ANALYTE MEASURING DEVICE WITH AN ADHESIVE PLASTER

Description

DOMAINE DE L'INVENTION

[0001] The present invention relates to a body monitoring system via analysis of body fluid, typically interstitial, using microneedles. More specifically, the present invention relates to a patch for managing the retention of microneedles in the skin. ETAT DE LA TECHNIQUE

[0002] Some pathologies such as diabetes require daily monitoring of biochemical parameters of the human body, i.e. 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 make a drop of blood appear, and to analyze this drop either reactively (for example with a strip), or electronically (for example by at least one analytical sensor), in order to estimate the target parameter(s).

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

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

[0006] We know of devices with microneedles, which have the advantage of being less invasive than conventional needles. However, it is important that these microneedles remain in place.

[0007] There are permanent devices for this purpose, where microneedles are held on the skin with an adhesive strip. However, continuous or near-continuous monitoring is desired, which requires autonomous devices. One example is the GlucoWatch device, which used iontophoresis (rather than needles).

[0008] The device in document WO2018104647 is also known, which has a housing comprising a removable capsule, the capsule housing microneedles configured to sample interstitial fluid. The housing, for its part, houses most of the electronics.

[0009] This portable device, typically worn on the wrist, allows continuous measurement and it is sufficient to change the capsule to change microneedles.

[0010] However, when such a device is worn on the wrist, a difficulty lies in the prior adjustment of the device to a comfortable location for the user. Indeed, the adjustment of the device is difficult to reconcile with the presence of microneedles in the skin because the microneedles can damage the skin during their insertion.

[0011] Prior art devices include a patch, but no means of adjustment to a user's limb. Such devices are also often applied to the skin in a single application with an applicator, without the possibility of readjustment. WO2019121324 describes another prior art device. EXPOSE DE L'INVENTION

[0012] An aim of the invention is to propose a solution for manufacturing a body monitoring system making it possible to resolve at least in part the problems of the aforementioned prior art.

[0013] This aim is achieved within the framework of the present invention thanks to a body monitoring system, comprising: a capsule for measuring a bodily analyte, the capsule comprising a first face suitable for being placed in contact with the skin of a user, and microneedles fixedly mounted on the first face, a patch comprising a main body, the main body comprising a second face suitable for being opposite the skin of a user, the patch comprising a layer of adhesive covering at least in part the second face, and a peelable covering the layer of adhesive, the peelable comprising at least two separate parts, the parts being adjacent to each other, the main body and the layer of adhesive comprising a central part in which an opening is formed suitable for receiving the capsule, the opening having a maximum diameter greater than 2 mm, preferably greater than 5 mm, the peelable covering entirely the opening, the capsule being received in a removably manner in the opening, and the peelable covering the microneedles.

[0014] The invention is advantageously supplemented by the following characteristics, taken individually or in any of their technically possible combinations: the patch extends mainly in a longitudinal direction, and the two parts are arranged on either side of an axis parallel to the longitudinal direction, the patch has an oblong shape in the longitudinal direction, each part of the peelable comprises a tab adapted to be gripped by a user, at least one of the tabs is connected to one end of the peelable relative to the longitudinal direction, the tab is fixedly mounted at one end of the peelable, at least one tab extends mainly along a main axis having a non-zero component in the longitudinal direction, the absolute value of an angle formed between the longitudinal direction and the main axis is preferably between 30° and 60°, the main body has a thickness greater than a thickness of the adhesive layer, and preferably a thickness greater than 50 µm, in particular greater than 100 µm, the patch has a contour,and parts of the contour arranged on either side of the opening in a direction transverse to the longitudinal direction form saw teeth, the peelable part comprises at least one outer layer arranged opposite the main body relative to the rest of the peelable part, the outer layer covers the microneedles, the peelable part also comprising at least one spacer arranged at least partly around the opening, a thickness of the spacer being configured to raise a part of the outer layer covering the opening relative to the rest of the outer layer so as to form a space between the outer layer and a top of each microneedle, the system comprises two spacers arranged on either side of the opening in a direction transverse to the longitudinal direction, each spacer extending mainly in the longitudinal direction.

