BODY SURVEILLANCE SYSTEM

Description

GENERAL TECHNICAL FIELD

[0001] The present invention relates to a body monitoring system via analysis of body fluid, typically interstitial, using microneedles.

[0002] More specifically, the present invention relates to a patch for managing the retention of microneedles in the skin. STATE OF THE ART

[0003] Certain 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).

[0004] For 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).

[0005] Today, we have sophisticated, far less invasive systems that simply analyze interstitial fluid, that is, the fluid that fills the space between blood capillaries and cells. It has an ionic composition close to that of blood plasma.

[0006] These advanced systems thus make it possible to monitor the desired biochemical parameters transcutaneously, that is to say without the need to regularly pierce the skin and take samples.

[0007] 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.

[0008] For this purpose, there are in-dwelling devices where microneedles are held in place on the skin with an adhesive strip. However, continuous or near-continuous monitoring is desired, which requires self-contained devices. One example is the GlucoWatch device, which used iontophoresis (rather than needles).

[0009] WO 2016140760 describes a body monitoring system intended to be attached to a limb, comprising a patch and a capsule positioned in a housing held in place on the limb by a strap.

[0010] We are also familiar with the device described in document WO2018104647, which features a housing containing a removable capsule. This capsule holds microneedles configured to collect interstitial fluid. The housing itself contains most of the electronic components.

[0011] This portable device, typically worn on the wrist, allows for continuous measurement and simply changing the capsule is enough to change the microneedles.

[0012] However, when such a device is worn on the wrist, the difficulty lies in reconciling a system that keeps the microneedles in position in the skin with a replaceable system.

[0013] Furthermore, it is important that the device be easy to use.

[0014] The invention aims to address these difficulties. PRESENTATION OF THE INVENTION

[0015] To address some of these issues, the invention proposes a system according to claim 1.

[0016] The system of the invention is advantageously complemented by the features of claims 2 to 8, taken alone or in any technically feasible combination thereof.

[0017] In one embodiment, the rigid area has a break line, interrupted by the orifice, the break line being configured to allow the rigid area of ​​the patch to be folded.

[0018] In one embodiment, the breakability line is an axis of symmetry of the orifice.

[0019] In one embodiment, the orifice includes on an internal wall a groove or point indentations, configured to receive a capsule.

[0020] In one embodiment, the rigid zone has a higher shore hardness than the flexible zone, for example a shore hardness between 20 and 40 for the flexible zone and a shore hardness between 60 and 80 for the rigid zone.

[0021] In one embodiment, the material of the rigid zone is harder than the material of the flexible zone, the two materials being different.

[0022] In one embodiment, the rigid area is at least twice as thick as the flexible area, preferably at least three times as thick.

[0023] In one embodiment, the patch includes a flat adhesive substantially covering a flat face of the rigid and flexible areas.

[0024] In one embodiment, the adhesive is either silicone-based or acrylic-based.

[0025] In one embodiment, the main body, preferably the flexible area, comprises a plurality of through openings.

[0026] In one embodiment, the main body, preferably the flexible area, comprises a plurality of through openings, and the adhesive comprises a plurality of through openings, the size of the openings of the main body being greater than the size of the openings of the adhesive, and / or the opening surface density of the main body is greater than the opening surface density of the adhesive, and / or the opening density of the main body is greater than the opening density of the adhesive.

[0027] In one embodiment, the openings of the main body are angled.

[0028] In one embodiment, the rigid zone includes a step having a thickness less than the thickness of the rest of the rigid zone.

