Patent Description:
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: a connector <NUM> for joining the electrode to a medical device, the connector <NUM> being made of conductive material, e.g., metal; one or more flexible sheets or films <NUM> for supporting the connector <NUM>, which may be made of e.g., cloth, plastic, foam, or any other suitable material for mechanically supporting the connector <NUM> on the patient's body; a conductive area <NUM>, e.g., conductive gel, for electrically connecting the connector <NUM> to the skin of the patient; and adhesive <NUM> for securing the flexible sheet or film <NUM> on the patient's body.

The adhesive <NUM> may further be covered by a liner or covering, such as a flexible sheet or film that can be manually peeled off from the electrode by a user. Typically, each medical electrode is packaged separately from or can be easily separated from other medical electrodes, such that when a user applies a plurality of medical electrodes to a patient's body, each medical electrode is applied separately.

However, when multiple medical electrodes are to be applied to a patient's body or to an external medical device, applying each medical electrode separately may result in unsatisfactory accuracy of the applied positions of the medical electrodes and/or consistency in the attachment/adhesion of the electrodes, which may affect the quality of the signals captured by a medical device that monitors the electrodes, or the quality of the signals output from a medical device and delivered to the patient's body. Further, peeling off the liner from each medical electrode separately can be time consuming and inconvenient.

<CIT> describes a medical electrode includes a conductive member having a top and a bottom side and a plurality of cutouts establishing a pattern of islands interconnected by conductive member bridges.

<CIT> describes an electrode for applying electric fields to a patient includes a plurality of ceramic elements (e.g., ceramic discs) that are designed to be positioned against the patient's skin.

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.

In a first aspect, there is provided an electrode assembly according to claim <NUM>.

In an embodiment, the at least two covering sheets are made of flexible material.

In another embodiment, the flexible material of the first covering sheet is different from the flexible material of the second covering sheet.

In yet another embodiment, each of the plurality of medical electrode members includes a first adhesive layer removably attached to the first covering sheet and a second adhesive layer removably attached to the second covering sheet.

In a non-limiting example, the first adhesive layer has different adhesive properties to that of the second adhesive layer.

In another example, the relative positions of the plurality of medical electrode members on the at least two covering sheets corresponds to the relative positions of a plurality of electrode connecting portions of a medical device.

In yet another example, the electrode assembly further comprises a non-electrode adhesive pad for holding a medical device, wherein the at least two covering sheets are also removably attached to the adhesive pad.

In an embodiment, the non-electrode adhesive pad may be arranged to form a shape selected from the group of: a circle, ellipse, triangle, square, rectangle, rhombus, trapezoid, rounded triangle, rounded square, rounded rectangle, rounded rhombus, rounded trapezoid or an irregular shape.

In another embodiment, the non-electrode adhesive pad may include an aperture arranged to form a shape selected from the group of: a circle, ellipse, triangle, square, rectangle, rhombus, trapezoid, rounded triangle, rounded square, rounded rectangle, rounded rhombus, rounded trapezoid or an irregular shape.

In yet another embodiment, the adhesive pad is located at or proximate to the centre of the at least two covering sheets.

In a non-limiting example, a device-side of the adhesive pad is spaced apart from each of the plurality of medical electrode members.

In another example, the at least one covering sheet includes at least one perforated section.

In a second aspect, there is provided a method of using an electrode assembly according to claim <NUM>.

In an embodiment, the steps of removing the second covering sheet from the electrode assembly and attaching the electrode assembly with the plurality of medical electrode members to the patient's body are performed prior to the steps of removing the first covering sheet of the electrode assembly and attaching the electrode assembly to the medical device having the corresponding plurality of electrode connecting portions.

In an embodiment, the step of removing the first covering sheet of the electrode assembly exposes a first adhesive surface on each of the plurality of medical electrode members of the electrode assembly.

In another embodiment, the step of removing the second covering sheet of the electrode assembly exposes a second adhesive surface on each of the plurality of medical electrode members of the electrode assembly.

In yet another embodiment, the electrode assembly further includes a non-electrode adhesive pad for holding the medical device.

In a non-limiting example, the method further includes the step of detaching at least one perforated section of the first covering sheet and/or the second covering sheet, the at least one perforated section in removable connection with at least one of the plurality of medical electrode members, such that the perforated section can be separated from the electrode assembly so that the at least one of plurality of medical electrode members can be attached to a patient's body or a medical device.

The present application also describes a method of using an electrode assembly, including: attaching an electrode assembly having a plurality of medical electrode members to a patient's body or a medical device; and removing at least two covering sheets of the electrode assembly from both sides the plurality of medical electrode members.

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

Described herein is an electrode assembly <NUM> (also referred to as a multi-electrode assembly) that allows efficient and accurate application of multiple medical electrodes to a patient's body and/or a medical device. In the Figures, like reference numerals are used to identify like parts throughout the Figures.

