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 the outer surface of the subject's skin to sense and measure electrical potential at the plurality of electrodes 102. The electrode patch 100 also includes at least one connector portion 104 for connection to a connector device. The connector portion 104 is spaced apart from and electrically connected to the electrodes 102. A connector device for connection to such an electrode patch is also disclosed.

Description

[0001] This invention relates to an electrode patch and a connection system. More specifically, but not exclusively, this invention relates to an electrode patch suitable for monitoring gastrointestinal electrical activity and a connection system for such an electrode patch. Background Technology

[0002] Disruptions to the gastric rhythm are underlying or contributing factors to conditions such as gastroparesis, chronic nausea and vomiting, functional dyspepsia, and gastroesophageal reflux disease (GERD). Gastroparesis is a condition characterized by the inability of the stomach to empty properly after meals, leading to symptoms of early fullness, bloating, pain, nausea, vomiting, and malnutrition, and in severe cases, death. Medical guidelines recommend that most patients suspected of having gastroparesis undergo upper gastrointestinal (GI) endoscopy (video-guided examination of the inside of the stomach). Chronic unexplained nausea and vomiting presents similarly to gastroparesis, but with a normal gastric emptying test. Functional dyspepsia is a condition characterized by symptoms of “chronic dyspepsia” 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 sensation, and postprandial discomfort syndrome, characterized by premature satiety and postprandial fullness. Other symptoms of functional dyspepsia may include bloating, nausea, and pain after eating. The exact cause of functional dyspepsia is unclear; however, disturbances in gastric activity rhythm are clearly involved, with up to 60% of adult dyspepsia patients exhibiting abnormal gastric electrical activity in some studies. Delayed gastric emptying occurs in 25%–40% of functional dyspepsia cases. Upper GI endoscopy is a standard diagnostic tool used to evaluate patients with dyspepsia to rule out other lesions. Delayed gastric emptying also affects an important subgroup of patients with GERD and is associated with gastric rhythm disturbances. Post-gastric surgery, gastric electrical activity may also be disturbed, leading to delayed gastric emptying and / or the aforementioned symptoms.

[0003] Peristaltic activity in the gastrointestinal tract is coordinated by propagating electrical activity known as slow waves. GI slow waves are initiated and propagated through the Cajal interstitial cell (ICC) network, which is coupled to the smooth muscle layer in the gastrointestinal wall. In the human stomach, slow waves originate from pacemakers on the greater curvature and propagate towards the antrum at a normal frequency of approximately three cycles per minute.

[0004] Electrocardiography (EGG) is a routine diagnostic test for cardiac arrhythmias, in which electrodes are placed on the skin to record electrical activity in distant organs. Electrogastrography (EGG) assesses gastric electrical activity using a small number of skin electrodes placed on the surface of the abdomen. EGG has been proposed as a diagnostic test for gastric disorders, but despite research efforts, it has not met clinical expectations. A key reason why EGG fails to reliably diagnose gastric dysfunction is that the test relies on measurements of frequency and power, while modern high-resolution spatial mapping techniques show that gastric rhythm disturbances typically occur at frequencies within the normal range. Therefore, EGG may miss many abnormalities. Recent studies have indicated the need to map spatial patterns of gastric electrical activity to reliably differentiate 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 slow-wave cycles in an individual. Another reason for the unreliability of EGG is that the signal strength of the gastric electrical signal is very low, and noise may be mistaken for a signal. Furthermore, due to the use of only a small number of electrodes, in many patients, EGG electrodes often do not directly cover the stomach, meaning that gastric signals are unlikely to be retrieved.

[0005] SQUIDs (Superconducting Quantum Interferometers) can be used to measure magnetic fields associated with GI electrical activity, but they are multi-million dollar devices that must be housed in magnetically shielded chambers, and the analysis of the acquired signals is complex and not yet reliably implemented. Furthermore, the resolution obtained through SQUIDs may not be optimal.

[0006] Placing mobile electrodes at continuous locations on the gastric mucosa, or arranging a small number of electrodes linearly and connecting them to a nasogastric tube, can provide some indication of GI rhythm disturbances, but may not reliably provide information on the spatial propagation of slow-wave activity in the stomach, and therefore cannot accurately describe the abnormal velocity, direction of propagation, or rhythm disturbance. Gastric intubation is also a relatively invasive method for measuring gastric dysfunction, and this method may require sedation or be poorly tolerated in some patients. Furthermore, these measures can only be performed in a fasting state, while patients typically only experience symptoms after eating.

[0007] High-resolution mapping of GI electrical activity by measuring on the serous membrane surface requires invasive surgery, therefore high-resolution mapping is not suitable for clinical use in the vast majority of patients with gastrointestinal symptoms.

[0008] The procedure of inserting catheters or similar devices into a subject during minimally invasive surgery or via endoscopy is difficult and therefore typically requires highly skilled physicians. Furthermore, this invasive procedure causes discomfort to the subject and exposes them to the risk of infection or other complications, which is clearly undesirable. Some patients may require a considerable period of recovery after an invasive procedure. Moreover, such invasive procedures usually require a visit to a hospital, clinic, or similar facility, which is both inconvenient and expensive.

[0009] Existing technological systems and scientific research articles attempt to achieve non-invasive monitoring of GI activity, for example, by using skin surface electrode arrays.

[0010] For example, WO2017201538 discloses an apparatus, system, and method for monitoring the physiological function of surface electrophysiological sensors. It discloses an apparatus including an electrophysiological sensor structure comprising an electrode array spatially arranged on a substrate, operable to acquire electrophysiological signals to obtain a series of data. It discloses using a data processing unit to process spatially resolved time-series data based on electrophysiological signals to determine wave propagation parameters.

[0011] Similarly, U.S. Patent No. 9,474,482B2 discloses an apparatus and method for diagnosing GI (Gas Intestinal Gastrointestinal) movement disorders in humans. It discloses measuring electrical signals from the gastrointestinal tract while a patient is performing normal daily activities, recording the measured signals on a portable electronic device worn by the body, having the patient record one or more bodily symptoms in real time, and analyzing the characteristics of the recorded electrical signals using the recorded bodily symptoms for the diagnosis of gastrointestinal diseases.

[0012] However, conventional / previously known devices do not offer the feature of allowing simple and reliable coupling between electrode patches and connector devices (e.g., user-worn portable electronic devices, such as data acquisition devices). If the mechanism for the connection between the electrode patch and such connector device is unreliable or inappropriate / weak, the electrode patch and connector device are likely to disconnect accidentally, in which case the system will be unable to achieve its purpose of allowing real-time electrophysiological monitoring. Furthermore, such previously known devices do not offer the feature of allowing the device to be comfortably worn by the subject while the subject is engaged in normal daily activities. Moreover, due to their weight, the connector device can easily detach / remove from the electrode patch, and even detach and fall off the subject's body, which not only damages the connector device but also leads to confusion, dissatisfaction, and poor treatment adherence. Conventional devices do not address this problem.

[0013] Furthermore, to monitor GI electrical activity, due to the low signal amplitude, it may be necessary to place electrodes on the abdominal surface as close as possible to the target gastrointestinal organs. Since the skin on the abdominal surface typically deforms considerably with normal body movement, it may be necessary to embed the electrode patch in a conformal material that can sufficiently deform with the skin. If rigid electrodes or non-conformal materials are used, the electrode patch or electrode may peel off from the skin, resulting in unreliable signal quality. Conventional / previously known devices have failed to address or adequately address this issue.

[0014] Furthermore, misalignment of the electrode patch when connecting to the connector device can lead to connection failure and crosstalk.

[0015] In addition, traditional electrode patches do not focus on optimizing the design of the electrode patch's contact pad within a minimum area, which means that traditional electrode patches may be bulkier and uncomfortable to wear, especially in the abdominal area.

[0016] It is difficult to provide the minimum width of the electrical conductors required for screen printing, while simultaneously providing a suitable physical layout that allows all electrodes to meet at a common connector section for connection with the connector assembly, which means that conventional electrode patches are larger in size.

[0017] Traditional / previously known connector devices may require cables or wires to connect the electrode patches to the connector device. Cables involving a large number of electrodes are cumbersome to wear, difficult to manufacture, or expensive, and are common points of failure, further reducing the wearability of electrophysiological monitoring devices.

[0018] Invention Objective

[0019] The object of the present invention is to provide an electrode patch that overcomes or at least partially improves some of the limitations and risks described above, or at least provides the public with a useful alternative.

[0020] Alternatively or additionally, the object of the present invention is to provide a connection system for electrode patches that overcomes or at least partially improves some of the limitations and risks described above, or at least provides a useful option for the public. Summary of the Invention

[0021] In a first aspect, the present invention relates to an electrode patch for monitoring electrical activity generated by a subject, the electrode patch comprising:

[0022] Multiple spatially arranged electrodes are used to contact the outer surface of the subject's skin to sense and measure the potential at multiple electrodes; and

[0023] At least one connector portion for connecting to a connector assembly, the at least one connector portion being spaced apart from an electrode by a distance, and being electrically connected to the electrode by an electrical conductor serving as a conductive track between the electrode and the at least one connector portion.

[0024] In one embodiment, at least one tongue is formed on an electrode patch extending from the remainder of the electrode patch, and wherein the at least one connector portion is located at the at least one tongue.

[0025] In some embodiments, at least one tongue is coplanar with the remainder of the electrode patch.

[0026] In some embodiments, the electrode patch is flexible and stretchable.

[0027] In some embodiments, the electrode patch includes a flexible substrate and the electrodes are spatially arranged on the flexible substrate.

[0028] In some embodiments, the flexible substrate is stretchable.

[0029] In some embodiments, the flexible substrate comprises or is made of thermoplastic polyurethane (TPU) film.

[0030] In some embodiments, the at least one connector portion is electrically connected to the electrode via an electrical conductor, the electrical conductor serving as a conductive track or conductive line between the electrode and the at least one connector portion.

[0031] In some embodiments, the hydrogel is placed on top of the flexible substrate.

[0032] In some embodiments, the electrical conductor is arranged on the flexible substrate.

[0033] In some embodiments, the at least one connector portion includes a plurality of conductive contact pads.

[0034] In some embodiments, the plurality of conductive contact pads are arranged in an interlaced pattern.

[0035] In some embodiments, each contact pad is substantially square.

[0036] In some embodiments, the contact pad is electrically connected to the electrode via the electrical conductor.

[0037] In some embodiments, the total number of contact pads in the electrode patch is the same as the total number of electrodes.

[0038] In some embodiments, the total number of contact pads in the electrode patch is the same as the total number of electrodes and the total number of electrical conductors.

[0039] In some embodiments, the total number of contact pads in the electrode patch is greater than the total number of electrodes.

[0040] In some embodiments, the electrode patch includes at least one cutout.

[0041] In some embodiments, the at least one incision is located at the at least one tongue.

[0042] In some embodiments, the shape of the at least one cut is substantially rectangular.

[0043] In some embodiments, the at least one cut is located between the two connector portions.

[0044] In some embodiments, the electrode patch includes two connector portions spaced apart from each other and separated from the electrodes.

[0045] In some embodiments, the two connector portions are located on the same side of the electrode patch and on the same tongue.

[0046] In some embodiments, the two connector portions are a first connector portion and a second connector portion, wherein a fixed number of electrodes are electrically connected to the first connector portion and a fixed number of electrodes are electrically connected to the second connector portion.

[0047] In some embodiments, half of a fixed number of electrodes are electrically connected to a first connector portion, and the remaining half of a fixed number of electrodes on the electrode patch are electrically connected to a second connector portion.

[0048] In some embodiments, the electrode array comprises 64 electrodes arranged in 8 rows and 8 columns.

[0049] In some embodiments, the electrode array contains more or fewer than 64 electrodes.

[0050] In some embodiments, the electrode array comprises 32 electrodes.

[0051] In some embodiments, 32 electrodes are arranged in 8 rows and 4 columns.

[0052] In some embodiments, the 32 electrodes are arranged in 4 rows and 8 columns.

[0053] In some embodiments, the electrode patch is polygonal in shape.

[0054] In some embodiments, the electrode patch includes a main region, and at least one tongue is formed on the electrode patch extending from the main region, the at least one tongue being coplanar with the main region.

[0055] In some embodiments, the main area is substantially rectangular in shape.

[0056] In some embodiments, the electrodes are located in the main region.

[0057] In some embodiments, at least one intermediate portion is located between the at least one tongue and the main region, and the at least one intermediate portion is narrower than the at least one tongue and the main region.

[0058] In some embodiments, the shape of the at least one tongue is substantially rectangular.

[0059] In some embodiments, the electrode patch has rounded corners to prevent curling.

[0060] In some embodiments, two tongues extending from the remainder of the patch are formed on the patch, the two tongues being coplanar with each other and with the remainder of the patch, the two tongues being a first tongue and a second tongue.

[0061] In some embodiments, the one or more connector portions are located in one or both of the first or second tongues.

[0062] In some embodiments, the first tongue and the second tongue are located on opposite sides of the main region.

[0063] In some embodiments, the first tongue is substantially rectangular in shape.

[0064] In some embodiments, the second tongue is substantially rectangular in shape.

[0065] In some embodiments, at least one intermediate portion is substantially trapezoidal in shape.

[0066] In some embodiments, the electrode patch includes an adhesive for allowing the electrode patch to adhere to the outer surface of the subject's skin.

[0067] In some embodiments, the adhesive is located at the edge of the electrode patch.

[0068] In some embodiments, the adhesive is located at the edge of the main area and at the at least one tongue.

[0069] In some embodiments, the adhesive located at the at least one tongue is spaced apart from the at least one connecting portion.

[0070] In some embodiments, the adhesive forms an adhesive layer.

[0071] In some embodiments, the electrode patch includes a plurality of positioning holes at or near at least one connector portion.