[0029] In one embodiment, the capsule has the same thickness as the rigid area of ​​the main body of the patch. PRESENTATION OF THE FIGURES

[0030] Other features and advantages of the present invention will become apparent from the following description of a preferred embodiment. This description will be given with reference to the accompanying drawings in which: There figure 1 illustrates in exploded view a bracelet, a case, a capsule and a patch as usable within the scope of the invention, The Figures 2a and 2b illustrate a three-dimensional view, full and cutaway, of a patch and a capsule attached to the patch, The figure 3 illustrates a cross-sectional view of figures 2a and 2b , There figure 4 illustrates the arrangement of the different modules that form the system (dimensions different from the dimensions of the figures 2a and 2b ). DETAILED DESCRIPTION General Architecture

[0031] With reference to figures 1 to 4 ,The present invention relates to an electronic body monitoring system 1. It is an improvement on the device described in document WO2018104647. Therefore, the invention falls within the same general concept of a self-contained, low-pain, low-hygienic, and reusable system.

[0032] Body monitoring refers to the verification of biochemical constants in a person with system 1, typically the concentration of a protein, hormone, marker, oxygen, nutrients, etc., in the person's interstitial fluid. Blood glucose is an example. A professional skilled in the art may also monitor other bodily parameters such as lactate, hydration, etc., if necessary.

[0033] The description will be illustrated with interstitial fluid but applies to other bodily fluids such as blood.

[0034] System 1 is said to be autonomous because it does not require the use of additional hardware.

[0035] System 1 is designed to be attached to a limb of a living being, typically a human arm or leg. The preferred attachment point is the wrist, where System 1 functions similarly to a watch.

[0036] System 1 consists of two modules, 100 and 200. ( figure 1 ) connected by a reusable, separable link 300. This defines a coupled position and a free position. In the coupled position, the two modules 100 and 200 are not physically separated and can exchange data.

[0037] The first module 100 includes, in particular, attachment and tightening means 110 for the system 1 to a limb (which will be called a strap 112 or bracelet), and the second module 200 includes a capsule 220 that incorporates microneedles 210 configured for insertion into the skin (into a superficial part of the epidermis). These microneedles 210, when the first module 100 is in position on the limb, allow for the collection and / or analysis of a bodily fluid, as mentioned previously.

[0038] The microneedles advantageously consist of an array of microneedles 210 in contact with the skin when the capsule 220 is placed on a person's body. The microneedles 210 can therefore be either hollow, for collecting fluid, or solid, for directly analyzing the fluid. In the first case, typically, the microneedles 210 allow for the painless extraction of interstitial fluid from the dermis without bloody beading, and deliver it to a sensor in system 1 (more precisely, preferably in the second module 200). In the second case, the microneedles 210 do not collect fluid and instead incorporate the sensor on their surface, in the form of a biochemical material capable of reacting with the analyte to be measured in the fluid.In the case of perforated microneedles forming a channel in each microneedle, sampling can be performed by fluidically connecting an interstitial fluid pumping system to the channel, or simply by capillary action. An analytical system may consist of microneedles, each equipped with an electrode or a set of electrodes, or may be positioned downstream of the microneedles, so as to induce an electrochemical reaction suitable for detecting an analyte in the interstitial fluid.

[0039] Preferably, said microneedles comprise between four and fifty microneedles, substantially pyramidal, with tips of a height between 100µm and 1000µm, preferably 0.3mm and 0.8mm. Each of these advantageous characteristics of the 210 microneedles can be taken separately or in combination with the others.

[0040] The two modules 100 and 200 each have a coupling face 122, 222, of complementary shape, which allows the second module 200 to be placed in a location intended for the first module 100

[0041] Finally, the first module 100 and the second module 200 are configured to be coupled by a separable link 300.

[0042] As illustrated on the Figures 1 And 4 ,The first module 100 also includes a housing 120 containing data processing means (in particular a processor or a microcontroller) configured to process measurements acquired by the sensor, and, where applicable, data storage means (notably memory, particularly flash memory, and / or the microcontroller's memory) allowing, for example, the storage of these measurements and / or the date of first use of each sensor to calculate an expiration date for the sensor(s) (biochemical sensors have a limited lifespan). The data processing means also serve to generate instructions for different components. For the purposes of this description, these different functions are performed by a single unit. However, it is possible to provide dedicated processors.The system also includes a battery for powering the components, advantageously rechargeable, for example via a port (which can also be used to connect system 1 for example to a computer to download the acquired and / or processed data).

