WO2019141743A1

WO2019141743A1 - Body-monitoring system with adhesive

Info

Publication number: WO2019141743A1
Application number: PCT/EP2019/051075
Authority: WO
Inventors: Luc Pierart
Original assignee: Pkvitality
Priority date: 2018-01-16
Filing date: 2019-01-16
Publication date: 2019-07-25
Also published as: FR3076703A1

Abstract

The invention proposes a body-monitoring device, comprising at least one needle (25) and at least one sensor (24) for a physical parameter of bodily fluid, the sensor being configured to measure a physical parameter of the fluid, in which: - the needle (25) and the sensor (24) are part of a capsule (3) configured to engage removably with a casing (2), and the device additionally comprises an adhesive (80) configured to make the capsule (3) adhere to the body.

Description

Body monitoring system with adhesive

GENERAL TECHNICAL FIELD

The present invention relates to microfluidics. More specifically, it relates to a body monitoring system via body fluid analysis, typically interstitial.

STATE OF THE ART

Some pathologies such as diabetes require daily monitoring of biochemical parameters of the human body, i.e. concentrations of certain compounds (glucose in the example of glucose).

For this, it is common to stitch a point of the skin so as to bead a drop of blood, and analyze this drop either reactively (for example with a strip), or electronically (for example by less than an analytical sensor), so as to estimate the target parameter or parameters.

Evolved systems that are much less invasive today are content with analyzing the interstitial fluid, that is to say the fluid that fills the space between the blood capillaries and the cells. It has indeed an ionic composition close to that of the blood plasma.

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 collect.

In particular, it has been proposed a device worn on the wrist called GlucoWatch, implementing a phenomenon called iontophoresis (or iontophoresis) in which electric field allows "to attract" the interstitial fluid through the skin to a sensor on the wall of the device. However, this concept was quickly abandoned as only 6% of patients withstood the pain of electrical extraction. In addition, the results of the measurements were unreliable. Transcutaneous probes were alternatively provided in the form of a self-adhesive patch plating a "needle-sensor" just under the skin, so as to put the sensor in permanent fluid communication with the interstitial fluid, for continuous monitoring.

Some of these patch-type transcutaneous probes comprise wireless communication means making it possible to trace the measurements on the interstitial liquid, for example to a mobile terminal, for storage and processing (verification of thresholds and variations, production of statistics, triggering of alerts if necessary, etc.). Examples include sugarBEAT ™ or FreeStyle Libre systems.

Such systems provide satisfaction (the patches are much more reliable and less painful than iontophoresis devices), but prove to be restrictive and expensive because of the single-use patch, which must be changed regularly. In addition patches tend to peel off, tear when changing clothes or makes sudden movements, and are very visible: the wearer can be branded as "sick".

It would be desirable to have a portable electronic alternative system that avoids the frequent use of patches, without pain, and without there being the slightest hygienic risk. Finally, it is important to find a system that hinders the user as little as possible in his daily life.

PRESENTATION OF THE INVENTION

The present invention thus relates to a body monitoring device, comprising at least one needle, at least one sensor of a physical body fluid quantity, the sensor being configured to measure a physical quantity of the fluid,

in which:

the needle and the sensor are part of a capsule configured to engage with a housing removably,

the device further comprises an adhesive configured to adhere the capsule to the body, wherein the device further comprises a patch, said patch being attached to the capsule, the adhesive being disposed on the patch.

The body fluid may be interstitial fluid or blood, for example.

The device may include the following features, taken alone or in combination:

the one or more needles are transcutaneous sampling means for body fluid and the device comprises a fluidic circuit comprising the needles,

the adhesive is placed on the capsule or on the patch,

said patch is removably attached to the capsule,

said patch is non-releasably attached with the capsule,

the patch comprises a rigid portion with an opening, said opening receiving the capsule, the rigidity making it possible to ensure the interface and the maintenance of the connection between the capsule and the patch,

the removability of the patch is permitted thanks to at least one clipable lug on the patch which engages with an edge of the capsule,

- The patch is annular or U-shaped, inside which the needle or hands,

the patch is in a rigid or semi-rigid material, for example plastic, or flexible, such as rubber,

the patch has a maximum dimension less than or equal to 75 mm, or 65 mm, or 50 mm, preferably 40 mm,

the capsule has a contact face, preferably flat, on which are the needle or needles, and wherein the patch can extend beyond the contact face and covers a portion of the housing by engaging in a footprint of the case,

the sensor is located at the end of the needle or needles configured to be inserted into the body,

the sensor is in the form of a coating disposed on the needle or needles, and the latter are preferably solid, the adhesive can be removed from the patch, in order to deposit a new adhesive,

- The adhesive comprises a tab to be able to remove the adhesive from the patch.

