Dressing for a wound and for the electrochemical detection of at least one analyte and its method of manufacture

Abstract

The invention relates to a wound dressing (100, 200). The dressing (100, 200) comprises a flexible substrate (3), at least one working electrode (11), a reference electrode (13), a counter electrode (15), and a biocompatible conductive layer (17) intended to be placed in contact with a wound. The electrodes (13, 15, 17) are arranged on the first surface (5) of the flexible substrate (3). The biocompatible conductive layer (17) is configured to allow an electrochemical interaction between at least one analyte and the electrode array (9), the concentration of said analyte being determinable from a response generated by this electrochemical interaction. The invention also relates to a method for manufacturing such a dressing (100, 200). Figure for the abstract: Fig. 1

Description

Title of the invention: Dressing for a wound and for the electrochemical detection of at least one analyte and its method of manufacture

[0001] Field of the invention The present invention relates to a wound dressing and a method for manufacturing such a dressing. The invention is particularly relevant to the field of dressings designed to improve wound healing and monitor wound healing non-invasively through electrochemical detection of at least one analyte. Technological background

[0002] Wounds and their complications constitute a major problem, both in hospitals and at home. Some wounds, sometimes chronic, heal only slowly, such as those of people with diabetes. It is therefore important to be able to improve the treatment and healing times of these types of wounds. In the medical field, innovation in dressings for monitoring and improving wound healing has seen significant progress thanks to the integration of electronic technologies into dressings.

[0003] These devices are particularly aimed at either monitoring wound conditions in real time, such as humidity level, temperature, pH, or the presence of infections, or at improving wound healing by means of targeted electrical stimulations.

[0004] However, these devices require numerous components, particularly optical ones, and are therefore expensive and complex to manufacture. Dressings that release an active ingredient to improve wound healing usually require a delivery or activation electrode for the active ingredient. This again makes the devices complex and expensive to manufacture.

[0005] The present invention aims to overcome these drawbacks by proposing a dressing that is simple and economical to manufacture, combining electrochemical detection functionalities of at least one analyte.

[0006] The object of the invention is achieved by means of a first aspect of the invention. According to the first aspect of the invention, a dressing for a wound and for the electrochemical detection of at least one analyte is provided. The dressing comprises a biocompatible conductive layer. The biocompatible conductive layer is intended to be placed in contact with a wound. The dressing also comprises a flexible substrate having a first surface and a second surface opposite the first surface, and an electrode assembly. The electrode assembly comprises at least one working electrode, one reference electrode, and one counter electrode. Each electrode in the electrode array is disposed on the first surface of the flexible substrate. Each electrode in the electrode array is electrically connected to at least one interface. At least one interface is disposed on the second surface of the flexible substrate. The biocompatible conductive layer is disposed directly on the first surface of the flexible substrate and covers at least one electrode array. The biocompatible conductive layer is configured to allow an electrochemical interaction between at least one analyte and the electrode array, the concentration of which can be determined from the response generated by this electrochemical interaction. The generated response can be, in particular, a change in voltage or current.

[0007] The dressing according to the first aspect provides a simple structure, as its structure requires only a limited number of elements. The two surfaces of the flexible substrate are electrically connected. This electrical connection between the two surfaces of the flexible substrate improves the compactness of the dressing. Furthermore, it simplifies the integration of electrodes and electronic components, for example, electronic components at the connection interface. The dressing according to the first aspect thus reduces the complexity, time, and cost of its manufacture.

[0008] Furthermore, the flexible substrate provides a supple structure. This allows the dressing to adapt to irregular or anatomical surfaces of the human body. This can improve patient comfort while wearing the dressing. The flexible substrate can contribute to better contact and increased stability between the dressing and the skin, thus improving the dressing's effectiveness.

[0009] The biocompatible conductive layer can be configured to transmit charges between the electrodes and the wound, or between the electrodes themselves. In particular, the biocompatible conductive layer may contain at least one electrolyte. The electrolyte can enable the transport of charges within the biocompatible conductive layer. The electrolyte allows an electric current to flow, particularly between the electrodes, through the biocompatible conductive layer. For example, the biocompatible conductive layer may contain an electrolyte such as NaCl.

[0010] Depending on the electrode material, particularly the working electrode, reference electrode, and counter electrode, different electrolyte species may be preferred. In particular, the biocompatible conductive layer may contain a biocompatible conductive polymer such as polyaniline or polypyrrole.

[0011] It is also possible to dope the electrolyte contained in the biocompatible conductive layer. In particular, if the electrolyte is a conductive polymer, it is It is possible to dope it with metallic particles, for example silver or gold, or with carbon particles (graphene, carbon nanotubes). This doping increases the conductivity of the electrolyte. In particular, the choice of electrolytes can improve electrochemical interactions with the electrodes, as well as the generation of electrical signals in the electrode array.

[0012] The biocompatible conductive layer may also include at least one analyte. The analyte is a target substance for the analysis. The analyte may, for example, be oxygen, glucose, lactate, or any other relevant analyte.