[0015] Another aspect of the invention is a device for attachment to a limb, comprising: a system according to the invention, a housing capable of being removably attached to the capsule of the system, inside which there is a battery and a processor, the processor being configured to process data obtained using the measurement made by at least one of the microneedles, a strap, configured to hold the housing in place on the limb. DESCRIPTION DES 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: There figure 1 schematically illustrates a patch according to an embodiment of the invention, in side view. The figure 2 schematically illustrates a patch according to an embodiment of the invention, seen from below. The figure 3 schematically illustrates a body monitoring system comprising a capsule and a patch according to one embodiment of the invention, in section. The figure 4 schematically illustrates a patch comprising tabs, according to one embodiment of the invention, seen from below. The figure 5 schematically illustrates a patch having sawtooth contours, according to an embodiment of the invention, seen from below. The figure 6 schematically illustrates a body monitoring system according to one embodiment of the invention, in section, in which the patch comprises a spacer. The figure 7 schematically illustrates different layers, in exploded view, forming a patch according to an embodiment of the invention. The figure 8 schematically illustrates different layers, in exploded view, forming a patch according to one embodiment of the invention.

[0017] Throughout the figures, similar elements have identical references. DEFINITIONS

[0018] The "diameter" of an opening is understood to mean the maximum size of this opening, whatever the shape of the opening, or the maximum distance between two points on the outline of the opening. DESCRIPTION DETAILLEE DE L'INVENTION

[0019] In reference to the figure 1 and to the figure 2 , a patch 5 comprises a main body 6. The main body 6 is of overall planar shape, and has a thickness e . The main body 6 comprises a second face 7 suitable for facing the skin of a user when the body monitoring system 1 is worn on a limb of the user. The main body 5 may be made of polyurethane (PU). The patch 5 also comprises a first layer of adhesive 8 covering at least in part, preferably completely, the second face 7 of the main body 6.

[0020] The first adhesive layer 8 preferably comprises an adhesive allowing the patch 5 to be reused on the user's skin. The adhesive of the first adhesive layer 8 may preferably comprise silicone.

[0021] The patch 5 also comprises a peelable 9 covering the first adhesive layer 8. The term "peelable" means a surface covering that can be detached dry and without breaking. In other words, the peelable 9 is intended to be detached from the first adhesive layer 8 by the user, and makes it possible to protect the latter when it covers it.

[0022] The main body 6 and the first adhesive layer 8 comprise a central part 11. An opening 12 is formed in the central part 11. The opening 12 is intended to receive a capsule 2.

[0023] In reference to the figure 3 , the body detection system 1 comprises the patch 5 and a capsule 2 for measuring body analyte. The capsule 2 comprises a first face 3, suitable for being placed in contact with the skin of a user. Microneedles 4 are fixedly mounted on the first face 3. By "microneedle", we mean a needle having a base and a top, and whose base has a size less than 600 µm, and whose distance from the base to the top of the needle is less than 1 mm, preferably less than 800 µm. The first face 3 is not limited to a flat face. It may have one or more recesses, in which the base of each microneedle 4 can be fixedly mounted.

[0024] The opening 12 of the patch 5 is configured to removably receive the capsule 2, as illustrated in the figure 3 The opening 12 has a maximum diameter greater than 2 mm, in particular greater than 5 mm, and preferably greater than 1 cm. Thus, the capsule 2 can be housed in the opening 12.

[0025] In reference to the figure 2 , the peelable part 9 comprises at least two separate parts 10, each of the parts being adjacent to each other. The peelable part 9 completely covers both the opening 12 and the microneedles 4 of the capsule 2.

