Patent Application
20220365015
The subject matter described generally relates to a monolithic molecularly imprinted polymer (MIP) sensor for multiple analytes and, in particular, to a handheld MIP sensor device with a replaceable MIP sensor.
Personalized medicine aims to provide medical diagnostics and treatment to people based on their individual characteristics. In pursuit of this goal, a range of devices and sensors have been developed that enable people to collect physiological data at home without the need for a medical professional to be present. Many households also now have reliable, high-speed connections to the internet, allowing this data to be provided to a remote facility for analysis almost immediately, and the results of that analysis can be returned just as fast. According to some projections, personalized medicine will become a trillion-dollar industry in the next few years. Thus, there is significant demand for low-cost, convenient ways for people to collect physiological data.
A handheld multi-analyte sensing device is disclosed. The multi-analyte sensing device measures the concentration of two or more analytes in a biological sample from a user using a multi-analyte sensor. In one embodiment, the multi-analyte sensor is replaceable. The multi-analyte sensing device includes a body and a controller housed within the body. The multi-analyte sensor is configured to be attached and detached from the controller. The multi-analyte sensor may be detached from multi-analyte sensing device in order to replace the multi-analyte sensor with another multi-analyte sensor or to reconfigure the multi-analyte sensor for measuring different analytes.
In one embodiment, the multi-analyte sensor includes a plurality of masks stacked on the multi-analyte sensor. Each mask exposes a specific set of analyte electrodes that are used to sense the concentration of analytes in a biological sample. In one embodiment, the analytes sensed using each mask may be different analytes. Alternatively, the analytes sensed using each mask may be the same allowing for measurements of the same analytes over a period of time.
The multi-analyte sensor may be used to take a plurality of measurements where each measurement is performed using a different one of the masks. After completion of a measurement, the multi-analyte sensor is detached from the controller and the topmost mask is removed from the multi-analyte sensor. The multi-analyte sensor is then re-attached to the device. By removing the topmost mask, another mask is revealed which exposes another set of analyte electrodes that are used to sense the concentration of analytes in a biological sample.
In one embodiment, the case of the multi-analyte sensor device is waterproof. The case may include one or more gaskets that prevent or at least reduce the exposure of the controller to substances that may degrade the controller. The gaskets may be located at the perimeter of the case as well as in an opening in the case through which the multi-analyte sensor attaches to the controller.
The figures and the following description describe certain embodiments by way of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods may be employed without departing from the principles described. Wherever practicable, similar or like reference numbers are used in the figures to indicate similar or like functionality. Where elements share a common numeral followed by a different letter, this indicates the elements are similar or identical. A reference to the numeral alone generally refers to any one or any combination of such elements, unless the context indicates otherwise.
The multi-analyte sensing device 110 measures the concentration of two or more analytes in a biological sample from a user. The multi-analyte sensing device 110 may obtain the sample by exposing a multi-analyte sensor 112 included in the device 110 to the sample. In one embodiment, the sample may be saliva, sweat, blood, or urine.
In the embodiment shown in
The server 120 and client device 130 are computer systems that may store and analyze measurements provided by the multi-analyte sensing device 110. In one embodiment, the server 120 receives measurements of analyte concentrations from the multi-analyte sensing device 110 and tracks variations in the concentrations over time. The server 120 correlates the variations with one or more health conditions and provides information regarding those health conditions to the client device 130 for display to the user. For example, a sudden spike in cortisol levels indicates acute stress and the user may be advised to undertake relaxation exercises (e.g., deep breathing) whereas consistently high level of cortisol indicates chronic stress and the user might be advised to consider a dietary supplement such as ashguawanda or a lifestyle change.
