BODY MONITORING SYSTEM WITH ADHESIVE

Abstract

The present invention relates to a body monitoring device, comprising a housing and a capsule, the capsule comprising at least one microneedle, the capsule having a first face having the microneedle(s), the capsule being configured to engage with the housing in a releasable manner, the device comprising a patch, the patch having a second face, such that adhesion of the patch to the skin by the adhesive layer results in retention of the microneedle(s) in the skin, the adhesive being chosen so as to result in a peel strength of the patch of between 0.001 N / mm and 1.4 N / mm, the housing comprising a main body and means for attachment to the user's body adapted so that the main body exerts pressure on the patch when attaching the device to the user's body. Figure for abstract: Fig. 1

Description

Title of the invention: BODY MONITORING SYSTEM WITH ADHESIVE FIELD OF THE INVENTION

[0001] The present invention relates to a device for measuring a bodily analyte. More specifically, it relates to a device for body monitoring by analyzing bodily fluid, typically interstitial. STATE OF THE ART

[0002] Certain pathologies such as diabetes require daily monitoring of biochemical parameters of the human body, in particular the concentrations of certain compounds (blood sugar in the example of glucose).

[0003] To do this, it is common to prick a point on the skin so as to cause a drop of blood to appear, and to analyze this drop either reactively (for example with a strip), or electronically (for example by at least one analytical sensor), so as to estimate the target parameter(s).

[0004] Today we know of advanced, much less invasive systems that simply analyze the interstitial fluid, that is, the fluid that fills the space between the blood capillaries and the cells. It has an ionic composition close to that of blood plasma.

[0005] These advanced systems thus make it possible to monitor the desired biochemical parameters transcutaneously, without the need to regularly pierce the skin and take samples.

[0006] In particular, a wrist-worn device called GlucoWatch was proposed, implementing a phenomenon called iontophoresis (or iontophoresis) in which an electric field allows interstitial fluid to be "attracted" through the skin to a sensor on the wall of the device. However, this concept was quickly abandoned because only 6% of patients tolerated the pain of electric extraction. In addition, the measurement results were unreliable.

[0007] Alternatively, transcutaneous probes have been proposed in the form of a self-adhesive patch placing a “needle sensor” just under the skin, so as to place the sensor in permanent fluid communication with the interstitial liquid, for continuous monitoring.

[0008] Some of these transcutaneous patch-type probes include wireless communication means enabling measurements on the interstitial fluid to be sent to a mobile terminal, for storage and / or processing of the measurements (verification of thresholds and variations, production of statistics, triggering of alerts if necessary, etc.). Examples include the sugarBEAT™ or FreeStyle Libre systems.

[0009] Such systems provide satisfaction (the patches are significantly more reliable and less painful than iontophoresis devices), but are restrictive and expensive due to the single-use patch, which must be changed regularly. In addition, the patches tend to come off or tear off when changing clothes or making sudden movements. Such systems are very visible: the wearer may be stigmatized as "sick". Such systems can cause allergies or skin irritation. Finally, such systems do not tolerate errors in placing the system on the skin: the insertion of the needle goes hand in hand with the adhesion of the patch to the skin. Once the system adheres to the skin, it is no longer possible, or painful, to move the system. Statement of the invention

[0010] An aim of the invention is to propose a solution for manufacturing a system allowing a user to make an error when placing the patch on the skin, without causing pain due to the removal and reinsertion of a needle into the user's skin.

[0011] This aim is achieved within the framework of the present invention by means of a body monitoring device, comprising a housing and a capsule, the capsule comprising at least one microneedle adapted to be inserted into the skin of a user, the capsule having a first face presenting the microneedle(s) and adapted to be brought into contact with the skin, the capsule being configured to engage with the housing in a removable manner, the device comprising a patch, the patch having a second face and comprising a layer of adhesive at least partially covering the second face, such that the adhesion of the patch to the skin by the layer of adhesive results in the microneedle(s) being held in the skin, the device being characterized in that: - the adhesive is chosen so as to result in a peel strength of the patch of between 0.001 N / mm and 1.4 N / mm, in particular between 0.002 and 0.03 N / mm, and preferably between 0.01 N / mm and 0.02 N / mm, and - the housing comprises a main body and means for attachment to the user's body adapted so that the main body exerts pressure on the patch when attached to the user's body.

