Patent Description:
The present disclosure relates to medical electrodes, and to devices, systems methods and assemblies for monitoring and/or controlling the use of medical electrodes.

Medical electrodes have been used in monitoring or delivering electrical signals from or to a human or animal body. Typically, a medical electrode includes a conductive member that can be placed on and electrically connected to the skin of a patient, the conductive member being also connected to an external medical device that monitors or outputs electrical signals.

Various types of medical electrodes have been developed. For example, <FIG> illustrate the front side and back side views of different medical electrodes, each of which includes the following components:.

However, the arrangement of these components in different medical electrodes may vary, and for each component its shape, dimensions and material used may be different. As a result, different types of medical electrodes may provide different signal quality and deliver different performance.

For example, different types of medical electrodes may present different signal-to-noise ratios, different duration of attachment, and/or different shelf life. Further, some medical electrodes may be designed for a specific type of medical device, and using these electrodes with other medical devices may result in poor signal quality or even cause damage to the electrodes or the medical devices.

Although some medical institutions (e.g., government institutions, hospitals or clinics) have set out regulatory standards or policies regarding the use of medical electrodes, in reality these standards or policies may be difficult to enforce and their effects are hard to test. Further, in some cases two different electrode types may both comply with required standards or regulations, but still present variations in their results due to each using different:.

Some electrode manufacturers have been providing documentation and labelling on packages of electrodes to inform the user about the intended uses or applications of the electrodes. For example, some electrode manufacturers colour code electrodes to provide indication of suitability for a given application. However, to a standard clinical user, these methods do not provide a clear indication of the potential impacts on electrical signals from using these electrodes with a particular medical device.

Currently, technologies for monitoring the use of different types of electrodes, and identifying whether the electrodes used are in fact compatible with the medical device, are insufficiently effective at least in some applications.

In addition, medical device and electrode manufacturers often have limited ability to track the specific device-and-electrode combinations being used, or to control the use of the electrodes outside their recommended uses. This presents further issues in performance monitoring and quality control of electrode products and the implementation of suitable product improvements.

<CIT> describes a biological signal measuring wearing device.

<CIT> describes a wireless ECG sensor system.

<CIT> describes an implantable electrostimulation assembly.

It is desired to address or ameliorate one or more disadvantages or limitations associated with the prior art, or to at least provide a useful alternative.

The invention relates to a system according to claim <NUM>.

Optional features of the system are described in claims <NUM> to <NUM>.

The invention also relates to a method according to claim <NUM>.

Optional features of the method are described in claims <NUM> to <NUM>.

Some embodiments of the present invention are hereinafter described, by way of example only, with reference to the accompanying drawings, wherein:.

Provided herein are systems and methods for monitoring the use of medical electrodes. The provided systems and methods allow identification of whether an electrode is in fact compatible with a specific medical device. The results can be used to control the use of the electrode with that medical device. Accordingly, the use of electrodes outside their recommended uses can be prevented or reduced.

According to at least some embodiments, the provided systems and methods further enable tracking of the use of electrodes with medical devices, and tracking of the performances of the electrodes when used with different medical devices. Accordingly, the compatibility of different electrodes with different medical devices can be further assessed and analysed over time, so that future use of the electrodes may be optimised or improved based on their previous performances.

According to at least some embodiments, the provided systems and methods further allow monitoring of abnormalities that occurred during the use of the medical electrodes. The monitoring results and the abnormalities detected can be subsequently reported to the manufacturer of the electrodes. This provides a more effective and efficient way of performance monitoring and quality control for electrode products, and allows product improvements to be implemented in a timely manner.

It is noted that in the Figures, like reference numerals are used to identify like parts throughout the Figures. Referring now to <FIG>, there is provided an example of a trackable electrode device <NUM>. The trackable electrode device <NUM> includes at least one electrode member <NUM> (which may also be referred to as a "medical electrode" or "traditional electrode") and a radio-frequency (RF) tag <NUM>. The electrode member <NUM> and the RF tag <NUM> are attached or fitted in proximity to each other within or upon a substrate <NUM>. The substrate <NUM> attaches the electrode member <NUM> to the RF tag <NUM>, i.e., holds the electrode member <NUM> and the RF tag <NUM> together.

The substrate <NUM> can be made from one or more flexible materials, e.g., cloth, paper, plastic or foam. The substrate <NUM> may be separable from the electrode member <NUM> and the RF tag <NUM>, i.e., the substrate <NUM> may be removed from the electrode member <NUM> and the RF tag <NUM> during use by a person. Thus, the substrate <NUM> may be in the form of a removable sheet or cover that is removed by a clinician or operator before or after applying the electrode member <NUM> to the patient or connecting it to the medical device. This form of the substrate <NUM> may be referred to as a "removable substrate", which is discussed in further detail below. During storage and initial manual handling, this removable substrate holds the electrode member <NUM> and the RF tag <NUM> in a preselected arrangement; then the removable substrate is removed from the electrode member <NUM> and/or the RF tag <NUM> for application to (and generally adhesion to) the subject's skin or the external medical device. The RF tag <NUM> may have its own adhesive/backing independent of the electrode member <NUM>, so once the removable substrate is removed, the electrode member <NUM> and/or the RF tag <NUM> are no longer attached to and held by the substrate <NUM>.

Alternatively, the substrate <NUM> may remain integral with the electrode member <NUM> and the RF tag <NUM> during use, i.e., the substrate <NUM> is not removed from the electrode member <NUM> and the RF tag <NUM> during use. Thus the substrate <NUM> may be in the form of a flexible pad or sheet integrated with the electrode member <NUM>. This form of the substrate <NUM> may be referred to as an "integral substrate". This is described in further detail below.

In some embodiments, the trackable electrode device <NUM> further includes a non-electrode adhesive pad for facilitating securing the medical device to the patient's body, and/or to the medical electrodes members. The RF tag <NUM> may be embedded or accommodated in the non-electrode adhesive pad. The non-electrode adhesive pad may be located at or proximate to the centre of the trackable electrode device <NUM>, or any other location on the trackable electrode device <NUM> that allows the RF tag <NUM> to communicate with an external RF reading device. In a further embodiment, the electrode member <NUM> may have the same structure as a known medical electrode device.

