BODY MONITORING DEVICE
The device addresses uneven microneedle penetration by using spacers and rotational alignment to ensure consistent skin contact, enhancing measurement accuracy and reliability in body monitoring devices.
Patent Information
- Application Number
- FR2021001486
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-02-16
- Publication Date
- 2024-12-20
- Estimated Expiration
- 2041-02-16
AI Technical Summary
Existing body monitoring devices with microneedles face issues of uneven penetration into the skin due to variations in user morphology, leading to measurement errors or unusable readings, particularly when worn on the wrist.
A body monitoring device with a housing and sensor configuration that allows for uniform microneedle contact with the skin by incorporating spacers to exert pressure and enable rotational movement, leveraging the sensor's morphology to align with the skin, and using complementary shapes to limit parallel movement, ensuring consistent penetration and electrical connectivity.
The device ensures uniform and stable microneedle insertion into the skin, reducing measurement errors and enabling continuous, accurate monitoring of biochemical parameters like glucose and lactate concentrations.
Smart Images
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Abstract
Description
Title of the invention: BODY MONITORING DEVICE FIELD OF THE INVENTION
[0001] The present invention relates to a device for body monitoring by analysis of body fluid, typically interstitial, for example using microneedles.
[0002] More specifically, the present invention relates to a device adapting to the morphology of the user. 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] 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).
[0005] Today we know of advanced systems that are much less invasive and 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.
[0006] 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.
[0007] Devices with microneedles are known, 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 permanent devices, where microneedles are held on the skin with an adhesive strip. However, we want to be able to carry out continuous or quasi-continuous monitoring, which requires autonomous devices. We can cite the GlucoWatch device, which used iontophoresis (and not needles).
[0009] The device of document WO2018104647 is also known, which has a housing comprising a removable capsule, the capsule accommodating microneedles configured to sample interstitial fluid. The housing, for its part, accommodates the majority of the electronics.
[0010] This portable device allows continuous measurement of an analyte in the user's body. This device comprises a capsule removably attached to a housing, which allows the user to change microneedles while keeping the housing.
[0011] However, when such a device is worn on the wrist, differences in the insertion of the needles into the skin can lead to measurement errors, or even unusable measurements, thus preventing the user from measuring a physiological or biochemical quantity. Statement of the invention
[0012] An aim of the invention is to propose a solution for manufacturing a system allowing at least part of the microneedles to be inserted or brought into contact uniformly in the skin of a user.
[0013] This aim is achieved within the framework of the present invention thanks to a body monitoring device, comprising: - a housing comprising a first face intended to be placed opposite the skin of a user, - means of attaching the box to a limb of the user, - a sensor, the sensor comprising a second face arranged opposite the first face and a third face intended to be opposite the user's skin, the sensor comprising at least one module configured to measure a physiological or biochemical quantity of the user, in contact with the user's skin and / or penetrating the user's skin, the measurement module being arranged at least partly on the third face, - the housing being configured to limit, preferably prevent, the movement of the sensor relative to the housing in directions parallel to the first face, - the sensor being movable in rotation relative to the housing when the sensor is in contact with the housing, around an axis of rotation parallel to the first face, - the housing comprising one or more spacers configured to exert a force on the sensor making it possible to move the sensor away from the first face when the sensor is in contact with the housing.