[0012] The invention is advantageously supplemented by the following characteristics, taken individually or in any of their technically possible combinations: - the adhesive comprises a layer of pressure-sensitive elastomer, - the adhesive comprises at least one element chosen from natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber and low molecular weight polyisobutylenes, and silicone gel, - the means of attachment to the body are chosen at least from a bracelet configured to surround a limb of the user and preferably a watch bracelet, a strap, the means of attachment to the body being reusable, - the attachment means are a watch strap, the patch extending under the main body as well as at least under a part of the watch strap, the patch preferably having ears arranged opposite the watch strap, - the housing has a third face facing the patch, the third face having at least one boss adapted to exert pressure on the patch greater than the pressure exerted by the rest of the third face on the patch when the device is attached to a user's body, - the boss(es) are arranged so as to exert pressure on the periphery of the patch, and preferably to exert pressure less than 5 mm from an edge of the patch, in particular less than 3 mm from an edge of the patch and preferably less than 2 mm from an edge of the patch, - the patch is removably attached to the capsule.

[0013] Another aspect of the invention is a patch configured for use in a device according to the invention.

[0014] Another aspect of the invention is a method of mounting a device according to the invention, comprising at least the steps of: - positioning on the skin of a user of a patch having a second face and comprising a layer of adhesive covering at least in part the second face, the adhesive being chosen so as to result in a peel strength of the patch of between 0.001 N / mm and 1.4 N / mm, in particular of between 0.002 and 0.03 N / mm, and preferably of between 0.01 N / mm and 0.02 N / mm, and - engagement of the housing with the capsule and attachment of the device to a user's body.

[0015] Another aspect of the invention is a kit comprising: - a capsule comprising at least one microneedle adapted to be inserted into the skin of a user, the capsule having a first face adapted to be placed in contact with the skin, the first face having the microneedle(s), the capsule being configured to engage with a housing in a removable manner, the housing comprising a main body and means for attachment to the body of the user adapted so that the main body exerts pressure on the patch and on the skin of the user. - a patch having a second side and comprising a layer of adhesive covering at least in part the second face, so that the adhesion of the patch to the skin by the adhesive layer results in the microneedle(s) being held in the skin, the adhesive being chosen so as to result in a peel strength of the patch of between 0.001 N / mm and 1.4 N / mm, in particular of between 0.002 and 0.03 N / mm, and preferably of between 0.01 N / mm and 0.02 N / mm. DESCRIPTION OF FIGURES

[0016] Other characteristics, aims and advantages of the invention will emerge from the following description, which is purely illustrative and non-limiting, and which must be read in conjunction with the appended drawings in which:

[0017] [fig. 1] Figure 1 schematically illustrates a device according to a mode of rea lization of the invention.

[0018] [fig.2] Figure 2 schematically illustrates a section of part of a device according to one embodiment of the invention.

[0019] Throughout the figures, similar elements bear identical references. The distances and proportions are chosen to illustrate embodiments of the invention in a purely schematic manner. DEFINITIONS

[0020] "Pressure-sensitive elastomer" means the class of elastomer requiring the application of pressure deforming the elastomer to be adhesive.

[0021] Preferably, the elastomer comprises silicone. The elastomer may also comprise a mixture of silicone and acritical adhesive.

[0022] The adhesive may also be an elastomeric foam.

[0023] The term "microneedle" means a needle, hollow or solid, whose diameter size at the base of the needle (at the opposite end from the tip of the needle) is between 1 μm and 900 μm. DETAILED DESCRIPTION OF THE INVENTION

[0024] With reference to Figure 1, a device 1 according to one embodiment of the invention comprises a housing 5 and a capsule 2. The capsule 2 is configured to engage in the housing 5 in a removable manner. The housing 5 may for example have a third face Fb, the shape of at least a portion of the third face Fb being complementary to the shape of a portion of the capsule 2, so as to allow the capsule 2 to be engaged in the housing 5.

