Reusable saliva testing device

Abstract

A device (100) for measuring a parameter (P) of the human body by saliva test, comprising a body (10) and at least one pair of measuring elements (30, 40) consisting of at least one saliva collection vector (30) placed on the body (10) and at least one associated sensor (40); the saliva collection vector being configured to absorb a quantity of saliva when applied against a user's oral area with low pressure; said vector also being configured to return a sufficient quantity of saliva for measurement when pressed with high pressure directly onto the sensor, without any intermediary, and for a prolonged period of time necessary to perform the measurement, to allow for repeated measurements and to render said device reusable. Figure for the abbreviation: Figure 1

Description

Title of the invention: Reusable saliva testing device technical field

[0001] The present invention relates to the field of devices for measuring and monitoring a parameter of the human body, particularly by saliva testing, and more specifically concerns a reusable saliva testing device comprising at least one saliva collection vector and at least one associated sensor. These two measuring elements are arranged so as to improve the efficiency of the measurements, to allow the device to be reused as is, and to reduce the risk of cytotoxicity.

[0002] The invention finds a direct, but not exclusive, application in the measurement and monitoring of blood glucose. State of the art

[0003] Saliva testing devices have been widely used in various fields for several years, including for Covid-19 screening, drug detection in drivers, and even for the diagnosis of diseases such as HIV.

[0004] Research in the field of saliva tests for measuring blood glucose is a current topic. These tests offer a non-invasive alternative to traditional blood sampling methods using needles and are based on the detection of biomarkers in saliva, which reflect the level of glucose in the blood. It is crucial to note that glucose concentrations in saliva are significantly lower than those in blood, by 10 to 100 times, which represents a major challenge in terms of the sensitivity and specificity of the sensors.

[0005] Saliva tests are easier to perform and less painful for the patient than blood tests. They are also faster and do not require specialized medical personnel to collect the sample.

[0006] Document CN114002292A describes, for example, a salivary blood glucose measurement device comprising a housing, a processing and detection unit, salivary blood glucose test paper, and a display unit. The housing can be formed by combining two half-shells. The housing has several buttons, a battery compartment, a battery cover, and a port for inserting the test paper. The specific position of the insertion port corresponds to the processing and detection unit. The processing and detection unit stores a salivary glucose reference table in advance, which is used to provide the measured blood glucose value by comparing electrochemical parameters.

[0007] These devices are single-use and therefore disposable. Reusing these devices multiple times is not feasible for several reasons: their systems microfluidics that carry saliva to the sensor are damaged by saliva residue after the first use; their sensors are designed for single use (based on antibodies and colorimetry); and high risks of cytotoxicity may appear in the event that toxic particles travel back up the microfluidic circuit after humidification.

[0008] A cytotoxic accident can, for example, occur during the handling of devices comprising a foam or saliva collection paper and a sensor in several ways.

[0009] Cytotoxic accidents can occur through contamination of the foam. Indeed, if the foam comes into contact with a cytotoxic substance, it can absorb that substance. If this contaminated foam is reused, it will come into contact with the skin or mucous membranes, and this can lead to excessive cytotoxic exposure if the operation is repeated.

[0010] A cytotoxic accident can also occur due to a leak in the sensor. Indeed, if the sensor contains a cytotoxic substance and it leaks or breaks, this can lead to cytotoxic exposure on the surface of the sensor, which is problematic if, for example, a person happens to touch the sensor with a finger that they then carelessly put in their mouth.

[0011] In the latter case, leaks are often due to a weakening of the sensor, which can, for example, lead to micro-leaks of liquid. The saliva collection foam can then accumulate a critical quantity of cytotoxic substance more rapidly when it comes into contact with the sensor leaks.

[0012] Enzymatic sensors are, for example, weakened due to their exposure to light, heat, shocks, temperature variations, etc.

[0013] It is important to note that these scenarios depend on many factors, including the type of foam and sensor used, the cytotoxic substance in question, the location of these measuring elements in the device, and the specific conditions of handling and use of the device.

[0014] Moreover, in previous saliva testing solutions, the sensors are single-use and neither the question of lifespan nor the question of reusability arises.

