TW202235055A - Layer structure with local reservoir - Google Patents

Abstract

The invention relates to a layer structure (10, 110) for application to a surface of a subject, in particular for use in medical products. The layer structure (10, 110) comprises a support layer (12); a backing layer (14) that is removably attached to the support layer (12); at least one local reservoir (16) provided at a predetermined position between the backing layer (14) and the support layer (12); and a fluidic substance (20) and a solid substance (22) being arranged inside the at least one local reservoir (16) and being in contact with one another. The fluidic substance (20) is configured to continuously condition the solid substance (22).

Description

Layer structure with local storage

The invention relates to a layer structure applied on the surface of an object, in particular for use in medical products such as medical patches.

In both medical and non-medical fields, various layer structures are used to interact with the surface of objects, such as the body of a patient.

For example, layer structures in the form of electrode patches are used for ECG monitoring (ECG: electrocardiography), ie to obtain biometric parameters of a subject. A prior art electrode patch is known from document US 2012/323104 A1.

Furthermore, layer structures are also known from the field of cosmetics, in which layer structures are provided in the form of cosmetic or dermopharmaceutical patches. Furthermore, the layer structure can be used, for example, in EMS clothing (EMS: Electrical Muscle Stimulation).

In many prior art layer structures to be applied to the surface of an object and interact with the object, some gel or other electrochemical coupling agent is provided to the layer structure to improve the function of the layer structure. For example, in electrode patches, the electrodes are often covered or coated with a conductive gel prior to application of the electrode patch to a patient in order to achieve adequate signal detection. Furthermore, cosmetic patches are typically applied to the subject in a pre-moistened condition, wherein the moisture improves the interaction of the patch with the subject. However, common gels or electrochemical coupling agents are often insufficient, especially for long-term use. Furthermore, pre-moistened layer structures generally have a limited shelf life, and in terms of the optimum amount of gel and the ease of applying the gel at the desired location on the layer structure, prior to applying the layer structure to an object, The gel applied to the layer structure is often insufficient. [Purpose of the invention]

It is an object of the present invention to provide a layer structure for application to a surface of an object which overcomes the aforementioned disadvantages.

In particular, it is an object of the present invention to provide a layer structure which has an improved shelf life and which enables long-term use of the layer structure.

Furthermore, a preferred object of the present invention is to provide a layer structure that can be easily and quickly attached to objects.

These objects are achieved by the subject matter of the independent claims. Alternative embodiments and optional features are specified in the appended claims and the description below.

One aspect of the invention relates to a layer structure for application to a surface of a subject, preferably to the skin of a subject such as a patient. The layer structure may be a substantially planar layer structure, a patch structure and/or a layer assembly, preferably a multi-electrode patch structure. In particular, this layer structure can be used or used in medical products, such as medical patches. However, the layer structures according to the invention are not limited to medical applications, but can also be used in other fields, such as cosmetics and the like. The preferred technical applications of the layer structure are electrotherapy applications, diagnostic applications, multi-electrode patches, sensor applications, multi-sensor patches, performing electroencephalography (EEG, electroencephalography), electromyography (EMG, electromyography), Electrocardiography (ECG), electrooculography (EOG), microcardiac defibrillation, cardiac defibrillation, etc., application of EMS-clothes (EMS: electrical muscle stimulation), external cardiac mapping (external cardiac mapping), devices Navigation, such as pacemaker navigation (based on monitored electrical signals), compresses containing active substances, and/or contraceptive patches (transdermal patches).

The layer structure includes a support layer and a backing layer removably attached to the support layer. The backing layer may be removably attached to the support layer via an adhesive. The adhesive may be an adhesive layer, such as an adhesive film provided on the support layer and/or the backing layer. The adhesive can be elastic (stretchable). The adhesive may be an inherent property of the support layer and/or the backing layer. The adhesive may be provided locally in certain regions of the support layer and/or the backing layer, or may substantially cover the entire surface of the support layer and/or the backing layer. Adhesives can be printed, dispensed, sprayed or deposited by other methods. In embodiments where an adhesive is provided on at least less than the support layer, the adhesive may be used to securely attach the layer structure to the surface of the object. The adhesive may be skin-friendly to avoid skin irritation and enhance the comfort of the layer structure. In particular, the adhesive may be biocompatible. Preferably, according to DIN EN ISO 10933-10:2010, the ratio of cell survival of the cells contacted with the adhesive during the cytotoxicity test may be greater than 0.7, preferably greater than 0.8, more preferably greater than 0.9.