The network 170 provides the communication channels via which the other elements of the networked computing environment 100 communicate. The network 170 can include any combination of local area and/or wide area networks, using both wired and/or wireless communication systems. In one embodiment, the network 170 uses standard communications technologies and/or protocols. For example, the network 170 can include communication links using technologies such as Ethernet, 802.11, worldwide interoperability for microwave access (WiMAX), 3G, 4G, 5G, Bluetooth, Bluetooth Low Energy (BLE), Long Range Radio (LoRa), code division multiple access (CDMA), digital subscriber line (DSL), etc. Examples of networking protocols used for communicating via the network 170 include multiprotocol label switching (MPLS), transmission control protocol/Internet protocol (TCP/IP), hypertext transport protocol (HTTP), simple mail transfer protocol (SMTP), and file transfer protocol (FTP). Data exchanged over the network 170 may be represented using any suitable format, such as hypertext markup language (HTML) or extensible markup language (XML). In some embodiments, all or some of the communication links of the network 170 may be encrypted using any suitable technique or techniques.
A MIP is a polymer material that has binding sites with a strong affinity for a target analyte. The MIP is formed by polymerizing monomers in the presence of a template (which is often the target analyte). The monomers polymerize around some or all of the template. Thus, when the template is removed, a cavity is left behind that has a size, shape, and charge distribution that corresponds to the target analyte. Thus, when the MIP is exposed to the target analyte, molecules of the target analyte tend to bind to the MIP (similar to how antibodies bind to an antigen). Generally, the higher the concentration of the target analyte, the greater the number of molecules will bind to the MIP. MIP sensors detect the concentration of the corresponding target analyte by measuring changes in electrical properties of the sensor as molecules of the target analyte bind to the binding sites. For example, the impedance of a circuit including one class of MIP decreases as the number of molecules of the target analyte bound to the MIP increases, and thus the impedance decreases as the concentration of the target analyte increases. For another class of MIP, the impedance of the circuit increases as target molecules bind to the MIP, and thus the impedance increases with the concentration of the target analyte.
The multi-analyte sensor 112 shown in
The multi-analyte sensor 112 includes a plurality of analyte electrodes 205 and a reference electrode 207. The plurality of analyte electrodes 205 are arranged in a plurality of rows 216A to 216J and columns 217A and 217B. As shown in
Each analyte electrode 205 is coated with a MIP for a target analyte. In one embodiment, each analyte electrode 205 is configured to detect a different analyte. Thus, each analyte electrode 205 may be coated with a different MIP. Alternatively, some or all of the analyte electrodes 205 are configured to detect the same analyte. That is, multiple analyte electrodes 205 are configured to detect the same analyte, or all of the analyte electrodes are configured to detect the same analyte. Example target analytes that can be detected using the multi-analyte sensor 112 include cortisol, dehydroepiandrosterone (DHEA), melatonin, progesterone, estrogen, testosterone, cytokines, C-reactive protein, and cholesterol, among many others. In contrast, the reference electrode 207 may have no coating or has been treated to have substantially invariant electrical properties regardless of the presence of target analytes.
The multi-analyte sensor 112 also includes a plurality of electrical lines 209 made from an electrical conductor such as copper. The electrical lines 209 extend from electrical pins in the adaptor 203 to the analyte electrodes 205. For example, the electrical lines 209 extend from the analyte electrodes 205 in the second column 217B of analyte electrodes to the pins of the adaptor 203. In one embodiment, each electrical line 209 is connected to a corresponding one of the analyte electrodes 205 in the second column 217B.