[0014] The invention is advantageously supplemented by the following characteristics, taken individually or in any of their technically possible combinations:
[0015] - the third face is opposite the second face with respect to the sensor,
[0016] - the housing and the sensor have a shape complementarity configured for limit the movement of the sensor relative to the housing in directions parallel to the first face,
[0017] - the spacer(s) are configured to exert pressure on the second face when the sensor is in contact with the housing,
[0018] - the measuring module comprises a microneedle adapted to be inserted into the user's skin,
[0019] - the spacer(s) comprise pins arranged between the first face and the second face, and each pin preferably comprises a fixed part attached to the housing or to the sensor and a part movable relative to the fixed part, the pin being configured to allow movement of the movable part relative to the fixed part in only one translation direction,
[0020] - the spacer(s) comprise at least one element having properties elastic, the element(s) being mounted fixed to the first face and / or to the second face,
[0021] - the spacer(s) comprise at least one spring, each spring being attached to the moving part of a spindle and the fixed part of a spindle,
[0022] - the spacer is configured to allow an electrical connection between the housing and the sensor,
[0023] - the device comprises an electrical connection between the housing and the sensor, the electrical connection comprising a pair, the pair comprising a pin and an electrical contact block, the electrical contact block having a connection face arranged on one element chosen from the second face of the sensor and the first face of the housing, and the fixed part of the pin being fixedly mounted to the other element chosen from the second face of the sensor and the first face of the housing,
[0024] - the device comprises a plurality of spacers, and the spacers are distributed asymmetrically strictly and non-concentrically on the first face, or on the second face opposite the second face,
[0025] - the device comprises a plurality of spacers, and the spacers are distributed uni formed on the first side or on the second side,
[0026] - the device comprises a plurality of spacers, and the spacers are distributed in concentrically with respect to the center of the first face and / or symmetrically on the first face,
[0027] - the spacer(s) are configured to allow a translation of an amplitude between 50 pm and 5 mm inclusive when the sensor is in contact with the housing,
[0028] - the device comprises at least one microneedle having a height h, and the spacers are configured to allow a translation of an amplitude between one twentieth of the height h of the microneedle and twice the height h of the microneedle,
[0029] - the sensor comprises a first zone having a first thickness average, the sensor comprising a second zone having a second average thickness, the first average thickness being strictly greater than the second average thickness,
[0030] - which at least one face chosen from the first face, the second face and / or the third face has a boss,
[0031] - the measuring module comprises at least one microneedle adapted to be inserted in the user's skin, the microneedle(s) being arranged in the first area,
[0032] - the device comprises a removable connection between the sensor and the housing,
[0033] - the removable connection comprises at least one magnet arranged in the housing or in the sensor. DESCRIPTION OF FIGURES
[0034] 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:
[0035] [Fig.l] [Fig.l] schematically illustrates a device according to one embodiment of the invention, in section.
[0036] [Fig.2] [Fig.2] schematically illustrates a device according to one embodiment of the invention.
[0037] [Fig.3] [Fig.3] schematically illustrates a device according to one embodiment of the invention.
[0038] [Fig.4] [Fig.4] schematically illustrates a section of a part of the device according to one embodiment of the invention.
[0039] [Fig.5] [Fig.5] schematically illustrates a section of a part of the device according to one embodiment of the invention.
[0040] [Fig.6] [Fig.6] schematically illustrates a section of a sensor having a boss according to one embodiment of the invention.
[0041] [Fig.7] [Fig.7] schematically illustrates a section of a sensor having a boss according to one embodiment of the invention.
[0042] [Fig.8] [Fig.8] schematically illustrates a section of a sensor having two bosses according to one embodiment of the invention,
[0043] [Fig.9] [Fig.9] schematically illustrates a section of a sensor according to a mode of realization of the invention.
[0044] Throughout the figures, similar elements bear identical references. DETAILED DESCRIPTION OF THE INVENTION
[0045] General architecture of device 1
[0046] With reference to [Fig.l], [Fig.2] and [Fig.3], a device according to one embodiment of the invention comprises a housing 2. The housing 2 comprises a first face 3 intended to be placed opposite the skin 9 of a user. Preferably, the first face 3 is a part of the wall of the housing 2 intended to be placed opposite a sensor.
[0047] The device 1 also comprises means 4 for attaching the housing 2 to a limb of the user. The attachment means 4 may comprise a bracelet or an armband. The attachment means 4 are adapted to keep the housing 2 in contact with the skin 9 of the user, and to cause pressure exerted by the housing 2 on the skin 9 of the user.
[0048] The device 1 comprises a sensor 5. The sensor 5 comprises a second face 6 arranged opposite the first face 3. The sensor 5 also comprises a third face 7 intended to be opposite the skin 9 of the user. The sensor 5 comprises at least one module 8 configured to measure a physiological or biochemical quantity of the user, in contact with the skin 9 of the user and / or by penetrating the skin 9 of the user. The measurement module 8 being arranged at least partly on the third face 7.
[0049] Preferably, the measurement module 8 comprises at least one microneedle 14 adapted to be inserted into the user's skin. Thus, it is possible to measure the concentration of an analyte in the interstitial liquid when the microneedle 14 penetrates the skin 9 and the microneedle 14 comes into contact with the interstitial liquid. Preferably, the module 8 comprises a network of microneedles 14. Preferably, when the module 8 comprises a plurality of microneedles 14, the microneedles 14 are distributed in a non-uniform manner, and preferably in a non-concentric manner on the third face 7. Preferably, the module 8 is arranged opposite the second face 6 relative to the sensor 5.
[0050] A microneedle 14 may comprise a surface treatment configured to react with an analyte of the user. Preferably, the surface treatment is configured to allow an electrochemical reaction between the analyte and a surface of the microneedle 14. Preferably, the analyte is chosen from glucose and lactate.
