BODY SURVEILLANCE SYSTEM WITH A MICRONALE

Description

FIELD OF THE INVENTION

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

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

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

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

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

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

[0007] Alternatively, transcutaneous probes have been proposed in the form of a self-adhesive patch placing a “microneedle 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 include wireless communication means allowing measurements on the interstitial fluid to be sent to a mobile terminal, for storage and / or processing of the measurements (verification of thresholds and variations, production of statistics, triggering of alerts if necessary, etc. ) . Examples include the sugarBEAT ™ or FreeStyle Libre systems.

[0008] Sensors for body monitoring system comprising microneedles are known from US-2016 / 278672-A1, WO-2019 / 141742-A1, WO-2018 / 104647-A1, US-2002 / 193754-A1, US-2018 / 279929-A1, US-2015 / 276758-A1, and US-2015 / 335288-A1.

[0009] Many proposed systems include an array of micro-microneedles. However, it turns out that many rejects of microneedle arrays are necessary during the manufacturing of a system due to defects in a few microneedles. This results in an increase in the production costs of the system. This problem is solved in the prior art by proposing arrays comprising many microneedles. Thus, manufacturing defects of a microneedle can be minimized during an analyte measurement. STATEMENT OF THE INVENTION

[0010] The main aim of the invention is to remedy the problems thus posed.

[0011] A sensor for a body monitoring system according to the invention is defined by claim 1.

[0012] According to the invention each elementary support plate is fixedly mounted on the support base by an electrically conductive glue so as to allow an electrical connection between the support base and the support plate, the sensor comprises several support plates, the sensor comprises several microneedles distributed on the support plate.

[0013] The invention is advantageously supplemented by the following characteristics, taken individually or in any of their technically possible combinations: each plate has dimensions less than 10x10mm, and preferably less than 3x3mm, each elementary support plate is fixedly mounted with two hundred microneedles or less, advantageously eight microneedles or less and preferably with four microneedles or less, each elementary support plate and the support base comprise electrical tracks for connecting the microneedles, the support base and each elementary support plate comprise shape-complementing elements intended to ensure the immobilization of the elementary support plates on the support base, the shape-complementing elements comprise cavities formed in the support base with a geometry complementary to the contour of the elementary support plates, the shape-complementing elements comprise bosses arranged on the support base and adapted to receive at least one support plate,the support base is suitable for receiving the elementary support plates at different depths.

[0014] Another aspect of the invention is a body monitoring system comprising a sensor according to the invention, and further comprising a module configured to exploit an electrical signal delivered by the support base and provide information representative of an analyte.

[0015] Another aspect of the invention is a method of manufacturing a sensor according to the invention, comprising at least one step of fixed mounting of a support plate, on which several microneedles are distributed, on a support base, so that each of the microneedles is electrically connected to the support base.

[0016] The fixed mounting of the support plate on the support base is advantageously implemented at a temperature below 50°C.

[0017] Another aspect of the invention is a body monitoring method comprising a step in which a sensor according to the invention is used. DESCRIPTION OF FIGURES

[0018] Other characteristics, aims and advantages of the present invention will appear on reading the detailed description which follows, and with regard to the appended drawings, given as non-limiting examples and in which: [ Fig. 1 ] - there figure 1 is a perspective view of a sensor comprising four microneedles, [ Fig. 2 ] - there figure 2 is a perspective view from a different angle of observation than the figure 1 of such a sensor, [ Fig. 3 ] - there figure 3 represents a rear view of such a sensor, [ Fig. 4 ] - there figure 4 represents a side view of this sensor, [ Fig. 5 ] - there Figure 5 represents a tip side view of the sensor, [ Fig. 6 ] - there figure 6represents a side view of a microneedle according to one embodiment of the invention, [ Fig. 7 ] - there figure 7 represents a schematic perspective view of a body monitoring system incorporating a sensor according to the present invention, [ Fig. 8 ] - there figure 8 represents a view of a capsule adapted to carry a plurality of sensors according to the invention, [ Fig. 9 ] - there figure 9 represents an enlarged view of part of this capsule, [ Fig. 10 ] - there figure 10 represents an enlarged view of a part of a capsule according to a different embodiment of the invention, DEFINITION