The invention also proposes a body monitoring system, comprising

a housing, comprising an electrical connection or a wireless link,

a device as described above, in which the capsule is configured to engage the housing removably.

The system may include the following features, taken alone or in combination:

the casing is detachable from the capsule even when the system is worn, that is to say detachable without touching the capsule and / or without having access to a contact surface,

the housing comprises data processing means configured to process measurements acquired by said sensor,

the housing comprises reusable body attachment means.

The invention also proposes a kit comprising a system as described above, and comprising at least one other patch, the two patches each having an adhesive with identical or different adhesive forces, or comprising at least one other adhesive, the two adhesives having identical or different adhesive forces.

PRESENTATION OF FIGURES

Other features and advantages of the present invention will appear on reading the following description of a preferred embodiment. This description will be given with reference to the appended drawings in which: FIG. 1 illustrates a diagram representing a system comprising a capsule, a case and a patch placed on the capsule,

FIGS. 2a to 2c show three-dimensional views of the engagement of the capsule in the housing,

FIGS. 3a to 3c show a three-dimensional view of the patch, and of the capsule and the patch,

FIG. 4 represents the housing alone,

FIG. 5 represents the housing, the capsule and the patch,

- Figure 6 illustrates a sectional view of the housing and the capsule.

DETAILED DESCRIPTION

General Architecture

Two general system architectures can be used in particular in the context of the invention.

Referring to Figure 1, and Figures 2a, 2b and 2c, which show a general scheme, the present invention relates to an electronic body monitoring system 1 according to a first embodiment.

A second embodiment will also be presented (but not shown).

By body monitoring means the verification of biochemical constants of a person carrying system 1, typically the concentration of a protein, a hormone, a marker, oxygen, nutrients, etc., in the interstitial fluid of the person. An example is blood glucose. Those skilled in the art will be able to monitor other physical body quantities such as temperature, hydration, etc. if necessary.

The description will be illustrated with interstitial fluid but applies to other body fluids such as blood. As will be explained hereinafter, the system 1 is separated into two modules in particular: a housing 2 and a capsule 3. The term device will be used particularly with regard to the capsule 3.

The system 1 thus comprises at least one sensor 24 of a physical quantity of the interstitial liquid, in particular a sensor of a "biochemical" nature, that is to say allowing the analysis of the interstitial liquid, in particular by detecting a compound, for example thanks to several electrodes in contact with the interstitial liquid, and advantageously at least a second sensor such as a temperature sensor for adjusting the analysis of the interstitial fluid removed (taking into account the viscosity of the fluid as a function of temperature) .

The system 1 also comprises data processing means 11 (in particular a processor or a microcontroller) configured to process measurements acquired by the sensor 24, and possibly data storage means 12 (in particular a memory, particular flash type, and / or the memory of the microcontroller) allowing for example to store these measurements, and / or a date of the first use of each sensor 24 to calculate an expiry date of the sensor or sensors 24 (the biochemical sensors have a limited life). The data processing means 11 are also used to generate instructions to different components. As part of this description, these different functions are provided by the same unit. However, it is possible to provide dedicated processors. The system 1 also includes a battery for powering the components, advantageously rechargeable, for example via the port 10 (which is understood that it can also be used to connect the system 1 for example to a computer to download the data acquired and / or processed).

Preferably, the system 1 may comprise wireless connection means (in particular of the 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, possibly touch to display the results of monitoring to the user. It will be understood that one skilled in the art knows algorithms for processing sensor measurements 24 and associated interfaces, and will be able to implement them in the present system 1.