In contrast, each analyte electrodes 205 in the first column 217A of analyte electrodes 205 is connected to a corresponding via 211. In one embodiment, the opposite side of the circuit board 201 also includes a plurality of electrical lines that are electrically connected to the vias 211 shown in
Furthermore, the electrical lines 209 include one or more electrical lines that are electrically connected to the reference electrode 207 as shown in
In on embodiment, a single measurement is made using analyte electrodes 205 include in a single row 216 (e.g., using one or more masks as will be described below). As shown in
If the analyte electrodes 205 of the multi-analyte sensor 112 are exposed to a sample, changes in the sensor's electrical properties may be used to detect the concentration of the target analytes in the sample. The target analytes selectively bond to the corresponding MIPs in each analyte electrode 205, which in turn change the electrical properties of the circuits formed by the corresponding electrical lines 209 and the reference line 207 (or lines). For example, as the concentration of a target analyte increases, a greater number of target analyte molecules bind to the MIP for that analyte, and the impedance between a corresponding electrical line 209 and reference line 207 decreases. The multi-analyte sensor device 110 may be calibrated to convert measured impedance values from the multi-analyte sensor 112 into concentrations. Additionally or alternatively, variations in the capacitance, inductance, resistance, or any other electrical property may be measured and calibrated to provide a measure of the concentration of a target analyte in the sample.
The position of the plurality of openings 300 in the single use mask 300 corresponds to the position of the plurality of analytes electrodes 205 included in the multi-analyte sensor 112. That is, each opening 300 is aligned with a corresponding one of the analyte electrodes 205 while the mask 300 is disposed on the multi-analyte sensor 112. Similarly, the position of the second opening 303 corresponds to the position of the reference electrode 207 included in the multi-analyte sensor 112 such that the second opening 303 is aligned with the reference electrode 207 while the mask 300 is disposed on the multi-analyte sensor 112. In one embodiment, the single use mask 300 is made of a film such as polyethylene (PET), polyvinyl chloride (PVC), Kapton, or any thin polymer robust enough to be peeled off from the multi-analyte sensor 112. However, other materials such as metal may be used for the single mask 300 in other embodiments.
In one embodiment, each mask from the plurality of masks 400 corresponds to a particular row 216 of analyte electrodes 205 where the position of the plurality of openings 401 in each mask 400 corresponds to the position of the particular pair of analytes electrodes 205 in the particular row 216. For example, the first mask 400A may correspond to the first row 216A of analyte electrodes 205 where the openings 401A correspond to the position of the analyte electrodes 205 included in the first row 216A and the second opening 403A corresponds to the position of the portion of the reference electrode 207 disposed between the analyte electrodes 205 in the first row 216A. Similarly, the second mask 400B may correspond to the second row 216B of analyte electrodes 205 where the first openings 401B correspond to the position of the analyte electrodes 205 included in the second row 216B and the second opening 403B corresponds to the position of the portion of the reference electrode 207 disposed between the analyte electrodes 205 in the second row 216B.
In one embodiment, the masks 400 all have the same width but different lengths with the first mask corresponding to the first row of analyte electrodes (e.g., the analyte electrodes furthest from the adaptor 203) having the longest length and the last mask corresponding to the last row of analyte electrodes (e.g., the analyte electrodes closest to the adaptor 204) having the shortest length. By using masks 400 with different lengths, the amount of material required for the masks 400 is reduced. In other embodiments, the masks 400 all have the same width and length.
Although only two masks 400 are shown in
By exposing only a pair of analyte electrodes 205 at a time using masks 400, the multi-analyte sensor 112 is configured as a multi-use analyte sensor in one embodiment. Each usage of the multi-analyte sensor 112 using the masks 400 exposes only a single pair of analyte electrodes 205 during the measurement of analytes. During subsequent usages of the multi-analyte sensor 112, a mask 400 is removed from the multi-analyte sensor 112 thereby exposing another mask that is disposed underneath the mask that was removed.
At a later time (e.g., the next day), a second measurement of analytes from a second sample may be required. Accordingly, the first mask 400A may be removed by peeling off the first mask 400A for example. The first mask 400A may be discarded at that time. By removing the first mask 400A, the second mask 400B is exposed as shown in
In one embodiment, the case 501 includes an insertion point 605 through which the sensor 112 is inserted in order to connect the sensor 112 to a connector 603 of the controller 114. The insertion point 605 is an opening formed at one end of the case 501 when both case parts 501A and 501B are attached together. The opening has a size large enough for the sensor 112 to be inserted into in order to connect the sensor 112 to the connector 603 of the controller 114.
