CN115956908B - Sensor and method for obtaining analyte concentration taking into account temperature compensation - Google Patents
Sensor and method for obtaining analyte concentration taking into account temperature compensation Download PDFInfo
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- CN115956908B CN115956908B CN202111187931.3A CN202111187931A CN115956908B CN 115956908 B CN115956908 B CN 115956908B CN 202111187931 A CN202111187931 A CN 202111187931A CN 115956908 B CN115956908 B CN 115956908B
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Abstract
本公开提供了在考虑温度补偿的情况下获得分析物浓度的方法，包括：在佩戴分析物传感器之前，在预定分析物浓度的情况下获得植入部分的灵敏信息，灵敏信息为植入部分的灵敏度与温度变化的关系；将植入部分置于皮下并将敷贴部分置于体表，通过温度传感器获得体表温度，并基于体表温度获得皮下温度；选取参考温度；基于灵敏信息、参考温度和皮下温度获得校准信息，并基于校准信息对由植入部分获得的响应信号进行校准；并且基于参考温度、以及校准后的响应信号获得分析物浓度。由此，能够提高获得的分析物浓度的精准度。
The present disclosure provides a method for obtaining analyte concentration under the condition of temperature compensation, including: obtaining sensitive information of the implanted part under the condition of a predetermined analyte concentration before wearing the analyte sensor, the sensitive information being the relationship between the sensitivity of the implanted part and the temperature change; placing the implanted part subcutaneously and placing the applied part on the body surface, obtaining the body surface temperature through a temperature sensor, and obtaining the subcutaneous temperature based on the body surface temperature; selecting a reference temperature; obtaining calibration information based on the sensitive information, the reference temperature and the subcutaneous temperature, and calibrating the response signal obtained by the implanted part based on the calibration information; and obtaining the analyte concentration based on the reference temperature and the calibrated response signal. Thus, the accuracy of the obtained analyte concentration can be improved.
Description
Technical Field
The present disclosure relates generally to the field of medical devices, and more particularly to a sensor and method for obtaining an analyte concentration with temperature compensation in mind.
Background
Diabetes is a disease of a series of metabolic disorders of sugar, protein, fat, water, electrolytes, etc., and if not well controlled, it may cause complications such as ketoacidosis, lactic acidosis, chronic renal failure, retinopathy, etc. In diabetic patients, if glucose concentration can be monitored continuously in real time, the occurrence of complications such as glucose disorder and hyperglucose disorder can be predicted with priority.
Studies have shown that when the glucose concentration in blood begins to decrease, the glucose concentration in tissue fluid decreases earlier than in blood, and that a decrease in glucose concentration in tissue fluid can be predicted for an impending low glucose. Glucose sensors for sensing glucose concentration generally include an implanted portion that can be subcutaneously placed to sense changes in glucose concentration in subcutaneous tissue fluid, thereby enabling predictions to be made of glucose concentration in blood.
The temperature at the location of the implanted portion will vary due to both ambient temperature changes and internal temperature changes. The implanted portion generally includes an enzyme that catalyzes a glucose reaction. Since the activity of the enzyme is affected by temperature, a deviation of the response signal output from the implanted part may occur, resulting in an inaccurate calculation of the glucose concentration based on the response signal. It is therefore necessary to calibrate the output response signal taking into account temperature compensation.
Disclosure of Invention
The present disclosure has been made in view of the above-described state of the art, and an object thereof is to provide a sensor and a method for obtaining an analyte concentration in consideration of temperature compensation, so as to improve the accuracy of the obtained analyte concentration.
To this end, the present disclosure provides a method of obtaining an analyte concentration taking into account temperature compensation, the analyte concentration being obtained by an analyte sensor comprising a subcutaneously positionable implanted part and an applied part with a temperature sensor, the method comprising obtaining sensitive information of the implanted part, which is a relation of sensitivity of the implanted part to temperature, before wearing the analyte sensor at a predetermined analyte concentration, subcutaneously placing the implanted part and the applied part on a body surface, obtaining a body surface temperature by the temperature sensor and a subcutaneous temperature based on the body surface temperature, selecting a reference temperature, obtaining calibration information based on the sensitive information, the reference temperature and the subcutaneous temperature, and calibrating a response signal obtained by the implanted part based on the calibration information, and obtaining the analyte concentration based on the reference temperature and the calibrated response signal.