[0025] The capsule 2 has a first face Fc intended to be placed in contact with the skin of a user. The capsule 2 comprises at least one microneedle 4, intended to be inserted into the skin of the user, to measure the presence and / or the quantity of a bodily analyte, and preferably the glucose concentration. The first face Fa has the microneedle(s) 4. The microneedle(s) 4 are preferably entially fixedly mounted on the first face Fc of the capsule 2. A microneedle 4 makes it possible to collect information on the presence of an analyte: it can for example be a means of in situ electrochemical detection or a means of sampling an interstitial liquid. The capsule 2 makes it possible to collect information representative of the presence or concentration of an analyte originating from the measurements of the microneedles 4. Such information can for example be an electric current. The microneedle(s) 4 are connected for example by a fluidic and / or electrical connection to the capsule 2. The capsule 2 also makes it possible to transmit information representative of the presence of an analyte to the housing 5. This information can for example be transmitted by an electrical connection connecting the capsule 2 to the housing 5, and / or by a wireless connection.The information representative of the presence of an analyte can thus be processed by the housing 5. The housing 5 can comprise a microprocessor, a memory, and a device for displaying information to a user.

[0026] The device 1 comprises a patch 6. The capsule 2 is preferably adapted to be engaged in the patch 6 (and vice versa). Preferably, the patch 6 is attached to the capsule 2. The patch 6 can be removably attached to the capsule 2. Thus, it may be possible for the user to first stick the patch 6 on a part of his skin, then to attach the capsule 2, or to directly stick a patch 6 previously attached to the capsule 2. It is also possible to change the capsule 2, comprising the microneedle(s) 4, without detaching the patch and thus keeping exactly the same implantation position of the microneedle(s) 4.

[0027] The patch 6 has a second face Fa, intended to come into contact with the user's skin. The second face Fa is covered at least in part by a layer of adhesive 7. The attachment between the patch 6 and the capsule 2 is configured so that the adhesion of the patch 6 to the skin by the layer of adhesive 7 results in the microneedle(s) 4 being held in the user's skin.

[0028] The adhesive 7 is chosen so as to result in a peel strength of the patch 6 of between 0.001 N / mm and 1.4 N / mm, in particular between 0.002 and 0.03 N / mm, and preferably between 0.01 N / mm and 0.02 N / mm. These strength ranges correspond to adhesions described as weak to the skin by those skilled in the art. Lui et al. (Liu, L., Kuffel, K., Scott, DK, Constantinescu, G., Chung, HJ, & Rieger, J. (2017), Silicone-based adhesives for long-term skin application: cleaning protocols and their effect on peel strength. Biomedical Physics & Engineering Express, 4(1), 015004) describe for example methods for measuring the peel strength of a patch comprising an adhesive to the skin. The adhesive 7 is preferably a pressure-sensitive elastomer. Such an adhesive 7 is for example different from acrylic resin type adhesives, which can bond the patch 6 to the skin with a force higher adhesion. Preferably, the pressure-sensitive elastomer comprises at least one element chosen from natural rubber, silicone rubber (called silicone, or "silicone rubber" in English), acrylonitrile rubber, polyurethane rubber, low molecular weight polyisobutylenes and a silicone gel. Preferably, the pressure-sensitive elastomer comprises silicone rubber (or simply silicone). The adhesive 7 may also be an acrylic-based adhesive, in which the surface concentration of acrylic is adapted so that the peel strength of the patch 6 to the skin is in one of the aforementioned ranges. Thus, it is possible to remove the patch 6 from the skin and stick it back to the skin if the first application of the patch 6 is implemented in a location that is not suitable for the user. The removal of the patch 6 can be implemented without hair removal and / or without irritation.In addition, allergies can be avoided for the user.