[0013] The biocompatible conductive layer may also initially be analyte-free. Initially, it is understood that in the dressing as it comes off the production line, in other words, before the dressing is applied to a wound, the biocompatible conductive layer does not contain any analyte. In this embodiment of the invention, the biocompatible conductive layer can be configured to allow the transfer, particularly by electrochemical reaction, of the analyte present in the wound or exudate, from the wound or exudate to the biocompatible conductive layer, in particular to the electrode array, and more specifically to the working electrode, the reference electrode, and the counter electrode. The biocompatible conductive layer thus configured makes it possible to measure and monitor the concentration of an analyte contained in the wound.

[0014] The biocompatible conductive layer can be configured to transfer one or more analytes from the biocompatible layer to the wound. In particular, these analytes may have properties that improve or accelerate wound healing.

[0015] The biocompatible conductive layer may comprise at least one biomolecule, in particular an enzyme, aptamer, or antibody. This at least one biomolecule may improve the targeting of an analyte.

[0016] Furthermore, the dressing is suitable for monitoring and improving wound healing, particularly scarring, by allowing the determination of an analyte concentration. Specifically, the dressing can enable the monitoring of changes in the concentration of an analyte over time within the biocompatible conductive layer.

[0017] In the case of oxygen as the analyte, the biocompatible conductive layer can be configured to allow the transfer or circulation of oxygen, in particular dissolved oxygen, within the biocompatible conductive layer. In particular, the biocompatible conductive layer can be configured to allow the transfer of oxygen that is reduced at the surface of at least one of the electrodes so as to generate a measurable current.

[0018] In the case of glucose as an analyte, the biocompatible conductive layer can act as an electrolyte and enable the electrochemical detection of glucose via a specific enzymatic reaction at the working electrode. In particular, the biocompatible conductive layer can comprise a combination of at least one electrolyte and at least one biomolecule. This combination can be adapted to target glucose as an analyte. A combination made of a mixture of conductive polymers as electrolytes with an enzyme as a biomolecule for glucose detection can improve glucose targeting. In particular, a combination of polypyrrole (electrolyte) and glucose oxidase (biomolecule) in the biocompatible conductive layer can improve glucose targeting.

[0019] The biocompatible conductive layer may, in particular, be made of a gel, and more especially of a hydrogel. This biocompatible conductive layer may also be made of a foam or a film. The biocompatible conductive layer may be continuous, formed in one piece. Alternatively, the biocompatible conductive layer may comprise a plurality of islands of material, such as dots or droplets, particularly of hydrogel. In all cases, the biocompatible conductive layer covers at least the entire electrode assembly, in particular the working electrode, the reference electrode, and the counter electrode.

[0020] The electrode assembly can be encapsulated by the biocompatible conductive layer. The biocompatible conductive layer prevents direct contact between the electrode assembly and the wound, skin, or tissue over which the dressing is applied. The biocompatible conductive layer is intended to be in direct physical contact with the wound or with a surface to which the dressing is applied. The biocompatible conductive layer can also be configured to adhere to the surface with which it is in contact. Monitoring or enhancing healing, or both, can be achieved non-invasively using the dressing.

[0021] The biocompatible conductive layer may have a composition that improves the wound healing process. The biocompatible conductive layer may have healing properties. The biocompatible conductive layer may have antibacterial properties.

[0022] For example, the biocompatible conductive layer may include propylene glycol. The biocompatible conductive layer including propylene glycol may limit bacterial proliferation. The biocompatible conductive layer may include carboxymethylcellulose (or CMC). The biocompatible conductive layer including carboxymethylcellulose (or CMC) may facilitate the absorption of wound exudates. Alternatively or in combination, the biocompatible conductive layer may include hyaluronic acid. The presence Hyaluronic acid in the biocompatible conductive layer can stimulate cellular activity, especially tissue regeneration, more specifically, wound healing.

[0023] The electrode assembly comprises at least one working electrode, one reference electrode, and one counter electrode. The electrode assembly may comprise more electrodes, in particular more than three. Furthermore, the dressing according to the invention may comprise several electrode assemblies, each of these electrode assemblies comprising at least one working electrode, one reference electrode, and one counter electrode. Having several electrode assemblies increases the effective surface area for monitoring and improving wound healing. Indeed, if a wound is large and extensive, it is then possible to apply a dressing that covers the entire wound while still providing precise, targeted, and effective monitoring and improvement of wound healing, even locally.In the case of a dressing with multiple electrode sets, the biocompatible conductive layer covers each electrode of each electrode set.

[0024] The working electrode, the reference electrode and the counter electrode form an electrochemical sensor.

[0025] The electrochemical sensor enables the monitoring of the concentration of a target analyte, for example, oxygen, in the biocompatible conductive layer. The electrochemical sensor can be electrically connected to a processing unit via at least one connection interface of the flexible substrate. In particular, the processing unit may contain a potentiostat. The potentiostat can establish and vary an electrical potential or an electrical current in the electrochemical sensor. For example, an electrochemical method implemented by the processing unit may consist of applying and measuring either an electrical potential across the electrodes or an electrical current flowing through the electrical circuit formed by the electrodes. Another electrochemical method may consist of measuring an electrical potential across the electrodes without applying any potential, current, or voltage.