[0072] In some embodiments, the electrode patch includes a plurality of positioning holes surrounding one or each of at least one connector portion.

[0073] In some embodiments, the electrode patch is a disposable electrode patch.

[0074] In some embodiments, electrode patches are used to monitor the gastrointestinal electrical activity of a subject.

[0075] In some embodiments, the electrode patch is used to monitor the colonic electrical activity of the subject.

[0076] In some embodiments, the subjects are pediatric patients.

[0077] In some embodiments, the electrode patch includes a flat surface, wherein at least a portion of each electrode, connector portion, and electrical conductor is exposed on the flat surface.

[0078] In some embodiments, a flat surface is a surface configured to contact the outer surface of the subject's skin.

[0079] In some embodiments, a flat surface is a substantially flat surface.

[0080] In some embodiments, the electrode patch is formed as a monolithic material or essentially as a panel.

[0081] In some embodiments, the electrode patch is polygonal in shape.

[0082] In some embodiments, the electrode patch extends between a first end and a second end opposite to the first end, wherein the electrode is closer to the first end than the second end, and the connector portion is closer to the second end than the first end.

[0083] In some embodiments, the electrodes are spaced apart from the connector portion by a distance of at least one-quarter of the total distance between the first and second ends.

[0084] In some embodiments, the connector portion is spaced at least 5 cm from each electrode.

[0085] In a second aspect, the present invention relates to a connector device comprising a first clamping member and a second clamping member, or a first clamping member and a second clamping member, the first clamping member and the second clamping member being configured to move between a clamping position and a release position; in the clamping position, the first clamping member and the second clamping member being configured to clamp an electrode patch or at least a portion thereof to allow physical and operative connection between the connector device and the electrode patch; in the release position, the first and second clamping members being configured to move away from the clamping position to allow the electrode patch or a portion thereof to be released from the connector device.

[0086] 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.

[0087] In some embodiments, in the clamping position, the first clamping member moves toward the second clamping member, and in the releasing position, the first clamping member moves away from the second clamping member.

[0088] In some embodiments, the first and second clamping members are magnetic clamping members.

[0089] In some embodiments, at least one of the first and second clamping components includes at least one connector configured to be physically and operatively connected to an electrode patch or a portion thereof for receiving electrical signals from a plurality of electrodes of the electrode patch to allow monitoring of electrical activity generated by the subject.

[0090] In some embodiments, at least one connector is one or more array connectors.

[0091] In some embodiments, the at least one connector is one or more inserters.

[0092] In some embodiments, the connector device includes a body having a flat surface, an electrode patch or a portion thereof configured to be placed on the flat surface, the body including a first end and a second end positioned opposite to each other, wherein a first clamping member is mounted to the body at or near the first end, and the second clamping member is the body, wherein in a clamped position the first clamping member is configured to move toward the flat surface of the body, and in a released position the first clamping member is configured to move away from the flat surface of the body.

[0093] In some embodiments, the first clamping member is hinged to the body.

[0094] In some embodiments, the first clamping component includes at least one connector.

[0095] In some embodiments, the first clamping 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 clamping member is exposed to the surrounding environment, and in the closed position, the connector of the at least one first clamping member is concealed in the surrounding environment.

[0096] In some embodiments, in the clamping position, the first clamping member is configured to pivotally move toward the flat surface of the body and to at least partially conceal at least a portion of the flat surface of the body.

[0097] In some embodiments, the connector device includes a body having a flat surface, an electrode patch or a portion thereof configured to be placed on the flat surface, the body including a first end and a second end positioned opposite to each other, wherein a first clamping member is mounted to the body at or near the first end, and a second clamping member is mounted to the body at or near the second end, wherein in a clamped position, the first and second clamping members are each configured to move toward the flat surface, and in a released position, the first and second clamping members are each configured to move away from the flat surface.

[0098] In some embodiments, the first and second clamping members are hinged to the body.

[0099] In some embodiments, the first and second clamping components each include at least one connector.

[0100] In some embodiments, the first and second clamping 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 clamping members is exposed to the surrounding environment, and in the closed position, the connector of each of the first and second clamping members is concealed in the surrounding environment.

[0101] In some embodiments, the connector device includes at least one positioning feature configured to position and / or retain an electrode patch or a portion thereof on the connector device.

[0102] In some embodiments, the connector device includes at least one positioning feature configured to position and / or retain an electrode patch or a portion thereof on the connector device, wherein the at least one positioning feature is located on or substantially on a flat surface between a first end and a second end.

[0103] In some embodiments, the at least one positioning feature is located on a flat surface between the first end and the second end, or substantially on the flat surface.

[0104] In some embodiments, at least one positioning feature is a protrusion configured to be received by at least one complementary cut formed in the electrode patch.

[0105] In some embodiments, the protrusion is located at or near the center of the first end and the second end.

[0106] In some embodiments, the protrusion is substantially rectangular or cuboid in shape.

[0107] In some embodiments, when the protrusion is received by at least one complementary cut formed in the electrode patch, the protrusion is sized to prevent lateral movement of the electrode patch between the first end and the second end.

[0108] In some embodiments, the connector device further includes a plurality of locating pins configured to be received by complementary locating holes formed in the electrode patch.

[0109] In some embodiments, the locating pin is located on either side of the protrusion.

[0110] In some embodiments, six locating pins are located on any one or both sides of the protrusion.

[0111] In some embodiments, in the clamping position, both the first clamping member and the second clamping member are configured to pivotally move toward a flat surface and at least partially conceal the flat surface except for the protrusion.

[0112] In some embodiments, in the clamped position, at least a portion of the protrusion is exposed to the surrounding environment.

[0113] In some embodiments, a portion of the protrusion exposed to the surrounding environment includes a display screen.

[0114] In some embodiments, the connector device is a portable electronic device.

[0115] In some embodiments, the connector device is a data acquisition device.

[0116] In some embodiments, the connector device is a data recording device.

[0117] 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, in which the electronic components of the connector device are at least partially disposed.

[0118] In some embodiments, the connector device is powered by a battery.

[0119] In some embodiments, the connector device is powered by a lithium-ion battery.

[0120] In some embodiments, the electronic device includes electronic circuitry and a memory, with instructions stored in the memory, wherein execution of the instructions causes the electronic device to receive signals from electrode patches, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject.

[0121] In some embodiments, the connector device includes at least one analog-to-digital converter to amplify and digitize the biopotential measurement signal received from the electrode patch.

[0122] In some embodiments, the at least one analog-to-digital converter is an analog-to-digital converter chip.

[0123] In some embodiments, the connector device includes a microcontroller configured to receive signals from an analog-to-digital converter, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject.

[0124] In some embodiments, at least one analog-to-digital converter is electrically connected to the microcontroller via a flexible cable.

[0125] In some embodiments, the electronic device further includes flash memory, one or more near field connectivity (NFC) modules, and / or one or more charging circuits.

[0126] In some embodiments, the connector device is part of a connector system that includes a mating device having a connector device receiving compartment configured to receive the connector device.

[0127] In some embodiments, the docking device is a wireless charging device used to facilitate wireless charging of the connector device when the connector device is housed within a connector device housing compartment.

[0128] In some embodiments, the electrode patch is part of the connector system.

[0129] In some embodiments, the connector device includes a biasing member configured to move toward at least one of first and second clamping members toward the electrode patch.

[0130] In some embodiments, the biasing component is a spring sheet.

[0131] In a third aspect, the present invention relates to a connector device, comprising:

[0132] A body extending from a first end to a second end opposite to the first end, the body having a top surface and a bottom surface, the top surface being configured to accommodate an electrode patch or at least a portion of an electrode patch having multiple electrodes for monitoring electrical activity generated by a subject.

[0133] At least one clamping component is mounted on the main body;

[0134] At least one clamping member is configured to move between an open position and a closed position, wherein in the open position, the at least one clamping member is configured to move away from the top surface and be at least partially exposed to the top surface, and in the closed position, the at least one clamping member is configured to move toward the top surface and be at least partially concealed within the top surface;

[0135] The at least one clamping component includes at least one connector configured to be physically and operably connected to the electrode patch or a portion thereof for receiving electrical signals from a plurality of electrodes to allow monitoring of electrical activity generated by the object.

[0136] In some embodiments, the at least one clamping member is hinged to the body.

[0137] In some embodiments, both the first and second clamping components include at least one connector.

[0138] In some embodiments, the at least one clamping member is configured to move between an open position and a closed position, wherein in the open position, the at least one connector of the at least one clamping member is exposed to the surrounding environment, and in the closed position, the at least one connector of the at least one clamping member is concealed in the surrounding environment.

[0139] In some embodiments, at least one connector is one or more array connectors.

[0140] In some embodiments, the at least one connector is one or more inserters.

[0141] In some embodiments, in the closed position, the at least one clamping member is configured to pivotally move toward the top surface and at least partially conceal the top surface.

[0142] In some embodiments, the connector device is a wearable electronic device, and at least a body and at least one clamping member together form a housing, with the electronic components of the connector device at least partially disposed within the housing.

[0143] In some embodiments, the connector device includes at least one positioning feature configured to position and / or retain an electrode patch or a portion thereof on the top surface.

[0144] In some embodiments, at least one positioning feature is located or substantially located on the top surface.

[0145] In some embodiments, at least one positioning feature is a protrusion configured to be received by at least one complementary cut formed in the electrode patch.

[0146] In some embodiments, the protrusion is located at or near the center of the first end and the second end.

[0147] In some embodiments, the protrusion is substantially rectangular or cuboid in shape.

[0148] In some embodiments, when the protrusion is received by at least one complementary cut formed in the electrode patch, the protrusion is sized to prevent lateral movement of the electrode patch between the first end and the second end.

[0149] In some embodiments, the connector device further includes a plurality of locating pins configured to be received by complementary locating holes formed in the electrode patch.

[0150] In some embodiments, the locating pin is located on either side of the protrusion.

[0151] In some embodiments, six locating pins are located on each side of the protrusion.

[0152] In some embodiments, in the closed position, at least one clamping member is configured to pivotally move toward the top surface and to at least partially conceal the top surface except for the protrusion.

[0153] In some embodiments, at least two clamping components are mounted on the body, and the at least two clamping components are a first clamping component and a second clamping component.

[0154] In some embodiments, the first and second clamping members are configured to move between an open position and a closed position, wherein when in the open position, both the first and second clamping members are configured to move toward the top surface and at least partially conceal the top surface; and

[0155] At least one of the first and second clamping components includes at least one connector configured to be physically and operatively connected to an electrode patch or a portion thereof for receiving electrical signals from a plurality of electrodes to allow monitoring of electrical activity generated by the subject.

[0156] In some embodiments, the first and second clamping 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 clamping members is exposed to the surrounding environment, and in the closed position, the connector of each of the first and second clamping members is concealed in the surrounding environment.

[0157] In some embodiments, the at least one positioning feature is located on a flat surface between the first end and the second end, or substantially on the top surface.

[0158] In some embodiments, in the closed position, both the first and second clamping members are configured to pivotally move toward the top surface and to at least partially conceal the top surface except for the protrusion.

[0159] 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, in which the electronic components of the connector device are at least partially disposed.

[0160] In some embodiments, the connector device is powered by a battery.

[0161] In some embodiments, the connector device is powered by a lithium-ion battery.

[0162] In some embodiments, the connector device includes electronic circuitry and a memory, with instructions stored in the memory, wherein the execution of the instructions causes the electronic device to receive signals from the electrode patches, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject.

[0163] In some embodiments, the connector device is a data acquisition device.

[0164] In some embodiments, the connector device is a data recording device.

[0165] In some embodiments, the connector device is part of a connector system that includes a mating device having a compartment configured to accommodate the connector device.

[0166] In some embodiments, the docking device is a wireless or contact charging device used to facilitate wireless or contact charging of the connector device when the connector device is housed within a connector device housing compartment.

[0167] In some embodiments, the connector device includes at least one analog-to-digital converter to amplify and digitize the biopotential measurement signal received from the electrode patch.

[0168] In some embodiments, the at least one analog-to-digital converter is an analog-to-digital converter chip.

[0169] In some embodiments, the connector device includes a microcontroller configured to receive signals from an analog-to-digital converter, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject.

[0170] In some embodiments, at least one analog-to-digital converter is electrically connected to the microcontroller via a flexible cable.

[0171] In some embodiments, the electronic component further includes flash memory, one or more near field connectivity (NFC) modules, and / or one or more charging circuits.

[0172] In some embodiments, the electrode patch is part of the connector system.

[0173] In some embodiments, the electrode patch is an electrode patch as defined in the first aspect.

[0174] In a fourth aspect, the present invention primarily pertains to a system for monitoring electrical activity generated by a subject, the system comprising:

[0175] An electrode patch includes spatially arranged electrodes for contacting the outer surface of a subject's skin to sense and measure potentials at multiple electrodes, wherein the electrodes are routed to at least one connector portion spaced apart from the electrodes and electrically connected to the electrodes via an electrical conductor serving as a conductive track between the electrodes and the at least one connector portion.

[0176] A connector device having at least one connector configured to be physically and operatively connected at said at least one connector portion to an electrode patch or at least a portion of an electrode patch for receiving electrical signals from a plurality of electrodes to allow monitoring of electrical activity generated by the subject.

[0177] In some embodiments, the connector device is an electronic device.

[0178] In some embodiments, the connector device includes electronic circuitry and a memory, with instructions stored in the memory, wherein the execution of the instructions causes the electronic device to receive signals from the electrode patches, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject.

[0179] In some embodiments, the connector device is a data acquisition device.

[0180] In some embodiments, the connector device is a data recording device.

[0181] In some embodiments, the system further includes a docking device with a compartment configured to accommodate a connector device.