- First embodiment

The system 1 comprises pumping means 21 A, 21 B. These are advantageously part of the device. They will be detailed later.

The system 1 comprises needles, in the form of transcutaneous sampling means 25, configured for sampling interstitial fluid under the skin of the user. The needles are hollow.

The system 1 comprises a fluid circuit 20 on which are disposed the transcutaneous sampling means 25 interstitial fluid, said sensor

24, an absorbent foam 21 B called measuring foam, which stores the liquid for analysis by the sensor 24 and which can serve as pumping means and optionally an intermediate foam 21 A, located between the transdermal sampling means 25 and the foam of measure 21 B, to pump. In one embodiment, the absorbent foam 21A, 21B acts as a pump for sucking the interstitial fluid by the transcutaneous sampling means.

25.

It is also possible to provide a discharge foam, downstream, whose function is to empty the measuring foam 21 B with a controllable hydrophilicity (for example by means of heating means such as a resistor). The French patent application in the name of the same applicant filed concomitantly with the present application, entitled "Body monitoring system with double foam" describes such a system (with a reference 21 C for the exhaust foam). The other numerical references are identical.

Said transcutaneous sampling means 25 interstitial fluid advantageously consist of a network of micro-needles in contact with the skin when the device is placed on the body of a person (see how further). The micro-needles allow the extraction of interstitial fluid from the dermis painlessly without bleeding blood.

Preferably, said transcutaneous sampling means 25 comprise between four and sixteen or twenty-five microneedles (in particular four, nine or sixteen in the form of a square), substantially pyramidal, with peaks of a height of between 0.3 mm and 0.9. mm, each with a hole with a diameter between 0.04 and 0.22mm. Each of these advantageous features of the micro-needles can be taken separately or in combination with the others.

The absorbent foam 21 A or 21 B causes transcutaneous extraction (through the epidermis) via the transcutaneous fluid sampling means interstitial from the body (the dermis under the epidermis), its circulation through the circuit 20 to upon arrival at the absorbent foam 21 B thus allowing to store it. Finally, this foam is brought into contact with the sensor 24 which will analyze the interstitial liquid. The evacuation of the liquid from the foam is done by evaporation (the foam is advantageously in exchange with the atmosphere, in particular through a porous gas fabric, so as to allow this evaporation, but advantageously liquid-tight (for example polytetrafluoroethylene base) so as to avoid the penetration of liquids such as sweat from the outside).

The system 1 may also comprise an electrode assembly 40, comprising an electrode 41 and an electrode 42 (coinciding with one or more needles of the transcutaneous sampling means 25) for measuring the conductivity of the skin and / or causing electrophoresis under the skin to accumulate the interstitial fluid at the level of the transdermal sampling means 25. The French patent application on behalf of the same applicant filed concomitantly with the present application, entitled "Body monitoring system with electrophoresis" describes such a system. The numerical references are identical.

The system 1 may also comprise a conductivity meter 44, which makes it possible to know whether the foams 21A or 21B are soaked with liquid. In particular, the conductimetry of the foam 21 B (which may be mobile, not illustrated here: see the French patent application entitled "Body monitoring system with mobile foam", filed concurrently with the present application by the same applicant. The numerical references are identical).

- Second embodiment

In another embodiment, the device comprises at least one needle (preferably a plurality), which act as piercing means of the skin. On the needle or hands are positioned one or sensors, typically in the form of a coating (chemical sensor) at the end of the needle which is inserted into the body.

In this embodiment, there is therefore no transcutaneous fluid sampling. The measurement obtained by the sensor is then recovered and processed. Yoon et al. ("Fabrication of a Microneedle / CNT Hierarchical Micro / Nano Surface Electrochemical Sensor and Its In Vitro Glucose Sensing Characterization", in Sensors 2013, 13 (12), 16672-16681; doi: 10.3390 / s131216672) describes a type of sensor- needle.

The electrophoresis mechanism can be applied here by providing needles for electrophoresis (see patent application cited above: "Body monitoring system with electrophoresis").

The needles are then usually full, but they can also be hollow.

Apart from the fluidic circuit and the elements that form it that are no longer present, the rest of the measuring system 1 is applicable to this embodiment (processing means, connectivity, etc.).

