the electrode patch comprises a flexible substrate, and the electrodes are spatially arranged on the flexible substrate.

[0025] In some embodiments, the flexible substrate is stretchable.

[0026] In some embodiments, the flexible substrate comprises or is made of a thermoplastic polyurethane (TPU) film.

[0027] In some embodiments, the at least one connector portion is electrically connected to the electrode via a conductor that extends as a conductive track (or conductive trace) between the electrode and the at least one connector portion.

[0028] In some embodiments, a hydrogel is disposed on top of a flexible substrate.

[0029] In some embodiments, the electrical conductors are disposed on a flexible substrate.

[0030] In some embodiments, at least one connector portion includes a plurality of conductive contact pads.

[0031] In some embodiments, the plurality of conductive contact pads are in a staggered pattern.

[0032] In some embodiments, each of the contact pads is substantially square in shape.

[0033] In some embodiments, the contact pad is electrically connected to the electrode via an electrical conductor.

[0034] In some embodiments, the total number of contact pads in an electrode patch is the same as the total number of electrodes.

[0035] In some embodiments, the total number of contact pads in an electrode patch is the same as the total number of electrodes and the total number of conductors.

[0036] In some embodiments, the total number of contact pads in the electrode patch is greater than the total number of electrodes.

[0037] In some embodiments, the electrode patch includes at least one notch.

[0038] In some embodiments, the at least one notch is disposed in the at least one tang.

[0039] In some embodiments, the at least one cutout is substantially rectangular in shape.

[0040] In some embodiments, the at least one notch is disposed between the two connector portions.

[0041] In some embodiments, the electrode patch includes two connector portions spaced apart from each other and from the electrode.

[0042] In some embodiments, the two connector portions are located on the same side and on the same tongue of the electrode patch.

[0043] In some embodiments, the two connector portions are a first connector portion and a second connector portion, with a fixed number of electrodes electrically connected to the first connector portion and a fixed number of electrodes electrically connected to the second connector portion.

[0044] In some embodiments, half of the fixed number of electrodes are electrically connected to the first connector portion and the other half of the fixed number of electrodes of the electrode patch are electrically connected to the second connector portion.

[0045] In some embodiments, the array of electrodes comprises 64 electrodes arranged in 8 rows and 8 columns.

[0046] In some embodiments, the array of electrodes includes more or less than 64 electrodes.

[0047] In some embodiments, the array of electrodes comprises 32 electrodes.

[0048] In some embodiments, the 32 electrodes are arranged in 8 rows and 4 columns.

[0049] In some embodiments, there are 32 electrodes arranged in 4 rows and 8 columns.

[0050] In some embodiments, the electrode patch is polygonal in shape.

[0051] In some embodiments, the electrode patch includes a primary region, and at least one tongue is formed on the electrode patch extending from the primary region, the at least one tongue being coplanar with the primary region.

[0052] In some embodiments, the primary region is substantially rectangular in shape.

[0053] In some embodiments, the electrodes are disposed in the primary region.

[0054] In some embodiments, the at least one intermediate portion is located between the at least one tongue and the primary region, and the at least one intermediate portion is narrower than the at least one tongue and the primary region.

[0055] In some embodiments, at least one tongue is substantially rectangular in shape.

[0056] In some embodiments, the electrode patch has rounded corners to prevent curling.

[0057] In some embodiments, two tongues are formed in the patch that extend from the remainder of the patch, the two tongues are coplanar with each other and with the remainder of the patch, and the two tongues are a first tongue and a second tongue.

[0058] In some embodiments, the one or more connector portions are disposed on one or both of the first or second tongues.

[0059] In some embodiments, the first tongue and the second tongue are disposed on two opposite sides of the primary region.

[0060] In some embodiments, the first tongue is substantially rectangular in shape.

[0061] In some embodiments, the second tongue is substantially rectangular in shape.

[0062] In some embodiments, at least one intermediate portion is substantially trapezoidal in shape.

[0063] In some embodiments, the electrode patch includes an adhesive to allow the electrode patch to adhere to the outer surface of the subject's skin.

[0064] In some embodiments, the adhesive is disposed on the edges of the electrode patch.

[0065] In some embodiments, adhesive is disposed on the edges of the primary region and on at least one tongue.

[0066] In some embodiments, the adhesive disposed on the at least one tongue is spaced apart from the at least one connecting portion.

[0067] In some embodiments, the adhesive is formed as an adhesive layer.

[0068] In some embodiments, the electrode patch includes a plurality of alignment holes at or near at least one connector portion.

[0069] In some embodiments, the electrode patch includes a plurality of alignment holes surrounding at least one or each of the connector portions.

[0070] In some embodiments, the electrode patch is a disposable electrode patch.

[0071] In some embodiments, the electrode patch is for use in monitoring gastrointestinal electrical activity of a subject.

[0072] In some embodiments, the electrode patch is for use in monitoring the electrical activity of a subject's colon.

[0073] In some embodiments, the subject is a pediatric patient.

[0074] In some embodiments, the electrode patch includes a planar surface, with at least a portion of each of the electrodes, connector portions, and electrical conductors exposed at the planar surface.

[0075] In some embodiments, the flat surface is a surface configured to contact the outer surface of the subject's skin.

[0076] In some embodiments, the plane is a substantially flat surface.

[0077] In some embodiments, the electrode patch is formed as a single sheet of material or substantially as a panel.

[0078] In some embodiments, the electrode patch is polygonal.

[0079] In some embodiments, the electrode patch extends between a first end and a second end opposite the first end, the electrode is positioned closer to the first end than to the second end, and the connector portion is positioned closer to the second end than to the first end.

[0080] In some embodiments, the electrode is spaced from the connector portion by a distance that is at least one-quarter of the total distance between the first end and the second end.

[0081] In some embodiments, Connector part are spaced at a distance of at least 5 cm from each electrode.

[0082] In a second aspect, the invention resides in a connector device including or in the form of first and second clamping members configured to move between a clamping position in which the first and second clamping members are configured to clamp the electrode patch or at least a portion of the electrode patch to enable a physical and operable connection between the connector device and the electrode patch, and a release position in which the first and second clamping members are configured to move away from the clamping position to enable the electrode patch or portion of the electrode patch to be released from the connector device.

[0083] In some embodiments, the first and second clamping members are configured to apply pressure to the electrode patch or a portion of the electrode patch when in the clamped position.

[0084] In some embodiments, in the clamped position, the first clamp member moves toward the second clamp member, and in the released position, the first clamp member moves away from the second clamp member.

[0085] In some embodiments, the first and second clamping members are magnetic clamping members.

[0086] In some embodiments, at least one of the first and second clamping members includes at least one connector configured to be physically and operably connected to the electrode patch or a portion of the electrode patch to receive electrical signals from the plurality of electrodes of the electrode patch and enable monitoring of electrical activity generated by the subject.

[0087] In some embodiments, at least one connector is an array connector or an array connector.

[0088] In some embodiments, at least one connector is one or more interposers.

[0089] In some embodiments, the connector device includes a body having a planar surface configured to receive an electrode patch or a portion of an electrode patch, the body including a first end and a second end opposite each other, a first clamping member attached to the body at or near the first end, and the second clamping member being the body, wherein in a clamped position the first clamping member is configured to move toward the planar surface of the body, and in a released position the first clamping member is configured to move away from the planar surface of the body.

[0090] In some embodiments, the first clamping member is hingedly attached to the body.

[0091] In some embodiments, the first clamping member includes at least one connector.

[0092] In some embodiments, the first clamp member is configured to move between an open position and a closed position, wherein in the open position at least one connector of the first clamp member is exposed to the surroundings and in the closed position at least one connector of the first clamp member is hidden from the surroundings.

[0093] In some embodiments, in the clamped position, the first clamping member is configured to pivotally move toward the plane of the body and at least partially obscure at least a portion of the plane of the body.

[0094] In some embodiments, the connector device includes a body having a planar surface configured to receive an electrode patch or a portion of an electrode patch, the body including a first end and a second end opposite each other, a first clamping member attached to the body at or near the first end and a second clamping member attached to the body at or near the second end, and in a clamped position, the first and second clamping members are each configured to move toward the planar surface, and in a released position, the first and second clamping members are each configured to move away from the planar surface.

[0095] In some embodiments, the first and second clamp members are hingedly attached to the body.

[0096] In some embodiments, the first and second clamping members each include at least one connector.

[0097] In some embodiments, the first and second clamp members are configured to move between an open position and a closed position, wherein in the open position at least one connector of each of the first and second clamp members is exposed to the environment and in the closed position at least one connector of each of the first and second clamp members is hidden from the environment.

[0098] In some embodiments, the connector device comprises at least one alignment mechanism configured to align and / or retain the electrode patch or a portion of the electrode patch on the connector device.

[0099] In some embodiments, the connector device comprises at least one alignment feature configured to align and / or retain the electrode patch or a portion of the electrode patch to the connector device, the at least one alignment feature being disposed on or substantially on a plane between the first end and the second end.

[0100] In some embodiments, the at least one alignment feature is disposed on or substantially on a plane between the first end and the second end.

[0101] In some embodiments, the at least one alignment feature is a protrusion configured to be received by at least one complementary notch formed in the electrode patch.

[0102] In some embodiments, the protrusion is located at or near the center of the first end and the second end.

[0103] In some embodiments, the protrusions are substantially rectangular or cuboid in shape.

[0104] In some embodiments, the protrusion is of sufficient size to prevent at least lateral movement of the electrode patch between the first end and the second end when received by at least one complementary notch formed in the electrode patch.

[0105] In some embodiments, the connector device further includes a plurality of alignment pins configured to be received by complementary alignment holes formed in the electrode patch.

[0106] In some embodiments, the alignment pins are located on one or both sides of the protrusion.

[0107] In some embodiments, there are six alignment pins located on either or each side of the protrusion.

[0108] In some embodiments, in the clamped position, the first clamp member and the second clamp member are both configured to pivotally move towards the plane and at least partially obscure the plane except for the protrusion.

[0109] In some embodiments, in the clamped position, at least a portion of the protrusion is exposed to the surroundings.

[0110] In some embodiments, the portion of the protrusion exposed to the surroundings comprises a display screen.

[0111] In some embodiments, the connector device is a portable electronic device.

[0112] In some embodiments, the connector device is a data acquisition device.

[0113] In some embodiments, the connector device is a data logging device.

[0114] In some embodiments, the connector device is a wearable electronic device, and at least the body, the first clamping member, and the second clamping member together form a housing within which the electronic components of the connector device are at least partially disposed.

[0115] In some embodiments, the connector device is battery powered.

[0116] In some embodiments, the connector device is powered by a lithium ion battery.

[0117] In some embodiments, the electronic device includes electronic circuitry and a memory with instructions stored in the memory, execution of the instructions enabling the electronic device to receive signals from the electrode patches, process the signals, and transmit data to a remote computing device to monitor electrical activity generated by the subject.

[0118] In some embodiments, the connector device includes at least one analog-to-digital converter for amplifying and digitizing the biopotential measurement signals received from the electrode patches.

[0119] In some embodiments, the at least one analog-to-digital converter is an analog-to-digital converter chip.

[0120] In some embodiments, the connector device includes a microcontroller configured to receive signals from the analog-to-digital converter, process the signals, and transmit data to a remote computing device so that electrical activity generated by the subject can be monitored.

[0121] In some embodiments, the at least one analog-to-digital converter may be electrically connected to the microcontroller by a flexible cable.

[0122] In some embodiments, the electronic device further includes flash memory, a near field communication (NFC) module, and / or charging circuitry.

[0123] In some embodiments, the connector device is part of a connector system that includes a docking device having a connector device-receiving compartment configured to receive the connector device.

[0124] In some embodiments, the docking device is a wireless charging device for facilitating wireless charging of the connector device when the connector device is received within the connector device receiving compartment.

[0125] In some embodiments, the electrode patch is part of a connector system.

[0126] In some embodiments, the connector device comprises a biasing member configured to bias at least one of the first and second clamping members to move towards the electrode patch.

[0127] In some embodiments, the biasing member is a leaf spring.

[0128] In a third aspect, the present invention provides a method for producing a medicament for the treatment of a pulmonary arthritis, comprising: a body extending from a first end to a second end, the second end being opposite the first end, the body having a top surface and a bottom surface, the top surface configured to receive an electrode patch or at least a portion of an electrode patch having a plurality of electrodes for use in monitoring electrical activity generated by a subject; at least one clamping member attached to the body; the at least one clamp member is configured to move between an open position and a closed position, wherein in the open position the at least one clamp member is configured to move away from the top surface to at least partially expose the top surface, and in the closed position the at least one clamp member is configured to move towards the top surface to at least partially conceal the top surface; The at least one clamping member is in a connector device including at least one connector configured to be physically and operably connected to an electrode patch or a portion of an electrode patch to receive electrical signals from the plurality of electrodes and enable monitoring of electrical activity generated by the subject.