Referring now to <FIG>, there is provided an example of the electrode member <NUM>. In this example, the electrode member <NUM> includes a flexible sheet <NUM> that is adaptable to the contour of the skin of a patient. The flexible sheet <NUM> is made of an insulating material, e.g., cloth, plastic, closed cell foam, or any other suitable insulating material.

The electrode member <NUM> further includes an adhesive layer <NUM> containing a sticking substance on one side of the flexible sheet <NUM>, for securing the flexible sheet <NUM> to the skin of the patient. The sticking substance is referred to as an adhesive, which may include but not be limited to acrylic, silicone, and polyurethane based adhesives. The electrode member <NUM> further includes a removable cover <NUM>, which may form the (removable) substrate <NUM>, that covers the adhesive layer <NUM> during storage, and which is removed by a clinician shortly before applying the adhesive layer <NUM> to the skin of the patient.

Also provided on that side of the flexible sheet <NUM> is a conductive area <NUM>. The conductive area <NUM> is formed of conductive substance that can electrically connect the skin of the patient with an electrode connector <NUM> (also referred to as an "electrode-side connector" herein), the conductive substance being, e.g., conductive hydrophilic gel. The electrode-side connector <NUM> is made of a conductive material (e.g., metal), and may be a fastener, and in some embodiments has a shape similar to a male/female snap fastener, or has the form of a tab, wire or custom connector, and can be electrically connected, via a flexible conductive cable (also known as a "lead") or directly, to an external medical device that monitors or generates electrical signals. While <FIG> illustrates one example of the electrode member <NUM>, the electrode member <NUM> may alternatively have any other suitable structure and components known to a person skilled in the art.

Referring now to <FIG>, there is provided an example structure of the RF tag <NUM>, which includes an antenna <NUM> and an integrated circuit <NUM>. The RF tag <NUM> may include, e.g., a radio-frequency identification (RFID) tag or a near-field communication (NFC) tag, which can be read by an RFID reader or an NFC reader of an external electronic device. Alternatively, the RF tag <NUM> may be any other suitable type of compact RF communication device. Although not shown in <FIG>, the RF tag <NUM> can further include a tag connector that connects to a cooperating tag holder of the medical device <NUM>, e.g., cooperating press-stud parts and/or an adhesive.

The RF tag <NUM> stores, e.g., in the integrated circuit <NUM>, tag identification data representing a tag identifier (ID) associated with the electrode member <NUM>. The tag ID can be used by an external device for determining detail information of the trackable electrode device <NUM>, and in particular, detail information of the electrode member <NUM>, including for example, any one or more of the following:.

For example, an exemplary tag ID is in the form of an alphanumeric sequence "ABCDEDZX", where A represents the connector type, B represents the flexible sheet type, C represents the application(s) for which the trackable electrode will be used, G represents the conductive gel type, E represents the adhesive type, D represents the date of manufacture, Z represents the batch number or batch identifier (batch ID), and X represents the product identifier within a batch.

Optionally, the tag identification data may include additional information regarding the trackable electrode device <NUM> and/or the electrode member <NUM>, e.g., a product serial number of the trackable electrode device <NUM> or the electrode member <NUM>. The tag identification data may also include any other suitable information.

The detail information of the electrode member <NUM> may be used for determining how the trackable electrode device <NUM> should be used, and/or whether it should be used with a certain monitoring or stimulating medical device. That is, the compatibility between the trackable electrode device <NUM> and an external medical device can be determined using the tag ID.

Accordingly, an external medical device can control the use of the trackable electrode device <NUM> based on the determined compatibility. For example, controlling the use by allowing the use of a compatible trackable electrode device <NUM>, or by prohibiting the use of an incompatible trackable electrode device <NUM>. In some embodiments, the trackable electrode device <NUM> may be partly compatible with a medical device, i.e., the electrode member <NUM> may be suitable for some functions of the medical device, but unsuitable for other functions of the medical device. Accordingly, the medical device may allow the trackable electrode device <NUM> to be used for those suitable functions, while prohibiting other functions.

In some embodiments, the external medical device may notify a user that the trackable electrode device <NUM> the user is attempting to use is not compatible or not fully compatible with the medical device, e.g., by triggering an alarm or displaying a warning message on a display of the medical device.

Referring again to <FIG>, the substrate <NUM> fits and holds the RF tag <NUM> in proximity to the electrode member <NUM>. The substrate <NUM> is made of a flexible material, e.g., cloth, paper, plastic or foam, so that when the electrode member <NUM> is attached to the skin of a patient, the substrate <NUM> can flex in a similar manner as the flexible sheet <NUM> of the electrode member <NUM>. This facilitates securing the trackable electrode device <NUM> to the patient's body or to the medical device.

<FIG> illustrate some possible arrangements of the electrode member <NUM> and the RF tag <NUM> fitted within or upon the substrate <NUM>. As shown in <FIG>, the electrode member <NUM> may be attached to one side of the substrate <NUM>, with the electrode member <NUM> passing through the substrate <NUM> so that an end of the electrode-side connector <NUM> is exposed on the other side of the substrate <NUM>. The RF tag <NUM> may be attached to either side of the substrate <NUM>. In an embodiment <FIG> the substrate <NUM> may be integral to the electrode member <NUM>. That is, where the at least one substrate is an integral substrate, the substrate is arranged to maintain the at least one medical electrode together with the RF tag in use, as it is not removed when the electrode member <NUM> is attached to the patient and/or medical device. In an embodiment, the flexible sheet <NUM> may form at least a portion of the integral substrate <NUM>.

For example, when the substrate <NUM> is integral to the electrode member <NUM>, the flexible sheet <NUM> of the electrode member <NUM> is permanently bonded to the substrate <NUM>, by way of adhesives or other suitable engagement means. Further, the RF tag <NUM> and the electrode member <NUM> may be also permanently bonded to the substrate <NUM>, by way of adhesives or other suitable engagement means.