In the method according to the present disclosure, before wearing the analyte sensor, sensitive information of the implanted part is obtained at a predetermined analyte concentration, i.e. a sensitivity versus temperature of the implanted part is obtained. The implant part is placed subcutaneously and the application part with the temperature sensor is placed on the body surface, the body surface temperature is obtained by the temperature sensor, and the subcutaneous temperature is obtained based on the body surface temperature. The reference temperature is selected, calibration information is obtained based on the sensitivity information, the reference temperature, and the subcutaneous temperature, and the response signal obtained by the implanted portion is calibrated based on the calibration information, whereby a calibrated response signal can be obtained. Based on the reference temperature and the calibrated response signal, the analyte concentration is calibrated, whereby the accuracy of the obtained analyte concentration can be improved.
Additionally, in the methods contemplated by the present disclosure, optionally, the implanted portion is placed in a reagent comprising the analyte, the temperature of the reagent is changed and the sensitivity of the implanted portion is measured as a function of the temperature of the reagent to obtain sensitivity information of the implanted portion. In this case, the sensitivity of the implanted portion is measured in relation to the temperature by using a reagent containing an analyte before wearing the analyte sensor, whereby the sensitivity information of the implanted portion can be conveniently obtained in advance.
Additionally, in the methods contemplated by the present disclosure, optionally, the concentration of the analyte in the reagent is maintained as the temperature of the reagent is changed. In this case, by controlling the concentration of the analyte in the reagent to be constant and changing the temperature of the reagent, the relationship between the sensitivity of the implanted portion and the temperature can be obtained more accurately.
Additionally, in the method according to the present disclosure, optionally, the calibration information is obtained based on the sensitivity information and a difference or ratio of the subcutaneous temperature to the reference temperature. In this case, temperature compensation can be facilitated by taking into account the relationship between the sensitivity of the implanted portion and the temperature, and the relationship between the subcutaneous temperature at which the implanted portion is located and the reference temperature.
Additionally, in the methods related to the present disclosure, optionally, when the temperature sensor senses temperature at a body surface and outputs the body surface temperature, the implanted portion is inserted subcutaneously while sensing subcutaneous analyte concentration and outputting a response signal. In this case, the subcutaneous temperature, that is, the temperature of the location where the implanted portion is located, and the response signal of the implanted portion sensing the analyte concentration output can be obtained at the same time, whereby the response signal of the implanted portion can be temperature-compensated in real time, so that the accuracy of the analyte concentration calibration can be improved.
Additionally, in the method according to the present disclosure, optionally, there is no time delay between the output of the response signal by the implanted portion and the output of the body surface temperature by the temperature sensor. Thereby enabling an improved accuracy of the analyte concentration calibration.
Additionally, in the methods contemplated by the present disclosure, optionally, the analyte is one or more of acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotrophin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, ketone bodies, lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. Thus, the concentration of the analyte such as acetylcholine, amylase, bilirubin, etc. can be obtained.
Additionally, in the methods contemplated by the present disclosure, optionally, the calibrated analyte concentration is obtained based on a relationship of the response signal of the implanted portion to the change in analyte concentration at the reference temperature, and the calibrated response signal.
The present disclosure also provides an analyte sensor for obtaining an analyte concentration taking into account temperature compensation, the analyte sensor comprising a subcutaneously positionable implant part, a topically positionable applicator part having a temperature sensor, and a processing module storing a first mapping between a subcutaneous temperature and a body surface temperature obtained by the temperature sensor, sensitive information of the implant part, and a second mapping between a response signal output by the implant part at a predetermined temperature and an analyte concentration change, wherein the sensitive information is a relation between the sensitivity of the implant part at a predetermined analyte concentration and a temperature change, the temperature sensor sensing the temperature of the body surface and outputting the body surface temperature when the implant part is subcutaneously positioned and the applicator part is positioned on the body surface, the processing module being configured to obtain a reference temperature based on the body surface temperature and the first mapping, obtain a calibration information based on the sensitive information, the subcutaneous temperature and the reference temperature, obtain the calibration information based on the response signal, obtain the calibration information based on the implant part, and obtain the calibration signal based on the second mapping.
