Patent ID: 12245862

DETAILED DESCRIPTION OF THE INVENTION

Conventional medical apparatus for monitoring electrical activity may use sensing device comprising an electrode patch and a connector device which could be an electronic device such as a data acquisition device that is in electronic communication with such patch. However, such conventional apparatus does not focus on coupling mechanism for the electrode patch and the connector device to ensure that the connections between the two are reliable and proper. If such connections are not proper, then accidental disconnection between the connector device and the electrode patch is highly likely in which case real-time monitoring of physiological/electrical activity cannot be performed. Further, due to its weight, the connector device can easily disconnect from the electrode patch and detach and fall from the body of the subject which can not only damage the connector device but can also cause confusion, dissatisfaction, and poor compliance. Therefore, it is desirable to provide an electrode patch connection system that allows simple but reliable coupling between an electrode patch and connector device that may be worn by the subject. Also, it is desirable to provide an electrode patch connection system for a non-invasive medical apparatus that can be worn by a subject to monitor the physiological condition in a comfortable and reliable manner, while the subject is engaged in normal daily activities. Also, it is desirable to provide electrode patch connect system that can be easily set easy set up and used by new patients having minimal or no experience of using any system for monitoring physiological functions. Further, it is desirable to provide electrode patch connection system that do not require cables for connection between electrode patch and the connector of a connector device.

It is also desirable to have an electrode patch that does not skew when connected to the connector device can cause failed connections and cross talks.

It is also desirable to have an electrode patch that is designed to allow optimal packaging of the contact pads of the electrode patch within a minimum area so that the design of an electrode patch that is less bulky and more comfortable to wear especially on abdominal regions can be achieved.

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

It is also desirable to have an electrode patch that requires use no or less wires during use so that there no or less tangling or wires.

It is also desirable to have an electrode patch that feels comfortable to the subject when connected to an outer surface of a skin of the subject during use.

Having a connector device and electrode patch assembly that do not easily dislodge when connected to outer surface of a skin of a patient/subject is also desirable.

Reference will now be made to the accompanying drawings in whichFIG.1shows one example of electrode patch100according to one preferred embodiment of the invention.

The electrode patch100is configured to be used as part of a system for monitoring physiological functions on a subject. The subject is preferably a human but optionally the subject may be a non-human animal. Most preferably, the electrode patch100is configured to be used as part of a system for monitoring gastro-intestinal (GI) electrical activity of a subject. In some embodiments, the electrode patch100may be configured to monitor electrical/physiological activity on other regions of the subject such as but not limited to colonic regions, and/or monitoring cardiac or other smooth muscle systems such as uterus or bladder, or of brain signals (EEG) or skeletal muscle signals (EMG).

The electrode patch100is basically a sensing device and comprises a plurality of spatially arranged surface electrophysiological sensors in the form of electrodes for contacting an outer surface of the skin of the subject to sense and measure electrical potentials at multiple electrodes. In the example shown inFIG.1, there are total of 66 electrodes out of which 64 electrodes are arranged in an array of 8 rows and 8 columns and the remain two electrodes102a,102bare the ground and reference electrodes. In use electrical potentials may be measured as the difference between each of the 64 electrodes and the reference electrode102a. The ground electrode102amay be the “driven right leg” or “bias” electrode. The purpose of the ground electrode102ais to keep voltage level of the subject's body within an acceptable range and to minimize any common-mode in the subject's body (e.g., 50/60 Hz power-line noise). The driven right leg will act as a source or sink as necessary (within reason) to accomplish this. However, the electrode patch100may comprise more than 66 electrodes or less than 66 electrodes. The ground and reference electrodes102a,102bmay be different than what is shown inFIG.1.

Preferably, the electrode patch100is configured to be removably attached to the outer surface of the skin of the subject, most preferably at or near an abdominal region, so that the electrodes102,102a,102bcan contact the outer surface of the skin of the subject at or near the abdominal region to sense and measure electrical signals from the GI tract of the subject. If the electrode patch100is for sensing and measuring electrical signals from other regions, then the electrode patch may be configured to be removably attached to the outer surface of the skin of the subject at or near at suitable regions, so that the electrodes102,102a,102bcan contact the outer surface of the skin of the subject at or near such region to sense and measure electrical signals from the that region of subject's body. This may include a colonic region.

The electrode patch100may be made out of a flexible and stretchable material. The electrode patch100may comprise a flexible substrate and the electrodes may be spatially arranged on the flexible substrate. The flexible substrate may also be stretchable. By being flexible and stretchable, the electrode patch100can properly adhere to the skin of the subject which can result in improved electrode impedance. In order to monitor the electrical activity, for example a GI electrical activity, the electrodes may be required to be placed on the abdominal surface as close to the gastrointestinal organ of interest due to low signal amplitude. Since, the skin of the subject on the abdominal surface generally experiences large deformations from normal bodily movements, the electrode spatially arranged in a conformal/flexible substrate can adequately deform with the and consequently reduce the chances of delaminating from the skin of the subject. By reducing the chances of delaminating from the skin of the subject, chances of unreliable signal quality are also minimized.

The flexible substrate may comprise or may be made of a Thermoplastic Polyurethane (TPU) film which may be a thin adhesive film/layer. A hydrogel may be placed on top of the flexible substrate and that improve conductivity of the biological signals.

As shown inFIG.1, the electrode patch may comprise at least one connector portion104. The connector portion104may be spaced apart at a distance from the electrodes102,102a,102b. The connector portion104is not any of the electrodes102,102a,102b. The connector portion104may be spaced apart from the primary region P of the electrode patch containing electrodes102,102a,102band the connector portion104is electrically connected with the electrodes102,102a,102b. As shown, the primary region P may substantially rectangular as shown. Alternatively, the primary region P may be of any other suitable polygonal shape. In certain embodiments, the primary region P may be circular in shape. As shown, the electrode patch100may extend between a first end and a second end that is located opposite the first end. The electrodes102,102a,102bmay be located more proximal to the first end than the second end and the connector portion is located more proximal to the second end that the first end. In certain embodiments, the electrodes102,102a,102bmay be spaced apart from the connector portion104at a distance that is at least a quarter of the total distance between the first end and the second end. The electrode patch100may be spaced apart at a distance of at least 5 centimetres from each of the electrodes102,102a,102b.

By having the connector portion104that is spaced apart from the electrodes at a distance, any connector device that is attached to the connector portion104may also be located at a distance from the electrodes. This can minimize the interference with the electrodes and/or contact between the electrodes102,102a,102band the outer surface of the skin of the subject, during the physical interaction with the connector device and/or any physical interaction at the connector portion104.

The electrode patch100may comprise/have a planar surface and at least a portion of each of the electrodes102,102a,102b, the connector portion104and the electrical conductors106may be exposed at the planar surface. The planar surface may be the surface that is configured to contact the outer surface of a skin of the subject. The planar surface may be a substantially flat surface. The electrode patch100may be formed as a single sheet of material or as a substantially panel. Such planar surface arrangement enhances the comfort and provides better adherence to the skin of the subject during use as there are no bulges in the skin contact region of the electrode patch nor are there any components of the electrode patch100that are protruding in the skin contact region of the electrode patch. At least one tongue103may be formed on the electrode patch100extending from rest of the electrode patch100. The tongue103may be co-planar with rest of the electrode patch100. The connector portion104may be located in the tongue103but in one embodiment could be located near/proximal to the tongue. Having a connector portion104on a tongue103which is narrower than the primary region facilitates easy and better connection between the electrode patch100. This also means a smaller connector device can be used to connect to connector portion104of the electrode patch100and clamp the electrode patch as opposed to large connector device that would be necessary if the connector portion104was located in other wide areas of the electrode patch100. Therefore, having a tongue103and connector portion104located on the tongue reduces the volume and potentially also the weight of the overall apparatus (i.e. apparatus containing the connector device and electrode patch) that to be worn by the subject during use. As shown an intermediate region I may be formed between the primary region P and the tongue103. The intermediate region I may be substantially trapezoidal in shape.

As shown, the electrode patch100may comprise a second tongue105and the ground and reference electrodes102a,102bmay be located on that second tongue105. As shown, the end of the tongue103that is furthest (most distal) from the electrodes102(and further from the primary region P) is formed as a C-shaped portion107. As shown, a cut-out109may be located between the electrodes102and the connector portion104. As shown, the second tongue105may be substantially rectangular in shape.