[0182] In some embodiments, the electrode patch is an electrode patch as defined in the first aspect.

[0183] In some embodiments, the connector device is a connector device as defined in the second or third aspect.

[0184] In some embodiments, the system is used to monitor gastrointestinal electrical activity.

[0185] In some embodiments, the electrode patch is an electrode patch as defined in the first aspect.

[0186] In a fifth aspect, the present invention primarily pertains to a method for connecting electrode patches to a connector device, the method comprising:

[0187] Electrode patches are provided;

[0188] A connector device is provided having first and second clamping members, the first and second clamping members being configured to clamp the electrode patch or at least a portion of the electrode patch;

[0189] The first clamping member and the second clamping member are moved between a clamping position and a release position, wherein in the clamping position, the first clamping member and the second clamping member are configured to clamp the electrode patch or at least a portion of the electrode patch to allow physical and operational connection between the connector device and the electrode patch or a portion of the electrode patch; and in the release position, the first and second clamping members are configured to move away from the clamping position to allow the electrode patch or a portion of the electrode patch to be released from the connector device.

[0190] 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, wherein the method further includes:

[0191] In the release position, the electrode patch or a portion thereof is positioned on the connector assembly such that at least one protrusion is received by the at least one cutout; and

[0192] Move the first and second clamping components from the release position to the clamping position.

[0193] In some embodiments, the electrode patch includes a plurality of positioning holes, and the connector device includes a plurality of complementary positioning pins configured to be received by the positioning holes, wherein the method further includes:

[0194] In the release position, the electrode patch or a portion of the electrode patch is positioned on the connector assembly such that multiple locating pins are received by multiple locating holes; and

[0195] Move the first and second clamping components from the release position to the clamping position.

[0196] In some embodiments, the electrode patch is an electrode patch as defined in the first aspect.

[0197] In some embodiments, the connector device is a connector device as defined in the second or third aspect.

[0198] Other aspects of the invention will become apparent from the following description, which is given by way of example only and with reference to the accompanying drawings.

[0199] In this specification, references to patent specifications, other external documents, or other sources of information are generally made for the purpose of providing background for discussing the features of the invention. Unless otherwise specifically stated, references to such external documents should not be construed as an admission that such documents or sources of information are prior art or form part of general common knowledge in the art within any jurisdiction.

[0200] For descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives are intended to refer to the orientation of the invention in the accompanying drawings. However, it should be understood that various alternative variations of the invention may be employed unless otherwise expressly stated. It should also be understood that the specific devices illustrated in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0201] It is generally accepted that the term 'comprises' can have an exclusive or inclusive meaning in different jurisdictions. For the purposes of this specification, and unless otherwise indicated, the term 'comprises' should be interpreted inclusively, meaning not only that which includes the listed parts directly referenced therein, but also that which includes other unspecified parts or elements. When used in connection with one or more steps in a system, method, or process, the terms 'comprises,' 'comprised,' or 'comprising' have similar meanings.

[0202] As used above and below, the term “and / or” means “and,” “or,” or both.

[0203] As used above and below, the “(s)” after a noun indicates the plural and / or singular form of the noun.

[0204] When used in the claims, and unless otherwise stated, the word 'for' should be interpreted as meaning only "suitable for," and not specifically 'adapted' or 'configured' for, for example, the stated particular purpose. Attached Figure Description

[0205] Preferred embodiments of the invention will be described by way of example only and with reference to the following figures, wherein:

[0206] Figure 1 : This is an example / embodiment of an electrode patch according to the first preferred embodiment of the present invention.

[0207] Figure 2 It shows Figure 1 The connection part of the electrode patch.

[0208] Figure 3 : Shows what can be used to connect to Figure 1 Examples of connectors with electrode patches.

[0209] Figure 4 It shows Figure 3 Cross-sectional view of the connector.

[0210] Figure 5 Example / embodiment of a connector device according to a first preferred embodiment of the present invention is shown, which is configured to connect to Figure 1 Electrode patches.

[0211] Figure 6 This is an example / embodiment of a connector device according to a second preferred embodiment of the present invention.

[0212] Figure 7 :yes Figure 6 Exploded view of the connector assembly.

[0213] Figure 8 It shows Figure 1 An example of the electrode patch hole arrangement in the connector portion of the electrode patch.

[0214] Figure 9 Example / embodiment of an electrode patch according to a second preferred embodiment of the present invention is shown. A connector for the connector device is also shown.

[0215] Figure 10 and 11 It shows Figure 9 An example of the connector portion of the electrode patch is shown, and an electrical conductor connected to the connector portion is also shown.

[0216] Figure 12 Example / embodiment of a connector device in the clamped position according to a third preferred embodiment is shown.

[0217] Figure 13 : Shows what can be used to connect to Figure 10 and 11 Connector examples for the connector section.

[0218] Figure 14 It shows Figure 13 How are connectors used to connect to Figure 10 and 11 An example of the connector portion.

[0219] Figure 15 Example / embodiment of a connector device according to a fourth preferred embodiment of the present invention is shown.

[0220] Figure 16: Shows what can be used to connect to Figure 10 and 11 A top view of another example of a connector in the connector section.

[0221] Figure 17 It shows Figure 16 A perspective view of the connector.

[0222] Figure 18 It shows Figure 16 Side view of the connector.

[0223] Figure 19 It shows Figure 9 An example of the connector portion of the electrode patch is shown, and an electrical conductor connected to the connector portion is also shown.

[0224] Figure 20 Example / embodiment of an electrode patch according to a third preferred embodiment of the present invention is shown. A schematic diagram of a connector device is also shown.

[0225] Figure 21 It shows Figure 15 Examples / implementations of the connector portion of the electrode patch.

[0226] Figure 22 Example / embodiment of an electrode patch according to a third preferred embodiment of the present invention is shown. A schematic diagram of a connector device is also shown.

[0227] Figure 23 Example / embodiment of a connector device in the open / released position according to the fifth preferred embodiment is shown.

[0228] Figure 24 : Indicates the closed / clamped position Figure 23 Examples / implementations of connector devices.

[0229] Figure 25-30 The sequence is shown Figure 23 How the connector assembly is placed on the mating assembly, and Figure 23 How the connector device is used to connect to the electrode patch.

[0230] Figure 31 Example / embodiment of a connector device in the open / released position according to the sixth preferred embodiment is shown.

[0231] Figure 32 Example / embodiment of a connector device in the open / released position according to a seventh preferred embodiment is shown. An electrode patch according to another preferred embodiment of the invention is also shown.

[0232] Figure 33Example / embodiment of a connector device in the open / release position according to the eighth preferred embodiment is shown. An electrode patch according to another preferred embodiment of the invention is also shown.

[0233] Figure 34 An electrode patch according to a fifth preferred embodiment of the present invention is shown.

[0234] Figure 35 It shows what will be placed on the docking device. Figure 23 The connector device is engaged Figure 35 Electrode patches.

[0235] Figure 36 It shows the relationship with Figure 23 The connector device is engaged Figure 35 The electrode patch is placed on the docking device, wherein... Figure 23 The connector assembly is in the open / release position.

[0236] Figure 37 Examples / implementations of connector devices are shown. Figure 35 electrode patches and Figure 23 The connector assembly engages, wherein Figure 23 The connector assembly is in the closed / clamped position.

[0237] Figure 38 An example / embodiment of a connector device in the open / released position according to the ninth preferred embodiment is shown.

[0238] Figure 39 An example / embodiment of a connector device in the closed / clamped position according to the ninth preferred embodiment is shown.

[0239] Figure 40 An example / embodiment of an electrode patch according to another preferred embodiment is shown, the electrode patch being placed on a docking device. Figure 37 The connector assembly is engaged. Detailed Implementation

[0240] Conventional medical devices for monitoring electrical activity may use sensing devices comprising electrode patches and connector devices, which can be electronic devices, such as data acquisition devices that communicate electronically with such patches. However, these conventional devices do not focus on the coupling mechanism between the electrode patch and the connector device to ensure a reliable and correct connection between the two. If this connection is incorrect, the connector device and the electrode patch are likely to disconnect accidentally, in which case real-time monitoring of physiological / electrical activity cannot be performed. Furthermore, due to its weight, the connector device can easily detach from the electrode patch and fall off the subject's body, which not only damages the connector device but also leads to confusion, dissatisfaction, and poor treatment adherence. Therefore, it is desirable to provide an electrode patch connection system that allows for a simple yet reliable coupling between the electrode patch and a connector device that can be worn by the subject. Furthermore, it is desirable to provide an electrode patch connection system for non-invasive medical devices that can be worn by the subject to monitor physiological conditions comfortably and reliably while the subject is engaged in normal daily activities. Additionally, it is desirable to provide an electrode patch connection system that can be easily set up and used by new patients with little or no experience using any systems for monitoring physiological functions. Furthermore, it is desirable to provide an electrode patch connection system that eliminates the need for cables to connect the electrode patch and the connector assembly.

[0241] There is also a desire for an electrode patch that does not skew when connected to a connector device, as skew can lead to connection failures and crosstalk.

[0242] There is also a desire for an electrode patch designed to allow for optimal encapsulation of the contact pad within a minimal area, thereby enabling a smaller electrode patch design that is more comfortable to wear, especially in the abdominal area.

[0243] There is also a desire for an electrode patch that is simple to design and inexpensive to manufacture via screen printing.

[0244] There is also a desire for an electrode patch that requires little or no wiring during use, thus minimizing or eliminating tangling, or having little or no wiring.

[0245] It is also desirable to have an electrode patch that makes the subject feel comfortable when it is attached to the outer surface of the subject's skin during use.

[0246] It is also desirable to have a connector device and electrode patch assembly that are not easily moved when attached to the patient's / subject's skin surface.

[0247] Now refer to the attached diagram, in which Figure 1 An example of an electrode patch 100 according to a preferred embodiment of the present invention is shown.

[0248] The electrode patch 100 is configured to be used as part of a system for monitoring the physiological functions of a subject. The subject is preferably a human, but optionally, the subject may be a non-human animal. Most preferably, the electrode patch 100 is configured to be used as part of a system for monitoring the gastrointestinal (GI) electrical activity of the subject. In some embodiments, the electrode patch 100 may be configured to monitor the electrophysiological activity of other areas of the subject (e.g., but not limited to the colon region), and / or monitor the heart or other smooth muscle systems (e.g., the uterus or bladder), or monitor brain signals (EEG) or skeletal muscle signals (EMG).

[0249] The electrode patch 100 is essentially a sensing device and includes a plurality of spatially arranged surface electrophysiological sensors in the form of electrodes for contacting the outer surface of the subject's skin to sense and measure the potential at the plurality of electrodes. Figure 1 In the example shown, there are a total of 66 electrodes, with 64 arranged in an 8x8 array, and the remaining two electrodes 102a and 102b serving as a ground electrode and a reference electrode, respectively. In use, the potential can be measured as the difference between each of the 64 electrodes and the reference electrode 102a. The ground electrode 102a can be either a "driving right leg" or a "bias" electrode. The purpose of the ground electrode 102a is to maintain the voltage level of the subject's body within an acceptable range and minimize any common-mode noise (e.g., 50 / 60Hz power line noise) within the subject's body. The driving right leg will act as a source or sink if necessary (within reasonable limits) to achieve this. However, the electrode patch 100 may include more than 66 electrodes or fewer than 66 electrodes. The ground electrode 102a and the reference electrode 102b may differ from... Figure 1 As shown.

[0250] Preferably, the electrode patch 100 is configured to be removably attached to the outer surface of the subject's skin, most preferably to the abdominal region or its vicinity, such that electrodes 102, 102a, 102b can contact the outer surface of the subject's skin in or near the abdominal region to sense and measure electrical signals from the subject's gastrointestinal tract. If the electrode patch 100 is used to sense and measure electrical signals from other regions, the electrode patch can be configured to be removably attached to the outer surface of the subject's skin at or near a suitable region, such that electrodes 102, 102a, 102b can contact the outer surface of the subject's skin at or near that region to sense and measure electrical signals from that region of the subject's body. This may include a colonic region.

[0251] Electrode patch 100 can be made of a flexible and stretchable material. Electrode patch 100 may include a flexible substrate, and electrodes may be spatially arranged on the flexible substrate. The flexible substrate may also be stretchable. Because it is flexible and stretchable, electrode patch 100 can be suitably adhered to the subject's skin, which can improve electrode impedance. To monitor electrical activity (e.g., GI electrical activity), due to the low signal amplitude, it may be necessary to place the electrodes as close as possible to the target gastrointestinal organs on the abdominal surface. Since the subject's skin on the abdominal surface typically undergoes significant deformation due to normal body movement, electrodes spatially arranged in a conformal / flexible substrate can deform accordingly, thereby reducing the likelihood of detachment from the subject's skin. By reducing the likelihood of detachment from the subject's skin, the possibility of unreliable signal quality is also minimized.

[0252] The flexible substrate may include or be made of thermoplastic polyurethane (TPU) film, which may be a thin adhesive film / layer. Hydrogels may be placed on top of the flexible substrate to enhance the transmissibility of biological signals.

[0253] like Figure 1 As shown, the electrode patch may include at least one connector portion 104. The connector portion 104 may be spaced apart from electrodes 102, 102a, and 102b. The connector portion 104 is not any of electrodes 102, 102a, and 102b. The connector portion 104 may be spaced apart from a main region P of the electrode patch containing electrodes 102, 102a, and 102b, and the connector portion 104 is electrically connected to electrodes 102, 102a, and 102b. As shown, the main region P may be a generally rectangular shape as shown. Alternatively, the main region P may be any other suitable polygonal shape. In some embodiments, the main region P may be circular. As shown, the electrode patch 100 may extend between a first end and a second end opposite to the first end. Electrodes 102, 102a, and 102b may be located closer to the first end than the second end, and the connector portion may be located closer to the second end than the first end. In some embodiments, electrodes 102, 102a, and 102b may be spaced apart from connector portion 104 by a distance at least one-quarter of the total distance between the first and second ends. Electrode patch 100 may be spaced at least 5 centimeters apart from each of electrodes 102, 102a, and 102b.

