Multilayer covering for holding a device on a body

Abstract

The invention relates to a covering (1) for holding a device on the body of an individual. The covering (1) comprises a stack of layers (2-7, 11, 12) assembled using a roll-to-roll method.

Description

Technical Field

[0001] The present invention relates to the field of holding a device on the body of an individual. In a non-limiting manner, the device may be a medical device and / or a device for measuring physiological data and / or for diffusing an active ingredient in liquid form and / or for sampling body fluids.

[0002] For example, the device may include electronic components (such as sensors or antennas, wired or wireless communication devices, data recording and storage devices, etc.), electromechanical devices (such as micropumps, microneedles or other vibrators, etc.), elements that act on the body (such as pharmacologically active ingredient dispensers with microneedles or in patch form, etc.) or magnets, liquid sampling devices (such as blood or sweat, etc.), in vitro diagnostic equipment, etc.

[0003] The invention is particularly focused on the field of patient data as an aid to diagnosis, but is not limited thereto, and the device is in particular a medical temperature measuring device for continuously measuring body temperature over a period of hours or days. It can therefore also find application in the fields of chronotherapy and chronopharmacology. Background Art

[0004] The first device retention technique known in the prior art involves using double-sided tape to adhere the device to the skin. Among other disadvantages, the adhesive on the tape can contaminate the device, necessitating cleaning when it is reused. Furthermore, this method of attachment does not maintain the attachment of the device when significant forces are applied to the device. This obviously makes it easier for the device to be peeled off by the movement of an individual lying in bed.

[0005] A second known technique consists in using an adhesive film made of polysiloxane or polyurethane to hold the device in place, the film being selected to be wider and longer than the device, with a large surface area, so as to extensively cover the device. The device is usually arranged in a central portion of the film, which is attached to the skin via the peripheral portions. Usually, such adhesive films have adhesive on both the peripheral and central portions, leading to contamination of the device.

[0006] Some adhesive films include an adhesive layer that covers only the peripheral portion of the film, thereby avoiding deposition of adhesive residues on the device. However, in practice, such films are difficult to apply and are prone to wrinkling and tension, preventing the device from being properly held, especially when the device is relatively heavy and / or large. In order to improve adhesion, such adhesive films may also require the use of adhesive types and / or amounts that may increase the aggressiveness of the skin.

[0007] A third known technique consists in housing the device in an elastic sleeve or cuff that surrounds a limb, such as an arm. Known cuffs are usually sewn onto a textile or leather or elastic matrix. They may move around or slide along the limb, making it impossible to keep the device in a precise position on the body. Not to mention that when the device is relatively heavy and / or large, it may be necessary to tighten the cuff or sleeve around the limb, making it painful or even unbearable for the individual wearing it. In addition, this type of technology does not allow the device to be kept on certain parts of the body, such as the torso or flank. Finally, this technology is difficult to industrialize and requires cleaning before reuse. Summary of the invention

[0008] The present invention aims to provide a solution for holding the device on the body in a stable, precise, durable and comfortable manner while overcoming the above mentioned drawbacks.

[0009] A specific object of the invention is to provide a solution that reduces manufacturing costs.

[0010] Another object of the invention is to provide a retaining system that simplifies the installation of the system and of the device it is intended to retain, as well as the various steps associated with the use of the system (particularly in a hospital environment), in particular the switching on and off of the device in the case of active devices, the visual check of the operating state of the system, the visual check of the correct positioning of the system, the removal of the device from the cover and / or the removal of the device from the cover.

[0011] To this end, the object of the present invention is a cover for holding a device, such as a medical device and / or a device for measuring physiological data and / or for diffusing an active ingredient (for example an active ingredient in liquid form) and / or for sampling a body fluid near or against the skin surface of an individual. According to the invention, the cover comprises a first layer and a second layer connected to each other so that the first layer and the second layer are pressed against each other when the cover is in an initial state, the cover being configured to allow the second layer to deform so as to transform the cover from the initial state into a use state, wherein the first layer and the second layer define between them a receiving space suitable for receiving the device.

[0012] The cover of the present invention includes an opening configured to allow a device to be inserted into the receiving space and, when necessary, to be removed from the receiving space.

[0013] The first layer comprises an outer surface having an adhesive material, such as a silicone or acrylate adhesive, for attaching the cover to the skin surface.

[0014] The present invention thus provides a cover of relatively simple overall construction (ie two layers initially pressed together) while enabling the device to be held in place in a stable, precise and durable manner.

[0015] The layered structure simplifies and reduces the cost of manufacturing the cover on the one hand, and makes it disposable on the other hand, to better comply with hygiene standards and reduce management restrictions, especially in hospital environments.

[0016] The cover of the present invention can obviously be used to hold the device against or near the skin surface of various body parts, such as parts with a large radius of curvature (such as the torso), or such as an arm or other limb.