The connector portion104may be arranged on the flexible substrate. As shown inFIG.1, the connector portion104may be electrically connected with the electrodes102,102A,102B through electrical conductors106running as conductive tracks (which may also be referred to as conductive traces) between the electrodes102and the connector portion104, the electric conductors106may be conductive tracks. In one embodiment, it may be wires. Conductive track is advantageous over less preferred embodiment that may use wires. For example, mass production can be achieved at lower cost by using conductive tracks as opposed to using wires. Further, conductive tracks provide low electric noise as compared to wires. Additionally, wires can move and therefore can tangle or dislodge easily whereas conductive tracks are fixed to the electrode patch and hence are immune to such undesirable movement and tangling. Therefore, conductive tracks bring better reliability in the performance of the electrode patch. Furthermore, use of conductive tracks as opposed to wires can avoid bulges or similar in the surface of the electrode patch that is configured to be in contact with the outside skin (outer surface of the skin) of the subject thereby providing comfort during use. The electric conductors106may be arranged on the flexible substrate.

As shown inFIG.2, the connector portion104may comprise a plurality of electrically conductive contact pads108. The contact pads108may be arranged on the flexible substrate. The contact pads108may be electrically connected to the electrodes through the electric conductors106. As shown inFIG.1, the electrical conductors106may run as conductive tracks between the electrodes102and the contact pads108.

In the electrode patch100, total number of said contact pads108may be same as total number of electrodes102. In the example shown inFIG.1, there are 66 electrodes and 66 contact pads108in the electrode patch108. The electrodes102and the contact pads108may be connected in such a manner that one electrode is electrically connected with only one contact pad and no two electrodes are electrically connected with the same contact pad. As shown inFIG.1, both reference and ground electrodes102a,102bcan be separate from the array of electrodes102.

In some embodiments, the total number of contact pads108may be greater than the total number of electrodes102. Having such additional/spare contact pad(s) can be advantageous as they can be used for many purposes. As one example, the spare contact pad(s) may be used for detecting the version or model of connector device used with the electrode patch. For example, if the spare contact pad(s) connect(s) to the connector of the contact device when such connection was not expected, then that may imply to the user that incorrect version or model of the connector device is used. Similarly, if the spare contact pad(s) does/do not connect to the connector of the contact device when such connection was expected, then that may imply to the user that incorrect version or model of the connector device is used. User may receive error message or some other mechanism that may trigger them to use the correct version of the connector device.

Each of the electrodes102,102A,102B and contact pads108may be electrically connected as using electrical conductors106in such a manner that one electrode is electrically connected with only one electric contact pad108using only one electric conductor and no electric conductor electrically connects more than one pair of electrode and contact pad that are electrically connected with each other.

In the patch, total number of electrical conductors106be same as total number of said electrodes102,102a,102b. As shown inFIG.1, in patch100there are sixty-six electrical conductors106.

The electrodes102,102a,102bmay be Ag—AgCl electrodes.

Each of the electrodes102,102a,102bmay 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 certain embodiments, the width of the patch may be more or less than 21 cm.

The electrode patch100may comprise an adhesive which may be formed as an adhesive layer. The electrode patch100may be a single-use peel-and-stick patch. As shown, the corners of electrode patch100may be rounded to prevent curling.

The electrode patch100may be mass produced using screen printing. For the design of the patch ofFIG.1, one of the major challenges is to provide the minimum width of the electrical conductors106that is needed for screen printing, and at the same time providing a suitable physical layout of getting all electrodes, in this example all sixty-six electrodes, to meet at the connector portion104for connecting with a connector of a connector device. Each contact pad108also requires a certain flat surface area to operate effectively and reliably. The electrode patch100of the invention can achieve this by configuring groups of contact pads108in a staggered format/pattern as shown inFIG.2. Preferably each of the contact pads108are square in shape as shown to maximize the x/y tolerance required to make electrical contact with the connector device. Alternatively, the contact pads108may be rectangular in shape. As shown inFIG.1, the electrical conductors106on the electrode patch100may run into the contact pads108at staggered spatial intervals and travel/run in curves. The configuration as described above allows an optimal packaging of the contact pads108within a minimum area. Such configuration also allows connector portion104to effectively and efficiently connect with a connector150of a connector device such as a connector device600shown inFIG.5.

One example of a connector150that can be used to electrically connect with the contact pads108of the electrode patch100is shown inFIG.3. The connector150may comprises a plurality of conductive contact pins152that are configured to be electrically connected to the contact pads108of the connector portion104during use. The connector150may be an interposer or array connector and the contact pins152may be in the form of solder balls as shown inFIG.4. Such connector150may work by compression and may require cumulative contact force that can increase by the number of contact pins152that are used. By using such connector150no cable may be required for connecting the connector portion104(and consequently the electrodes) to the connector device, such as connector device500as described below with reference toFIG.5. One example of the connector150that may be used is a 1.0 mm Ultra Low Power Micro Array connector. An example of such connector is disclosed in https://www.samtec.com/products/za8, the entirety of which is herein incorporated by reference. By using connectors such as connector150, cables/wires are not required for electrically connecting the connector150and the electrode patch100.

FIG.5shows one embodiment of a connector device500for clamping the electrode patch100or at least the portion thereof. Such clamping may exert a pressure on the electrode patch or the portion of the electrode patch when in the clamped position. As shown, the connector device500may be in a form of two separate connecting or clamping members, namely a first clamping member510which in this example is a lower clamping member and a second clamping member520which in this example is an upper clamping member. The first clamping member510and the second clamping member520are configured to clamp the electrode patch100, more specifically the connector portion140of the electrode patch between them. In this example, the first and second clamping members510,520are shown to be two separated elements and the two clamping members510and520are preferably connected by flexible printed circuit board(s)515. As shown inFIG.2, the connector portion104of the electrode patch100may comprise holes110a,110b,110c, hereinafter referred to as electrode patch holes110a,110b,110c. The holes110a,110b,110cmay be macro holes. The first clamping member510and the second clamping member520may be attached through the electrode patch holes110a,110b,110cusing magnetic coupling. The number, size and/or configuration of the of electrode patch holes110a,110c,110cmay be different than what is shown inFIG.2. The electrode patch holes110a,110b,110cmay also function as alignment for aligning the connector portion104of the patch to the connector150. For example, the connector device500may have alignment pins that are configured to be received by the electrode patch holes110a,110b,110cto ensure that the connection portion104is properly aligned and connected to the connector150.

FIG.6shows another preferred embodiment of connector device600for connecting to the connector portion104of the electrode patch100andFIG.7is an exploded view of the connector device600ofFIG.6. As shown inFIGS.6and7, the connector device600comprises a first clamping member610and a second clamping member620. The first clamping member610and the second clamping member620are configured to clamp the electrode patch100, more specifically the connector portion104of the electrode patch100between them.

As shown the first clamping member610is the bottom/lower clamping member that is configured to clamp the connector portion104of the electrode patch100from the bottom when the first and second clamping members610,620are secured together to a clamped position.

The first clamping member110comprises a first clamping plate611, a connector650and a foam layer612. As shown, the first clamping member plate611may be elongated extending longitudinally from a first end portion611aand a second end portion611band has a lower surface611cand an upper surface611d. The foam layer612is located on the lower surface611cand is configured to contact the outer surface of the subject's skin during use. The upper surface611dmay comprise a first stud614aat or near the first end portion611a, and a second stud614bat or near the second end portion611b. The studs614aand614bmay be externally threaded. A plurality of dowels615a,615band615cmay be located at the upper surface611dbetween the first and second studs614aand614b. The dowels615a,615band615cmay be smaller in size (preferably in length, diameter and/or height) as compared to the studs614a, and614b. Plurality of connector securing pins616aand616bmay be located adjacent the dowels. In this example, there are two connector securing pins616aand616bare located adjacent the dowels615a,615b. The connector securing pin616ais located adjacent the dowel615aand the connector securing pin616bis located adjacent the dowel615b. No connector securing pin may be located adjacent the intermediate dowel615c. In one embodiment (not shown), a connector securing pin may optionally be located adjacent the dowel615ctoo.