In the analyte sensor according to the present disclosure, an implanted portion is placed subcutaneously and an applied portion having a temperature sensor is placed on a body surface, a body surface temperature is obtained by the temperature sensor, and a subcutaneous temperature is obtained based on the body surface temperature. The processing module is configured to obtain a subcutaneous temperature based on the body surface temperature and the first mapping relation, to select a reference temperature, to obtain calibration information based on the sensitivity information, the subcutaneous temperature and the reference temperature, to calibrate a response signal obtained by the implanted portion based on the calibration information, and to obtain an analyte concentration based on the reference temperature, the calibrated response signal and the second mapping relation, whereby the analyte concentration with temperature compensation taken into account can be obtained, and the accuracy of analyte concentration sensing by the analyte sensor is improved.
In addition, in the analyte sensor according to the present disclosure, the implanted portion includes a working electrode capable of reacting with an analyte, and a counter electrode that forms a circuit with the working electrode. Whereby the implanted portion is capable of sensing the analyte concentration.
According to the present disclosure, a sensor and a method for obtaining an analyte concentration in consideration of temperature compensation can be provided, whereby the accuracy of the obtained analyte concentration can be improved.
Drawings
Fig. 1 is a schematic diagram showing a wearing state of an analyte sensor for obtaining an analyte concentration in consideration of temperature compensation according to an embodiment of the present disclosure.
Fig. 2 is a schematic diagram illustrating a structure of an implanted portion of an analyte sensor according to an embodiment of the present disclosure.
Fig. 3 is a schematic structural view of a working electrode showing an implanted portion according to an embodiment of the present disclosure.
Fig. 4 is a graph showing a first map between subcutaneous temperature and body surface temperature obtained by a temperature sensor according to an embodiment of the present disclosure.
FIG. 5A is a graph showing the results of a linear regression simulation of response current versus temperature for an implanted portion according to embodiments of the present disclosure;
fig. 5B is a table showing correspondence to the linear regression simulation result map of fig. 5A.
Fig. 6 is a second map showing response current versus analyte concentration in accordance with an embodiment of the present disclosure.
Fig. 7 is a flow chart illustrating a method of obtaining an analyte concentration with temperature compensation in mind in accordance with an embodiment of the present disclosure.
Detailed Description
The present disclosure is described in further detail below with reference to the drawings and detailed description. In the drawings, the same components or components having the same functions are denoted by the same reference numerals, and repetitive description thereof will be omitted.
The present disclosure relates to a method of obtaining an analyte concentration taking into account temperature compensation, which may calibrate the obtained analyte concentration taking into account temperature compensation. The method according to the present embodiment can contribute to an improvement in accuracy of the obtained analyte concentration.
In the method of obtaining an analyte concentration under consideration of temperature compensation to which the present disclosure relates, the analyte concentration may be obtained by an analyte sensor. For ease of understanding, the present disclosure first describes an analyte sensor that obtains an analyte concentration with temperature compensation in mind.
In some examples, the analyte sensor may also sometimes be referred to as an implantable analyte sensor, analyte monitor, or analyte monitor. The names are used to indicate the analyte sensor according to the present embodiment, which can improve the accuracy of the obtained analyte concentration in consideration of temperature compensation, and should not be construed as limiting.
Fig. 1 is a schematic diagram showing a wearing state of an analyte sensor 1 that obtains an analyte concentration in consideration of temperature compensation according to an embodiment of the present disclosure.
In some examples, the analyte sensor 1 may include a subcutaneously positionable implant portion 2, a body surface positionable applicator portion 3, and a processing module (see fig. 1, processing module not shown). In some examples, when implant portion 2 is placed subcutaneously, implant portion 2 may sense the concentration of the subcutaneous analyte and output a response signal. In some examples, the applicator portion 3 may have a temperature sensor 4 (see fig. 1). In some examples, the temperature sensor 4 may detect the temperature of the body surface and output the body surface temperature when the application portion 3 is placed on the body surface. In some examples, the processing module may receive the response signal output by implanted portion 2 and the body surface temperature output by temperature sensor 4, and calculate and output a calibrated analyte concentration.
Fig. 2 is a schematic diagram showing the structure of an implanted portion 2 of the analyte sensor 1 according to the embodiment of the present disclosure.
In some examples, as described above, analyte sensor 1 may include an implanted portion 2 (see fig. 1). In some examples, the implanted portion 2 of the analyte sensor 1 may be placed subcutaneously and in contact with subcutaneous interstitial fluid (see fig. 1). The implanted portion 2 may sense the concentration of the analyte in the tissue fluid and output a response signal.