Capsule and box

The remainder of the description is made for the first embodiment, but is applicable immediately to the aforementioned second embodiment. Unlike known systems, the system 1 is integral. This means that there is not a main module such as a mobile terminal connected wirelessly to a bulky and expensive secondary module (because of the need to equip it with a battery, wireless communication means , etc.) in the form of a patch stuck to the skin. The system 1 is thus autonomous.

To be used, it is either plated on the skin as needed by the user for a few seconds (it is in this case devoid of any means of attachment to the body), or directly worn on the body, in particular on a limb, and preferentially on the wrist. The system 1 then takes the form of a watch, with a face F against the skin of the arm, and an opposite face accommodating for example a screen.

As such, it advantageously comprises reusable body attachment means, typically consisting of a strap or a bracelet configured to surround the member (and not a sticky element), in particular a wristwatch. "Reusable" means here in effect as opposed to "single-use" as was the case with patches, which can not be reused after being peeled off the skin and must be discarded. A bracelet can be opened and closed many times.

The system 1 is configured so that when it is placed on the skin (ie when the attachment means attach it to the body) the transcutaneous sampling means 25 are held against the skin (or at least in the immediate vicinity) to allow the sample.

In all cases, as illustrated in FIGS. 2a, 2b and 2c, the system 1 contains two subsets:

the housing 2 in which at least the data processing means 11 (and also the main components such as the battery, the memory, the possible user interface, etc.) are arranged;

the capsule 3 in which are arranged the fluidic circuit 20, the sensor 24, the foams 21A, 21B (as preferentially explained in exchange with the atmosphere to promote the evaporation of the fluid and thus limit its stagnation, if appropriate via a window 26 through the capsule 3), the transcutaneous sampling means 25, the electrodes

41, 42, the conductivity meter 44, etc.

The capsule 3 is configured to engage with the housing 2 removably. The capsule 3 engages preferably in a cavity C of the housing 2 located on its face F intended to be in contact with the skin.

In other words, and as can be seen in FIG. 1 and FIGS. 2a-2c, which represent a preferred embodiment, the system 1 is composed of two modules 2, 3 but these modules are not physically separated as this could be the case in the prior art and are even in direct connection, mechanical.

The housing 2 and the capsule 3 respectively comprise for this purpose transmission means for transmitting electrical signals, such as wireless links (transmitter / receiver) without contact or electrical connections 12a and 12b (contacts) that can be seen particularly in Figures 2a and 2b, configured so that when the capsule 3 is engaged with the housing 2 said electrical connectors 12a, 12b provide a connection between the data processing means 1 1 and the sensor 24 (to trace the data of measures).

The capsule 3 thus constitutes an interchangeable subset of the system 1 which can be chosen according to the type of surveillance desired. Indeed, insofar as the capsule contains the sensor (s) 24, changing the capsule makes it possible to change sensors 24 if they are at the end of their life or if it is desired to change the measured physical quantity, in a simple manipulation. , fast and sure, without having to throw other parts (in particular limiter 2). Note that the capsule 3 very effectively preserves the sensors 24, and needs to be changed less often than a patch (the same capsule can be used a month).

And insofar as the capsule 3 contains neither "pump" (in the traditional sense of the term), nor advanced electronic equipment such as a battery or means of wireless communication, it is significantly cheaper than a patch.

The present system is therefore much more practical than the known systems of the prior art, but especially much cheaper to use, without there being the slightest hygienic risk, and without pain due to the insertion of a needle or strong electricity.

Advantageously, the capsule 3 is the only part of the system 1 that can be in contact with interstitial liquid, since it contains the pumping means in the form of absorbent foam 21 B (beyond which the fluid sampled can not rise) . Thus, the removable capsule prevents contamination of the housing 2 and can be used to replace the capsule 3 at the end of life of the sensors 24 or change the type of capsule 3 in a simple, fast and safe, without having to throw other parts.

A contact face FC is defined at the capsule 3. This is the face which is free to be on the side of the skin, when the capsule 3 is engaged in the housing 2. The contact face FC partially comprises the means The FC contact face of the capsule 3 and the face F of the casing are generally substantially level (with the patch - see below) and generally form a flat surface (with the exception of the sampling means). transcutaneous 25).