As shown, the connector650is configured is located at the upper surface611dof the first clamping member610, more specifically the upper surface611dof the first clamping plate611with the contact pins652of the connector650facing upwards, i.e. towards the direction of the second clamping member620. The connector650may be an array connector. The connector650may be an interposer. As shown, the connector650may comprise a plurality of dowel receiving connector holes653a,653band653cfor receiving dowels. The dowel receiving connector holes653a,653band653cmay receive the dowels615a,615band615crespectively as shown inFIG.6. The connector650may comprise securing pin receiving holes654aand654bfor receiving connector securing pins616aand616b. The securing pin receiving holes654aand654bmay receive the connector securing pins616a,616brespectively as shown.

The connector650may be similar to the connector150as described above with reference toFIGS.3and4. It can be appreciated that the first clamping member610may comprise any number of dowels, connector securing pins and/or studs to suit the type of electrode patch100that is configured to be clamped by the connector device600and the type of connector650used.

As shown the second clamping member620is the top/upper clamping member for clamping the connector portion104of the electrode patch100from the top when the first and second clamping members610,620are secured together to the clamped position.

The second clamping member620comprises a second clamping member plate621and cover plate622.

The second clamping member plate621extends longitudinally between a first end portion621aand a second end portion621band comprises a lower surface621cand an upper surface621d. The cover plate622is configured to be secured to the second clamping member plate621at the upper surface621d.

The second clamping member plate621may comprise a first stud receiving hole624aat or near the first end621a, and a second stud receiving hole624bat or near the second end621b. Although, not shown, the stud receiving holes624aand624bmay optionally comprise threaded arrangements (e.g. internal threads) for engaging with the external threads of the first and second studs614aand614brespectively. A plurality of dowel receiving holes625a,625band625cmay be located between the first and second studs receiving holes624aand624b. The dowels615a,615band615cmay be received through the dowel receiving holes625a,625band625crespectively when the first and second clamping members610,620are in a clamped position. The dowels receiving holes625a,625band625care shown to be less in diameter as compared to the stud receiving holes624a,624bas in this example the dowels615a,615b,615care less in diameter as compared to the studs614a,614b. Plurality of connector securing pin receiving holes626aand626bmay be located adjacent the dowel receiving holes625aand625brespectively for receiving the dowel securing pins616aand616brespectively. As shown, there may be additional connector securing pin receiving holes626a′ and626b′ which may be located adjacent the dowel receiving holes625aand625brespectively and opposite to the connector securing pin receiving holes626aand626brespectively. These additional connectors securing pin receiving holes626a′ and626b′ can receive the dowel securing pins616a,616brespectively if the second clamping member620is turned/rotated 180 degrees in the same plane from the position shown inFIG.7. This means first and second clamping members610and620can be secured together to clamp the electrode patch in between them even if one of the clamping members is rotated 180 degrees in a same plane in either a clockwise or anti-clockwise direction.

As shown, the cover plate622may comprise a first thumb screw head627aand a second thumb screw head627b. The thumb screw heads are rotatable and may have internal threads configured to engage with the threads of the studs614a,614b. The first thumb screw head627amay be configured to rotatably engage with the first stud614aand the second thumb screw head627bmay be configured to rotatably engage with the second stud614b. As shown, the cover plate622may also comprise optional plate securing screws628aand628bthat are configured to be received by complimentary plate securing screws receiving holes629aand629brespectively that are located at the optional second clamping member plate621to further secure cover plate622together with the second clamping member plate621. The complimentary plate securing screws receiving holes628aand628bmay be formed on the upper surface621dof the second clamping member plate621.

In order to clamp the electrode patch100between the first and second clamping members610,620, the first clamping member610and the second clamping member720may be first detached from each other as shown inFIG.6. The electrode patch100may then be placed on top of the first clamping member610. More specifically, the connector portion104of the electrode patch100may be placed above the connector750facing down on the connector650so that the contact pads108located at the connector portion104of the electrode patch100may be physically connected to the contact pins652of the connector650.

The first stud614amay pass through the cut-out109of the electrode patch100and the second stud614bmay pass through the C-shaped portion107of the electrode patch. The dowels615a,615b,615cmay align with the electrode patch holes110a,110band110crespectively. The electrode patch holes110a,110band110cmay be larger in diameter to also receive the connector securing pins616a,616b,616c. Alternatively, there may be additional electrode patch holes to receive the connector securing pins616a,616band616c.

The second clamping member620may be then placed on top of the first clamping member610and portion of the electrode patch100that is placed on top of the first clamping member610. The screw heads627a,627bare then tightened by rotating in either clockwise or anti-clockwise direction to thereby clamp the electrode patch100between the connecting device600. The electrode patch100that is clamped by the connector device100may then be adhered to the outer surface of the skin of the subject using adhesive or similar with the electrodes102and foam layer612contacting the outer surface of the skin of the subject.

Due to the foam layer612being a soft material the abrasions or injury on the skin of the subject during use can be prevented. Similarly, it can be appreciated that having a foam layer612for contacting on patient side rather than a hard surface may mean that the connection device600of the invention will be more comfortable to be worn by the subject as compared to similar devices having a harder surface.

The connector device600may be a portable electronic device such as a data acquisition unit or data logging device or similar that may be worn by the subject to allow electrophysiological monitoring and is preferably battery powered (e.g. using Li-ion battery). Alternatively, the connector device600may be an intermediary device configured to be worn by the subject and the connector650of that intermediate device600may be electrically connected (either by wire or wirelessly) to an electronic device such as a data acquisition device or data logging device to allow electrophysiological monitoring. If the connector device600includes any cables or wires, then those cables or wires may be routed through the cut-out109formed on the electrode patch100.

The principals and operations of the data acquisition device or data logging device is well known to a person skilled and need not be described here. However, the connector device600may comprise at least one analogue to digital convertor to amplify and digitize a biopotential measurements signals received from the electrode patch100. There may be multiple (e.g. four) analogue to digital convertors. The analogue to digital convertor(s) may be analogue to digital convertor chip(s). The connector device600may comprise a microcontroller. The microcontroller may be configured to receive signals from the analogue to digital convertor, process the signals, and transmit data to a remote computing device to allow monitoring of electrical activity generated by the subject. The analogue to digital convertor(s) may be electrically connected to the microcontroller with a flexible cable(s). The flexible cable(s) may be flexible printed circuit board(s). The electronic component may further comprise a flash memory, Near Field Connection (NFC) module(s) and/or charging circuit(s).

Connector device500as described above with reference toFIG.5may also be a similar portable electronic device or an intermediate device and may comprise a connector similar to connector650in either a first clamping member or a second clamping member.

The connector device600may be a part of a connector system comprising a docking device having a compartment that is configured to receive the connector device. The docking device may be a wireless charging device for facilitating wireless charging of the connector device when the connector device is received within the connector device receiving compartment.

It can be appreciated that due to presence of cut-out109and electrode patch holes110a,110band110cskewing of the electrode patch100may be prevented when the connector portion104of the electrode patch100is clamped together by the connector device600. Preventing skewing of electrode patch100can be important to prevent failed connections and cross talks.

After use, the electrode patch may be detached (e.g. peeled out) from the outer surface of the skin of the subject's body. The connection between screw heads627a,627band studs614a,614bmay be loosed by rotating, and the first clamping member610and the second clamping member620may then be detached from each other. The electrode patch100may then be removed from the connector device600. The electrode patch100is preferably a disposable device and can be disposed after use.

Although,FIGS.6and7show, the first clamping member610as the upper clamping member and the second clamping member620as the lower clamping member, in an alternative configuration, the first clamping member610may be the upper clamping member and the second clamping member620may be the lower clamping member. In such configuration, the connector portion104of the electrode patch can be placed on top of second clamping member plate621of the second clamping member620and the connector portion104of the electrode patch100may face upward towards the downwardly facing connector650of the first clamping member610.

FIG.8shows another example of a connector portion of the electrode patch100. InFIG.8, the contact pads and electrical conductors are not shown inFIG.8for the sake of clarity. The connector portion ofFIG.8is substantially the same as connection portion104as described above most of the description above with reference to connector portion104applies equally to the connector portion and only the differences will be described herein.

As shown, the connector portion ofFIG.8comprises total of 5 electrode patch holes110a′,110b′,110c′,110d′ and110e′ that are alignment holes.