[0129] In some embodiments, the at least one clamping member is hingedly attached to the body.

[0130] In some embodiments, both the first and second clamping members include at least one connector.

[0131] In some embodiments, the at least one clamp member is configured to move between an open position and a closed position, wherein in the open position at least one connector of the at least one clamp member is exposed to the environment and in the closed position at least one connector of the at least one clamp member is hidden from the environment.

[0132] In some embodiments, at least one connector is an array connector or an array connector.

[0133] In some embodiments, at least one connector is one or more interposers.

[0134] In some embodiments, in the closed position, the at least one clamp member is configured to pivotally move toward the top surface and at least partially obscure the top surface.

[0135] In some embodiments, the connector device is a wearable electronic device, wherein at least the body and the at least one clamping member together form a housing within which the electronic components of the connector device are at least partially disposed.

[0136] In some embodiments, the connector device comprises at least one alignment mechanism configured to align and / or retain the electrode patch or a portion of the electrode patch on the upper surface.

[0137] In some embodiments, the at least one alignment feature is located on or substantially on the top surface.

[0138] In some embodiments, the at least one alignment feature is a protrusion configured to be received by at least one complementary notch formed in the electrode patch.

[0139] In some embodiments, the protrusion is located at or near the center of the first end and the second end.

[0140] In some embodiments, the protrusions are substantially rectangular or cuboid in shape.

[0141] In some embodiments, the protrusion is of sufficient size to prevent at least lateral movement of the electrode patch between the first end and the second end when received by at least one complementary notch formed in the electrode patch.

[0142] In some embodiments, the connector device further includes a plurality of alignment pins configured to be received by complementary alignment holes formed in the electrode patch.

[0143] In some embodiments, the alignment pins are located on one or both sides of the protrusion.

[0144] In some embodiments, there are six alignment pins located on either side of the protrusion.

[0145] In some embodiments, in the closed position, the at least one clamp member is configured to pivotally move toward the top surface and at least partially obscure the top surface except for the protrusion.

[0146] In some embodiments, at least two clamp members are attached to the body, the at least two clamp members being a first clamp member and a second clamp member.

[0147] In some embodiments, the first and second clamp members are configured to move between an open position and a closed position, and when in the open position, the first clamp member and the second clamp member both move toward the top surface and at least partially obscure the top surface; At least one of the first and second clamping members includes at least one connector configured to be physically and operably connected to an electrode patch or a portion of an electrode patch to receive electrical signals from the plurality of electrodes and enable monitoring of electrical activity generated by the subject.

[0148] In some embodiments, the first and second clamp members are configured to move between an open position and a closed position, wherein in the open position at least one connector of each of the first and second clamp members is exposed to the environment and in the closed position at least one connector of each of the first and second clamp members is hidden from the environment.

[0149] In some embodiments, the at least one alignment feature is located on or substantially on the top surface between the first end and the second end.

[0150] In some embodiments, in the closed position, both the first clamp member and the second clamp member are configured to pivotally move toward the top surface and at least partially obscure the top surface except for the protrusion.

[0151] In some embodiments, the connector device is a wearable electronic device, and at least the body, the first clamping member, and the second clamping member together form a housing within which the electronic components of the connector device are at least partially disposed.

[0152] In some embodiments, the connector device is battery powered.

[0153] In some embodiments, the connector device is powered by a lithium ion battery.

[0154] In some embodiments, the connector device includes electronic circuitry and a memory with instructions stored in the memory, execution of the instructions causing the electronic device to receive signals from the electrode patches, process the signals, and transmit data to a remote computing device to monitor electrical activity generated by the subject.

[0155] In some embodiments, the connector device is a data acquisition device.

[0156] In some embodiments, the connector device is a data logging device.

[0157] In some embodiments, the connector device is part of a connector system that includes a docking device having a compartment configured to receive the connector device.

[0158] In some embodiments, the docking device is a wireless or contact charging device for facilitating wireless or contact charging of the connector device when the connector device is received within the connector device receiving compartment.

[0159] In some embodiments, the connector device includes at least one analog-to-digital converter for amplifying and digitizing the biopotential measurement signals received from the electrode patches.

[0160] In some embodiments, the at least one analog-to-digital converter is an analog-to-digital converter chip.

[0161] In some embodiments, the connector device includes a microcontroller configured to receive signals from the analog-to-digital converter, process the signals, and transmit data to a remote computing device so that electrical activity generated by the subject can be monitored.

[0162] In some embodiments, the at least one analog-to-digital converter may be electrically connected to the microcontroller by a flexible cable.

[0163] In some embodiments, the electronic component further includes flash memory, a near field communication (NFC) module, and / or charging circuitry.

[0164] In some embodiments, the electrode patch is part of a connector system.

[0165] In some embodiments, the electrode patch is as defined in the first aspect.

[0166] In a fourth aspect, the present invention provides a system for monitoring electrical activity generated by a subject, comprising: an electrode patch including spatially arranged electrodes for contacting an external surface of a subject's skin for sensing and measuring electrical potentials at a plurality of electrodes, the electrodes being routed to at least one connector portion spaced apart from the electrodes and electrically connected to the electrodes via electrical conductors extending as conductive tracks between the electrodes and the at least one connector portion; and a connector device having at least one connector configured to be physically and operably connected to an electrode patch or a portion of an electrode patch at at least one connector portion to receive electrical signals from the plurality of electrodes and enable monitoring of electrical activity generated by the subject.

[0167] In some embodiments, the connector device is an electronic device.

[0168] In some embodiments, the connector device includes electronic circuitry and a memory with instructions stored in the memory, execution of the instructions causing the electronic device to receive signals from the electrode patches, process the signals, and transmit data to a remote computing device to monitor electrical activity generated by the subject.

[0169] In some embodiments, the connector device is a data acquisition device.

[0170] In some embodiments, the connector device is a data logging device.

[0171] In some embodiments, the system further includes a docking device having a compartment configured to receive the connector device.

[0172] In some embodiments, the electrode patch is as defined in the first aspect.

[0173] In some embodiments the connector device is as defined in the second or third aspect.

[0174] In some embodiments, the system is for monitoring gastrointestinal electrical activity.

[0175] In some embodiments, the electrode patch is as defined in the first aspect.

[0176] In a fifth aspect, the invention broadly resides in a method of connecting an electrode patch to a connector device, the method comprising: Preparing an electrode patch; providing a connector device having first and second clamping members configured to clamp the electrode patch or at least a portion of the electrode patch; The method includes moving the first and second clamping members between a clamping position, in which the first and second clamping members are configured to clamp the electrode patch or portion of the electrode patch to enable a physical and operable connection between the connector device and the electrode patch or portion of the electrode patch, and a release position, in which the first and second clamping members are moved from the clamping position away from the electrode patch or portion of the electrode patch and are configured to be released from the connector device.

[0177] In some embodiments, the electrode patch includes at least one notch and the connector device includes at least one complementary protrusion configured to be received by the notch, and the method further comprises: placing the electrode patch or a portion of the electrode patch onto the connector device while in the released position such that the at least one protrusion is received by the at least one notch; and Further comprising moving the first and second clamping members from a release position to a clamping position.

[0178] In some embodiments, the electrode patch includes a plurality of alignment holes, and the connector device includes a plurality of complementary alignment pins configured to be received by the alignment holes, and the method further comprises: placing the electrode patch or a portion of the electrode patch on the connector device while in the released position such that the plurality of alignment pins are received by the plurality of alignment holes; and Further comprising moving the first and second clamping members from a release position to a clamping position.

[0179] In some embodiments, the electrode patch is as defined in the first aspect.

[0180] In some embodiments the connector device is as defined in the second or third aspect.

[0181] Other aspects of the present invention will become apparent from the following detailed description, given by way of example only and with reference to the accompanying drawings, in which:

[0182] References herein to patents, other external documents, or other sources of information are generally for the purpose of providing a context for discussing features of the present invention. Unless otherwise expressly stated, the reference to such external documents shall not be construed as an admission that such documents or such sources are prior art or form part of the common general knowledge in the art in any jurisdiction.

[0183] In the following detailed description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives refer to the present invention as oriented in the drawings. It should be understood, however, that the present invention may assume various alternative forms, unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following detailed description are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0184] It is recognized that the term "comprise" can be ascribed either an exclusive or an inclusive meaning in various jurisdictions. For purposes of this specification, unless otherwise specified, the term "comprise" shall have an inclusive meaning, allowing for the inclusion of not only the listed components or elements but also other unspecified components or elements. The terms "comprises" or "comprised" or "comprising" have similar meanings when used in connection with a system, or one or more steps of a method or process.

[0185] As used herein, the term "and / or" means "and" or "or," or both.

[0186] As used herein and elsewhere in this specification, "(s)" following a noun refers to the plural and / or singular form of the noun.

[0187] When used in the claims, unless otherwise expressly stated, the word "for" should be construed to mean only "suitable for," and not, for example, specifically "adapted" or "configured" for a particular stated purpose.

[0188] Preferred embodiments of the present invention will now be described, by way of example only, with reference to the drawings in which: [Brief explanation of the drawings]

[0189] [Figure 1] 1 is an example / embodiment of an electrode patch according to a first preferred embodiment of the present invention. [Figure 2] 2 shows the connector portion of the electrode patch of FIG. 1. [Figure 3] 2 shows an example of a connector that can be used for connecting the electrode patch of FIG. 1. [Figure 4]4 shows a cross-sectional view of the connector of FIG. 3. [Figure 5] 2 shows an example / embodiment of a connector device according to a first preferred embodiment of the present invention configured to be connected to the electrode patch of FIG. 1; [Figure 6] 10 is an example / embodiment of a connector device according to a second preferred embodiment of the present invention. [Figure 7] FIG. 7 is an exploded view of the connector device of FIG. 6. [Figure 8] An example of an electrode patch hole arranged in the connector portion of the electrode patch in Figure 1 is shown. [Figure 9] 1 shows an example / embodiment of an electrode patch according to a second preferred embodiment of the present invention, the connector of the connector device is also shown. [Figure 10] 10 shows an example of a connector portion of the electrode patch of FIG. 9, also showing the electrical conductors connected to the connector portion. [Figure 11] 10 shows an example of a connector portion of the electrode patch of FIG. 9, also showing the electrical conductors connected to the connector portion. [Figure 12] 13 illustrates an example / embodiment of a connector device according to a third preferred embodiment in a clamped position. [Figure 13] 12 shows an example of a connector that can be used to connect to the connector portion of FIGS. 10 and 11. [Figure 14] 10 and 11. An example of how the connector of FIG. 13 can be used to connect to the connector portions of FIGS. [Figure 15] 10 shows an example / embodiment of a connector device according to a fourth preferred embodiment of the present invention; [Figure 16] 12 shows a plan view of another example of a connector that can be used to connect to the connector portion of FIGS. 10 and 11. FIG. [Figure 17] FIG. 17 shows a perspective view of the connector of FIG. 16. [Figure 18] FIG. 17 shows a side view of the connector of FIG. 16. [Figure 19] 10 shows an example of a connector portion of the electrode patch of FIG. 9, also showing the electrical conductors connected to the connector portion. [Figure 20]10A-10C show examples / embodiments of an electrode patch according to a third preferred embodiment of the present invention, and a schematic diagram of a connector device is also shown. [Figure 21] 16 shows an example / embodiment of the connector portion of the electrode patch of FIG. 15. [Figure 22] 10 is an example / embodiment of an electrode patch according to a fourth preferred embodiment of the present invention, also showing a schematic diagram of a connector device. [Figure 23] 13 illustrates an example / embodiment of a connector device according to a fifth preferred embodiment in an open / release position; [Figure 24] 24 shows the example / embodiment of the connector of FIG. 23 in an open / release position. [Figure 25] We will now explain how the connector device of FIG. 23 can be placed in a docking device and used to connect to an electrode patch. [Figure 26] We will now explain how the connector device of FIG. 23 can be placed in a docking device and used to connect to an electrode patch. [Figure 27] We will now explain how the connector device of FIG. 23 can be placed in a docking device and used to connect to an electrode patch. [Figure 28] We will now explain how the connector device of FIG. 23 can be placed in a docking device and used to connect to an electrode patch. [Figure 29] We will now explain how the connector device of FIG. 23 can be placed in a docking device and used to connect to an electrode patch. [Figure 30] We will now explain how the connector device of FIG. 23 can be placed in a docking device and used to connect to an electrode patch. [Figure 31]13 illustrates an example / embodiment of a connector device according to a sixth preferred embodiment in an open / release position; [Figure 32] 10 shows an example / embodiment of a connector device according to a seventh preferred embodiment in an open / release position, and an electrode patch according to a further preferred example / embodiment of the present invention. [Figure 33] 13 shows an example / embodiment of a connector device according to an eighth preferred embodiment in an open / release position.An electrode patch according to a further preferred example / embodiment of the present invention is also shown. [Figure 34] 10 shows an electrode patch according to a fifth preferred embodiment of the present invention. [Figure 35] 36 shows the electrode patch of FIG. 35 about to engage with the connector device of FIG. 23 positioned in a docking device. [Figure 36] 36 shows the electrode patch of FIG. 35 engaging with the connector device of FIG. 23 placed in a docking device with the connector device of FIG. 23 in an open / release position. [Figure 37] 36 illustrates an example / embodiment of an electrode patch of the connector device of FIG. 35 engaging with the connector device of FIG. 23 with the connector device of FIG. 23 in a closed / clamped position. [Figure 38] Fig. 13 illustrates an example / embodiment of a connector device according to the ninth preferred embodiment, in an open / release position. [Figure 39] 13 illustrates an example / embodiment of a connector device according to the ninth preferred embodiment in a closed / clamped position. [Figure 40] 38 shows an example / embodiment of an electrode patch according to a further preferred example / embodiment about to engage with the connector device of FIG. 37 disposed on a docking device. DETAILED DESCRIPTION OF THE INVENTION