[0026] The working electrode is an electrode where, at its interface with the biocompatible conductive layer, an electrochemical reaction takes place, in particular a reaction involving charge transfer, more specifically a redox reaction. This electrochemical reaction takes place in combination and simultaneously with the electrochemical reaction taking place at the interface of the counter electrode and the biocompatible conductive layer.

[0027] The reference electrode has a known and constant electrochemical potential over time. The potential of the reference electrode acts as a reference value and is used to calculate the electrochemical potential of the working electrode during the The electrical voltage between the working electrode and the reference electrode is measured. The potential of the reference electrode also serves as a reference for applying the electrochemical potential of the working electrode, particularly when measuring electrical current. It is then possible to deduce the concentration of the target analyte contained in the biocompatible conductive layer. Specifically, the concentration of the target analyte in the biocompatible conductive layer can be determined as a function of the electrical potential or current.

[0028] The electrochemical sensor can be subjected to a change in electrical potential or to an electric current. For example, a processing means can be disposed on the second surface of the flexible substrate and can be electrically connected to the dressing via at least one connection interface of the dressing. The processing means can generate a change in voltage or electric current. In particular, a potentiostat can be used to vary the voltage or electric current. The potentiostat can also be used to collect the electrical signals from the electrochemical sensor. The response generated by the electrochemical sensor can be proportional to the concentration of the target analyte, such as a target chemical substance in the wound or exudate. The concentration can be determined by the processing means, which collects the signals detected via at least one connection interface of the dressing.

[0029] The counter electrode can be relatively far from the working electrode. This avoids altering the concentration of the target analyte as well as the chemical environment around the working electrode. If the distance between the counter electrode and the working electrode is too small, interference, particularly chemical interference, may occur. If the distance between the counter electrode and the working electrode is too large, the diffusion of the species of interest may be limited, which can lead to malfunction of the electrochemical sensor, particularly a slower response time. A minimum distance between the counter electrode and the working electrode is preferably between 1 millimeter and 5 millimeters.

[0030] The working electrode, the reference electrode, and the counter electrode can have various shapes, particularly circular or rectangular. The working electrode, the reference electrode, and the counter electrode can also have the shape of a portion of a ring.

[0031] In one embodiment, the dressing may include a single sensor, the sensor being an electrochemical sensor, in particular an electrochemical sensor formed by the working electrode, the reference electrode, and the counter electrode. The dressing may be devoid of optical or physical sensing means, which simplifies its design and reduces its manufacturing costs.

[0032] In one embodiment of the invention, the working electrode may be disc-shaped. The reference electrode may be annular or arc-shaped. The counter electrode may be annular or arc-shaped. The reference electrode and the counter electrode may each be arc-shaped, with the arcs arranged to form an annular shape. The working electrode, particularly in the form of a disc, may be positioned at the center of this annular shape.

[0033] Such a geometry and arrangement of the electrodes allows for good diffusion of the species of interest, in particular analytes and biomolecules, between the electrodes, especially between the working electrode, the reference electrode, and the counter electrode. Furthermore, this electrode arrangement allows for good potential distribution.

[0034] The counter electrode serves, in particular, to compensate electrically, and especially electrochemically, for the reaction taking place at the working electrode. It is possible to define a surface area ratio between the surfaces of the two electrodes. This surface area ratio corresponds to the ratio of the surface area of ​​the counter electrode to the surface area of ​​the working electrode. A surface area ratio strictly greater than 1, in other words, a counter electrode surface area larger than that of the working electrode, allows for good potential distribution. Moreover, the higher this surface area ratio, the more stable the electrical potential or current measurements. In particular, the higher this surface area ratio, the lower the polarization of the counter electrode, which improves the accuracy and stability of the measurements. The surface area ratio between the counter electrode and the working electrode can, in particular, be at least 10.A surface area ratio between 3 and 10 may also be preferred. In particular, a surface area ratio between 3 and 10 allows one to benefit from the advantages mentioned above while reducing the quantities of raw materials required and therefore manufacturing costs.

[0035] In another embodiment of the invention, the working electrode may have a rectangular shape, in particular a square shape. The reference electrode may also have a rectangular shape. The counter electrode may have a shape comprising at least one right angle. In particular, the counter electrode may partially surround the working electrode. The reference electrode and the counter electrode may each be formed with at least one right angle and arranged to form a rectangle surrounding the working electrode. In particular, the counter electrode may have a surface area at least three times larger than the surface area of ​​the working electrode.

[0036] Each of the electrodes in the electrode assembly can be directly placed on the same surface of the flexible substrate. In an embodiment of the first aspect of the invention, each of the electrodes in the electrode assembly can be electrodeposited onto the first surface of the flexible substrate.

[0037] Having each electrode of the electrode assembly electrodeposited on the first surface of the flexible substrate facilitates the manufacturing of the dressing. This reduces manufacturing time and costs. In particular, it eliminates the need for an additional layer, especially a printed circuit board. The electrodes can be placed directly onto the flexible substrate.

[0038] An electrodeposition process allows precise control of the thickness and shape of the deposited electrodes.