When clamped by the connector device600, the electrode patch holes110a′ may be configured to receive the first stud614a; the electrode patch hole110b′ may be configured to receive the dowel615aand pin615b; the electrode patch hole110c′ may be configured to receive the dowel615c; the electrode patch hole110d′ may be configured to receive the dowel615b; and the electrode patch hole110e′ may be configured to receive the second stud614b. It can be appreciated that due to presence of electrode patch holes110a′,110b′,110c′,110d′ and110e′ skewing of the electrode patch100is prevented when the connector portion104of the electrode patch100is clamped together by the connector device600. These also ensure proper alignment between the connector portion104′ and the connector104. As mentioned above, preventing skewing of electrode patch100can be important to prevent failed connections and cross talks. In the electrode patch having the connector portion ofFIG.8, the cut-out109and/or C-shaped portions107may be optional. Alternatively, the cut-out109may still be present in the electrode patch100so that if the connector device600includes any cables or wires, then those cables or wires may be routed through the cut-out109formed on the electrode patch100. The size of the connector device for clamping an electrode patch100having connector portion104′ may be different from the size of the size of the connector device for clamping an electrode patch100having connector portion104. Alternatively, or additionally, the size of the tongue103of the electrode patch100may be different to suit the connector portions.

FIG.9shows as example of an electrode patch200according to another preferred embodiment of the invention. Most features of the electrode patch200is substantially similar to the electrode patch as described above and therefore most of the description above with reference to electrode patch100may apply equally to the connector patch200and only the differences will be described herein.

The electrode patch200may comprise two connector portions. The electrical conductors206running as conductive tracks between the electrodes202,202a,202bare routed to two separate connector portions. Electrode202ais a ground electrode and electrode202bis a reference electrode. InFIG.9, the connector portions cannot be seen as they are covered by connectors250a,250b. The two connectors250a,250bmay be the similar as connectors150or750as described above. Preferably, the two connectors250a,250bare identical. Optionally, the connector250ais different from connector250b.

Preferably, the two connectors250a,250bshown inFIG.9are not part of the electrode patch200and are instead part of one or more connector devices that are adapted to clamp the electrode patch200. The connector device(s) can be same as the connector device(s)500, or600as described above. InFIG.9, the full connector device(s) are not shown for the sake of clarity.

Splitting the connector portions into two or more parts is advantageous over one connector portion because by spiting connector portions in that way, less mating force will be required at each connecting portion to achieve reliable coupling between the electrode patch200and connector device(s).

There are two cut-outs209a,209bin electrode patch200. Cut-outs may be optional.

In one alternative optional embodiment, the connectors650are adhered to the connector portions (e.g. by adhesive or similar) and are part of the electrode patch200instead of being part of the connector devices. In such embodiment, one or more connector device may comprise cables for allowing electric communication between the connectors650and the one or more connector device.

The shape of the tongue203of the electrode patch200is shown to be substantially rectangular. However, the tongue203may be of many other suitable shapes. Although not shown, the tongue203may optionally comprise C-shaped portion adjacent each of the connector portions.

Each connector portion of the electrode patch200may be similar to the connector portions described above. Each connector portion may look like the first half104aor a second half104bof the connector portions shown inFIG.2. More specifically, the groups of contact pads of each connector portion of electrode patch200may be in a staggered format as shown in the first half104aor a second half104bof the connector portion as shown inFIG.2.

FIGS.10and11show one example of one of the connector portions of the electrode patch200. In other words, the connector portion204shown inFIGS.10and11is one of the two connector portions of the electrode patch200. As shown, the connector portion204may comprise 34 contact pads208in total in a staggered format. The 34 contact pads are connected with 32 of the 64 array electrodes202, a ground electrode202aand a reference electrode202bthrough electrical conductors206. The electrical conductors206run as conductive tracks between the electrodes202,202a,202band the connector portion204, more specifically, between the electrodes202,202a,202band the contact pads of the connector portion204. Another one of the two connector portions of the electrode patch200may be similar to the connector portion204and that connector portion204may also have 34 contact pads connected with the remaining 32 of the 64 array electrodes202, a ground electrode202aand a reference electrode202busing electrical conductors206.

FIG.12shows another example of a preferred embodiment of the connector device700and electrode patch200that is clamped between the first clamping member710and second clamping member720of the electrode patch.

The connector device700of this example is similar in most aspects to the connector device600described above and the differences can be identified by comparingFIGS.5and6withFIG.12. InFIG.12, the features that are similar to those shown inFIG.6are identified with the same reference numeral, incremented by 100. Most of the description of the connector device600of a preferred embodiment above, equally applies to the connector device600and therefore and therefore need not be described again in too much detail. Only the main features will be discussed.

As shown, the connector device700only comprises two dowels715a,715bbetween first and second studs714a,714b, unlike connector device600comprising the dowels615a,615b,615c. The connector750is part of the second clamping member720instead of the first clamping member. The first and second clamping members710,720may both comprise housing723a,723bthat are both half elliptical in shape with smooth external surface and in the clamped position as shown inFIG.12, the connector device700is substantially elliptical in shape. Due to external surface of both housings723a,723bbeing smooth and of the same shape, either of the first and second clamping members can be placed proximal to the outer surface of the skin of the subject during use. If the first clamping member710is to be placed proximal to the outer surface of the skin of the subject, then the electrode patch200will been to be placed on top of the first clamping member with the contact pads208of the electrode patch200facing upwards towards the second clamping member720. This is because the second clamping member720comprises the connector750. Similarly, if the first clamping member710is to be placed proximal to the outer surface of the skin of the subject, then the electrode patch200will been to be placed on top of the first clamping member with the contact pads208of the electrode patch200facing downwards towards the second clamping member820comprising the connector750. Although, not shown, a foam layer may optionally be added to the surface of the connector device700that is configured to be attached to the outer surface of the skin of the subject.

The first and second clamping members710,720may be secured together to be in the clamped position using many suitable securing means such as but not limited to magnetic coupling, latch arrangement, snap fit arrangement etc.

While clamping the electrode patch200using the connector device700, the electrode patch hole210amay be configured to receive the first stud714a; the electrode patch hole210bmay be configured to receive the dowel715a; the electrode patch hole210cmay be configured to receive the dowel715b; and the electrode patch hole210dmay be configured to receive the second stud714b. It can be appreciated that due to presence of electrode patch holes210a,210b,210c,210dskewing of the electrode patch200is prevented when the connector portion204of the electrode patch200is clamped together by the connector device700. The electrode patch holes210a,210b,210c,210dare also alignment holes as they allow for proper alignment of the connector portion204and the connector750.

Two separate connector devices700may be used to clamp two connector portions204.

The connector device ofFIG.15is preferably an electronic device such as a data acquisition device or data logging device and is preferably battery powered (see Li-ion battery741). The principals and designs of the data acquisition device or data logging device is well known to a person skilled and need not be described here. However, the connector device700may comprise at least one analogue to digital convertor to amplify and digitize a biopotential measurements signals received from the electrode patch200. There may be multiple (e.g. four) analogue to digital convertors. The analogue to digital convertor(s) may be analogue to digital convertor chip(s). The connector device700may comprise a microcontroller. The microcontroller may be configured to receive signals from the analogue to digital convertor, process the signals, and transmit data to a remote computing device to allow monitoring of electrical activity generated by the subject. The analogue to digital convertor(s) may be electrically connected to the microcontroller with a flexible cable(s). The flexible cable(s) may be flexible printed circuit board(s). The electronic component may further comprise a flash memory, Near Field Connection (NFC) module(s) and/or charging circuit(s).

As shown inFIG.12, there may be a main Printed Circuit Board (PCB)743. The PCB743may comprise a microcontroller and other electronic circuitry such as but not limited to microcontroller, flash memory, Near Field Connection (NFC) module(s) (e.g. Bluetooth modules), charging circuits etc. There may be another PCB721′ comprised or formed clamping plate721holding at least one analogue to digital converter (preferably 4 analogue to digital convertor chips). A zif connector745may be used to connect the PCB comprised or formed clamping plate721with the main PCB743using a flexible cable (e.f. flexible printed circuit board). A corresponding zif connector (not shown) may be located on the main PCB743and that corresponding zif connector may be electrically connected with the zif connector745using the flexible cable.