Referring to <FIG>, there is provided an example of the electrode assembly <NUM> (which may also be referred to as an "electrode sheet"), which includes a plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM>; and at least one covering sheet <NUM> removably attached to the plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM>. Each of the medical electrode members <NUM>, <NUM>, <NUM> and <NUM> may have the same structure as a known medical electrode device. An example of the medical electrode member <NUM> is shown in detail in <FIG>. The other medical electrode members <NUM>, <NUM> and <NUM> may have the same structure and components as the medical electrode members <NUM>.

In this example, the medical electrode member <NUM> includes a flexible sheet <NUM> (also referred to as an "electrode backing") 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 that does not conduct electrically, e.g., the electrode backing material can be a foam-and-plastic combination including an adhesive flexible seal that is adhered on top of the flexible sheet <NUM> around an electrode connector <NUM>. The adhesive flexible seal is described in further detail later in the specification.

An adhesive layer <NUM> containing a sticking substance is provided on one side of the flexible sheet <NUM>. The adhesive layer <NUM> secures the flexible sheet <NUM> to the skin of the patient. The sticking substance is referred to as an adhesive, for example including adhesives such as but not limited to acrylic, silicone, and polyurethane based adhesives. 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 the electrode connector <NUM>, the conductive substance being, e.g., conductive hydrophilic gel.

The electrode connector <NUM>, may be made of a conductive material (e.g., metal) and in some embodiments may have a shape similar to a male snap fastener, or be arranged in the form of a tab, wire or custom connector, can be electrically connected, either via a flexible conductive cable (also known as a "lead") or directly, to an external medical device that monitors or generates electrical signals. It would be understood by the skilled addressee that use of various different types of known electrode connectors <NUM> would be understood to fall within the scope of the invention as described and defined in the claims. The electrode connector <NUM> as shown is merely provided as an example to demonstrate the workings of the invention, and therefore is not to be taken as limiting.

While <FIG> illustrates one example of the medical electrode member <NUM>, the medical electrode member <NUM> may include other suitable structures and components known to a person skilled in the art, e.g., those shown in <FIG>. In some embodiments, one or more of the medical electrode members <NUM>, <NUM>, <NUM> and <NUM> may have different structures and/or components from the other medical electrode members of the electrode assembly <NUM>. Referring now to <FIG>, an example of a cross-sectional view of the electrode assembly <NUM> along line X'-X' in <FIG> is provided.

The covering sheet <NUM> may be arranged to removably cover the adhesive layer <NUM> of the medical electrode member <NUM>, as well as the adhesive layer of the medical electrode member <NUM>. Similarly, the covering sheet <NUM> removably covers the adhesive layer of each of the medical electrode members <NUM> and <NUM> (not shown). Accordingly, the covering sheet <NUM> (which may also be referred to as a "backing sheet", "backing film" or "liner") holds the plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM> together, such that each of the medical electrode members stays in a predetermined position relative to the other medical electrode members of the electrode assembly <NUM>. Alternatively, multiple covering sheets <NUM> may be used instead. For example, where a first backing sheet holds the medical electrode members <NUM> and <NUM> together and a second backing sheet holds the medical electrode members <NUM> and <NUM> together.

The covering sheet <NUM> may also be arranged to protect the adhesive layer of the medical electrode members during storage, and can be removed by a user (e.g., a clinician) shortly before applying the medical electrode members to the skin of the patient, so as to expose the adhesive layer. Further, the covering sheet <NUM> may be made from one or more flexible materials, e.g., paper, plastic, cloth, or foam, including polyester or polyethylene. In one non-limiting example, the side of the covering sheet <NUM> facing the medical electrode members is a smooth surface that allows easy removal from the adhesive layer of the medical electrode members.

In an embodiment, the covering sheet <NUM> may include at least one perforated section (not shown) to enable the at least one perforated section to be separated from the remainder of the covering sheet <NUM>. For example, a perforated boundary may be formed on a section of the covering sheet <NUM>, first covering sheet <NUM> and/or second covering sheet <NUM> that covers the adhesive layer for at least one of the electrode members <NUM>. The inclusion of perforated sections in the covering sheets <NUM>, <NUM> and/or <NUM> enables the at least one of the electrode members <NUM> to be removed from the rest of the covering sheet <NUM>, whilst still keeping the adhesive layer covered and protected. For example, detaching at least one perforated section of the covering sheets <NUM>, <NUM> and/or <NUM>, where the at least one perforated section in removable connection with at least one of the plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM>, such that the perforated section can be separated from the electrode assembly <NUM> so that at least one of the plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM> can be attached to a patient's body or a medical device <NUM>. This provides improved useability by enabling at least one of the electrode members <NUM> to be positioned separately, for example if connected to a wire extending from the main body of a medical device, whilst the rest of the electrode members remain in position relative to one another, for example when connected to the main body of a medical device.

With reference to <FIG>, another example of the cross-sectional view of the electrode assembly <NUM> along line X'-X' in <FIG> is provided. In this example, the covering sheet <NUM> includes a first covering sheet <NUM> removably attached to one side of each of the plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM>. Further the covering sheet <NUM> includes a second covering sheet <NUM> removably attached to an opposite side each of the plurality of medical electrode members <NUM>, <NUM>, <NUM> and <NUM>. That is, the medical electrode members <NUM>, <NUM>, <NUM> and <NUM> are covered on both sides.