[0190] Conventional medical devices for monitoring electrical activity can use a sensing device that includes an electrode patch and a connector device, which can be an electronic device such as a data acquisition device in electronic communication with the electrode patch. However, such conventional devices do not focus on the coupling mechanism between the electrode patch and the connector device to ensure that the connection between the two is reliable and appropriate. If such a connection is not appropriate, accidental disconnection between the connector device and the electrode patch is likely to occur, in which case real-time monitoring of physiological / electrical activity cannot be performed. Furthermore, due to its weight, the connector device can easily become detached from the electrode patch and fall off the subject's body, not only damaging the connector device but also causing confusion, frustration, and poor compliance. Therefore, it is desirable to provide an electrode patch connection system that enables a simple yet reliable coupling between an electrode patch and a connector device that a subject may wear. It is also desirable to provide an electrode patch connection system for a non-invasive medical device that a subject can wear to monitor physiological conditions in a comfortable and reliable manner while the subject is engaged in normal daily activities. It is also desirable to provide an electrode patch connection system that is easy to set up and use by new patients who have little or no experience using any system for monitoring physiological function. It would further be desirable to provide an electrode patch connection system that does not require a cable for connection between the electrode patch and the connector of the connector device.

[0191] It is also desirable to have electrode patches that do not distort when connected to a connector device, which can result in connection failure or crosstalk.

[0192] It is also desirable to have an electrode patch designed such that the contact pads of the electrode patch can be optimally packaged within a minimal area, so that a less bulky and more comfortable electrode patch design, particularly in the abdominal region, can be achieved.

[0193] It is also desirable to have an electrode patch that is simple in design and cost-effective to manufacture by screen printing.

[0194] It is also desirable to have an electrode patch that requires little or no wires during use, such that there are no or few tangles or wires.

[0195] It is also desirable to have an electrode patch that feels comfortable to the subject when connected to the external surface of the subject's skin during use.

[0196] It is also desirable to have a connector device and electrode patch assembly that does not easily become detached when connected to the external surface of the patient / subject's skin.

[0197] Reference is now made to the accompanying drawings, in which FIG. 1 shows an example of an electrode patch 100 according to one preferred embodiment of the present invention.

[0198] The electrode patch 100 is configured for use as part of a system for monitoring the physiological function of a subject. The subject is preferably a human, but optionally the subject can be a non-human animal. Most preferably, the electrode patch 100 is configured for use as part of a system for monitoring gastrointestinal (GI) electrical activity of a subject. In some embodiments, the electrode patch 100 can be configured to monitor electrical / physiological activity in other regions of the subject, such as, but not limited to, the colon region, and / or the heart or other smooth muscle systems, such as the uterus or bladder, or to monitor brain signals (EEG) or skeletal muscle signals (EMG).

[0199] The electrode patch 100 is essentially a sensing device comprising multiple spatially-spaced surface electrophysiological sensors in the form of electrodes for contacting the external surface of a subject's skin to sense and measure electrical potentials at the multiple electrodes. In the example shown in FIG. 1, there are a total of 66 electrodes, 64 of which are arranged in an 8-by-8 array, with the remaining two electrodes 102a and 102b serving as a ground and reference electrode. The electrical potential in use can be measured as the difference between each of the 64 electrodes and the reference electrode 102a. The ground electrode 102a may be the "drive right leg" or "bias" electrode. The purpose of the ground electrode 102a is to maintain voltage levels on the subject's body within acceptable limits and minimize any common-mode interference (e.g., 50 / 60 Hz power line noise) on the subject's body. The driven right leg acts as a source or sink as necessary (within reason) to achieve this. However, the electrode patch 100 may include more or fewer than 66 electrodes. The ground and reference electrodes 102a, 102b may differ from those shown in FIG.

[0200] Preferably, electrode patch 100 is removably attached to the outer surface of the subject's skin, most preferably at or near the abdominal region, so that electrodes 102, 102a, 102b can contact the outer surface of the subject's skin at or near the abdominal region to sense and measure electrical signals from the subject's gastrointestinal tract. If electrode patch 100 is intended for sensing and measuring electrical signals from other regions, the electrode patch may be configured to be removably attached to the outer surface of the subject's skin at or near the appropriate region, so that electrodes 102, 102a, 102b can contact the outer surface of the subject's skin at or near such region to sense and measure electrical signals from that region of the subject's body. This may include the colon region.

[0201] The electrode patch 100 can be made of a flexible and stretchable material. The electrode patch 100 can include a flexible substrate, and the electrodes can be spatially arranged on the flexible substrate. The flexible substrate can also be stretchable. Being flexible and stretchable allows the electrode patch 100 to properly adhere to the subject's skin, which can result in improved electrode impedance. To monitor electrical activity, such as GI electrical activity, electrodes may need to be placed on the abdominal surface as close as possible to the subject's gastrointestinal organs due to low signal amplitude. Because the subject's skin on the abdominal surface generally undergoes large deformation from normal body movement, electrodes spatially arranged on a conformal / flexible substrate can properly deform with the subject's skin, thereby reducing the likelihood of detachment from the subject's skin. Reducing the likelihood of detachment from the subject's skin also minimizes the likelihood of unreliable signal quality.

[0202] The flexible substrate may include or be made from a thermoplastic polyurethane (TPU) film, which may be a thin adhesive film / layer. A hydrogel may be placed on the flexible substrate to improve the conduction of biological signals.

[0203] As shown in FIG. 1 , the electrode patch can include at least one connector portion 104. The connector portion 104 can be spaced a distance from the electrodes 102, 102a, and 102b. The connector portion 104 can be separate from any of the electrodes 102, 102a, and 102b. The connector portion 104 can be spaced apart from a primary region P of the electrode patch that includes the electrodes 102, 102a, and 102b, and the connector portion 104 is electrically connected to the electrodes 102, 102a, and 102b. As shown, the primary region P can be substantially rectangular. Alternatively, the primary region P can be any other suitable polygonal shape. In certain embodiments, the primary region P can be circular in shape. As shown, the electrode patch 100 can extend between a first end and a second end opposite the first end. The electrodes 102, 102a, 102b may be positioned more proximal to the first end than to the second end, and the connector portion may be positioned more proximal to the second end than to the first end. In certain embodiments, the electrodes 102, 102a, 102b may be spaced from the connector portion 104 by a distance that is at least one-quarter of the total distance between the first and second ends. The electrode patch 100 may be spaced at least five centimeters from each of the electrodes 102, 102a, 102b.

[0204] By positioning connector portion 104 a distance away from the electrodes, any connector device attached to connector portion 104 can also be positioned away from the electrodes, which can minimize interference with the electrodes and / or contact between electrodes 102, 102a, 102b and the outer surface of the subject's skin during any physical interaction with the connector device and / or at connector portion 104.

[0205] The electrode patch 100 may include / have a flat surface, and at least a portion of each of the electrodes 102, 102a, 102b, the connector portion 104, and the electrical conductor 106 may be exposed at the flat surface. The flat surface may be a surface configured to contact the outer surface of a subject's skin. The flat surface may be a substantially flat surface. The electrode patch 100 may be formed as a single sheet of material or as a substantially panel. Such a flat surface arrangement enhances comfort and provides better adhesion to the subject's skin during use, as there is no bulge in the skin-contacting area of ​​the electrode patch, and no components of the electrode patch 100 protrude from the skin-contacting area of ​​the electrode patch. At least one tongue 103 may be formed on the electrode patch 100 that extends from the remainder of the electrode patch 100. However, the tongue 103 may be flush with the remainder of the electrode patch 100. The connector portion 104 may be located within the tongue 103. However, in one embodiment, it may be located near / proximal to the tongue. Having the connector portion 104 on the tongue 103, which is narrower than the primary region, facilitates easier and better connection between the electrode patches 100. This also means that a smaller connector device can be used to connect to the connector portion 104 of the electrode patch 100 and clamp the electrode patch, as opposed to a larger connector device that would be required if the connector portion 104 were located on an otherwise larger region of the electrode patch 100. Thus, by locating the tongue 103 and connector portion 104 on the tongue, the volume and potentially the weight of the overall device (i.e., the device including the connector device and the electrode patch) worn by a subject during use is reduced. As shown, an intermediate region I can be formed between the primary region P and the tongue 103. The intermediate region I can be substantially trapezoidal in shape.

[0206] As shown, the electrode patch 100 may include a second tongue 105, on which the ground and reference electrodes 102a, 102b may be disposed. As shown, the end of the tongue 103 furthest (most distal) from the electrode 102 (and further from the primary region P) is formed as a C-shaped portion 107. As shown, a notch 109 may be disposed between the electrode 102 and the connector portion 104. As shown, the second tongue 105 may be substantially rectangular in shape.

[0207] The connector portion 104 can be disposed on a flexible substrate. As shown in FIG. 1 , the connector portion 104 can be electrically connected to the electrodes 102, 102A, 102B via a conductor 106 that extends as a conductive track (also called a conductive trace) between the electrode 102 and the connector portion 104, and the conductor 106 can be a conductive track. In one embodiment, it can be a wire. The conductive track has advantages over less preferred embodiments that may use wires. For example, using a conductive track rather than a wire can achieve mass production at lower cost. Furthermore, the conductive track produces less electrical noise compared to a wire. Furthermore, while a wire can move and easily become tangled or dislodged, the conductive track is fixed to the electrode patch and is therefore not subject to such unwanted movement or tangling. Therefore, the conductive track increases the reliability of the electrode patch's performance. Furthermore, using a conductive track as opposed to a wire can avoid bulges or similar on the surface of the electrode patch configured to contact the subject's outer skin, thereby providing comfort during use. The electrical conductors 106 may be disposed on a flexible substrate.

[0208] As shown in FIG. 2, the connector portion 104 may include a plurality of conductive contact pads 108. The contact pads 108 may be disposed on a flexible substrate. The contact pads 108 may be electrically connected to the electrodes via electrical conductors 106. As shown in FIG. 1, the electrical conductors 106 may extend as conductive tracks between the electrodes 102 and the contact pads 108.

[0209] In the electrode patch 100, the total number of contact pads 108 can be the same as the total number of electrodes 102. In the example shown in FIG. 1, there are 66 electrodes and 66 contact pads 108 in the electrode patch 108. The electrodes 102 and contact pads 108 can be connected such that one electrode is electrically connected to only one contact pad and no two electrodes are electrically connected to the same contact pad. As shown in FIG. 1, both the reference and ground electrodes 102a, 102b can be separate from the array of electrodes 102.

[0210] In some embodiments, the total number of contact pads 108 may be greater than the total number of electrodes 102. Having such additional / spare contact pads can be advantageous because they can be used for multiple purposes. As an example, the spare contact pads may be used to detect the version or model of a connector device used with the electrode patch. For example, if the spare contact pads connect to a connector of the contact device when such connection is not expected, it may indicate to the user that an incorrect version or model of the connector device is being used. Similarly, if the spare contact pads do not connect to a connector of the contact device when such connection is expected, it may indicate to the user that an incorrect version or model of the connector device is being used. The user may receive an error message or other mechanism that may trigger them to use the correct version of the connector device.

[0211] Each of the electrodes 102, 102A, 102B and the contact pad 108 may be electrically connected using the electrical conductors 106 such that one electrode is electrically connected to only one electrical contact pad 108 using only one electrical conductor, and no electrical conductor is electrically connected to multiple pairs of electrodes and contact pads that are electrically connected to each other.