FIG.13shows another example of a connector350to physically connect with the connector portion204described above. The connector350of this example is similar in most aspects to the connector150described above and the differences can be identified by comparingFIG.3withFIG.13. The smaller number of conductive contact pins352on the connector inFIG.13is designed for a configuration that allows for reduced mating force. The reliability and lifespan of the coupling device may be improved when there is reduced mating force. InFIG.13, the features that are similar to those shown inFIG.6are identified with the same reference numeral, incremented by 200.

One of the corners of the connector is shown to be angled inFIG.13but need not be angled.

The conductive contact pins352may optionally be trapezoidal in shape. Although, not shown inFIG.13, the conductive contact pins352may optionally protrude out from the body of the connector352.

The conductive contact pins352are arranged/spaced in a specific orientation as shown inFIG.13to be in contact with the contact pads208of the connector portion204.FIG.14shows the conductive contact pins352being in contact with the contact pads208when physically connected to the contact pads208. As shown, each contact pad208may be configured to be in contact with two conductive contact pins. This enables a backup contact between the contact pad208and conductive contact pins. Therefore, even if one of the two conductive contact pins become damaged, worn, or covered by residue e.g. when the device is cleaned between patients, the device will still function normally.

FIG.15shows another example of a preferred embodiment of the connector device800that is configured to clamp the electrode patch200that is configured to clamp the electrode patch200between the first clamping member810and second clamping member820.

The connector device800of this example is similar in most aspects to the connector device700described above and the differences can be identified by comparingFIG.12withFIG.15. InFIG.15, the features that are similar to those shown inFIG.12are identified with the same reference numeral, incremented by 100. Most of the description of the connector device700of a preferred embodiment above, equally applies to the connector device800and therefore need not be described again in too much detail. Only the main differences will be discussed.

As shown, the connector device800only comprises two dowels815a,815b. Unlike in the connector device700where the dowels715a,715bare located between first and second studs714a,714b, the first and second studs814a,814bof the connector device700are located between the dowels815a,815b. Although, not shown, a foam layer may optionally be added to the surface of the connector device800that is configured to be attached to the outer surface of the skin of the subject.

While clamping the electrode patch200using the connector device800, the electrode patch hole210amay be configured to receive the dowel815a; the electrode patch hole210bmay be configured to receive the first stud814a; the electrode patch hole210cmay be configured to receive the second stud814band the electrode patch hole210dmay be configured to receive the dowel815b. It can be appreciated that due to presence of electrode patch holes210a,210b,210c,210dskewing of the electrode patch200is prevented when the connector portion204of the electrode patch200is clamped together by the connector device800.

Two separate connector devices800may be used to clamp two connector portions204.

The connector device ofFIG.15is preferably an electronic device such as a data acquisition device or data logging device and is preferably battery powered (see Li-ion battery841). The principals and operations of the data acquisition device or data logging device are well known to a person skilled and need not be described here. However, the connector device800may comprise at least one analogue to digital convertor to amplify and digitize a biopotential measurements signals received from the electrode patch200. There may be multiple (e.g. four) analogue to digital convertors. The analogue to digital convertor(s) may be analogue to digital convertor chip(s). The connector device800may comprise a microcontroller. The microcontroller may be configured to receive signals from the analogue to digital convertor, process the signals, and transmit data to a remote computing device to allow monitoring of electrical activity generated by the subject. The analogue to digital convertor(s) may be electrically connected to the microcontroller with a flexible cable(s). The flexible cable(s) may be flexible printed circuit board(s). The electronic component may further comprise a flash memory, Near Field Connection (NFC) module(s) and/or charging circuit(s).

As shown inFIG.15, there may be a main Printed Circuit Board (PCB)843. The PCB843may comprise a microcontroller and other electronic circuitry such as but not limited to microcontroller, flash memory, Near Field Connection (NFC) module(s) (e.g. Bluetooth modules), charging circuits etc. There may be another PCB821′ comprised or formed clamping plate821holding at least one analogue to digital converter (preferably 4 analogue to digital convertor chips). A zif connector845may be used to connect the PCB comprised or formed clamping plate821with the main PCB843using a flexible cable (e.f. flexible printed circuit board). A corresponding zif connector846may be located on the main PCB843and that corresponding zif connector may be electrically connected with the zif connector845using the flexible cable.

The connector device800comprises a biasing member which in this example is a leaf spring855. The leaf spring855is shown inFIG.15to be located in the second clamping member820. The leaf spring is configured to bias the second clamping member to move towards the direction of the electrode patch (more specifically, connector portion of the electrode patch) that is sandwiched between the first clamping member810and second clamping member820. Such biasing of the second clamping member820to move towards the direction of the electrode patch will allow for a proper connection between the conductive contact pins852of the connector850and the connector portion of the electrode patch.

FIGS.16-18show another example of a connector450which may be an array connector or an interposer to physically connect with the connector portion204.1described below in Reference toFIG.19. The connector450of this example is similar in most aspects to the connector350described above and the differences can be identified by comparingFIG.13withFIGS.16-18The smaller number of conductive contact pins on the connector450inFIGS.16-18are designed for a configuration that allows for reduced mating force. The reliability and lifespan of the connector450may be improved when there is reduced mating force. InFIGS.16-18, the features that are similar to those shown inFIG.13are identified with the same reference numeral, incremented by 100.

One of the corners of the connector is shown to be angled inFIGS.16-18but need not be angled.

The conductive contact pins452may protrude out from the body of the connector452as shown inFIG.18. The conductive contact pins452may be located on both opposing face sides of the connector450as shown so that the connector pins on either face side of the connector450can be used to contact pads208.1of the connector portion204.1described below with reference toFIG.19. It may be possible that the connector150,250,350also has connector pins on each face side.

The conductive contact pins452are arranged is a specific way as shown inFIG.14to be in contact with the contact pads208.1of the connector portion204.1. The conductive contact pins452may be in contact with the contact pads208.1when physically connected to the contact pads208.1. Each contact pad208.1may be configured to be in contact with only one conductive contact pin. This reduces the overall force required for connecting to the contact pads208.1.

FIG.19shows another example of one of the connector portions of the electrode patch200. In other words, the connector portion204.1shown inFIGS.10and11is one of the two connector portions of the electrode patch200. As shown, the connector portion204.1may comprise 38 contact pads208in total in a staggered format. The 34 contact pads are connected with 32 the 64 array electrodes202, a ground electrode202aand a reference electrode202bthrough electrical conductors206.1. The electrical conductors206.1run as conductive tracks between the electrodes202,202a,202band the connector portion204.1, more specifically, between the electrodes202,202a,202band the contact pads208.1of the connector portion204.1. Another one of the two connector portions of the electrode patch200may be similar to the connector portion204and that connector portion204.1may also have 34 contact pads connected with the remaining 32 of the 64 array electrodes202, a ground electrode202aand a reference electrode202busing electrical conductors.

One major difference between the connector portion204ofFIG.10and connector portion204.1ofFIG.19, is that the connector portion204.1ofFIG.19comprises 4 additional connector pads208.1a,208.1b,208.1c,208.1dat or near the centre of the connector portion204.1. Also, the orientation of conductive contact pins452of connector450are different from the orientation of the conductive contact pins352on connector350.

It can be appreciated that different versions of connectors may be used to connect to the connector portion204.1ofFIG.19and the 4 additional connector pads208.1a,208.1b,208.1c,208.1dmay allow to determine the type of connector that is connected to the connector portion204.1. For example, the connector350or connector450may be used to connect to the connector portion204.1. The 4 additional connector pads2.8.1a,2.8.1b,208.1a,208.1dat the centre of the connector portion2.4.1allows to determine which version of the connector is used to connect to the connector portion204.1. If connection with conductive contact pins at all of the 4 additional connector pads2.8.1a,2.8.1b,208.1a,208.1dis detected that may indicate that connector450ofFIGS.16-18is used to connect to the connector portion204.1. Similarly, if no connection with conductive contact pins at all of the 4 additional connector pads2.8.1a,2.8.1b,208.1a,208.1dis detected then that may indicate that connector350ofFIG.13is used to connect to the connector portion204.1.

While clamping the electrode patch200at connector portion204.1using the connector device800, the electrode patch hole210a′ may be configured to receive the dowel815a; the electrode patch hole210b′ may be configured to receive the first stud814a; the electrode patch hole210c′ may be configured to receive the second stud814band the electrode patch hole210d′ may be configured to receive the dowel815b. It can be appreciated that due to presence of electrode patch holes210a′,210b′,210c′,210d′ skewing of the electrode patch200is prevented when the connector portion204.1of the electrode patch200is clamped together by the connector device800. InFIG.19, the electrode patch holes210a′ and201d′ are shown to be of a larger diameter than electrode patch holes210b′ and201c′ that is because in the connector device800, the dowel815a,815bare larger in diameter than first and second studs814a,814b.