The layer structure includes providing at least one local reservoir at a predetermined location between the backing layer and the support layer. The layer structure further comprises arranging a fluid substance and a solid substance in this at least one partial reservoir and in contact with each other, wherein the fluid substance is configured to continuously condition the solid substance. In particular, the solid mass is arranged such that a first surface of the solid mass faces the support layer and a second surface of the solid mass opposite the first surface faces the backing layer. Fluid substances and solid substances may be in direct contact with each other. Alternatively, an additional insulating layer may be arranged between the fluid substance and the solid substance, for example to reduce and/or select the area of the contact surface to specifically affect the accommodation of the fluid substance to the solid substance.

In the sense of the present invention, the expression "solid substance" includes solid compositions (such as foams and/or fabrics and/or porous solids), gels and/or gel compositions, where the viscosity of the gel/gel composition is at least 230000 mPas, preferably at least 500000 mPas, more preferably at least 800000 mPas, and wherein the viscosity of the gel/gel composition is higher than the viscosity of the liquid substance. In other words, solid substances are not limited to solid compositions, but can also describe high-viscosity gel/gel compositions, ie, solid-like gel/gel compositions. In the sense of the present invention, the expression "liquid substance" encompasses liquids, gases, fluids, gels and/or gel compositions. Viscosity values specified herein may relate to the viscosity of a substance at 23°C and may be measured according to ISO 3219:1993, eg with a Brookfield RST CC contact rheometer.

A solid substance may have a higher viscosity than a liquid substance. Preferably, the ratio of the viscosity of the solid substance to the viscosity of the liquid substance, i.e. viscosity _solid /viscosity _liquid , may be at least 10, preferably at least 250, more preferably at least 1000, even more preferably at least 10000, even more preferably At least 100000. A gel (which can form a liquid substance and/or a solid substance) can be a cross-linked sol. A gel (which can form a liquid substance and/or a solid substance) can be a colloidal suspension. The viscosity of the liquid substance may be at least 0.25 mPas, preferably at least 0.5 mPas, more preferably at least 1 mPas. The viscosity of the liquid substance may be 220000 mPas or lower, preferably 70000 mPas or lower, more preferably 10000 mPas or lower. The viscosity of the liquid substance may be between 0.25 mPas and 220000 mPas, more preferably between 0.5 mPas and 70000 mPas, more preferably between 1 mPas and 10000 mPas. The viscosity of the solid matter may be at least 230000 mPas, preferably at least 500000 mPas, more preferably at least 800000 mPas. The viscosity of the solid matter may be 1000000000 mPas or lower, preferably 100000000 mPas or lower, more preferably 10000000 mPas or lower. The viscosity of the solid matter may be between 230000 mPas and 1000000000 mPas, preferably between 500000 mPas and 100000000 mPas, more preferably between 800000 mPas and 10000000 mPas. All viscosity values indicated herein can be related to the viscosity of the substance at 23°C and can be measured according to ISO 3219:1993, eg with a Brookfield RST CC contact rheometer.

Providing interacting solid and fluid substances in the layer structure, in particular a continuous adjustment of the fluid substance to the solid substance, increases the shelf life of the layer structure, since the desired conditions of the solid substance can be maintained during storage of the layer structure. Furthermore, by virtue of the solid matter, a long-term use of the layer structure can be permitted. This is even more applicable when the solid matter is continuously conditioned by the fluid matter to maintain the properties and functionality of the solid matter.

Since the fluid substance and the solid substance are arranged in the same local reservoir and in contact with each other, the regulation is continuous automatically, ie in a predetermined and/or in a self-working manner. In other words, there is no need to perform continuous adjustment manually.

Furthermore, by arranging or pre-positioning solid and fluid substances in local reservoirs, continuous regulation is performed locally and thus selectively. More precisely, the fluid substance only conditions the solid substance to which it is dispensed, but not other parts or large areas of the layer structure. Moreover, by arranging or pre-positioning solid and fluid substances in local reservoirs, immediately after removal of the backing layer, the layer structure is ready to be applied to the surface of the object without further preparations such as adding additional fluid substances to the object layer structure or surface. This simplifies the attachment of the layer structure to the surface of the object and reduces the preparation time for the user.

The layer structure may comprise a plurality of partial reservoirs, each containing at least one solid substance and at least one fluid substance, as described for at least one partial reservoir. The layer structure may comprise at least two local reservoirs, preferably at least twelve local reservoirs, more preferably at least 15 local reservoirs, even more preferably at least 18 local reservoirs, even more preferably more than 100 local storage.