In another example shown in <FIG>, the substrate <NUM> is integral to the electrode member <NUM>. In this example, the electrode member <NUM> is attached to the substrate <NUM> in the same way as in <FIG>, whilst, the RF tag <NUM> is integrally formed with the substrate <NUM>, for example by embedding the RF tag <NUM> within the (integral) substrate <NUM> or including it when manufacturing the (integral) substrate <NUM>.

Alternatively, another example is provided as shown in <FIG>, where the substrate <NUM> is integral to the electrode member <NUM>. In this example, both the electrode member <NUM> and the RF tag <NUM> may be embedded within the (integral) substrate <NUM>. For example by embedding the RF tag <NUM> within the (integral) substrate <NUM> or including it when manufacturing the (integral) substrate <NUM>.

Alternatively, <FIG> illustrates a possible arrangement of the electrode member <NUM> and the RF tag <NUM>, wherein the substrate includes:.

In this embodiment, the first substrate layer <NUM> may be removable and the second substrate <NUM> may be integral. The first substrate layer <NUM> function in a similar way to the removable cover <NUM>, in that it is removable to expose an adhesive surface but does not include any adhesive surfaces. In this example, the first substrate layer <NUM> is removed to expose the adhesive layer <NUM> on the patient-side of the medical electrode <NUM> mentioned previously. Further, the first substrate layer <NUM> may also be removed to expose an RF tag adhesive layer (not shown) similar to that of the adhesive layer <NUM> that is provided to the patient-side surface of the RF tag. The adhesive layer <NUM> on the patient-side of the medical electrode <NUM> and/or said RF tag adhesive layer are arranged to aid adhering the trackable electrode device <NUM> to the patient.

In any of the above embodiments where the substrate <NUM> is integrally formed with the electrode member <NUM>, a patient adhesive layer (not shown) may be provided on the patient-side of the substrate <NUM> (i.e. the side of the substrate <NUM> facing the skin of the patient), which may further facilitate securing the trackable electrode device <NUM> on the body of the patient. In a further optional embodiment, a medical device adhesive layer may be provided to the device-side of the second substrate layer <NUM>, i.e., the side facing the medical device <NUM>, to aid in attaching the medical electrode <NUM> to the medical device for any integral substrate <NUM> herein described.

In alternate embodiments, the substrate <NUM> may be manually removable from the at least one electrode member <NUM> and the RF tag <NUM>. For example, <FIG> may show an alternate embodiment where the flexible sheet <NUM> of the electrode member <NUM> is non-permanently bonded to the substrate <NUM>, by way of adhesive provided to the device-side of the flexible sheet <NUM> that permits separation, or other suitable engagement means. Further, the RF tag <NUM> and the electrode member <NUM> may be also be non-permanently bonded to the substrate <NUM>, by way of adhesives that permit separation, or other suitable engagement means.

Removal of the removable substrate <NUM> may occur to enable the electrode member <NUM> to be fastened to a medical device <NUM> using the aforementioned adhesive provided to the device-side of the flexible sheet <NUM>. In such an embodiment, a second substrate layer <NUM> may form the removable cover <NUM>, or the shared removable cover if there is a plurality of electrode members <NUM>. In this example, the removable cover <NUM> is removed to expose the adhesive layer <NUM> mentioned previously. Further, an additional removable cover (not shown) may also be provided to the patient-side of the electrode member <NUM>, that when removed exposes an additional adhesive layer (not shown) provided to the patient-side surface of the RF tag <NUM>.

In this example, the RF tag <NUM> may be fastened to the medical device <NUM> when the electrode member(s) <NUM> are fastened thereto, e.g., by a fastener of the medical device <NUM> (e.g., in the leads or a fastener on the housing of the medical device <NUM>), which may include the OLI(TM) device to which a plurality of electrode members <NUM> can be fastened, as described in <CIT> titled "Apparatus for monitoring pregnancy or labour" and/or in PCT Application No. <CIT> of the same name.

Alternatively, an alternate embodiment is also provided by <FIG>, wherein the electrode member <NUM> and the RF tag <NUM> are non-permanently attached to two removable substrates, which may include:.

In use, a user may peel off the first substrate layer <NUM> to expose the adhesive beneath that is provided to the patient-side of the electrode member <NUM> and the RF tag <NUM>, and apply the remaining assembly of the second substrate layer <NUM>, electrode member <NUM> and the RF tag <NUM> on the patient's skin. The assembly will adhere to the patient's skin because of the exposed adhesive, which was previously covered by the first substrate layer <NUM>. In this regard, the first substrate layer <NUM> functions similarly to the removable cover <NUM>. However, the first substrate layer <NUM> simultaneously covers adhesive provided to both the patient-side of the electrode member <NUM> and the RF tag <NUM>.

Once the electrode <NUM> and the RF tag <NUM> are secured to the patient's skin, the user may then peel off the second substrate layer <NUM> to expose the adhesive beneath. The user can then attach the medical device <NUM> to the exposed adhesive surface of the electrode member <NUM> (and optionally the RF tag <NUM>), thereby securing the medical electrode <NUM> (and optionally the RF tag <NUM>) to the medical device <NUM>. After the monitoring is completed, the used electrode member <NUM> and the RF tag <NUM> may be removed from the medical device <NUM> and from the patient's skin, and disposed of.

As described hereinbefore, the electrode member <NUM> and the RF tag <NUM> may take any suitable form different from those shown in <FIG>. For example, <FIG> illustrates another example of the trackable electrode device <NUM> that includes a different type of electrode member <NUM> and a different type of RF tag <NUM>.