[0039] In one embodiment of the first aspect of the invention, at least the working electrode, the reference electrode, and the counter electrode of the electrode assembly may be coplanar. Coplanarity allows the electrodes to be manufactured in a single step on the flexible substrate. This simplifies the production process, particularly for techniques such as electrodeposition. Coplanarity simplifies the electrical connection between the electrodes and the connection interface, especially when connected by metal screws. The coplanar arrangement of the electrodes can reduce the overall size of the dressing.

[0040] In an embodiment of the invention where the dressing comprises several sets of electrodes, at least the working electrode, the reference electrode, and the counter electrode of each set of electrodes may be coplanar. It is also possible that at least one of the sets of electrodes may not have a coplanar working electrode, reference electrode, and counter electrode.

[0041] In an embodiment of the first aspect of the invention, the dressing may include a border that may extend from the first surface of the flexible substrate. And, the biocompatible conductive layer may be at least partially surrounded by the border.

[0042] The border acts as a structural element improving the stability of the biocompatible conductive layer. The border can extend perpendicularly from the first surface of the flexible substrate.

[0043] In one embodiment of the invention, the border may be discontinuous. The border may comprise several portions. This makes it possible, in particular, to reduce the amount of material used while improving the structural stability of the biocompatible conductive layer.

[0044] In an embodiment of the first aspect of the invention, the border can form a continuous contour surrounding the biocompatible conductive layer. In particular, the border can completely surround the biocompatible conductive layer. Specifically, the border can have a circular, elliptical, or rectangular shape.

[0045] A border forming a continuous contour surrounding the biocompatible conductive layer further enhances the structural stability of the layer The biocompatible conductive material also allows the user to easily apply the dressing correctly and precisely to the wound or area of ​​interest. A circular, elliptical, or rectangular border further enhances the dressing's effectiveness by adapting it to the different shapes of various wounds.

[0046] In an embodiment of the first aspect of the invention, the border may have a height equal to or greater than the height of the biocompatible conductive layer, in particular a maximum height of the biocompatible conductive layer. In particular, the border may have a height in a direction orthogonal to the plane formed by the first surface of the flexible substrate, equal to or greater than the height of the biocompatible conductive layer in that same direction orthogonal to the first surface.

[0047] This height difference allows for points of contact between the border and the application area, particularly with the skin or wound. Furthermore, this difference helps retain and maintain the biocompatible conductive layer within the contour formed by the border in the event of external overpressure exerted on the dressing. Specifically, in the case of overpressure in the direction orthogonal to the first surface of the flexible substrate.

[0048] In one embodiment of the first aspect of the invention, the border can be made of foam, in particular silicone foam or polyethylene foam.

[0049] A foam border, particularly made of silicone or polyethylene, makes the dressing lighter. This also reduces manufacturing costs, as these materials are readily available and relatively inexpensive. The border can also be made of any other biocompatible material suitable for delimiting and retaining the biocompatible conductive layer.

[0050] In an embodiment of the first aspect of the invention, the flexible substrate may include an adhesive region suitable for adhering to the skin or a wound.

[0051] The adhesive region may, in particular, be located on the first surface of the flexible substrate. More specifically, the adhesive region may be located on a separate surface from the surface on which the biocompatible conductive layer is located. The flexible substrate may also include several adhesive regions. This adhesive region allows the dressing to adhere more closely to the patient's skin. This therefore improves the dressing's usability. In particular, the dressing can thus be applied to body surfaces with a high curvature, for example, a finger.

[0052] In one embodiment of the first aspect of the invention, the second surface of the flexible substrate may have three distinct connection interfaces and respectively associated with an electrode. In particular, the connection interfaces can have a circular or rectangular shape.

[0053] In particular, each of the three connection interfaces can be electrically connected and associated respectively with a working electrode, a reference electrode and a counter electrode.

[0054] In an embodiment of the first aspect of the invention, the flexible substrate may comprise or may be made of: polymer, polyethylene, polypropylene, polyamides, polyethylene terephthalate (PET), polyetheretherketone (PEEK), polyetherketone (PEK), or any combinations of these materials.

[0055] A flexible substrate comprising or made of polymer, polyethylene, polypropylene, polyamides, PET, PEEK, PEK, or any combination of these materials, reduces manufacturing costs. These materials are relatively inexpensive and readily available. A flexible substrate made with these materials can have a reduced mass compared to rigid or metallic substrates.

[0056] The reduction in manufacturing costs is all the more important as the dressing is specifically intended for single use.

[0057] In one embodiment of the invention, the thickness of the flexible substrate can be between 200 micrometers and 500 micrometers, particularly having a thickness of less than 500 micrometers. Such a thickness of the flexible substrate allows the dressing to be both flexible enough for use on curved surfaces and rigid enough to withstand and remain intact under stresses to which the dressing may be subjected, such as shocks or torsion. Such a thickness also allows the dressing to be flexible enough to be produced using the reel-to-reel technique. The production of flexible substrates by the reel-to-reel technique consists of unwinding a flexible material from a first reel, processing it continuously, for example by coating, printing, deposition, or other means, and then winding the resulting flexible substrate around a second reel.This method of producing flexible substrates is known to be fast and economical. Therefore, manufacturing costs can be reduced.