[0051] The housing 2 is configured to limit, preferably to prevent, the movement of the sensor 5 relative to the housing 2 in directions parallel to the first face 3. Thus, when the attachment means 4 are arranged on a limb of the user, the housing 2 exerts pressure both on the sensor 5 and on the limb of the user and prevents movement of the sensor 5 in directions parallel to the skin, which makes it possible to maintain the sensor 5 in position on the skin 9 of the user.
[0052] Preferably and with reference to [Fig. 1], the housing 2 and the sensor 5 have a complementary shape configured to limit, preferably for prevent the movement of the sensor 5 relative to the housing 2 in directions parallel to the first face 3. This complementarity of shape makes it possible to limit or even mechanically prevent the movements and displacements of the sensor 5 in directions parallel to the first face 3 when the sensor 5 and the housing 2 are in contact.
[0053] The sensor 5 is rotatable relative to the housing 2 when the sensor 5 is in contact with the housing 2, around an axis of rotation 11 parallel to the first face 3. By "rotatable", it is meant that the sensor 5 has freedom of rotational movement along the axis of rotation 11 allowing the sensor 5 to adapt to the morphology of the user's limb to which the device can be attached. Preferably, the sensor 5 can pivot by an angle greater than 2°, in particular greater than 5°, preferably greater than 8° relative to the housing 2 along the axis of rotation 11. Indeed, the inventors have discovered that there are locally notable differences between the morphology of the first surface 3 of the housing 2 when the device 1 is attached to a limb of the user and the morphology of the skin 9 opposite the housing 2.These differences in morphology between the two surfaces, that of the housing 2 and that of the skin 9, result in poor penetration of the microneedles 14 into the skin, or even no penetration at all. These irregularities in penetration of the microneedles 14 into the skin result in measurement errors, or even the impossibility of measuring an analyte in the interstitial fluid of the user. The device 1 is configured so that the sensor 5 aligns with the main plane of the skin opposite the sensor 5, in particular by rotation, so that the module 8, and preferably a portion of the microneedles 14 when the module 8 comprises microneedles 14, is in contact with the skin of the user, or is regularly inserted into the skin of the user.
[0054] The housing 2 comprises one or more spacers 13 configured to exert a force on the sensor 5 making it possible to separate the sensor 5 from the first face 3 when the sensor 5 is in contact with the housing 2. Thus, it is possible to combine the rotation of the sensor 5 relative to the housing 2 and pressure from the sensor 5 on the skin so as to press the module 8, and preferably the microneedles 14 or a portion of the microneedles 14 onto the skin. This has the effect of allowing at least a portion of the third surface 7 to be in perfect contact with a portion of the skin 9. The spacers 13 also make it possible to authorize a translational movement of the sensor 5 between the housing 2 and the skin 9 when the device 1 is in contact with the skin 9.
[0055] Spacers 13
[0056] With reference to Figure 1, [Fig. 3], and [Fig. 4], the spacer(s) 13 may be configured to exert pressure on the second face 6 when the sensor 5 is in contact with the housing 2. Thus, the sensor 5 transmits the pressure exerted by the spreaders 13 on the skin 9 via the module 8, and preferably the third surface 7 and the microneedles 14.
[0057] With reference to [Fig. 4], the spacer(s) 13 may comprise pins arranged between the first face 3 and the second face 6. Each pin 15 may comprise a fixed part 16 attached to the housing 2 or to the sensor 5 and a movable part 17 relative to the fixed part 16, the pin 15 being configured to allow movement of the movable part 17 relative to the fixed part 16 in only one translation direction. Thus, it is possible to use solid spacers, in particular made of metal, so as to transmit an electric current between the sensor 5 and the housing 2, and thus to be able to transmit the data relating to the measurement of the sensor 5 to the housing 2, and preferably to the processing unit included in the housing 2. Preferably, the spacer(s) comprise at least one spring 18, each spring 18 being attached to the movable part 17 of a pin 15 and to the fixed part 16 of a pin 15.Thus, the spring 18 can ensure electrical conduction between the fixed part 16 and the mobile part 17.
[0058] Preferably, the spacer 13 is configured to allow an electrical connection between the housing 2 and the sensor 5. The spacer 13 is preferably conductive, in particular metallic, so as to allow the electrical connection between the housing 2 and the sensor 5.
[0059] The device 1 may comprise an electrical connection 19 between the housing 2 and the sensor 5. The electrical connection 19 comprises a pair 20. The pair 20 comprises a pin 15 and an electrical contact block 21. The electrical contact block 21 has a connection face arranged on an element chosen from the second face 6 of the sensor 5 and the first face 3 of the housing 2, and the fixed part 16 of the pin 15 being fixedly mounted to the other element chosen from the second face 6 of the sensor 5 and the first face 3 of the housing 2. The contact block 21 may be manufactured by selective metal deposition, or by an electrical via.