The layer structure may comprise at least one electrode, preferably a plurality of electrodes. Thus, the layer structure can be used, for example, as an electrode patch for a multiple-lead ECG. In particular, each local reservoir can be provided in the region of an electrode. Thus, the number of local reservoirs can be equal to the number of electrodes provided in the layer structure. The electrodes may contain silver or silver chloride.

The layer structure can be configured such that in a state where the layer structure of the backing layer is removed from the support layer and the layer structure is in contact with the surface of the object, the fluid substance is configured to continuously and locally condition at least one area of the surface of the object , more precisely at least the area of the object's surface in contact with the fluid substance. Thus, the fluid substance can continuously condition the solid substance and at least one area of the surface of the object. Thus, immediately after the layer structure has been applied to the surface of the object by means of the fluid substance, the layer structure can function or perform its intended function. On the contrary, in many known layer structures, before using the layer structure, the user needs to wait for a period of time until the layer structure is adjusted to the desired physicochemical conditions. For example, in EMS clothing or certain diagnostic applications, the user must wait until a sweat film forms between the electrodes/sensors and the surface of the subject to allow proper and sufficient signal transmission.

In one embodiment of the layer structure, the fluid substance may be configured to continuously maintain the solid substance in a desired state, preferably to continuously wet or retain moisture from the solid substance, and/or to Predetermined physicochemical conditions are continuously maintained in the area. Accordingly, the fluid substance can be configured to be continuously maintained in a desired state, preferably configured to continuously wet or retain moisture, and/or configured to be continuously in at least one reservoir and/or in the area of the object to which the layer structure is applied. To maintain predetermined physical and chemical conditions.

In an embodiment, at least a portion of the fluid substance may be disposed between the solid substance and the backing layer. Arranging at least a portion of the fluid substance between the solid substance and the backing layer means that the solid substance can be separated from the backing layer, thereby forming a cavity between the solid substance and the backing layer, wherein the cavity can accommodate at least a portion of the fluid substance. fluid substance. Another part of a fluid substance or quantity can be absorbed by a solid substance. Solid matter may have a substantially circular cross-sectional area.

In an embodiment, the solid substance may have a recess, wherein the liquid substance is at least partially accommodated in the recess. For example, the solid substance may be ring-shaped, having an internal recess or opening into which the liquid substance is partially or completely disposed. The notches can be circular, rectangular, oval, etc. In an embodiment where only a portion of the fluid mass is disposed in the recess of the solid mass, another portion may be disposed between the solid mass and the backing layer. The notches may extend axially through the solid mass, ie may have the same thickness axial extent as the axial length (thickness) of the solid mass. Alternatively, the notch may have an axial length which is less than the thickness of the solid mass. In this case, for example, the bottom of solid composition can be closed. For example, the bottom may be configured for contacting electrodes.

According to an embodiment, the fluid substance may comprise a gaseous substance and/or a liquid substance, in particular a liquid gel, preferably a liquid hydrogel. Fluid substances may be placed in at least one reservoir by dispensing, dosing, printing, pipetting, casting, and the like.

According to an embodiment, the solid substance may comprise a solid gel, preferably a solid hydrogel, a foam and/or a fabric, preferably a non-woven fabric. Alternatively or in addition, the solid matter may comprise semiconductors, sensor components and/or sensor surfaces. In particular, solid matter may have certain advantageous properties and/or may only function according to certain conditions of the solid matter. The condition of solid matter may depend on eg ambient conditions and may especially be affected by fluid matter.

In an embodiment of the layer structure, the fluid substance may have viscous and/or conductive properties. In particular, at usual ambient temperatures, for example in the range of 0 °C to at least 40 °C, preferably in the range of 5 °C to 35 °C, more preferably in the range of 10 °C to 30 °C , the fluid substance may have viscous and/or conductive properties. The conductivity of the fluid substance may be at least 5.5·10 ⁻⁶ S/m, preferably at least 5·10 ⁻³ S/m. The electrical conductivity of the fluid substance may be less than 3·10 ² S/m, preferably less than 5 S/m. The conductivity of the fluid substance may be in the range of 5.5·10 ⁻⁶ S/m to 3·10 ² S/m, preferably in the range of 5·10 ⁻³ S/m to 5 S/m. In the case of combined use of layer structures with electronic components, such conductivity may be preferred for optimal signal transmission.