[0015] In the context of chronic diseases requiring multiple daily measurements, patients must constantly carry several bulky, single-use devices. These devices, designed to minimize the cost of disposable consumables, do not include electronic components that would allow connection to a smartphone, for example. This lack of connectivity limits access to health data history and prevents sharing this information with relatives, doctors, or insurers. Switching to reusable devices allows the overall cost to be reduced, because this cost is then divided by the number of measurements possible with a single device.

[0016] In conclusion, although saliva testing devices have many advantages, they are single-use and, if reused, could present potential risks of cytotoxicity. Summary of the invention

[0017] The present invention aims to overcome all or part of the disadvantages of the prior art described above by proposing a reusable solution improving the effectiveness of saliva test measurements and reducing the risks of cytotoxicity.

[0018] To this end, the present invention relates to a device for measuring a parameter of the human body by saliva test, comprising a body and at least one pair of measuring elements consisting of at least one saliva collection vector placed on the body and at least one associated sensor. This device is remarkable in that the saliva collection vector is configured to absorb a quantity of saliva when applied against a user's oral area with low pressure, and in that said vector is also configured to return a sufficient quantity of saliva for measurement when pressed with high pressure directly onto the sensor, without any intermediary, and for a prolonged period within the time necessary to perform the measurement, thus allowing for repeated measurements and rendering said device reusable.

[0019] According to the invention, the fact that the device is reusable means that at least the sampling vector and the sensor are reusable.

[0020] Indeed, it is important to limit contact with the sensor to allow for its reuse because the enzyme is active and therefore wears out as soon as it comes into contact with oxygen and glucose even if there is no electrical current.

[0021] It should be noted that the relative terms "low" and "high" simply designate a comparison without referring to particular values ​​or excluding the case of equality between the compared sizes, and that the oral zone designates, for example, an internal part of the cheek or lip, the tongue or the gum.

[0022] The time required for the measurement is, for example, between 1 second and 5 minutes, and it is advisable to limit this time in order to avoid promoting the proliferation of potentially cytotoxic particles towards the sampling vector. Not all chemical components are cytotoxic. This depends on the body analytes being measured (for example, glucose is not cytotoxic but ketone is highly cytotoxic).

[0023] In the device according to the invention, there is direct contact between the sampling vector and its associated sensor, without any intermediary, the purpose of which is to avoid a microfluidic pathway of saliva that would preclude the possibility of reusing the device.

[0024] With low pressure sampling, the user can make a random movement with the body and obtain a sampling or restitution of a sufficient quantity of saliva as long as he applies a pressure at least equal to this low pressure.

[0025] According to one aspect of the invention, the device includes at least one saliva cleaning vector configured to come into contact with one or more sensors after each measurement and remove the residual saliva and debris thereon.

[0026] Advantageously, each saliva collection vector and each saliva cleaning vector are of the same nature and / or identical.

[0027] According to one embodiment, at least one saliva collection vector is reusable, chosen from: a foam, hairs, fibers or a textile, preferably a foam, preserving the same properties before and after its contact with the sensor and / or with saliva.

[0028] According to a particularly advantageous embodiment, the saliva collection vector is a reusable foam, preserving the same properties before and after its contact with the sensor, subject to an evaporation period.

[0029] This extends the life of the device by allowing it to be reused multiple times.

[0030] According to one embodiment, the device further comprises a cap in which each sensor is placed in order to be protected from external harmful agents and from contact with the user's fingers, said cap being configured to fit onto the body.

[0031] More particularly, the cap has two functional positions relative to the body: an intermediate position in which a saliva sampling vector is in contact with an associated sensor to perform the measurement; and a closed position in which a saliva cleaning vector is in contact with said sensor to clean it.

[0032] According to another particular aspect, the cap includes a locking element to cooperate with the body by locking itself in two stable positions corresponding respectively to the two functional positions of said cap.

[0033] More specifically, each saliva collection vector returns to its initial position after the cap has moved from the intermediate position to the closed position.

[0034] According to an advantageous aspect, each saliva sampling vector and an associated sensor are configured to apply themselves against each other with a pressure of non-zero normal component and in a limited time, preferably between 1s and 5min.