[0060] The spacer(s) 13 may comprise at least one element having elastic properties, the element(s) being mounted fixed to the first face 3 and / or to the second face 6. It is for example possible to use elements made of electrically conductive elastomer, or of foam made of an electrically conductive material.
[0061] The spacer(s) 13 are preferably configured to allow a translation of an amplitude of between 50 μm and 5 mm inclusive when the sensor 5 is in contact with the housing 2. Thus, the movements permitted by the spacers are adapted to the variations in characteristic height of the skin opposite the third surface 7. Preferably, the device comprises at least one microneedle having a height h, and the spacers are configured to allow a translation of an amplitude between one twentieth of the height h of the microneedle and twice the height h of the microneedle. Thus, the variations in height of the sensor 5 permitted by the spacers 13 make it possible to sufficiently push the microneedles into the skin 9.
[0062] A spacer 13 may also comprise a blade having elastic properties, and preferably a conductive blade, in particular metallic.
[0063] Leverage effect
[0064] The inventors have discovered that it is particularly effective for implementing contact between the third face 7 and the user's skin to use the sensor 5 as a lever relative to the housing 2. Thus, a part of the sensor 5 configured to move with a maximum amplitude relative to the housing 2 can come into contact with the skin by following its morphology while exerting maximum pressure on the skin.
[0065] In one embodiment of the invention, the device 1 comprises a plurality of spacers 13, and the spacers 13 are distributed asymmetrically and / or non-concentrically on the first face 3 or on the second face opposite the first face. Thus, it is possible to exert pressure in a non-uniform manner on the sensor 5, in such a way as to cause rotation of the sensor 5 at the same time as pressure on the sensor 5 and to cause a lever effect.
[0066] The shape of the first face 3 may have an area configured to be closer to the skin 9, when the user is in contact with the device 1, than another area of the first face 5. Thus, an inclination of the first face 5 with respect to the skin 9 may cause an inclination of the sensor 5, and thus allow the sensor 5 to be in contact with the skin 9 so as to avoid measurement errors.
[0067] Sensor shape
[0068] With reference to [Fig.6], [Fig.7], [Fig.8] and [Fig.9], the inventors have also discovered that when the sensor 5 has variations in thickness e, the thickness e being defined as the distance between the second face 6 and the third face 7, a part of the third face 7 exerts a pressure on the skin 9 of the user greater than the pressure exerted by other parts of the third face 7, this making it possible to establish contact between the module 8 and the skin while avoiding measurement errors.
[0069] Preferably, the sensor 5 may comprise a first zone 24 having a first average thickness e, the thickness being defined between the second face 6 and the third face 7, the sensor 5 comprising a second zone 25 having a second average thickness e, the first average thickness e being strictly greater than the second average thickness e.
[0070] Bossage
[0071] With reference to [Fig.5], [Fig.6], [Fig.7], and [Fig.8], at least one face chosen from the first face 3, the second face 6 and / or the third face 7 has a boss 22. The boss 22 makes it possible to tilt the sensor 5 relative to the device 2, so that a part of the third face 7 is in strong contact with the skin 9 by lever effect.
[0072] With reference to [Fig. 5], the first face 3 has a boss 22. The boss 22 is preferably arranged in a non-concentric manner relative to the first surface 3. Thus, the sensor 5 can come to bear on the boss 22 or on the spacers 13 arranged on the boss 22 so as to pivot and ensure contact suitable for measuring an analyte between the sensor 5 and the skin 9.
[0073] With reference to [Fig.6], the second face 6 may comprise a boss 22. Thus, the boss 22 may come to bear on the first face 3 so as to pivot and ensure contact suitable for measuring an analyte between the sensor 5 and the skin 9.
[0074] With reference to [Fig.7] and [Fig.8], the third face 7 may comprise a boss 22. The boss 22 of the third face 7 makes it possible to increase the pressure of a part of the 3 face 7 comprising the module 8, and preferably the microneedles 14.
[0075] Arrangement of microneedles 14 on the third surface
[0076] With reference to [Fig.6], [Fig.7] and [Fig.8] and [Fig.9], at least one microneedle suitable for insertion into the user's skin is arranged in the first zone 24. Preferably, the number of microneedles arranged in the first zone 24 is greater than the number of microneedles arranged in the second zone 25. Thus, the microneedles are arranged on the part of the third face 7 which exerts the most pressure on the skin, this making it possible to ensure the best possible contact between the microneedles 14 and the skin 9.