According to an embodiment, the backing layer and/or the support layer may comprise pre-formed bulge portions. The pre-formed raised portion may partially define at least one local reservoir. The raised portion can also be defined as a cup and/or pocket portion. When pre-formed in the backing layer, the raised portion may bend (bulge) in a direction away from the support layer. When pre-formed in the support layer, the raised portion may bend (bulge) in a direction away from the backing layer. The raised portion may have a substantially circular cross-sectional area. The raised portion may be dome-shaped.

In embodiments of the layer structure that do not contain any pre-formed protrusions, fluid substances placed at predetermined positions in the layer structure between the backing layer and the support layer are permeable, by means of the backing layer and/or the support layer. The flexible and/or elastic (stretchable) deformation of the layer forms at least one local reservoir.

In an embodiment, the layer structure may comprise protrusions laterally bordering the at least one partial reservoir to prevent lateral leakage of the fluid substance from the at least one partial reservoir. The protrusion may laterally surround at least one reservoir. In embodiments having a plurality of local reservoirs, some or all of the reservoirs may be provided with corresponding interface protrusions.

Preferably, the protrusions are formed on the supporting layer and/or the backing layer. The protrusions may be integral with the support layer and/or the backing layer, respectively. Alternatively, the protrusions may be a separate component such as an additional layer. The protrusions may be printed, dispensed, sprayed or deposited by other methods.

The protrusions may have a substantially circular shape. The outer profile of the protrusion can be completely closed. The protrusions may be completely circular, or may have an oval or rectangular shape.

In an embodiment, the layer structure may comprise at least one sensor assembly and/or actuator assembly arranged in the region of at least one local reservoir between the solid matter and the support layer. The sensor assembly and/or the actuator assembly may be configured to interact with the surface of the object via solid and fluid matter.

According to an embodiment, the backing layer may comprise a polymer film, a paper film and/or a hydrogel film. The backing layer can be siliconized. The backing layer can be siliconized on the surface facing the support layer. In particular, the backing layer can be siliconized in certain contact areas of the backing layer which are in contact with the fluid substance. In terms of easy removability of the backing layer, at least partially siliconized backing layer may be preferred.

In an embodiment, the layer structure may comprise an absorbent material attached to the backing layer in the region of at least one reservoir. The absorbent material may be configured to absorb and remove a portion of the fluid substance when the backing layer is removed. In particular, the absorbent material may be configured to absorb and remove an amount of fluid matter which is excess in the state in which the layer structure is applied to the surface of the object. Absorbent material may be attached to the backing layer inside the raised portion. The absorbent material can be fabric, foam, non-woven, etc.

In an embodiment, the layer structure, in particular the backing layer and/or the support layer, may be provided with a barrier layer in the region of the at least one reservoir, in order to prevent the fluid substance from drying out or dehumidification. A barrier layer may for example be provided between the solid or fluid substance and the backing or support layer. The barrier layer can be printed, sprayed, coated or dispensed onto the backing and/or support layer. The barrier layer can be a polymer layer, such as polymethyl methacrylate (PMMA) or thermoplastic polyurethane layer, preferably a heat-curable or UV-curable polymer layer. The backing layer and the support layer may be provided with barrier layers comprising the same or different materials.

The barrier layer can be a dielectric. The barrier layer may be arranged adjacent to, and preferably in direct contact with, the electrodes provided in the layer structure. A barrier layer may be provided between the electrode and the support layer.

The barrier layer can reduce the moisture vapor transmission rate (MVTR) of the layer structure in the region of the barrier layer (i.e., the region of the local reservoir) to 500 g/m ² or lower for 24 hours, less Preferably reduced to 50 g/m ² or lower, more preferably reduced to 5 g/m ² or lower.

The support layer may comprise a polymer, such as a thermoplastic polymer, in particular at least one of TPU, PET, silicone and the like. Alternatively or additionally, the support layer may comprise other materials such as paper or fabric. The support layer can be a nonwoven, woven, film, foam, coating, or the like. The support layer can be siliconized. The support layer may be breathable. The support layer may have a moisture vapor transmission rate (MVTR) of at least 600 g/m², preferably at least 700 g/m² for 24 hours. The support layer may have a moisture vapor transmission rate of 700 to 25000 ^g /m2 for 24 hours.

