Multi-layered cover to hold a device on a human body

Abstract

A cover (1) intended to hold a device on an individual's body. The cover (1) comprises a stack of layers (2-7, 11, 12) assembled using a roll-to-roll process. Figure for the abstract: Fig. 1

Description

Title of the invention: Multilayer cover for securing a device to a human body technical field

[0001] The invention relates to the field of securing a device to an individual's body. Without limitation, this device may be a medical device and / or a device for measuring physiological data and / or for delivering an active ingredient in liquid form and / or for collecting a bodily fluid.

[0002] By way of example, the device may include electronic components such as sensors or antennas, wired or wireless communication means, data recording and storage means, electromechanical equipment such as micro-pumps, micro-needles or vibrators, organs acting on the body such as pharmacological active ingredient diffusers, with micro-needles or in patch form, or magnets, means for collecting fluid such as blood or perspiration, means for in vitro diagnostics, etc.

[0003] The invention is of particular, but not limited to, interest in the field of patient data for diagnostic support, the device being in particular a thermometry medical device designed to measure body temperature continuously over a period of several hours or days. As such, it may also find applications in the fields of chronotherapeutics and chronopharmacology. Prior art

[0004] A first device fixation technique, known in the prior art, consists of attaching the device to the skin using double-sided adhesive tape. Among other drawbacks, the adhesive from the tape can contaminate the device, requiring cleaning before reuse. Furthermore, this method of attachment does not allow the device to remain attached when a relatively significant force is exerted on it. This can, in particular, facilitate the device's detachment due to movement by the individual in bed.

[0005] A second known technique consists of securing the device with an adhesive film, made of silicone or polyurethane, choosing a film with a generous surface area, wider and longer than the device so as to extensively cover it. The device is typically positioned at a central portion of the film, which is adhered to the skin by peripheral portions. Generally, such an adhesive film contains glue on both the peripheral and central portions, thus resulting in soiling of the device.

[0006] Some adhesive films include an adhesive layer covering only peripheral parts of the film, thus preventing the deposition of adhesive residue on the device. In practice, however, such a film is difficult to apply and tends to generate creases and tension that prevent the device from being held securely, especially when it is relatively heavy and / or bulky. To improve adhesion, such an adhesive film may also require the use of a type and / or quantity of adhesive that could increase skin irritation.

[0007] A third known technique involves housing the device in an elastic sheath or cuff that encircles a limb such as an arm. Known cuffs are generally made by sewing onto a fabric, leather, or elastomer base. They are prone to moving around the limb or sliding along it, making it impossible to hold the device in a precise position on the body. Furthermore, when the device is relatively heavy and / or bulky, it may be necessary to tighten the cuff or sheath considerably around the limb, making wearing it uncomfortable or even unbearable for the individual. This type of technology is also incompatible with securing the device to body parts such as the torso or side. Finally, this type of technology is difficult to industrialize and requires cleaning before reuse. Description of the invention

[0008] The invention aims to provide a solution for maintaining a device on a body in a stable, precise, durable and comfortable manner, while remedying the aforementioned disadvantages.

[0009] A particular object of the invention is to provide a solution for reducing manufacturing costs.

[0010] Another object of the invention is to provide a retention system to simplify the installation of this system and the device it is intended to retain, as well as the various steps associated with the use of this system, particularly in a hospital setting, including the activation of the device in the case of an active device, the visual check of its operating status, the visual check of its correct positioning, the extraction of the device from the cover and / or its removal from the cover.

[0011] To this end, the invention relates to a cover intended to hold a device such as a medical device and / or a device for measuring physiological data and / or for the delivery of an active ingredient, for example in liquid form, and / or for collecting a bodily fluid near, or against, a skin surface of an individual. According to the invention, this cover comprises a first layer and a second layer connected to each other so as to be pressed against each other when the cover is in its initial state, the cover being configured to allow deformation of the second layer taking the cover from the initial state to a state of use in which the first layer and the second layer define between them a receiving space suitable for receiving said device.

[0012] The cover of the invention includes an opening configured to allow the device to be introduced into the receiving space and, where appropriate, to be removed from this receiving space.

[0013] The first layer comprises an external surface provided with an adhesive material such as silicone or acrylate glue allowing the cover to be fixed to said skin surface.

[0014] The invention thus provides a cover which has a relatively simple overall configuration, namely two layers initially pressed against each other, while allowing the device to be held in position in a stable, precise and durable manner.