[0254] By isolating connector portion 104 from the electrodes, any connector device attached to connector portion 104 can also be positioned at a distance from the electrodes. This minimizes interference with the electrodes and / or contact between electrodes 102, 102a, 102b and the outer surface of the subject's skin during physical interactions with the connector device and / or any physical interactions at connector portion 104.

[0255] Electrode patch 100 may include / have a flat surface, and at least a portion of each of electrodes 102, 102a, 102b, connector portion 104, and 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. Electrode patch 100 may be formed as a single sheet material or substantially a panel. This planar surface arrangement improves comfort and provides better adhesion to the subject's skin during use because there are no protrusions in the skin contact area of ​​the electrode patch, and no part of the electrode patch 100 protrudes in the skin contact area. At least one tongue 103 may be formed on the electrode patch 100 extending from the remainder of the electrode patch 100. The tongue 103 may be coplanar with the remainder of the electrode patch 100. Connector portion 104 may be located in the tongue 103, but in one embodiment may be located near / closest to the tongue. Having a connector portion 104 on the tongue 103, which is narrower than the main 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, whereas a larger connector device would be required if the connector portion 104 were located in other, wider areas of the electrode patch 100. Therefore, having the tongue 103 and the connector portion 104 located on the tongue reduces the volume and potential weight of the entire device worn during use (i.e., the device including the connector device and the electrode patches). As shown, an intermediate region I can be formed between the main region P and the tongue 103. The shape of the intermediate region I can be approximately trapezoidal.

[0256] As shown, the electrode patch 100 may include a second tongue 105, and the ground electrode 102a and the reference electrode 102b may be located on the second tongue 105. As shown, the end of the tongue 103 furthest from the electrode 102 (and further from the main region P) is formed as a C-shaped portion 107. As shown, a cutout 109 may be located between the electrode 102 and the connector portion 104. As shown, the second tongue 105 may be generally rectangular in shape.

[0257] The connector portion 104 can be disposed on a flexible substrate. For example... Figure 1As shown, connector portion 104 can be electrically connected to electrodes 102, 102A, 102B via an electrical conductor 106 serving as a conductive track (also referred to as a conductive line) between electrodes 102 and connector portion 104. This electrical conductor 106 can be a conductive track. In one embodiment, it can be a wire. A conductive track is preferable to a less preferred embodiment that might use wires. For example, mass production can be achieved at a lower cost by using a conductive track (instead of a wire). Furthermore, conductive tracks provide lower electrical noise compared to wires. Additionally, wires can move and are prone to tangling or displacement, while conductive tracks are fixed to the electrode patches, thus preventing such undesirable movement and tangling. Therefore, conductive tracks provide better reliability for the performance of the electrode patches. Moreover, unlike wires, using conductive tracks avoids protrusions or similar features on the surface of the electrode patch, which is configured to contact the subject's external skin (the outer surface of the skin), thereby providing comfort during use. The electrical conductor 106 can be arranged on a flexible substrate.

[0258] like Figure 2 As shown, the connector portion 104 may include a plurality of conductive contact pads 108. The contact pads 108 may be arranged on a flexible substrate. The contact pads 108 may be electrically connected to electrodes via electrical conductors 106. Figure 1 As shown, the electrical conductor 106 can serve as a conductive track between the electrode 102 and the contact pad 108.

[0259] In the electrode patch 100, the total number of contact pads 108 can be the same as the total number of electrodes 102. Figure 1 In the example shown, there are 66 electrodes and 66 contact pads 108 in the electrode patch 108. The electrodes 102 and contact pads 108 can be connected in such a way that one electrode is electrically connected to only one contact pad, and no two electrodes are electrically connected to the same contact pad. For example... Figure 1 As shown, both the reference electrode 102a and the ground electrode 102b can be separated from the electrode array 102.

[0260] 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 serve a variety of purposes. As an example, spare contact pads can be used to detect the version or model of the connector device used with the electrode patch. For instance, if one or more spare contact pads connect to the connector of the contact device when such a connection is not expected, this may suggest to the user that an incorrect version or model of connector device is being used. Similarly, if one or more spare contact pads connect / disconnect to the connector of the contact device when such a connection is expected, this may suggest to the user that an incorrect version or model of connector device is being used. The user may receive error messages or other mechanisms that might trigger them to use the correct version of the connector device.

[0261] Each of electrodes 102, 102A, 102B and contact pad 108 can be electrically connected using an electrical conductor 106 in such a way that an electrode is electrically connected to an electrical contact pad 108 using only one electrical conductor, and no electrical conductor is electrically connected to more than one pair of electrodes and contact pads that are electrically connected to each other.

[0262] In the patch, the total number of electrical conductors 106 is the same as the total number of electrodes 102, 102a, and 102b. For example... Figure 1 As shown, there are 66 electrical conductors 106 in patch 100.

[0263] Electrodes 102, 102a, and 102b can be Ag-AgCl electrodes.

[0264] Each of electrodes 102, 102a, and 102b may be at least 2 cm apart from each other. The maximum length of the patch may be 21 cm. The maximum width of the patch may be 16 cm. In some embodiments, the width of the patch may be greater than or less than 21 cm.

[0265] The electrode patch 100 may include an adhesive that can be formed into 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.

[0266] Electrode patches 100 can be mass-produced using screen printing. For Figure 1 One of the main challenges in designing the electrode patch is providing the minimum width of the conductor 106 required for screen printing, while simultaneously providing a suitable physical layout so that all electrodes (all 66 electrodes in this example) converge at the connector portion 104 for connection to the connector assembly. Each contact pad 108 also requires a certain flat surface area for efficient and reliable operation. The electrode patch 100 of the present invention can be configured as follows: Figure 2This is achieved through the staggered / patterned configuration of the contact pads 108 shown. Preferably, as shown, each contact pad 108 is square to maximize the x / y tolerances required for electrical contact with the connector assembly. Alternatively, the contact pads 108 may be rectangular in shape. Figure 1 As shown, the electrical conductors 106 on the electrode patch 100 can enter the contact pad 108 with staggered spatial spacing and travel / extend in a curved path. This configuration, as described above, allows the contact pad 108 to be optimally encapsulated within a minimal area. This configuration also allows the connector portion 104 to connect effectively and efficiently to the connector 150 of the connector assembly, for example... Figure 5 The connector device 600 shown.

[0267] Figure 3 An example of a connector 150 for electrical connection to the contact pad 108 of an electrode patch 100 is shown. The connector 150 may include a plurality of conductive pins 152 configured to be electrically connected to the contact pad 108 of the connector portion 104 during use. The connector 150 may be an inserter or an array connector, and the pins 152 may be as follows: Figure 4 The solder ball form is shown. This connector 150 can operate by compression and may require accumulated contact force, which can increase with the number of contacts 152 used. By using this connector 150, cables can be eliminated to connect the connector portion 104 (and electrodes) to the connector device, as shown below. Figure 5 The connector device 500 is described. One example of a usable connector 150 is a 1.0mm 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 cable / wire is required to electrically connect connector 150 and electrode patch 100.

[0268] Figure 5An embodiment of a connector device 500 for clamping an electrode patch 100 or at least a portion thereof is shown. When in the clamped position, this clamping can apply pressure to the electrode patch or a portion thereof. As shown, the connector device 500 can be in the form of two separate connecting or clamping components: a first clamping component 510, which in this example is a lower clamping component, and a second clamping component 520, which in this example is an upper clamping component. The first clamping component 510 and the second clamping component 520 are configured to clamp the electrode patch 100, and more specifically, clamp the connector portion 140 of the electrode patch between them. In this example, the first clamping component 510 and the second clamping component 520 are shown as two separate elements, and the two clamping components 510 and 520 are preferably connected via a flexible printed circuit board 515. Figure 2 As shown, the connector portion 104 of the electrode patch 100 may include holes 110a, 110b, and 110c, hereinafter referred to as electrode patch holes 110a, 110b, and 110c. Holes 110a, 110b, and 110c may be enlarged holes. The first clamping member 510 and the second clamping member 520 may be attached via the electrode patch holes 110a, 110b, and 110c using magnetic coupling. The number, size, and / or configuration of the electrode patch holes 110a, 110c may differ from those of the second clamping member 520. Figure 2 As shown in the diagram, the electrode patch holes 110a, 110b, and 110c can also serve as positioning elements for positioning the connector portion 104 of the patch to the connector 150. For example, the connector assembly 500 may have a positioning pin configured to be received by the electrode patch holes 110a, 110b, and 110c to ensure that the connection portion 104 is correctly positioned and connected to the connector 150.

[0269] Figure 6 Another preferred embodiment of a connector device 600 for connecting to the connector portion 104 of the electrode patch 100 is shown. Figure 7 yes Figure 6 An exploded view of the connector assembly 600. (See attached diagram.) Figure 6 and Figure 7 As shown, the connector assembly 600 includes 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, clamp the connector portion 104 of the electrode patch 100 between them.

[0270] As shown in the figure, the first clamping member 610 is a bottom / lower clamping member, which is configured to clamp the connector portion 104 of the electrode patch 100 from the bottom when the first clamping member 610 and the second clamping member 620 are fixed together in the clamping position.

[0271] The first clamping member 110 includes a first clamping plate 611, a connector 650, and a foam layer 612. As shown, the first clamping member 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 located on the lower surface 611c and is 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 have external threads. A plurality of pins 615a, 615b, and 615c may be located on the upper surface 611d between the first stud 614a and the second stud 614b. Compared to studs 614a and 614b, pins 615a, 615b, and 615c can be smaller in size (preferably in length, diameter, and / or height). Multiple connector retaining pins 616a and 616b may be located near the pins. In this example, two connector retaining pins 616a and 616b are located near pins 615a and 615b. Connector retaining pin 616a is located near pin 615a, and connector retaining pin 616b is located near pin 615b. No connector retaining pin may be located near the intermediate pin 615c. In one embodiment (not shown), the connector retaining pin may also optionally be located near pin 615c.

[0272] As shown in the figure, connector 650 is configured to be located on the upper surface 611d of the first clamping member 610, more specifically, on the upper surface 611d of the first clamping plate 611, wherein the contact pin 652 of connector 650 faces upward, i.e., toward the second clamping member 620. Connector 650 may be an array connector. Connector 650 may be an inserter. As shown in the figure, connector 650 may include a plurality of pin receiving connector holes 653a, 653b, and 653c for receiving pins. Figure 6 As shown, connector holes 653a, 653b, and 653c can accommodate pins 615a, 615b, and 615c, respectively. Connector 650 may include retaining pin receiving holes 654a and 654b for accommodating connector retaining pins 616a and 616b. As shown, retaining pin receiving holes 654a and 654b can accommodate connector retaining pins 616a and 616b, respectively.

[0273] Connector 650 can be similar to the one mentioned above. Figure 3 and 4 The connector 150 is described. It is understood that the first clamping member 610 may include any number of pins, connector retaining pins and / or studs to accommodate the type of electrode patch 100 configured to be clamped by the connector assembly 600 and the type of connector 650 used.

[0274] As shown in the figure, the second clamping member 620 is a top / upper clamping member used to clamp the connector portion 104 of the electrode patch 100 from the top when the first clamping member 610 and the second clamping member 620 are fixed together in the clamping position.

[0275] The second clamping component 620 includes a second clamping component plate 621 and a cover plate 622.

[0276] The second clamping member plate 621 extends longitudinally between the first end 621a and the second end 621b and includes a lower surface 621c and an upper surface 621d. The cover plate 622 is configured to be fixed to the second clamping member plate 621 at the upper surface 621d.

[0277] The second clamping member plate 621 may 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 may optionally include threaded structures (e.g., internal threads) for engaging with the external threads of the first stud 614a and the second stud 614b, respectively. A plurality of pin receiving holes 625a, 625b, and 625c may be located between the first stud receiving hole 624a and the second stud receiving hole 624b. When the first clamping member 610 and the second clamping member 620 are in the clamped position, pins 615a, 615b, and 615c may be received through the pin receiving holes 625a, 625b, and 625c, respectively. Compared to stud receiving holes 624a, 624b, the diameters of pin receiving holes 625a, 625b, and 625c appear smaller because, in this example, the diameters of pins 615a, 615b, and 615c are smaller than the diameters of studs 614a, 614b. Multiple connector retaining pin receiving holes 626a and 626b can be located near pin receiving holes 625a and 625b, respectively, for receiving pin retaining pins 616a and 616b. As shown, additional connector retaining pin receiving holes 626a' and 626b' can be present, located near pin receiving holes 625a and 625b, respectively, and opposite to connector retaining pin receiving holes 626a and 626b. If the second clamping member 620... Figure 7 The positions shown are rotated / rotated 180 degrees in the same plane, and these additional connector retaining pin receiving holes 626a' and 626b' can respectively accommodate pin retaining pins 616a and 616b. This means that the first clamping member 610 and the second clamping member 620 can be fixed together to clamp the electrode patch between them, even if one of the clamping members is rotated 180 degrees clockwise or counterclockwise in the same plane.

[0278] As shown, the cover plate 622 may include a first wing screw head 627a and a second wing screw head 627b. The wing screw heads are rotatable and may have internal threads configured to engage with the threaded studs 614a, 614b. The first wing screw head 627a may be configured to rotatably engage with the first stud 614a, and the second wing screw head 627b may be configured to rotatably engage with the second stud 614b. As shown, the cover plate 622 may also include optional plate retaining screws 628a and 628b, configured to be received by complementary plate retaining screw receiving holes 629a and 629b respectively located at an optional second clamping member plate 621, to further secure the cover plate 622 to the second clamping member plate 621. The complementary plate retaining screw receiving holes 628a and 628b may be formed on the upper surface 621d of the second clamping member plate 621.