It may be appreciated that the size, shape, orientation and number of the electrode patch holes in a connector portion of an electrode patch may be customized to suit a connector device that is being used to clamp the connector portion of that electrode patch.

InFIG.19, a cut-out209′ is shown which is optional. The cut-out is same as cut-out209a, or209bshown inFIG.9except that the cut-out209′ is shown inFIG.19as being circular in shape (but that cut-out209acan be any other shape).

FIG.20shows as example of an electrode patch300according to another preferred embodiment of the invention. Most features of the electrode patch300is substantially similar to the electrode patch100as described above and therefore most of the description above with reference to electrode patch100may apply equally to the connector patch300and only the differences will be described herein.

The electrode patch300may comprise two connector portions304a,304b(seeFIG.21) on two opposite sides of the electrode patch300—two opposite side of the array electrodes300. InFIG.20, connector device is schematically shown for connecting to two connector portions. The connector device may be any one of the connector devices500,600,700and800as described above. The configuration of electrode patch300as shown inFIG.20is advantageous because, it has an advantage of distributing the weight and bulk of connector devices in two different regions to be better balanced during use. Since two connector devices will be needed to connect to two connector portions304a,304b, additional electrical conductor(s)206′ may run as conductive tracks to electrically connect the two connector portions304a,304b. The additional electrical conductor(s) may run as conductive tracks through the substrate of the electrode patch300but without any physical contact with any other electrical conductors206and electrodes302of the electrode patch300. Such additional electrical conductor(s)306′ allows the connector that is connected to the connector portion304aand the connector that is connected to the connector portion304bto both receive signals that are time-synchronized. It also allows connector connected to connector portion304aand the connector connected to connection portion304bto operate together.

The connector portions304a,304bmay be similar to the connector portion104as described above. This is shown inFIG.21. Alternatively, the connector portions304a,304bmay be similar to the connector portion204or204.1as described above.

In one alternative embodiment, the connector portions204a,204bof the electrode patch200may be located at two opposite sides of the array electrodes202instead of being located at the same side of the array electrodes202. Additional electrical conductor(s) similar to electrical conductor(s)306′ may be used to connect the connector portions204aand204bin a similar manner as described above with reference toFIG.21.

FIG.22shows as example of an electrode patch400according to another preferred embodiment of the invention. Most features of the electrode patch400is substantially similar to the electrode patch100as described above and therefore most of the description above with reference to electrode patch100may apply equally to the connector patch400and only the main differences will be described herein.

InFIG.22, the electrode patch400is shown to contain contains 36 array electrodes402, a ground electrode402aand a reference electrode402b. However, the number of array electrodes402may be more than 32 (such as 64 as described in previous embodiments or even more than 64). In some embodiments, the electrode patch400may have less than less than 32 array electrodes402.

The electrode patch400may comprise two connector portions404a,402b. The electrical conductors406running as conductive tracks between the electrodes402,402a,402bare routed to two separate connector portions404a,404b.

Splitting the connector portions402a,402binto two or more parts is advantageous over one connector portion because by spiting connector portions in that way, less mating force will be required at each connecting portion to achieve reliable coupling between the electrode patch400and connector device(s). Also, splitting the connector portions402a,402binto two or more parts means the connector portions will be smaller than a single connector portion and can be placed strategically within the electrode patch400to reduce the overall size of the electrode patch400.

A large cut-out409that is located between the connector portions402a,402b. The cut-out409is shown to be substantially rectangular. However, the cut-out409may be of many other suitable shapes. The cut-out409is for a proper alignment of the electrode patch400on a connector device such as connector device900as described below.

The shape of the tongue403of the electrode patch400is shown to be substantially rectangular. However, the tongue403may be of many other suitable shapes. In retain embodiments, there may be no tongue and the dimension of the primary region comprising electrodes402may be same or substantially the same as the dimension of the region should inFIG.22as the tongue403. In certain embodiments, the primary region containing electrodes402,402a,402bmay be of different shapes than what is shown inFIG.22. The primary region may be wider or smaller than what is shown inFIG.22depending upon the intended application of the patch400.

Each connector portion of the electrode patch200may be similar to the connector portions104,204described above. Alternatively, each connector portion may look like the first half104aor a second half104bof the connector portion104shown inFIG.2. More specifically, the groups of contact pads of each connector portion of electrode patch400may be in a staggered format as shown in the first half104aor a second half104bof the connector portion as shown inFIG.2.

The electrode patch may comprise adhesive or layer of adhesive413on the edges and on the tongue403as shown inFIG.17to allow the electrode patch400to adhere to the outer surface of the skin of the subject during use. Although not shown, the electrode patch100,200,300as described above may also contain adhesive layer in the tongue(s) and the edges, specifically edges of the primary region in a similar manner.

The electrode patch400may comprise a plurality of alignment holes414near each of the connector portions404a,404b. In the example shown inFIG.17, there are 6 alignment holes414near connector portion404aand another 6 alignment holes near connector portion404b. The alignment holes414are for a proper alignment of the electrode patch400on a connector device such as a connector device900described below. Even more specifically, the alignment holes414are for a proper alignment of the connector portions404a,404bof electrode patch400with the connectors such as connectors950of the connector device900as described below.

FIG.23shows a connector device900according to a further preferred embodiment of the invention.

A connector device900comprises a main body905extending from a first end portion905ato a second end portion905bthat is located opposite the first end portion905a. The main body905has a planer surface which is a top surface905cand a bottom surface905d(seeFIG.25). The top surface805cis configured to receive an electrode patch400for use in monitoring electrical activity generated by a subject.

As shown inFIGS.17and18, the connector device900comprises a first clamping member910which is a flap that is hingedly/pivotally mounted to the main body905dat or near the first end portion905a. The connector device900also comprises a second clamping member920which is also a flap that is hingedly/pivotally mounted to the main body at or near the second end portion905b.

The first and second clamping members910,920are configured to move between an open position as shown inFIG.23and a closed position as shown inFIG.19. As shown, in the open position the first clamping member910and the second clamping member920are both configured to pivotally move away from the top surface905cand at least partially, preferably fully, reveal the top surface905c. Similarly, in the closed position the first clamping member910and the second clamping member920are both configured to move pivotally towards the top surface905cand partially, preferably fully, conceal the top surface905c.

At least one, but preferably both of the first and second clamping members910,920comprise at least one connector950that is configured to be physically and operatively connected with the electrode patch400for receiving the electrical signals from multiple electrodes of the electrode patch400to allow monitoring the electrical activity generated by the subject. Therefore, no cable is required to connection between the connector850and the electrode patch400. The connector may be the connector150or350as described above.

The connector device900may comprise at least one alignment feature configured to align and/or retain the electrode patch400onto the top surface. InFIG.23a plurality of alignment features930,935are shown. The alignment features are in the form of a protrusion935and alignment pins935. The protrusion that is configured to be received by at least one complementary cut-out409formed in the electrode patch400to align and/or retain the electrode patch400onto the top surface905cof the connector device900. The protrusion935may be substantially rectangular or substantially cuboid in shape. The protrusion935may be of a size that is sufficient to prevent at least a lateral movement of the electrode patch between the first end portion905aand the second end portion905bwhen the protrusion935is received by the at least one complementary cut-out formed in the electrode patch.

The alignment pins935are configured to be received by complementary alignment holes414formed in the electrode patch400. The alignment pins935may be located on either or both sides of the protrusion930. In the example shown inFIG.23, 6 alignment pins935are located on both sides (lateral sides) of the protrusion930. The alignment pins may be more than or less than 6.

As shown inFIG.24, in the closed position the first clamping member910and the second clamping member910may both be configured to move pivotally towards the top surface and at least partially (preferably fully) conceal the top surface905csave for the protrusion930or at least the portion thereof.

The connector device900is preferably a wearable electronic device. Preferably, the main body905, the first clamping member910, and the second clamping member920together form a housing inside which various electronic components of the connector device are at least partially disposed. InFIG.23, the connectors950are shown to slightly protrude out from the first and second clamping members910,920.