[0077] With reference to [Fig.6], [Fig.7] and [Fig.8], the microneedle(s) may be arranged on the third face 7 opposite the boss 22, whether the boss is arranged on the third face 7, on the second face 6 and / or on the first face 3. Thus, the microneedles are arranged on the part of the third face 7 which exerts the most pressure on the skin, this making it possible to ensure the best possible contact between the microneedles 14 and the skin 9.
[0078] Preferably, the microneedles 14 are arranged on a part of the third face configured to exert the most pressure on the skin 9. In particular, the arrangement of the microneedles 14 is not concentric, and / or is not symmetrical with respect to an axis of symmetry of the third face 7.
[0079] Removable connection
[0080] The device 1 preferably comprises a removable connection between the sensor 5 and the housing 2. Thus it is possible to change the sensor 5 without changing the housing 2. The removable connection is preferably implemented by a pair of magnets. Preferably, the removable connection comprises at least one magnet arranged in the housing 2 or in the sensor 5.
[0081] The spacer(s) 13 exert a force both on the remainder of the housing 2 and on the sensor 5. In the case of a removable connection implemented by one or more magnets, the magnet(s) exert a force on the housing 2 on the attractive sensor 5. Preferably, the force exerted by the magnet(s) is strictly less than the force exerted by the spacer(s) 13. Thus, in the absence of constraints caused by the user, the spacer(s) 13 are not crushed between the sensor 5 and the housing 2 by the force of the magnets, which allows a potential rotation of the sensor 5 during contact with the skin 9 of the user.
Claims
Claims
1. Device (1) for body monitoring, comprising: - a housing (2) comprising a first face (3) intended to be placed opposite the skin (9) of a user, - means (4) for attaching the housing (2) to a limb of the user, - a sensor (5), the sensor (5) comprising a second face (6) arranged opposite the first face (3) and a third face (7) intended to be opposite the skin of the user, the sensor (5) comprising at least one measurement module (8) comprising a microneedle adapted to be inserted into the skin of the user, the module (8) being configured to measure a physiological or biochemical quantity of the user, by penetrating the skin (9) of the user, the measurement module (8) being arranged at least partly on the third face (7),the device being characterized in that: - the housing (2) being configured to limit the movement of the sensor (5) relative to the housing (2) in directions parallel to the first face, - the sensor (5) is movable in rotation relative to the housing (2) when the sensor (5) is in contact with the housing (2), around an axis of rotation (11) parallel to the first face (3), - the housing comprises a plurality of spacers (13) configured to exert a force on the sensor (5) making it possible to separate the sensor (5) from the first face (3) when the sensor (5) is in contact with the housing (2), the spacer (13) being configured to allow an electrical connection between the housing (2) and the sensor (5).,
2. Device according to the preceding claim, in which the housing (2) and the sensor (5) have a complementary shape configured to limit the movement of the sensor (5) relative to the housing (2) in directions parallel to the first face.
3. Device according to one of the preceding claims, in which the spacer(s) (13) are configured to exert pressure on the second face (6) when the sensor (5) is in contact with the housing (2).
4. Device (1) according to one of the preceding claims, in which the spacer(s) (13) comprise at least one element having elastic properties, the element(s) being mounted fixed to the first face and / or the second face.
5. Device (1) according to one of the preceding claims, wherein the spacer(s) comprise at least one spring (18), each spring (18) being attached to the movable part (17) of a pin (15) and to the fixed part (16) of a pin (15).
6. Device (1) according to one of the preceding claims, comprising a plurality of spacers, wherein the spacers (13) are distributed uniformly on the first face (3) or on the second face (6).
7. Device (1) according to one of the preceding claims, in which the spacers (13) are configured to allow a translation of an amplitude between 50 pm and 5 mm inclusive when the sensor (5) is in contact with the housing (2).
8. Device (1) according to one of the preceding claims, in which the sensor (5) comprises a first zone (24) having a first average thickness, the sensor (5) comprising a second zone (25) having a second average thickness, the first average thickness being strictly greater than the second average thickness.
9. Device (1) according to claim 8, wherein the measuring module (8) comprises at least one microneedle adapted to be inserted into the skin of the user, the microneedle(s) being arranged in the first zone (24).
10. Device (1) according to one of the preceding claims, comprising a removable connection between the sensor (5) and the housing (2).
11. Device (1) according to claim 12, wherein the removable connection comprises at least one magnet arranged in the housing or in the sensor.