[0017] The receiving space and the opening allow the device to be releasably received in the cover and held in place unattached, which both prevents contamination of the device and reduces the risk of the device becoming detached.

[0018] In one embodiment, the first layer and the second layer each include an inner surface, and are connected to each other by bonding or welding portions of their inner surfaces.

[0019] In one embodiment, the first layer and / or the second layer comprises a nonwoven material.

[0020] The term "nonwoven" has a very broad meaning in this context and includes all lightweight, thin materials that can be supplied on rolls.

[0021] These materials have the advantage of being generally inexpensive and also having the advantage of being convertible in an in-line process to produce a functionally interesting product that is economically optimized enough for single use.

[0022] The material chosen is a true nonwoven material, ie a material made of random or oriented fibers held together and linked by friction and / or cohesion and / or bonding according to the definition of ISO 9092.

[0023] Natural fibers such as wool, linen, cotton or cellulose can be used, but also mineral fibers such as glass or ceramic fibers. However, in industry, non-manufactured cloth is basically made of plastic fibers, which have many variants: polypropylene, polyethylene, polyester, polyvinyl chloride fibers, etc.

[0024] Paper is another material included in the definition of nonwoven material in this document. Although the bonds between the cellulose fibers are not exactly the same between the papermaking process and the nonwoven process, the methods are very similar and their behavior can be used for the manufacture of the layers according to the invention.

[0025] Similarly, films cast, blown or extruded from polymers are included in the definition of nonwovens according to the invention, as their behavior can be used in the manufacture of some layers according to the invention. Particularly noteworthy in this category is the presence of elastomeric films, which can impart a certain elasticity to the material of possible interest, in particular the material of the first layer.

[0026] Finally, a certain amount of lightweight fabrics may be included in the covering of the invention in terms of functionality and also compatible with the price target. Particular attention should be paid to the possibility of using woven yarns or lightweight textile pieces. Woven yarns or lightweight fabrics may be used for both the first layer and the second layer, but woven yarns or lightweight fabrics generally have disadvantages and will therefore preferably be used for the second layer rather than for the first layer. Woven yarns or lightweight fabrics may also have interesting elastic characteristics, which are of particular interest for the second layer.

[0027] In one embodiment, the first layer and / or the second layer may comprise a nonwoven material as defined in standard ISO 9092, or comprise a plastic or elastomeric material.

[0028] In a preferred embodiment, the first layer comprises a nonwoven material as defined in standard ISO 9092 and the second layer comprises a plastic material.

[0029] Alternatively, the first layer and / or the second layer may comprise a fabric.

[0030] More generally, the first layer and the second layer may be made of the same material as each other or different materials from each other. Thus, by way of non-limiting example, the first layer may include a first material, such as a fabric material, and the second layer may include a second material, such as an elastomeric material. As a further example, both the first layer and the second layer may include plastic materials, such as the first layer including polypropylene and the second layer including polyurethane.

[0031] The use of nonwoven materials, as defined above in a broad sense, makes it possible in particular to manufacture lightweight, economical covers that are compatible with a "roll-to-roll" manufacturing method (see below), thereby simplifying the joining / welding of the various layers and thus achieving a cost price that is compatible with the fact that the cover is considered a disposable item.

[0032] In one embodiment, the second layer is stretchable or elastic.

[0033] Of course, the first layer may also be stretchable or elastic.

[0034] Regardless of the respective materials of the first and second layers, the covering preferably allows a greater plastic or elastic deformation of the second layer than the first layer.

[0035] In particular, this feature reduces the risk of wrinkles forming in the first layer and improves the fit of the cover on the skin surface.

[0036] The coverings of the present invention may have a variety of sizes and geometries.

[0037] In a non-limiting manner, the thickness of the first layer may be greater than the thickness of the second layer, such as greater than twice the thickness of the second layer.

[0038] In addition, the drape coefficient of the first layer can be greater than the drape coefficient of the second layer, for example greater than twice the drape coefficient of the second layer, and / or the "hand" (see below) of the first layer can be higher than the "hand" of the second layer, for example greater than twice the "hand" of the second layer, and / or the cylindrical strength (see below) of the first layer can be greater than the cylindrical strength of the second layer, for example greater than twice the cylindrical strength of the second layer.

[0039] These features enhance the conformability of the covering to the skin surface and improve retention of the device in place, not to mention when these features are combined with each other and / or with the relative plastic / elastic deformation features of the two layers described above.

[0040] In a non-limiting manner, when the covering is in the initial state, the length of the first layer can be greater than the width of the first layer, preferably the length of the first layer is greater than three times the width of the first layer. As a guide, the length of the first layer can be 30mm to 800mm, preferably 60mm to 400mm.

[0041] In one embodiment, the first layer comprises a cutout that allows a portion of the device to be in direct contact with the skin surface when the device is received in the receiving space.