[0279] In order to clamp the electrode patch 100 between the first clamping member 610 and the second clamping member 620, the first clamping member 610 and the second clamping member 620 can first be separated from each other, such as Figure 6 As shown. Then, the electrode patch 100 can be placed on top of the first clamping member 610. More specifically, the connector portion 104 of the electrode patch 100 can be placed above the connector 650, facing down, so that the contact pad 108 located at the connector portion 104 of the electrode patch 100 can be physically connected to the contact pin 652 of the connector 650.

[0280] The first stud 614a can pass through the cutout 109 of the electrode patch 100, and the second stud 614b can pass through the C-shaped portion 107 of the electrode patch. Pins 615a, 615b, and 615c can be aligned with electrode patch holes 110a, 110b, and 110c, respectively. The diameters of the electrode patch holes 110a, 110b, and 110c can be larger to accommodate connector retaining pins 616a, 616b, and 616c. Optionally, additional electrode patch holes may be provided to accommodate connector retaining pins 616a, 616b, and 616c.

[0281] Then, the second clamping member 620 can be placed on top of the first clamping member 610 and the portion of the electrode patch 100 placed on top of the first clamping member 610. The electrode patch 100 is then clamped between the connecting devices 600 by tightening the screw heads 627a, 627b by rotating them clockwise or counterclockwise. The electrode patch 100, clamped by the connector device 100, can then be adhered to the outer surface of the subject's skin using an adhesive or similar substance, with the electrode 102 and the foam layer 612 in contact with the outer surface of the subject's skin.

[0282] Because the foam layer 612 is a soft material, it can prevent abrasions or injury to the subject's skin during use. Similarly, it is understood that having a foam layer 612 for contact on the patient side rather than a hard surface may mean that the subject will be more comfortable wearing the connection device 600 of the present invention compared to similar devices with a harder surface.

[0283] The connector device 600 may be a portable electronic device (such as a data acquisition unit or data recording device) that can be worn by a subject to allow 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 (via wired or wireless means) to an electronic device (such as a data acquisition device or data recording device) to allow electrophysiological monitoring. If the connector device 600 includes any cables or wires, then these cables or wires may pass through the cutouts 109 formed on the electrode patch 100.

[0284] The principles and operation of data acquisition or data recording devices are well-known to those skilled in the art and need not be described here. However, connector device 600 may include at least one analog-to-digital converter (ADC) to amplify and digitize the biopotential measurement signal received from electrode patch 100. Multiple (e.g., four) ADCs may be present. One or more ADCs may be one or more ADC chips. Connector device 600 may include a microcontroller. The microcontroller is configured to receive signals from the ADCs, process the signals, and transmit data to a remote computing device to allow monitoring of electrical activity generated by the subject. One or more ADCs may be electrically connected to the microcontroller via one or more flexible cables. The one or more flexible cables may be one or more flexible printed circuit boards. Electronic components also include flash memory, one or more near-field communication (NFC) modules, and / or one or more charging circuits.

[0285] The above reference Figure 5 The described connector device 500 may also be a similar portable electronic device or intermediate device, and may include a connector similar to connector 650 in the first clamping member or the second clamping member.

[0286] Connector device 600 is part of a connector system that includes a mating device having a compartment configured to receive the connector device. The mating device may be a wireless charging device to facilitate wireless charging of the connector device when it is received within the connector device receiving compartment.

[0287] It is understood that, due to the presence of the notch 109 and the electrode patch holes 110a, 110b, and 110c, misalignment of the electrode patch 100 can be prevented when the connector portion 104 of the electrode patch 100 is clamped together by the connector assembly 600. Preventing misalignment of the electrode patch 100 may be important for preventing connection failures and crosstalk.

[0288] After use, the electrode patch can be detached (e.g., peeled off) from the outer surface of the subject's skin. The connection between the screw heads 627a, 627b and the studs 614a, 614b can be loosened by rotation, and then the first clamping member 610 and the second clamping member 620 can be separated from each other. The electrode patch 100 can then be removed from the connector assembly 600. The electrode patch 100 is preferably a disposable device and can be discarded after use.

[0289] although Figure 6 and Figure 7 The diagram shows a first clamping member 610 as an upper clamping member and a second clamping member 620 as a lower clamping member. However, in an alternative configuration, the first clamping member 610 can be the upper clamping member and the second clamping member 620 can be the lower clamping member. In this configuration, the connector portion 104 of the electrode patch can be placed on top of the second clamping member plate 621 of the second clamping member 620, and the connector portion 104 of the electrode patch 100 can face upward toward the downward-facing connector 650 of the first clamping member 610.

[0290] Figure 8 Another example of the connector portion of the electrode patch 100 is shown. For clarity, Figure 8 The contact pad and electrical conductor are not shown. Figure 8 The connector portion is substantially the same as the connection portion 104 as described above, and most of the description of the connector portion 104 above also applies to this connector portion, and this document will only describe the differences.

[0291] As shown in the figure, Figure 8 The connector portion includes a total of five electrode patch holes, 110a', 110b', 110c', 110d' and 110e', which serve as positioning holes.

[0292] When clamped by connector assembly 600, electrode patch holes 110a' can be configured to receive a first stud 614a; electrode patch holes 110b' can be configured to receive pins 615a and 615b; electrode patch holes 110c' can be configured to receive pins 615c; electrode patch holes 110d' can be configured to receive pins 615b; and electrode patch holes 110e' can be configured to receive a second stud 614b. It is understood that the presence of electrode patch holes 110a', 110b', 110c', 110d', and 110e' prevents misalignment of the electrode patch 100 when the connector portion 104 of the electrode patch 100 is clamped together by connector assembly 600. These also ensure proper positioning between connector portion 104' and connector 104. As described above, preventing misalignment of the electrode patch 100 can be important for preventing connection failures and crosstalk. Figure 8 In the electrode patch of the connector portion, the cutout 109 and / or C-shaped portion 107 may be optional. Optionally, the cutout 109 may still be present in the electrode patch 100 such that if the connector assembly 600 includes any cables or wires, then those cables or wires can pass through the cutout 109 formed on the electrode patch 100. The dimensions of the connector assembly for clamping the electrode patch 100 having the connector portion 104' may differ from the dimensions of the connector assembly for clamping the electrode patch 100 having the connector portion 104'. Alternatively or additionally, the dimensions of the tongue 103 of the electrode patch 100 may differ to fit the connector portion.

[0293] Figure 9 An example of an electrode patch 200 according to another preferred embodiment of the present invention is shown. Most features of the electrode patch 200 are substantially similar to those of the electrode patch described above, and therefore most of the description above regarding the electrode patch 100 can also be applied to the connector patch 200, and only the differences will be described herein.

[0294] Electrode patch 200 may include two connector portions. An electrical conductor 206, serving as a conductive track between electrodes 202, 202a, and 202b, is routed to two separate connector portions. Electrode 202a is a ground electrode, and electrode 202b is a reference electrode. Figure 9 In the image, the connector portions are not visible because they are covered by connectors 250a and 250b. The two connectors 250a and 250b can be similar to connectors 150 or 750 as described above. Preferably, the two connectors 250a and 250b are identical. Alternatively, connector 250a may be different from connector 250b.

[0295] Preferably, Figure 9The two connectors 250a and 250b shown are not part of the electrode patch 200, but rather part of one or more connector assemblies adapted to clamp the electrode patch 200. One or more connector assemblies may be identical to one or more connector assemblies 500 or 600 as described above. Figure 9 For clarity, the complete connector assembly is not shown.

[0296] Dividing the connector into two or more parts is better than having a single connector part, because by separating the connector parts in this way, a smaller mating force is required at each connection point to achieve reliable coupling between the electrode patch 200 and the connector device.

[0297] There are two cutouts 209a and 209b in the electrode patch 200. The cutouts are optional.

[0298] In an alternative embodiment, connector 650 is adhered to a connector portion (e.g., by adhesive or the like) and is part of electrode patch 200, not part of a connector assembly. In this embodiment, one or more connector assemblies may include cables for allowing electrical communication between connector 650 and one or more connector assemblies.

[0299] The tongue 203 of the electrode patch 200 is shown to be generally rectangular. However, the tongue 203 can have many other suitable shapes. Although not shown, the tongue 203 may optionally include a C-shaped portion adjacent to each connector portion.

[0300] Each connector portion of the electrode patch 200 can be similar to the connector portion described above. Each connector portion can look like... Figure 2 The first half 104a or the second half 104b of the connector portion shown. More specifically, the contact pad assembly of each connector portion of the electrode patch 200 can be arranged as follows: Figure 2 The first half 104a or the second half 104b of the connector portion shown are arranged in an alternating pattern.

[0301] Figure 10 and 11 An example of a connector portion of the electrode patch 200 is shown. In other words, Figure 10 and 11The connector portion 204 shown is one of two connector portions of the electrode patch 200. As shown, connector portion 204 may include a total of 34 staggered contact pads 208. These 34 contact pads are connected via electrical conductors 206 to 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b. The electrical conductors 206 extend as conductive tracks between the electrodes 202, 202a, 202b, and connector portion 204, and more specifically, between the contact pads of the electrodes 202, 202a, 202b, and connector portion 204. The other of the two connector portions of the electrode patch 200 may be similar to connector portion 204, and this connector portion 204 may also have 34 contact pads connected via electrical conductors 206 to the remaining 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b.

[0302] Figure 12 Another example of a preferred embodiment of the connector device 700 and the electrode patch 200 is shown, wherein the electrode patch is clamped between a first clamping member 710 and a second clamping member 720.

[0303] The connector device 700 in this example is similar to the connector device 600 described above in most respects, and by comparison Figure 5 and Figure 6 and Figure 12 The differences are noticeable. Figure 12 In, with Figure 6 Similar features are identified by the same reference numerals plus 100. Much of the description of the connector device 600 of the preferred embodiment described above also applies to the connector device 600, and therefore need not be described in detail again. Only the main functions will be discussed.

[0304] As shown in the figure, unlike the connector device 600 which includes pins 615a, 615b, and 615c, the connector device 700 includes only two pins 715a and 715b between the first stud 714a and the second stud 714b. The connector 750 is a second clamping member 720, not part of the first clamping member. Both the first clamping member 710 and the second clamping member 720 can include housings 723a and 723b, which are semi-elliptical in shape, have smooth outer surfaces, and are as follows... Figure 12In the clamping position shown, the connector device 700 is substantially elliptical in shape. Since the outer surfaces of both housings 723a and 723b are smooth and have the same shape, either the first or second clamping member can be placed close to the outer surface of the subject's skin during use. If the first clamping member 710 is to be placed close to the subject's skin, the electrode patch 200 will be placed on top of the first clamping member with its contact pad 208 facing upwards toward the second clamping member 720. This is because the second clamping member 720 includes the connector 750. Similarly, if the first clamping member 710 is to be placed close to the subject's skin, the electrode patch 200 will be placed on top of the first clamping member with its contact pad 208 facing downwards toward the second clamping member 720, which includes the connector 750. Although not shown, a foam layer may optionally be added to the surface of the connector device 700, which is configured to attach to the outer surface of the subject's skin.

[0305] The first clamping member 710 and the second clamping member 720 can be fixed together in a variety of suitable ways to be in a clamped position, such as, but not limited to, magnetic coupling, latching devices, snap-fit ​​devices, etc.

[0306] When the connector assembly 700 clamps the electrode patch 200, the electrode patch hole 210a can be configured to receive a first stud 714a; the electrode patch hole 210b can be configured to receive a pin 715a; the electrode patch hole 210c can be configured to receive a pin 715b; and the electrode patch hole 210d can be configured to receive a second stud 714b. It is understood that the presence of electrode patch holes 210a, 210b, 210c, and 210d prevents misalignment of the electrode patch 200 when the connector portion 204 of the electrode patch 200 is clamped together by the connector assembly 700. Electrode patch holes 210a, 210b, 210c, and 210d also serve as positioning holes, as they allow for proper positioning of the connector portion 204 and the connector 750.

[0307] Two separate connector units 700 can be used to clamp the two connector portions 204.

[0308] Figure 15The connector device is preferably an electronic device (such as a data acquisition device or data recording device), and is preferably battery-powered (see lithium-ion battery 741). The principles and design of the data acquisition device or data recording device 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 (ADC) to amplify and digitize the biopotential measurement signal received from the electrode patch 200. Multiple (e.g., four) ADCs may be present. One or more ADCs may be one or more ADC chips. The connector device 700 may include a microcontroller. The microcontroller is configured to receive signals from the ADCs, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject. One or more ADCs may be electrically connected to the microcontroller via one or more flexible cables. The one or more flexible cables may be one or more flexible printed circuit boards. The electronic components also include flash memory, one or more near-field connectivity (NFC) modules, and / or one or more charging circuits.

[0309] like Figure 12 As shown, a main printed circuit board (PCB) 743 may be present. PCB 743 may include a microcontroller and other electronic circuitry, such as, but not limited to, a microcontroller, flash memory, one or more near-field connectivity (NFC) modules (e.g., a Bluetooth module), charging circuitry, etc. Another PCB 721' may be present, which includes or forms a clamp 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 including or forming the clamp 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 located on the main PCB 743, and the corresponding ZIF connector may be electrically connected to the ZIF connector 745 using a flexible cable.