[0029] The adhesives 7 described according to the embodiments of the invention have lower adhesion forces to the skin than the adhesives used in the prior art to enable the adhesion of body monitoring systems: therefore, they do not allow the device 1 to be held securely on the skin. The housing 5 comprises a main body 11 and means 8 for attaching the housing to the user's body, adapted so that the main body 11 exerts pressure on the patch 6 and on the user's skin when attaching the device to the user's body. More specifically, the attachment means 8 cause the housing 5 to exert pressure on the patch 6, which, in turn, causes pressure on the adhesive layer 7 at the interface between the patch 6 and the skin.It is thus possible to use a reusable adhesive 7 which is less prone to allergies and irritations, while ensuring that the device 1 is held in place on the user's body.

[0030] The means 8 for attaching to the body may for example be chosen from a bracelet configured to surround a limb of the user, preferably a watch bracelet, and a strap. The means 8 for attaching are mechanical means, not physicochemical means, such as adhesive elements. A bracelet can be opened and closed numerous times, at will.

[0031] The housing 5 has a third face Fb. The third face Fb faces the patch 6 and the capsule 2. The patch 6 extends at least partly under the main body 11, facing the third face Fb. Preferably, the patch 6 may also extend under the attachment means 8, and preferably under a part of the strap(s) of the wristwatch. The patch 6 may, for example, have ears arranged facing the watch strap. Thus, it is possible to increase the adhesive surface of the patch 6 while avoiding giving the device a medical appearance, which is conducive to discrimination that may be made against users of the continuous blood glucose monitoring devices, for example.

[0032] With reference to Figure 1 and Figure 2, the third face Fb of the housing 5 may preferably have at least one boss 10 adapted to exert a pressure on the patch 6 greater than the pressure exerted by the rest of the third face Fb on the patch 6 when the device 1 is attached to the user's body. Thus, it is possible to avoid the patch 6 detaching from the skin when a stress on the housing 5 causes a stress on the patch 6. Preferably, the boss 10 has a profiled structure of constant section which extends over the third face Fb. The boss 10 may preferably be curved. The boss(es) are preferably arranged on the third face Fb so as to exert pressure on the periphery of the patch 6, preferably less than 5 mm from an edge of the patch 6, in particular less than 3 mm from an edge of the patch 6, and preferably less than 2 mm from the edge of the patch 6.By "border of the patch" is meant both a border defining the maximum dimensions of the patch 6, and an internal border, for example resulting from an opening in the patch 6. Thus, it is possible to avoid the initiation of detachment of the patch 6. Indeed, when the housing 5 is stressed, the concentration of mechanical stresses is particularly high near the edge of the patch 6 with respect to the rest of the patch 6, which can cause detachment of the border of the patch 6. The boss(es) 10 may have a pointed edge, or on the contrary a rounded shape. The choice of a pointed edge makes it possible to impose on the patch 6 a higher local pressure than a pointed edge. The boss(es) 10 may describe a line or a network of lines. A boss may also form a circle at the edge of the main body 11. The bosses 10 may also be arranged in a network of point or quasi-point bosses 10.Thus, each punctual or quasi-punctual boss 10 exerts a pressure on the patch 6 locally higher than the pressure which would be, for example, exerted by a linear boss 10.

[0033] The device 1 can be distributed as a kit, so that certain parts can be changed or reused, for example the housing 5, the patch 6 and / or the capsule 2.

[0034] The mounting of a device 1 comprises the steps of positioning the patch 6 on the skin of a user, the adhesive layer 7 being brought into contact with the user's skin, followed by engaging the housing 5 with the capsule 2 and attaching the device to the body of a user. The first step of positioning on the skin may be repeated until the user finds the position that suits him best. In addition, the mounting comprises a step of fixing the patch 6 with the capsule 2, which may precede or be subsequent to the step of positioning the patch 6 on the skin.