On one side, the second covering sheet <NUM> is attached to the medical electrode members <NUM>, <NUM>, <NUM> and <NUM> via the adhesive layer <NUM> of each medical electrode member. Whilst, on the other side, each medical electrode member may include a further adhesive layer <NUM>, which is covered and protected by the first covering sheet <NUM>.

In an example, the first and second covering sheets <NUM> and <NUM> may be made from one or more flexible materials, e.g., paper, plastic, cloth, or foam. In one non-limiting example, at least one side of each of the covering sheets <NUM>, <NUM> is a smooth surface that allows easy removal from the medical electrode members. In some embodiments, one of the first and second covering sheets <NUM> and <NUM> may be formed as a plurality of separate covering sheets, each covering a medical electrode member.

In the example shown in <FIG>, the electrode assembly <NUM> includes four medical electrode members <NUM>, <NUM>, <NUM> and <NUM>. Alternatively, the electrode assembly <NUM> may include a plurality of medical electrode members, as long as it is suitable for capturing signals from or sending signals to a patient's body as would be understood by the person skilled in the art. For example, in some embodiments, the electrode assembly <NUM> may include two medical electrode members, as shown in <FIG>. In some other embodiments, the electrode assembly <NUM> may include three medical electrode members, as shown in <FIG>.

Further, it would also be within the purview of the skilled addressee that the covering sheet may be arranged in any shape or form. For example as shown in <FIG>, the covering sheet(s) <NUM> of the electrode assembly <NUM> has a square shape. Alternatively, the covering sheet(s) <NUM> may have any other shape suitable for holding the relative positions of the medical electrode members and for attaching the medical electrode members to a patient's body, e.g., rectangle, triangle, circle, polygon, an "X" shape, etc. For example, in some embodiments, the covering sheet(s) <NUM> may have a rectangular shape, as shown in <FIG>. In some other embodiments, the covering sheet(s) <NUM> may have a circular shape, as shown in <FIG>.

Further, in some embodiments, the electrode assembly <NUM> may further include a non-electrode adhesive pad (also referred to as a "non-electrode adhesive hub") that attaches to the medical device, primarily for holding the medical device to the patient. The covering sheet <NUM> may be removably attached to the medical electrode members and the adhesive pad, for example. as shown in <FIG>.

In <FIG>, the electrode assembly <NUM> includes a covering sheet <NUM> (also referred to as a "liner"), removably attached to five medical electrode members <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and a non-electrode adhesive pad <NUM>. The adhesive pad <NUM> is a shaped pad made of a material of varied pliancy. For example adhesive pad <NUM> may be made of a rigid, semi-rigid or flexible material. In an embodiment, the adhesive pad <NUM> is made from the same material as the flexible sheet <NUM>, e.g., cloth, plastic, or closed cell foam or the same material as the covering sheets, e.g. paper, plastic cloth or foam.

The adhesive pad <NUM> may include an adhesive layer that is provided on one or both sides. The adhesive pad <NUM> can have a ring shape, or a square shape. This figure shows a non-limiting example of the electrode assembly <NUM> with a circular non-electrode adhesive pad. However, other embodiments, such as that shown in <FIG>, provide a non-electrode adhesive pad in a square or rectangular shape. Therefore, as would be understood by the skilled addressee, the non-electrode adhesive pad may take many forms such as but not limited to a circle, ellipse, triangle, square, rectangle, rhombus, trapezoid, rounded triangle, rounded square, rounded rectangle, rounded rhombus, rounded trapezoid or an irregular shape. As would be further understood, the solid non-electrode adhesive pad may be a solid shape of any of the above shapes and may also include a gap or aperture formed in the pad that may be formed as any one of the above shapes.

In an embodiment, one side of the adhesive pad <NUM> can adhere to the patient's body. The opposite side of the adhesive pad <NUM> can adhere or securely attach to the medical device that monitors or delivers electrical signals from/to the medical electrode members of the electrode assembly <NUM>. In this way, the adhesive pad <NUM> facilitates securing the medical device to the electrode assembly <NUM> and/or the patient's body, by supporting at least part of the weight of the medical device. This may enhance the security of the connection between the electrode assembly <NUM> and the medical device, and thereby improve the quality of the signals captured by/sent from the medical device.

In the example shown in <FIG>, the non-electrode adhesive pad <NUM> is located at or proximate to the centre of the covering sheet <NUM>. Alternatively, the non-electrode adhesive pad <NUM> may be located in any other location on the covering sheet <NUM> that allows supporting the medical device. Further, the non-electrode adhesive pad <NUM> may have any other shape, as long as it allows the non-electrode adhesive pad <NUM> to adhere to the patient's body and support the medical device on attachment. <FIG> shows exemplary dimensions of the electrode assembly <NUM> of <FIG>.

