Embedded systems for sensor consumables for wearable devices

Abstract

The present invention relates to a wearable device for continuous monitoring of the health status of a patient or athlete without the need for blood sampling. The device comprises a housing in which at least a part of a processing unit is enclosed, means for attaching the main housing to a part of the user's body, and consumable parts configured to be manually coupled and decoupled from the main housing in a simple but sealed manner. The consumable parts include a sweat collection inlet for collecting sweat when the device is worn by a user and at least one sensor for measuring sweat biomarkers. The processing unit is configured to receive and process data provided by the sensor. The invention can be advantageously used in the sports medicine and / or sports health field for remote exercise and / or fatigue assessment.

Description

[Technical field]

[0001] The present invention relates to wearable medical devices for clinical and sports use. [Background technology]

[0002] There are various types of wearable devices that are worn by the user to continuously monitor daily activities such as walking, running, etc. without interruption. These wearable devices contain electronics and physiological sensors configured to sense certain physiological parameters of the wearer, such as heart rate, as well as motion sensors and GPS.

[0003] These known devices generally have similar configurations, are configured to monitor only one physiological parameter of the wearer, and have limited capabilities in terms of electronic processing and communication capabilities.

[0004] Furthermore, when these sensors measure sweat-related values, another drawback is that past sweat droplets can interfere with current ones, resulting in erroneous measurements. Thus, there is an unmet need for a wearable device that can monitor multiple physiological parameters of the wearer, including sweat-related parameters so that erroneous measurements are not caused by previous sweat samples. Summary of the Invention

[0005] The object of the present invention is to provide a wearable device that can be used in a variety of applications to monitor the health status of a patient or athlete without the need to draw blood, and that can be used in a simple and intuitive way.

[0006] The invention can be advantageously used in the field of sports medicine and / or sports health for remote exercise and / or fatigue assessment.

[0007] The present invention relates to a wearable device for continuously monitoring health parameters of a user, comprising three main parts: a housing, a means for attaching the housing to a part of the user's body, and a replaceable consumable part configured to be manually and removably attached to the housing and to be discarded after use.

[0008] The consumable components consist of a sweat collection inlet for collecting sweat when the device is worn by a user, at least one sensor for measuring sweat biomarkers, and a microfluidic channel for transporting collected sweat from the inlet to the sweat sensor.

[0009] Preferably, the consumable part has a sensing chamber in communication with the sweat inlet via a microfluidic channel, and at least one sensor disposed in the sensing chamber is a sweat lactate sensor, a sweat conductivity sensor, a metabolite sensor, an ion sensor, and / or an amino acid sensor.

[0010] The advantage of this form of wearable device, formed by a permanent part (the housing with the device's electronics) and a consumable part with sensors that can be disposed of after use, is that the same device can be used for a wide variety of health monitoring applications by simply providing a set of consumables, each with the sensors required for each specific application.

[0011] The wearable device further comprises a processing unit enclosed within the housing and configured to process data provided by the one or more sensors, and electrical connection means for electrically connecting the one or more sensors to the processing unit when the consumable part is operably attached to the main housing.

[0012] Preferably, the wearable device includes a communication module enclosed in the housing for wirelessly transmitting data processed and calculated by the processing unit to an external device such as a smartphone, a smartwatch, etc.

[0013] The housing has a front and a back, and the consumable part is mountable to the back of the housing such that the consumable part overlaps the back of the housing when the two are operatively attached.

[0014] The consumable part has a contact surface adapted to contact the user's skin when the consumable part is operably attached to the housing and the housing is attached to a portion of the user's body, and a sweat collection inlet is provided on the contact surface of the consumable part to collect sweat from the user's skin.

[0015] The housing has a cavity on its underside for receiving a battery that powers the processing unit and other electronics of the device, and includes a lid for closing the cavity and enclosing the battery therein, the lid needing to be removed to replace the battery, and the device is configured such that the consumable part rests on the lid when the consumable part is operably attached to the housing.