[0035] The fundamental concepts of the invention having been set forth above in their most elementary form, other details and features will become clearer upon reading the following description and with reference to the accompanying drawings, which give, by way of non-limiting example, an embodiment of a reusable saliva testing device in accordance with the principles of the invention. Presentation of the drawings

[0036] The figures are given for illustrative purposes only to facilitate a better understanding of the invention without limiting its scope. The various elements may be represented schematically and are not necessarily to scale. Throughout the figures, identical or equivalent elements are identified by the same numerical reference.

[0037] It is thus illustrated in:

[0038] [Fig. 1: a partial perspective view of a saliva test device according to a first embodiment, with the cap in the open position (a), in the intermediate position (b) and in the closed position (c);

[0039] [Fig.2a]: a partial perspective view of the body of the saliva test device;

[0040] [Fig.2b]: a top view of the body of the [Fig.2a];

[0041] [Fig.2c]: a top view of the body according to an alternative embodiment in which said body exhibits rotational symmetry;

[0042] [Fig.3]: a partial longitudinal sectional view of the device in the open position (a), in intermediate position (b) and in closed position (c);

[0043] [Fig.4]: a simplified diagram of [Fig.3];

[0044] [Fig. 5]: a partial longitudinal sectional view of the device in its two functional positions, with cavities for maintaining said positions;

[0045] [Fig.6]: A perspective view of a saliva testing device according to a second embodiment, using an ordinary toothbrush;

[0046] [Fig.7]: a perspective view of the device, before the insertion of the measuring rod (a) and during the deposition of saliva by the toothbrush in (b);

[0047] [Fig.8]: a saliva testing device according to a third embodiment, using a dental glass and a piston docking station;

[0048] [Fig.9]: an alternative of the device according to the third embodiment, in in which the cleaning vector is placed on a piston integrated into the docking station. Detailed description of embodiments

[0049] It should be noted that certain technical elements well known to those skilled in the art are recalled here to avoid any insufficiency or ambiguity in the understanding of the present invention.

[0050] In the embodiment described below, reference is made to a saliva testing device, primarily intended for measuring and monitoring blood glucose levels. This non-limiting example is given for a better understanding of the invention and does not preclude the use of the device to measure other physiological, biochemical, or other parameters related to the human body.

[0051] Fig. 1 represents a device 100 for measuring a human body parameter, in particular blood glucose, by saliva test, comprising a body 10 and a removable cap 20, according to a first embodiment.

[0052] The body 10 has a head 11 at its open end onto which the cap 20 can be fitted.

[0053] Figure 1 shows the device 100 with the cap 20 completely removed from the body 10 in (a), partially removed in (b), and fitted onto said body in (c). This last position corresponds to the body 10 being closed by the cap 20.

[0054] According to the illustrated embodiment, the head 11 of the body 10 has an overall truncated conical shape, extending from a straight cylindrical part partially visible on [Fig.1], and the cap 20 is designed to fit firmly onto said head.

[0055] Figures 2a and 2b represent the body 10 with a frustoconical head 11.

[0056] Figure 2c represents a body 10' according to an alternative in which the head 11 exhibits rotational symmetry.

[0057] The body 10 and the cap 20 can be made of different materials such as plastic, and have local elasticity at the interlocking area to ensure a firm closure by elastic deformation or preferably by clipping.

[0058] The body 10 has on its head 11 saliva sampling vectors 30 and 35: a first vector 30 for the extraction of saliva from a buccal area, and a second vector 35 for the cleaning of a measuring sensor described later.

[0059] According to one embodiment, the saliva collection vectors 30 and 35 are foams.

[0060] In the remainder of the description and with reference to this embodiment, the first vector 30 and the second vector 35 shall be designated respectively extraction foam 30 and cleaning foam 35.

[0061] These foams 30 and 35 are intended to come into contact with a measuring sensor 40 placed inside the cap 20 and represented by a dashed line on the [Fig.1].

[0062] In [Fig. 1], only one pair (foams - sensor) is shown. However, the device 100 may comprise several pairs. For example, the body 10 and the cap 20 may have several faces, in equal number, with two foams 30 and 35 on each face of the body 10 and a sensor 40 on each face of the cap 20.

[0063] The cap 20 has two functional positions relative to the body 10, an intermediate position and a closed position, in each of which one of the vectors 30 and 35 performs a determined function.

[0064] The intermediate position and the closed position correspond respectively to configurations (b) and (c) of [Fig.1].