The backing layer may comprise a polymer, such as a thermoplastic polymer, especially at least one of TPU, PET, silicone and the like. Alternatively or additionally, the backing layer may comprise other materials such as paper or fabric. The backing layer can be non-woven fabric, woven fabric, film, foam, coating, etc. The backing layer can be siliconized. The backing layer may have a moisture vapor transmission rate (MVTR) of less than 5 g/m2, preferably less than 3.5 g/ ^m² , preferably less than 2 g/m² or lower for 24 hours.

According to an embodiment, the volume of the fluid substance may be between 0.001 ml and 10 ml, preferably between 0.01 ml and 5 ml, more preferably between 0.1 ml and 2.5 ml, still more preferably 0.5 ml and 1.5 ml. The volume of the fluid substance may be at least 0.001 ml, preferably at least 0.01 ml, more preferably at least 0.1 ml, even more preferably at least 0.5 ml. The volume of the fluid substance may be 10 ml or less, preferably 5 ml or less, more preferably 2.5 ml or less, even more preferably 1.5 ml or less.

According to an embodiment, the thickness (axial extension) of the solid mass may be between 0.0024 mm and 2.4 mm, preferably between 0.01 mm and 2 mm, more preferably between 0.05 mm and 1.0 mm. The solid mass may have a thickness of at least 0.0024 mm, preferably at least 0.01 mm, more preferably 0.05 mm. The thickness of the solid matter may be 2.4 mm or less, preferably 2 mm or less, more preferably 1 mm or less.

In one embodiment, the impedance of the fluid substance and/or the solid substance may be 3000 ohms or less, preferably 2900 ohms or less, more preferably 2800 ohms or less at a frequency of 10 Hz.

In one embodiment, the volume resistivity of the fluid substance may be in the range of 0.01 Ωm to 100 Ωm, preferably in the range of 0.1 Ωm to 50 Ωm, more preferably in the range of 1 Ωm to 10 Ωm. The volume resistivity of the fluid substance may be a volume resistivity of at least 0.01 Ωm, preferably at least 0.1 Ωm, more preferably at least 1 Ωm. The volume resistivity of the fluid substance may be 100 Ωm or less, preferably 50 Ωm or less, more preferably 10 Ωm or less.

In one embodiment, the ratio of the viscosity of the fluid substance to the volume resistivity, that is, the ratio of the viscosity of stainless steel (180° peeling force, in g/in) to the volume resistivity (in Ω∙in) is in In the range of 0.5 to 1.5, preferably in the range of 0.6 to 1.0. The ratio of viscosity to volume resistivity of the fluid substance may be at least 0.5, preferably at least 0.6. The ratio of viscosity to volume resistivity of the fluid substance may be 1.5 or less, preferably 1.0 or less. Considering that both viscosity and volume resistivity to solid matter and to the surface of the object affect signal transmission, such a ratio is preferable to achieve sufficient viscosity and optimal signal transmission.

The fluid substance may have disinfecting properties and may be configured to disinfect surface areas of the object that come into contact with the fluid substance. The fluid substance may have absorbent properties and may be configured to absorb residues, substances, particles from the surface area of the object in contact with the fluid substance.

In an embodiment, the layer structure may be biocompatible and/or skin-friendly to avoid skin irritation and enhance the comfort of the layer structure. In particular, the fluid substance may be biocompatible and/or skin-friendly. In particular, the fluid substance may be biocompatible and/or skin friendly. Preferably, during the cytotoxicity test, the cell viability of the cells in contact with the layer structure and/or the fluid substance may be greater than 0.7, preferably greater than 0.8, more preferably greater than 0.9 according to PN EN ISO 10933-5:2009 test. The cumulative irritation index of the layer structure and/or fluid substance may be in the range of 0 to 1.9, preferably in the range of 0 to 0.4, more preferably in the range of 0 to 0.1, according to PN-EN ISO 10993-10: 2015-2 to test. According to the ISO scale defined in PN-EN ISO 10993-10:2015-2, the sensitization (grade) effect of layer structures and/or fluid substances can be from 0 to 1, better 0.

According to an embodiment, at least 90% of the area of the layer structure may be radiolucency by virtue of the radiolucency of each of the support layer, the solid substance and/or the fluid substance. Preferably, at least 95% of the area of the layer structure may be radiation transparent, more preferably at least 97%. More preferably 100% of the area of the layer structure, ie the entire area, can be radiolucent. Since a layer structure may have a generally planar shape or configuration, the area of a layer structure refers to the surface area of the layer structure.