Further, although the trackable electrode device <NUM> shown in <FIG> includes a single electrode member <NUM>, the trackable electrode device <NUM> may alternatively include a plurality of electrode members <NUM>. The trackable electrode device <NUM> can include a shared flexible sheet connected to a plurality of conductive areas <NUM> (one for each of the plurality of electrode members <NUM>), and the trackable electrode device <NUM> can include a shared removable cover that covers a plurality of the adhesive layers <NUM> (one for each of the plurality of electrode members <NUM>). The RF tag <NUM> can include one tag ID that represents the trackable electrode device <NUM> (which include its plurality of electrode members <NUM>), or the RF tag <NUM> can include a plurality of tags IDs for the respective electrode members <NUM> of the trackable electrode <NUM>.

<FIG> shows another example of the trackable electrode device <NUM>, which includes two electrode members 110A, 110B and a single RF tag <NUM>. The two electrode members 110A, 110B may have the same structure and composition. Alternatively, the structure and composition of the two electrode members 110A, 110B may be different from each other. An external device may use the tag identification data stored in the RF tag <NUM> to determine detailed information relating to each of the two electrode members 110A and 110B.

<FIG> shows another example of the trackable electrode device <NUM>, which includes four electrode members 110A, 110B, 110C and 110D, as well as a single RF tag <NUM>. An external device may use the tag identification data stored in the RF tag <NUM> to determine detailed information relating to each of the four electrode members 110A, 110B, 110C and 110D.

Further, in some other embodiments, the trackable electrode device <NUM> may include a plurality of RF tags <NUM> (an example of which is shown in <FIG>), each storing tag identification data associated with one or a group of electrode members <NUM>.

As described hereinbefore, the substrate may be removably attached to the medical electrode(s) and the RF tag(s). For example, the substrate may include:.

Accordingly, the electrode(s) and the RF tag may become separate from each other once the substrate or the substrate layers are removed. In some embodiments, the RF tag <NUM> and the electrode member <NUM> are attached to each other in a way that they overlap with each other. This may allow minimising the footprint of the trackable electrode device <NUM> on the patient's skin, and/or improving proximity to a RF reader when the RF reader is integrated with the cable for connecting the electrode member <NUM> with the medical device.

<FIG> illustrate some other examples of the trackable electrode device <NUM> with the integral form of the substrate <NUM>. In these examples, the RF tag <NUM> is integrated with the electrode member <NUM>, and the substrate <NUM> is formed by at least a portion of the flexible sheet <NUM>. For example, <FIG> show examples of the trackable electrode device <NUM>. In these examples, the RF tag <NUM> is attached upon the electrode member <NUM>, with the antenna <NUM> positioned around the electrode connecter <NUM> of the electrode member <NUM>.

Further, <FIG> show some further examples of the trackable electrode device <NUM>, in which the RF tag <NUM> is attached upon the electrode member <NUM> and positioned next to the electrode connecter <NUM> of the electrode member <NUM>. Alternatively, the RF tag <NUM> may be attached in proximity to the electrode member <NUM> in any other suitable manner.

<FIG> shows an example of a system <NUM> for controlling the use of the trackable electrode device <NUM> in the medical device <NUM>. The medical device <NUM> may be an electronic device for monitoring and/or recording the electrical signals received from the trackable electrode device <NUM>, e.g., an electroencephalography (EEG) device, an electrocardiography (ECG) device, or the OLI(TM) mentioned hereinbefore.

Alternatively, the medical device <NUM> may be an electronic device for generating electrical signals to be fed to the trackable electrode device <NUM> for stimulating the patient, e.g., an electroconvulsive therapy (ECT) device, a defibrillator, or a transcutaneous electrical nerve stimulation (TENS) device. In another alternative embodiment, the medical device <NUM> may be any other suitable type of medical device that utilises electrodes in operation.

As shown in <FIG>, in some embodiments, the medical device <NUM> includes an RF reader <NUM>. The RF reader <NUM> of the system <NUM> is configured to read the RF tag <NUM> of the trackable electrode device <NUM>. The RF reader <NUM> may be any suitable type of RF device that can read the RF tag <NUM>. For example, if the RF tag <NUM> is an NFC tag, then the RF reader <NUM> may be an NFC reader. Alternatively, if the RF tag <NUM> is an RFID tag, then the RF reader <NUM> may be an RFID reader. Alternatively, the RF tag <NUM> may be any other suitable type of RF tag, and the RF reader <NUM> may be a device for reading that RF tag.

The RF reader <NUM> is electrically connected to the medical device <NUM> to receive any necessary electrical power from the medical device <NUM>. The RF reader <NUM> is electronically connected to the medical device <NUM> to transmit signals to the medical device <NUM>, including data representing the RF tag <NUM>.

In embodiments, the RF reader <NUM> is attached to or integrated within the medical device <NUM>, i.e., to a housing of the medical device <NUM> and/or to a printed circuit board (PCB) of the medical device <NUM>, and the electrical and electronic connections between the RF reader <NUM> and the medical device <NUM> are direct connections, i.e., without separate cables. The RF reader <NUM> may be attached to an outside of the housing of the medical device <NUM>, e.g., retrofitted to an pre-existing medical device; or integrated in and within the housing of the medical device <NUM> (i.e., regarded as an integrated part of the medical device <NUM> itself). When integrated in and within the housing of the medical device <NUM>, the RF reader <NUM> may be assembled with other components of the medical device <NUM> during an assembly or manufacturing process, and/or assembled with electronic components on the PCB of the medical device <NUM>. Further, the housing may be a sealed housing, including a water-resistant or water-proof sealed housing, and the RF reader <NUM> can be inside or outside the sealed housing, depending on the embodiment.

The medical device <NUM> includes an electrical signal interface <NUM> that transmits the electrical signals that are generated by or received by the medical device <NUM>. The electrode member <NUM> of the trackable electrode device <NUM> is electrically connected to the medical device <NUM> via the electrical signal interface <NUM>. The system <NUM> includes a conductive connector on the device that is referred to herein as a device-side connector <NUM>. The device-side conductive connector <NUM> connects to the electrode-side conductive connector <NUM>, so is of a cooperating connector type. The device-side connector <NUM> connects electrically to the electrode-side connector <NUM> to transmit the electrical signals between the medical device <NUM> and the electrode member <NUM>. The device-side connector <NUM> and the cooperating electrode-side connector <NUM> are made of a conductive material (e.g., metal), can be cooperating fasteners, and in some embodiments have a shape similar to a female/male snap fastener, or have the form of a tab, wire or custom connector (as mentioned hereinbefore), including press-stud fasteners, e.g., where the electrode-side connector <NUM> is a male part (as shown in <FIG>) and the device-side connector <NUM> is a cooperating female part.