Further, as described hereinbefore, the structure of each of the medical electrode members <NUM>, <NUM>, <NUM>, <NUM>, <NUM> is not limited to the example shown in <FIG>. For instance, <FIG> illustrates another example structure of the medical electrode member <NUM>. In this example, the medical electrode member <NUM> includes a substrate <NUM> that may be formed of cloth, plastic foam or any other suitable material for supporting a connector <NUM>. On a patient side of the substrate <NUM>, there is provided a flexible layer <NUM>, wherein the flexible layer <NUM> is connected to the substrate <NUM> by means of an adhesive or other suitable engagement means. The substrate <NUM> may be formed of cloth, plastic foam or any other suitable material for supporting a connector <NUM> and may also be of a material that is adapted for contact and/or adherence to human skin (i.e. be suitable for sensitive skin). The flexible layer <NUM> forms at least part of the flexible sheet <NUM> as shown in <FIG>. In a further embodiment, the flexible layer <NUM> may be breathable, where the term breathable material is understood to mean that the material layer allows for the passage of air through the layer.

The flexible material layer <NUM> may be connected to a patient-side adhesive layer <NUM> that is arranged to contact the skin of the patient. The patient-side adhesive layer <NUM> is arranged to attach the medical electrode <NUM> to the skin of the patient and support the weight of the medical electrode <NUM> in use. Further, the patient-side adhesive layer <NUM> is arranged to create a waterproof seal around an electrode sensor <NUM>, when the medical electrode is provided to the patient.

Further, the patient side of the substrate <NUM> may also include a conductive printed layer <NUM>, as such but not limited to an Ag/AgCL printed layer. In an embodiment, the conductive printed layer <NUM> may be directly printed onto the patient-side of the substrate <NUM> to deliver current to a male electrode stud connector <NUM> provided to a device-side of the substrate <NUM>. Further, the conductive printed layer <NUM> is arranged to connect to an electrode sensor <NUM> and a hydro-gel layer <NUM>, where the hydro-gel layer <NUM> is arranged to interface between the electrode sensor <NUM> and the skin of the patient.

On the device-side of the substrate <NUM>, the male electrode stud connector <NUM> and the adhesive flexible seal <NUM> may be provided, where the substrate <NUM> and the conductive printed layer <NUM> are arranged to include an aperture that enables the electrode sensor <NUM> to connect directly with the male electrode stud connector <NUM>. A device-side surface of the adhesive flexible seal <NUM> includes a device-side adhesive layer (not shown) that is similar to the patient-side adhesive layer, but the adhesive on the device-side of the adhesive flexible seal <NUM> aids in attaching the electrode assembly <NUM> to the medical device. The device-side adhesive layer is arranged to adhere to the underside of the medical device to create a waterproof barrier and aids with movement impact on signals. The adhesive flexible seal <NUM> reduces signal noise and artefacts present in the signals collected by the electrode assembly <NUM>. Furthermore, the adhesive flexible seal <NUM> improves the connection of the electrode to the device and waterproofs the connection, which is particularly advantageous where the patient is moving or submerged in water.

The device-side adhesive flexible seal <NUM> may be of varying thickness and may be of varying shapes, such as but not limited to circular, square, triangular or another regular polygon. The adhesive flexible seal may formed of foam, plastic, adhesive gel, cloth or polymer, or another material. In an embodiment, the adhesive flexible seal <NUM> may include an adhesive layer (not shown) on the device side of the adhesive flexible seal <NUM>. The adhesive on the device-side of the adhesive flexible seal <NUM> aids in attaching the electrode assembly <NUM> to the medical device. Further, the adhesive flexible seal <NUM> may also include another adhesive layer (not shown) on the patient-side of the adhesive flexible seal <NUM> (i.e. the adhesive layer facing the substrate <NUM>) to aid in attaching the adhesive flexible seal <NUM> to the substrate <NUM>.

In one embodiment, the adhesive flexible seal <NUM> may comprise a thin layer of material and adhesive as shown in <FIG>. Alternatively, the adhesive flexible seal may include a foam portion including a layer of adhesive provided to the device side of the adhesive flexible seal as shown in <FIG>.

In another non-limiting embodiment, the patient-side adhesive layer <NUM> and the device-side adhesive layer provided to the adhesive flexible seal <NUM> may include the same adhesive or bonding agent. Alternatively, the patient-side adhesive layer <NUM> and the device-side adhesive layer provided to the adhesive flexible seal <NUM> may include different adhesives or bonding agents that are optimised to suit the different properties and requirements of human skin adhesion versus adhesion to the device. This improves the use-life of the electrode, while also minimising patient discomfort.

Moreover, in another embodiment, the patient-side covering sheet provided to the adhesive layer <NUM> and the device-side covering sheet provided to the adhesive layer <NUM> may be formed from the same covering sheet material. Alternatively, the patient-side covering sheet and the device-side covering sheet may be formed from different materials to satisfy different adhesion requirements for different sized electrodes members or different adhesives as discussed above. Varying the material of the covering sheet to suit such factors reduces the risk of certain parts of the electrode assembly being pulled away from the patient-side covering sheet when the device-side covering sheet is removed.