[0019] The term "electrode" means a conductive device for sensing variations in electrical potential in a living organism. An electrode comprises a terminal having a connection end and at least one detection end through which an electrical potential or an electrical current is transmitted, each detection end being carried by a microneedle. The electrode may thus have a single detection end. It may also have a plurality of detection ends. In this case, it should be noted that the electrode remains unique, even if several detection ends are intended to penetrate the body of a living organism. DETAILED DESCRIPTION OF THE INVENTION

[0020] We will describe the particular and non-limiting embodiment of a sensor according to the present invention as illustrated in the figures 1 to 6 annexed. Microneedle(s)

[0021] In reference to the figures 1 to 6, a sensor comprises a support plate 10 provided with four microneedles 20, and preferably a plurality of support plates 10, in particular at least three support plates 10. The outline of the plate can be the subject of numerous variant embodiments. According to the representation given on the figures 1 to 5 , the plate 10 has a square outline. The four microneedles are located respectively near the corners of the plate 10. The microneedles 20 extend perpendicular to the base plane of the plate 10. In other words, the central axis 21 of each microneedle 20 extends perpendicular to the base surface of the plate 10.

[0022] In reference to the figures 1 to 3, the face of the plate 10 opposite the microneedles 20 comprises four electrically conductive pads 30, each pad 30 being electrically connected to the active part 25 of each microneedle 20. The electrically conductive pads 30 allow electrical continuity of an electrode when they are electrically connected to a base, for example a working or counter-electrode, in the microneedle 20, and this potentially separately so that each working electrode is independent of the other working electrodes. In practice, these pads 30 may be integral with the microneedles 20 or electrically connected to the microneedles 20 by any suitable means through or around the plate 10. The support plate 10 may be made of any electrically suitable material, for example electrically insulating or conductive. Similarly, the microneedles 20 may be formed of any suitable material.They are suitable for conveying an electrical signal captured by the active surface 25. Preferably, the microneedles 20 can be formed from polycarbonate or silicon. The microneedle(s) 20 are preferably solid, i.e., devoid of a cavity. Thus, the manufacture of microneedles 20 suitable for analyte measurement is facilitated, while allowing electrochemical measurement of an analyte. The microneedle can mainly comprise silicon. In the case of silicon, the microneedle has an external non-conductive protective layer of SiO 2 , formed by oxidation of the silicon on the surface. Thus, the microneedle may not comprise an additional coating to the SiO 2 layer.

[0023] In reference to the figure 2 and to the figure 6, each microneedle 20 comprises a base shaft 22 and a pointed apex 24. The shaft 22 may preferably taper towards the pointed apex 24 of the microneedle 20. The pointed apex 24 has a slope greater than that of the shaft 22, that is to say it forms an angle B with the central axis 21 greater than the angle A formed between the base shaft 22 and the central axis 21. The microneedle 20 has a break or slope transition 23 between the base shaft 22 and the pointed apex. The slope transition 23 may be materialized by an edge.

[0024] The base shaft 22 and the pointed apex 24 may have a square section. In this case, the base shaft 22 is quadrangular and the tip 24 is of the pyramidal type. The entire microneedle 20 may preferably have the shape of an obelisk.

[0025] Alternatively, however, the microneedle 20 may have a circular section. In this case, the base shaft 22 has the shape of a circular truncated cone of revolution and the tip 24 is formed from a conical tip of revolution.

[0026] Preferably, the pointed apex 24 extends exclusively at a distance of between 350 µm and 1100 µm from the base of the base barrel 22 of the microneedle, i.e. from the face 12 of the support plate 10, and preferably between 600 µm and 1000 µm from the base of the microneedle and this surface 12 of the support plate 10. The term “extends exclusively at a distance of between 350 µm and 1100 µm” means that the portion of the pointed apex 24 closest to the base of the base barrel is arranged at a distance greater than 350 µm from the base of the base barrel 22, and that the portion furthest from the base of the base barrel 22 is arranged at a distance less than 1100 µm.