[0015] The layered structure makes it possible on the one hand to simplify and reduce the manufacturing costs of the cover and, on the other hand, to make it disposable in order to improve compliance with hygiene standards and reduce management constraints, particularly in a hospital setting.

[0016] The cover of the invention can in particular be used to hold a device against or near a skin surface of different parts of the body, for example a part such as the torso having a large radius of curvature, or such as an arm or other limb.

[0017] Said receiving space and said opening allow the device to be housed in the cover in a removable manner and to be held in position without gluing, which makes it possible both not to soil the device and to reduce the risk of tearing.

[0018] In one embodiment, the first layer and the second layer each comprise an internal surface and are connected to each other by gluing or welding parts of their internal surface.

[0019] In one embodiment, the first layer and / or the second layer comprise a non-woven material.

[0020] The term “nonwoven” is used here in a very broad sense and includes all lightweight and thin materials that can be supplied in rolls.

[0021] These materials have the advantage of generally being inexpensive and also of being transformable in an online process allowing a functionally interesting product to be obtained while being sufficiently economically optimized to be disposable.

[0022] The preferred material is nonwoven in the proper sense, that is to say according to the ISO 9092 definition, a material consisting of randomly or directionally oriented fibers, consolidated and bonded by friction, and / or cohesion and / or adhesion.

[0023] The fibers used may be natural such as wool, hemp, cotton, cellulose, mineral fibers such as glass or ceramic fibers, but in industry we mainly find non-wovens whose fibers are made of plastic materials, with many variants: polypropylene fibers, polyethylene, polyester, polyvinyl chloride, etc.

[0024] Paper is another material included in the definition of nonwoven fabric in this document. Although the bonds between the cellulose fibers differ between paper production processes and nonwoven processes in the strict sense, the process is very similar and its behavior can be incorporated into the manufacture of diapers according to the invention.

[0025] Similarly, films cast, blown, or extruded from polymers are also included in the definition of nonwovens according to the invention because their behavior can be relevant to the manufacture of certain layers according to the invention. In particular, this category includes elastomeric films that can impart a certain elasticity to the material, which may be advantageous, especially for the first layer.

[0026] Finally, certain lightweight textiles can be functionally incorporated into the design of the cover of the invention, and also be compatible with the price objectives. In particular, the possibility of using woven sails or lightweight fabrics is noted. These can be used for both the first and second layers, but they generally have a low bulk and will therefore be used preferentially for the second layer rather than the first. They can also have interesting elasticity characteristics, which is particularly advantageous for the second layer.

[0027] In one embodiment, the first layer and / or the second layer may comprise a non-woven material, as defined in ISO 9092, or a plastic or elastomer material.

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

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

[0030] More generally, the first layer and the second layer may be made of the same material or of different materials. Thus, by way of non-limiting example, the first layer may comprise a first material such as a textile material and the second layer may comprise a second material such as an elastomeric material. As another example, the first and second layers may both comprise a plastic material, for example, polypropylene for the first layer and polyurethane for the second. second layer.

[0031] The use of nonwoven materials, in the broad sense defined above, makes it possible in particular to manufacture a light, economical cover, compatible with a manufacturing process by unwinding rolls of material, of the "roll to roll" type (see further below), to simplify the gluing / welding of the different layers and thus to achieve a cost price compatible with considering the cover as disposable.

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

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

[0034] Regardless of the respective material of the first and second layers, it is preferred that the cover allow a greater plastic or elastic deformation of the second layer than of the first layer.

[0035] Such a feature makes it possible in particular to reduce the risk of crease formation in the first layer and to improve the fit of the cover on the skin surface.

[0036] The cover of the invention can have many dimensional and geometric characteristics.

[0037] By way of non-limitation, the first layer may have a greater thickness, for example more than twice the thickness of the second layer.

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

[0039] Such characteristics, a fortiori when combined with each other and / or with the aforementioned characteristic of relative plastic / elastic deformation of the two layers, make it possible to improve the fit of the cover on the skin surface as well as the holding of the device in position.

[0040] By way of exception, when the cover is in its initial state, the first layer may have a length greater than its width, preferably more than three times its width. For example, the length of the first layer may be between 30 mm and 800 mm, preferably between 60 mm and 400 mm.

[0041] In one embodiment, the first layer includes a cutout allowing direct contact of a part of the device with the skin surface when the device is received in the receiving space.