[0042] Such cutouts may in particular allow parts or elements of the device (such as microneedles or even optical sensors) to directly contact the skin and / or avoid blocking perspiration.

[0043] As a guide, the size of the cutout may be as high as 70% of the total surface area of ​​the first layer while still retaining a sufficiently large bonding area.

[0044] In one embodiment, the covering comprises a third layer comprising a first portion connected to the first layer and / or the second layer, and a second portion configured to be attached to the skin surface and / or to a portion of the covering and / or to a portion of the device, for example to form a cuff.

[0045] In one embodiment, the first layer and / or the second layer includes an inner surface coated with an additive material such as oil, polytetrafluoroethylene, talc or even nanoparticle powder to reduce slippage of the device when received by the receiving space of the cover.

[0046] A subject of the invention is also an assembly comprising a cover as defined above and a device, such as a medical device and / or a device for measuring physiological data and / or for diffusing active ingredients and / or for sampling body fluids.

[0047] In one embodiment, the device is a medical temperature measuring device for continuously measuring body temperature, for example over a period of hours or days.

[0048] Generally, the device may include electronic components (such as sensors or antennas, wired or wireless communication devices, data recording and storage devices, etc.), electromechanical devices (such as micropumps, microneedles or other vibrators, etc.), elements acting on the body (such as pharmacologically active ingredient dispensers with microneedles or in patch form, etc.) or magnets, in vitro diagnostic devices, data acquisition and / or body fluid analysis devices, etc.

[0049] The invention also relates to a method for producing a covering as defined above.

[0050] The method preferably comprises the steps of unrolling one or more rolls of film to form the first layer and / or the second layer, and assembling the first layer with the second layer.

[0051] This method, known as "roll-to-roll", enables the manufacturing of the covering according to the invention at a high rate, since the film roll can typically be unwound at a speed of approximately one meter per second.

[0052] More generally, this approach reduces manufacturing costs.

[0053] In one embodiment, the assembling step comprises unrolling one or more rolls of adhesive film, in particular a double-sided adhesive film.

[0054] The present invention also relates to a method for applying and / or attaching a covering as defined above to the skin surface of an individual.

[0055] The method includes the step of applying a first layer to the skin surface.

[0056] The method may include the step of inserting a device into a receiving space of the cover.

[0057] Preferably, the insertion is performed before the cover is attached to the skin surface, so that the device is inserted into the cover. Of course, alternatively, the device can be inserted after the cover is attached to the skin surface.

[0058] Other advantages and characteristics of the invention will become apparent from the detailed, non-limiting description which follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] The following is a detailed description with reference to the accompanying drawings, in which:

[0060] [ Figure 1 ] is a schematic exploded perspective view of a cover according to a first embodiment of the present invention;

[0061] [ Figure 2 ]yes[ Figure 1 ] is a schematic top view of the first layer of the covering shown in FIG.

[0062] [ Figure 3 ]yes[ Figure 1 ] is a schematic top view of the second layer of the covering shown in FIG.

[0063] [ Figure 4 ] is intended to be contained in [ Figure 1 ] a schematic top view of the device in the cover shown in ];

[0064] [ Figure 5 ]yes[ Figure 4 ] a schematic bottom view of the device shown in ];

[0065] [ Figure 6 ] is a schematic cross section of a cylinder of material and a tool for testing the strength of the cylinder;

[0066] [ Figure 7 ] is a schematic exploded perspective view of a cover according to a second embodiment of the present invention; DETAILED DESCRIPTION

[0067] The drawing includes a reference coordinate system that defines a longitudinal direction D1 , a transverse direction D2 , and a lateral direction D3 that are orthogonal to each other.

[0068] [ Figure 1 ] shows an exploded view of the various layers making up the covering 1 according to the invention.

[0069] In this document, a layer refers to a structure that has a small thickness relative to its surface area.

[0070] Reference [ Figure 1 ], each layer of the covering 1 comprises two surfaces spaced apart along the direction D2, one of the two surfaces of each layer is called the "first surface", in [ Figure 1 ], the other surface of each layer is called the “second surface”, in [ Figure 1 For each layer, the distance between the first surface and the second surface along D2 defines the thickness of the layer.

[0071] In this non-limiting example, the covering 1 more particularly comprises layers referenced 2 to 7 , 11 and 12 , which are stacked along a direction D2 .

[0072] Reference [ Figure 2 ],[ Figure 2] Layer 2 is shown alone, which has a substantially rectangular shape and is elongated along direction D1.

[0073] In this particular example, layer 2 comprises nonwoven polypropylene and has a length X1 of 280 mm, a width X2 of 50 mm and a thickness of 410 μm.

[0074] Layer 2 has two longitudinal ends 21 and 22 along D1. In this example, end 21 forms a semicircle with a radius corresponding to half the width X2 (25 mm in this case), constituting a rounded end 21. End 22 has rounded corners, each with a radius of 15 mm in this example.