[0212] In the patch, the total number of conductors 106 is the same as the total number of electrodes 102, 102a, 102b. As shown in Figure 1, there are 66 conductors 106 in the patch 100.

[0213] The electrodes 102, 102a, 102b may be Ag-AgCl electrodes.

[0214] Each of the electrodes 102, 102a, 102b may be at least 2 cm apart. The maximum length of the patch is 21 cm. The maximum width of the patch may be 16 cm. In certain embodiments, the width of the patch may be greater or less than 21 cm.

[0215] The electrode patch 100 may include an adhesive, which may be formed as an adhesive layer. The electrode patch 100 may be a disposable peel-and-stick patch. As shown, the corners of the electrode patch 100 may be rounded to prevent curling.

[0216] The electrode patch 100 can be mass-produced using screen printing. In the patch design of FIG. 1, one of the major challenges is providing the minimum width of the conductors 106 required for screen printing while also providing a proper physical layout to accommodate all of the electrodes. As an example, all 66 electrodes meet at the connector portion 104 for mating with the connector of a connector device. Each contact pad 108 also requires a specific flat surface area to operate effectively and reliably. The electrode patch 100 of the present invention can achieve this by arranging the groups of contact pads 108 in a staggered format / pattern, as shown in FIG. 2. Preferably, each of the contact pads 108 is square in shape, as shown, to maximize the x / y tolerance required to make electrical contact with the connector device. Alternatively, the contact pads 108 can be rectangular in shape. As shown in FIG. 1, the conductors 106 on the electrode patch 100 meet the contact pads 108 at staggered spacing intervals, allowing them to move / extend in a curved line. This configuration allows for optimal packaging of the contact pads 108 within a minimum area. Such a configuration also allows the connector portion 104 to effectively and efficiently connect with the connector 150 of a connector device, such as the connector device 600 shown in FIG.

[0217] An example of a connector 150 that can be used to electrically connect with the contact pads 108 of the electrode patch 100 is shown in FIG. 3. The connector 150 may include a plurality of conductive contact pins 152 configured to electrically connect to the contact pads 108 of the connector portion 104 during use. The connector 150 may be an interposer or an array connector, and the contact pins 152 may be in the form of solder balls, as shown in FIG. 4. Such a connector 150 may function by compression and require a cumulative contact force that may increase with the number of contact pins 152 used. By using such a connector 150, a cable may not be required to connect the connector portion 104 (and, consequently, the electrodes) to a connector device, such as the connector device 500 described below with reference to FIG. 5. One example of a connector 150 that can be used is a 1.0 mm ultra-low power microarray connector. An example of such a connector is disclosed at https: / / www.samtec.com / products / za8, which is incorporated herein by reference in its entirety. By using a connector such as connector 150, no cables / wires are required to electrically connect connector 150 and electrode patch 100.

[0218] FIG. 5 illustrates one embodiment of a connector device 500 for clamping the electrode patch 100, or at least a portion thereof. Such a clamp may apply pressure to the electrode patch or a portion thereof when in a clamped position. As shown, the connector device 500 may be in the form of two separate connecting or clamping members: a first clamping member 510, which in this example is the lower clamping member, and a second clamping member 520, which in this example is the upper clamping member. The first clamping member 510 and the second clamping member 520 are configured to clamp the electrode patch 100, more specifically, the connector portion 140 of the electrode patch, between them. In this example, the first and second clamping members 510, 520 are shown to be two separate elements, and the two clamping members 510 and 520 are preferably connected by a flexible printed circuit board 515. As shown in FIG. 2 , the connector portion 104 of the electrode patch 100 may include holes 110 a, 110 b, and 110 c (hereinafter referred to as electrode patch holes 110 a, 110 b, and 110 c). The holes 110 a, 110 b, and 110 c may be macro-holes. The first clamp member 510 and the second clamp member 520 may be attached via the electrode patch holes 110 a, 110 b, and 110 c using magnetic coupling. The number, size, and / or configuration of the electrode patch holes 110 a, 110 c, and 110 c may differ from that shown in FIG. 2 . The electrode patch holes 110 a, 110 b, and 110 c may also function as alignment holes for aligning the connector portion 104 of the patch with the connector 150. For example, the connector device 500 may have alignment pins configured to be received by the electrode patch holes 110a, 110b, 110c to ensure that the connecting portion 104 is properly aligned and connected to the connector 150.

[0219] Figure 6 shows another preferred embodiment of a connector device 600 for connecting to the connector portion 104 of the electrode patch 100, and Figure 7 is an exploded view of the connector device 600 of Figure 6. As shown in Figures 6 and 7, the connector device 600 comprises a first clamping member 610 and a second clamping member 620. The first clamping member 610 and the second clamping member 620 are configured to clamp the electrode patch 100, and more specifically, the connector portion 104 of the electrode patch 100 therebetween.

[0220] As shown, the first clamping member 610 is a bottom / lower clamping member configured to clamp the connector portion 104 of the electrode patch 100 from below when the first and second clamping members 610, 620 are secured together in a clamped position.

[0221] The first clamp member 110 includes a first clamp plate 611, a connector 650, and a foam layer 612. As shown, the first clamp member plate 611 may be elongated extending longitudinally from a first end 611a and a second end 611b and has a lower surface 611c and an upper surface 611d. The foam layer 612 is disposed on the lower surface 611c and configured to contact the outer surface of the subject's skin during use. The upper surface 611d may include a first stud 614a at or near the first end 611a and a second stud 614b at or near the second end 611b. The studs 614a and 614b may be threaded. A plurality of dowels 615a, 615b, and 615c may be disposed on the upper surface 611d between the first and second studs 614a and 614b. Dowels 615a, 615b, and 615c may be smaller in size (preferably length, diameter, and / or height) compared to studs 614a and 614b. Multiple connector fixation pins 616a and 616b may be positioned adjacent to the dowels. In this example, there are two connector fixation pins 616a and 616b positioned adjacent to dowels 615a and 615b. Connector fixation pin 616a is positioned adjacent to dowel 615a, and connector fixation pin 616b is positioned adjacent to dowel 615b. No connector fixation pin may be positioned adjacent to intermediate dowel 615c. In one embodiment (not shown), a connector fixation pin may optionally be positioned adjacent to dowel 615c.

[0222] As shown, the connector 650 is disposed on the upper surface 611 d of the first clamp member 610. More specifically, the connector 650 is disposed on the upper surface 611 d of the first clamp plate 611 with the contact pins 652 of the connector 650 facing upward, i.e., toward the second clamp member 620. The connector 650 may be an array connector. The connector 650 may be an interposer. As shown, the connector 650 may include a plurality of dowel-receiving connector holes 653 a, 653 b, and 653 c for receiving dowels. As shown in FIG. 6 , the dowel-receiving connector holes 653 a, 653 b, and 653 c can receive the dowels 615 a, 615 b, and 615 c, respectively. The connector 650 may include locking pin-receiving holes 654 a and 654 b for receiving the connector locking pins 616 a and 616 b. The fixation pin receiving holes 654a and 654b can receive connector fixation pins 616a, 616b, respectively, as shown.

[0223] Connector 650 may be similar to connector 150, as described above with reference to Figures 3 and 4. It may be appreciated that first clamping member 610 may include any number of dowels, connector locking pins, and / or studs to suit the type of electrode patch 100 configured to be clamped by connector device 600 and the type of connector 650 used.

[0224] As shown, the second clamping member 620 is a top / upper clamping member for clamping the connector portion 104 of the electrode patch 100 from above when the first and second clamping members 610, 620 are secured together in a clamped position.

[0225] The second clamping member 620 includes a second clamping member plate 621 and a cover plate 622 .

[0226] The second clamping member plate 621 extends longitudinally between a first end 621 a and a second end 621 b and includes a lower surface 621 c and an upper surface 621 d. The cover plate 622 is configured to be secured to the second clamping member plate 621 at the upper surface 621 d.

[0227] The second clamp member plate 621 can include a first stud-receiving hole 624a at or near the first end 621a and a second stud-receiving hole 624b at or near the second end 621b. Although not shown, the stud-receiving holes 624a and 624b can optionally include thread configurations (e.g., female threads) for engaging with the external threads of the first and second studs 614a and 614b, respectively. A plurality of dowel-receiving holes 625a, 625b, and 625c can be disposed between the first and second studs to receive the holes 624a and 624b. The dowels 615a, 615b, and 615c can be received through the dowel-receiving holes 625a, 625b, and 625c, respectively, when the first and second clamp members 610, 620 are in the clamped position. In this example, dowels 615a, 615b, 615c have a smaller diameter compared to studs 614a, 614b, and therefore dowel receiving holes 625a, 625b, and 625c have a smaller diameter compared to stud receiving holes 624a, 624b. Multiple connector fixation pin receiving holes 626a and 626b may be positioned adjacent to dowel receiving holes 625a and 625b, respectively, to receive dowel fixation pins 616a and 616b, respectively. As shown, there may be additional connector fixation pin receiving holes 626a' and 626b', which may be positioned adjacent to and opposite dowel receiving holes 625a and 625b, respectively. These additional connector securing pin receiving holes 626a' and 626b' can accept dowel securing pins 616a, 616b, respectively, when second clamping member 620 is rotated / turned 180 degrees in the same plane from the position shown in Figure 7. This means that the first and second clamping members 610 and 620 can be secured together to clamp an electrode patch between them even if one of the clamping members is rotated 180 degrees in the same plane in either the clockwise or counterclockwise direction.

[0228] As shown, cover plate 622 may include first and second thumbscrew heads 627a and 627b. The thumbscrew heads may be rotatable and have internal threads configured to engage with the threads of studs 614a, 614b. First thumbscrew head 627a may be configured to rotatably engage with first stud 614a, and second thumbscrew head 627b may be configured to rotatably engage with second stud 614b. As shown, cover plate 622 may also include optional plate locking screws 628a and 628b configured to be received by complementary plate locking screw receiving holes 629a and 629b, respectively, disposed in optional second clamp member plate 621 to further secure cover plate 622 with second clamp member plate 621. Complementary plate fixation screw receiving holes 628a and 628b may be formed in the top surface 621d of the second clamping member plate 621.

[0229] To clamp the electrode patch 100 between the first clamp member 610 and the second clamp member 620, the first clamp member 610 and the second clamp member 720 can first be detached from each other, as shown in FIG. 6 . The electrode patch 100 can then be placed on top of the first clamp member 610. More specifically, the connector portion 104 of the electrode patch 100 can be positioned facing downward and above the connector 650, such that the contact pads 108 located on the connector portion 104 of the electrode patch 100 can be physically connected to the contact pins 652 of the connector 650.

[0230] The first stud 614a can pass through the notch 109 in the electrode patch 100, and the second stud 614b can pass through the C-shaped portion 107 of the electrode patch. The dowels 615a, 615b, and 615c can align with the electrode patch holes 110a, 110b, and 110c, respectively. The electrode patch holes 110a, 110b, and 110c can be larger in diameter to also accept the connector fixation pins 616a, 616b, and 616c. Alternatively, there can be additional electrode patch holes to accept the connector fixation pins 616a, 616b, and 616c.

[0231] The second clamping member 620 may then be placed on top of the first clamping member 610, with a portion of the electrode patch 100 placed on top of the first clamping member 610. The screw heads 627a, 627b are then tightened by rotating them in either a clockwise or counterclockwise direction, thereby clamping the electrode patch 100 between the connection device 600. The electrode patch 100 clamped by the connector device 100 may then be adhered to the outer surface of the subject's skin using an adhesive or the like, with the electrode 102 and foam layer 612 contacting the outer surface of the subject's skin.

[0232] Because foam layer 612 is a soft material, it can prevent abrasion or damage to the subject's skin during use. Similarly, it can be appreciated that having foam layer 612 for contact with the patient side rather than a hard surface can mean that connection device 600 of the present invention can be more comfortable for a subject to wear compared to similar devices with a harder surface.

[0233] The connector device 600 may be a portable electronic device, such as a data acquisition unit or data logging device, that can be worn by a subject to enable electrophysiological monitoring and is preferably battery-powered (e.g., using a lithium-ion battery). Alternatively, the connector device 600 may be an intermediate device configured to be worn by a subject, and the connector 650 of the intermediate device 600 may be electrically connected (either wired or wirelessly) to an electronic device, such as a data acquisition or data logging device, to enable electrophysiological monitoring. If the connector device 600 includes any cables or wires, the cables or wires may be routed through the notches 109 formed on the electrode patch 100.