[0310] Figure 13 Another example of a connector 350 physically connected to the connector portion 204 described above is shown. This example of connector 350 is similar in most respects to the connector 150 described above, and by comparison... Figure 3 and Figure 13 The differences are noticeable. Figure 13 The fewer conductive contacts 352 on the connector are designed to allow for a reduced mating force. Reduced mating force improves the reliability and lifespan of the coupling device. Figure 13 In, with Figure 6 Similar features are identified by the same reference numerals plus 200.

[0311] One corner of the connector is Figure 13 It is displayed as tilted, but tilting is not necessary.

[0312] The conductive contact 352 may optionally be trapezoidal in shape. Although Figure 13 As not shown, the conductive contact 352 may optionally protrude from the body of the connector 352.

[0313] like Figure 13 As shown, conductive contacts 352 are arranged / spaced in a specific direction to contact the contact pads 208 of the connector portion 204. Figure 14 The diagram shows the conductive pin 352 contacting the contact pad 208 when physically connected. As shown, each contact pad 208 can be configured to contact two conductive pins. This provides a backup contact between the contact pad 208 and the conductive pins. Therefore, the device will continue to function normally even if one of the two conductive pins is damaged, worn, or covered with residue (e.g., when cleaning the device between patients).

[0314] Figure 15 Another example of a preferred embodiment of a connector device 800 is shown, which is configured to clamp an electrode patch 200 between a first clamping member 810 and a second clamping member 820.

[0315] The connector device 800 in this example is similar to the connector device 700 described above in most respects, and by comparison Figure 12 and Figure 15 The differences are noticeable. Figure 15 In, with Figure 12 Similar features are identified by the same reference numerals followed by 100. Much of the description of the connector device 700 of the preferred embodiment described above also applies to the connector device 800, and therefore need not be described in detail again. Only the main differences will be discussed.

[0316] As shown in the figure, the connector device 800 includes only two pins 815a and 815b. Unlike connector devices 700 where pins 715a and 715b are located between a first stud 714a and a second stud 714b, in connector device 700, the first stud 814a and the second stud 814b are located between pins 815a and 815b. Although not shown, a foam layer may optionally be added to the surface of the connector device 800, which is configured to attach to the outer surface of a subject's skin.

[0317] When the connector device 800 clamps the electrode patch 200, the electrode patch hole 210a can be configured to receive the pin 815a; the electrode patch hole 210b can be configured to receive the first stud 814a; the electrode patch hole 210c can be configured to receive the second stud 814b; and the electrode patch hole 210d can be configured to receive the pin 815b. It is understood that the presence of electrode patch holes 210a, 210b, 210c, and 210d prevents the electrode patch 200 from tilting when the connector portion 204 of the electrode patch 200 is clamped together by the connector device 800.

[0318] Two separate connector devices 800 can be used to clamp the two connector portions 204.

[0319] Figure 15 The connector device is preferably an electronic device (such as a data acquisition device or a data recording device), and is preferably battery-powered (see lithium-ion battery 841). The principles and operation of the data acquisition device or data recording device 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 (ADC) to amplify and digitize the biopotential measurement signal received from the electrode patch 200. Multiple (e.g., four) ADCs may be present. One or more ADCs may be one or more ADC chips. The connector device 800 may include a microcontroller. The microcontroller is configured to receive signals from the ADCs, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject. One or more ADCs may be electrically connected to the microcontroller via one or more flexible cables. The one or more flexible cables may be one or more flexible printed circuit boards. The electronic components also include flash memory, one or more near-field connectivity (NFC) modules, and / or one or more charging circuits.

[0320] like Figure 15 As shown, a main printed circuit board (PCB) 843 may be present. PCB 843 may include a microcontroller and other electronic circuitry, such as, but not limited to, a microcontroller, flash memory, one or more near-field connectivity (NFC) modules (e.g., a Bluetooth module), charging circuitry, etc. Another PCB 821' may be present, which includes or forms a clamp 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 including or forming the clamp 821 to the main PCB 843 using a flexible cable (e.g., a flexible printed circuit board). A corresponding ZIF connector 846 may be located on the main PCB 843, and the corresponding ZIF connector may be electrically connected to the ZIF connector 845 using a flexible cable.

[0321] The connector assembly 800 includes a biasing component, which in this example is a spring sheet 855. The spring sheet 855... Figure 15 The image shows the second clamping member 820. A spring sheet is configured to bias the second clamping member 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. This biasing of the second clamping member 820 toward the electrode patch allows for proper connection between the conductive contact 852 of the connector 850 and the connector portion of the electrode patch.

[0322] Figures 16-18 Another example of connector 450 is shown, which can be an array connector or an inserter, in conjunction with the following reference. Figure 19 The connector portion 204.1 described herein is used for physical connection. The connector 450 of this example is similar in most respects to the connector 350 described above, and by comparison... Figure 13 and Figure 16-18 The differences can be identified. Figures 16-18 The fewer conductive contacts on connector 450 are designed to allow for a reduced mating force. Reduced mating force improves the reliability and lifespan of connector 450. Figures 16-18 In, with Figure 13 Similar features are identified by the same reference numerals plus 100.

[0323] One corner of the connector is Figures 16-18 It is displayed as tilted, but tilting is not necessary.

[0324] like Figure 18 As shown, conductive contact 452 can protrude from the body of connector 452. As illustrated, conductive contact 452 can be located on two opposite front faces of connector 450, such that connector pins on either front face of connector 450 can be used with the connector pins shown below. Figure 19 The contact pad 208.1 of the described connector portion 204.1 is in contact with it. Connectors 150, 250, and 350 may also have connector pins on each front side.

[0325] Conductive contact 452 as follows Figure 14 The specific arrangement shown is configured to contact the contact pad 208.1 of connector portion 204.1. When physically connected to the contact pad 208.1, the conductive pin 452 can contact the contact pad 208.1. Each contact pad 208.1 can be configured to contact only one conductive pin. This reduces the total force required to connect to the contact pad 208.1.

[0326] Figure 19Another example of a connector portion of the electrode patch 200 is shown. In other words, Figure 10 and 11 The connector portion 204.1 shown is one of two connector portions of the electrode patch 200. As shown, connector portion 204.1 may include a total of 38 staggered contact pads 208. 34 of these contact pads are connected via electrical conductors 206.1 to 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b. Electrical conductors 206.1 extend as conductive tracks between electrodes 202, 202a, 202b and connector portion 204.1, and more specifically, between electrodes 202, 202a, 202b and the contact pads 208.1 of connector portion 204.1. The other of the two connector portions of the electrode patch 200 may be similar to connector portion 204, and this connector portion 204.1 may also have 34 contact pads connected via electrical conductors to the remaining 32 of the 64 array electrodes 202, the ground electrode 202a, and the reference electrode 202b.

[0327] Figure 10 Connector part 204 and Figure 19 One of the main differences between the connector sections of 204.1 and those of other 204.1 is that... Figure 19 The connector portion 204.1 includes four additional connector pads 208.1a, 208.1b, 208.1c, and 208.1d at or near its center. Furthermore, the conductive pin 452 of the connector 450 is oriented differently from the conductive pin 352 on the connector 350.

[0328] It is understandable that different versions of connectors can be used to connect to... Figure 19 The connector portion 204.1 and four additional connector pads 208.1a, 208.1b, 208.1c, and 208.1d are located at the center of connector portion 204.1, allowing determination of 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. The four additional connector pads 208.1a, 208.1b, 208.1a, and 208.1d allow determination of which version of connector is used to connect to connector portion 204.1. If a connection is detected with the conductive contact at all four additional connector pads 208.1a, 208.1b, 208.1a, and 208.1d, it can indicate... Figures 16-18 Connector 450 is used to connect to connector portion 204.1. Similarly, if no connection is detected with the conductive contacts at all four additional connector pads 2.8.1a, 2.8.1b, 208.1a, and 208.1d, it can indicate... Figure 13 Connector 350 is used to connect to connector part 204.1.

[0329] When the connector device 800 clamps the electrode patch 200 at the connector portion 204.1, the electrode patch hole 210a can be configured to receive a pin 815a; the electrode patch hole 210b can be configured to receive a first stud 814a; the electrode patch hole 210c can be configured to receive a second stud 814b; and the electrode patch hole 210d can be configured to receive a pin 815b. It can be understood that the presence of electrode patch holes 210a, 210b, 210c, and 210d prevents the electrode patch 200 from tilting when the connector portion 204.1 of the electrode patch 200 is clamped together by the connector device 800. Figure 19 In the diagram, electrode patch holes 210a' and 201d' are shown to have larger diameters than electrode patch holes 210b' and 201c' because in the connector assembly 800, the diameters of pins 815a and 815b are larger than the diameters of the first stud 814a and the second stud 814b.

[0330] It is understood that the size, shape, orientation, and number of electrode patch holes in the connector portion of the electrode patch can be customized to suit the connector device used to clamp the connector portion of the electrode patch.

[0331] exist Figure 19 The optional cut 209' is shown in the image. This cut is related to... Figure 9 The cuts 209a or 209b shown are the same, except that cut 209' is in... Figure 19 It is shown as a circle (but cutout 209a can be any other shape).

[0332] Figure 20 An example of an electrode patch 300 according to another preferred embodiment of the present invention is shown. Most features of the electrode patch 300 are substantially similar to those of the electrode patch 100 described above, and therefore most of the description of the electrode patch 100 above can also be applied to the connector patch 300, and only the differences will be described herein.

[0333] Electrode patch 300 may include two connector portions 304a, 304b on two opposite sides of electrode patch 300 (two opposite sides of array electrode 300) (see Figure 21 ).exist Figure 20 The diagram schematically illustrates a connector assembly for connecting two connector portions. The connector assembly can be any of the connector assemblies 500, 600, 700, and 800 described above. Figure 20The configuration of the electrode patch 300 shown is advantageous because it distributes the weight and volume of the connector assembly across two distinct areas, resulting in better balance during use. Since two connector assemblies are required to connect to the two connector portions 304a, 304b, an additional electrical conductor 206' can serve as a conductive track to electrically connect the two connector portions 304a, 304b. One or more additional electrical conductors can act as conductive tracks across the substrate of the electrode patch 300 without any physical contact with any other electrical conductors 206 and electrodes 302 of the electrode patch 300. This additional electrical conductor 306' allows both the connector connected to connector portion 304a and the connector connected to connector portion 304b to receive time-synchronized signals. It also allows the connectors connected to connector portion 304a and the connector connected to connector portion 304b to operate together.

[0334] Connector portions 304a and 304b can be similar to connector portion 104 as described above. This is as follows: Figure 21 As shown. Optionally, connector portions 304a, 304b may be similar to connector portions 204 or 204.1 as described above.

[0335] In an alternative embodiment, the connector portions 204a, 204b of the electrode patches 200 may be located on opposite sides of the array electrodes 202, rather than on the same side of the array electrodes 202. One or more additional electrical conductors, similar to electrical conductor 306', may be used in a manner similar to that described above. Figure 21 The connector parts 204a and 204b are connected in the manner described.

[0336] Figure 22 An example of an electrode patch 400 according to another preferred embodiment of the present invention is shown. Most features of the electrode patch 400 are substantially similar to those of the electrode patch 100 described above, and therefore most of the description of the electrode patch 100 above can also be applied to the connector patch 400, and only the main differences will be described herein.

[0337] exist Figure 22 In this embodiment, electrode patch 400 is shown to include 36 array electrodes 402, a ground electrode 402a, and a reference electrode 402b. However, the number of array electrodes 402 may be more than 32 (such as 64 or even more as described in previous embodiments). In some embodiments, electrode patch 400 may have fewer than 32 array electrodes 402.

[0338] The electrode patch 400 may include two connector portions 404a and 402b. An electrical conductor 406, serving as a conductive track between electrodes 402, 402a and 402b, is routed to the two separate connector portions 404a and 404b.

[0339] Dividing connector portions 402a and 402b into two or more parts is preferable to having a single connector portion because, by separating the connector portions in this way, a smaller mating force is required at each connection point to achieve reliable coupling between the electrode patch 400 and the connector device. Furthermore, dividing connector portions 402a and 402b into two or more parts means that the connector portions will be 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.

[0340] A large cutout 409 is located between connector portions 402a and 402b. The cutout 409 is shown as generally rectangular in shape. However, the cutout 409 can have many other suitable shapes. The cutout 409 is used for the proper positioning of the electrode patch 400 on the connector assembly (connector assembly 900 described below).

[0341] The tongue 403 of the electrode patch 400 is shown to be generally rectangular. However, the tongue 403 can have many other suitable shapes. In some embodiments, there may be no tongue, and the dimensions of the main area comprising the electrode 402 can be... Figure 22 The regions that serve as the tongue 403 are the same or substantially the same size. In some embodiments, the main regions containing electrodes 402, 402a, and 402b may have the same dimensions as... Figure 22 Different shapes are shown. The main area can be compared to... Figure 22 The width or size shown depends on the intended application of patch 400.

[0342] 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... Figure 2 The first half 104a or the second half 104b of the connector portion 104 shown. More specifically, the contact pad assembly of each connector portion of the electrode patch 400 can be arranged as follows: Figure 2 The first half 104a or the second half 104b of the connector portion shown are arranged in an alternating pattern.

[0343] like Figure 17 As shown, the electrode patch may include an adhesive or adhesive layer 413 on the edges and tongue 403 to allow 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 the edges of the main area) in a similar manner.

[0344] The electrode patch 400 may include a plurality of positioning holes 414 adjacent to each connector portion 404a, 404b. Figure 17 In the example shown, there are six positioning holes 414 near connector portion 404a and another six positioning holes near connector portion 404b. The positioning holes 414 are used for the correct positioning of the electrode patch 400 on the connector assembly (connector assembly 900 as described below). More specifically, the positioning holes 414 are used for the correct positioning of the connector portions 404a, 404b of the electrode patch 400 with the connector (such as connector 950 of connector assembly 900), as described below.