[0075] The width of layer 2 between end 21 and end 22 is substantially constant along D1, except for a region 23 of layer 2 having a reduced width. This reduction in width takes the form of a half-moon-shaped cutout 24 located at a longitudinal distance X3 from end 22. In this example, X3 is approximately equal to 190 mm.

[0076] Layer 2 thus comprises two portions 26 and 27 extending longitudinally on either side of zone 23 .

[0077] Layer 2 also comprises longitudinally, in the vicinity of zone 23 , two openings 28 and 29 , respectively formed in portions 26 and 27 .

[0078] The openings 28 and 29 are formed as slots extending laterally across most of the width of the layer 2, so as to have a lateral dimension X4 substantially corresponding to the width of the zone 23. In this example, X4 is approximately equal to 33 mm.

[0079] The portion 27 of the layer 2 also comprises a longitudinally extending long cut 30. In this example, the cut 30 has a length X5 of about 70 mm, a width X6 of about 11 mm along most of the length of the cut 30, and a central section having a slightly larger width X7, which in this example is about 13 mm.

[0080] Reference [ Figure 3 ], the geometry of layer 3 is substantially identical to the geometry of layer 2. Layer 3 will be described below only with respect to its differences relative to layer 2, the above description being applicable by analogy.

[0081] In this particular example, layer 3 is made of polyurethane and has a thickness of 30 μm.

[0082] This material imparts elastic properties to layer 3 .

[0083] Layer 3 comprises neither openings such as openings 28 and openings 29 in layer 2 nor cuts such as long cuts 30 in layer 2 .

[0084] However, portion 27 of layer 3 comprises a cutout 31 the position and dimensions of which correspond substantially to the position and dimensions of said central portion of cutout 30 in layer 2 .

[0085] Reference [ Figure 1 ], layer 11 is a double-sided adhesive film layer that is cut during the method to form different parts configured to join layer 2 and layer 3 together.

[0086] More precisely, different portions of the adhesive layer 11 are arranged so as to be placed on peripheral portions of the first surface of the layer 2 and on corresponding peripheral portions of the second surface of the layer 3 .

[0087] The portion 26 of the layers 2 and 3 thus assembled forms a first space which is defined in this case by:

[0088] - laterally, it is defined on the one hand by a portion of the first surface of layer 2 and on the other hand by a portion of the second surface of layer 3, so that the first surface of layer 2 and the second surface of layer 3 form an inner surface,

[0089] - longitudinally, on the side of the longitudinal end 21, by the portion 41 of the adhesive layer 11,

[0090] - laterally, by sections of the portion 41 of the adhesive layer 11 .

[0091] Similarly, the portion 27 of layers 2 and 3 thus assembled forms a second space defined by:

[0092] - laterally, defined by a portion of the inner surface of layers 2 and 3,

[0093] - longitudinally, on the side of the longitudinal end 22, by the portion 42 of the adhesive layer 11,

[0094] - laterally, by sections of the portion 42 of the adhesive layer 11 and by further portions 43 .

[0095] When the covering 1 is in the initial state, the layers 2 and 3 are pressed together so that the first space and the second space formed by the layers 2 and 3 have a dimension or thickness along D2, which is very small or zero in some places. In this example, in the initial state, the entire inner surface of the layer 3 faces the inner surface of the layer 2, and the inner surface of the layer 2 faces the entire inner surface of the layer 3.

[0096] Layer 3 is more susceptible to deformation than layer 2, especially considering the respective thickness of these layers and their respective materials. In this case, the deformability of layer 2 is negligible relative to layer 3.

[0097] We will now describe Figure 1 ]The structure of the other layers of the covering 1 in FIG.

[0098] The geometry of layer 5 is roughly equivalent to the geometry of layer 2. The following describes layer 5 only in terms of its differences relative to layer 2. Figure 2 ] applies by analogy.

[0099] In this example, layer 5 is a silicone adhesive layer having a thickness of about 180 μm.

[0100] The adhesive layer 5 is arranged against (and thereby bonded to) the second surface of the layer 2 forming the outer surface of the layer 2 to form an adhesive cover.

[0101] The geometry of layer 6 is substantially identical to the geometry of a portion of layer 2, including region 23 and portions 26 and 27 of layer 2 including openings 28 and 29 (see Figure 1 and Figure 2 ) section.

[0102] In this particular example, layer 6 is made of polyethylene terephthalate and has a thickness of about 23 μm.

[0103] Layer 6 is placed against (and thereby bonded to) the second surface of adhesive layer 5 such that the openings 28 and 29 formed in each of layers 2, 5 and 6 overlap.

[0104] Layer 6 thus forms a covering layer constituting longitudinally non-adhesive areas at areas 23 and openings 28 and 29 in layer 2. Unlike layer 7 present underneath, which is a peel-off protective layer, layer 6 is intended to remain on the covering during use.