In some examples, the implanted portion 2 may be flexible. The implant part 2 may be provided in a puncture needle (not shown) from which the implant part 2 is separable. In wearing the analyte sensor 1, the puncture needle wrapped with the implant part 2 may be inserted into tissue, and then the puncture needle is pulled out and separated from the implant part 2, whereby the implant part 2 is subcutaneously placed.
In some examples, the implant part 2 may be configured in an arm (see fig. 1), an abdomen, a waist, a leg, or the like.
In some examples, the implant portion 2 may be placed subcutaneously 3mm to 20mm. In some examples, the depth to which the implant portion 2 is placed subcutaneously is determined from the penetration location. The placement is deeper when the fat layer is thicker, such as in the human abdomen, and the placement depth may be about 10mm to 15mm. The fat layer is placed shallower, for example at the arm, and the depth of placement may be about 5mm to 10mm.
In some examples, the implanted portion 2 may include a substrate S (see fig. 2).
In some examples, the substrate S may be flexible. The substrate S may be generally made of at least one of Polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polyethylene terephthalate (PET), and polyethylene naphthalate (PEN). In addition, in other examples, the substrate S may also be made substantially of a metal foil, ultra-thin glass, a single-layer inorganic film, a multi-layer organic film, a multi-layer inorganic film, or the like. In some examples, the substrate S may also be inflexible.
In some examples, the implant portion 2 may include a working electrode 10 and a counter electrode 30 (see fig. 2). In some examples, working electrode 10 may form a loop with working electrode 10. Whereby the implanted portion 2 is capable of sensing the analyte concentration.
In some examples, the implanted portion 2 may also include a reference electrode 20. In some examples, the implanted portion 2 may also include contacts 40 (see fig. 2) connected to the working electrode 10 via leads. Thereby, the implanted portion 2 is able to transmit a response signal outwards via the contact 40.
In some examples, the working electrode 10, the reference electrode 20, and the counter electrode 30 can be disposed on a substrate S (see fig. 2).
Fig. 3 is a schematic structural view of the working electrode 10 showing the implanted portion 2 according to the embodiment of the present disclosure.
In some examples, as described above, the implanted portion 2 may include a working electrode 10 (see fig. 2). In some examples, working electrode 10 may be provided with a base layer 110, a nanoparticle layer 120, an analyte enzyme sensing layer 130, a semi-permeable membrane 140, and a biocompatible membrane 150. The base layer 110, the nanoparticle layer 120, the analyte enzyme sensing layer 130, the semipermeable membrane 140, and the biocompatible membrane 150 may be sequentially laminated (see fig. 3).
In some examples, the base layer 110 may be electrically conductive. In some examples, the base layer 110 may be made of at least one selected from gold, glassy carbon, graphite, silver chloride, palladium, titanium, iridium. In this case, the base layer 110 has good conductivity, and the electrochemical reaction of the base layer 110 can be suppressed, whereby the stability of the base layer 110 can be improved.
In some examples, the base layer 110 may be disposed on the substrate S by a deposition or plating method. In some examples, the method of deposition may include physical vapor deposition, chemical vapor deposition, and the like. Plating methods may include electroplating, electroless plating, vacuum plating, and the like. In addition, in some examples, the base layer 110 may also be provided on the substrate S by screen printing, extrusion, or electrodeposition, among others.
In some examples, the substrate layer 110 may have an analyte enzyme sensing layer 130 disposed thereon.
In some examples, the concentration of multiple analytes may be obtained by altering the analyte enzyme sensing layer 130 on the implanted portion 2. For example, in some examples, the analyte may be one or more of acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotrophin, creatine kinase, creatine, DNA, fructosamine, glucose, glutamine, growth hormone, ketone body, lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. In other examples, the concentration of a drug in the body fluid, such as antibiotics (gentamicin, vancomycin, etc.), digitoxin, digoxin, theophylline, warfarin (warfarin), etc., may also be monitored by altering the analyte enzyme sensing layer 130 on the implanted portion 2.
In some examples, the nanoparticle layer 120 may be disposed on the substrate layer 110. That is, between the base layer 110 and the analyte enzyme sensing layer 130, a nanoparticle layer 120 may be provided. In this case, the nanoparticle can further catalyze the analyte reaction, reduce the operating voltage required for the analyte reaction and increase the reaction rate.