[0027] Furthermore, tests have shown that the surface area of ​​the active detection part 25 must be between 0.04 and 0.9 mm 2< . Consequently, when the measurement is made with a single microneedle 20, the active part 25 of this microneedle 20 is between 0.04 and 0.9 mm 2< . When the measurement is made with several microneedles 20, the surface area of ​​the aforementioned active part, between 0.04 and 0.9 mm 2<, is understood to be the total active surface area of ​​the microneedles considered.

[0028] Those skilled in the art will understand that the obelisk shape of the microneedles 20, or the shape of a similar circular body of revolution but having a break in slope between the base shaft 22 and the pointed apex 24, makes it possible to solve a problem posed by the microneedles 20 known from the state of the art, namely minimizing the penetration diameter into the skin while maximizing the surface area of ​​the active part 25 present in the part of the skin between the epidermis and the nerves.

[0029] The microneedles 20 according to the present invention can be made using any suitable microfabrication method.

[0030] The active part 25 comprises an electrically conductive face, preferably covered with a coating which is the subject of various variants depending on the type of measurement sought and the type of analyte to be measured. For a blood glucose measurement, the active part 25 is provided with a coating capable of implementing an enzymatic reaction with the glucose. The active part 25 may also not comprise a coating specific to a predetermined analyte, for example in the case of the active part 25 of a counter-electrode or a reference electrode.

[0031] Furthermore, according to the particular embodiment shown in the figures 1 to 5 , and by way of non-limiting example: the height l 4 of the base barrel 22 is of the order of 380 µm, the total height l 5 of each microneedle 20 is of the order of 750 µm, the width at the base l 6 of each microneedle 20 is of the order of 0.25mm, the widthl 7 of the microneedle at the slope transition 23 is of the order of 0.2 mm, the angle A of convergence of the base shaft 22 relative to the central axis 21 is of the order of 7°, the angle B of the tip apex 24 relative to the central axis 21 is of the order of 30°. Microneedle array

[0032] The microneedle(s) 20 according to the invention make it possible to reduce the number of microneedles 20 of a working electrode 70. Preferably, a working electrode comprises between one and seven, in particular between one and five and preferably between one and three active parts 25 each covering at least part of the surface of the pointed apex 24 of a different microneedle 20. The known systems of the state of the art do not make it possible to use so few microneedles.

[0033] The invention makes it possible to drastically reduce the number of microneedles 20 required for the measurement compared to known systems of the state of the art, it is possible, for a given sensor surface, to minimize the density of microneedles. Each pair of adjacent microneedles 20 is preferably separated by a distance between the tips of the apexes 24 of at least 1 mm and preferably at least 1.5 mm, or even at least 1.8 mm where appropriate. This has the effect of avoiding a homogeneous deformation of the skin when a network of microneedles 20 comes into contact with the skin, known in other technical fields as the fakir effect, and on the contrary of promoting a deformation of the skin localized around each of the microneedles.Thus, the pain caused by the penetration of needles into the skin can be significantly reduced, or even eliminated, and penetration occurs very naturally, the needles having in fact become mechanically independent.

[0034] Furthermore, according to the particular embodiment shown in the figures 1 to 5 , and by way of non-limiting example, the center distance l 3 between each pair of microneedles 20 is of the order of 1.5 mm. Electrodes

[0035] The sensor is preferably adapted to measure the presence or concentration of an analyte by electrochemistry. A sensor may comprise a working electrode 70, adapted to evaluate the presence of an analyte in the body of a user. The working electrode 70 comprises at least a first end electrically connected to a module configured to exploit the electrical signal of the working electrode 70, and at least one second end formed by the active portion 25. It may also comprise a plurality of second ends. The active portion 25 of the microneedle 20 covers at least a portion of the surface of the pointed apex 24 and preferably the entire surface of the pointed apex 24. For this purpose, the active portion 25, at the level of the pointed apex 24, is coated with any coating suitable for the desired measurement, typically a coating suitable for detecting blood glucose by electrochemistry.