In one embodiment, the multi-analyte sensor 112 is removable such that the user of the multi-analyte sensing device 110 can disconnect the sensor 112 from the controller 114 by pulling the sensor 112 away from the case 501 in a direction 607 along the length of the case 501. The multi-analyte sensor 112 may be disconnected from the controller 112 in order for the user to remove a mask from the sensor 112 as previously described above, for example. In another example, the multi-analyte sensor 112 may be disconnected from the controller 112 in order to replace the multi-analyte sensor 112 with another multi-analyte sensor. As described above, a multi-analyte sensor 112 has a finite number of uses before needing to be replaced. The user may remove the multi-analyte sensor 112 from the device 110 and replace the used sensor 112 with another unused multi-analyte sensor 112 for example.
As shown in
Similarly, the connector 603 includes a first set of pins 611A on a first side of the connector 603 and a second set of pins 611B on a second side of the connector 603 that is opposite the first side. The first set of pins 611A are configured to connect to the first set of pins 609A of the adaptor 203 and the second set of pins 611B are configured to connect to the second set of pins 609B on the adaptor. In one embodiment, each pin from the first set of pins 611A is configured to connect to a corresponding pin from the first set of pins 609A and each pin from the second set of pins 611B is configured to connect to a corresponding pin from the second set of pins 609B.
The samples used for measuring of analyte concentrations in the samples may be made of material (e.g., saliva) that may damage components of the device 110 upon contact of the components. In one embodiment, the case 501 of the multi-analyte sensing device 110 includes one or more sealing mechanisms to form a watertight seal that prevents or at least reduces exposure of the components of the device 110 to the sample and the environment. In one embodiment, the sealing mechanisms are gaskets, but other sealing mechanisms may be used.
In one embodiment, the case 501 includes a plurality of grooves in which the one or more gaskets 701 are disposed. As shown in
The gaskets 701 may also include a second gasket 701B that surrounds the opening 605 of the case through which the sensor 112 is inserted into the connector 603 to form the watertight seal in the area 705 of the connector 603. In one embodiment, each half of the case 501A and 501B includes a second gasket 701B. Thus, the device 110 includes at least two second gaskets 701B. For example, the second gasket 701B may include a first second gasket disposed at a position on the first case part 501A that is aligned with but non-overlapping with the connector 603, and the second case part 501B includes a second gasket disposed at a position on the second case part 501B that is aligned with but non-overlapping with the connector 603.
When both halves of the cases 50A and 501B are attached together, the two second gaskets 701B contact each other to form a watertight seal in the area 705 thereby protecting the connector 603 from the sample. That is, the second gaskets 701B prevent or at least reduce the connector 603 from exposure to the sample. In one embodiment, an opening is formed between the second gaskets 701B having a size that is large enough for the sensor 112 to pass through in order to connect to the connector 603 while reducing the amount of sample that may be exposed to the connector 603, if any. Thus, a portion of the sensor 112 is between the pair of second gaskets 701B while the sensor 112 is connected to the controller 114 via the connector 603. As shown in
Although
As used herein, any reference to “one embodiment” or “an embodiment” means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. Similarly, use of “a” or “an” preceding an element or component is done merely for convenience. This description should be understood to mean that one or more of the element or component is present unless it is obvious that it is meant otherwise.
Where values are described as “approximate” or “substantially” (or their derivatives), such values should be construed as accurate +/−10% unless another meaning is apparent from the context. From example, “approximately ten” should be understood to mean “in a range from nine to eleven.”
As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).
Upon reading this disclosure, those of skill in the art will appreciate still additional alternative structural and functional designs for a multi-analyte sensor as well as methods for making and using such a sensor. Thus, while particular embodiments and applications have been illustrated and described, it is to be understood that the described subject matter is not limited to the precise construction and components disclosed. The scope of protection should be limited only by the following claims.