[0043] Preferably, system 1 may include wireless connection means (in particular WiFi type, but also Bluetooth, or even 3G / 4G) for connection to a network, in particular the internet, and a user interface such as a screen 113, possibly touch-sensitive, to display the monitoring results to the user.

[0044] The person skilled in the art is familiar with algorithms for processing measurements from sensors 24 and associated interfaces, and will be able to implement them in the present system 1.

[0045] The housing 120 also includes electrical connectors, on its coupling face 122, which couples with the coupling face 222 of the capsule 220.

[0046] The capsule 220 of the second module 200 has a closed, typically sealed, box shape that can be coupled with the housing 120. This capsule 220 is interchangeable, resulting in an economical and efficient system where only the consumable parts need to be replaced. The capsule 220 can be annular in shape, with a through-hole 224 in the center. In a previously mentioned variant, the sensor is positioned inside the capsule 220 (or within the housing 120) and analyzes the fluid drawn by the microneedles. The capsule 220 includes electrical connectors 226 on a coupling face 222 with the housing 120, which can cooperate with the electrical connectors of the housing 120. If fluid is transferred from the second module to the first, then additional fluid connectors are provided on the capsule 220 and the housing 120.

[0047] Finally, the second module 200 includes a patch 250, removably attached to the capsule 220, which is described in detail below.

[0048] The second module 200 (capsule 220 and patch 250) forms an interchangeable set of the system which is chosen according to the type of monitoring required and depending on the state of deterioration of the microneedles 210 and / or the sensor.

[0049] Indeed, since capsule 220 contains microneedles 210 and / or the sensor (especially in the case of microneedles that collect samples), changing capsule 220 allows you to change the equipment if it is at the end of its life or if you want to change the physical quantity being measured, in a simple, quick and safe operation, without having to throw away other parts (in particular the first module 100).

[0050] And because the 220 capsule minimizes the amount of expensive components and / or materials (advanced electronic equipment such as a battery or wireless communication means), it is relatively inexpensive. Patch 250 ( figures 2a, 2b and 3)

[0051] The 250 patch acts as an adhesive to hold the 210 microneedles in place under the skin. Since the 220 capsule is attached to the 250 patch, it benefits from the patch's adhesive properties to remain firmly attached to the skin.

[0052] The inexpensive 250 patch can be changed more frequently than the 220 capsule. This is made possible by the removable attachment between the 250 patch and the 220 capsule.

[0053] It is designed to look like a bandage, so that people who wear it do not feel stigmatized by wearing an unusual item.

[0054] Patch 250 has a length L between 3cm and 10cm, a width I between 3cm and 10cm and a thickness e between 0.1cm and 1cm.

[0055] The patch 250 comprises a main body 251 with an opening, called the central opening 252, configured to receive the capsule 220, and advantageously an adhesive 260 (if the patch material(s) do not already function as an adhesive, for example). By central, it is understood that the central opening 252 is entirely within the main body 251, and not on an edge. However, "central" does not necessarily mean "centered": the central opening 252 may not be centered on the main body 251.

[0056] The 252 orifice is at least 2mm in diameter (so it is not a micro-orifice which allows the patch to be ventilated).

[0057] The main body 251 comprises two zones: a rigid zone 256, which extends around the central opening 252, and a flexible zone 258, which extends at least on either side (preferably all around) of the rigid zone 256. The flexible zone 258 extends essentially along two opposite sides of the rigid zone 256 in the longitudinal direction L, to conform to the curvature of the limb. Preferably, however, the flexible zone 258 lies all around the rigid zone 256, with a greater length in the longitudinal direction L (between 1 and 3 cm, for example) than in the width direction (between 0.2 and 0.5 cm, for example).