[0026] This configuration of the body monitoring system 1 allows both the removal of the peelable 9 after having placed the system 1 opposite the user's skin, without damaging the microneedles 4, by separating the peelable 9 into several separate parts, and at the same time to protect the microneedles 4 from the external environment by covering the microneedles 4 with the peelable 9.

[0027] In reference to the figure 2 , to the figure 4 and to the figure 5 , the patch 5 is preferably elongated in a longitudinal direction 13, or in other words extends mainly in a longitudinal direction 13. By "extends mainly in a direction", it is meant that the maximum size of the patch is described by said direction. Thus, it is possible to increase the part of the patch 5 having a first layer of adhesive 8 and to increase the adhesion of the system 1 to the skin for a predetermined capsule size. The patch 5 preferably has an oblong shape in the longitudinal direction 13. Thus, the patch 5 does not form an angle likely to come off the user's skin.

[0028] In reference to the figure 2 , the patch 5 preferably comprises two parts 10, each part 10 being arranged on either side of an axis parallel to the longitudinal direction 13. Thus, once the system is placed opposite the skin by the user, it is possible to detach each of the parts 10 from the rest of the patch 5 more easily and without damaging the microneedles 4 of the capsule 2.

[0029] Alternatively, the patch 5 may also comprise four parts, each part being adjacent to two other parts, the parts 10 joining in the center of the patch 5. The four parts 10 then form quarters of the surface of the patch 5. Thus, the removal of the peelable part 9 when the system is placed by the user opposite the skin is facilitated.

[0030] In reference to the figure 4 , at least one part 10 of the peelable part 9, and preferably each part 10 of the peelable part 9 comprises a tab 14 adapted to be grasped by a user. This tab preferably stands out from the shape of the rest of the patch 5. Thus, when the system 1 is placed opposite the user's skin and adjusted to a suitable location for a measurement, the user can pull on the tab 14 so as to remove the peelable part from the rest of the patch 5 without having to move the patch 5 to detach it.

[0031] The tab 14 may be manufactured by the following methods, in a non-limiting manner. The cutting shape of the peelable 9 may be made so as to form the tab 14 in the same plane and the same material as a portion of the rest of the peelable, in a single piece. Alternatively, the tab 14 may be glued or fixed to a portion of the peelable. The arrangement of the tab 14 may be controlled by folding the tab.

[0032] When the patch 5 has an elongated shape, it has two ends 15. The tab is preferably linked, or fixedly mounted, to the end 15 of the patch 5. Thus, it is possible to remove the peelable part 9 from the rest of the patch 5 by pulling on the tab 14 and bringing it towards the center of the system 1.

[0033] The tab 14 preferably extends along a main axis 16, the main axis having a non-zero component along the longitudinal direction 13. Thus, when the tab 14 is pulled by a user, the detachment of the peelable at its end 15 is promoted, and the detachment of the peelable 14 from the rest of the patch 5 is thus facilitated. The absolute value of an angle formed between the longitudinal direction 13 and the main axis 16 is preferably between 30° and 60°.

[0034] In reference to the figure 1 , the main body 6 has a thickness e greater than a thickness of the first adhesive layer 8, and preferably a thickness greater than 50 µm, in particular greater than 100 µm. The thickness e of the main body 6 is notably greater than the thickness of any other layer forming the patch 5. Thus, the rigidity of the patch 5 is ensured when the peelable part is removed by the user.

[0035] In reference to the figure 5 , the patch 5 has an outline 17. The patch 5 may comprise parts of the outline 17, arranged on either side of the opening 12 in a direction transverse to the longitudinal direction 13, forming saw teeth. The inventors have in fact discovered by comparing two patches 5 having the same adhesive power to the skin of a user, that a patch 5 having parts of its outline in saw teeth causes less pain when removing the patch from the skin of the user than a patch not having this type of outline. Indeed, the saw teeth make it possible to reduce surface contact with the skin and therefore the pulling out of the user's hairs. By "saw teeth", it is meant that the outline 17 of the patch 5 has a notched shape. Preferably, the notches of the notched shape have a maximum length of 5 mm. Each notch may have a rounded top.The angle formed by two successive notches is preferably between 20° and 70°.