[0058] The biocompatible conductive layer can have a thickness of between 500 micrometers and 3 millimeters, particularly less than 1 millimeter. The thinner the biocompatible conductive layer, the easier the chemical transfer between the wound and the electrodes.

[0059] In one embodiment of the first aspect of the invention, the working electrode may be made of platinum (Pt), gold (Au), or graphene. The reference electrode may be made of Ag / AgCl. The counter electrode may be made of platinum (Pt) or gold (Au).

[0060] In particular, the working electrode, the reference electrode, and the counter electrode can be made simultaneously and respectively of Pt, Ag / AgCl, and Au. More broadly, the counter electrode can be made of a non-corrosive metal, for example, graphite or titanium (Ti). The working electrode can, in particular, be made of an inert metal such as gold, Pt, or inert carbon (glassy carbon, boron-doped diamond, pyrolytic carbon, etc.). Electrodes made with the materials mentioned above improve the performance of the electrochemical sensor. Indeed, this enhances the electrochemical reactions at the interfaces of the different electrodes. This also allows the electrochemical sensor to generate detectable electrical signals, particularly by a processing unit, and to determine the concentration of a target analyte in the biocompatible conductive layer.

[0061] In one embodiment of the first aspect of the invention, a support layer may be disposed over at least the entire surface of the second flexible substrate. In particular, the support layer may be made of fabric, polyurethane, or polyethylene.

[0062] This support layer can enhance the structural stability of the dressing. It can also improve the dressing's adhesion to the application area, particularly to the user's skin or a wound. Indeed, the support layer can have a larger total surface area than the flexible substrate. Thus, areas of the support layer where the flexible substrate is not located can include at least one adhesive region capable of adhering to the skin or a wound.

[0063] At least one adhesive region can be made, for example, from polymers such as acrylate or can be silicone-based, which helps to avoid irritation.

[0064] The backing layer may also have additional properties such as, for example, waterproofing, tear resistance and / or flexibility. This improves the durability of the dressing.

[0065] In one embodiment of the invention, at least one connection interface can be connected to at least one other connection interface disposed on the support layer. In particular, this at least one other connection interface can be disposed on a surface of the support layer opposite a surface of the support layer on which the flexible substrate is disposed. Thus, in one embodiment of the invention, a processing unit can be electrically connected to the dressing via the connection interface disposed on the support layer. In particular, a processing unit can be electrically connected to the connection interface disposed on the surface of the support layer opposite the surface of the support layer on which the flexible substrate is placed. In addition, the support layer may include several connection interfaces, in particular three.

[0066] In an embodiment of the first aspect of the invention, the biocompatible conductive layer may be doped with an active ingredient or active substance having healing properties; in particular, the biocompatible conductive layer may be doped with oxygen. This active ingredient or active substance may be a molecule, an atom, an ion, or a cation. In particular, this active ingredient or active substance may be oxygen. The biocompatible conductive layer may be a gel doped with an active substance. In particular, the biocompatible conductive layer may be a hydrogel doped with an active substance. Furthermore, the biocompatible conductive layer may further comprise an acid or an inorganic material, in particular a conductive polymer, more specifically polypyrrole or polyaniline, for example.

[0067] In particular, the active ingredient may be a biomolecule, more specifically an enzyme, aptamer, or antibody, particularly for targeting a specific analyte. The active ingredient may be one or more silver particles, particularly for their antibacterial properties. The active ingredient may also be activated charcoal, particularly for absorbing odors and toxins from the wound. Any other wound-healing agent mentioned above may also be an active ingredient.

[0068] For example, a hydrogel containing lactate can be used to measure the acidity of a wound in a wound healing monitoring device.

[0069] A biocompatible conductive layer doped with an active principle or active substance improves wound healing and scar formation. This reduces wound healing time.

[0070] In an embodiment of the first aspect of the invention, positioning or guiding elements can be arranged on the second surface of the flexible substrate and are configured to facilitate the association of the connection interfaces of the flexible substrate with the housing.

[0071] In an embodiment of the first aspect of the invention, the dressing comprises a support layer and positioning elements. The positioning elements can be arranged on the support layer. In particular, the positioning elements can be arranged on the surface of the support layer opposite the surface of the support layer on which the flexible substrate is disposed.

[0072] A second aspect of the invention relates to an assembly. The assembly comprises a dressing according to one of the embodiments of the first aspect of the invention and a processing unit. The processing unit comprises at least one potentiostat. The unit the treatment is electrically coupled to the electrode array via at least one connection interface disposed on the second surface of the flexible substrate of the dressing.

[0073] The processing unit makes it possible, in particular, to ensure a constant electrical potential at at least the working electrode, the reference electrode, and the counter electrode of the dressing, especially with the potentiostat. The processing unit can also be configured to impose, control, and measure an electrical current in the electrochemical sensor, especially in the electrical circuits of the working electrode and the counter electrode. Preferably, the reference electrode is not traversed by an electrical current. The processing unit can also be configured to collect electrical signals, especially electrical currents or potentials. These electrical signals originate from the electrode array of the dressing, especially from the working electrode, the reference electrode, and the counter electrode of the dressing.The processing unit can also be configured to process these electrical signals, specifically to calculate the concentration of a target analyte, particularly the oxygen concentration, contained in the biocompatible conductive layer. The processing unit can also be configured to store and transmit the collected electrical signals, as well as the results of their processing.