Specifically, taking GO X (FAD) as an example of glucose oxidase, in analyte sensing layer 130, when GO X (FAD) encounters glucose in tissue, the following reaction occurs:
glucose+GOx (FAD) glucolactone → +. GOx (FADH 2.) the reaction formula (I)
GOx (FADH 2)+O2→GOx(FAD)+H2O2. Reactive formula (II))
During the above reaction, H 2O2 is generated in reaction formula (II), and the aggregation of H 2O2 causes a decrease in the enzyme activity in the analyte enzyme sensing layer 130.
The nanoparticle layer 120 may act as a catalyst to cause the decomposition reaction of H 2O2, as follows:
H 2O2→2H++O2+2e-. Reaction type (III)
By the above-described reaction formulae (I) to (III), the reaction of the implanted portion 2 with glucose can be continued. In addition, the nanoparticle layer 120 catalyzes the decomposition of hydrogen peroxide, so that the voltage required to be applied in the reaction process can be reduced, thereby being beneficial to improving the sensitivity of the implanted portion 2, prolonging the service time of the analyte sensor 1, and obtaining a low operating voltage. In other words, the nanoparticle layer 120 can continuously obtain a high-sensitivity sensing signal of tissue glucose, and prolong the service life of the analyte sensor 1, while the low operating voltage is beneficial to improving the anti-interference performance.
In some examples, the nanoparticle layer 120 may be porous. In this case, the analyte enzymes in the analyte enzyme sensing layer 130 may permeate the nanoparticle layer 120. Thus, the nanoparticle layer 120 can sufficiently contact and catalyze the analyte reaction, thereby more effectively promoting the analyte reaction.
In some examples, the analyte enzyme may also be disposed in a three-dimensional network of conductive polymer nanofibers, i.e., the three-dimensional network of nanofibers is disposed between the nanoparticle layer 120 and the analyte enzyme sensing layer 130. Thereby, the adhesion of the analyte enzyme to the nanoparticle layer 120 is increased, and the immobilized amount of the analyte enzyme is increased.
In some examples, the analyte enzyme may also be disposed on carbon nanotubes, wherein the carbon nanotubes are disposed on the nanoparticle layer 120. Thereby, the adhesion and immobilization of the analyte enzymes on the nanoparticle layer 120 is increased.
In some examples, the semi-permeable membrane 140 may be distributed over the analyte enzyme sensing layer 130. In some examples, the semipermeable membrane 140 may further include a diffusion control layer and an anti-tamper layer laminated on the diffusion control layer.
In some examples, the diffusion control layer may be disposed outside the tamper resistant layer. In the semipermeable membrane 140, a diffusion control layer can control the diffusion of analyte molecules and an anti-interference layer can prevent the diffusion of non-analyte substances. Thus, the interstitial fluid or blood components passing through the semipermeable membrane 140 may be reduced, and then the interfering substances may be blocked outside the semipermeable membrane 140 by the anti-interference layer. Common interferents may include uric acid, ascorbic acid, acetaminophen, and the like, which are ubiquitous in the body. In other examples, an anti-tamper layer may also be provided outside the diffusion-control layer. Thereby, it is also possible to reduce inaccuracy of the sensing result due to interference of impurities with the working electrode 10 and to extend the service life of the implanted portion 2.
In some examples, the semipermeable membrane 140 may control the rate of passage of analyte molecules, i.e., the semipermeable membrane 140 may limit the number of analyte molecules in the interstitial fluid or blood that reach the analyte enzyme sensing layer 130. Specifically, the diffusion control layer of the semipermeable membrane 140 may be effective to reduce the amount of analyte that diffuses to the analyte enzyme sensing layer 130 by a certain proportion.
In some examples, the biocompatible membrane 150 may be disposed on the semi-permeable membrane 140. In some examples, the biocompatible film 150 may be made of a plant material. The plant material may be sodium alginate, tragacanth, pectin, acacia, xanthan gum, guar gum, agar or starch derivatives, cellulose derivatives, and other natural material derivatives. In other examples, the biocompatible film 150 may also be made of synthetic materials. The synthetic material may be a polyolefin. Thus, the immune response of the human body to the implanted portion 2 can be reduced, and the service life of the implanted portion 2 can be prolonged.
Additionally, in some examples, the semipermeable membrane 140 may also be biocompatible. Thus, the use of the biocompatible film 150 can be avoided, and the manufacturing cost can be reduced.