[0042] Such a cut allows in particular direct contact of parts or elements of the device, such as micro-needles or optical sensors, with the skin and / or allows not to block perspiration.

[0043] As an indication, the cutout can have a dimension of up to 70% of the total surface area of ​​the first layer, while still retaining a sufficient bonding area.

[0044] In one embodiment, the cover includes a third layer having a first part connected to the first layer and / or the second layer and a second part configured to be glued to said skin surface and / or to a part of the cover and / or to a part of the device, for example so as to form an armband.

[0045] In one embodiment, the first layer and / or the second layer comprise an internal surface coated with an adjuvant material such as an oil, polytetrafluoroethylene, talc or a nanoparticle powder, so as to reduce the slippage of the device when it is received in the receiving space of the cover.

[0046] The invention also relates to 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 an active ingredient and / or for collecting a body fluid.

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

[0048] More generally, the device may integrate electronic components such as sensors or antennas, wired or wireless communication means, data recording and storage means, electromechanical equipment such as micro-pumps, micro-needles or vibrators, organs acting on the body such as pharmacological active ingredient diffusers, with micro-needles or in patch form, or magnets, in vitro diagnostic means, means for capturing data and / or analyzing body fluids, etc.

[0049] The invention also relates to a method for manufacturing a cover as defined above.

[0050] The process preferably includes a step of unwinding one or more reels of film so as to form the first layer and / or the second layer and a step of assembling the first layer with the second layer.

[0051] Such a process, known as "roll-to-roll", makes it possible to manufacture covers according to the invention at a high rate, the speed of unwinding the film reels typically being on the order of one meter per second.

[0052] Such a process more generally makes it possible to reduce manufacturing costs.

[0053] In one embodiment, the assembly step includes a sequence of or several rolls of adhesive film, including double-sided adhesive film.

[0054] Furthermore, the invention also relates to a method of applying and / or fixing a cover as defined above on a skin surface of an individual.

[0055] This process includes a step of applying the first layer to the skin surface.

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

[0057] The insertion is preferably carried out before the cover is attached to the skin surface, in order to facilitate insertion of the device into the cover. Of course, the device can alternatively be inserted after the cover has been glued to the skin surface.

[0058] Other advantages and features of the invention will become apparent from the following detailed, non-limiting description. Brief description of the drawings

[0059] The following detailed description refers to the attached drawings on which:

[0060] [Fig-1] is a schematic, perspective and exploded view of a cover conforming to a first embodiment of the invention;

[0061] [Fig.2] is a schematic top view of a first layer of the cover of the [Fig.l];

[0062] [Fig.3] is a schematic top view of a second layer of the cover of the cover of the [Fig.l];

[0063] [Fig.4] is a schematic top view of a device intended to be housed in the cover of the [Fig.l];

[0064] [Fig.5] is a schematic view from below of the device of [Fig.4];

[0065] [Fig.6] is a schematic cross-sectional view of a cylinder of material and a tooling allowing the resistance of the cylinder to be tested;

[0066] [Fig.7] is a schematic, perspective and exploded view of a cover conforming to a second embodiment of the invention. Detailed description of implementation methods

[0067] The figures include a reference frame defining a longitudinal direction D1, a transverse direction D2 and a lateral direction D3 orthogonal to each other.

[0068] It is shown in [Fig.1], exploded view, different layers forming a cover 1 according to the invention.

[0069] In this document, a layer refers to a structure having a small thickness compared to its surface area.

[0070] With reference to [Fig. 1], each of the layers of the cover 1 comprises two surfaces spaced along the direction D2, one of these surfaces, called the "first surface", being visible in [Fig.1], the other surface of each of the layers, called the "second surface", is not visible in [Fig.1]. For each of the layers, the distance along D2 between the first surface and the second surface defines the thickness of that layer.

[0071] In this embodiment, which is not limiting, the cover 1 more specifically comprises the layers referenced 2 to 7, 1 and 12 which are stacked along the direction D2.

[0072] With reference to [Fig.2] which shows layer 2 separately, this layer 2 has an overall rectangular shape and is elongated along the direction Dl.

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

[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, i.e., 25 mm in this case, constituting a rounded end 21. End 22, on the other hand, has rounded corners which, in this example, each have a radius of 15 mm.

[0075] The width of layer 2 is substantially constant along Dl, between the ends 21 and 22, except for a region 23 of layer 2 which has a reduced width. This reduction in width is achieved by means of semi-circular cutouts 24, positioned at a longitudinal distance X3 from the end 22. In this example, X3 is approximately 190 mm.