As mentioned hereinbefore, the electrode assembly <NUM> can be used together with an external medical device that monitors or delivers electrical signals from/to the plurality of medical electrode members of the electrode assembly <NUM>. Referring now to <FIG> where an example is provided a medical device <NUM> that can be used together with the electrode assembly <NUM> shown in <FIG>, e.g., 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.

The medical device <NUM> includes a plurality of electrode connecting portions <NUM>, <NUM>, <NUM> and <NUM>. Each of the electrode connecting portions is adapted to be connected to a corresponding one of the medical electrode members <NUM>, <NUM>, <NUM> and <NUM>. Accordingly, the relative positions of the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> in the electrode assembly <NUM> may be arranged based on the relative positions of the corresponding electrode connecting portions <NUM>, <NUM>, <NUM> and <NUM> on the medical device <NUM>. As such, it would be understood by the skilled addressee that variations to the shape and arrangement of the features of the of the corresponding electrode connecting portions <NUM>, <NUM>, <NUM> and <NUM> in accounting for relative positions of the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> is within the scope of the invention as described and defined in the claims.

The electrode members <NUM>, <NUM>, <NUM>, <NUM> are mutually spaced apart in the electrode assembly <NUM> to mitigate mechanical and electrical interference between adjacent ones of the electrode members <NUM>, <NUM>, <NUM>, <NUM>. The electrode members <NUM>, <NUM>, <NUM>, <NUM> are also spaced apart to connect to selected points on the skin, depending on the particular medical procedure and medical device <NUM>. Example dimensions of the electrode assembly <NUM> can be about <NUM> millimetres (mm) between electrode members along each side, i.e., a square with sides over <NUM>. Example spacings of the electrode members <NUM>, <NUM>, <NUM>, <NUM> can be over <NUM> centre-to-centre, e.g., <NUM> between centres, e.g., about <NUM> between centres along each side of the square arrangement in <FIG>.

The term "patient" used in this disclosure 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.

In an embodiment, there is provided a method of using the electrode assembly <NUM> together with the medical device <NUM>. Referring to <FIG> illustrate an exemplary method of using the electrode assembly <NUM> together with the medical device <NUM>.

<FIG> shows the electrode assembly <NUM> before use. In an example, the covering sheet <NUM> includes the first covering sheet <NUM> and the second covering sheet <NUM>. The first covering sheet <NUM> is removably attached to the device-side of each of the plurality of medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM>, and the non-electrode adhesive pad <NUM>. The second covering sheet <NUM> removably attached to the opposite side (patient-side) of each of the plurality of medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM>, and the non-electrode adhesive pad <NUM>.

In a first step, as shown in <FIG>, the user peels off the first covering sheet <NUM> from the side of the electrode assembly <NUM> that is to be attached to the medical device <NUM>. In removing the first covering sheet <NUM> of the electrode assembly <NUM> from the plurality of medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM>, it exposes a first adhesive surface of the adhesive flexible seal <NUM> on each of a plurality of medical electrode members of the electrode assembly <NUM>.

The user then attaches the electrode assembly <NUM> to the medical device <NUM>, as shown in <FIG>. This may occur by pressing the electrode assembly <NUM> and the medical device <NUM> together. The electrode assembly <NUM> may be connected to the medical device <NUM> so that each of the medical electrode members is secured to a corresponding one of the electrode connecting portions. The user may fasten the fastener (made of a conductive material (e.g., metal), and of a fastener type including a snap fastener (male or female), a tab, a wire or a custom connector) of the electrode connector <NUM> of each medical electrode member (<NUM>, <NUM>, <NUM>, <NUM> or <NUM>) to a cooperating fastener (which is made of a conductive material (e.g., metal), and of a cooperating type to the fastener's type, e.g., a snap fastener (female or male), a tab, a wire or a custom connector respectively) on a corresponding electrode connecting portion of the medical device <NUM>. <FIG> shows the electrode assembly <NUM> when connected to the medical device <NUM>.

Alternatively or additionally, the user may adhere the flexible sheet of each medical electrode member (<NUM>, <NUM>, <NUM>, <NUM>, or <NUM>) to a flat surface on the corresponding electrode connecting portion of the medical device <NUM>. In addition, the user may further fasten or adhere the non-electrode adhesive pad <NUM> to a corresponding electrode connecting portion of the medical device <NUM>. In a further embodiment, the method may further include the step of detaching a perforated section of the second covering sheet that is connected to at least one of the plurality of medical electrode members and attaching the at least one of the electrode assembly to a patient's body or a medical device.