[0016] As a means for attaching the housing to a part of the user's body, a flexible band or strap is preferably used, having two ends each capable of being coupled to the housing. Preferably, the flexible band comprises at least one biosensor for measuring a vital sign or physiological indication of the user when the flexible band is attached to a part of the user's body, such as the arm, wrist, chest, etc., so that in addition to measuring sweat, one or more vital signs are also measured simultaneously with the same device while the sweat parameters are being measured, in direct contact with the skin. The one or more biosensors are selected from a heart rate sensor, a respiration rate sensor, a blood pressure sensor, a body temperature sensor, and an oxygen saturation sensor.

[0017] Alternatively, the means for attaching the main housing to a part of the user's body may include an adhesive surface suitable for adhering to the user's skin, for example, the adhesive surface may be provided on a surface of the consumable part that contacts the user's skin.

[0018] The device has a pair of connectors for mechanically connecting the flexible band to the housing and electrically connecting the biosensor to the processing unit.

[0019] Preferably, the consumable part is generally a flat, card-like body so that it does not protrude from the housing when the two are joined.

[0020] A portion of the rear surface of the housing is generally flat, and the consumable part can be attached to and detached from the housing by moving the consumable part flush with the generally flat portion of the rear surface of the housing. This method of coupling the consumable part to the housing has the advantage that the user can easily and intuitively attach and detach the consumable part to and from the housing even when the device is worn by the user.

[0021] In a preferred embodiment, the housing has a pair of opposing guides on a rear surface thereof for mounting the consumable part to the housing, and the consumable part has a pair of side wings sized to fit within a space defined between the pair of guides, and the consumable part can be attached to and detached from the housing by sliding the side wings along the guides to move the consumable part over the rear surface of the housing.

[0022] When coupled to the housing, the consumable component remains securely attached to the housing while the user runs or exercises, and when coupled, the pair of guides sealingly and operably couple the electrical connections of the consumable component.

[0023] Those skilled in the art will appreciate that the means for attaching and detaching the consumable parts from the housing can be embodied in many different ways within the scope of the present invention.

[0024] Preferably, the consumable part further comprises a sweat rate sensor for measuring the amount of sweat collected, and the processing unit is configured to receive and process data provided by the sweat biomarker sensor, the vital signs biosensor of the flexible band, and the sweat rate sensor.

[0025] The sweat rate sensor comprises a microfluidic circuit or a microfluidic reservoir in fluid communication with and disposed downstream of the sensing chamber, and a pair of electrodes disposed between the two electrodes such that a capacitance between the two electrodes is variable depending on the amount of sweat in the reservoir, the two electrodes being a pair of opposing strips, more preferably the electrodes are embodied as conductive flexible strips.

[0026] The microfluidic reservoirs can be of any shape, for example, they can be straight or curved conduits, or can be formed as conduits having a serpentine configuration.

[0027] In a preferred embodiment, the sweat sensor is a sweat lactate sensor and the vital signs sensor is a heart rate sensor, and the processing unit is further configured to calculate or estimate, preferably by a machine learning algorithm, a blood lactate concentration based on data provided by the sweat lactate sensor, the sweat rate sensor and the heart rate sensor. This data received by the processing unit is in the form of an electrical signal.

[0028] In summary, the main advantages of the present invention are:

[0029] - some form of wearable device is already used by athletes (heart rate monitors) and is familiar to them during their regular training;

[0030] - if no chemical measurements by the expendable part are required (e.g. already known training routines), the permanent part of the device (housing) can be used alone;

[0031] - the permanent part (housing) is compatible with different types of wear parts depending on the parameter to be measured, making the device a useful tool not only for the end user but also for doctors and sports physicians in clinics who can adapt the device to the requirements of their patients and studies;

[0032] -By simply inserting the consumable parts, they can be installed in the same position every time, reducing the variation caused by the user's own operation;

[0033] -Equipped with advanced electronics with advanced capabilities compared to patch-type wearable devices, such as battery management, data processing, and flash memory when data communication is not possible;

[0034] To improve adhesion with the permanent part, the wear part can have an adhesive surface.

[0035] The main application of the invention is focused on the sports medicine or sports health sector, for example for dehydration monitoring in athletes, however depending on the combination of sensors used the product can be aimed at different applications.