[0076] Layer 2 thus comprises two parts 26 and 27 which extend longitudinally on either side of region 23.

[0077] Layer 2 also includes two openings 28 and 29 made respectively in parts 26 and 27, longitudinally near region 23.

[0078] The openings 28 and 29 are made in the form of slots extending laterally over a large part of the width of the layer 2, so as to present a lateral dimension X4 which corresponds substantially to the width of the region 23. In this example, X4 is approximately equal to 33 mm.

[0079] Part 27 of layer 2 also includes an oblong cutout 30 extending longitudinally. In this example, the cutout 30 has a length X5 of approximately 70 mm and a width X6 of approximately 11 mm over most of its length, the cutout 30 having a central part with a slightly greater width X7, in this example a width X7 of approximately 13 mm.

[0080] With reference to [Fig.3], layer 3 has an overall geometry identical to that of layer 2. Layer 3 is described below only in terms of its differences from layer 2, the preceding description applying by analogy.

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

[0082] This material makes it possible to give layer 3 elastic properties.

[0083] Layer 3 does not include openings such as openings 28 and 29 of the layer 2, nor a cutout such as the oblong cutout 30 of layer 2.

[0084] Part 27 of layer 3 however includes a cutout 31 whose position and dimensions correspond substantially to those of said central part of the cutout 30 of layer 2.

[0085] With reference to [Fig. 1], layer 11 is a layer of double-sided adhesive film which has undergone cuts during the process in order to form different parts configured to connect layers 2 and 3 to each other.

[0086] More specifically, the different parts of the glue layer 11 are arranged so as to be positioned on a peripheral part of the first surface of the layer 2 and on a corresponding peripheral part of the second surface of the layer 3.

[0087] Part 26 of layers 2 and 3 thus assembled forms a first space which is in this case delimited: - transversely, on the one hand, by a part of the first surface of layer 2 and, on the other hand, by a part of the second surface of layer 3, the first surface of layer 2 and the second surface of layer 3 thus forming internal surfaces, - longitudinally on the side of the longitudinal end 21, by a part 41 of the adhesive layer 11, - laterally, by portions of part 41 of the glue layer 11.

[0088] Similarly, part 27 of layers 2 and 3 thus assembled forms a second delimited space: - transversely, through a portion of the internal surfaces of layers 2 and 3, - longitudinally on the side of the longitudinal end 22, by a part 42 of the adhesive layer 11, - laterally, by portions of part 42 and by other parts 43 of the glue layer 11.

[0089] When the cover 1 is in its initial state, layers 2 and 3 are pressed against each other such that the first and second spaces they form have a dimension along D2, or thickness, that is very small or zero in places. In this example, in the initial state, the entire internal surface of layer 3 is aligned with the internal surface of layer 2 and vice versa.

[0090] Layer 3 is likely to be deformed more significantly than layer 2, particularly given the respective thicknesses of these layers and their respective material. In this case, the deformability of layer 2 is negligible compared to layer 3.

[0091] The structure of the other layers of cover 1 of [Fig. 1] will now be described

[0092] Layer 5 has an overall geometry identical to that of layer 2. Layer 5 is described below only in terms of its differences from layer 2, the previous description of [Fig.2] applying by analogy.

[0093] In this example, layer 5 is a silicone adhesive layer having a thickness of approximately 180 pm.

[0094] The glue layer 5 is disposed against, and therefore glued to, the second surface of layer 2 which forms an external surface of layer 2, so as to constitute an adhesive coating.

[0095] Layer 6 has a geometry that is generally identical to a part of layer 2, this part including region 23 of layer 2 and a portion of parts 26 and 27 including openings 28 and 29 (see figures 1 and 2).

[0096] In this particular example, layer 6 is made of polyethylene terephthalate and has a thickness of approximately 23 pm.

[0097] Layer 6 is positioned against, and therefore glued to, the second surface of the glue layer 5 so as to make the openings 28 and 29 made in each of the layers 2, 5 and 6 coincide.

[0098] Layer 6 thus forms a coating enabling the formation of a non-adhesive zone longitudinally at the level of region 23 and the openings 28 and 29 of layer 2. Unlike layer 7 shown below, which is a peelable protector, layer 6 is intended to be left on the cover during use.

[0099] Layer 7 comprises two parts 8 and 9 having an overall geometry identical to parts 26 and 27 of layer 2.