The adhesive

The device comprises an adhesive 80 on the FC contact face side of the capsule (Figure 1 and not visible in the other figures). This adhesive 80 makes it possible to hold the capsule 3 in place on the wrist, even in the absence of the case 2.

With this, it is possible, when the system 1 is worn, to detach the housing 2 without removing the capsule 3 and keeping it glued against the body. Such a configuration makes it possible to avoid removing the capsule 3 for certain tasks that involves only box 2: battery charging, repair, replacement, data extraction to a computer, etc.

Thus, the needles are held down when removing the housing 2, which avoids having to clean and re-insert each time the adhesive is removed.

The adhesive 80 is hypoallergenic and known per se, as used on the existing patches described in the prior art.

The patch

In a preferred embodiment, the device comprises a patch 90, that is to say a wafer or a piece of generally flat shape which is fixed at the contact face FC of the capsule 3 in a removable manner (FIGS. 3a, 3b and 3c). The term "patch" used here is to be distinguished from the term patch used for the description of the prior art.

The adhesive 80 is then positioned on the patch 90: one face of the patch 90 is attached to the contact face FC of the capsule 3 and an opposite face of the patch 90 is at least partially covered with adhesive 80.

Thanks to this, it is also possible to remove the capsule 3 without having to tear a sticky element of the skin, since the patch 90 is not necessarily removed.

This provides a modularity that improves the usability of the system according to the different situations of everyday life. To load the case 2, the user keeps the capsule 3 stuck with the patch 90 and the adhesive 80. To bathe in the sea or in a swimming pool, the user can keep only the patch 90 and remove the capsule 3 and the case 2. Alternatively, it can also remove the patch 90. In addition, the patch 90 allows the user to keep the same location on the skin for the insertion of the transcutaneous sampling means 25. It thus serves as a positioning guide.

In order to allow the transcutaneous sampling means 25 to be on the skin, the patch 90 comprises a through central opening 91: in this way, the patch 90 can still surround said means 25 (Figure 4).

The patch 90 can be removably mounted on the capsule 3 in different ways.

In a variant, the patch 90 comprises a tongue 92, in the form of an elongated protuberance which cooperates with a recess 36, in the form of groove 36 of substantially complementary shape present on the contact face FC of the capsule 3. The tongue 92 may have a closed or open form.

In a variant, the tongue 92 is a point protrusion, and the recess 36 is in the form of a blind hole. A plurality of tabs 92 and recess 36 are then provided.

In these cases, the engagement is done simply by forcing slightly.

In a variant, the patch 90 comprises one or more clipping lugs 94 which snap, by deformation of elastic elements, to the contact face FC of the capsule (FIGS. 3a, 3b).

In a variant, the patch 90 is screwed.

In another embodiment, the patch 90 is secured to the capsule 3, in that it is not removably mounted. In other words, the patch 90 and the capsule 3 are manufactured, assembled, and then delivered to the user without the latter being able to separate the capsule 3 from the patch 90 or be encouraged to separate the capsule 3 from the patch 90.

Whether the patch 90 is designed to be removably mounted or not, it advantageously comprises a rigid portion configured to be at the interface with the capsule 3. By rigid means at least that the portion does not deform substantially under its own weight.

More specifically, the rigid portion comprises a through opening configured to receive the capsule 3. The thickness of the rigid portion is substantially equal to the thickness of the capsule 3.

The patch 90 advantageously has the shape of a ring (of circular or square shape, generally depending on the shape of the capsule 3) or a torus or a U, with the central recess 91 to allow the passage of the transdermal sampling means 25 and optionally electrodes 41, 42.

In one embodiment, the capsule 3 comprises a protuberance 37 configured to extend in the center of the ring-shaped patch 90. This configuration is convenient if the thickness of the patch 90 is greater than the free length (that is to say outside the capsule 3) of the transdermal sampling means 25. By definition, the contact face FC then comprises not this protuberance 37.