[0036] The present invention also relates to a wearable device for continuously monitoring health parameters of a user, the wearable device comprising: a housing having a front and a back surface and enclosing a processing unit therein; means for attaching the housing to a part of the user's body; and a consumable part configured to be manually coupled and uncoupled from the housing, the consumable part having a contact surface that contacts the user's skin when the consumable part is operably coupled to the housing and the housing is attached to the part of the user's body, the consumable part comprising: a sweat collection inlet formed on the contact surface of the consumable part for collecting sweat when the device is worn by a user; at least one sensor for measuring sweat biomarkers; and a microfluidic channel for transmitting the collected sweat from the inlet to a sweat emission sensor.

[0037] The wearable device further comprises electrical connection means for electrically connecting the sensor with a processing unit when the consumable part is operably coupled with the housing, the processing unit being configured to process data provided by the sensor, and the mating surfaces of the pair of guides and the consumable part being configured to be operably coupled in a sealing manner to seal the electrical connection.

[0038] In a more preferred embodiment, the surfaces of the consumable part configured to contact the surfaces of the pair of guides that form the electrical connection means comprise an adhesive surface configured to further seal the bond. [Brief description of the drawings]

[0039] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a preferred embodiment of the present invention including a mounting band or strap. [Diagram 2] FIG. 13 is a perspective view showing the main housing and the consumable portion partially mated. [Diagram 3] 13 is another perspective view of the main housing from above and shows a portion of the band end. [Figure 4] FIG. [Diagram 5] FIG. 4 is a perspective view of the main housing as seen from below. [Figure 6] FIG. 2 is an exploded view of the main housing parts. [Figure 7A] FIG. 4 is a perspective view of the main housing as seen from below. [Figure 7B] FIG. 13 is a bottom perspective view of the main housing with some of the consumable parts attached. [Figure 7C] FIG. 13 is a bottom perspective view of the main housing with the consumable parts fully joined. [Figure 8] 1 is a schematic diagram of a sweat rate sensor, showing four stages (A-D) of filling of the microfluidic channel. [Figure 9]FIG. 2 is a perspective view of the consumable device from the side opposite the surface that contacts the skin. [Figure 10] FIG. 2 is a schematic plan view of a consumable device. [Figure 11] FIG. 11 is a cross-sectional view of the consumable device taken along section AA in FIG. [Figure 12] 11 is another cross-sectional view of the consumable device taken along section line BB of FIG. 10. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] FIG. 1 shows an exemplary embodiment of a wearable device 1 in accordance with the present invention, comprising a housing 2, a flexible band or strap 3 for attaching the main housing to a part of a user's body, and a pair of electrical and mechanical connectors or snap buttons 4 on the housing 2 for mechanically and electrically connecting the ends of the flexible band to the housing 2.

[0041] The flexible band 3 is embodied as a stretchable woven tape with female connectors at each end for mating with snap buttons 4. The flexible band 3 is conventionally fitted in a known manner with at least one biosensor for measuring the user's vital signs or physiological indications, for example a pair of electrodes for measuring heart rate. The electrodes are made of bioelectrical silicone for capturing an electrocardiogram signal to extract the heart rate, are sufficiently conductive to obtain a high quality heart rate signal, and can withstand continuous use and washing.

[0042] As shown more clearly in FIG. 2 , the wearable device 1 includes a consumable part 5 configured to be manually attached and detached from the housing 2, the consumable part 5 having a contact surface 6 arranged to contact the user's skin when the consumable part 5 is coupled to the housing 2 and the housing 2 is attached to the user's body by the flexible band 3.

[0043] As shown in Figure 6, the housing 2 is formed by two connectable parts, a base 2a and a cover 2b, which when connected define a space in which an electronic circuit 7 is enclosed. The electronic circuit 7 implements a processing unit, sensor instrumentation, battery management, a data processing module for wirelessly transmitting data processed by the processing unit, and a communication module.

[0044] The housing 2, and in particular the base 2a, includes a recess or cavity 8 for receiving a battery 9 which powers the electronic circuitry 7, and a lid 10 for opening and closing the cavity 8.

[0045] As shown in Figures 2, 7B and 7C, the consumable part 5 is generally flat, and the housing 2 and the consumable part 5 are configured such that the consumable part 5 and the housing 2 can be coupled together by moving the consumable part 5 flush with the generally flat back surface 19 of the housing 2.

[0046] With this arrangement, the consumable part 5 is located on top of the lid 10 when fully installed in the housing 2, and the lid 10 is only accessible when the consumable part 5 is removed from the housing 2, as shown in FIG. 7C.