[0100] In this example, each of parts 8 and 9 of layer 7 is made of low-density polyethylene and has a thickness of approximately 50 pm.

[0101] Part 9 of layer 7 includes a cutout identical to the oblong cutout 30 of layer 2. However, layer 7 does not include openings such as openings 28 and 29 of layer 2.

[0102] Layer 7 is disposed against the second surface of the glue layer 5 and layer 6, resulting in the first surface of part 8 of layer 7 being glued to a part of the second surface of part 26 of the glue layer 5 and the first surface of part 9 of layer 7 being glued to a part of the second surface of part 27 of the glue layer 5.

[0103] Layer 7 forms a protective film intended to be removed to glue the cover 1 in place during its use (see further below).

[0104] When layers 2, 3, 5, 6, 7, and 11 are assembled as described above, the openings 28 made in layers 2, 5, and 6 are aligned with each other so as to form a common opening 28 passing through these different layers. Similarly, the openings 29 made in layers 2, 5, and 6 are aligned with each other so as to form a common opening 28 passing through these different layers. Furthermore, the cutouts 30 made in layers 2, 5, and 7 are also aligned with each other so as to form a common cutout 30 passing through these different layers.

[0105] Regarding layer 4, it also has an overall geometry identical to that of layer 2.

[0106] In this example, layer 4 is also made of polypropylene nonwoven and has a thickness of 410 pm.

[0107] Layer 4 differs from layer 2 in that it lacks openings such as openings 28 and 29 of layer 2 and a cutout such as cutout 30 of layer 2.

[0108] The layer 12 is a layer of glue formed of two parts 13 and 14 arranged against, and therefore glued to, the first surface of the layer 3.

[0109] In particular, part 13 is configured to form a bonding zone at the longitudinal end 21 of layer 3, part 14 being configured to form a bonding zone at the longitudinal end 22 of layer 3.

[0110] In this example, part 13 of the glue layer 12 is covered on its first surface with a protective film (not shown) of the same type as the protective film 7 and also intended to be removed when using the cover 1 (see further below).

[0111] In this example, the second surface of layer 4 is positioned against the first surface of layers 12 and 3 and the protective film covering the first surface of part 13 of the adhesive layer 12, resulting in only the second longitudinal end of layer 4 being bonded to the second longitudinal end of layer 3 via part 14 of the adhesive layer 12. Since part 13 of the adhesive layer 12 is provided with the protective film, it does not adhere to the first longitudinal end of layer 4.

[0112] In the initial state, such an assembly of the different layers of the cover 1 gives it a total thickness of the order of 1.3 mm, that is to say a total thickness including the peelable protections which remains small in relation to the longitudinal and lateral dimensions of the cover 1.

[0113] Such a cover 1 is preferably manufactured by unwinding film reels (not shown) so as to form, with each of these films, one of the respective layers described above. In other words, the cover 1 of the invention can be manufactured using a roll-to-roll process, which is a manufacturing technique known in itself allowing such covers to be produced in series at a very high rate and low cost.

[0114] In this example, the cover 1 of [Fig.1] is intended to receive a device, such as the device 50 shown in Figures 4 and 5.

[0115] Device 50, taken here as a non-limiting example, is a medical thermometry device intended to measure an individual's core temperature non-invasively. Document WO 2020 / 249665 A1 describes examples of embodiments of a similar device.

[0116] With reference to Figures 4 and 5, the device 50 is in the form of a ribbon cable 51 extending along the DI direction and a housing 52 incorporating, in particular, electronic components (not shown) and a battery (not shown). The ribbon cable 51 comprises a portion 53 extending longitudinally from one side of the housing 52 and a portion 54 extending longitudinally from the other side of the housing 52.

[0117] The ribbon cable 51 and the housing 52 are here overmolded in a flexible silicone-type material envelope, allowing deformation of the ribbon cable 51, in particular in rotation around an axis parallel to the direction D3.

[0118] In this example, the device 50 comprises seven sensors 55 carried by the portion 53 of the ribbon cable 51 and having a measuring end opening transversely onto a first face of the ribbon cable 51 (see [Fig. 5]). The device 50 also comprises a sensor 56, also carried by the portion 53 of the ribbon cable 51, having a measuring end opening transversely onto a second face of the ribbon cable 51 (see [Fig. 4]). The device 50 further comprises a sensor 57 carried by the housing 52 and opening transversely from the housing on the same side as the sensor 56 (see [Fig. 4]).