The patch 90 preferably extends in the plane beyond the contact face FC of the capsule 3 (as illustrated in FIGS. 3c and 5).

In the same way, the patch 90 preferably covers the entire contact face FC of the capsule 3 (and also, as previously indicated, only the contact face FC), with the exception of the areas where needles or electrodes are present. as the transcutaneous sampling means 25 or the electrodes 41, 42.

The patch 90 can be removed from the wrist by tearing. This step is painful but it is much less frequent than on existing technologies since the capsule 3 can be changed without having to remove the patch 90.

The patch 90 is reusable and a new layer of adhesive 80 must then be redeposited. For this, an adhesive film 80 of similar size to that of the face patch 90 in contact with the skin is deposited. A tongue of the gripping tongue type is advantageously provided.

It is also possible to simply change everything, which is the simplest option for the user: just set up a new patch that already includes the adhesive. Such a patch allows to directly manipulate the housing 2 to remove the glue and / or put it back.

In both cases, the strength of the adhesive can be chosen by the user.

A kit is defined which comprises at least two adhesives with different adhesive properties (for example an adhesive which is more resistant to very humid environments, for a journey, etc.) or which comprises at least two adhesives with the same adhesive properties ( to make a simple replacement).

In order to be worn on the wrist, the patch 90 has a maximum dimension of less than or equal to 75 mm, preferably 65 mm, or even 50 mm (generally from the side, since the patch has a substantially square or rectangular shape, for example of square shape 50 × 50 mm or round diameter 50mm), or even 40mm, for a thickness of less than 6mm, preferably 4mm.

Due to the small thickness of the patch 90, the face F of the housing 2 can be level with the capsule 3 (see Figure 1 high) or with the patch 90 (see Figure 1 lower part), or between the two (see figure 1 middle part). In the latter case, the patch 90 extends partially inside the cavity C.

The preferred embodiment is that in which the housing 2 is level with the patch 90, as shown in FIGS. 1, 4 and 5. In this case, the housing 2 comprises a cavity 2a of shape complementary to that of the patch 90. The cavity C is housed in the cavity 2a. The patch 90 is preferably rigid or semi-rigid because it is preferable that it does not deform. Plastic may be suitable. However rubber or other soft material may be suitable.

Removing the capsule without accessing the FC contact face

In order to remove the housing 2 without removing the device, it is expected that the capsule can be detached without having to access the face F of the housing 2, since it is pressed against the skin.

To this end, the device comprises a disengagement mechanism 29 accessible when the system 1 is worn, typically using a button located on a side wall of the housing 2.

Capsule change

The capsule 3 engages with the housing 2 according to two successive translational movements T1 and T2 (Figures 2a to 2c). The reverse movement makes it possible to disengage the capsule 3. The first movement T1 consists in bringing the capsule 3 towards the casing 2 to attach the electrical connectors 12a / b and the second movement T2 consists in sliding the capsule 3 along the casing 2 to engage the mechanical connection 70. The electrical connectors 12a / b are flexible (with spring for example).

Thanks to one or more abutments 3a (FIGS. 3b and 3c), once the T2 translation has been performed, the capsule 2 is locked in the direction of the translation T1. These stops 3a are wedged between the bottom of the cavity C and a rail 2b (Figure 2a). The rail 2b comprises one or more openings 3b to allow the translation T1, allowing the abutment (s) 3a to pass. At the end of the translation T2, as indicated above, the stops 3a are jammed and prevent movement in the direction of the translation T 1.

The disengagement mechanism 29 comprises in this embodiment a movable stop (FIG. 4) mounted movably on the housing 2, which makes it possible to lock the displacement of the capsule 3 according to the translation T2. During insertion, the capsule 3 presses the movable stop 29 which is not biased in its locking position. Once the translations T1 and T2 are completed, the stop 29 goes into the blocking position (by translation in the direction of the translation T1), either by action of the user, or by return means (not shown). The stop 29 in the engaged position is visible in Figure 2c.

To unlock the system, the user moves the movable stop 29, for example with the index, and with the thumb it pushes the housing 2 to perform a translation-T2 (inverse of the translation T2). Then simply pull the housing away from the wrist to perform the translation -T1 (inverse T1 translation).