[0047] A pair of electrical connectors 12 are provided on the underside 13 of the base 2a of the housing 2 for electrically connecting the sensors attached to the consumable parts 5 with the processing unit 7. These connectors 12 are well known spring biased connectors such that when the consumable parts 5 are coupled to the housing 22, the connectors 12 establish electrical contact with corresponding electrical pads 17 on the consumable parts 5, in a well known manner.

[0048] The consumable part 5 is mechanically and electrically connectable and detachable from the housing 2 in a manner that is quick and intuitive for the user, while still ensuring functionality and good electrical connection with the housing 2 .

[0049] The housing 2 has a back surface 13 with a pair of opposing guides 15 that define a space or pocket between the guides 15 for receiving the consumable part 5. The consumable part 5 has a pair of side wings 16 that are sized and shaped to fit into the space defined between the guides 15 of the housing 2, and can be attached to the housing 2 by inserting the side wings 16 into the guides 15, respectively, and moving the consumable part 5 over the back surface 13 of the housing 2, as shown in the sequence of Figures 7A, 7B, and 7C.

[0050] As shown in Figures 5, 6, 7A, 7B, and 7C, the pair of guides 15 further includes a pair of electrical connectors 12, and the pair of guides 15 provides a high surface, so that the pair of guides 15 can appropriately include the pair of electrical connectors 12 such that the distance to the rear surface 13 of the pair of electrical connectors 12 is at most the same as that of the pair of guides 15. In this way, when the consumable part 5 is attached to the housing 2, the pair of electrical connectors 12 electrically contact the corresponding electrical pads 17 in a sealed state. Thus, electrical contact is established without sweat affecting the measurement value, since the electrical contact is configured between the surface of the consumable part 5 and the surface of the pair of guides 15 such that sweat does not reach the electrical contact location. It should be noted that the connection is simply tightened sufficiently to provide a seal that prevents sweat from contacting the electrical connection between the electrical connectors 12 and the corresponding electrical pads 17.

[0051] Advantageously, this allows for a simple integration system that does not require moving elements or coupling systems that are prone to incorrect manual coupling, e.g., using magnets, yet still provides a sealed electrical connection between the housing 2 and the consumable part 5. This is essential in many applications, such as sports use, where there is a high amount of sweat and / or water present around the consumable part 5.

[0052] In a more preferred embodiment, the surface of the consumable part 5, which includes the electrical pads 17 and is configured to contact the surface of the pair of guides 15, which includes the pair of electrical connectors 12, includes an adhesive surface configured to further seal the connection between the consumable part 5 and the housing 2. Advantageously, this allows for such a system in which the housing 2, being the permanent part, only has a simple built-in surface for the connection, while the consumable part 5, which is replaced each time, includes an additional sealing element that is subject to wear through its use. The system is thus configured to ensure that the electrical connection between the housing 2 and the consumable part 5 is always sealed. This is particularly important in environments where there is little space to seal out errors, such as underwater environments.

[0053] The consumable part 5 has a sweat rate sensor 18, shown diagrammatically in FIG. 8, which includes a microfluidic circuit or microfluidic reservoir 19 in fluid communication with and positioned downstream of a sensing chamber 21, such that sweat enters the inlet 11 and flows along the microfluidic channel 22 and the sensing chamber 21 gradually filling the reservoir 19, as shown more clearly in FIG. 10.

[0054] Furthermore, the sweat rate sensor 18 is composed of a pair of electrodes (20, 20') and a microfluidic reservoir 19 disposed between the two electrodes, such that the capacitance value between the two electrodes changes depending on the amount of sweat in the reservoir.

[0055] The consumable part 5 can be fabricated as a stack of layers of plastic material, with the microfluidic channels and sensing chambers formed by laser or die cutting. The integrated sensors are electrochemical in nature and therefore require electrodes which are fabricated by screen printing.

[0056] As shown in FIGS. 11 and 12, in this particular embodiment, the sweat inlet 11, the microfluidic channel 22 and the sensing chamber 21 are positioned above the microfluidic reservoir 19.