[0119] In this example, the sensors 55 are intended to measure a skin temperature, the sensor 56 is intended to measure a temperature in a cavity formed by an armpit of the individual and the sensor 57 is intended to measure an ambient temperature.

[0120] The device 50 may also include other sensors, not described, for example one or more temperature sensors, photoplethysmography and / or one or more motion sensors.

[0121] In this example, the device 50 also includes means for recording measurement data provided by such sensors and means for communication, for example wireless, enabling the transfer of such data to a remote computer terminal.

[0122] In this particular example, the ribbon 51 and the housing 52 have a thickness, that is to say a dimension along the direction D2, of about 4 mm and 15 mm, respectively, the device 50 having a total mass between 60 and 70 grams.

[0123] With reference to Figures 1 to 5, the cover 1 and the device 50 are respectively di- mentioned to allow: - the introduction of part 54 of layer 51 of device 50 into said first space of cover 1 via the opening 28 passing through layers 2, 5 and 6 of cover 1, and - the introduction of part 53 of the sheet 51 of the device 50 into said second space of the cover 1 via the opening 29 through the layers 2, 5 and 6 of the cover 1,

[0124] so that the sensors 55 of the device 50 emerge from the cover 1 through the cut 30 through the layers 2, 5 and 7 of the cover 1, transversely towards the bottom of the [Fig.1], and so that the sensor 56 emerges from the cover 1 through the cut 31 of the layer 3 of the cover 1, transversely towards the top of the [Fig.1].

[0125] In this example, the cover 1 thus forms a receiving space for the device 50 consisting of the said first space and second space described above.

[0126] When the device 50 is introduced into the cover 1, the cover 1 goes from the initial state described above in which layers 2 and 3 are pressed against each other, to a so-called state of use in which the volume of the receiving space is increased by deformation of layers 2 and 3, under the action of the introduction of the device 50 into the cover 1.

[0127] 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 with the glue from the layer 5. The sensor 57 is oriented transversely towards the top of the [Fig.1], that is to say, it is in direct proximity to the notch 23 of the layer 3.

[0128] In the application described here by way of non-limiting example, the assembly consisting of the cover 1 and the device 50 thus introduced into the cover 1 is placed on a skin surface of an arm of the individual, after removal of the film 7, so as to fix the cover 1 on this skin surface with the layer of glue 5.

[0129] The application is carried out so that the sensors 55 of the device 50 come into direct contact with the skin of the arm and so that the sensor 56 is positioned in the vicinity of the individual's armpit.

[0130] In this example, layer 4 of the cover 1 is used as an additional fastening means to form a cuff, in order to improve the retention of the device 50 in position on the individual's arm. After the cover 1 is bonded by the adhesive layer 5, layer 4 is oriented so as to go around the arm to bond the longitudinal end 21 of the first surface of layer 4 to the part 13 of the adhesive layer 12, which is initially provided with a protector or "liner".

[0131] Since layer 4 is folded back on itself at its longitudinal end 22, this bonding, in use, is subjected to peeling and is therefore liable to detach in the event of overstress. This does not pose a problem since the function of layer 4, when present, is essentially to "finish" the perimeter and to prevent an extreme edge of the cover from snagging and causing the cover to tear. The inventors observed that when a cylinder on which the cover is placed expands, particularly due to muscular effort (such as biceps contraction), the adhesive still holds sufficiently.

[0132] There are, however, situations where very significant changes in limb diameter occur. These involve certain hospitalized patients suffering from cardiovascular system failure. To compensate for low blood pressure, practitioners may hyperperfuse them, that is, administer a large quantity of saline solution into the vascular system to increase arterial and venous pressure. This results in the passage of this fluid into the extracellular space. The body then becomes swollen with water, and the arm diameter can change significantly, for example, by 1 cm. This dilation, of course, lasts for a long time. The inventors were surprised to find that in this situation, the adhesive can partially fail. The adhesive design then acts as a kind of fuse, allowing some of the tension to be released through peeling.If the bond is, for example, 25 mm long along the axis of the cover, it can thus release almost 50 mm in diameter before releasing, which is very significant compared to the situation described. In the example of [Fig. 1], layer 2 behaves very differently from layer 3. Layer 2 is indeed thicker, but more importantly, it is layer 2 which, once shaped, for example, into a cylinder along a transverse axis, induces the deformation by elongation of layer 3.

[0133] The inventors sought ways to characterize this phenomenon and were interested in the notion of "hand" used here to compare their behavior.