[0074] The assembly, comprising a dressing according to one of the embodiments of the first aspect of the invention and a processing unit, enables the detection and measurement of electrical signals generated by an electrochemical reaction at the electrochemical sensor. The assembly also enables the determination, from these electrical signals, of the concentration of a target analyte contained in the biocompatible conductive layer.

[0075] In one embodiment of the second aspect of the assembly, the processing unit can be configured to transmit detected electrical signals and the results of processing these signals via a wireless connection, in particular via a Bluetooth® connection. This embodiment of the invention facilitates the transmission and communication of the signals collected by the processing unit and the results of processing these signals.

[0076] In one embodiment of the assembly, the treatment unit may be contained within a housing. The housing may include a display screen. The display screen may be touch-sensitive and may allow a user to interact with the screen by means of touch presses. The housing containing the treatment unit may be used and reused with different dressings by being successively connected and then disconnected from the connection interface of each dressing.

[0077] A third aspect of the invention relates to a method for manufacturing a dressing, in particular a dressing according to one of the embodiments of the first aspect of the invention. The manufacturing method comprises the steps of: providing a flexible substrate, in particular the flexible substrate provided may comprise a first surface and a second surface opposite the first surface. The method also comprises a step for forming, in particular by electrodeposition, an electrode array on a first surface of the flexible substrate. The electrode array comprises at least one working electrode, one reference electrode, and one counter electrode. And, the method also comprises a step for forming at least one connection interface on a second surface of the flexible substrate, opposite the first surface.The method also includes a step to electrically connect each electrode of the electrode array to at least one connection interface. Specifically, at least one connection interface can be disposed on the second surface of the flexible substrate. Furthermore, at least one connection interface can be configured to be electrically connected to a processing unit. The method further includes a step to provide a biocompatible conductive layer and a step to dispose of the biocompatible conductive layer on the first surface of the flexible substrate. The biocompatible conductive layer covers at least one electrode array.

[0078] This manufacturing method makes it possible to produce a dressing in a relatively simple and inexpensive way.

[0079] The dressing thus obtained has all the technical effects and advantages associated with one of the embodiments described in the first aspect of the invention.

[0080] The drawings accompanying the invention are incorporated into the description and form an integral part thereof to illustrate several embodiments of the present invention. These drawings, together with the description, serve to explain the principles of the invention. The drawings are intended solely to illustrate preferred and alternative examples of how the invention can be implemented and used, and should not be interpreted as limiting the invention to only the embodiments illustrated and described. Furthermore, several aspects of the embodiments may, individually or in various combinations, constitute solutions according to the present invention. The embodiments described below may therefore be considered individually or in any arbitrary combination.

[0081] Other features and advantages will become apparent from the following more detailed description of the various embodiments of the invention, as illustrated in the accompanying drawings, in which similar references refer to similar elements, and where:

[0082] The [Fig.1] is a schematic representation of a section, orthogonal to the plane formed by the flexible substrate, of the dressing according to a first embodiment of the first aspect of the invention.

[0083] Fig. 2 is a schematic representation of a top view of the dressing, on the wound side, according to a second embodiment of the first aspect of the invention.

[0084] The invention will be described in more detail using advantageous embodiments, by way of example, and with reference to the drawings. The embodiments described are simply possible configurations such that the individual features as described can be provided independently of each other or can be omitted when implementing the present invention.

[0085] Figure 1 shows a dressing 100 according to a first embodiment of the first aspect of the invention. The dressing 100 comprises a flexible substrate 3. The flexible substrate 3 has a first surface 5 and a second surface 7 opposite the first surface 5. The dressing 100 also comprises an electrode assembly 9. The electrode assembly 9 comprises a working electrode 11, a reference electrode 13, and a counter electrode 15.

[0086] The dressing comprises a biocompatible conductive layer 17, with a first surface 19. In particular, the first surface 19 is intended to be placed in contact with the wound. The first surface 19 may allow the dressing 100 to adhere to the wound or the skin. The biocompatible conductive layer 17 may comprise at least one electrolyte. The biocompatible conductive layer 17 may comprise at least one analyte and / or be capable of transporting an analyte. The biocompatible conductive layer 17 may comprise at least one biomolecule or other additive.

[0087] Each of the electrodes 11, 13, 15 of the electrode assembly 9 is arranged on the first surface 5 of the flexible substrate 3. And each of the electrodes 11, 13, 15 of the electrode assembly 9 is respectively electrically connected to three connection interfaces 33, 31, 29 by means of electrical connections 34, 32, 30. The electrical connection means 34, 32, 30 are arranged on the second surface 7 of the flexible substrate 3.

[0088] The electrical connection means 34, 32, 30 can be implemented using plated through holes that electrically connect the first surface 5 of the substrate and the second surface 7 of the substrate. Alternatively, Pogo pins can be used to implement the electrical connection means 34, 32, 30.