[0065] In the intermediate position, the extraction foam 30, located at the top of the head 11, presses against the sensor 40 to perform the blood glucose measurement. This position is maintained for a certain time before the device 100 indicates to the user to change position and move to the closed position.

[0066] In the closed position, it is the cleaning foam 35, located below the extraction foam 30 and therefore at the bottom of the head 11 according to this embodiment, which comes to be applied against the sensor 40 to clean it by absorbing the residual saliva.

[0067] The two positions of the cap 20 relative to the body 10 are stable thanks to suitable locking means shown in section view in figures 3 to 5. These clip functions could be achieved conventionally by the edges of the cap 20 coming into contact with the edges of the lower part of the head 11, but this would be less aesthetic than in the hidden version as shown here.

[0068] Indeed, with reference to [Fig. 3], the cap 20 comprises a locking element 21 in the shape of an inverted pin with a ball 211 at its free end. This ball is designed to cooperate with the hollow interior of the body 10 by passing through a terminal hole 111 provided with an elastic passage membrane. This membrane 111, visible in Figures 2a to 2c, is, for example, star-shaped so as to return to its closed position after the removal of the cap 20 and the locking element 21, thus preventing the possible penetration of saliva during the application of the extraction foam 30 to the oral area.

[0069] The interior of the body 10 is thus shaped to lock the ball 211 in two stable positions corresponding to the intermediate and closed positions of the cap 20. For this purpose, the interior of the body 10 has two successive cavities 112 and 113 of sufficient diameter to receive the ball 211 of the locking member 21.

[0070] With reference to [Fig.5], each of the cavities 112 and 113 has an ovoid or spherical shape open axially through to allow the passage of the ball 211. More particularly, the through opening of each cavity has a diameter smaller than that of the ball 211, so that the passage of said ball is achieved by elastic deformation of the edges of the cavities.

[0071] Thus, a first press of the body 10 against the cap 20, or vice versa, allows the ball 211 to come to rest in the first cavity 112 located in its path (1), and a second press allows the said ball to be moved into the second cavity 113 (2).

[0072] When the ball 211 is blocked in the first cavity 112, the cap 20 is in an intermediate position with the extraction foam 30 pressed against the sensor 40.

[0073] When the ball 211 is blocked in the second cavity 113, the cap 20 is in the closed position with the cleaning foam 35 applied against the sensor 40.

[0074] The extraction foam 30 is placed on a "broken" slope 12 of the head 11 as shown in Figures 2a to 2c and comes into contact with the sensor 40 after a pivoting caused by the push of the ball 211 on the head 11 in the first cavity 112 as shown in [Fig.5], the broken area serving as a spring effect to allow the head 11 to return to its rest position when the ball leaves the cavity 112.

[0075] Fig. 4 represents such a spring 13 placed between the break slope 12 and the rest of the head 11.

[0076] The pivoting of the walls of the broken slope 12 of the head 11 is facilitated by a support member 121 which the ball 211 pushes when it enters the head 11.

[0077] According to one embodiment, the head 11 of the body 10 is provided with a protective mask that provides access to only one face of the head at a time, via an access window. Such a protective mask is described in document FR2400985 of the same inventor. Indeed, this mask facilitates access to the different successive faces of the device. In a 4-face configuration, for example, the ball 211, in a counter-supported position against the three faces locked by the mask, is only able to push the face of the head 11 that is opposite the window of the mask. This face of the head 11 is therefore the only one that can pivot, through the window of the mask. It should also be noted that the foot of the locking member 21 has sufficient flexibility to allow a degree of freedom to the ball 211, facilitating its thrust in the appropriate direction, i.e. towards the single open window and therefore the face of the associated head 11 which is free to move.

[0078] Fig. 2c represents such a mask 15 placed on the head 11 and giving access to a single pair of foams 30 and 35. In this specific case, the mask 15 is rotatable with a simple design adapted to the symmetry of revolution of the head 11.

[0079] Of course, other designs can be considered for the mask.

[0080] The location of the extraction foam 30 on the slope 12 in break also prevents this foam from shearing on contact with the sensor 40 and thus losing saliva before the measurement.

[0081] For this reason also, the extraction foam 30 comes to rest against the sensor 40 at a sufficient angle, substantially normal to the surface of the sensor, thus limiting the loss of saliva.