The connector device900may comprise an electronic circuit and a memory with the instructions stored in the memory. The implementation of the instructions may cause the connector device900to receive signals from the electrode patch400, process the signals, and transmit 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 data logging device. The data may be transmitted wirelessly and/or with a wire to a computing device for processing, filtering or analysis.

Preferably, the connector device900is battery powered (e.g. by a Li-ion battery). The principals and operations of the data acquisition device or data logging device are well known to a person skilled and need not be described here. However, the connector device800may comprise at least one analogue to digital convertor to amplify and digitize a biopotential measurements signals received from the electrode patch400. There may be multiple (e.g. four) analogue to digital convertors. The analogue to digital convertor(s) may be analogue to digital convertor chip(s). The connector device800may comprise a microcontroller. The microcontroller may be configured to receive signals from the analogue to digital convertor, process the signals, and transmit data to a remote computing device to allow monitoring of electrical activity generated by the subject. The analogue to digital convertor(s) may be electrically connected to the microcontroller with a flexible cable(s). The flexible cable(s) may be flexible printed circuit board(s). The electronic component may further comprise a flash memory, Near Field Connection (NFC) module(s) and/or charging circuit(s).

FIGS.25-29show an example of a docking device1500of the connector device900and how the docking device1500may be used to receive the connector device900. As shown, the docking device1500may comprise a compartment1550which is a connector device receiving compartment.

The docking device1500may be a wireless charging device for facilitating wireless or contact charging of the connector device when the connector device is received within the compartment1550as shown inFIG.25. The principals and designs of the wireless or contact charging device is well known to a person skilled and need not be described here.

One purpose of the docking device1500is to provide a large flat surface1510where the operator can conveniently assemble the electrode patch400′ and the connector device900together. The electrode patch400′ (shown inFIGS.28,29,30) may be substantially the same as electrode patch400as described above. The only major difference being in the number of electrodes. The electrode patch400′ may comprise 64 array electrodes402′, a ground electrode402a′ and a reference electrode402b′. However, the electrode patch400′ may have more than or less than 64 electrodes. InFIGS.23-25, the electrical conductors and the connector portions, the alignment holes, the adhesives are not shown for the sake of clarity. InFIGS.20-25, the alignment pins935are not shown for the sake of clarity. InFIGS.25-29, the front portion400a′ of the electrode patch400is shown. InFIG.30, the rear portion400b′ of the electrode patch400is shown.

The mode of assembly in one embodiment occurs as follows.

The connector device900is placed into a depression, i.e. compartment1550within the surface of the docking device1500. The connector device900has a consistent geometry with this compartment1550so that a correct orientation is readily achieved. The clamping members910,920formed on the connector device900are then moved to the opened position to expose the connectors950. The electrode array400′ is then positioned on the flat surface1510of the docking device1500. This flat surface1510preferably has enough friction so that the electrode patch400′, which may be made of a material that is slippery, remains easily in position. The electrode array400′ is then draped over the open surface of the connector device900, and the alignment holes and pins of the electrode patch400′ and the connector device400′ respectively are matched. The clamping members910,920on the connector device900are then moved to the closed position securely onto the electrode patch400′, forming a tight connection at the correct alignment.

A person skilled in the art may appreciate that the connectors950should not be cleaned with clinical disinfectant solution to prevent being clogged with residues and/or to prevent being damaged due to cleaning, however the connector device900may need to be cleaned between patients for hygiene reasons. The connector device900of the invention allows easy cleaning and avoid accidental cleaning of the connectors950because the connectors950of the connector device900are only exposed when the clamping members910,920are in the open position. In order to clean the connector device900, the clamping members910,920can be moved to the closed position and wiped with clinical disinfectant and that may avoid cleaning of the connectors950. Further, since the connectors950are only exposed when the clamping members910,920are in the open position, there is a less prone to damage and less prone to clogging by dust or similar.

Another purpose of the docking device1550is to charge the connector device900when it is not in use. This can be achieved by having a contact charging points. Alternatively, a wireless charging coil (not shown) may be placed at a suitable location, preferably beneath the compartment1550in the docking device1500. A consistent geometry between the connector device900and the compartment1550in the docking device1500ensure that the charging connection is made reliable. The compartment1550may shaped and sized to snugly receive the connector device900within the compartment1550and that can ensure that the charging connection between the docking device1500and the connector device900is reliable.

A significant force must be achieved at the connection between electrode patch400and first and second connection members910,920for a connection device. In connection device900, the first and second clamping members910,920may be locked in a closed position by magnets. However, other suitable locking means such as latch arrangement, snap fit arrangement etc. are equally possible.

A preferred method of using the system2000comprising the coupling device900, the docking device1500and an electrode patch400′ will now be further described with reference toFIGS.25-30. As mentioned above, the electrode patch400′ (shown inFIGS.28,29,30) may be substantially the same as electrode patch400as described above. The only major difference being in the number of electrodes. The electrode patch400′ may comprise 64 array electrodes402′, a ground electrode402a′ and a reference electrode402b′. However, the electrode patch400′ may have more than or less than 64 electrodes.

FIG.25shows the docking device1500that is ready to receive the connector device900inside the depression, i.e. the compartment1550.

As shown inFIG.26, the connector device900is placed in the docking device1500, more specifically the connector device1500is placed within the compartment1550formed in the docking device1500. Also, when not in used, the connector device900may be placed in the docking device as shown inFIG.21to allow the connection device to be charged wirelessly or by contact charging.

The electrode patch400′ is positioned on the flat surface1510of the docking device. This flat surface1510preferably has enough friction so that the electrode patch400′, which may be made of a material that is slippery, remains easily in position. The electrode patch400′ is then draped over the open surface of the connector device900.

In order to couple the electrode patch400′ with the connector device900, the first and second clamping members910,920are moved to be in open position as shown inFIG.28.

The electrode patch400′ is then guided down into the connector device900.

Close or exact alignment of the connector portions of the electrode patch and the connectors950on the first and second clamping members910,920are necessary for reliable coupling. This is achieved by the alignment features in the form of protrusion930that is received by the cut-out409′ and alignment pins935that are received by the alignment holes of the electrode patch400′. As mentioned above, inFIGS.25-29, the alignment pins935and complementary alignment holes to receive the alignment pins935are not shown for the sake of clarity. The protrusion and the alignment pins help to prevent skewing of the electrode patch and allows close or exact registration of the connector950to the connector portions of the electrode patch. This can help prevent failed connections and cross talks.

The first and second clamping members910,920are then moved to the closed position where each clamping member910,920clamps the portion of the electrode patch (connection portions of the electrode patch) between that clamping member and the top surface905aof the connector device900.

The connector device900and the connector device assembly in assembled configuration as shown inFIG.30is then ready for attachment to outer surface of the skin of the subject. By having a tongue403′ with adhesive on the one side (right side) of the connector device900and remaining portion on the other side (left side) with adhesive on the edges (see adhesive413shown inFIG.22), the electrode patch400′ and connector device assembly can stick firmly to the outer surface of the skin of the subject on each side of the connector device900. This also means that the electrode patch900may be well attached on each side of the connector device900and does not dislodge easily.

In some embodiments, the top surface of the protrusion may comprise a display screen for displaying useful information to the user. Such useful information may be information relating to the electrical activity that is being monitored using the connector device900, or information on connectivity, test status or device errors.

FIG.31shows a connector device1000according to another preferred embodiment of the invention. Connector device1000of this example is similar in most aspects to the connector device900described above and the differences can be identified by comparingFIG.23withFIG.31. InFIG.31, the features that are similar to those shown inFIG.23are identified with the same reference numeral, incremented by 100. Most of the description of the connector device900of a preferred embodiment above, equally applies to the connector device1000and therefore, only the differences will be discussed.

As shown, the connector device1000may comprise latching arrangement comprising latches1070that are configured to engage with catches1072formed on the first and second clamping members1010,1020when in the closed position. InFIG.31, only catches1072on the second clamping member1020can be seen. The engagement of the latches1070with the latches1072allow the first and second clamping members to remain in the closed position. As shown, the connector device may comprise a push button1075, which when depressed may allow the latches to move their position thereby disengage with the catches to allow the first and second clamping members to be in the open position. Preferably, the first and second clamping members1010,1020are spring biased to be in open position so that when the push button1075is depressed, the latches1070disengage with the catches1072and both the first and second members1010,1020move from the closed position to the open position. As shown, the latches may be position on each side of the protrusion1030. The latches1072and the protrusion1030may both be received by the cut-out400′ of the electrode patch400′ when the electrode patch400′ in position on the top surface1005cof the connector device1000. Instead of a push button1075, a sliding button or many other suitable types of buttons may be used which when slide either on one side cause the latches1070to disengage with the catches1072. The latches1070are preferably mechanical latches. Many other suitable latches and catches arrangement may be used.