Next, the user peels off or removes the second covering sheet <NUM> from the electrode assembly <NUM>, to expose the patient-side adhesive layer <NUM> of each medical electrode member (<NUM>, <NUM>, <NUM>, <NUM> or <NUM>), and the patient-side adhesive layer of the non-electrode adhesive pad <NUM>. The user then attaches the medical device <NUM> with the plurality of medical electrode members to a patient's body such that the plurality of medical electrode members are secured to the patient's body. For example, the medical device <NUM> with the medical electrode members <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and the patient-side adhesive layer of the non-electrode adhesive pad <NUM> is applied to the patient's body as shown. The medical device <NUM>, along with the medical electrode members <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and the non-electrode adhesive pad <NUM> are secured to the patient's body through the adhesive layer of each medical electrode member and the adhesive layer of the non-electrode adhesive pad <NUM>, as shown in <FIG>.

After being secured to the patient's body, the medical device <NUM> and the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM> can then be used to monitor or stimulate the patient, as shown in <FIG>. The medical device <NUM> monitors the electrical signals captured by the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM>, or outputs electrical signals to the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM> for stimulating the patient's body.

After user, the medical device <NUM> and the medical electrode members <NUM>, <NUM>, <NUM> or <NUM> can be removed from the patient's body, as shown in <FIG>. The user may then remove the medical electrode members <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and the non-electrode adhesive pad <NUM> from the electrode connecting portion (<NUM>, <NUM>, <NUM> and <NUM>) of the medical device <NUM>, as shown in <FIG>. The used medical electrode members <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and the non-electrode adhesive pad <NUM> may be disposed after use.

In some other embodiments, the user may first attach the electrode assembly <NUM> to the patient's body before attaching the medical electrode members to the medical device <NUM>. An example of an alternate method for attaching the electrode assembly <NUM> shown in <FIG>, if the covering sheet <NUM> includes two covering sheet <NUM> and <NUM>, the user may:.

Further, in some embodiments, as shown in <FIG>, the electrode assembly <NUM> may not include the non-electrode adhesive pad <NUM>. In another embodiment as described hereinbefore, the covering sheet <NUM> may only include one covering sheet, which covers one side of each medical electrode member, i.e., the side with the adhesive layer <NUM>. Accordingly, when using the electrode assembly <NUM>, the user may:.

According to at least some embodiments, the electrode assembly <NUM> described herein allows fast, easy and convenient application of a plurality of medical electrodes to a patient's body, which enhances the usability and efficiency of the electrode application process.

According to at least some embodiments, the electrode assembly <NUM> also ensures the medical electrodes be applied accurately to positions on the patient's body that are corresponding to the position of the electrode connecting portions on the medical device <NUM>. This may enhance the security of the connection between the electrode assembly <NUM> and the medical device <NUM>, and thereby improve the quality of the signals captured by/sent from the medical device <NUM>.

According to at least some embodiments, the electrode assembly <NUM> further includes a non-electrode adhesive pad for facilitating securing the medical device <NUM> to the patient's body, and/or to the medical electrodes members. This may further strengthen the connection between the electrode assembly <NUM> and the medical device <NUM>, and thereby improve the quality of the signals captured by/sent from the medical device <NUM>.

The following examples provide more detailed discussion of particular embodiments. The examples of the electrode assembly are shown in <FIG> are intended to be merely illustrative and not limiting to the scope of the present invention as defined in the claims.

<FIG> show a front view and back view respectively of an example of the electrode assembly <NUM> including: five medical electrode members being traditional style electrodes, with a removable covering sheet (also referred to as a "backing film") covering adhesive and hydrogel prior to application to skin. The electrode assembly <NUM> further includes a non-electrode adhesive pad (also referred to as a (non-electrode adhesive hub) in its centre.

The electrode assembly <NUM> is adapted to attach to a medical device by combination of (i) the conductive connectors (in this example press stud) of the medical electrode members, and (ii) the non-electrode adhesive hub in centre.

The electrode assembly <NUM> is adapted to attach to the patient's skin by combination of the medical electrode members and the non-electrode adhesive hub in centre. The non-electrode adhesive hub in the centre facilitates positioning the medical device and supporting the weight of the medical device on attachment. In this example, the non-electrode adhesive hub has a hole in centre, which allows a sensor of the medical device to protrude.

The adhesive on the side to be attached to the patient's body is protected by the removable covering sheet in the form of a plastic film. The adhesive on the opposite side of each medical electrode member and the non-electrode adhesive hub to be attached to the medical device is protected by a coated (paper) film.

<FIG> show an example of the electrode assembly <NUM> including: five medical electrode members being traditional style electrodes with stud connectors, five respective device-side adhesive flexible seals <NUM> shaped as ring that are arranged to located around the stud connectors <NUM>, and a removable covering sheet (also referred to as a "backing film") covering adhesive and hydrogel prior to application to skin. The electrode assembly <NUM> further includes a non-electrode adhesive pad <NUM> (also referred to as a "non-electrode adhesive hub") in its centre. The adhesive of the non-electrode adhesive pad <NUM> may be covered by a separate cover that is removed before application of the non-electrode adhesive pad <NUM> to the skin as shown in <FIG>.

The electrode assembly <NUM> is adapted to attach to a medical device by combination of (i) the conductive connectors (in this example press stud) of the medical electrode members, and (ii) the non-electrode adhesive hub in its centre.