[0082] When the ball 211 is blocked in the second cavity 113, the cleaning foam 35 comes to be applied against the sensor 40 to clean it by pushing away any physical debris during the lateral movement of the cap 20 and by absorbing liquid debris such as residual saliva in the closed position of the cap 20, with sustained pressure and with low pressure on the sensor 40, allowing an absorbing effect.

[0083] This cleaning advantageously extends the life, and therefore the reuse, of the sensor 40.

[0084] In addition to this, the position of the sensor 40 inside the cap 20 also helps to extend its lifespan by protecting it from light, direct shocks, contact, etc.

[0085] To ensure its reusability, the sensor 40 is based on a reusable enzymatic technology, rather than an antibody-based one, unlike prior art salivary devices. Cleaning the sensor 40 with the foam 35 helps to extend its lifespan and therefore its reusability.

[0086] Furthermore, the limited time to perform the measurement prevents overuse of the sensor and thus makes it reusable by extending its lifespan.

[0087] The potential cytotoxicity of the sensor 40 can be mitigated by applying a biocompatible chemical outer membrane positioned over the sensor. However, this configuration may affect the initial stability time of the device 100. For a continuous glucose monitor (CGM) with a 14-day lifespan, a one-hour delay before the first measurement is acceptable. However, this delay is not appropriate for a product intended for spot measurements, such as conventional blood glucose meters (BGMs) and the device of the present invention, where the maximum time to perform a test must be between 5 and 30 seconds.

[0088] The device 100 also prevents the extraction foam 30 from remaining in permanent contact with the sensor 40. This prevents toxic ions from migrating into the foam, and consequently into the mouth, in the event of sensor damage, during reuse of the body 10. In addition, the opening of the cap 20 is designed to be reduced in order to protect access to the sensor 40 and to limit the possibility of inserting a finger and touching said sensor.

[0089] In alternative embodiments, the extraction and cleaning foams can be replaced by fabric, fibers, nylon bristles, and any other material suitable for absorbing saliva when it comes into contact with a salivary oral area.

[0090] Figures 6 and 7 represent a reusable saliva test device 200, according to another embodiment in which said device is used with an unmodified everyday object, which is a toothbrush 250.

[0091] The toothbrush 250 allows saliva to be collected from the user's mouth and deposited in the device 200 which performs the blood glucose measurement.

[0092] For this purpose, the housing 200 is in the form of a clamshell housing and includes a base 210 and a tilting clamshell 220 articulated on it.

[0093] The base 210 includes a housing 214 for inserting a measuring rod 240 which includes a sensor 245. When the rod 240 is correctly inserted into the housing 214, the sensor 245 is revealed through an opening 215 provided on the base 210, so that the user can deposit saliva into it by rubbing the toothbrush 250 as shown in (b) on [Fig.7].

[0094] Once the measurement is complete, the valve 220 can be closed, in which case a cleaning foam 225 can be used to clean the sensor 245.

[0095] This embodiment therefore corresponds to the use of an unmodified everyday object, a toothbrush, supplied with the device or already owned by the user, for collecting and ejecting saliva by means of its bristles, while remaining reusable. The toothbrush bristles are particularly compact and dense, which naturally creates microfluidic channels between them, facilitating a capillary effect of saliva. This phenomenon allows saliva to be captured when the bristles are rubbed in the mouth, for example, on the gums. The flexibility of the bristles helps them conform to the shape of the gums, thus increasing the contact surface area to optimize the amount of saliva collected.

[0096] The flexibility of the bristles also allows the collected saliva to be expelled when compressed against the sensor, the amount of saliva ejected depending on the force applied. It should be noted that less pressure is required for collection than for expulsion, and that the amount of saliva does not affect the measurement as long as it is above a minimum that a toothbrush naturally exceeds.

[0097] After use, the toothbrush can be easily cleaned and reused after a few hours. The rapid evaporation and drying of the brush bristles, which occurs within 1 to 2 hours, ensures that saliva collected subsequently will not be affected by potential contaminants such as toothpaste or food debris.

[0098] Figure 8 represents a reusable saliva test device 300, according to another embodiment, in which a dental glass 310 cooperates with an electronic docking station 320 for performing the measurement. The glass 310 comprises a first row of saliva extraction foams 330 and a second row cleaning foams 335, located below the first row. The docking station 320 includes a measuring sensor 340 placed on a wall intended to be opposite the glass 310.