As used herein, the term "radiation penetrable" means, in a manner and to an extent similar to that of human soft tissue, such as muscle tissue, sensitive to electromagnetic, magnetic and/or electric fields and/or to those used in common (medical) imaging procedures such as X-ray or MRI. Materials or composites that are largely or completely transparent to radiation are used. In particular, the layer structure can be radiation-transmissive for electromagnetic, magnetic and/or electric fields and/or for electromagnetic, magnetic and/or electric field radiation. In other words, the layer structure in this exemplary embodiment does not block X-ray or MRI electromagnetic radiation, but allows it to pass through and thus appear undisturbed in X-ray or MRI images. Thus, the layer structure can be worn by the patient during X-ray and/or MRI treatment without negatively affecting the treatment. In particular, radiolucency can mean that the layer structure, i.e. the radiolucent material, does not render the image in general hospital x-rays (Radioisotope Thermoelectric Generators; RTG) and/or fluoroscopy and/or in angiography and and/or X-ray films taken during other cardiac/neurological/radiological procedures (diagnostic and/or therapeutic) darkened by more than 60% of image intensity. An exemplary system for general hospital X-rays may be a Siemens Artis Zee with exemplary settings for lamp voltage of 40 kV to 70 kV and lamp current of 8 mA to 12 mA. This maximum darkness should not be exceeded so that practitioners can still evaluate and evaluate images. In particular, radiolucent may mean that the layer structure, i.e. the radiolucent material, does not darken the image of a general hospital x-ray (RTG) by more than 50%, preferably not more than 40%, more preferably No more than 30%, no more than 28%, no more than 18%, no more than 5%. The less the image intensity is darkened by the layer structure, the better the practitioner can assess and evaluate the resulting image. In other words, radiation penetrability preferably means a layered structure, i.e. a material that is radiopaque, that does not attenuate radiation by more than 40.0 µGy/min, preferably not more than 30.0 µGy/min, more preferably not more than 26.0 µGy/min, more preferably not more than 23.0 µGy/min. In other words, radiation penetrability preferably means that during the process, the ratio of the radiation dose attenuated by the layer structure, i.e. the radiation transparent material, to the total radiation dose of the radiation does not exceed 5%, preferably does not exceed 3.5 %, more preferably no more than 2%, more preferably no more than 1.7%, and still more preferably no more than 1.5%.

In other embodiments, the layer structure may comprise additional layers, films, coatings and/or components.

Another aspect of the invention relates to a method for producing a layer structure of the above-mentioned type.

Another aspect of the invention relates to a storage system comprising a packaging container, a plurality of adjustment beads and a layer structure of the above-mentioned type, wherein the plurality of adjustment beads and the layer structure are accommodated in the packaging container. The packaging container may be a bag, a box, or the like. Conditioning beads can be humidifier or humidity stabilizing beads. The conditioning beads may be adapted to maintain a desired state within the packaging container, for example to maintain a desired humidity inside the packaging container by releasing moisture in the packaging container.

Various examples of embodiments of the invention will be explained in more detail by means of the following embodiments which are depicted in the drawings and/or described below.

FIG. 1 shows a layer structure 10 comprising a support layer 12 and a backing layer 14 removably attached to the support layer 12 by means of an adhesive film (not shown) provided on the support layer 12 . In the state shown in FIG. 1 , the layer structure 10 can be stored or transported before use, ie before applying the layer structure 10 to a surface of an object, for example the skin of a patient. In the illustrated embodiment, the support layer 12 is a breathable TPU layer and the backing layer 14 is a PET layer.

The layer structure 10 comprises local reservoirs 16 provided at predetermined positions between the backing layer 14 and the support layer 12 . The local reservoir 16 is formed by a protrusion 18 disposed in a portion of the backing layer 14 . The protrusion 18 has a convex curvature in the direction facing away from the support layer 12 and is substantially dome-shaped.

A fluid substance 20 and a solid substance 22 are arranged within the local reservoir 16 . In the illustrated embodiment, the fluid substance 20 is a liquid hydrogel and the solid substance 22 is a solid hydrogel. The fluid substance 20 and the solid substance 22 are in direct contact with each other, wherein the fluid substance 20 is placed between the solid substance 22 and the backing layer 14 . By direct contact, the fluid substance 20 continuously wets the solid substance 22 . Thus, the fluid substance 20 preserves the desired state of the solid substance 22 and maintains the solid substance 22 in the desired state.