The electrode assembly <NUM> is adapted to attach to the patient's skin by combination of the medical electrode members and the non-electrode adhesive hub in its centre. The non-electrode adhesive hub in the centre facilitates positioning the medical device and supporting the weight of the medical device on attachment. In this example, the non-electrode adhesive hub has a hole in its centre, which allows a sensor of the medical device to protrude.

The adhesive flexible seals <NUM> around the conductive connectors of the medical electrode members facilitate positioning of the medical device, reducing movement artefacts, and preventing fluid ingress. The adhesive on the side to be attached to the patient's body is protected by the removable covering sheet in the form of a plastic film. The adhesive on the opposite side of each medical electrode member (i.e., the medical device side) and the non-electrode adhesive hub to be attached to the medical device is protected by a coated (paper) film.

<FIG> show an example of the electrode assembly <NUM> including: five medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM>, each being traditional style electrodes and each having a respective adhesive flexible seal <NUM> around the stud connectors <NUM>, and two removable covering sheets <NUM>, <NUM> (also referred to as "backing films"). The electrode assembly <NUM> further includes a non-electrode adhesive pad <NUM> (also referred to as a "non-electrode adhesive hub") in its centre.

One of the removable covering sheets <NUM> covers adhesive and hydrogel prior to application to skin. The other removable covering sheet <NUM> covers the non-electrode adhesive hub in centre and the adhesive flexible seals <NUM>. The electrode assembly <NUM> is adapted to attach to a medical device by combination of (i) the conductive connectors (in this example press stud) of the medical electrode members, and (ii) the non-electrode adhesive hub in centre.

Further, the electrode assembly <NUM> is adapted to attach to the patient's skin by combination of the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM> and the non-electrode adhesive hub <NUM> in its centre. The non-electrode adhesive hub <NUM> in the centre facilitates positioning the medical device and supporting the weight of the medical device on attachment. In this example, the non-electrode adhesive hub <NUM> has a hole in its centre, which allows a sensor of the medical device to protrude.

The device-side adhesive flexible seal <NUM> is arranged around the conductive connectors <NUM> of each of the medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM> to aid in positioning the medical device, reducing movement artefacts, and preventing fluid ingress. The adhesive on the side to be attached to the patient's body is protected by one of the removable covering sheets, taking the form of a plastic film. Meanwhile, the adhesive on the opposite side of the non-electrode adhesive hub <NUM> and adhesive flexible seal <NUM> that is to be attached to the medical device is covered and protected by the other removable covering sheet <NUM> in the form of a plastic film.

<FIG> shows an example of the electrode assembly <NUM> including: five medical electrode members <NUM>, <NUM>, <NUM>, <NUM> and <NUM> being traditional style electrodes, and a single removable covering sheet <NUM> (also referred to as a "backing film") covering adhesive and hydrogel prior to application to skin. In this example, the electrode assembly <NUM> does not include the non-electrode adhesive pad.

The electrode assembly <NUM> is adapted to attach to a medical device by the conductive connectors (in this example press stud) of the medical electrode members. The electrode assembly <NUM> is adapted to attach to the patient's skin through the adhesive on one side of the medical electrode members, the adhesive being covered by a single removable covering sheet.

In the above-described Examples <NUM> and <NUM>, the device-side adhesive flexible seals <NUM> around the conductive connectors of the medical electrode members are raised from the surface with a foam layer. This configuration may provide a better performance of positioning the medical device, reducing movement artefacts, and/or preventing fluid ingress under movement of the patient's body or the medical device. However, in some embodiments, the device-side adhesive flexible seal <NUM> may be a thin film and adhesive that sits flush with the surface of the electrode. In some other embodiments, adhesive flexible seal <NUM> may have a thicker layer that increases the distance between the substrate <NUM> connecting surface of the adhesive flexible seal <NUM> and the medical device contacting surface of the adhesive flexible seal <NUM>. As aforementioned, instead of using a foam layer, the adhesive flexible seal <NUM> may be a layer of adhesive gel, cloth or polymer.

Referring to <FIG>, there is provided an example of an alternative removable covering sheet ("film backing"), which includes a cup <NUM> for each electrode (as opposed to flush plastic as shown in <FIG> and <FIG>). The cup <NUM> can contain hydrogel and cover the conductive connector's surface that attaches to the medical device. The covering sheet that includes the cups <NUM> can include various types of plastics or coated papers.

Referring now to <FIG> an example of a coated paper film for covering a non-electrode adhesive pad is provided. <FIG> illustrates an example of a coated paper film for covering the foam ring-shaped adhesive flexible seal that is arranged around a conductive connector of a medical electrode member, which is shown being removed in <FIG>.

<FIG> and <FIG> show an example of an electrode assembly <NUM> including: five medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) each being traditional style electrodes with electrode connectors <NUM> including stud connectors, and two removable covering sheets <NUM> (also referred to as "backing films") provided to each side of the electrode members. The electrode assembly <NUM> further includes a non-electrode adhesive pad <NUM> (also referred to as a "non-electrode adhesive hub") in its centre. <FIG> is a front view, <FIG> is a back view and <FIG> is a detailed front view.