[0058] The rigid 256 and flexible 258 zones correspond to different portions of the patch.

[0059] The rigid zone 256 is solid and difficult to bend under normal use with fingers. Conversely, the flexible zone 258 bends easily, almost under its own weight.

[0060] The rigid zone 256 and the flexible zone 258 do not have the same thickness. Preferably, the rigid zone 256 is twice as thick, or even three times as thick, as the flexible zone 258. The flexible zone 258, on the other hand, is as thin as possible, for two reasons: grip and shock absorption.

[0061] Indeed, like a bandage, its flexibility allows it to conform to the contour of the limb, and in particular the wrist, which ensures good adhesion.

[0062] Furthermore, to prevent the unintentional removal of the microneedles 210 from the skin, it is important that the pulling forces exerted on the patch 250 are not transmitted to the capsule 220. In this respect, the flexibility of the soft zone 258 ensures that no torque or force is transmitted to the rigid zone 256 and therefore to the capsule 220. The thinness of the soft zone 258 also makes it invisible in use and therefore less likely to be accidentally removed.

[0063] Conversely, the rigid zone 258 has the function of holding the capsule 220 in place and transmitting to it the holding forces which it receives from the second module 200, which presses on the rigid zone towards the skin.

[0064] The 250 patch, with its rigid and flexible zones, thus fulfills two important functions of the 250 patch.

[0065] Viewed from the side ( figure 3 ), patch 250 has a flat side, configured to be in contact with the skin, and a non-planar side, because of the rigid area 258, configured to be in contact with the first module 100.

[0066] The rigid zone 256 has a shape, in the plane, similar to the shape of the case 120, so that when system 1 is worn, the rigid zone 256 is concealed by the case 120 and the bracelet 110. On the figures, This shape is rectangular with rounded corners.

[0067] The rigid zone 256 and the flexible zone 258 are typically made of two materials (e.g., polymers) with different physical characteristics. The Shore hardness of the rigid zone 256 is, for example, between 40 and 60, while the Shore hardness of the flexible zone 258 is, for example, between 20 and 40. The difference in rigidity is achieved either by a different thickness, by a different choice of material, by the same material with different properties, or by a combination of these two criteria.

[0068] For example, the flexible area 258 is made of silicone and the rigid part is made of another plastic (added part).

[0069] For example, the rigid zone 256 is also made of silicone, which is more rigid.

[0070] In one embodiment, a rigid part is attached to a flexible layer to form the rigid area. In another embodiment, the flexible layer is attached around a rigid part. The 250 patch and the 220 capsule, breakability of the 250 patch.

[0071] Around the opening 252, the thickness of the rigid zone 256 is approximately equal to (or even the same as) the thickness of the capsule 220 (within approximately 5% of the thickness of the capsule 210). The flexible zone is thinner to conform to the shape of the limb and to minimize any inconvenience to the user in their daily life. Indeed, in the case of a wrist, the capsule 220 is positioned on a relatively flat area of ​​the limb, while the flexible zone 258 of the patch 250 extends to the curve of the wrist.

[0072] To secure the capsule 220 to the patch 250 (or vice versa), the central orifice 252 includes, on its inner wall, a groove or point indentations 254. These function as notches to receive a protrusion 228 on an outer annular wall of the capsule 220. Preferably, the arrangement of the notches 254 and the protrusions 228 is such that it prevents the capsule 220 from rotating within the central orifice 252 of the patch 250. A preferred solution is to provide one or more point notches, which block rotation.

[0073] Furthermore, the rigidity of the rigid zone 258 allows the patch 250 to be cut on either side of the central opening 252, facilitating the insertion of the capsule 220: simply insert the capsule 220 against a portion of the central opening 252, then unfold the patch 250 to lay it flat. In this respect, a suitable choice of material for the rigid zone 256 may suffice, but there is a risk that the cut will not occur in the correct location. To remedy this problem, the rigid zone 256 includes a break line 257 that extends across its entire width (in the figures: along the width I), passing through the central opening 252. This break line 257 facilitates the rupture of the patch 250 for the insertion of the capsule 220, thus simplifying handling.Preferably, the break line 257 corresponds to an axis of symmetry of the opening 252 (with the notches 258 nearby), which is generally an axis of symmetry of the rigid zone 256 and the main body 251. The break line 257 is typically made by a groove on the surface of the rigid zone 256.