[0234] The principles and operation of data acquisition or data logging devices are well known to those skilled in the art and need not be described here. However, the connector device 600 may include at least one analog-to-digital converter to amplify and digitize the biopotential measurement signals received from the electrode patch 100. There may be multiple (e.g., four) analog-to-digital converters. The analog-to-digital converter may be an analog-to-digital converter chip. The connector device 600 may include a microcontroller. The microcontroller may be configured to receive signals from the analog-to-digital converter, process the signals, and transmit data to a remote computing device to monitor electrical activity generated by the subject. The analog-to-digital converter may be electrically connected to the microcontroller by a flexible cable. The flexible cable may be a flexible printed circuit board. The electronic components may further include a flash memory, a near-field communication (NFC) module, and / or a charging circuit.

[0235] The connector device 500 described above with reference to FIG. 5 may also be a similar portable electronic device or an intermediate device and may include a connector similar to connector 650 in either the first clamping member or the second clamping member.

[0236] Connector device 600 may be part of a connector system that includes a docking device having a compartment configured to receive the connector device. The docking device may be a wireless charging device to facilitate wireless charging of the connector device when the connector device is received within the connector device receiving compartment.

[0237] It can be appreciated that the presence of the notch 109 and the electrode patch holes 110a, 110b, and 110c can prevent distortion of the electrode patch 100 when the connector portions 104 of the electrode patch 100 are clamped together by the connector device 600. Preventing distortion of the electrode patch 100 can be important to prevent failed connections and crosstalk.

[0238] After use, the electrode patch may detach (e.g., peel off) from the outer surface of the subject's body skin. The connection between the screw heads 627a, 627b and the studs 614a, 614b may be loosened by rotation, and the first clamp member 610 and the second clamp member 620 may then be moved away from each other. The electrode patch 100 may then be removed from the connector device 600. The electrode patch 100 is preferably a disposable device and may be discarded after use.

[0239] 6 and 7 show, the first clamp member 610 can be the upper clamp member and the second clamp member 620 can be the lower clamp member, or in an alternative configuration, the first clamp member 610 can be the upper clamp member and the second clamp member 620 can be the lower clamp member. In such a configuration, the connector portion 104 of the electrode patch can be positioned on top of the second clamp member plate 621 of the second clamp member 620, and the connector portion 104 of the electrode patch 100 can face upward, toward the downward-facing connector 650 of the first clamp member 610.

[0240] Figure 8 shows another example of a connector portion of an electrode patch 100. For clarity, the contact pads and electrical conductors are not shown in Figure 8. The connector portion of Figure 8 is substantially similar to the connection portion 104 described above, and most of the above description of the connector portion 104 applies equally to the connector portion, with only the differences being described herein.

[0241] As shown, the connector part in Figure 8 has a total of five alignment holes. Electrode patch hole Including 110a', 110b', 110c', 110d' and 110e'.

[0242] When clamped by the connector device 600, the electrode patch hole 110a' may be configured to receive the first stud 614a. The electrode patch hole 110b' may be configured to receive the dowel 615a and the pin 615b. The electrode patch hole 110c' may be configured to receive the dowel 615c. The electrode patch hole 110d' may be configured to receive the dowel 615b. And, the electrode patch hole 110e' may be configured to receive the second stud 614b. It can be appreciated that the presence of the electrode patch holes 110a', 110b', 110c', 110d', and 110e' prevents tilting of the electrode patch 100 when the connector portion 104 of the electrode patch 100 is clamped together by the connector device 600. They also ensure proper alignment between the connector portion 104' and the connector 104. As mentioned above, preventing distortion of the electrode patch 100 can be important to prevent connection failure and crosstalk. In the electrode patch with a connector portion of FIG. 8 , the notch 109 and / or C-shaped portion 107 may be optional. Alternatively, the notch 109 may still be present in the electrode patch 100, so that if the connector device 600 includes any cables or wires, those cables or wires can be routed through the notch 109 formed on the electrode patch 100. The size of the connector device for clamping the electrode patch 100 with the connector portion 104′ may be different from the size of the connector device for clamping the electrode patch 100 with the connector portion 104. Alternatively, or in addition, the size of the tongue 103 of the electrode patch 100 may be different to fit the connector portion.

[0243] 9 shows an example of an electrode patch 200 according to another preferred embodiment of the present invention. Most features of the electrode patch 200 are substantially similar to the electrode patches described above, and therefore most of the above description of the electrode patch 100 can be equally applied to the connector patch 200, and only the differences will be described herein.

[0244] The electrode patch 200 may include two connector portions. A conductor 206 running as a conductive track between the electrodes 202, 202a, and 202b is routed to two separate connector portions. The electrode 202a is a ground electrode, and the electrode 202b is a reference electrode. In FIG. 9, the connector portions are not visible because they are covered by the connectors 250a and 250b. The two connectors 250a and 250b may be similar to the connectors 150 or 750 described above. Preferably, the two connectors 250a and 250b are identical. Optionally, the connector 250a is different from the connector 250b.

[0245] Preferably, the two connectors 250a, 250b shown in Figure 9 are not part of the electrode patch 200, but instead are part of one or more connector devices adapted to clamp the electrode patch 200. The connector devices can be the same as connector devices 500 or 600 described above. In Figure 9, the complete connector devices are not shown for clarity.

[0246] Splitting the connector portion into two or more portions is advantageous over a single connector portion because by doing so, less mating force is required at each connection portion to achieve a reliable bond between the electrode patch 200 and the connector device.

[0247] There are two notches 209a, 209b in the electrode patch 200. The notches may be optional.

[0248] In one alternative optional embodiment, connector 650 is adhered to the connector portion (e.g., by adhesive or the like) and is part of the electrode patch 200 rather than being part of the connector device. In such an embodiment, the one or more connector devices may include a cable to enable electrical communication between connector 650 and the one or more connector devices.

[0249] The tongues 203 of the electrode patch 200 are shown to be substantially rectangular in shape. However, the tongues 203 may be many other suitable shapes. Although not shown, the tongues 203 may optionally include C-shaped portions adjacent each of the connector portions.

[0250] Each connector portion of the electrode patch 200 may be similar to the connector portions described above. Each connector portion may appear as the first half 104a or the second half 104b of the connector portion shown in Figure 2. More specifically, the group of contact pads on each connector portion of the electrode patch 200 may be in a staggered format, as shown on the first half 104a or the second half 104b of the connector portion, as shown in Figure 2.

[0251] 10 and 11 show an example of one of the connector portions of the electrode patch 200. In other words, the connector portion 204 shown in FIGS. 10 and 11 is one of two connector portions of the electrode patch 200. As shown, the connector portion 204 may include a total of 34 staggered contact pads 208. The 34 contact pads are connected to 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b via electrical conductors 206. The electrical conductors 206 extend as conductive tracks between the electrodes 202, 202a, and 202b and the connector portion 204, more specifically, between the electrodes 202, 202a, and 202b and the contact pads of the connector portion 204. Another of the two connector portions of the electrode patch 200 may be similar to connector portion 204, which may also have 34 contact pads connected to the remaining 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b using electrical conductors 206.

[0252] FIG. 12 shows another example of a preferred embodiment of a connector device 700 and electrode patch 200 clamped between a first clamping member 710 and a second clamping member 720 of the electrode patch.

[0253] Connector device 700 of this example is similar in most respects to connector device 600 described above, and differences can be identified by comparing Figures 5 and 6 with Figure 12, where features similar to those shown in Figure 6 are identified with the same reference numerals incremented by 100. Most of the description of connector device 600 of the preferred embodiment above applies equally to connector device 600 and therefore need not be described again in great detail. Only the main features will be described.

[0254] As shown, connector device 700 includes only two dowels 715a, 715b between first and second studs 714a, 714b, unlike connector device 600, which includes dowels 615a, 615b, 615c. Connector 750 is part of second clamping member 720, not the first clamping member. Both first and second clamping members 710, 720 can be semi-elliptical with smooth outer surfaces and include housings 723a, 723b in the clamping position, as shown in FIG. 12, such that connector device 700 is substantially elliptical. Because the outer surfaces of both housings 723a, 723b are smooth and have the same shape, either of the first and second clamping members can be positioned proximal to the outer surface of the subject's skin during use. When the first clamping member 710 is placed proximal to the outer surface of the subject's skin, the electrode patch 200 is to be placed on top of the first clamping member with the contact pads 208 of the electrode patch 200 facing upward toward the second clamping member 720, since the second clamping member 720 constitutes the connector 750. Similarly, when the first clamping member 710 is placed proximal to the outer surface of the subject's skin, the electrode patch 200 is to be placed on top of the first clamping member with the contact pads 208 of the electrode patch 200 facing downward toward the second clamping member 820, which constitutes the connector 750. Although not shown, a foam layer may optionally be added to the surface of the connector device 700 configured to attach to the outer surface of the subject's skin.

[0255] The first and second clamping members 710, 720 may be secured together in the clamped position using any number of suitable securing means, including but not limited to magnetic coupling, latching arrangements, snap fit arrangements, and the like.

[0256] During clamping of the electrode patch 200 using the connector device 700, the electrode patch hole 210a may be configured to receive a first stud 714a. The electrode patch hole 210b may be configured to receive a dowel 715a. The electrode patch hole 210c may be configured to receive a dowel 715b. And, the electrode patch hole 210d may be configured to receive a second stud 714b. It can be appreciated that the presence of the electrode patch holes 210a, 210b, 210c, and 210d prevents distortion of the electrode patch 200 when the connector portion 204 of the electrode patch 200 is clamped together by the connector device 700. The electrode patch holes 210a, 210b, 210c, and 210d are also alignment holes because they allow for proper alignment of the connector portion 204 and the connector 750.

[0257] Two separate connector devices 700 can be used to clamp the two connector portions 204 together.

[0258] The connector device of FIG. 15 is preferably an electronic device, such as a data acquisition or data logging device, and is preferably battery-powered (see lithium-ion battery 741). The principles and design of data acquisition or data logging devices are well known to those skilled in the art and need not be described here. However, the connector device 700 may include at least one analog-to-digital converter to amplify and digitize the biopotential measurement signals received from the electrode patch 200. There may be multiple (e.g., four) analog-to-digital converters. The analog-to-digital converter may be an analog-to-digital converter chip. The connector device 700 may include a microcontroller. The microcontroller may be configured to receive signals from the analog-to-digital converter, process the signals, and transmit data to a remote computing device to monitor electrical activity generated by the subject. The analog-to-digital converter may be electrically connected to the microcontroller by a flexible cable. The flexible cable may be a flexible printed circuit board. The electronic components may further include a flash memory, a near-field communication (NFC) module, and / or a charging circuit.

[0259] As shown in FIG. 12 , there may be a main printed circuit board (PCB) 743. The PCB 743 may include, but is not limited to, a microcontroller and other electronic circuits, such as, but not limited to, a microcontroller, flash memory, a near-field wireless connectivity (NFC) module (e.g., a Bluetooth module), a charging circuit, etc. There may be a separate PCB 721′ configured or formed as a clamping plate 721 that holds at least one analog-to-digital converter (preferably four analog-to-digital converter chips). A zif connector 745 may be used to connect the PCB configured or formed as the clamping plate 721 to the main PCB 743 using a flexible cable (e.g., a flexible printed circuit board). A corresponding zif connector (not shown) may be disposed on the main PCB 743, and the corresponding zif connector may be electrically connected to the zif connector 745 using a flexible cable.

[0260] FIG. 13 illustrates another example of a connector 350 for physically connecting with the connector portion 204 described above. The connector 350 of this example is similar in most respects to the connector 150 described above, and differences can be identified by comparing FIG. 3 with FIG. 13. The fewer number of conductive contact pins 352 on the connector of FIG. 13 is designed for a configuration that allows for reduced mating forces. Reduced mating forces may improve the reliability and lifespan of the mating device. In FIG. 13, features similar to those shown in FIG. 6 are identified with the same reference numbers increased by 200.

[0261] In Figure 13, one of the corners of the connector is shown angled, but it need not be angled.

[0262] The conductive contact pins 352 may optionally be trapezoidal in shape, although, although not shown in FIG.

[0263] The conductive contact pins 352 are positioned / spaced in a specific direction, as shown in FIG. 13 , to make contact with the contact pads 208 of the connector portion 204. FIG. 14 shows the conductive contact pins 352 in contact with the contact pads 208 when physically connected to the contact pads 208. As shown, each contact pad 208 can be configured to make contact with two conductive contact pins. This allows for backup contact between the contact pads 208 and the conductive contact pins. Thus, even if one of the two conductive contact pins becomes damaged, worn, or covered with residue, for example, if the device is washed between patients, the device will still function normally.

[0264] FIG. 15 shows another example of a preferred embodiment of a connector device 800 configured to clamp an electrode patch 200 between a first clamping member 810 and a second clamping member 820.

[0265] Connector device 800 of this example is similar in most respects to connector device 700 described above, and differences can be identified by comparing Figure 12 to Figure 15. In Figure 15, features similar to those shown in Figure 12 are identified with the same reference numerals incremented by 100. Most of the description of connector device 700 of the preferred embodiment above applies equally to connector device 800 and therefore need not be described again in great detail. Only the major differences will be described.