[0105] Layer 7 comprises two portions 8 and 9 , the geometry of which is substantially identical to the geometry of portions 26 and 27 of layer 2 .

[0106] In this example, the portions 8 and 9 of the layer 7 are each made of low-density polyethylene and have a thickness of about 50 μm.

[0107] The portion 9 of the layer 7 comprises a cut which is equivalent to the long cut 30 in the layer 2. However, the layer 7 does not comprise an opening such as the openings 28 and 29 in the layer 2.

[0108] Layer 7 is arranged to abut against the second surfaces of adhesive layer 5 and layer 6, resulting in the first surface of portion 8 of layer 7 being joined to a portion of the second surface of portion 26 of adhesive layer 5, and the first surface of portion 9 of layer 7 being joined to a portion of the second surface of portion 27 of adhesive layer 5.

[0109] The layer 7 forms a protective film which is intended to be removed during use of the cover 1 in order to join the cover 1 (see below).

[0110] When the layers 2, 3, 5, 6, 7 and 11 are assembled as described above, the openings 28 formed in the layers 2, 5 and 6 are aligned with each other to form together a common opening 28 through these different layers. Similarly, the openings 29 formed in the layers 2, 5 and 6 are aligned with each other to form together a common opening 28 through these different layers. In addition, the cutouts 30 formed in the layers 2, 5 and 7 are also aligned with each other so that these cutouts together form a common cutout 30 through these different layers.

[0111] The geometry of layer 4 is also roughly equivalent to that of layer 2 .

[0112] In this example, layer 4 is also made of non-woven polypropylene and has a thickness of 410 μm.

[0113] Layer 4 differs from layer 2 in that layer 4 lacks openings such as openings 28 and 29 in layer 2 and lacks cutouts such as cutout 30 in layer 2 .

[0114] The layer 12 is an adhesive layer composed of two parts 13 and 14 arranged against the first surface of the layer 3 so as to be bonded thereto.

[0115] In particular, the portion 13 is arranged to form a joining region at a longitudinal end 21 of the layer 3 and the portion 14 is configured to form a joining region at a longitudinal end 22 of the layer 3 .

[0116] In this example, a protective film (not shown) of the same type as the protective film 7 covers the first surface of the portion 13 of the adhesive layer 12 , which protective film is also intended to be removed when the cover 1 is in use (see below).

[0117] In this example, the second surface of layer 4 is arranged to abut against the first surfaces of layers 12 and 3 and the protective film covering the first surface of portion 13 of adhesive layer 12, resulting in only the second longitudinal end of layer 4 being joined to the second longitudinal end of layer 3 via portion 14 of adhesive layer 12. Since portion 13 of adhesive layer 12 is provided with the protective film, portion 13 of adhesive layer 12 is not bonded to the first longitudinal end of layer 4.

[0118] In the initial state, this assembly of the layers of the cover 1 results in a total thickness thereof of about 1.3 mm, ie including the peel protection, which is still very small compared to the longitudinal and lateral dimensions of the cover 1 .

[0119] Such a cover 1 is preferably manufactured by unwinding a film roll (not shown) to form one of the layers described above with each of these films. In other words, the cover 1 of the invention can be manufactured using a "roll-to-roll" method, which is a known manufacturing technology per se, enabling such a cover to be mass-produced at very high speed and low cost.

[0120] In this example, [ Figure 1 ] The cover 1 shown is used to receive a device, such as Figure 4 and Figure 5 The device 50 shown in FIG.

[0121] The device 50 used here as a non-limiting example is a medical thermometry device for measuring the core temperature of an individual in a non-invasive manner. Document WO 2020 / 249665 A1 discloses an exemplary embodiment of a similar device.

[0122] Reference Figure 4 and Figure 5 , the device 50 is in the form of a web 51 extending along a direction D1 and a housing 52 including, in particular, electronic components (not shown) and a battery (not shown). The web 51 includes a portion 53 extending longitudinally on one side of the housing 52, and a portion 54 extending longitudinally on the other side of the housing 52.

[0123] The fabric 51 and the shell 52 are here overmolded in an envelope of flexible silicone type material, allowing the fabric 51 to deform, in particular when rotated about an axis parallel to the direction D3 .

[0124] In this example, the device 50 comprises seven sensors 55 carried by a portion 53 of a fabric 51 and comprising measuring ends appearing transversely on a first face of the fabric 51 (see [ Figure 5 ]). The device 50 also comprises a sensor 56, which is also carried by the portion 53 of the fabric 51, said sensor 56 comprising a measuring end which appears transversely on the second side of the fabric 51 (see [ Figure 4 ]). The device 50 also includes a sensor 57 carried by the housing 52, the sensor 57 emerging laterally from the housing from the same side as the sensor 56 (see [ Figure 4 ]).