[0099] When the user collects his saliva with an extraction foam 330, he places the glass 310 on the docking station 320 which is equipped with a piston 350 allowing the glass to have two functional positions: a measurement position, represented in (a), in which the extraction foam 330 is in contact with the sensor 340; and a cleaning position, represented in (b), in which the cleaning foam 335 is in contact with said sensor.

[0100] In both positions, the glass 310 is pressed against the sensor 340 by means of an elastomer-type spring 321 located on a wall opposite the wall containing the sensor 340.

[0101] According to one embodiment, each row of foams comprises eight foams.

[0102] Figure 9 represents a device 300' according to a variant of this embodiment in which the glass 310 does not have cleaning foams, these being replaced by a cleaning foam 335 mounted on a piston 360, itself placed directly on the docking station 320 between the glass 310 and the wall of the sensor 340.

[0103] Thus, after each measurement, the piston 360 is actuated to clean the sensor 340 with the foam 335 which comes to press against said sensor to absorb the saliva residue.

[0104] In order to easily penetrate between the glass 310 and the sensor 340, the support for the cleaning foam 335 has bosses 336 on its back shaped for this purpose, in order to separate the glass 310 and create a space between said glass and the sensor 340. After cleaning is complete, the piston 360 lowers the cleaning foam 335 back into its rest position. This allows the glass 310, and therefore the extraction foam 330, to come into contact with the sensor 340 under the action of the spring 321.

[0105] Indeed, the piston 360 remains in the cleaning position, covering the sensor 340, to protect it from external aggressions (light, dust, fingers, etc.) until the glass 310 is removed for subsequent use, which removal triggers the return of the piston to its rest position.

[0106] The movements of the piston 360 are automatically controlled via suitable sensors placed in the docking station 320.

[0107] Thus, in view of these different embodiments, it appears from the present description that certain non-essential elements of the reusable saliva test device can be modified, replaced or removed without departing from the scope of the invention as defined by the claims.

Claims

Demands

1. Device (100) for measuring a parameter (P) of the human body by saliva test, comprising a body (10) and at least one pair of measurement elements (30, 40) consisting of at least one saliva collection vector (30) placed on the body (10) and at least one associated sensor (40), characterized in that the saliva collection vector is configured to absorb a quantity of saliva when applied against a user's oral area with low pressure, and in that said vector is also configured to return a sufficient quantity of saliva for measurement when pressed with high pressure directly on the sensor, without any intermediary, and for a prolonged period within the time necessary to perform the measurement, to allow the measurements to be repeated and to make said device reusable.

2. Device according to claim 1, comprising at least one saliva cleaning vector (35) configured to come into contact with one or more sensors (40) after each measurement and remove residual saliva and debris thereon.

3. Device according to claim 2, wherein said at least one saliva collection vector (30) and one saliva cleaning vector (35) are of the same nature and / or identical.

4. Device according to any one of the preceding claims, wherein at least one saliva collection vector (30) is reusable, selected from: a foam, hairs, fibers or a textile, preferably a foam, preserving the same properties before and after its contact with a sensor (40) and / or with saliva.

5. Device according to any one of the preceding claims, further comprising a cap (20) in which each sensor (40) is placed in order to be protected from external harmful agents and from contact with the user's fingers, said cap being configured to fit onto the body (10).

6. Device according to claim 5, wherein the cap (20) has two functional positions relative to the body (10): an intermediate position in which a saliva sampling vector (30) is in contact with an associated sensor (40) to perform the measurement; and a closed position in which a saliva cleaning vector (35) is in contact with said sensor to clean it.

7. Device according to claim 5, wherein the cap (20) has a locking member (21) to cooperate with the body (10) by locking itself in two stable positions corresponding respectively to the two functional positions of said cap.

8. Device according to claim 6, wherein each saliva collection vector (30) returns to its initial position after the cap (20) has moved from the intermediate position to the closed position.

9. Device according to any one of the preceding claims, wherein each saliva sampling vector (30) and an associated sensor (40) are configured to apply themselves against each other with a pressure of non-zero normal component and in a limited time, preferably between 1s and 5min.

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