During this operation, the adhesive may be particularly stressed, which can damage it. Thus, the patch 90 may comprise a tongue 96 which extends in the plane outside the housing 2. This means that when the system is worn on the wrist, the tongue 96 is visible on the skin. The tongue 96 is preferably located on the opposite side to the movable stop 29.

When the user performs the translation-T1, he can simultaneously press the tab 96 to press the patch 90 against the skin (for example with the thumb) and avoid over-stressing the adhesive.

This gives a reliable, fast and not very complex system for assembling a housing 2 and a capsule 3 without accessing the contact face of the system (in other words, instead of putting a capsule in the housing, the housing is placed on the capsule).

In this commitment or disengagement procedure, the capsule 3 is fixed and the casing 2 is movable (in a fixed wrist frame).

Claims

claims

A body monitoring device, comprising at least one needle (25), at least one sensor (24) of a physical body fluid magnitude, the sensor being configured to measure a physical quantity of the fluid, wherein:

the needle (25) and the sensor (24) are part of a capsule (3) configured to engage with a housing (2) removably,

the device further comprises an adhesive (80) configured to adhere the capsule (3) to the body.

characterized in that the device further comprises a patch (90), said patch (90) being attached to the capsule (3), the adhesive (80) being disposed on the patch (90).

2. Device according to claim 1, wherein the patch (90) is non-removably attached to the capsule (3).

3. Device according to any one of the preceding claims, wherein the patch (90) is removably attached to the capsule (3).

4. Device according to claim 3, wherein the removability of the patch (90) is permitted thanks to at least one snap lug on the patch (90) which engages with the capsule (3).

5. Device according to any one of claims 3 to 4, wherein the patch (90) is annular or U-shaped, within which pass or needles (25).

6. Device according to any one of claims 3 to 5, wherein the patch has a maximum dimension less than or equal to 75mm, or 65mm, or 50mm, preferably 40mm.

7. Device according to any one of claims 3 to 6, wherein the capsule (3) has a contact face (FC), preferably flat, on which are the needle or (25), and wherein the patch (90) extends beyond the contact face (FC) and is configured to cover a portion of the housing by engaging in a cavity (2a) of the housing (2).

8. Device according to any one of the preceding claims, wherein

the one or more needles (25) are transcutaneous body fluid sampling means and the device comprises a fluid circuit (20) comprising the one or more needles (25), and / or

the sensor (24) is in the form of a coating disposed on the needle (s) (25), and the latter are preferably solid.

9. Apparatus according to any one of the preceding claims, wherein the adhesive (80) can be removed from the patch (90), in order to deposit a new adhesive.

10. Device according to any one of the preceding claims, wherein the patch (90) comprises a rigid portion, said rigid portion being configured to be at the interface with the capsule (3).

1 1. Body surveillance system (1), comprising

a housing (2), comprising an electrical connection (12a) or a wireless link,

- A device according to any one of the preceding claims, wherein the capsule (3) is configured to engage with the housing (2) removably.

12. System (1) according to claim 1 1, wherein the capsule (3) is engageable with the housing (2) with two successive translations, preferably orthogonal to each other.

13. System (1) according to claim 10, comprising a movable stop (29) disposed on an outer face of the system (1) and configured to lock the capsule (3) in the housing (2) in the direction of the second translation. (T2).

14. System (1) according to any one of claims 11 to 13, wherein the housing (2) is detachable from the capsule (3) including when the system is worn, that is to say detachable without touching to the capsule (3) and / or without access to a contact surface (FC).

The system (1) according to any one of claims 11 to 14, wherein the patch (90) comprises a tab (96) extending beyond the case in the plane of the patch (90).

16. System (1) according to any one of claims 11 to 15, wherein the housing (2) comprises data processing means (1 1) configured to process measurements acquired by said sensor.

17. System (1) according to any one of claims 11 to 16, wherein the housing (2) comprises reusable body attachment means.

18. Kit comprising a system (1) according to any one of claims 1 1 to 17, and comprising at least one other patch, the two patches each having an adhesive with different or identical adhesive forces, or comprising at least one other adhesive, the two adhesives having different or identical adhesive forces.