As shown in <FIG>, in some embodiments, the system <NUM> includes a conductive cable <NUM> between the electrical signal interface <NUM> and the device-side connector <NUM>. In an embodiment, the device-side connector <NUM> can be integrated into the end of the cable <NUM>.

In some embodiments, the RF reader <NUM> may be integrated with the conductive cable <NUM>. The conductive cable <NUM> includes the device-side connector <NUM> at the one end for connecting to the electrode member <NUM>, and the RF reader <NUM> at or near the same end for reading the RF tag <NUM> attached to the electrode member <NUM>. The other end of the conductive cable is configured for connection to the medical device <NUM>, e.g., using a pre-existing plug. As the RF reader <NUM> and the device-side connector <NUM> are provided in proximity to each other in these embodiments, reading with the RF reader <NUM> and connecting the device-side connector <NUM> to the electrode member <NUM> can be performed by a single connection action. In addition, having the RF reader <NUM> next to the device-side connector <NUM> mitigates interference from other RF tags attached to other electrode members that may be nearby, and thus provides better signal quality and more accurate results. In an embodiment, the conductive cable <NUM> may include additional components, e.g., a memory for storing data.

Referring to <FIG>, there is provided an alternate embodiment where the system <NUM> does not include the conductive cable <NUM>. Instead, the device-side connector <NUM> is mounted on or in the medical device <NUM>, and may be regarded as an integrated part of the medical device <NUM> itself. In this embodiment, the device-side connector <NUM> may be referred to as an integrated device-side conductive connector. The device-side connector <NUM> may be inflexibly or flexibly mounted in or on at least part of the housing and/or an electronic circuit board (e.g., PCB) of the medical device <NUM> (e.g., as in the OLI(TM) device), without an intervening cable.

As described hereinbefore, the RF reader <NUM> and electrical signal interface <NUM> may also be integrated within the housing of the medical device <NUM> for reading the RF tag <NUM> of the trackable electrode device <NUM> that connects to the integrated device-side conductive connector <NUM>. Further, the RF reader <NUM> may be arranged in close proximity to the device-side connector <NUM> on or in the medical device <NUM> for improved signal reception from the RF tag <NUM>. The trackable electrode device <NUM> may include a plurality of electrode members <NUM> on the same substrate <NUM>. For example, as shown in <FIG>, the system <NUM> includes a trackable electrode device <NUM> that includes four electrode members <NUM> and a single RF tag <NUM> provided to a single substrate. The four electrode members <NUM> are arranged on the substrate to align and connect with the device-side connectors <NUM> provided to the housing of the medical device <NUM>.

The medical device <NUM> may be in data communication with a server <NUM>, via a communication network <NUM>. The server <NUM> may take any suitable form, e.g., a cloud server, or a dedicated server. The server <NUM> may be a local server in a hospital, or a cloud-based server accessed by secure Internet connections.

The medical device <NUM> may also be in data communication with a terminal computing device <NUM> via the communication network <NUM> or via another method of wireless communication, such as but not limited to Bluetooth Low Energy technology. The terminal computing device <NUM> may be arranged to receive, store and/or display information relating to the data or information stored on the RF tag <NUM> and/or the signals received by or from the electrode member <NUM>. The terminal computing device <NUM> may include computers, laptop, tablet, mobile device or any similar device. Moreover, the medical device <NUM> may be in communication with any number of terminal computing devices <NUM> or servers <NUM> at any given time.

The communications network <NUM> may take any appropriate form, e.g., the Internet and/or one or a number of local area networks (LANs). In practice, the medical device <NUM> and the server <NUM> may communicate via any appropriate mechanism, such as via wired and/or wireless connections, including, but not limited to mobile networks, private networks, such as an <NUM> network, the Internet, LANs, WANs, as well as via direct or point-to-point connections, such as Wi-Fi or Bluetooth.

<FIG> illustrates an example in which the RF reader <NUM> is integrated with the conductive cable <NUM>. As shown in <FIG>, a power line <NUM> is used for supplying power to the RF reader <NUM> from the medical device <NUM>, and/or for carrying signals between the RF reader <NUM> and the medical device <NUM>. The conductive cable <NUM> further includes a signal line for carrying signals between the electrode-side connector <NUM> and the medical device <NUM>.

<FIG> illustrates an exemplary workflow executed by the medical device <NUM> shown in <FIG> or <FIG> for controlling the use of the trackable electrode device <NUM>. Prior to or after the electrode member <NUM> of the trackable electrode device <NUM> is connected to the electrical signal interface <NUM> of the medical device <NUM>, the medical device <NUM> uses the RF reader <NUM> to receive, from the RF tag <NUM> of the trackable electrode device <NUM>, tag identification data representing a tag ID (Step <NUM>). The tag ID is associated with the electrode member <NUM>.

The medical device <NUM> then obtains device identification data, which represents a device identifier (ID) associated with the medical device <NUM> (Step <NUM>). The device identification data may be stored in a memory of the medical device <NUM>, or in a memory of one or more conductive cables configured for use with the medical device <NUM>. Storing the device ID in the conductive cable can be useful when the conductive cable includes the RF reader <NUM>.

Based on the received tag ID and the obtained device ID, at Step <NUM> the medical device <NUM> obtains a control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server <NUM>. The medical device <NUM> may send both the tag ID and the device ID to the server <NUM> via the communication network <NUM>. Based on the combination of the tag ID and the device ID, the server <NUM> determines a control signal indicating the compatibility between the medical device <NUM> and the trackable electrode device <NUM>, and sends the control signal back to the medical device <NUM>. The server <NUM> determines the compatibility control signal by using data representing the compatibilities between the devices ID and the tag IDs, e.g., in compatibility tables.