[0036] The sensor may comprise a counter electrode. The counter electrode may comprise a first end intended to be electrically connected to a module configured to exploit an electrical signal, and at least one other end for exploiting an electrical signal in the user's body. The other end of the counter electrode may cover a counter electrode microneedle, for example a microneedle according to the invention. However, the counter electrode does not have the same active surface area requirements as the working electrode. Thus, the pointed apex of the counter electrode may extend exclusively at a distance of between 100 µm and 1100 µm from the base shaft of the microneedle. Alternatively, the other end of the counter electrode may cover the entire surface of the counter electrode microneedle.

[0037] In the case of a sensor according to an embodiment of the invention comprising several working electrodes, each working electrode can be adapted to detect the same analyte as another working electrode, or be adapted to detect an analyte different from another working electrode.

[0038] In the case where several working electrodes are adapted to detect the same analyte, each working electrode may comprise an active part 25 comprising the same type of coating. Thus, it may be possible to implement independent measurements for the same analyte, and thus to obtain better measurement accuracy of the analyte. Each working electrode may also comprise different active parts 25, comprising different coatings, but adapted to detect the same analyte. The concentration of the analyte can thus be detected more precisely than by using a single coating for the active part 25.

[0039] Each electrode can also be adapted to detect different analytes. Thus, it is possible to monitor several pathologies with the same monitoring system. Support plate

[0040] As seen previously, the microneedle(s) 20 may be arranged on a support plate 10. With reference to the figures 1 to 4 , the thickness e 1 of the support plate is advantageously between 0.1 mm and 1 mm, and preferably of the order of 0.2 mm. The dimensions of the microneedles 20 can be the subject of numerous variant embodiments. The same applies to the support plate 10. As a non-limiting example with reference to the particular embodiment shown in the figures 1 to 5, the support plate 10 has sides having a width l 1 less than 10 mm, advantageously less than 3 mm, for example of the order of 2.3 mm. The electrically conductive pads 30 are pads, for example square, having a side l 2 of the order of 0.8 mm. These areas 30 can be located at a distance e 2 of the order of 0.2 mm from the edges of the support plate.

[0041] The support plates 10 can themselves be the subject of different embodiment variants. Some support plates 10 can be adapted to support, for example, four microneedles while other support plates 10 can be adapted to support only two microneedles 20.

[0042] The support plate(s) 10 are adapted to be mounted on a support base 80. The support base 80 may be, for example, the housing 40, a capsule 50, or a structure for receiving the housing 40, for example linked to the body attachment means.

[0043] Each support plate 10 may be fixedly mounted with eight or fewer microneedles 20, and preferably with four or fewer microneedles 20. Thus, for a given manufacturing failure rate of a microneedle 20 in a given microneedle array 20, the manufacturing frequency of a microneedle array 20 in which all the microneedles 20 are valid increases compared to microneedle arrays comprising, for example, more than 50 or more than 100 microneedles. The sensor may comprise a plurality of plates 10, each plate 10 having a limited number of microneedles, for example less than eight microneedles, and preferably less than four microneedles, so as to avoid rejection of a microneedle array due to the failure of one of the microneedles in the array. This makes it possible to reduce the manufacturing costs of the sensor.

[0044] Each support plate 10 and the base 80 preferably comprise electrical tracks for connecting the microneedles 20. Thus, an electrode, for example a working electrode or a counter electrode, can pass through the support plate 10, so as to have a first end in the support base and at least one other end on a microneedle 20. According to the invention, provision is made to use an electrically conductive adhesive so as to mount the support plate 10 fixedly on the support base 80 and to allow an electrical connection between the support base 80 and the support plate 10, and by extension the microneedle 20.The use of an adhesive to securely mount a support plate 10 on the support base 80 is particularly advantageous when a plurality of support plates 10 are mounted on the support bases 80, for example when more than three support plates 10, preferably more than four support plates 10, and in particular more than eight support plates 10, are mounted on the support base 80.