[0345] Figure 23 A connector device 900 according to another preferred embodiment of the present invention is shown.

[0346] The connector assembly 900 includes a body 905 extending from a first end 905a to a second end 905b opposite to the first end 905a. The body 905 has flat surfaces, namely a top surface 905c and a bottom surface 905d (see...). Figure 25 The top surface 805c is configured to receive the electrode patch 400 for monitoring electrical activity generated by the subject.

[0347] like Figure 17 and Figure 18 As shown, the connector assembly 900 includes a first clamping member 910, which is a flap hinged / pivoted to the body 905d at or near a first end 905a. The connector assembly 900 also includes a second clamping member 920, which is also hinged / pivoted to the flap of the body at or near a second end 905b.

[0348] The first clamping member 910 and the second clamping member 920 are configured to, for example Figure 23 The opening position shown and as Figure 19 The clamping members move between the closed positions shown. As shown, in the open position, both the first clamping member 910 and the second clamping member 920 are configured to pivotally move away from the top surface 905c and at least partially, preferably completely, expose the top surface 905c. Similarly, in the closed position, both the first clamping member 910 and the second clamping member 920 are configured to pivotally move toward the top surface 905c and partially, preferably completely, conceal the top surface 905c.

[0349] At least one, but preferably both, of the first clamping member 910 and the second clamping member 920 includes at least one connector 950 configured to physically and operatively connect to the electrode patch 400 for receiving electrical signals from a plurality of electrodes of the electrode patch 400 to allow monitoring of electrical activity generated by the subject. Therefore, the connection between the connector 950 and the electrode patch 400 does not require a cable. The connector may be connector 150 or 350 as described above.

[0350] The connector assembly 900 may include at least one positioning feature configured to position and / or retain the electrode patch 400 on its top surface. Figure 23 The diagram illustrates multiple positioning features 930, 935. These positioning features are in the form of protrusions 935 and positioning pins 935. The protrusion is configured to be received by at least one complementary cutout 409 formed in the electrode patch 400 to position and / or retain the electrode patch 400 on the top surface 905c of the connector assembly 900. The protrusion 935 may be generally rectangular or generally cuboid in shape. When the protrusion 935 is received by at least one complementary cutout formed in the electrode patch, the size of the protrusion 935 is sufficient to at least prevent lateral movement of the electrode patch between the first end 905a and the second end 905b.

[0351] The locating pin 935 is configured to be received by a complementary locating hole 414 formed in the electrode patch 400. The locating pin 935 may be located on one or both sides of the protrusion 930. Figure 23 In the example shown, six locating pins 935 are located on both sides (sides) of the protrusion 930. There may be more or fewer than six locating pins.

[0352] like Figure 24 As shown, in the closed position, both the first clamping member 910 and the second clamping member 910 can be configured to pivotally move toward the top surface and, except for the protrusion 930 or at least a portion thereof, at least partially (preferably completely) conceal the top surface 905c.

[0353] The connector device 900 is preferably a wearable electronic device. Preferably, the body 905, the first clamping member 910, and the second clamping member 920 together form a housing, within which various electronic components of the connector device are at least partially disposed. Figure 23 In the diagram, connector 950 is shown protruding slightly from the first clamping member 910 and the second clamping member 920.

[0354] The connector device 900 may include electronic circuitry and a memory, in which instructions are stored. Execution of these instructions causes the connector device 900 to receive signals from the electrode patch 400, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject. The electronic device may be a data acquisition device or a data recording device. The data may be transmitted wirelessly and / or via wire to the computing device for processing, filtering, or analysis.

[0355] Preferably, the connector device 900 is powered by a battery (e.g., a lithium-ion battery). The principles and operation of data acquisition or data recording devices are well known to those skilled in the art and need not be described herein. However, the connector device 800 may include at least one analog-to-digital converter (ADC) to amplify and digitize the biopotential measurement signal received from the electrode patch 400. Multiple (e.g., four) ADCs may be present. One or more ADCs may be one or more ADC chips. The connector device 800 may include a microcontroller. The microcontroller is configured to receive signals from the ADCs, process the signals, and transmit the data to a remote computing device to allow monitoring of electrical activity generated by the subject. One or more ADCs may be electrically connected to the microcontroller via one or more flexible cables. The one or more flexible cables may be one or more flexible printed circuit boards. The electronic components also include flash memory, one or more near-field communication (NFC) modules, and / or one or more charging circuits.

[0356] Figures 25-29 An example of a mating device 1500 of a connector assembly 900 is shown, and how the mating device 1500 can be used to receive the connector assembly 900. As shown, the mating device 1500 may include a compartment 1550, which is a connector assembly receiving compartment.

[0357] The docking device 1500 can be a wireless charging device, used when the connector device is housed in, for example, Figure 25 The compartment 1550 shown facilitates wireless or contact charging of the connector device. The principles and design of wireless or contact charging devices are well known to those skilled in the art and will not be described further here.

[0358] One purpose of the docking device 1500 is to provide a large, flat surface 1510 in which the operator can easily assemble the electrode patch 400' and the connector device 900 together. The electrode patch 400' (e.g., Figure 28 , 29 The electrode patch 400 (shown in Figure 30) is essentially the same as the electrode patch 400 described above. The only major difference is the number of electrodes. The electrode patch 400' may include an array of 64 electrodes 402', a ground electrode 402a', and a reference electrode 402b'. However, the electrode patch 400' may have more or fewer than 64 electrodes. Figures 23-25 For clarity, electrical conductors and connector portions, positioning holes, and adhesives are not shown. Figures 20-25 For clarity, locating pin 935 is not shown. Figures 25-29 The image shows the front portion 400a' of the electrode patch 400. Figure 30 The rear portion 400b' of the electrode patch 400 is shown in the image.

[0359] One embodiment of the assembly mode is as follows.

[0360] The connector assembly 900 is placed in a recess, specifically in a compartment 1550 within the surface of the mating assembly 1500. The connector assembly 900 has a geometry consistent with the compartment 1550, facilitating correct orientation. The clamping members 910 and 920 formed on the connector assembly 900 are then moved to an open position to expose the connector 950. The electrode array 400' is then positioned on the flat surface 1510 of the mating assembly 1500. This flat surface 1510 preferably has sufficient friction to easily hold the electrode patch 400', made of a smooth material, in place. The electrode array 400' is then placed over the open surface of the connector assembly 900, and the positioning holes and pins of the electrode patch 400' and the connector assembly 400' are respectively matched. The clamping members 910 and 920 on the connector assembly 900 are then moved to a closed position and securely fixed to the electrode patch 400', thereby forming a tight connection at the correct positioning.

[0361] Those skilled in the art will understand that connector 950 should not be cleaned with clinical disinfectant solutions to prevent clogging by residues and / or damage due to cleaning; however, for hygiene reasons, connector device 900 may need to be cleaned between patients. The connector device 900 of the present invention makes connector 950 easy to clean and avoids accidental cleaning of the connector because connector 950 is only exposed when clamping members 910, 920 are in the open position. To clean connector device 900, clamping members 910, 920 can be moved to the closed position and wiped with a clinical disinfectant, thus avoiding cleaning of connector 950. Furthermore, since connector 950 is only exposed when clamping members 910, 920 are in the open position, it is less susceptible to damage and less prone to clogging by dust or the like.

[0362] Another purpose of the docking device 1550 is to charge the connector device 900 when not in use. This can be achieved by contacting the charging point. Optionally, a wireless charging coil (not shown) can be placed in a suitable location, preferably below the compartment 1550 in the docking device 1500. The consistent geometry between the connector device 900 and the compartment 1550 in the docking device 1500 ensures a reliable charging connection. The shape and size of the compartment 1550 can be designed to tightly accommodate the connector device 900 within the compartment 1550, and this ensures a reliable charging connection between the docking device 1500 and the connector device 900.

[0363] A considerable force must be obtained at the connection between the electrode patch 400 and the first connecting member 910 and the second connecting member 920 for the connecting device. In the connecting device 900, the first clamping member 910 and the second clamping member 920 can be locked in the closed position by a magnet. However, other suitable locking devices (such as latching devices, snap-fit ​​devices, etc.) can also be used.

[0364] Now refer to Figures 25-30 A preferred method for using a system 2000 including a coupling device 900, a docking device 1500, and an electrode patch 400' is further described. As described above, the electrode patch 400' (e.g. Figure 28 , 29 The electrode patch 400 (shown in Figure 30) can be substantially the same as the electrode patch 400 described above. The only major difference is the number of electrodes. The electrode patch 400' may include an array of 64 electrodes 402', a ground electrode 402a', and a reference electrode 402b'. However, the electrode patch 400' may have more or fewer than 64 electrodes.

[0365] Figure 25 A docking device 1500 is shown, which is prepared to accommodate a connector device 900 within a recess (i.e., compartment 1550).

[0366] like Figure 26 As shown, the connector device 900 is placed within the mating device 1500; more specifically, the connector device 1500 is placed within the compartment 1550 formed in the mating device 1500. Furthermore, when not in use, the connector device 900 can be placed within the mating device, such as... Figure 21 As shown, this allows for wireless or contact charging of connected devices.

[0367] Electrode patch 400' is located on the flat surface 1510 of the mating device. This flat surface 1510 preferably has sufficient friction to easily hold the electrode patch 400', made of a smooth material, in place. The electrode patch 400' is then placed over the opening surface of the connector device 900.

[0368] To couple the electrode patch 400' to the connector assembly 900, the first clamping member 910 and the second clamping member 920 are moved as follows: Figure 28 The opening position is shown.

[0369] Then, the electrode patch 400' is guided downward into the connector assembly 900.

[0370] A tight or precise positioning of the connector portion of the electrode patch with the connector 950 on the first clamping member 910 and the second clamping member 920 is necessary for reliable coupling. This is achieved by a positioning feature in the form of a protrusion 930 received by a notch 409' and a positioning pin 935 received by a positioning hole of the electrode patch 400'. As described above, in Figures 25-29 For clarity, the locating pin 935 and its complementary locating hole for receiving the locating pin 935 are not shown. The protrusion and locating pin help prevent electrode patch misalignment and allow the connector 950 to be tightly or precisely positioned with the connector portion of the electrode patch. This helps prevent connection failures and crosstalk.

[0371] Then, the first clamping member 910 and the second clamping member 920 are moved to the closed position, wherein each clamping member 910, 920 clamps a portion of the electrode patch (the connection portion of the electrode patch) between the clamping member and the top surface 905a of the connector device 900.

[0372] Then, in such Figure 30 The connector device 900 and connector device assembly shown in the assembly configuration are prepared for attachment to the outer surface of the subject's skin. This is achieved by using an adhesive-backed tongue 403' on one side (right side) of the connector device 900 and adhesive on the edge of the band (see [reference]). Figure 22 The remaining portion of the other side (left side) of the adhesive 413 shown allows the electrode patch 400' and connector assembly to adhere firmly to the outer surface of the subject's skin on each side of the connector assembly 900. This also means that the electrode patch 900 can adhere well to each side of the connector assembly 900 and is not easily detached.

[0373] In some embodiments, the raised top surface may include a display screen for showing useful information to the user. This useful information may be related to electrical activity being monitored using the connector device 900, or it may be information about connectivity, test status, or device malfunctions.

[0374] Figure 31 A connector device 1000 according to another preferred embodiment of the present invention is shown. This example of connector device 1000 is similar in most respects to the connector device 900 described above, and by comparison... Figure 23 and Figure 31 The differences are noticeable. Figure 31 In, with Figure 23 Similar features are identified by the same reference numerals plus 100. Much of the description of the connector device 900 of the preferred embodiment described above also applies to the connector device 1000; therefore, only the differences will be discussed.

[0375] As shown in the figure, the connector assembly 1000 may include a latching device comprising a latch 1070 configured to engage, when in a closed position, a latch 1072 formed on a first clamping member 1010 and a second clamping member 1020. Figure 31 Only the latch 1072 on the second clamping member 1020 is visible. Engagement of the latch 1070 with the latch 1072 allows the first and second clamping members to be held in a closed position. As shown, the connector assembly may include a button 1075, which, when pressed, allows the latch to move itself, disengaging from the latch to allow the first and second clamping members to be in an open position. Preferably, the first clamping member 1010 and the second clamping member 1020 are spring-biased to the open position such that when the button 1075 is pressed, the latch 1070 disengages from the latch 1072, and the first member 1010 and the second member 1020 move from the closed position to the open position. As shown, the latch may be located on each side of the protrusion 1030. When the electrode patch 400' is properly positioned on the top surface 1005c of the connector assembly 1000, both the latch 1072 and the protrusion 1030 can be received by the cutout 400' of the electrode patch 400'. A sliding button or many other suitable types of buttons can be used instead of button 1075, which disengages latch 1070 from latch 1072 when slid to one side. Latch 1070 is preferably a mechanical latch. Many other suitable latch and latch devices can be used.

[0376] Figure 32 A connector device 1100 according to another preferred embodiment of the present invention is shown. This example of connector device 1100 is similar in most respects to the connector device 900 described above, and by comparison... Figure 23 and Figure 32 The differences are noticeable. Figure 32 In, with Figure 23 Similar features are identified by the same reference numerals plus 200. Much of the description of the connector device 900 of the preferred embodiment described above also applies to the connector device 1100; therefore, only the main differences will be discussed.

[0377] A key feature of the connector device 900 is the multiple amplifier chips 1190 (which may be analog-to-digital converter chips) adjacent to the connector 1150. This is useful for at least the following reasons:

[0378] It allows signals from electrode patches 400' to be instantly converted into digital signals. This means that only a small number of wires 1180 are needed to pass through clamping members 1120, 1120 to reach the body 1105. Understandably, if the amplifier chip 1190 is located on the body 1105 of the connector assembly 1100, then this would require a much larger number of wires to be laid across the hinged clamping members 1110, 1120 (e.g., 66 wires for 66 electrodes), which could cause some problems for the design or operation of the clamping members 1110, 1120, or lead to increased wear and failure rates.