Alternatively, in some embodiments, the medical device <NUM> may be offline, i.e., the medical device <NUM> may be not connected to the server <NUM>. In those cases, the medical device <NUM> may be configured to determine the control signal based on a predefined algorithm, e.g., by executing a computer program pre-stored on the medical device <NUM>, and based on pre-stored data in the medical device <NUM>. The pre-stored data represent the compatibilities between the devices ID and the tag IDs, e.g., as compatibility tables. The offline medical device <NUM> has the tag ID pre-stored, and this can be updated sporadically, e.g., in a software update. Therefore, based on the combination of the tag ID and the device ID, the medical device <NUM> determines the compatibility between the devices ID and the tag IDs, e.g., in compatibility tables.

Upon receiving the control signal from the server <NUM> or determining the control signal by executing the computer program pre-stored on the medical device <NUM> and accessing the pre-stored data, the medical device <NUM> then controls the use of the trackable electrode device <NUM> according to the control signal (Step <NUM>), e.g., by allowing the use of a compatible trackable electrode device <NUM>, or prohibiting the use of an incompatible trackable electrode device <NUM>.

Alternatively, in some embodiments, the medical device <NUM> may not be directly connected to the communication network <NUM>. Instead, the medical device <NUM> is communicatively connected to a terminal computing device <NUM>, the latter being connected to the communication network <NUM> and capable of communicating with the server <NUM>. The terminal computing device <NUM> may be any suitable terminal computing device, e.g., a smart phone, a tablet computer, a laptop computer, a desktop computer, a personal digital assistant, or a smart wearable device.

The data communication between the medical device <NUM> and the terminal computing device <NUM> may take any suitable form, for example, through wired and/or wireless connection. In some embodiments, the medical device <NUM> and the terminal computing device <NUM> may be connected to each other via Wi-Fi, NFC, or Bluetooth connections. Accordingly, to control the use of the trackable electrode device <NUM>, the medical device <NUM> uses the RF reader <NUM> to receive, from the RF tag <NUM> of the trackable electrode device <NUM>, tag identification data representing a tag ID. The tag ID is associated with the electrode member <NUM>.

The medical device <NUM> then obtains device identification data, which represents a device ID associated with the medical device <NUM>. The device identification data may be stored in a memory of the medical device <NUM>. The medical device <NUM> then sends the tag ID and the device ID to the terminal computing device <NUM>. The terminal computing device <NUM> determines the control signal corresponding to the combination of the tag ID and the device ID by querying the server <NUM>. The server <NUM> determines the compatibility between the medical device <NUM> and the electrode member <NUM> based on the combination of the tag ID and the device ID, and sends data indicating the compatibility back to the terminal computing device <NUM>. Based on the data received from the server <NUM>, the terminal computing device <NUM> determines a control signal and sends the control signal to the medical device <NUM>. Alternatively, in some embodiments, the medical device <NUM> may be not be connected to the server <NUM> or the terminal computing device <NUM>. In those cases, the medical device <NUM> may be configured to determine the control signal based on a predefined algorithm, e.g., by executing a computer program pre-stored on the medical device <NUM>.

Upon receiving the control signal from the terminal computing device <NUM>, or upon determining the control signal by executing the computer program pre-stored on the medical device <NUM>, the medical device <NUM> then controls the use of the electrode member <NUM> according to the control signal.

<FIG> shows a further example of the system <NUM> for controlling the use of the trackable electrode device <NUM> in the medical device <NUM>. In this example, the medical device <NUM> does not include the RF reader <NUM>. The terminal computing device <NUM>, instead, includes an RF reader (e.g., an NFC reader, or an RFID reader) that can read the RF tag <NUM>.

Accordingly, to control the use of the trackable electrode device <NUM>, the terminal computing device <NUM> uses its RF reader to receive, from the RF tag <NUM>, tag identification data representing a tag ID associated with the electrode member <NUM>. The terminal computing device <NUM> then obtains device identification data, which represents a device ID associated with the medical device <NUM>. The device identification data may be acquired by the terminal computing device <NUM> from the medical device <NUM> via data communication. Alternatively, the device identification data may be obtained by the terminal computing device <NUM> in any other suitable manner, for example, by a user inputting the device ID of the medical device <NUM> into the terminal computing device <NUM>, or by the terminal computing device <NUM> scanning a barcode, a quick response (QR) code, or any other type of machine readable code attached to the medical device <NUM>.

The terminal computing device <NUM> then obtains the control signal corresponding to the combination of the tag ID and the device ID, e.g., by querying the server <NUM>. The server <NUM> determines the compatibility between the medical device <NUM> and the electrode member <NUM> based on the combination of the tag ID and the device ID, and sends data indicating the compatibility to the terminal computing device <NUM>. Based on the data received from the server <NUM>, the terminal computing device <NUM> determines and outputs a control signal.

For example, the terminal computing device <NUM> may send the control signal to the medical device <NUM>, to instruct the medical device <NUM> to use or not use the electrode member <NUM> according to the control signal. Alternatively, the terminal computing device <NUM> may output the control signal in any other suitable manner. For example, the terminal computing device <NUM> may display a control message on a screen of the terminal computing device <NUM> to inform a user of the medial device <NUM>, the control message indicating whether and/or how the electrode member <NUM> should be used with the medical device <NUM>. Alternatively or additionally, the terminal computing device <NUM> may trigger an alarm if it determines that the electrode member <NUM> is incompatible with the medical device <NUM>.

In some embodiments, a manufacturer of the trackable electrode device <NUM> (or the electrode member <NUM>) or a relevant regulatory authority may set a shelf life or expire date for the electrode member <NUM>. The server <NUM> may determine the shelf life or expire date of the electrode member <NUM> based on the tag ID, and send it to the medical device <NUM>, e.g., as part of the control signal, to control the use of the trackable electrode device <NUM> accordingly. For example, if the shelf life of the electrode member <NUM> has expired, the medical device <NUM> may notify the user and require a replacement of the trackable electrode device <NUM>.