[0125] In this example, sensor 55 is used to measure skin temperature, sensor 56 is used to measure the temperature within the cavity formed by the individual's armpit, and sensor 57 is used to measure ambient temperature.

[0126] The device 50 may also include other sensors not depicted, such as one or more temperature sensors, optical volume scanning marker sensors, and / or one or more motion sensors.

[0127] In this example, the device 50 also comprises means for recording the measurement data provided by such sensors, as well as communication means, for example wireless communication means, enabling such data to be transmitted to a remote computer terminal.

[0128] In this particular example, the thicknesses of the fabric 51 and the housing 52 (ie the dimensions along the direction D2) are approximately 4 mm and 15 mm respectively, and the overall mass of the device 50 is 60 to 70 grams.

[0129] Reference Figures 1 to 5 , the dimensions of the cover 1 and the device 50 respectively allow:

[0130] - the portion 54 of the fabric 51 of the device 50 is introduced into said first space of the covering 1 through the opening 28 through the layers 2 , 5 and 6 of the covering 1 , and

[0131] - the portion 53 of the fabric 51 of the device 50 is inserted into said second space of the cover 1 through the opening 29 through the layers 2 , 5 and 6 of the cover 1 ,

[0132] The sensor 55 of the device 50 is [ Figure 1 ] laterally downwardly through the layers 2, 5 and 7 of the cover emerge from the cover 1 through the cutout 30, and so that the sensor 56 is in [ Figure 1 ] emerges from the covering 1 laterally upwards through the cut 31 in the layer 3 of the covering 1.

[0133] In this example, the cover 1 thus forms a receiving space for the device 50 , said receiving space being composed of said first and second spaces described above.

[0134] When the device 50 is inserted into the cover 1, the cover 1 is transferred from the initial state described above (in which layers 2 and 3 are pressed against each other) to the so-called use state (in which the volume of the receiving space increases due to the deformation of layers 2 and 3 under the effect of inserting the device 50 into the cover 1).

[0135] In this configuration, the housing 52 of the device 50 is positioned on the second surface of the layer 6, which prevents the device 50 from being contaminated by the adhesive of the layer 5. The sensor 57 is in [ Figure 1 ] is oriented laterally upward, i.e. directly adjacent to the recess 23 of layer 3.

[0136] In the application described herein by way of non-limiting example, the assembly consisting of the cover 1 and the device 50 inserted therein is placed on the skin surface of the individual's arm after removing the membrane 7 to attach the cover 1 to the skin surface with the adhesive layer 5.

[0137] The device is mounted so that sensor 55 of device 50 is in direct contact with the skin of the arm, and so that sensor 56 is positioned near the individual's armpit.

[0138] In this example, layer 4 of cover 1 is used as an additional attachment means to form a cuff to improve the retention of device 50 in place on the individual's arm. Once cover 1 has been joined with adhesive layer 5, layer 4 is oriented around the arm to join the longitudinal end 21 of the first surface of layer 4 to the portion 13 of adhesive layer 12 that was initially provided with a protective layer or "pad".

[0139] Since the layer 4 is folded onto itself in a given manner at its longitudinal ends 22, this connection is subject to peeling stresses in use and is liable to fall off in the event of excessive tightening. This is not a problem since the function of the layer 4, when present, is essentially to "finish" the outer edge and prevent the very edge of the covering from getting caught and causing the covering to peel off. The inventors have found that when the cylinder on which the covering is placed expands, in particular due to the action of muscles (e.g. contraction of the biceps), the adhesive nevertheless remains sufficiently resistant.

[0140] However, in some cases the diameter of the limb can change significantly. This is the case with some patients in hospitals who suffer from cardiovascular collapse. To compensate for the low blood pressure, practitioners can superperfuse them, i.e. increase the arterial and venous pressure by sending large amounts of saline through the vascular system. This causes fluid to enter the extracellular space. The body then swells with water and the diameter of the arm may change significantly, for example by 1 cm. Of course, this expansion can last for a long time. The inventors were surprised to find that in this case the connection could partially fail. The design of the connection then acts as a kind of disconnection protector, allowing some of the tension to be released by peeling off. For example, if the length of the connection on the axis of the covering is 25 mm, it will be able to release a diameter length of nearly 50 mm before loosening, which is very important in the described situation. In [ Figure 1 ], layer 2 behaves very differently from layer 3. Layer 2 is of course thicker, but most importantly, this layer introduces deformations by elongation of layer 3 once it has been formed, for example, into a cylinder along a transverse axis.

[0141] The inventors sought a way to characterize this phenomenon and focused on the concept of a "hand" used herein to compare their behaviors.

[0142] In general, the hand of a layer depends primarily on the thickness and density of the layer, as well as the orientation of the fibers and any calendering effects.