[0266] As shown, connector device 800 includes only two dowels 815 a, 815 b. Unlike connector device 700, in which dowels 715 a, 715 b are positioned between first and second studs 714 a, 714 b, first and second studs 814 a, 814 b of connector device 700 are positioned between dowels 815 a, 815 b. Although not shown, a foam layer may optionally be added to a surface of connector device 800 configured to be attached to the outer surface of a subject's skin.

[0267] During clamping of the electrode patch 200 using the connector device 800, the electrode patch hole 210a may be configured to receive a dowel 815a. The electrode patch hole 210b may be configured to receive a first stud 814a. The electrode patch hole 210c may be configured to receive a second stud 814b, and the electrode patch hole 210d may be configured to receive a dowel 815b. It can be appreciated that the presence of the electrode patch holes 210a, 210b, 210c, and 210d prevents distortion of the electrode patch 200 when the connector portion 204 of the electrode patch 200 is clamped together by the connector device 800.

[0268] Two separate connector devices 800 can be used to clamp the two connector portions 204 together.

[0269] The connector device of FIG. 15 is preferably an electronic device, such as a data acquisition or data logging device, and is preferably battery-powered (see lithium-ion battery 841). The principles and operation of data acquisition or data logging devices are well known to those skilled in the art and need not be described here. However, the connector device 800 may include at least one analog-to-digital converter to amplify and digitize the biopotential measurement signals received from the electrode patch 200. There may be multiple (e.g., four) analog-to-digital converters. The analog-to-digital converter may be an analog-to-digital converter chip. The connector device 800 may include a microcontroller. The microcontroller may be configured to receive signals from the analog-to-digital converter, process the signals, and transmit data to a remote computing device to monitor electrical activity generated by the subject. The analog-to-digital converter may be electrically connected to the microcontroller by a flexible cable. The flexible cable may be a flexible printed circuit board. The electronic components may further include a flash memory, a near-field communication (NFC) module, and / or a charging circuit.

[0270] As shown in FIG. 15 , there may be a main printed circuit board (PCB) 843. The PCB 843 may include, but is not limited to, a microcontroller and other electronic circuits, such as, but not limited to, a microcontroller, flash memory, a near-field wireless communication (NFC) module (e.g., a Bluetooth module), a charging circuit, etc. There may be a clamping plate 821 configured or formed as a separate PCB 821′ that holds at least one analog-to-digital converter (preferably four analog-to-digital converter chips). A zif connector 845 may be used to connect the PCB configured as or formed as the clamping plate 821 to the main PCB 843 using a flexible cable (e.g., a flexible printed circuit board). A corresponding zif connector 846 may be disposed on the main PCB 843, and the corresponding zif connector may be electrically connected to the zif connector 845 using a flexible cable.

[0271] The connector device 800 includes a biasing member, which in this example is a leaf spring 855. The leaf spring 855 is shown in FIG. 15 as being disposed on the second clamping member 820. The leaf spring is configured to bias the second clamping member to move toward the electrode patch (more specifically, the connector portion of the electrode patch) sandwiched between the first clamping member 810 and the second clamping member 820. Such biasing of the second clamping member 820 to move toward the electrode patch enables proper connection between the conductive contact pins 852 of the connector 850 and the connector portion of the electrode patch.

[0272] FIGS. 16-18 show another example of a connector 450, which may be an array connector or interposer for physically connecting with connector portion 204.1, described below with reference to FIG. 19. This example connector 450 is similar in most respects to connector 350 described above, and differences can be identified by comparing FIG. 13 with FIGS. 16-18. The number of conductive contact pins in connector 450 of FIGS. 16-18 is designed to be reduced, resulting in a configuration that allows for reduced mating forces. The reliability and lifespan of connector 450 may be improved when mating forces are reduced. In FIGS. 16-18, features similar to those shown in FIG. 13 are identified by the same reference numerals, increased by 100.

[0273] Although one of the corners of the connector is shown angled in Figures 16-18, it need not be angled.

[0274] As shown in Figure 18, conductive contact pins 452 may protrude from the body of connector 452. The conductive contact pins 452 may be located on both opposing sides of connector 450 so that connector pins on either side of connector 450 can be used to contact contact pads 208.1 of connector portion 204.1, described below with reference to Figure 19. Connectors 150, 250, 350 may also have connector pins on each side.

[0275] The conductive contact pins 452 are arranged in a specific manner to make contact with the contact pads 208.1 of the connector portion 204.1, as shown in FIG. 14. The conductive contact pins 452 may be in contact with the contact pads 208.1 if they are physically connected to the contact pads 208.1. Each contact pad 208.1 may be configured to make contact with only one conductive contact pin. This reduces the overall force required to connect to the contact pads 208.1.

[0276] FIG. 19 shows another example of one of the connector portions of the electrode patch 200. In other words, the connector portion 204.1 shown in FIGS. 10 and 11 is one of two connector portions of the electrode patch 200. As shown, the connector portion 204.1 may include a total of 38 contact pads 208 in a staggered format. The 34 contact pads are connected to 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b via electrical conductors 206.1. The electrical conductors 206.1 extend as conductive tracks between the electrodes 202, 202a, and 202b and the connector portion 204.1, and more specifically, between the electrodes 202, 202a, and 202b and the contact pads 208.1 of the connector portion 204.1. Another of the two connector portions of the electrode patch 200 may be similar to connector portion 204, and that connector portion 204.1 may also have 34 contact pads connected using electrical conductors to the remaining 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b.

[0277] One significant difference between connector portion 204 of Figure 10 and connector portion 204.1 of Figure 19 is that connector portion 204.1 of Figure 19 includes four additional connector pads 208.1a, 208.1b, 208.1c, and 208.1d at or near the center of connector portion 204.1. Also, the orientation of conductive contact pins 452 of connector 450 is different from the orientation of conductive contact pins 352 of connector 350.

[0278] It can be appreciated that different versions of connectors can be used to connect to connector portion 204.1 of FIG. 19, and that four additional connector pads 208.1a, 208.1b, 208.1c, and 208.1d can determine the type of connector connected to connector portion 204.1. For example, connector 350 or connector 450 can be used to connect to connector portion 204.1. Four additional connector pads 2.8.1a, 2.8.1b, 208.1a, and 208.1d in the center of connector portion 2.4.1 can determine the version of connector used to connect to connector portion 204.1. If connections with conductive contact pins are detected on all four additional connector pads 2.8.1a, 2.8.1b, 208.1a, and 208.1d, this may indicate that connector 450 of FIGS. 16-18 is being used to connect to connector portion 204.1. Similarly, if no connection with conductive contact pins is detected at all four additional connector pads 2.8.1a, 2.8.1b, 208.1a, 208.1d, this may suggest that connector 350 of Figure 13 is being used to connect to connector portion 204.1.

[0279] During clamping of the electrode patch 200 with the connector portion 204.1 using the connector device 800, the electrode patch hole 210a' may be configured to receive a dowel 815a. The electrode patch hole 210b' may be configured to receive a first stud 814a. The electrode patch hole 210c' may be configured to receive a second stud 814b. The electrode patch hole 210d' may be configured to receive a dowel 815b. It can be appreciated that the presence of the electrode patch holes 210a', 210b', 210c', and 210d' prevents distortion of the electrode patch 200 when the connector portion 204.1 of the electrode patch 200 is clamped together by the connector device 800. FIG. 19 shows that the electrode patch holes 210a' and 201d' are larger in diameter than the electrode patch holes 210b' and 201c'. This is because in connector device 800, dowels 815a, 815b have a larger diameter than first and second studs 814a, 814b.

[0280] It will be appreciated that the size, shape, orientation, and number of electrode patch holes in the connector portion of the electrode patch can be customized to fit the connector device being used to clamp the connector portion of the electrode patch.

[0281] An optional cutout 209' is shown in Figure 19. The cutout is the same as cutout 209a or 209b shown in Figure 9, except that cutout 209' is shown in Figure 19 as being circular (while cutout 209a can be any other shape).

[0282] 20 shows an example of an electrode patch 300 according to another preferred embodiment of the present invention. Most features of the electrode patch 300 are substantially similar to the electrode patch 100 described above, and therefore most of the above description of the electrode patch 100 can be equally applied to the connector patch 300, and only the differences will be described herein.

[0283] The electrode patch 300 may include two connector portions 304a, 304b (see FIG. 21 ) on two opposing sides of the electrode patch 300—two opposing sides of the array electrode 300. FIG. 20 schematically illustrates a connector device for connecting to the two connector portions. The connector device may be any one of the connector devices 500, 600, 700, and 800 described above. The configuration of the electrode patch 300 shown in FIG. 20 is advantageous because it distributes the weight and bulk of the connector device to two different areas for better balance during use. Because two connector devices are required to connect to the two connector portions 304a, 304b, an additional conductor 206′ may extend as a conductive track to electrically connect the two connector portions 304a, 304b. The additional conductor may extend as a conductive track through the substrate of the electrode patch 300, but without any physical contact with any of the other conductors 206 and electrodes 302 of the electrode patch 300. Such additional electrical conductors 306' allow both the connector connected to connector portion 304a and the connector connected to connector portion 304b to receive time-synchronized signals, which also allows the connector connected to connector portion 304a and the connector connected to connector portion 304b to operate together.

[0284] Connector portions 304a, 304b may be similar to connector portion 104 described above, as shown in Figure 21. Alternatively, connector portions 304a, 304b may be similar to connector portions 204 or 204.1 described above.

[0285] In an alternative embodiment, the connector portions 204a, 204b of the electrode patch 200 may be located on two opposite sides of the array electrode 202, instead of being located on the same side of the array electrode 202. An additional conductor similar to conductor 306' may be used to connect the connector portions 204a and 204b in a manner similar to that described above with reference to FIG.

[0286] 22 shows an example of an electrode patch 400 according to another preferred embodiment of the present invention. Most features of the electrode patch 400 are substantially similar to the electrode patch 100 described above, and therefore most of the above description of the electrode patch 100 is equally applicable to the connector patch 400, with only the main differences being described herein.

[0287] 22, the electrode patch 400 is shown as including and containing 36 array electrodes 402, a ground electrode 402a, and a reference electrode 402b. However, the number of array electrodes 402 can be greater than 32 (e.g., 64, as described in the previous embodiment, or even greater than 64). In some embodiments, the electrode patch 400 can have fewer than 32 array electrodes 402.

[0288] The electrode patch 400 may include two connector portions 404a, 404b. An electrical conductor 406 that runs as a conductive track between the electrodes 402, 402a, 402b is routed to the two separate connector portions 404a, 404b.

[0289] Splitting the connector portions 402a, 402b into two or more portions is advantageous over a single connector portion because such splitting reduces the mating force required at each connection portion to achieve a reliable coupling between the electrode patch 400 and the connector device. Splitting the connector portions 402a, 402b into two or more portions also means that the connector portions are smaller than a single connector portion and can be strategically placed within the electrode patch 400 to reduce the overall size of the electrode patch 400.

[0290] A large cutout 409 is located between connector portions 402a, 402b. Cutout 409 is shown to be substantially rectangular; however, cutout 409 may be any number of other suitable shapes. Cutout 409 is for proper alignment of electrode patch 400 on a connector device, such as connector device 900, as described below.

[0291] The shape of the tongue 403 of the electrode patch 400 is shown to be substantially rectangular. However, the tongue 403 can be many other suitable shapes. In some embodiments, there may be no tongue, and the dimensions of the primary region containing the electrode 402 may be the same or substantially the same as the dimensions of the region that would be the tongue 403 in FIG. 22. In certain embodiments, the primary region containing the electrodes 402, 402a, 402b may be a different shape than that shown in FIG. 22. The primary region may be wider or smaller than that shown in FIG. 22 depending on the intended use of the patch 400.

[0292] Each connector portion of the electrode patch 200 may be similar to the connector portions 104, 204 described above. Alternatively, each connector portion may look like the first half 104a or second half 104b of the connector portion 104 shown in Figure 2. More specifically, the groups of contact pads on each connector portion of the electrode patch 400 may be staggered, as shown on the first half 104a or second half 104b of the connector portion, as shown in Figure 2.

[0293] The electrode patch may include an adhesive or adhesive layer 413 on the edges and tongue 403, as shown in Figure 17, to enable the electrode patch 400 to adhere to the outer surface of the subject's skin during use. Although not shown, the electrode patches 100, 200, 300 described above may also include an adhesive layer on the tongue and edges, particularly on the edges of the primary region, in a similar manner.