One of the removable covering sheets <NUM> on the patient-side covers the patient-side adhesive layer <NUM> and a hydrogel layer <NUM> prior to application to skin. The hydrogel layer <NUM> is contained within a plurality of concave deformations <NUM> formed in the patient-side covering sheet <NUM>. The deformations <NUM> function in a similar manner to the aforementioned cups <NUM>, however the deformations <NUM> are integrally formed with the patient-side covering sheet <NUM>.

The device-side removable covering sheet <NUM> covers the non-electrode adhesive hub <NUM> in centre and the electrode members (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>). The device-side removable covering sheet <NUM> may also include apertures <NUM> (best shown in <FIG>) that are arranged to allow the conductive electrode connectors <NUM> of the medical electrodes to pass through the device-side removable covering sheet <NUM>. This prevents the protruding electrode connectors <NUM> from pushing against the device-side removable covering sheet <NUM> and either damaging or prematurely removing said sheet.

The electrode assembly <NUM> is adapted to attach to a medical device by combination of (i) the conductive connectors (in this example press stud <NUM>) of the medical electrode members, (ii) the adhesive flexible seal provided to the device-side of each medical electrode and (iii) the non-electrode adhesive hub <NUM> in centre.

Further, the electrode assembly <NUM> is adapted to attach to the patient's skin by combination of the medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and the non-electrode adhesive hub <NUM> in its centre. The non-electrode adhesive hub <NUM> in the centre facilitates positioning the medical device and supporting the weight of the medical device on attachment. In this example, the non-electrode adhesive hub has a square-shaped hole in its centre.

In this example, the flexible layer <NUM> is a clear plastic film that includes the patient-side adhesive layer <NUM>. Further, the device-side flexible adhesive seal <NUM> is a foam seal including a device-side adhesive layer to adhere the medical electrodes (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to the device and another adhesive layer to adhere the device-side flexible adhesive seal <NUM> to the substrate <NUM>. The distance between an inner and outer radii of the device-side flexible adhesive seal <NUM> may vary to provide seals of different thickness. For example, as shown in <FIG> the distance between the inner and outer radii of the device-side flexible adhesive seal <NUM> is larger than the distance between the inner and outer radii of the device-side flexible adhesive seal <NUM> provided in <FIG>. The device-side flexible adhesive seal <NUM> is arranged sit around the electrode connector <NUM> of each of the medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to facilitate positioning and holding the medical device, reducing movement artefacts, and preventing fluid ingress.

In an embodiment, the adhesive that is used to adhere the electrode assembly <NUM> to the medical device may be different from the adhesive that is used to adhere the electrode assembly <NUM> to the patient. For example, the adhesive layer provided to the device-side flexible adhesive seal <NUM> to connect the medical electrode to the medical device may include an adhesive with a stronger bonding capacity (i.e.be stronger, sticker, more adhesive) relative to the patient-side adhesive layer <NUM> used to adhere the electrode assembly to the patient. Further, the material and material properties of the flexible layer <NUM> and the device-side flexible adhesive seal <NUM> may be varied in order to accommodate variations in the strengths or types of adhesives. In the example shown, the flexible layer <NUM> may be formed of thermoplastic polyurethane and the device-side flexible adhesive seal <NUM> may be formed of foam.

Although a preferred embodiment has been described in detail, it should be understood that modifications, changes, substitutions or alterations will be apparent to those skilled in the art without departing from the scope of the present invention as defined in the claims.

Optional embodiments may also be said to broadly include the parts, elements, steps and/or features referred to or indicated herein, individually or in any combination of two or more of the parts, elements, steps and/or features. Accordingly, many modifications will be apparent to those skilled in the art without departing from the scope of the present invention as defined in the claims.

The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprised", "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

As used herein, a, an, the, at least one, and one or more are used interchangeably, and refer to one or to more than one (i.e. at least one) of the grammatical object. By way of example, "an element" means one element, at least one element, or one or more elements.

Claim 1:
An electrode assembly (<NUM>) including:
a plurality of medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>); and
at least two covering sheets (<NUM>, <NUM>) removably attached to the plurality of medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>), wherein the at least two covering sheets (<NUM>, <NUM>) includes:
a first covering sheet (<NUM>) removably attached to one side of each of the plurality of medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>); and
a second covering sheet (<NUM>) removably attached to an opposite side of each of the plurality of medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>),
characterized in that
one of the at least two covering sheets (<NUM>, <NUM>) holds a first of the plurality of medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>) in a predetermined position relative to a second of the plurality of medical electrode members (<NUM>, <NUM>, <NUM> and <NUM>); and
each of the plurality of medical electrode members (<NUM>, <NUM>, <NUM>, <NUM>) has a connector (<NUM>) for connecting to a corresponding medical electrode connecting portion (<NUM>, <NUM>, <NUM>, <NUM>) on a medical device (<NUM>).