[0134] Generally speaking, the hand of a layer depends mainly on the thickness and density of that layer, as well as the direction of the fibers and possible calendering effects.

[0135] For a layer such as a conventional sheet of paper comprising plant fibers, the hand can be expressed as the ratio between the thickness of the sheet and its basis weight. However, with regard to a structure such as layers 2 and 3 of the cover 1 of the invention, which in this example comprise a non-woven material containing plastic fibers, this approximation does not provide a sufficiently reliable representation of the material's behavior and does not allow for realistic comparison.

[0136] The inventors then became interested in the concept of "drape," defined in the standard "ISO 9073-9:2008," drape expressing the ability of a fabric test specimen to deform under its own weight. This concept, widely used to compare the "fall" of fabrics, is nevertheless too limiting in this case, since the tensions present in the cover 1 once placed on the body can be incomparably more significant. load-bearing than the tensions present in a drape.

[0137] The inventors thus propose a new method for characterizing the behavior of layers 2 and 3, designed to take into account their actual stresses during the use of the cover 1. With this method, the mass that triggers the sagging of a cylinder 60 (see [Fig. 6]) formed by winding the material used to create these layers is measured. It is proposed here to call this parameter "cylindrical resistance".

[0138] In an example of implementation of this method, illustrated in [Fig.6], the cylinder 60 is formed by winding a layer of material in two turns so as to form a cylinder 60 having a diameter X8 of 40 mm and a length X9 of 38 mm. The cylinder 60 or roll thus formed is held in this form by means of a double-sided adhesive having in this example a width of 10 mm and extending over the entire length X9 of the cylinder 60 so as to fix a free end of the layer of material forming the cylinder to a surface formed by one of the turns of this cylinder 60. Rigid plastic discs 61 of thickness X10 equal to 6 mm are assembled concentrically, each disc 61 comprising an inner portion 62 having a diameter XI1 of 39 mm and an outer portion 63 having a diameter X12 of 50 mm and forming a shoulder relative to the inner portion 62. One of the discs 61, shown at the bottom of the [Fig.6] and called the "lower disc", is placed on a pan 65 of a balance and the cylinder 60 is arranged on this lower disc 61 so that its inner portion 62 extends radially into the cylinder 60 at one of its ends, the latter resting on the shoulder formed by the outer portion 63 of the lower disc 61. The balance is tared with the cylinder 60 and the lower disc 61 thus arranged on the pan 65. The other disc 61, shown at the top in [Fig. 6] and called the "upper disc", is then arranged symmetrically on the opposite end of the cylinder 60, in the manner illustrated in [Fig. 6]. Such an arrangement of the discs 61 relative to the cylinder 60, in particular the fact of housing the inner portion 62 of the discs 61 in the ends of the cylinder 60, makes it possible to avoid a radially inward sliding of the ends of the cylinder 60 and thus to avoid a premature crushing of the cylinder 60.

[0139] In this configuration, the cylinder 60 is progressively loaded by the application of a mechanical force whose main component is a force directed along the length of the cylinder 60, in this case from the top to the bottom of [Fig. 6]. Such a force can be generated by filling a reservoir (not shown) located on the upper disk 61 with a liquid, taking care to center the reservoir with respect to the cylinder 60. The force is applied progressively to the cylinder 60, for example at a rate of 20 grams per second, until the cylinder 60 collapses.

[0140] The operation just described is preferably carried out several times with several samples of similar material, for example five times. The average of the values ​​in the series will then be retained as the cylindrical resistance value, for example after excluding the highest and lowest values.

[0141] The cover 1 of the invention makes it possible in particular to avoid or reduce the risk of formation of folds of layer 2 and / or to avoid phenomena of detachment, slippage or rolling of the cover 1 on the skin surface.

[0142] More generally, the cover 1 of the invention allows a device such as device 50 to be pressed against the skin surface and to maintain precise positioning of this device, even when the cover 1 and / or device 50 are subjected to stresses caused by body movements. It is thus possible to perform reliable measurements, for example continuously over periods of several hours or days.

[0143] Of course, many variations can be made to the preceding description without departing from the scope of the invention. For example, the cover of the invention can be configured to receive a device different from the device 50 described above, in particular a measuring device including other types of sensors, for example thermal sensors, and / or comprising components intended, for example, to dispense an active ingredient in liquid form, such as microneedles, a reservoir, and / or a micropump. Furthermore, the cover 1 can be configured to be placed on body parts other than the arm, for example, on the torso or other body parts with significant curvature.