Claims

1. A wearable device for continuously monitoring a user's health parameters, comprising: a housing having a front and a back surface and enclosing the processing unit therein; means for attaching the housing to a part of a user's body; a consumable part configured to be manually coupled and uncoupled with a housing, the consumable part having a contact surface that contacts the user's skin when the consumable part is operably coupled with the housing and the housing is attached to a part of the user's body; The consumable parts are: a sweat collection inlet formed on a contact surface of the consumable part, for collecting sweat when the wearable device is worn by a user; at least one sensor for measuring sweat biomarkers; a microfluidic channel for transmitting collected sweat from the sweat collection inlet to a sweat sensor; Wearable devices also an electrical connection means for electrically connecting the sensor to the processing unit when the consumable part is operably coupled with the housing; the processing unit processes data provided by the sensors; the housing has a pair of guides facing each other, the consumable part has a pair of side wings, the housing and the consumable part are configured such that the consumable part can be coupled to the housing by inserting the side wings into the guides and moving the consumable part on the back surface of the housing; the electrical connection means is formed within the coupling surfaces of the pair of guides and the consumable part; the pair of guides and the mating surfaces of the consumable part are configured to be operably mated in a sealing manner to seal the electrical connection; A wearable device, wherein the surface of the consumable part that contacts the surfaces of the pair of guides that constitute the electrical connection means includes an adhesive surface that further seals the joint.

2. 2. The wearable device of claim 1, wherein a portion of the back surface of the housing is generally flat, and the consumable part is attachable to and detachable from the housing by moving the consumable part on a plane parallel to the generally flat portion of the back surface or on the same plane as the flat surface.

3. The wearable device of claim 1 , wherein the consumable part is a generally flat body.

4. The wearable device of claim 1 , wherein the means for attaching the main housing to a part of the user's body comprises a flexible band having two ends each connectable to the housing.

5. A wearable device as described in claim 1, wherein the means for attaching the main housing to a part of the user's body includes an adhesive surface suitable for adhering to the user's skin.

6. A wearable device as described in claim 5, wherein the adhesive surface is provided on the contact surface of the consumable part.

7. 2. The wearable device of claim 1, wherein the housing has a cavity on its back surface for receiving a battery that supplies power to the processing unit and a lid for closing the cavity and enclosing the battery therein, and the wearable device is configured such that the consumable part overlaps the lid when the consumable part is operably coupled to the housing.

8. The wearable device of claim 4, wherein the housing is provided with a pair of electrical connectors, and both ends of the flexible band are attached with metal connectors for mechanically and electrically connecting the flexible band and biosensor to the pair of electrical connectors of the housing.

9. 5. The wearable device of claim 4, wherein the flexible band comprises at least one biosensor positioned to measure a user's vital signs or physiological indications when the wearable device is worn by the user, the biosensor being selected from a heart rate sensor, a respiration rate sensor, a blood pressure sensor, a body temperature sensor, and an oxygen saturation sensor.

10. 10. The wearable device of claim 1, wherein the consumable part further comprises a sweat rate sensor for measuring the amount of collected sweat, and the processing unit is configured to receive and process data provided by the sweat rate sensor, the vital signs biosensor, and the sweat rate measurement device.

11. The wearable device of claim 1 , further comprising a communication module enclosed within the housing and configured for wireless transmission of data processed by the processing unit.

12. 11. The wearable device of claim 10, wherein the sweat sensor is a sweat lactate sensor and the vital signs sensor is a heart rate sensor, and the processing unit is further configured to calculate or estimate blood lactate concentration based on data provided by the sweat lactate sensor, the sweat rate sensor, and the heart rate sensor.

13. The wearable device described in claim 12, wherein the processing unit calculates or estimates blood lactate concentration using a machine learning algorithm.

14. 11. The wearable device of claim 10, further comprising a sensing chamber and at least one sensor of a sweat lactate sensor, a sweat conductivity sensor, a metabolite sensor, an ion sensor, or an amino acid sensor disposed within the sensing chamber, wherein the microfluidic channel communicates the sweat collection inlet with the sensing chamber.

15. 15. The wearable device of claim 14, wherein the sweat rate sensor comprises a pair of electrodes and a microfluidic reservoir located downstream of the sensing chamber, the microfluidic reservoir being fluidly connected to the sensing chamber between the pair of electrodes, and configured such that the capacitance value between the two electrodes varies depending on the amount of sweat in the microfluidic reservoir.

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