In the state where the backing layer 14 is removed from the support layer 12 , the remainder of the layer structure 10 can be firmly attached to the surface of the object by means of an adhesive film provided on the support layer 12 . In other words, when the support layer 12 is attached to the surface of the object, the support layer 12 is at least partially in contact with the surface of the object via the adhesive film. At the same time, the fluid substance 20 is locally in direct contact with the surface of the object. Locally means that the fluid substance 20 is in contact with the surface of the object at a selected location predetermined by the location of the reservoir 16 on the layer structure 10 and the positioning of the layer structure 10 on the surface of the object. Fluid substance 16 also continuously conditions the area of the object's surface by selectively contacting the object's surface. Thus, in this embodiment, when the fluid substance 16 is in contact with the surface of the object, it simultaneously and continuously wets the solid substance and an area of the surface of the object. Thus, the layer structure 10 can perform its intended function immediately after application of the layer structure 10 to the surface of the object.

FIG. 2 shows a layer structure 110 according to a second embodiment. Components and features that are the same or similar to those in FIG. 1 are provided with the same reference numerals. In addition to the embodiment of the layer structure 10 shown in FIG. 1 , the layer structure 110 of FIG. 2 further comprises a silver or silver chloride electrode 24 arranged subjacent to the solid mass 22 . The local store 16 is thus arranged in the region of the electrode 24 and surrounds the electrode 24 .

When layer structure 110 (or at least a portion of layer structure 110 ) of FIG. As described with respect to the embodiment of FIG. 1 , the fluid substance 20 continuously conditions or wets the solid substance 22 and the surface of the object. The combination of fluid substance 20 and solid substance 22 and their interaction are used to achieve optimal signal transmission between the surface of the subject and the electrodes 24, which allows adequate monitoring of the patient. Immediately after application of the layer structure 10 to the surface of the object by means of the solid substance 22 preconditioned both through the fluid substance 20 and immediately conditioning the surface of the object, sufficient signal quality is provided.

The illustrated layer structure 110 further comprises a barrier layer 26 arranged under the electrode 24 between the electrode 24 and the support layer 12 . The barrier layer 26 is a dielectric and thus shields the electrode 24 in the direction towards the support layer 12 . Furthermore, the barrier layer 26 has a water vapor transmission rate (Moisture vapor transmission rate; MVTR) of 500 g/m ² or lower for 24 hours, preferably 50 g/m ² or lower, more preferably 5 g/m ² or lower. Thus, the barrier layer 26 prevents or at least reduces drying of the components contained in the reservoir 16 , namely the fluid matter 20 and the solid matter 22 . This applies to the state in which the layer structure 10 is stored/transported, ie the backing layer 14 is attached to the support layer 12, and to the state in which the layer structure 10 (without the backing layer 14) is attached to the surface of the object. Thus, the barrier layer 26 increases the shelf life of the layer structure 10 and the long-term use of the layer structure 10 .

FIG. 3 shows a layer structure 210 according to a third embodiment. The same reference numerals as in Figures 1 and 2 are provided for the same or similar components and features. In contrast to the first embodiment of Fig. 1, the solid mass 22 of Fig. 3 is annular and comprises an inner circular recess in which the liquid mass 20 is arranged. The inner circular recess extends completely through the solid mass 22 in the axial direction. Thus, in this embodiment both the solid substance 22 and the fluid substance 20 may be in contact with adjacent surfaces on top of the substance, ie the surface of the object, and with underlying components such as electrodes (not shown in Figure 3).

Although the invention has been described with respect to a limited number of embodiments, it should be understood that many variations, modifications and other applications of the invention are possible and that various combinations and sub-combinations of the embodiments and features described herein are also possible , and it falls within the scope of this application.

10, 110, 210: layer structure 12: Support layer 14: Back support layer 16: Local storage 18: protrusion 20: Fluid matter 22: Solid matter 24: electrode 26: barrier layer

For a better understanding of embodiments of the invention, and to show how it can be practiced, reference is now made to the accompanying drawings, purely by way of example, wherein like reference numerals designate corresponding elements or parts throughout. In the attached drawings: FIG. 1 shows a schematic sectional view of a first exemplary embodiment of a layer structure, which shows the arrangement of the layer structure in the region of the local reservoir. FIG. 2 shows a schematic sectional view of a second exemplary embodiment of a layer structure, which reveals the configuration of the layer structure in the region of the local reservoir. FIG. 3 shows a schematic sectional view of a third exemplary embodiment of a layer structure, which reveals the arrangement of the layer structure in the region of the local reservoir.