[0294] The electrode patch 400 has a connector portion 404a, a connector portion 404b, and a Multiple alignment holes17, there are six alignment holes 414 near connector portion 404a and another six alignment holes 414 near connector portion 404b. The alignment holes 414 are for properly aligning the electrode patch 400 with a connector device, such as connector device 900, described below. More specifically, the alignment holes 414 are for properly aligning the connector portions 404a, 404b of the electrode patch 400 with a connector, such as connector 950 of connector device 900, as described below.

[0295] FIG. 23 shows a connector device 900 according to a further preferred embodiment of the present invention.

[0296] The connector device 900 includes a body 905 extending from a first end 905a to a second end 905b opposite the first end 905a. The body 905 has planar surfaces, a top surface 905c and a bottom surface 905d (see FIG. 25). The top surface 905c is configured to receive an electrode patch 400 for use in monitoring electrical activity generated by a subject.

[0297] 17 and 18, connector device 900 includes a first clamping member 910 that is a flap hinged / pivotedly attached to a body 905d at or near a first end 905a. Connector device 900 also includes a second clamping member 920 that is also a flap hinged / pivotedly attached to the body at or near a second end 905b.

[0298] The first and second clamp members 910, 920 are configured to move between an open position, as shown in Figure 23, and a closed position, as shown in Figure 19. As shown, in the open position, the first clamp member 910 and the second clamp member 920 are both configured to pivotally move away from the top surface 905c, at least partially, and preferably completely, exposing the top surface 905c. Similarly, in the closed position, the first clamp member 910 and the second clamp member 920 are both configured to pivotally move toward the top surface 905c, at least partially, and preferably completely, concealing the top surface 905c.

[0299] At least one, but preferably both, of the first and second clamping members 910, 920 comprise at least one connector 950 configured to be physically and operably connected to the electrode patch 400 to receive electrical signals from the multiple electrodes of the electrode patch 400, thereby enabling monitoring of electrical activity generated by the subject. Thus, no cable is required for connection between the connector 850 and the electrode patch 400. The connector may be connector 150 or 350, as described above.

[0300] The connector device 900 may include at least one alignment feature configured to align and / or retain the electrode patch 400 on the upper surface. Multiple alignment features 930, 935 are shown in FIG. 23 . The alignment features are in the form of protrusions 935 and alignment pins 935. The protrusions 935 are configured to be received by at least one complementary notch 409 formed in the electrode patch 400 to align and / or retain the electrode patch 400 on the upper surface 905 c of the connector device 900. The protrusions 935 may be substantially rectangular or substantially cuboid in shape. The protrusions 935 may be sized sufficiently to prevent at least lateral movement of the electrode patch between the first end 905 a and the second end 905 b when the protrusions 935 are received by the at least one complementary notch formed in the electrode patch.

[0301] The alignment pins 935 are configured to be received by complementary alignment holes 414 formed in the electrode patch 400. The alignment pins 935 can be located on one or both sides of the protrusion 930. In the example shown in Figure 23, six alignment pins 935 are located on each side (side) of the protrusion 930. There may be more or less than six alignment pins.

[0302] As shown in FIG. 24, in the closed position, both the first clamp member 910 and the second clamp member 910 can be configured to pivotally move toward the top surface and at least partially (preferably completely) obscure the top surface 905c except for the protrusion 930 or at least a portion thereof.

[0303] Connector device 900 is preferably a wearable electronic device. Preferably, body 905, first clamp member 910, and second clamp member 920 together form a housing within which various electronic components of the connector device are at least partially disposed. In FIG. 23, connector 950 is shown protruding slightly from first and second clamp members 910, 920.

[0304] The connector device 900 can include electronic circuitry and a memory with instructions stored therein. Execution of the instructions can cause the connector device 900 to receive signals from the electrode patch 400, process the signals, and transmit data to a remote computing device to enable monitoring of electrical activity generated by the subject. The electronic device can be a data acquisition or data logging device. The data can be transmitted wirelessly and / or wired to the computing device for processing, filtering, or analysis.

[0305] Preferably, the connector device 900 is battery-powered (e.g., by a lithium-ion battery). The principles and operation of data acquisition or data logging devices are well known to those skilled in the art and need not be described here. However, the connector device 800 may include at least one analog-to-digital converter to amplify and digitize the biopotential measurement signals received from the electrode patch 400. There may be multiple (e.g., four) analog-to-digital converters. The analog-to-digital converter may be an analog-to-digital converter chip. The connector device 800 may include a microcontroller. The microcontroller may be configured to receive signals from the analog-to-digital converter, process the signals, and transmit data to a remote computing device to monitor the electrical activity generated by the subject. The analog-to-digital converter may be electrically connected to the microcontroller by a flexible cable. The flexible cable may be a flexible printed circuit board. The electronic components may further include a flash memory, a near-field communication (NFC) module, and / or a charging circuit.

[0306] 25-29 show an example of a docking device 1500 for connector device 900 and how docking device 1500 can be used to receive connector device 900. As shown, docking device 1500 can include compartment 1550, which is a connector device receiving compartment.

[0307] Docking device 1500 may be a wireless charging device to facilitate wireless or contact charging of a connector device when the connector device is received within compartment 1550, as shown in Figure 25. The principles and design of wireless or contact charging devices are well known to those skilled in the art and need not be described here.

[0308] One purpose of the docking device 1500 is to provide a large, flat surface 1510 on which an operator can conveniently assemble the electrode patch 400′ and connector device 900 together. The electrode patch 400′ (shown in FIGS. 28, 29, and 30) can be substantially identical to the electrode patch 400 described above. The only significant difference is the number of electrodes. The electrode patch 400′ can include 64 array electrodes 402′, a ground electrode 402a′, and a reference electrode 402b′. However, the electrode patch 400′ can have more or fewer than 64 electrodes. For clarity, the conductor and connector portions, alignment holes, and adhesive are not shown in FIGS. 23-25. For clarity, the alignment pin 935 is not shown in FIGS. 20-25. The front portion 400a′ of the electrode patch 400 is shown in FIGS. 25-29. The rear portion 400b′ of the electrode patch 400 is shown in FIG. 30.

[0309] The mode of assembly in one embodiment occurs as follows.

[0310] The connector device 900 is placed in a recess, i.e., a compartment 1550, within the surface of the docking device 1500. The connector device 900 has a shape consistent with this compartment 1550, so that correct orientation is easily achieved. Next, the clamping members 910, 920 formed on the connector device 900 are moved to an open position to expose the connector 950. Next, the electrode array 400′ is placed on the flat surface 1510 of the docking device 1500. This flat surface 1510 preferably has sufficient friction so that the electrode patch 400′, which may be made of a slippery material, easily stays in place. Next, the electrode array 400′ is draped over the open surface of the connector device 900, and the alignment holes and pins of the electrode patch 400′ and the connector device 400′, respectively, are aligned. The clamping members 910, 920 on the connector device 900 are then moved firmly into a closed position onto the electrode patch 400', forming a tight connection in proper alignment.

[0311] Those skilled in the art will appreciate that although the connector 950 should not be washed with a clinical disinfectant to prevent clogging and / or damage from cleaning, the connector device 900 may need to be cleaned between patients for hygienic reasons. The connector device 900 of the present invention allows for easy cleaning of the connector 950 and prevents accidental cleaning of the connector 950 because the connector 950 of the connector device 900 is exposed only when the clamping members 910, 920 are in the open position. To clean the connector device 900, the clamping members 910, 920 can be moved to the closed position and wiped with a clinical disinfectant, thereby avoiding cleaning of the connector 950. Furthermore, because the connector 950 is exposed only when the clamping members 910, 920 are in the open position, it is less susceptible to damage and clogging due to dust and the like.

[0312] Another purpose of the docking device 1550 is to charge the connector device 900 when it is not in use. This can be achieved by having a contact charging point. Alternatively, a wireless charging coil (not shown) can be placed in an appropriate location, preferably underneath the compartment 1550 of the docking device 1500. A consistent geometry between the connector device 900 and the compartment 1550 of the docking device 1500 ensures that the charging connection is reliable. The compartment 1550 can be shaped and sized to snugly receive the connector device 900 within the compartment 1550, which can ensure that the charging connection between the docking device 1500 and the connector device 900 is reliable.

[0313] A significant force must be achieved in the connection between the electrode patch 400 and the first and second connection members 910, 920 of the connection device. In the connection device 900, the first and second clamp members 910, 920 may be locked in the closed position by magnets. However, other suitable locking means, such as latch arrangements, snap fit arrangements, etc., are possible as well.

[0314] 25-30, a preferred method of using the system 2000, including the coupling apparatus 900, the docking device 1500, and the electrode patch 400', will now be further described. As noted above, the electrode patch 400' (shown in FIGS. 28, 29, and 30) can be substantially identical to the electrode patch 400 described above. The only significant difference is the number of electrodes. The electrode patch 400' can include 64 array electrodes 402', a ground electrode 402a', and a reference electrode 402b'. However, the electrode patch 400' can have more or fewer than 64 electrodes.

[0315] FIG. 25 shows the docking device 1500 ready to receive the connector device 900 inside the recess or compartment 1550 .

[0316] 26, connector device 900 is disposed in docking device 1500, more specifically, connector device 1500 is disposed inside compartment 1550 formed in docking device 1500. When not in use, connector device 900 may also be disposed in the docking device as shown in FIG. 21 to allow the connected device to be charged wirelessly or by contact charging.

[0317] next, Electrode Patch 400´ The electrode patch 400' is placed on a flat surface 1510 of the docking device. This flat surface 1510 preferably has enough friction so that the electrode patch 400', which may be made of a slippery material, easily stays in place. The electrode patch 400' is then draped onto the open face of the connector device 900.

[0318] To couple the electrode patch 400' with the connector device 900, the first and second clamp members 910, 920 are moved to the open position as shown in FIG.

[0319] The electrode patch 400 ′ is then guided into the connector device 900 .

[0320] A reliable connection requires close or precise alignment between the connector portion of the electrode patch and the connector 950 of the first and second clamping members 910, 920. This is achieved by an alignment feature in the form of a protrusion 930 received by the notch 409′ and an alignment pin 935 received by an alignment hole in the electrode patch 400′. As noted above, in FIGS. 25-29, for clarity, the alignment pin 935 and the complementary alignment hole for receiving the alignment pin 935 are not shown. The protrusion and alignment pin help prevent distortion of the electrode patch and allow for tight or precise alignment of the connector 950 with the connector portion of the electrode patch. This can help prevent poor connections and crosstalk.

[0321] The first and second clamping members 910, 920 are then moved to a closed position in which each clamping member 910, 920 clamps the portion of the electrode patch between that clamping member and the top surface 905a of the connector device 900 (the connection portion of the electrode patch).

[0322] The connector device 900 and connector device assembly in the assembled configuration shown in Figure 30 is then ready to be attached to the outer surface of a subject's skin. By having a tongue 403' with adhesive on one side (right side) of the connector device 900 and the remainder of the opposite side (left side) with adhesive on the edges (see adhesive 413 shown in Figure 22), the electrode patch 400' and connector device assembly can be securely attached to the outer surface of a subject's skin on both sides of the connector device 900. This also allows the electrode patch 900 to be securely attached to the outer surface of the subject's skin on both sides of the connector device 900. Connector Device 900 This means that it attaches well to both sides and does not come off easily.

[0323] In some embodiments, the top surface of the prong may include a display screen for displaying useful information to the user, such useful information may be information related to electrical activity being monitored using the connector device 900, or information regarding connectivity, test status, or device errors.

[0324] Figure 31 shows a connector device 1000 according to another preferred embodiment of the present invention. Connector device 1000 of this example is similar in most respects to connector device 900 described above, and differences can be identified by comparing Figure 23 with Figure 31. In Figure 31, features similar to those shown in Figure 23 are identified with the same reference numerals incremented by 100. Most of the description of connector device 900 of the preferred embodiment described above applies equally to connector device 1000, and therefore only the differences will be described.

[0325] As shown, the connector device 1000 may include a latch arrangement including a latch 1070 configured to engage a catch 1072 formed on the first and second clamp members 1010, 1020 when the connector device 1000 is in the closed position. In FIG. 31 , only the catch 1072 on the second clamp member 1020 is visible. Engagement of the latch 1070 with the latch 1072 allows the first and second clamp members to remain in the closed position. As shown, the connector device may include a push button 1075 that, when pressed, allows the latches to move their position, thereby disengaging from the catch and allowing the first and second clamp members to be in the open position. Preferably, the first and second clamp members 1010, 1020 are spring-biased to the open position such that, when the push button 1075 is pressed, the latch 1070 disengages from the catch 1072 and both the first and second clamp members 1010, 1020 move from the closed position to the open position. As shown, a latch may be located on each side of the protrusion 1030. Both the latch 1072 and the protrusion 1030 may be received by the notch 400′ of the electrode patch 400′ when the electrode patch 400′ is in position on the top surface 1005c of the connector device 1000. A slide button or many other suitable types of button may be used in place of the push button 1075, which, when slid on either side, disengages the latch 1070 from the catch 1072. The latch 1070 is preferably a mechanical latch. Many other suitable latch and catch arrangements may be used.