[0143] For a layer such as a conventional paper comprising vegetable fibers, the hand can be expressed as the ratio between the thickness of the paper and its grammage. However, for structures such as layers 2 and 3 of the covering 1 of the invention, which in this example comprise a nonwoven material comprising plastic fibers, this approximation neither provides a sufficiently reliable representation of the material behavior nor allows a practical comparison.

[0144] The inventors then turned their attention to the concept of "drape" defined in the standard "ISO 9073-9:2008", which represents the ability of the tested textile to deform under its own weight. This concept is widely used to compare the "droop" of textile pieces, but it is too restrictive in this case because once the cover 1 is placed on the human body, the tension present in the cover 1 is much greater than the tension of the drape.

[0145] The inventors therefore propose a new method for characterizing the behavior of layers 2 and 3, designed to take into account the actual stresses in layers 2 and 3 during use of cover 1. With this method, we measure the mass that triggers the collapse of cylinder 60 (see [ Figure 6 ]), the cylinder 60 is formed by winding the materials used to form these layers. It is suggested to call this parameter "cylindrical strength".

[0146] In an example of how to implement this method, such as [ Figure 6 ], a cylinder 60 is formed by winding a layer of material twice to form a cylinder 60 with a diameter X8 of 40 mm and a length X9 of 38 mm. The cylinder 60 or roll thus formed is maintained in this form by means of a double-sided adhesive (in this example with a width of 10 mm extending along the entire length X9 of the cylinder 60) to attach the free end of the layer of material forming the cylinder to the surface formed by one turn of the cylinder 60. Rigid plastic discs 61 with a thickness X10 equal to 6 mm are concentrically assembled, each disc 61 comprising an inner section 62 with a diameter X11 of 39 mm and an outer section 63 with a diameter X12 of 50 mm, and the outer section 63 forms a shoulder relative to the inner section 62. [ Figure 6 ], one of the pans 61 shown below, called the "lower pan", is placed on a scale pan 65, on which the cylinder 60 is arranged so that the inner section 62 of the lower pan 61 extends radially at one end into the cylinder 60, which rests on a shoulder formed by the outer section 63 of the lower pan 61. The scale is tare-zeroed with the cylinder 60 and the lower pan 61 thus arranged on the pan 65. [ Figure 6 ] The other plate 61 shown above is called the "upper plate", which is then symmetrically arranged at the other end of the cylinder 60, as shown in [ Figure 6 This arrangement of the disk 61 relative to the cylinder 60, and in particular the fact that the inner section 62 of the disk 61 is received at the end of the cylinder 60, prevents the end of the cylinder 60 from sliding radially inwards, thereby avoiding premature crushing of the cylinder 60.

[0147] In this configuration, the loading of the cylinder 60 is gradually increased by applying a mechanical force whose major component is a force along the length of the cylinder 60, in this case from top to bottom [ Figure 6 ]. Such a force can be generated by filling a container (not shown) located on the upper plate 61 with liquid, taking care to center the container relative to the cylinder 60. The force is gradually applied to the cylinder 60, for example 20 grams per second, until the cylinder 60 collapses.

[0148] The operation just described is preferably carried out several times, for example five times, with several similar material samples. The cylinder strength value is then the average of the values ​​in the series, for example removing the highest and lowest values ​​first.

[0149] The cover 1 of the invention significantly prevents or reduces the risk of wrinkles forming in the layer 2 and / or prevents the cover 1 from detaching, sliding or even rolling on the skin surface.

[0150] More generally, the cover 1 of the present invention enables a device such as the device 50 to be placed on the surface of the skin and maintains accurate positioning of the device even when the cover 1 and / or the device 50 is affected by the movement of the body. Thus, reliable measurements can be made, for example, continuously over a period of hours or days.

[0151] Of course, numerous modifications may be made to the foregoing description without departing from the scope of protection of the present invention. For example, the cover of the present invention may be configured to receive devices other than the above-described device 50, in particular measuring devices, including other types of sensors, such as thermal sensors, and / or including elements for, for example, diffusing active ingredients in liquid form, such as microneedles, reservoirs and / or micropumps. Furthermore, the cover 1 may be configured to be placed on a body part other than an arm, for example, on the torso or other body part with a high degree of curvature.

[0152] Depending on, in particular, the type of device the cover is intended to receive and the part of the body against which the cover is intended to hold such device, the cover of the present invention may have a configuration similar to that described above with reference to [ Figure 1 ] different from the structural and / or geometric features described herein. For example, the covering may lack [ Figure 1 ] shown in layers 4 and 12, and / or may form a single receiving space, such as [ Figure 7 ] are shown in a non-limiting manner.