[0089] The working electrode 11, the reference electrode 13 and the counter electrode 15 are co-planar in dressing 100. In an alternative embodiment of the invention, the working electrode 11, the reference electrode 13 and the counter electrode 15 may not be aligned, and may not be co-planar.

[0090] The biocompatible conductive layer 17 is disposed on the first surface 5 of the flexible substrate 3 and covers at least the electrode assembly 9. Indeed, the electrode assembly 9 has a height H3 along the direction of an axis R, and the biocompatible conductive layer 17 has a height H2 along this same direction and this same axis R. The axis R corresponds to the normal to the first surface 5 of the flexible substrate 3. The height H2 is greater than the height H3. The height H3 is the same for the three electrodes 11, 13, and 15 in the dressing 100. However, in alternative embodiments of the invention, the heights of each of the electrodes may be different from one another.

[0091] The working electrode, the reference electrode, and the counter electrode are configured to interact electrochemically with the biocompatible conductive layer 17 which fully encapsulates the electrode assembly 9.

[0092] A response generated by electrochemical reaction is detectable by means of the electrode set 9 and allows the determination of a concentration of at least one analyte contained in the biocompatible conductive layer 17.

[0093] Furthermore, the dressing 100 includes a border 23 having a height H1 along the direction of the axis R. In particular, the height H1 is greater than the height H2 of the biocompatible conductive layer. This allows the biocompatible conductive layer 17 to be structurally supported. The border 23 also prevents the biocompatible conductive layer from extending beyond the contour defined by the border 23.

[0094] In [Fig.1], the dressing 100 includes a border 23 which completely encircles the biocompatible conductive layer.

[0095] The dressing 100 also includes a support layer 21 with a first surface 25 and a second surface 27. The flexible substrate 3 is disposed on the support layer 21. In particular, the second surface 7 of the flexible substrate 3 is in direct physical contact with the first surface 25 of the support layer 21.

[0096] The flexible substrate 3 can be bonded and arranged on the support layer 21 by means of an adhesive region disposed at the interface of the flexible substrate 3 and the support layer 21. This adhesive region may be only partially disposed at the interface of the flexible substrate 3 and the support layer 21. This adhesive region may, in addition, not be continuous.

[0097] For example, the assembly of layers 3 and 21 can be achieved by a layer lamination process.

[0098] The connection interfaces 29, 31, 33 can be extended through the support layer 21 by means of electrical connections not shown in [Fig. 1]. These connection means can then be linked to other connection interfaces, in this case 3 connection interfaces in the dressing 100. These three other connection interfaces can in particular be arranged on the second surface 27 of the support layer 21.

[0099] Thus, a treatment unit can be electrically associated with the dressing 100 by being arranged in direct physical contact with either the interfaces 29, 31, 33 of the flexible substrate 3, or, if there are any, with the other connection interfaces arranged on the second surface 27 of the support layer 21.

[0100] Fig. 2 schematically illustrates a dressing 200 according to a second embodiment of the first aspect of the invention from the point of view located on the side of the wound, above the dressing 200.

[0101] Dressing 200 differs from dressing 100 of [Fig. 1] in that the backing layer 21 comprises two adhesive regions 35, 37 intended to improve the adhesion of dressing 200 to the wound or skin. These adhesive regions 35, 37 can also be arranged on the flexible substrate 3.

[0102] In the example of [Fig.2], the reference electrode 13 and the counter electrode 15 are in the form of a portion of a ring and arranged along a circular circumference 39. And, the working electrode 11 is circular in shape and arranged at the center of the circular circumference 39.

[0103] The distance between the reference electrode 13 and the working electrode 11 is defined so as to be sufficient to prevent the reference electrode 13 from being disturbed by electrolytic or electrical currents. One role of the reference electrode 13 is to accurately measure the potential of the system formed by the electrodes 11, 13, 15.

[0104] The border 23 of the dressing 200 is essentially rectangular. The border 23 is arranged in a rectangle, in particular a rectangle with rounded corners. The border 23 can be arranged at different locations on the first surface 5. Similarly, the biocompatible conductive layer 17 and the electrode assembly 9 can be arranged at different locations on the first surface 5. Likewise, the flexible substrate 3 can be arranged at different locations on the first surface 25 of the support layer 21.

[0105] In alternative embodiments, the border can surround several sets of electrodes.

[0106] In other embodiments, there may be a border for each of the electrode sets of the dressing.

[0107] The dressing 100 of [Fig. 1] and the dressing 200 of [Fig. 2] can respectively be manufactured by a manufacturing method which comprises the steps of: providing the flexible substrate 3; forming, in particular by electrodeposition, the set 9 of electrodes 11, 13, 15 on the first surface 5 of the flexible substrate 3; forming at least one connection interface 29, 31, 33 on the second surface 7 of the flexible substrate 3; electrically connecting each of the electrodes 11, 13, 15 to the at least a connection interface 29, 31, 33 and provide the biocompatible conductive layer 17 and dispose of it on the first surface 5 of the flexible substrate 3, the biocompatible conductive layer 17 covering at least the electrodes 11, 13, 15.