In some embodiments, a manufacturer of the trackable electrode device <NUM> (or the electrode member <NUM>) or a relevant regulatory authority may set a maximum attachment duration or an ideal attachment duration that the electrode member <NUM> can be attached to the body of a patient. The server <NUM> may determine the maximum attachment duration of the electrode member <NUM> based on the tag ID, and send it to the medical device <NUM>, e.g., as part of the control signal, to control the use of the trackable electrode device <NUM>. For example, if the electrode member <NUM> has been used for a period of time exceeding the maximum attachment duration, the medical device <NUM> may notify the user and require a replacement of the trackable electrode device <NUM>.

In some embodiments, the medical device <NUM> monitors the use of the trackable electrode device <NUM>, and reports the usage to the server <NUM>. This may include the medical device <NUM> reporting to the server <NUM> any abnormality occurred during the use of the trackable electrode device <NUM>. For example, a manufacturer of the trackable electrode device <NUM> or a relevant regulatory authority may set a recommended attachment duration that the electrode member <NUM> can be attached to the body of a patient. The recommended attachment duration may be determined by the server <NUM> based on the tag ID, and sent to the medical device <NUM>, e.g., as part of the control signal. If during the use of the trackable electrode device <NUM>, the connection between the electrode member <NUM> and the patient's body is lost or unstable after a period of time less than the recommended attachment duration, the medical device <NUM> may report this failure to the server <NUM>. This allows the server <NUM> to collect usage data from multiple medical devices that use the trackable electrode devices, and to provide useful information to manufacturers and/or future users of the medical devices and the trackable electrode devices. For example, the recommended attachment duration and/or the maximum attachment duration may be updated by the server <NUM> based on the collected usage data, which allows determination of a more accurate recommended attachment duration and/or maximum attachment duration, and thus optimises the use of the trackable electrode device <NUM>.

As another example, the medical device <NUM> may further monitor the signal performance of the electrical signals received from the trackable electrode device <NUM>. The medical device <NUM> may include a data storage device that stores data representing the tag ID associated with the trackable electrode device <NUM> linked to the device ID associated with the medical device <NUM>, e.g., in a database. Further, the medical device <NUM> may store the tag ID and the device ID linked to signals recorded by the medical device <NUM> using the trackable electrode device <NUM> in the data storage device, e.g., in a database.

For example, an acceptable signal-to-noise ratio (SNR) may be predefined by a manufacturer of the medical device <NUM> or a regulatory institution, and obtained by the medical device <NUM>. If the medical device <NUM> detects that the SNR of the electrical signals received from the trackable electrode device <NUM> have fallen lower than the acceptable signal-to-noise ratio, the medical device <NUM> may trigger an alarm to notify the user and allow the user to manual check the attachment of the electrode member <NUM> to the patient and the connection between the electrode member <NUM> and the medical device <NUM>. The medical device <NUM> may report the result to the server <NUM>. This information may be collected by the server <NUM> and used for providing feedback to the manufacturer of the trackable electrode device <NUM> or the electrode member <NUM>. For example, the manufacturer may use this information to improve product training for users, or to determine whether the trackable electrode device <NUM> has quality issues and should be recalled.

The trackable electrode devices <NUM> with quality issues may be recorded by or registered at the server <NUM>, so that future use of these devices may be prohibited or warned. If the server <NUM> detects that a tag ID is associated with a trackable electrode device <NUM> that has quality issues or should be recalled, the server <NUM> may send this information to the medical device <NUM>, which can then notify the user regarding the product recall and/or prohibit the use of the trackable electrode device <NUM>, e.g., by displaying a notification on a user interface and/or control the medical device <NUM> to stop or pause operating. This may provide a more effective and efficient way of quality control, and a more thorough and timely way of addressing product recalls or potential defects of medical electrode products, even when the products have been sold via different distributors. This also allows the user of the electrodes (e.g., medical staff) to be informed of the potential defects of the trackable electrode device <NUM>, and assist the user to optimise the use of the trackable electrode device <NUM> and avoid potentially unreliable use.

<FIG> illustrates an exemplary workflow executed by the medical device <NUM> shown in <FIG>, <FIG> or <FIG> for controlling the use of the trackable electrode device <NUM>. In this example, the medical device <NUM> is a monitoring device, e.g., an electroencephalography (EEG) device, or an electrocardiography (ECG) device.

Firstly, at Step <NUM>, the trackable electrode device <NUM> is electrically connected to the medical device <NUM>, e.g., by connecting the electrode member <NUM> to the electrical signal interface <NUM> of the medical device <NUM>. At Step <NUM>, the medical device <NUM> uses the RF reader <NUM> to receive, from the RF tag <NUM> of the trackable electrode device <NUM>, tag identification data representing a tag ID associated with the electrode member <NUM>.

At Step <NUM>, the medical device <NUM> obtains device identification data, which represents a device identifier (ID) associated with the medical device <NUM>, e.g., by retrieving the device ID from a memory of the medical device <NUM>. At Step <NUM>, the medical device <NUM> determines whether it is connected to the communication network <NUM>. If the medical device <NUM> is connected to the communication network <NUM>, the medical device <NUM> sends the combination of the tag ID and the device ID to the server <NUM> at Step <NUM>. Preferably, the server <NUM> is a cloud server. In some embodiments, the server <NUM> may alternatively be a dedicated server.

Alternatively, if the medical device <NUM> is not connected to the communication network <NUM>, the medical device <NUM> sends the combination of the tag ID and the device ID to the network enabled terminal computing device <NUM>, which then sends the tag ID and the device ID to the server <NUM> (Step <NUM>).