[0045] The base 80 and the support plate(s) 10 preferably comprise complementary shaped elements intended to ensure the immobilization of the elementary support plates 10 on the support base 80. With reference to the figure 10, a shape-complementing element may preferably be a cavity formed in the support base 80, of geometry complementary to the contour of one or more support plates 10. Alternatively or additionally, the shape-complementing element may preferably be bosses arranged on the support base 80 and adapted to receive at least one support plate 10, for example so as to surround it and / or hold it. Thus, when mounting the support plates 10 on the base 80, the support plate 10 and the microneedles may be held in a controlled position, until the support plate(s) 10 are fixed to the base 80. In addition, each of the support plates 10 may thus be mounted fixed in a perfectly controlled position.

[0046] The support base 80 may preferably be adapted to receive the elementary support plates 10 at different depths. Thus, it is possible to manufacture a system comprising microneedles 20 having different heights, the microneedles 20 being manufactured by a method in which all the microneedles 20 obtained by the manufacturing method have the same size.

[0047] In reference to the figures 8 And 9 , the support base 80 may comprise electrical tracks. The shape-complementing elements of the base 80 and the electrical tracks of the base 80 may be arranged so that a support plate 10 also has one or more electrical tracks facing the electrical track of the base 80. Thus, an electrode, for example a working electrode or a counter-electrode, may be formed straddling the base and the support plate 10.

[0048] One aspect of the invention is a method of manufacturing a body monitoring system according to the invention, in which the support plate(s) 10 on which the microneedles 20 are distributed are fixedly mounted on the support base 80, such that each of the microneedles 20 is electrically connected to the support base 80, separately or not. Thus, it is possible to control, from the support base 80, the potential of the electrode parts of the support plate 10 and of each microneedle 20.

[0049] Each microneedle 20 may have an active part 25 comprising a coating comprising a biological active compound which may be denatured by excessively high temperatures. The step of fixed mounting of the support plate 10 is preferably carried out at a temperature below 80°C, in particular below 50°C. Thus, denaturation of the active compounds of the microneedles 20 is avoided. This fixed mounting step may be carried out by bonding by irradiation with ultraviolet rays between the support plate 10 and the support base 80, using an electrically conductive adhesive. Measuring system

[0050] The present invention can make it possible to independently measure the blood sugar level using a plurality of working electrodes 70. This has an undeniable advantage over the state of the art according to which such an independent measurement using a working electrode comprising a single microneedle was not possible because the measurement signal was too noisy using a single microneedle. Thus, the sensor preferably comprises several working electrodes 70, the measurement system being adapted to individually measure the electrical potential of each of the working electrodes 70.

[0051] The measurement of the potential of each of the working electrodes 70 can be multiplexed. In the context of the present invention, means are advantageously provided for rejecting the minimum or maximum measurement values ​​of the potential associated with a set of measurements, which was impossible using the sensors of the prior art.

[0052] The sensor according to the present invention can be implemented in different types of body monitoring system.

[0053] Preferably, the sensor according to the invention is implemented in a monitoring system of the type illustrated in the figures 7 to 10 annexed.

[0054] Such a system comprises a housing 40 in the form of a watch case comprising a bracelet 42 adapted to surround the wrist of an individual. The housing 40 houses a module configured to exploit the electrical signal delivered by each microneedle 20 and provide information representative of a physical quantity of the fluid, typically a blood sugar level.

[0055] As mentioned previously, the body monitoring system preferably used according to the invention comprises a capsule 50 comprising at least one sensor of the aforementioned type, and preferably a plurality of sensors as will be described in more detail below.

[0056] The body monitoring system according to the invention further comprises a patch 60 to which the capsule 50 is attached, the patch 60 itself being provided with an adhesive allowing the patch and capsule 50 assembly to adhere to the skin of an individual.

[0057] As represented on the figure 8 and partly on the figure 9 , the capsule 50 preferably has the general shape of a ring comprising a plurality of hollow housings 52 adapted to each respectively receive the support plate 10 of a aforementioned sensor.

[0058] In reference to the figures 7 and 8 , the capsule 50 may comprise electrically conductive pads 54 intended to be placed opposite the electrically conductive pads 30 provided on the support plate 10, to ensure an electrical connection between the microneedles 20 and the module provided in the housing 40 to exploit the electrical signal thus collected. The pads 54 are themselves interconnected with the aforementioned module by electrically conductive tracks 56a.