[0326] Figure 32 shows a connector device 1100 according to another preferred embodiment of the present invention. Connector device 1100 of this example is similar in most respects to connector device 900 described above, and differences can be identified by comparing Figure 23 with Figure 32. In Figure 32, features similar to those shown in Figure 23 are identified with the same reference numerals incremented by 200. Most of the description of connector device 900 of the preferred embodiment described above applies equally to connector device 1100, and therefore only the major differences will be described.

[0327] An important feature of connector device 900 is a number of amplifier chips 1190 (which may be analog to analog-to-digital converter chips) next to connector 1150. This is useful for at least the following reasons:

[0328] ● It allows the signal from the electrode patch 400' to be immediately converted to a digital signal. This means that only a small number of wires 1180 need to be routed across the clamping member 1120 and from 1120 to the body 1105. It can be appreciated that if the amplifier chip 1190 were on the body 1105 of the connector device 1100, more wires would need to be routed across the hinged clamping members 1110, 1120 (e.g., 66 wires for 66 electrodes), which could be problematic in the design or operation of the clamping members 1110, 1120 or lead to increased wear and failure rates. • Rapid digital conversion also means higher order signal quality due to shorter distances, fewer wires and fewer connections resulting in less signal loss / noise.

[0329] The connector device 1000 may also have multiple amplifier chips next to the connector 1150 .

[0330] FIG. 33 shows an electrode patch 200' according to another preferred embodiment disposed on a connector device 1200 according to another preferred embodiment.

[0331] The electrode patch 200' is substantially the same as the above-described electrode patch 200. Therefore, most of the description of the electrode patch 200 of the preferred embodiment above applies equally to the electrode patch 200' and therefore need not be described again.

[0332] Electrode patch 200' includes connecting portions 204a' and 204' similar to connecting portion 204 described with reference to Figures 10 and 11. Most of the features of electrode patch 200', such as the electrodes and complete conductors, are not shown in Figure 33 for clarity. Electrode patch 200' may include 66 array electrodes and a ground electrode, as well as a reference electrode similar to electrode patch 200, as described above with reference to Figure 9. Alternatively, electrode patch 200' may include more or less than 66 array electrodes, as well as a ground electrode and a reference electrode.

[0333] Connector device 1200 is substantially the same as connector device 900 described above. Accordingly, most of the description of the preferred embodiment electrode patch 200 above applies equally to electrode patch 200 and therefore need not be described again. The only difference is in connector 1250 of electrode device 1200, which is the same as connector 350 described above with reference to Figures 13 and 14. Alternatively, connector 1250 may be the same as connector 450, as described above with reference to Figures 16-18.

[0334] FIG. 34 discloses an electrode patch 200″ according to a further preferred embodiment of the present invention. The electrode patch 200″ is substantially the same as the electrode patch 200 described above. Therefore, most of the description of the electrode patch 200 of the preferred embodiment described above applies equally to the electrode patch 200′ and therefore need not be described again.

[0335] Electrode patch 200" includes connecting portions 204a" and 204b" that may be similar to connecting portion 204 described with reference to FIGS. 10 and 11. Most of the features of electrode patch 200", such as complete electrical conductors, are not shown in FIG. 34 for clarity. Electrode patch 200" may include the same number of electrodes as described above with reference to FIG. 9. As shown in FIG. 34, it is possible for electrode patch 200" to include more or less than 64 electrodes.

[0336] As shown in FIG. 34, there are at least three notches 209a'', 209b'', and 209c''.

[0337] To couple the electrode patch 200" with the connector device 900, the first and second clamp members 910, 920 are moved to the open position as shown in Figure 35. The electrode patch 200" is then guided into the connector device 900.

[0338] A reliable connection requires close or precise alignment of the connector portions 204a″ and 204b″ of the first and second clamping members 910, 920 and the connector 950. This is achieved by an alignment mechanism in the form of a protrusion 930 received by a notch 209c″ and an alignment pin 935 received by an alignment hole in the electrode patch 200″. The alignment pin 935 is not shown in FIGS. 35-37 for clarity, but can be seen, for example, in FIG. 23. The protrusion 930 and alignment pin 935 help prevent distortion of the electrode patch and allow the connector 950 to be tightly or accurately aligned with the connector portion of the electrode patch. This can help prevent poor connections and crosstalk.

[0339] Connector device 900 and the connector device assembly in the assembled configuration shown in Figure 37 are then ready to be attached to the exterior surface of a subject's skin. As can be seen from Figures 34-37, the tangs on the electrode patch may be optional. The electrode patch may be used equally well with devices 1000, 1100, and 1200, as described above.

[0340] The first and second clamping members 910, 920 are then moved to a closed position in which each clamping member 910, 920 clamps the portion of the electrode patch between that clamping member and the top surface 905a of the connector device 900 (the connection portion of the electrode patch).

[0341] In certain embodiments, the notches 209a'' and 209b'' may not be present and the dimensions of the electrode patch 200'' may be such that it can fit between similar first and second clamping members 910, 920 as shown in FIG.

[0342] Figures 38 and 39 show a connector device 1300 according to another preferred embodiment of the present invention. Connector device 1300 of this example is similar in most respects to connector device 900 described above, with differences being identified by comparing Figure 23 with Figure 38. In Figure 31, features similar to those shown in Figure 23 are identified with the same reference numerals incremented by 400. Most of the description of connector device 900 of the preferred embodiment described above applies equally to connector device 1000, and therefore only the differences will be described.

[0343] As shown, connector device 1300 may include only one clamping member 1310 hingedly attached to body 1305. However, it may also be understood that body 1305 also facilitates clamping of an array disposed between clamping member 1310 and body 1305, and in that sense, body 1305 may be construed as a second clamping member. Connector device 1300 may be considered a shortened version of connector device 900 and, due to its smaller size, is lighter than connector device 900. Due to its size and weight, connector device 1300 may be useful for monitoring the electrical activity of a pediatric subject.

[0344] Connector device 1300 may also have one or more features of connector devices 1000, 1100 and 1200, including but not limited to push buttons, slide buttons, latches, display screens, and the like.

[0345] FIG. 40 shows an electrode patch 100′ according to a further preferred embodiment of the present invention. The electrode patch 100′ is substantially the same as the electrode patch 100 described above. Therefore, most of the description of the electrode patch 100 of the preferred embodiment described above applies equally to the electrode patch 100′ and therefore need not be described again; differences can be identified by comparing FIG. 40 with FIG. 1. In FIG. 40, most features, such as complete electrical conductors, are not shown for clarity.

[0346] One major difference between electrode patch 100' and electrode patch 100 is the number of electrodes. Electrode patch 100' may include fewer electrodes than electrode patch 100. In the example shown in FIG. 40, electrode patch 100' has only 32 electrodes because it is intended for use with pediatric subjects.

[0347] To couple the electrode patch 100' with the connector device 900, the clamping member 1310 is moved to the open position as shown in Figure 40. The electrode patch 100' is then guided into the connector device 1300.

[0348] A reliable connection requires close or precise alignment of the connector portion 104′ with the connector 1350 of the clamping member 1310. This is achieved by alignment features in the form of protrusions 1530 received by the notches 109′ and alignment pins 1335 received by alignment holes in the electrode patch 109′. In FIG. 40, the alignment pins 1335 are not shown for clarity, but such pins can be seen in FIG. 38. The protrusions 1350 and alignment pins 1330 help prevent distortion of the electrode patch and allow for close or precise alignment of the connector 950 to the connector portion 104′ of the electrode patch 100′. This can help prevent poor connections and crosstalk.

[0349] The clamping member 1310 is then moved to a closed position in which the clamping member 1300 clamps the portion of the electrode patch between the clamping member and the top surface 1305a of the connector device 1300 (the connection portion of the electrode patch).

[0350] The connector device 1300 and electrode patch 100' in the assembled configuration are then ready to be attached to the external surface of the skin of a subject, preferably a pediatric subject.

[0351] It should be understood that the size, shape and number of electrodes of the electrode patch may differ from that described and illustrated in the accompanying drawings, which are described and shown herein by way of example only.

[0352] Where the foregoing description refers to elements or integers that have known equivalents, such equivalents are included as if they were individually set forth.

[0353] It will of course be understood that while the foregoing has been given as illustrative examples of the present invention, all such modifications and variations thereto which would be apparent to those skilled in the art are considered to be in the wide scope and range of various aspects when the invention is as described above and / or as defined in the claims.

Claims

1. 1. A portable connector device that allows for monitoring of gastrointestinal or colonic electrical activity, comprising: a connector device including a first clamping member and a second clamping member configured to move between a clamping position configured to clamp an electrode patch or at least a portion of the electrode patch for monitoring gastrointestinal or colonic electrical activity generated by a subject to enable a physical and operable connection between the connector device and the electrode patch or the portion of the electrode patch, and a release position configured to move the first and second clamping members away from the clamping position to enable the electrode patch or the portion of the electrode patch to be released from the connector device, the connector device including a body having a flat surface configured to have the electrode patch or the portion of the electrode patch disposed thereon; a wearable electronic device in which the connector device transmits the electrical activity wirelessly to a remote computing device, wherein at least the body and the first clamping member together form a housing within which electronic components of the connector device are at least partially disposed, the body including opposed first and second ends, the first clamping member attached to the body at or near the first end and the second clamping member attached to the body at or near the second end, wherein in the clamped position, the first and second clamping members are each configured to move toward the plane, and in the released position, the first and second clamping members are each configured to move away from the plane.

2. The connector device of claim 1 , wherein the first and second clamping members are configured to apply pressure to the electrode patch or the portion of the electrode patch when in the clamped position.

3. 2. The connector device of claim 1, wherein at least one of the first and second clamping members includes at least one connector configured to be physically and operably connected to the electrode patch or the portion of the electrode patch to receive electrical signals from a plurality of electrodes of the electrode patch and enable monitoring of the electrical activity generated by the subject.

4. The connector device of claim 1 , wherein the first clamping member and the second clamping member are hingedly attached to the body.

5. 2. The connector device of claim 1, wherein the connector device comprises at least one alignment feature configured to align and / or retain the electrode patch or the portion of the electrode patch to the connector device, the at least one alignment feature being positioned on or substantially on the plane between the first end and the second end.

6. 10. The connector device of claim 1, wherein the connector device comprises a biasing member configured to bias at least one of the first and second clamping members to move toward the electrode patch.

7. The connector device comprises: a) a data acquisition device; b) a data logging device, and / or c) battery-powered; The connector device of claim 1 .

8. 10. The connector device of claim 1, wherein the electronic device includes electronic circuitry and a memory with instructions stored therein, execution of the instructions causing the electronic device to receive signals from the electrode patch, process the signals, and transmit data wirelessly to the remote computing device to monitor electrical activity generated by the subject.

9. 10. The connector device of claim 1, wherein the connector device comprises a microcontroller configured to receive signals from at least one analog-to-digital converter that amplifies and digitizes biopotential measurement signals received from the electrode patch, process the signals, and transmit data wirelessly to the remote computing device to enable monitoring of electrical activity generated by the subject.

10. 10. The connector device of claim 1, wherein the connector device is configured to be attached to an external surface of a subject's skin with the electrode patches comprising an adhesive such that the electrode patches are attached to both sides of the connector device.

11. The connector device of claim 1 , wherein the electrode patch includes a tongue with adhesive and the remainder of the electrode patch includes adhesive on an edge of the electrode patch.

12. 12. The connector device of claim 11, wherein the connector device is configured to be attached to an external surface of the subject's skin by having the tongue of the electrode patch on a first side of the connector device and the remainder of the electrode patch on a second side of the connector device opposite the first side of the connector device.

13. 2. The connector device of claim 1, wherein each of the first and second clamp members has at least one connector, and the first and second clamp members are configured to move between an open position and a closed position, wherein in the open position, the at least one connector of each of the first and second clamp members is exposed to the surroundings, and in the closed position, the at least one connector of each of the first and second clamp members is hidden from the surroundings.

14. The connector device of claim 5 , wherein the at least one alignment feature is a protrusion configured to be received by at least one complementary notch formed in the electrode patch.

15. 15. The connector device of claim 14, further comprising a plurality of alignment pins configured to be received by complementary alignment holes formed in the electrode patch, the alignment pins being located on one or both sides of the protrusion.

16. 15. The connector device of claim 14, wherein the protrusion is located at or near the center of the first end and the second end, and wherein at least a portion of the protrusion is exposed to the surroundings in the clamped position.

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