[0036] In reference to the figure 6 , the peelable 9 preferably comprises at least one outer layer 18 arranged opposite the main body 6 relative to the rest of the peelable 9. The outer layer 18 covers at least the opening 12 and the microneedles 4. The peelable 9 also comprises at least one spacer 19 arranged at least in part around the opening 12. The spacer 19 has a thickness configured to raise a part of the outer layer 18 covering the opening 12 relative to the rest of the outer layer 18, so as to form a space between the outer layer 18 and the top of each microneedle 4. This configuration makes it possible to cover the microneedles 4 so as to protect them before using the system, while making it possible to align the first layer of adhesive 8 with the first face 3. Indeed, when using the system 1, these two faces are in contact with the skin and are preferentially aligned in the system.However, in the absence of spacer 19, the height of the microneedles 4 could protrude from a surface of the first adhesive layer 8 and come into contact with the peelable layer 9, which could damage the microneedles 4. The space imposed by the spacer 19 between the outer layer 18 and the top of each microneedle 4 is preferably greater than 10 µm, in particular 100 µm, and more preferably 500 µm.

[0037] The different elements of the peelable 9 can themselves be divided into several parts, so as to form the different parts 10 of the peelable 9. For example, the outer layer 18 is preferably divided into two or more parts adjacent to each other. Thus, the system 1 preferably comprises several spacers 19, in particular two spacers 19, arranged on either side of the opening 12. In this configuration, each part 10 of the peelable 9 comprises a spacer 19. Thus, when the peelable 9 is removed during use of the system 1, the spacer 19 does not risk damaging the microneedles 4.

[0038] In reference to the figure 7 , the peelable 9 preferably comprises, opposite the first layer of adhesive 8, a first coating 701, intended to be in contact with the first layer of adhesive 8. The first coating 701 can be made of polyurethane, polyethylene or any material known from the prior art.

[0039] The first coating 701 is covered, on the side opposite that of the first adhesive layer 8, by a third adhesive layer 704. The third adhesive layer 704 makes it possible to fixedly mount a spacer body 703 on the first coating 701.

[0040] The spacer body 703 covers the third adhesive layer 704 on the side opposite the first coating 701. The spacer 19 preferably comprises the spacer body 703 and the third adhesive layer 704. The spacer body 703 is preferably made of cotton.

[0041] A second layer of adhesive 702 covers the spacer body 703 on the side opposite the third layer of adhesive 704.

[0042] A second adhesive layer 702 may be arranged between the spacer body 703 and the outer layer 18. The second adhesive layer 702 preferably comprises a so-called strong adhesive, such as acrylic. The second adhesive layer 702 makes it possible to attach the outer layer 18 to the first coating 701 and preferably to maintain the spacer 19 between the outer layer 18 and the first coating 701.

[0043] In reference to the figure 8 , the second layer of adhesive 702 and the outer layer 18 only cover the spacer(s) 19, without being in contact with the first coating 701.

[0044] Another aspect of the invention is a device intended to be attached to a limb comprising a system according to an embodiment of the invention, a housing 21 capable of being removably attached to the capsule 2, inside which is a battery and a processor. The processor is configured to process data obtained using the measurement made by at least one of the microneedles 4. The device also comprises a strap configured to hold the housing 21 in place on the limb. Thus, it is possible for the user, initially, to place the system 1 above his skin, so that the microneedles 4 are placed above a part of the skin suitable for coming into contact with the microneedles 4, then adjust the position of the system 1, then remove the peelable 9 from the rest of the system 1, then finish tightening the strap to attach the system to the user's limb.