[0059] As seen from the examination of the figure 9, some of the ranges 54 can be individually connected to the aforementioned processing module by respective tracks 56a while other ranges 54 can be connected to the processing module by common tracks 56b. Implementation of a body analyte measurement

[0060] As previously indicated, the present invention also relates to a method of body monitoring using a sensor comprising a microneedle of the aforementioned type.

[0061] The monitoring method comprises a step of measuring bodily analyte using a microneedle 20 according to one embodiment of the invention. Due to the characteristics of the microneedle 20, the sensor may comprise a plurality of working electrodes. The measurement may for example be implemented by polarizing the working electrode(s) and the counter electrode(s) at an electrical potential suitable for causing an oxidation-reduction reaction involving the analyte to be measured.

[0062] The measuring step may preferably be implemented at least using two different working electrodes. The measuring step may for example be implemented independently, successively on each of the working electrodes 70, or in parallel on each of the working electrodes 70. Thus, the concentration of the electrolyte may be analyzed more precisely than with a system comprising for example a single working electrode having several ends in the form of microneedles.

[0063] Another aspect of the invention is a method for measuring a body analyte comprising a step of penetrating the microneedles of a sensor according to the invention into the skin of a user. Thus, the needles of the sensor can be introduced into the skin without an applicator, due to the spacing of the microneedles 20. A low force compared to the force provided by an applicator can be used for the penetration of the microneedles. Preferably, a force of less than 50 newtons, and preferably less than 30 newtons, can be used for the penetration of the microneedles 20. Thus, the penetration of the microneedles can be carried out with the hand, or preferably with mechanical attachment means of the system, for example a bracelet.

Claims

1. Sensor for body monitoring system comprising micro-needles (20) for measuring a body analyte, comprising a support base (80), several elementary support plates (10), and several micro-needles (20) distributed on each elementary support plate (10), each elementary support plate (10) being fixedly mounted on the support base (80) by an electrically conductive adhesive so as to allow an electrical connection between the support base (80) and the support plate (10).

2. Sensor according to claim 1, characterized in that the elementary support plate (10) is fixedly mounted with two hundred micro-needles (20) or less, advantageously eight micro-needles or less, and preferably four micro-needles (20) or less.

3. Sensor according to claim 1 or 2, characterized in that the elementary support plate (10) and the support base (80) comprise electrical tracks for connecting the micro-needles (20).

4. Sensor according to any one of claims 1 to 3, characterized in that the elementary support plate (10) is less than 10x10mm, and preferably less than 3x3mm.

5. Sensor according to any one of claims 1 to 4, characterized in that the support base (80) and each elementary support plate (10) comprise complementary shape elements intended to ensure the immobilization of the elementary support plates (10) on the support base.

6. Sensor according to claim 5, characterized in that the complementary shape elements comprise cavities formed in the support base (80) of complementary geometry to the contour of the elementary support plates (10).

7. Sensor according to claim 5 or 6, characterized in that the complementary shape elements comprise bosses arranged on the support base (80) and adapted to receive at least one support plate (10).

8. Sensor according to any one of claims 1 to 7, characterized in that the support base (80) is adapted to receive the elementary support plates (10) at different depths.

9. Sensor according to any one of claims 1 to 8, characterized in that each working electrode is adapted to detect a different analyte from another working electrode.

10. Sensor according to any one of claims 1 to 9, characterized in that each working electrode is adapted to detect the same analyte as another working electrode.

11. Body monitoring system, characterized in that it comprises a sensor according to any one of claims 1 to 10 and further comprises a module configured to exploit an electrical signal delivered by the support base (80) and provide information representative of an analyte.

12. Method of manufacturing a sensor according to any one of claims 1 to 10, comprising at least one step of fixedly mounting a support plate (10) on which several micro-needles (20) are distributed, on a support base (80), so that each of the micro-needles (20) is electrically connected to the support base (80).

13. Method of manufacturing according to claim 12, wherein the fixed mounting of the support plate (10) on the support base (80) is carried out at a temperature below 50°C.