At Step <NUM>, the server <NUM> analyses the combination of the tag ID and the device ID, and determines the compatibility between the medical device <NUM> and the electrode member <NUM>. The server <NUM> may further determine whether any constraints may apply in using the trackable electrode device <NUM> with the medical device <NUM>. For example, the server <NUM> may determine whether the trackable electrode device <NUM> has expired (e.g., the trackable electrode device <NUM> has passed its shelf life, or the trackable electrode device <NUM> is a defective product and needs to be recalled. ) Based on the analysis, the server <NUM> sends a control signal back to the medical device <NUM> at Step <NUM>. The control signal may be sent directly to the medical device <NUM> if the medical device <NUM> is network enabled. Alternatively, the control signal may be sent to the medical device <NUM> via the network enabled terminal computing device <NUM>.

The medical device <NUM> then determines whether the trackable electrode device <NUM> is suitable for using with the medical device <NUM> (Step <NUM>). For example, if the control signal received from the server <NUM> indicates that the trackable electrode device <NUM> is incompatible or unsuitable to be used with the medical device <NUM>, the medical device <NUM> may determine that the trackable electrode device <NUM> should not be used.

In some embodiments, if the trackable electrode device <NUM> has expired (e.g., the shelf life of the trackable electrode device <NUM> has passed), or if the trackable electrode device <NUM> is a defective product, the medical device <NUM> or the server <NUM> may also determine that the trackable electrode device <NUM> is unsuitable to be used.

In some embodiments, if the electrical signals received from the trackable electrode device <NUM> via the electrical signal interface <NUM> are illegible signals (e.g., the signal strength exceeds or falls below a predetermined threshold), the medical device <NUM> or the server <NUM> may also determine that the trackable electrode device <NUM> should not be used.

Once determined that the trackable electrode device <NUM> is unsuitable to be used, the medical device <NUM> may be configured to prohibit the use of the trackable electrode device <NUM>. The medical device <NUM> may notifying the user that the trackable electrode device <NUM> is unable to be used with the medical device <NUM> (Step <NUM>).

The medical device <NUM> may further disable the signal communication via the electrical signal interface <NUM> (Step <NUM>), until the user disconnects the electrode member <NUM> of the trackable electrode device <NUM> from the medical device <NUM> (Step <NUM>). If another trackable electrode device <NUM> is subsequently connected to the medical device <NUM>, the medical device <NUM> loops back to Step <NUM> and restarts the process.

Alternatively, if at Step <NUM> the medical device <NUM> determines that the trackable electrode device <NUM> is suitable for using with the medical device <NUM>, e.g., based on a control signal indicating the compatibility between the trackable electrode device <NUM> and the medical device <NUM>, the medical device may notify the user that the trackable electrode device <NUM> is compatible with the medical device <NUM> and that the monitoring will proceed (Step <NUM>). The medical device <NUM> then proceeds to Step <NUM> to allow the use of the trackable electrode device <NUM> with full functionality.

Alternatively, if at Step <NUM> the medical device <NUM> determines that the trackable electrode device <NUM> and the medical device <NUM> are not fully compatible, or the combination of the tag ID and the device ID does not provide sufficient information to determine whether the trackable electrode device <NUM> and the medical device <NUM> are compatible (e.g., if the control signal indicates that the combination of the tag ID and the device ID is unrecognisable), the medical device <NUM> may warn the user that the trackable electrode device <NUM> cannot be guaranteed to function properly with the medical device <NUM> (Step <NUM>), and require user input to confirm whether the user agrees to use the trackable electrode device <NUM> (Step <NUM>).

Upon receiving the user input that authorises the use of the trackable electrode device <NUM>, the medical device <NUM> proceeds to Step <NUM> to monitor the electrical signals by using the trackable electrode device <NUM>. Preferably, only a limited number of functions of the medical device <NUM> are allowed to be used. The functions to be used may be determined by the medical device <NUM> based on the control signal received from the server <NUM>. Alternatively, to track the application of the trackable electrode device <NUM>, the electrical signals are recoded by the medical device <NUM>, and/or transmitted to the enabled terminal computing device <NUM> or the server <NUM>, to monitor the performance of the medical electrodes in the trackable electrode device <NUM>.

As described hereinbefore, in some embodiments, the medical device <NUM> may be not connected to the server <NUM> or the terminal computing device <NUM>. In those cases, the medical device <NUM> may be configured to determine itself the control signal based on a predefined algorithm, e.g., by executing a computer program pre-stored on the medical device <NUM>. The pre-stored computer program determines the compatibility between the medical device <NUM> and the trackable electrode device <NUM> based on the combination of the device ID and the tag ID. Upon determining the control signal by executing the pre-stored computer program, the medical device <NUM> then controls the use of the electrode member <NUM> according to the control signal.

The methods and systems described in this disclosure provide an effective and efficient way of identifying whether the electrodes to be used are in fact suitable for being used with the medical device.

According to some embodiments, the methods and systems may also be used as a tool for manufacturers of electrodes or medical devices to track the application of the medical electrodes, and to monitor the performance of the medical electrodes. This may reveal elements of the electrode that could impact its performance, and may provide valuable information for product improvement or trainings for users.

According to some embodiments, the methods and systems may also be used to prevent or reduce overuse of electrodes, for example, by prohibiting an electrode to be used for longer than its intended shelf life or usable duration. This may ensure that the electrode when being used can provide desirable signal quality, and the monitoring or treatment results from using the electrodes are accurate.

Further, as shown in <FIG>, also described herein is a trackable electrode device <NUM>, including:.

Further, the term "patient" used hereinbefore includes both human and animal patients and users. Accordingly, the medical device <NUM> may include medical devices, well-being equipment and sport-monitoring equipment, for humans or veterinary devices for animals.

Claim 1:
A system including:
a radio-frequency (RF) reader (<NUM>) that reads an RF tag (<NUM>) attached to a medical electrode (<NUM>) to determine a tag identifier (ID) that identifies the medical electrode (<NUM>); and
a medical device (<NUM>) including the RF reader (<NUM>) that operates with the medical electrode (<NUM>) characterized in that the medical device has a device identifier (ID) that identifies the medical device (<NUM>).