[0045] In general, the system thus makes it possible to protect the microneedles 4 from possible contamination with the environment before the microneedles 4 come into contact with the user's skin, and to readjust the device on a limb of the user in a more comfortable position, without fear of damaging either the skin or the microneedles.

[0046] The system 1 is preferably adapted to measure a concentration of a bodily analyte chosen from glucose and lactate in the interstitial fluid of a user, and preferably continuously.

Claims

1. A body monitoring system (1), comprising: - a capsule (2) for measuring a body analyte, the capsule (2) comprising a first face (3) capable of being brought into contact with the skin of a user, and microneedles (4) fixedly mounted on the first face (3), - a patch (5) comprising a main body (6), the main body (6) comprising a second face (7) capable of being against the skin of a user, the patch (5) comprising a first layer of adhesive (8) covering at least partly the second face (7), and a peelable cover (9) covering the layer of adhesive (8), characterized in that: - the peelable cover (9) comprises at least two separate parts (10), the parts (10) being adjacent to each other, - the main body (6) and the first layer of adhesive (8) comprise a central part (11) in which an opening (12) capable of receiving the capsule (2) is formed, the opening (12) having a maximum diameter greater than 2 mm, preferably greater than 5 mm, - the peelable cover (9) entirely covers the opening (12), - the capsule (2) is removably received in the opening (12), and - the peelable cover (9) covers the microneedles (4).

2. The system (1) according to claim 1, wherein the patch (5) extends mainly along a longitudinal direction (13), and wherein the two parts (10) are arranged on either side of an axis parallel to the longitudinal direction (13).

3. The system (1) according to any of claims 1 or 2, wherein the patch has an oblong shape along the longitudinal direction (13).

4. The system (1) according to any of claims 1 to 3, wherein each part (10) of the peelable cover (9) comprises a tab (14) adapted to be gripped by a user.

5. The system (1) according to claim 4, wherein at least one of the tabs (14) is linked to one end (15) of the peelable cover (9) relative to the longitudinal direction (13).

6. The system (1) according to any of claims 4 or 5, wherein the tab (14) is fixedly mounted at one end (15) of the peelable cover (9).

7. The system (1) according to claim 5 or 6, wherein at least one tab (14) mainly extends along a main axis (16) having a non-zero component along the longitudinal direction (13).

8. The system (1) according to claim 7, wherein the absolute value of an angle formed between the longitudinal direction (13) and the main axis (16) is preferably comprised between 30° and 60°.

9. The system (1) according to any of claims 1 to 8, wherein the main body (6) has a greater thickness than a thickness of the layer of adhesive (8), and preferably a thickness greater than 50 µm, in particular greater than 100 µm.

10. The system (1) according to any of claims 1 to 9, wherein the patch (5) has a contour (17), and wherein parts of the contour (17) arranged on either side of the opening (12) along a direction transverse to the longitudinal direction (13) form sawteeth.

11. The system (1) according to any of claims 1 to 10, wherein the peelable cover (9) comprises at least one external layer (18) disposed opposite the main body (6) relative to the rest of the peelable cover (9), the external layer (18) covering the microneedles (4), the peelable cover also comprising at least one spacer (19) arranged at least partly around the opening (12), a thickness of the spacer being configured to raise a part of the external layer (18) covering the opening (12) relative to the rest of the external layer (18) so as to form a space between the external layer (18) and an top of each microneedle (4).

12. The system (1) according to claim 11, comprising two spacers (19) arranged on either side of the opening (12) along a direction transverse to the longitudinal direction (13), each spacer extending mainly along the longitudinal direction (13).

13. A device (20) intended to be attached to a limb, comprising: - a system (1) in accordance with any of claims 1 to 12, - a casing (21) able be removably fixed with the capsule (2), inside which there is a battery and a processor, the processor being configured to process data obtained using the measurement made by at least one of the microneedles (4), - a strap (22) configured to hold the casing (21) in place on the limb.