[0074] Because the capsule 220 is inserted by folding the central opening 252, the indentations in the inner wall of the central opening 252 are not arranged symmetrically with respect to the break line 257: in fact, the patch 250 is inserted onto one half of the folded central opening 252. Consequently, the arrangement of the grooves or indentations is adjusted accordingly. The 250 patch and the 110 lanyard / bracelet

[0075] When the two modules 100, 200 are assembled, the housing 120 and the patch 250 are in contact with the rigid area 256 which is around the opening 252 (see figure 4 ). This allows for an initial resumption of effort towards capsule 220, via patch 250.

[0076] More specifically, according to the embodiment illustrated on the Figures 1 , 2a And 3 ,In order to also have the bracelet or strap 210 exert pressure on the patch 250 (to hold it against the skin), the rigid area 256 includes, at its lateral ends, a notch 259 in the rigid area 256, which is characterized by a reduced thickness (but typically always greater than that of the flexible area 258). Additionally, the bracelet 110 includes, on each side (preferably on all four sides in the case of a rectangular shape or around the entire periphery in the case of a circular or oval shape), a tab 111 which is positioned above the notch 259 (and below the case 120). The tab 111 and the notch 259 are narrow, a few millimeters wide, but extend along the entire length of the rigid area 256.

[0077] In this description, unless otherwise stated, references to the thickness of the rigid zone 256 refer to the thickness in the absence of a step. We can thus define a main region of the rigid zone 256, which has the maximum thickness (approximately equal to that of the capsule), and a secondary region of the rigid zone 258, which corresponds to the step 259, and which has a lesser thickness.

[0078] The force transfer via the 110 bracelet offers two advantages: the first advantage is that the force comes from the 110 bracelet itself, which is tightened on the wrist or limb (direct transmission), and the second advantage is that system 1 can be worn without the 120 case. Therefore, to properly hold the 250 patch, the force must be transferred by the 110 bracelet and not the 120 case. Adhesive

[0079] The adhesive 260 is in the form of a flat layer, opposite the flat faces of the rigid 256 and flexible 254 areas, on the side intended to be on the skin.

[0080] The 260 adhesive used is advantageously silicone-based due to its ability to be easily removed and reapplied, its minimal irritation, its suitability for showering, and its lack of residue on the skin. Furthermore, silicone performs very well in lateral pull-out situations and less so in tensile situations, but this tensile strength is provided by the wristband / strap. Alternatively, an acrylic-based adhesive can be used, which has a stronger bond than silicone but is not removable and reappliable.

[0081] To protect the adhesive of patch 250 (packaging, transport, etc.), adhesive 260 can be covered with a layer of peelable paper. Breathability

[0082] To facilitate skin respiration and prevent maceration, the main body 251 includes a plurality of through-holes 270, both in the flexible and rigid areas. The openings have a diameter of between 0.1 and 2 mm. Similarly, the adhesive 260 includes through-holes (not visible in the figures) to allow air to circulate from the skin.

[0083] To ensure that the openings in the adhesive 260 communicate with the openings 270 in the main body 251, the density of the openings in the adhesive is greater than that of the openings 270 in the main body 251 and the size of the openings in the adhesive is less than that of the openings 270 in the main body 251. Thus, any overlap of the adhesive on the main body generates communication between the openings, without it being necessary to try to align the openings with each other.