10: layer structure

12: Support layer

14: Back support layer

16: Local storage

18: protrusion

20: Fluid matter

22: Solid matter

Claims (15)

A layer structure (10, 110) applied to a surface of an object, in particular for a medical product, comprising a support layer (12); a backing layer (14) removably attached to the support layer (12); providing at least one partial reservoir (16) at a predetermined location between the backing layer (14) and the support layer (12); and a fluid substance (20) and a solid substance (22), arranged in the at least one partial reservoir (16) and in contact with each other, and Wherein the fluid substance (20) is configured to continuously condition the solid substance (22). The layer structure (10, 110) of claim 1, wherein after removing the backing layer (14) from the support layer (12) and the layer structure (10, 110) is in contact with the surface of the object In one state, the fluid substance (20) is configured to continuously and locally condition at least one area of the surface of the substrate. The layer structure (10, 110) of claim 1, wherein the fluid substance (20) is configured to continuously maintain the solid substance (22) in a desired state, preferably to continuously wet the solid substance (22) And/or in the region of the at least one reservoir (16), a predetermined physicochemical condition is continuously maintained. The layer structure (10, 110) of claims 1-3, wherein at least a portion of the solid substance (20) is disposed between the solid substance (22) and the backing layer (14). The layer structure (10, 110) according to claims 1-4, wherein the fluid substance (20) comprises a gaseous substance and/or a liquid substance, especially a liquid gel, preferably a liquid hydrogel. The layer structure (10, 110) according to claims 1-4, wherein the solid substance (22) comprises solid gel, preferably solid hydrogel, foam and/or fabric, preferably non-woven fabric. The layer structure (10, 110) according to claims 1-4, wherein the fluid substance (20) has viscous and/or conductive properties. The layer structure (10, 110) of claims 1-4, wherein the backing layer (14) and/or the support layer (12) comprises a pre-formed protrusion (18), the protrusion partly The at least one local storage (16) is defined. The layer structure (10, 110) according to claims 1-4, further comprising a protrusion laterally bordering the at least one partial reservoir (16) to prevent the fluid substance (20) from the at least one partial reservoir The device (16) leaks laterally, wherein preferably the protrusion is formed on the support layer (12) and/or on the backing layer (14). The layer structure (10, 110) as claimed in claims 1-4, further comprising a sensor assembly (24) and/or actuator assembly (24), arranged between the solid substance (22) and the support layer (12 ) in the region of the at least one local storage (16). The layer structure (10, 110) of claims 1-4, wherein the backing layer (14) comprises a polymer film, a paper film and/or a hydrogel film, The backing layer (14) is preferably siliconized, especially on a contact area of the backing layer (14) which is in contact with the fluid substance (20). Layer structure (10, 110) according to claims 1-4, wherein an absorbent material is attached to the backing layer (14) in the region of the at least one reservoir (16), the absorbent material being arranged to be in A partial amount of the fluid substance (20) is absorbed and removed when the backing layer (14) is removed. The layer structure (10, 110) according to claims 1-4, wherein in the region of the at least one reservoir (16), the backing layer (14) and/or the support layer (12) are provided with a barrier layer (26) to prevent drying of the fluid substance (20), wherein preferably the barrier layer (26) is configured to reduce the moisture vapor transmission rate of the layer structure (10, 110) in the region of the barrier layer (moisture vapor transmission rate, MVTR) is reduced to 500 g/m ² or less or less, preferably 50 g/m ² or less, more preferably 5 g/m ² or less. Layer structure (10, 110) as described in claims 1-4, Wherein the volume of the fluid substance (20) is between 0.001 ml and 10 ml, preferably between 0.01 ml and 5 ml, more preferably between 0.1 ml and 2.5 ml, still more preferably between 0.5 ml and 1.5 ml room; and/or Wherein the thickness of the solid substance (22) is between 0.0024 mm and 2.4 mm, preferably between 0.01 mm and 2 mm, more preferably between 0.05 mm and 1.0 mm. The layer structure (10, 110) as described in claims 1-4, wherein the volume resistivity of the fluid substance (20) is from 0.01 Ωm to 100 Ωm, preferably from 0.1 Ωm to 50 Ωm, more preferably from 1 Ωm to 10 Ωm; and/or Wherein the ratio of viscosity to volume resistivity of the fluid substance (20) is 0.5 to 1.5, preferably 0.6 to 1.0.

Images