[0379] • Fast digital conversion also means higher signal quality, because shorter distances, fewer wires, and fewer connections reduce signal loss / noise.

[0380] The connector assembly 1000 may also have multiple amplifier chips adjacent to the connector 1150.

[0381] Figure 33 An electrode patch 200' according to another preferred embodiment is shown, which is placed on a connector device 1200 according to another preferred embodiment.

[0382] 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 also applies to electrode patch 200', and therefore does not need to be described again.

[0383] Electrode patch 200' includes reference Figure 10 and Figure 11 The described connection portion 204 is similar to connection portions 204a' and 204'. For clarity, most features of the electrode patch 200' (e.g., electrodes and intact conductors) are not shown. Figure 33 As shown in the figure. The electrode patch 200' may include 66 array electrodes, a ground electrode, and a reference electrode, similar to the reference above. Figure 9 The electrode patch 200 is described above. Optionally, the electrode patch 200' may include more or fewer than 66 array electrodes, as well as a ground electrode and a reference electrode.

[0384] Connector device 1200 is substantially the same as connector device 900 described above. Therefore, most of the description of electrode patch 200 in the above preferred embodiment also applies to electrode patch 200', and therefore does not need to be described again. The only difference is the connector 1250 of electrode device 1200, which is the same as the one described above. Figure 13 and Figure 14 The connector 350 described is the same. Alternatively, connector 1250 can be the same as the one referenced above. Figures 16-18 The connector 450 described is the same.

[0385] Figure 34 An electrode patch 200" according to a further preferred embodiment of the present invention is disclosed. 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 above preferred embodiment also applies to the electrode patch 200', and therefore does not need to be described again.

[0386] Electrode patch 200" includes reference Figure 10 and Figure 11 The described connection portion 204 is similar to connection portions 204a" and 204b". For clarity, most features of the electrode patch 200" (e.g., complete electrical conductors) are not shown. Figure 34 As shown in the figure. Electrode patch 200" may include the same as the one referenced above. Figure 9 The same number of electrodes as described. An electrode patch of 200" may include more or fewer than 64 electrodes, such as... Figure 34 As shown.

[0387] like Figure 34 As shown, there are at least three cuts 209a", 209b" and 209c".

[0388] To couple the electrode patch 200" to the connector assembly 900, the first clamping member 910 and the second clamping member 920 are moved as follows: Figure 35 The open position is shown. Then, the electrode patch 200" is guided downward into the connector assembly 900.

[0389] Tight or precise positioning of connector portions 204a" and 204b" with connector 950 on the first clamping member 910 and the second clamping member 920 is necessary for reliable coupling. This is achieved by a positioning feature in the form of a protrusion 930 accommodated by a notch 209c" and a positioning pin 935 accommodated by a positioning hole in the electrode patch 200". For clarity, the positioning pin 935 is not shown in the image. Figures 35-37 As shown in the figure, but for example, it can be found in Figure 23 As can be seen, protrusion 930 and locating pin 935 help prevent electrode patch misalignment and allow connector 950 to be tightly or precisely positioned with the connector portion of the electrode patch. This helps prevent connection failure and crosstalk.

[0390] Then, in such Figure 37 The connector device 900 and connector device components in the assembly configuration shown are prepared to be attached to the outer surface of the subject's skin. Figures 34-37 As can be seen, the tongue in the electrode patch is optional. The electrode patch can also be used with the devices 1000, 1100 and 1200 as described above.

[0391] Then, the first clamping member 910 and the second clamping member 920 are moved to the closed position, wherein each clamping member 910, 920 clamps a portion of the electrode patch (the connection portion of the electrode patch) between the clamping member and the top surface 905a of the connector device 900.

[0392] In some embodiments, cutouts 209a" and 209b" may be absent, and the size of the electrode patch 200" may allow it to be positioned similarly to Figure 29 The components are assembled between the first clamping component 910 and the second clamping component 920 in the manner shown.

[0393] Figure 38 and Figure 39 A connector device 1300 according to another preferred embodiment of the present invention is shown. This example of connector device 1300 is similar in most respects to the connector device 900 described above, and by comparison... Figure 23 and Figure 38 The differences are noticeable. Figure 31 In, with Figure 23 Similar features are identified by the same reference numerals plus 400. Much of the description of the connector device 900 of the preferred embodiment described above also applies to the connector device 1000; therefore, only the differences will be discussed.

[0394] As shown in the figure, connector device 1300 may consist of only a clamping member 1310 hinged to body 1305. However, it is also understood that body 1305 also facilitates clamping of an array located between clamping member 1310 and body 1305, and in this sense, body 1305 can be understood as a second clamping member. Connector device 1300 can be considered a simplified version of connector device 900 and is lighter than connector device 900 due to its smaller size. Due to its size and weight, connector device 1300 can be used to monitor the electrical activity of pediatric subjects.

[0395] Connector device 1300 may also have one or more features of connector devices 1000, 1100 and 1200, such as, but not limited to, buttons, slide buttons, latches, displays, etc.

[0396] Figure 40 An electrode patch 100" according to a further preferred embodiment of the present invention is shown. 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 above preferred embodiment also applies to electrode patch 100', and therefore need not be described again, and can be obtained by comparison. Figure 40 and Figure 1 The differences can be identified. For clarity, most features (such as a complete electrical conductor) are not shown. Figure 40As shown in the image.

[0397] A key difference between electrode patch 100' and electrode patch 100 is the number of electrodes. Electrode patch 100' may contain fewer electrodes than electrode patch 100. Figure 40 In the example shown, there are only 32 electrodes in electrode patch 100' because it is intended for use in pediatric subjects.

[0398] To couple the electrode patch 100' to the connector assembly 900, the clamping member 1310 is moved to such a position as... Figure 40 The open position is shown. Then, the electrode patch 100' is guided downward into the connector assembly 1300.

[0399] Tight or precise positioning of the connector 1350 on the connector portion 104' and clamping member 1310 is necessary for reliable coupling. This is achieved by a positioning feature in the form of a protrusion 1530 received by a notch 109' and a positioning pin 1335 received by a positioning hole in the electrode patch 109'. For clarity, the positioning pin 1335 is not shown in the image. Figure 40 As shown, but this pin can be... Figure 38 As seen in the image, protrusion 1350 and locating pin 1330 help prevent electrode patch misalignment and allow connector 950 to be tightly or precisely positioned with connector portion 104' of electrode patch 100'. This helps prevent connection failure and crosstalk.

[0400] Then, the clamping member 1310 is moved to the closed position, wherein the clamping member 1300 clamps the portion of the electrode patch (the connection portion of the electrode patch) between the clamping member and the top surface 1305a of the connector device 1300.

[0401] Then, the connector device 1300 and electrode patch 100' in the assembly configuration are ready to be attached to the outer surface of the subject's (preferably a pediatric subject) skin.

[0402] It is understood that the size, shape, and number of electrodes in the electrode patch may differ from those described above and depicted in the accompanying drawings, which are described and shown in this specification only by way of example.

[0403] In the preceding description, references were made to elements or wholes having known equivalents, which are included as if they were described separately.

[0404] Of course, it is to be expected that, although the foregoing has been provided with the aid of exemplary examples of the invention, all such modifications and variations will be apparent to those skilled in the art and are considered to fall within the broad scope and aspects of the invention as described above and / or as defined in the claims.

Claims

1. A system for monitoring gastrointestinal or colonic electrical activity generated by a subject, the system comprising: Electrode patch, the electrode patch comprising a flexible substrate and including: A primary region, comprising a plurality of surface electrophysiological sensors spatially arranged in the form of electrodes for contacting the outer surface of the subject's skin to sense and measure gastrointestinal or colonic potentials at the plurality of electrodes; and At least one tongue, the tongue extending from and narrower than the main region, and including at least one connector portion, the at least one connector portion including a plurality of conductive contact pads spaced apart from the electrode, the plurality of conductive contact pads being electrically connected to the electrode via an electrical conductor traveling as a conductive track between the electrode and the at least one connector portion, the conductive track being fixed to the electrode patch, and the electrode patch further including a plurality of positioning holes at or near the at least one connector portion; and A connector device having at least one connector configured to be physically and operatively connected to at least one connector portion of the electrode patch for receiving electrical signals from the plurality of electrodes to allow monitoring of gastrointestinal or colonic electrical activity generated by the subject, and for wirelessly transmitting electrical activity data to a remote computing device, wherein the connector device is further configured to attach to the outer surface of the subject's skin by using the electrode patch with adhesive, such that the main area with adhesive at the edge is located on a first side of the connector device and the tongue with adhesive is located on a second side of the connector device, wherein the second side is opposite to the first side.

2. The system of claim 1, wherein the patch includes another ground electrode and another reference electrode.

3. The system according to claim 1 or 2, wherein the electrode and the electrical conductor are disposed on the flexible substrate.

4. The system of claim 3, wherein the flexible substrate is stretchable.

5. The system according to claim 3 or 4, wherein the flexible substrate comprises or is made of a thermoplastic polyurethane (TPU) film.

6. The system according to any one of claims 3 to 5, wherein the hydrogel is placed on top of the flexible substrate.

7. The system according to any one of claims 1 to 6, wherein the plurality of conductive contact pads are arranged in an interlaced pattern.

8. The system according to any one of claims 1 to 7, wherein the total number of contact pads in the electrode patch is the same as the total number of electrodes.

9. The system according to any one of claims 1 to 7, wherein in the electrode patch, the total number of contact pads is greater than the total number of electrodes.

10. The system according to any one of claims 1 to 7, wherein in the electrode patch, the total number of contact pads is the same as the total number of electrodes and the total number of electrical conductors.

11. The system according to any one of claims 1 to 10, wherein the electrode patch includes at least one cutout.

12. The system of claim 11, wherein the at least one incision is located at the at least one tongue.

13. The system of claim 12, wherein the shape of the at least one cut is substantially rectangular.

14. The system according to any one of claims 1 to 13, wherein the electrode patch comprises two connector portions spaced apart from each other and spaced apart from the electrode.

15. The system of claim 14, wherein the two connector portions are located on the same side of the electrode patch.

16. The system of claim 14 or 15, wherein the two connector portions are a first connector portion and a second connector portion, wherein a fixed number of the electrodes are electrically connected to the first connector portion and a fixed number of the electrodes are electrically connected to the second connector portion.

17. The system of claim 16, wherein half of the fixed number of electrodes is electrically connected to the first connector portion, and the remaining half of the fixed number of electrodes of the electrode patch is electrically connected to the second connector portion.

18. The system according to any one of claims 1 to 17, wherein the at least one tongue is coplanar with the main region.

19. The system of claim 18, wherein at least one intermediate portion is located between the at least one tongue and the main region, the at least one intermediate portion being narrower than the at least one tongue and the main region.

20. The system according to any one of claims 1 to 19, wherein the electrode patch has rounded corners to prevent curling.

21. The system according to any one of claims 1 to 20, wherein two tongues extending from the remainder of the electrode patch are formed on the electrode patch, the two tongues being coplanar with each other and with the remainder of the electrode patch, the two tongues being a first tongue and a second tongue.

22. The system of claim 21, wherein the one or more connector portions are located in one or both of the first or second tongues.

23. The system of any one of claims 1 to 22, wherein the electrode patch comprises an adhesive for allowing the electrode patch to adhere to the outer surface of the subject's skin.

24. The system of claim 23, wherein the adhesive is located at the edge of the electrode patch.

25. The system according to any one of claims 1 to 24, wherein the electrode patch is a disposable electrode patch.

26. The system of claim 1, wherein the at least one tongue is coplanar with the remainder of the electrode patch.

27. The system of any one of claims 1 to 25, wherein the electrode patch comprises a flat surface, wherein at least a portion of each of the electrodes, the connector portion, and the electrical conductor is exposed on the flat surface.

28. The system of claim 27, wherein the flat surface is the surface configured to contact the outer surface of the subject's skin.

29. The system of claim 27 or 28, wherein the flat surface is a substantially flat surface.

30. A system for monitoring gastrointestinal or colonic electrical activity generated by a subject, the system comprising: An electrode patch for monitoring gastrointestinal or colonic electrical activity generated by a subject and comprising a flexible substrate, the electrode patch comprising a main region including spatially arranged electrodes for contacting an outer surface of the subject's skin to sense and measure potentials at multiple electrodes, wherein the electrode patch further comprises at least one tongue extending from and narrower than the main region, and including two connector portions and at least one cutout between the two connector portions, the two connector portions including multiple conductive contact pads, the electrodes being routed to the two connector portions spaced apart from the electrodes, and the multiple conductive contact pads being electrically connected to the electrodes via electrical conductors traveling as conductive tracks between the electrodes and the two connector portions; and A connector device having two connectors, each of which is configured to be physically and operatively connected at a corresponding connector portion of the two connector portions to an electrode patch or at least a portion of the electrode patch for receiving electrical signals from a plurality of electrodes to allow monitoring of gastrointestinal or colonic electrical activity generated by the subject, and for wirelessly transmitting electrical activity data to a remote computing device, the conductive track being fixed on the electrode patch, and the electrode patch further comprising a plurality of positioning holes at or near at least one connector portion, wherein the connector device is configured to attach to the outer surface of the subject’s skin by such that a tongue with adhesive is located on a first side of the connector device and a main area with adhesive at the edge is located on a second side of the connector device, wherein the second side of the connector device is opposite to the first side of the connector device.

31. The system of claim 30, wherein the system further comprises a docking device having a compartment configured to accommodate the connector device.

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