[0108] List of reference signs 3: Flexible substrate 5: First surface of the flexible substrate 7: Second surface of the flexible substrate 9: Electrode assembly 11: working electrode 13: reference electrode 15: counter electrode 17: biocompatible conductive layer 19: first surface of the biocompatible conductive layer 21: support layer 23: border 25: first surface of the support layer 27: second surface of the support layer 29: Connection interface 30: means of electrical connection 31: Connection interface 32: means of electrical connection 33: Connection interface 34: means of electrical connection 35: adhesive region 37: adhesive region 39: circular circumference 100: bandage 200: dressing H1: height of the border H2: height of the biocompatible conductive layer H3: height of the electrode assembly R: axis

Claims

Demands

1. A dressing (100, 200) for a wound and for the electrochemical detection of at least one analyte, the dressing (100) comprising: a biocompatible conductive layer (17), the biocompatible conductive layer (17) being intended to be placed in contact with a wound, and a flexible substrate (3) having a first surface (5) and a second surface (7) opposite the first surface (5), and an electrode set (9), the electrode set (9) comprising at least one working electrode (11), one reference electrode (13) and one counter electrode (15), and each of the electrodes (11, 13, 15) of the electrode set (9) is disposed on the first surface (5) of the flexible substrate (3), and each of the electrodes (11, 13, 15) of the electrode set (9) is respectively electrically connected to at least one connection interface (29, 31, 33) arranged on the second surface (7) of the flexible substrate (3),and the biocompatible conductive layer (17) is disposed on the first surface (5) of the flexible substrate (3) and covers at least the electrode assembly (9), and the biocompatible conductive layer (17) is configured to allow an electrochemical interaction between at least one analyte and the electrode assembly (9), a concentration of said analyte being determinable from a response generated by this electrochemical interaction.

2. The dressing (100, 200) according to claim 1, wherein each of the electrodes (11, 13, 15) of the electrode assembly (9) is electrodeposited on the first surface (5) of the flexible substrate (3).

3. The dressing (100, 200) according to claim 1 or 2, wherein at least the working electrode (11), the reference electrode (13) and the counter electrode (15) of the electrode assembly (9) are coplanar.

4. The dressing (100, 200) according to any one of the preceding claims, further comprising a border (23) extending from the first surface (5) of the flexible substrate (3), and the conductive layer biocompatible (17) is at least partially surrounded by the border (23).

5. The dressing (100, 200) according to claim 4, the border (23) of which forms a continuous contour surrounding the biocompatible conductive layer (17).

6. The dressing (100, 200) according to claims 4 or 5, the border (23) having a height (Hl) equal to or greater than a height (H2) of the biocompatible conductive layer (17).

7. The dressing (100, 200) according to any one of claims 4 to 6, the border of which (23) is made of foam, in particular silicone foam or polyethylene foam.

8. The dressing (100, 200) according to any one of the preceding claims, wherein the flexible substrate (3) comprises an adhesive region (35, 37) capable of adhering to the skin or a wound.

9. The dressing (100, 200) according to any one of the preceding claims, wherein the second surface (7) of the flexible substrate (3) has three separate connection interfaces (29, 31, 33) respectively associated with an electrode (11, 13, 15).

10. The dressing (100, 200) according to any one of the preceding claims, wherein the flexible substrate (3) comprises or is made of: polymer, polyethylene, polypropylene, polyamides, polyethylene terephthalate, polyetheretherketone, polyetherketone or any combinations of these materials.

11. The dressing (100, 200) according to any one of the preceding claims, wherein the working electrode (11) is made of platinum, gold or graphene; the reference electrode (13) is made of Ag / AgCl and the counter electrode (15) is made of platinum or gold.

12. The dressing (100, 200) according to any one of the preceding claims, wherein a support layer (21) is disposed over at least the entirety of the second surface (7) of the flexible substrate (3), in particular the support layer (21) is made of fabric, polyurethane or polyethylene.

13. The dressing (100, 200) according to any one of the preceding claims, wherein the biocompatible conductive layer (17) can be doped with an active ingredient or active substance having healing properties.

14. A dressing (100, 200) according to any one of the preceding claims and a treatment unit, the treatment unit including at least one potentiostat, and the treatment unit is electrically coupled to the electrode assembly (9) via at least one connection interface (29, 31, 33) disposed on the second surface (7) of the flexible substrate (3) of the dressing (100, 200).

15. A method for manufacturing a dressing, in particular a dressing (100, 200) according to any one of claims 1 to 13, the manufacturing method comprising the steps of: providing a flexible substrate (3), forming, in particular by electrodeposition, an electrode assembly (9) on a first surface (5) of the flexible substrate (3), the electrode assembly (9) comprising at least one working electrode (11), one reference electrode (13) and one counter electrode (15), and forming at least one connection interface (29, 31, 33) on a second surface (7) of the flexible substrate (3), opposite the first surface (5), electrically connecting each of the electrodes (11, 13, 15) of the electrode assembly (9) to at least one connection interface (29, 31, 33), and providing a biocompatible conductive layer (17) and disposing of it on the first surface (5) of the flexible substrate (3), the biocompatible conductive layer (17) covering at least the electrode assembly (9).

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