[0144] Depending in particular on the type of device it is intended to receive and the part of the body against which it is intended to hold such a device, the cover of the invention may have structural and / or geometric characteristics different from those described above with reference to [Fig. 1]. For example, the cover may lack layers 4 and 12 shown in [Fig. 1] and / or may form a unitary receiving space, for example as illustrated without limitation in [Fig. 7].

[0145] In the embodiment of [Fig. 7], the cover 1 differs from that of [Fig. 1] in that it does not include parts 23 and 26, nor layers 4 and 6, nor a cutout 31 in layer 3, layer 7 having an opening 29 aligned with the other openings 29 to allow insertion into the cover 1 of a device before removal of layer 7 and bonding of the assembly by the adhesive layer 5. The preceding description applies by analogy to this embodiment, which can, for example, be used to receive a device intended to release an active ingredient via the cutout 30.

[0146] In an alternative embodiment, not shown, the cover differs from that of [Fig. 7] in that it lacks the openings 29 and in that the adhesive layer 11 is configured so as not to glue layers 2 and 3 to each other by one of their longitudinal ends. For this purpose, a portion of part 41 of the adhesive layer 11 can be removed. Layers 2 and 3 can thus define an opening between them at one longitudinal end of the cover 1, formed by an unglued portion of layers 2 and 3, allowing insertion of the device between them without the need to make openings such as the openings 29.

[0147] By way of further example, materials other than those described above may be used for one or more layers of the cover 1. For example, layer 3 may comprise a material susceptible to plastic deformation.

[0148] The structure of the cover 1 in the various embodiments described is a stacked-layer structure, which has the advantage of being able to be manufactured using a roll-to-roll process. Of course, the cover 1 can nevertheless be manufactured using other techniques. Other manufacturing techniques can also make it possible to obtain certain advantages of the cover 1 of the invention with different structural characteristics. For example, it is possible to reduce the risk of creasing in layer 2 by creating a pleated layer 3, for instance, using a tension bonding process, material expansion by force or by curing, material shrinkage in layer 2, or thermoforming.

Claims

Demands

1. A cover (1) intended to hold a medical device (50) and / or a device for measuring physiological data and / or for delivering an active ingredient and / or for collecting a bodily fluid near, or against, a skin surface of an individual, said cover (1) comprising a first layer (2) and a second layer (3) connected to each other so as to be pressed against each other when the cover (1) is in an initial state, the cover (1) being configured to allow deformation of the second layer (3) causing the cover (1) to pass from the initial state to a state of use in which the first layer (2) and the second layer (3) define between them a receiving space suitable for receiving said device (50), the cover (1) comprising an opening (28, 29) configured to allow introduction of the device (50) into the receiving space,the first layer (2) comprising an external surface provided with an adhesive material such as silicone or acrylate glue for fixing the cover (1) to said skin surface, the first layer (2) having a drape coefficient greater than that of the second layer (3) and / or a cylindrical strength greater than that of the second layer (3).

2. Cover (1) according to claim 1, wherein the first layer (2) and the second layer (3) each comprise an internal surface and are connected to each other by gluing or welding parts of their internal surface.

3. Cover (1) according to claim 1 or 2, wherein the first layer (2) and / or the second layer (3) comprise a nonwoven material, for example a plastic or elastomer material, and / or a textile.

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

5. Cover (1) according to any one of claims 1 to 4, wherein the first layer (2) has a thickness greater, for example more than twice, than a thickness of the second layer (3) and / or wherein the first layer (2) has a drape coefficient more than twice that of the second layer (3) and / or wherein the first layer (2) has a cylindrical strength greater than twice as high as that of the second layer (3).

6. Cover (1) according to any one of claims 1 to 5, wherein the first layer (2) includes a cutout (30) permitting direct contact of a part (55) of the device (50) with the skin surface when the device (50) is received in the receiving space.

7. Cover (1) according to any one of claims 1 to 6, comprising a third layer (4) having a first part connected to the first layer (2) and / or to the second layer (3) and a second part configured to be glued to said skin surface and / or to a part of the cover (1) and / or to a part of the device (50), for example so as to form an armband.

8. Assembly comprising a cover (1) according to any one of claims 1 to 7 and a medical device (50) and / or device for measuring physiological data and / or for delivering an active ingredient and / or for sampling a body fluid such as a medical thermometry device.

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

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

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