[0084] Finally, for aesthetic reasons (absence of skin visibility when the patch is worn alone), the openings of the main body can be angled (relative to a plane formed by the 250 patch when it is laid flat). Marker

[0085] Finally, patch 250 includes a distinctive feature 272 near the opening to facilitate the orientation of capsule 220 within patch 250. This distinctive feature is represented by an arrow 272 in the figures. Two arrows 272 may be provided, one on each side, depending on the orientation of capsule 220. A similar feature may be present on capsule 220. The features between patch 250 and capsule 220 are preferably identical or symmetrical.

[0086] The distinctive markings 272 can be found under patch 250, on the skin side. Similarly, the markings between patch 250 and capsule 220 are preferably identical or symmetrical.

[0087] The direction of the arrow may change between the two sides of the patch so that visually the user can put the capsule in the right direction (i.e. put the microneedles on the skin side of the patch). Fixing

[0088] To be able to attach the patch 250 to the housing 120, magnets or ferromagnetic materials 304 can be located in the rigid area 256, preferably regularly around the opening 252. Patch kit

[0089] Due to its function, the 250 patch needs to be changed more frequently than the capsule. Therefore, it may be supplied in multiple identical copies. Alternatively, because the 250 patch must be adapted to the circumstances (skin type, limb size, conditions of use), the width and / or length and / or adhesive properties may differ between two patches in the kit.

[0090] In addition, different capsules can be used, with different shapes: the patches can therefore have 252 different orifice shapes.

Claims

1. A body monitoring system (1) intended to be attached to a limb, comprising: - a patch (250) comprising a main body (251) with an orifice (252) of at least 2 mm in diameter, the main body (251) comprising a flexible area (258) on which a rigid area (256) is arranged, the rigid area (256) being positioned around the opening (252), - a capsule (220), the capsule (220) being configured to be placed in the opening of the patch (250) and to be secured thereto, the capsule (220) comprising microneedles (210) configured to be inserted into the skin to sample or analyze a body fluid of the wearer of a body monitoring system (1) when the latter is positioned on a limb of a user, - a housing (120) adapted to be coupled with the capsule (220) inside which there is a battery and a processor, the processor being configured to process data obtained using the sample or the measurement performed by the microneedles (210), - a strap, configured to hold the housing (120) in place on the limb, the system being configured such that the capsule (220) is positioned within the central orifice (252) of the patch (250) and such that the orifice (120) is in contact with the rigid area (256) of the patch (250), so as to transmit the forces from the strap to the patch (250), thereby keeping the needles inserted through the capsule (220) attached to the rigid area (256) of the main body (251) of the patch (250.

2. The system of claim 1, wherein the capsule (220) has a thickness identical to the thickness of the rigid area (256) of the main body (501) of the patch (250).

3. The system of any one of claims 1 to 2, wherein the rigid area (256) has a Shore hardness greater than the flexible area (258), for example a Shore hardness comprised between 20 and 40 for the flexible area (258) and a Shore hardness comprised between 60 and 80 for the rigid area (256) or the material of the rigid area (256) is harder than the material of the flexible area (258), the two materials being different.

4. The system of any one of claims 1 to 3, wherein the rigid area (256) is at least twice as thick as the flexible area (258), preferably at least three times as thick.

5. The system of any one of claims 1 to 4, comprising a planar adhesive substantially covering a planar face of the rigid (256) and flexible (258) areas.

6. The system of claim 5, wherein the adhesive (260) is a silicone-based or an acrylic-based adhesive.

7. The system of any one of claims 1 to 6, wherein the flexible area (258) comprises a plurality of through openings.

8. The system of any one of claims 1 to 7, wherein - the main body (251), preferably the flexible area (258), comprises a plurality of through openings (270), and - the adhesive (260) comprises a plurality of through openings, - the size of the openings (270) of the main body (251) being greater than the size of the openings of the adhesive (260), and / or the opening area density (270) of the main body (251) is greater than the opening area density of the adhesive (260), and / or the opening density (270) of the main body is greater than the opening density of the adhesive (260).