FIG.32shows a connector device1100according to another preferred embodiment of the invention. Connector device1100of this example is similar in most aspects to the connector device900described above and the differences can be identified by comparingFIG.23withFIG.32. InFIG.32, the features that are similar to those shown inFIG.23are identified with the same reference numeral, incremented by 200. Most of the description of the connector device900of a preferred embodiment above, equally applies to the connector device1100and therefore, only the main differences will be discussed.

The key feature of the connector device900is a plurality of amplifier chips1190(which may be analogue to digital convertor chips) next to the connector1150. This is useful at least for the following reasons:

It allows conversion of the signals from the electrode patch400′ immediately to a digital signal. This means that only a small number of wires1180are required to be routed across the clamping members1120,1120to the main body1105. It can be appreciated that if the amplifier chips1190were on the main body1105of the connector device1100then that will require to route larger number of wires (e.g. 66 wires for 66 electrodes) across the hinged clamping members1110,1120, which could be problematic for the design or operation of the clamping members1110,1120, or lead to increased wear and failure rates.

Rapid digital conversion also means higher signal quality as there is less signal loss/noise with shorter distances, less wire and less connections.

The connector device1000may also have plurality of amplifier chips next to the connector1150.

FIG.33shows an electrode patch200′ according to another preferred embodiment that is placed on a connector device1200according to another preferred embodiment.

The electrode patch200′ is substantially the same as electrode patch200described above. Hence, most of the description of electrode patch200of a preferred embodiment above, equally applies to the electrode patch200′ and therefore need not be described again.

The electrode patch200′ comprises connection portions204a′ and204′ that are similar to connection portion204described with reference toFIGS.10and11. Most of the features of the electrode patch200′ such as electrodes and full electrical conductors are not shown inFIG.33for the sake of clarity. The electrode patch200′ may comprise 66 array electrodes and ground electrode and a reference electrode similar to electrode patch200as described above with reference toFIG.9. Alternatively, the electrode patch200′ may comprise more than or less than 66 array electrodes and a ground electrode and a reference electrode.

The connector device1200is substantially same as connector device900as described above. Hence, most of the description of electrode patch200of a preferred embodiment above, equally applies to the electrode patch200and therefore need not be described again. The only difference lies in the connector1250of the electrode device1200which is same as connector350described above with reference toFIGS.13and14. Alternatively, the connector1250may be same as the connector450as described above with reference toFIGS.16-18.

FIG.34discloses an electrode patch200″ according to a further preferred embodiment of the present invention. The electrode patch200″ is substantially the same as electrode patch200described above. Hence, most of the description of electrode patch200of a preferred embodiment above, equally applies to the electrode patch200′ and therefore need not be described again.

The electrode patch200″ comprises connection portions204a″ and204b″ that may be similar to connection portion204described with reference toFIGS.10and11. Most of the features of the electrode patch200″ such as full electrical conductors are not shown inFIG.34for the sake of clarity. The electrode patch200″ may comprise same number of electrodes as described above with reference toFIG.9. It is possible that electrode patch200″ comprises more than or less than 64 electrodes are shown inFIG.34.

As shown inFIG.34, there are at least three cut-outs209a″,209b″ and209c″.

In order to couple the electrode patch200″ with the connector device900, the first and second clamping members910,920are moved to be in open position as shown inFIG.35. The electrode patch200″ is then guided down into the connector device900.

Close or exact alignment of the connector portions204a″ and204b″ and the connectors950on the first and second clamping members910,920are necessary for reliable coupling. This is achieved by the alignment features in the form of protrusion930that is received by the cut-out209c″ and alignment pins935that are received by the alignment holes of the electrode patch200″. The alignment pins935are not shown inFIGS.35-37for the sake of clarity but can be seen for example inFIG.23. The protrusion930and the alignment pins935help to prevent skewing of the electrode patch and allows close or exact registration of the connector950to the connector portions of the electrode patch. This can help prevent failed connections and cross talks.

The connector device900and the connector device assembly in assembled configuration as shown inFIG.37is then ready for attachment to outer surface of the skin of the subject. As it can be appreciated fromFIGS.34-37, tongue in the electrode patch may be optional. The electrode patch may equally be used with devices1000,1100and1200as described above.

The first and second clamping members910,920are then moved to the closed position where each clamping member910,920clamps the portion of the electrode patch (connection portions of the electrode patch) between that clamping member and the top surface905aof the connector device900.

In certain embodiments, cut-outs209a″ and209b″ may not be present and the dimension of the electrode patch200″ may be such that it is able to fit between the first and second clamping members910,920in a similar manner as shown inFIG.29.

FIGS.38and39show a connector device1300according to another preferred embodiment of the invention. Connector device1300of this example is similar in most aspects to the connector device900described above and the differences can be identified by comparingFIG.23withFIG.38. InFIG.31, the features that are similar to those shown inFIG.23are identified with the same reference numeral, incremented by 400. Most of the description of the connector device900of a preferred embodiment above, equally applies to the connector device1000and therefore, only the differences will be discussed.

As shown, the connector device1300may comprises only one clamping member1310that is hinged mounted to the main body1305. Although, it may also be appreciated that the main body1305also facilitates clamping of an array positioned between the clamping member1310and the main body1305and in such a sense the main body1305can be interpreted as a second clamping member. The connector device1300can be considered as a truncated version of the connector device900and due to its smaller size, it is less heavy than connector device900. Due to its size and weight, the connector device1300can be useful for monitoring electrical activity of pediatric subjects.

The connector device1300may also have one or more features of the connector devices1000,1100and1200such as but not limited to push button, sliding button, latches, display screen etc.

FIG.40shows an electrode patch100′ according to a further preferred embodiment of the present invention. The electrode patch100′ is substantially the same as electrode patch100described above. Hence, most of the description of electrode patch100of a preferred embodiment above, equally applies to the electrode patch100′ and therefore need not be described again and the differences can be identified by comparingFIG.40withFIG.1. InFIG.40, most features such as full electrical conductors are not shown for the sake of clarity.

One main difference between electrode patch100′ and electrode patch100is the number of electrodes. The electrode patch100′ may comprise lesser number of electrodes than electrode patch100. In the example shown inFIG.40, there are only 32 electrodes in the electrode patch100′ as it is intended to be used on a pediatric subject.

In order to couple the electrode patch100′ with the connector device900, the clamping member1310is moved to be in open position as shown inFIG.40. The electrode patch100′ is then guided down into the connector device1300.

Close or exact alignment of the connector portion104′ and the connector1350on the clamping member1310are necessary for reliable coupling. This is achieved by the alignment features in the form of protrusion1530that is received by the cut-out109′ and alignment pins1335that are received by the alignment holes of the electrode patch109′. InFIG.40, the alignment pins1335are not shown for the sake of clarity but such pins can be seen inFIG.38. The protrusion1350and the alignment pins1330help to prevent skewing of the electrode patch and allows close or exact registration of the connector950to the connector portion104′ of the electrode patch100′. This can help prevent failed connections and cross talks.

The clamping member1310is then moved to the closed position where the clamping member1300clamps the portion of the electrode patch (connection portions of the electrode patch) between that clamping member and the top surface1305aof the connector device1300.

The connector device1300and the electrode patch100′ in assembled configuration is then ready for attachment to outer surface of the skin of the subject, preferably pediatric subject.

It may be appreciated that the size, shape and number of electrodes in the electrode patches may differ from what is described above and depicted in the accompanying drawings which are described and shown in this specification by way of examples only.

Where in the foregoing description reference has been made to elements or integers having known equivalents, then such equivalents are included as if they were individually set forth.

It will of course be realized that while the foregoing description has been given by way of illustrative example(s) of the invention, all such modifications and variations thereto as would be apparent to a person skilled inf the art are deemed to fall within the broad scope and ambit of the various aspects of invention as is hereinbefore described and/or defined in the claims.