Claims

Claims

1. A body monitoring device (1) comprising a housing (5) and a capsule (2), the capsule (2) comprising at least one microneedle (4) adapted to be inserted into the skin of a user, the capsule (2) having a first face (Fc) presenting the microneedle(s) and adapted to be brought into contact with the skin, the capsule (2) being configured to engage with the housing (5) in a removable manner, the device comprising a patch (6), the patch (6) having a second face (Fa) and comprising a layer of adhesive (7) at least partially covering the second face (Fa), such that the adhesion of the patch (6) to the skin by the layer of adhesive (7) results in the microneedle(s) (4) being held in the skin, the device being characterized in that: - the adhesive (7) is chosen so as to result in a peel strength of the patch (6) of between 0.001 N / mm and 1.4 N / mm, in particular between 0.002 and 0.03 N / mm,and preferably between 0.01 N / mm and 0.02 N / mm, and - the housing (5) comprises a main body (11) and means (8) for attachment to the user's body, adapted so that the main body (11) exerts pressure on the patch (6) when attaching the device (1) to the user's body.,

2. A device (1) according to claim 1, wherein the adhesive (7) is a pressure-sensitive elastomer.

3. Device (1) according to claim 1 or 2, wherein the adhesive comprises at least one member selected from natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber and low molecular weight polyisobutylenes, and silicone gel.

4. Device (1) according to one of claims 1 to 3, in which the means of attachment to the body (8) are chosen from a bracelet configured to surround a limb of the user, a watch bracelet and a strap, the means of attachment (8) to the body being reusable.

5. Device (1) according to one of claims 1 to 4, in which the attachment means (8) are a watch strap, the patch (6) extending under the main body (11) as well as at least under a part of the watch strap (11), the patch (6) preferably having ears arranged opposite the watch strap.

6. Device (1) according to one of claims 1 to 5, in which the housing (5) has a third face (Fb) facing the patch (6), the third face (Fb) having at least one boss (10) adapted to exert pressure on the patch (6) greater than the pressure exerted by the rest of the third face (Fb) on the patch (6) when attaching the device (1) to the body of a user.

7. Device (1) according to claim 6, in which the boss(es) (10) are arranged so as to exert pressure on the periphery of the patch (6), and preferably to exert pressure less than 5 mm from an edge of the patch (6), in particular less than 3 mm from an edge of the patch (6) and preferably less than 2 mm from an edge of the patch (6).

8. Device (1) according to one of claims 1 to 7, wherein the patch (6) is removably attached to the capsule (2).

9. Patch (6) configured for use in a device (1) according to one of claims 1 to 8.

10. Method for mounting a device (1) according to one of claims 1 to 8, comprising at least the steps of: - positioning on the skin of a user a patch (6) having a second face (Fa) and comprising a layer of adhesive (7) at least partially covering the second face (Fa), the adhesive (7) being chosen so as to result in a peel strength of the patch (6) of between 0.001 N / mm and 1.4 N / mm, in particular of between 0.002 and 0.03 N / mm, and preferably of between 0.01 N / mm and 0.02 N / mm, - engagement of the housing (5) with the capsule (2) and attachment of the device to the body of a user.

11. Kit comprising: - a capsule (2) comprising at least one microneedle (4) adapted to be inserted into a user's skin, the capsule (2) having a first face (Fc) adapted to be brought into contact with the skin, the first face having the microneedle(s) (4), the capsule (2) being configured to engage with a housing (5) in a removable manner, the housing (5) comprising a main body (11) and attachment means (8) to the user's body adapted so that the main body (11) exerts pressure on the patch (6) and on the user's skin. - a patch (6) having a second face (Fa) and comprising a adhesive layer (7) at least partially covering the second face (Fa), so that the adhesion of the patch (6) to the skin by the adhesive layer (7) results in the microneedle(s) (4) being held in the skin, - the adhesive (7) being chosen so as to result in a peel strength of the patch (6) of between 0.001 N / mm and 1.4 N / mm, in particular of between 0.002 and 0.03 N / mm.

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