[0153] exist[ Figure 7 ] In the embodiment shown in FIG. 1 , the covering 1 and the covering 1 are Figure 1 ] The cover 1 shown in FIG. 1 differs in that it comprises neither the portions 23 and 26 nor the layers 4 and 6 nor the cutout 31 in the layer 3, the layer 7 comprising an opening 29 which is aligned with the other openings 29 so that a device can be inserted into the cover 1 before the layer 7 is removed and the assembly is joined by the adhesive layer 5. The preceding remarks apply by analogy to this embodiment which can be used, for example, to receive a device intended to diffuse an active ingredient through the cutout 30.

[0154] In a variant not shown, the covering is Figure 7 ] differs from the cover of 1 in that it lacks opening 29 and in that the adhesive layer 11 is configured so as not to join layers 2 and 3 to each other at one of the longitudinal ends. To this end, a section of portion 41 of adhesive layer 11 can be removed. Layers 2 and 3 can thus define between them an opening at one longitudinal end of cover 1, consisting of non-joined portions of layers 2 and 3 and allowing the insertion of a device between layers 2 and 3 without the need to make an opening such as opening 29.

[0155] As a further example, materials other than those described above may be used for one or more layers of the covering 1. For example, layer 3 may comprise a plastically deformable material.

[0156] In the various embodiments described, the structure of the covering 1 is a structure formed by stacking layers, which has the advantage that it can be manufactured using a roll-to-roll process. Of course, however, the covering 1 can also be manufactured using other techniques. Other manufacturing techniques can also be used to obtain certain advantages of the covering of the present invention with different structural characteristics. Therefore, by providing a wrinkled layer 3, for example using methods such as tension bonding, stretching the material by force or firing, shrinking the material of layer 2, or using thermoforming, the risk of wrinkles forming in layer 2 can be significantly reduced.

Claims

1. A cover (1) for holding a medical device (50) and / or for measuring physiological data and / or for diffusing an active ingredient and / or for sampling a body fluid near or against the skin surface of an individual, the cover (1) comprising a first layer (2) and a second layer (3), the first layer (2) and the second layer (3) being connected to each other so that when the cover (1) is in an initial state, the first layer (2) and the second layer (3) are pressed against each other, the cover (1) being configured to allow the second layer (3) to deform so that the cover (1) is deformed from the initial state The state is transformed into a use state, in which the first layer (2) and the second layer (3) define a receiving space suitable for receiving the device (50) between the first layer (2) and the second layer (3), the cover (1) includes openings (28, 29), and the openings (28, 29) are configured to allow the device (50) to be inserted into the receiving space, and the first layer (2) includes an outer surface having an adhesive material, and the adhesive material is capable of attaching the cover (1) to the skin surface, for example, a silicone or acrylate adhesive.

2. The covering (1) according to claim 1, wherein the first layer (2) and the second layer (3) each comprise an inner surface and are connected to each other by bonding or welding parts of the inner surfaces of the first layer (2) and the second layer (3).

3. Cover (1) according to claim 1 or 2, wherein the first layer (2) and / or the second layer (3) comprises a non-woven material and / or a fabric, the non-woven material being for example a plastic or an elastomeric material.

4. The covering (1) according to any one of claims 1 to 3, wherein the second layer (3) is stretchable or elastic and / or allows a greater plastic or elastic deformation of the second layer (3) than the first layer (2).

5. The covering (1) according to any one of claims 1 to 4, wherein the thickness of the first layer (2) is greater than the thickness of the second layer (3), for example greater than twice the thickness of the second layer (3), and / or wherein the drape coefficient of the first layer (2) is greater than the drape coefficient of the second layer (3), for example greater than twice the drape coefficient of the second layer (3), and / or wherein the cylindrical strength of the first layer (2) is greater than the cylindrical strength of the second layer (3), for example greater than twice the cylindrical strength of the second layer (3).

6. A covering (1) according to any one of claims 1 to 5, wherein the first layer (2) comprises a cutout (30) which allows a portion (55) of the device (50) to be in direct contact with the skin surface when the device (50) is received in the receiving space.

7. A covering (1) according to any one of claims 1 to 6, comprising a third layer (4), the third layer having a first part connected to the first layer (2) and / or to the second layer (3), and a second part configured to be attached to the skin surface and / or to a part of the covering (1) and / or to a part of the device (50), for example to form a cuff.

8. An assembly comprising a cover (1) according to any one of claims 1 to 7 and a medical device (50) and / or a device for measuring physiological data and / or for diffusing active ingredients and / or for sampling body fluids, such as a medical thermometry device.

9. A method for manufacturing a covering (1) according to any one of claims 1 to 7, comprising the steps of unrolling one or more rolls of film to form the first layer (2) and / or the second layer (3), and assembling the first layer (2) with the second layer (3), the assembling step preferably comprising unrolling one or more rolls of adhesive film, in particular a double-sided adhesive film.

10. A method of applying a covering (1) according to any one of claims 1 to 7 to a skin surface of an individual, comprising the step of applying the first layer (2) to the skin surface.

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