In some examples, an analyte enzyme sensing layer 130 is formed on the base layer 110 of the working electrode 10 after a nanoparticle layer 120 for promoting analyte enzyme-catalyzed analyte reactions is provided thereon, a semipermeable membrane 140 coating is formed on the analyte enzyme sensing layer 130, and finally a biocompatible membrane 150 layer is formed on the semipermeable membrane 140 coating (see fig. 3). Thereby, the service life of the implanted portion 2 is prolonged, interference of other factors is reduced, and the response speed of the implanted portion 2 to the analyte is improved.
In some examples, as described above, the implanted portion 2 may include a counter electrode 30 (see fig. 2). In some examples, counter electrode 30 may be made of platinum, silver chloride, palladium, titanium, or iridium. Thus, the electrochemical reaction at the working electrode 10 can be unaffected with good conductivity. However, the present embodiment is not limited thereto, and in other examples, the counter electrode 30 may be made of at least one selected from gold, glassy carbon, graphite, silver chloride, palladium, titanium, or iridium. Thus, the influence on the working electrode 10 can be reduced with good conductivity.
In some examples, the implanted portion 2 of the present embodiment may be continuously monitored, thus enabling the purpose of continuously monitoring the analyte concentration value of the human body for a long period of time (e.g., 1 to 24 days).
In some examples, as described above, the analyte sensor 1 further comprises an application portion 3 (see fig. 1 and 2).
In some examples, the applicator portion 3 may have a housing 31 (see fig. 1). In some examples, the applicator portion 3 may have a temperature sensor 4 located within the housing 31 (see fig. 1).
In some examples, the temperature sensor 4 may be disposed on an inner wall surface of the housing 31 (see fig. 1) near the body surface. In other examples, the temperature sensor 4 may be provided on any wall surface of the housing 31.
In some examples, the number of temperature sensors 4 of the application portion 3 may be one. In other examples, the number of the temperature sensors 4 of the application portion 3 may be plural, whereby the accuracy of body surface temperature sensing can be improved, thereby improving the accuracy of subcutaneous temperature obtained based on the body surface temperature.
In some examples, the applicator portion 3 may be connected to the implant portion 2. In some examples, the portion of the implanted portion 2 that is located on the body surface may be electrically connected to the application portion 3 by a contact 40 (see fig. 2). Thereby, the current signal generated by the implanted part 2 can be transmitted to the application part 3 via the contact 40 through the base layer 110 and the transmission wire.
In some examples, the application portion 3 may be made of a flexible PCB and a flexible battery. Thus, the skin can be closely attached, and the influence on the daily life of the user can be reduced.
In some examples, as described above, the analyte sensor 1 further includes a processing module (not shown).
In some examples, the treatment module may be mounted on the application part 3. The current signal generated by the implanted part 2 can thus be fed via the contact 40 to the processing module for analysis, and the body surface temperature output by the temperature sensor 4 can be fed to the processing module for analysis.
In some examples, the processing module may store a first mapping relationship between the subcutaneous temperature and the body surface temperature. In some examples, as described above, the body surface temperature may be obtained by the temperature sensor 4. In some examples, the processing module may store sensitive information of the implanted portion 2. In some examples, the processing module may store a second mapping of the response signal output by implanted portion 2 to the change in analyte concentration. Specifically, the second map may be a second map of the response signal output by the implanted portion 2 with the change in the analyte concentration at a predetermined temperature.
In some examples, as described above, the processing module may store a first mapping between the subcutaneous temperature and the body surface temperature obtained by the temperature sensor 4.
Fig. 4 is a graph showing a first map between the subcutaneous temperature and the body surface temperature obtained by the temperature sensor 4 according to the embodiment of the present disclosure.
In some examples, three temperature sensors 4 having the same process parameters may be placed in the external environment, simulating the body surface of a living body, simulating the subcutaneous of a living body, respectively, at about 10 mm. In some examples, the three temperature sensors 4 may be set to output the respective sensed temperatures every 1 minute, changing the temperature of the external environment. The first map of the body surface temperature and the subcutaneous temperature can be obtained by the temperature of the external environment, the body surface temperature, and the subcutaneous temperature respectively output by the three temperature sensors 4 (see fig. 4).
The temperature sensor 4 with the same process parameter may refer to a temperature sensor 4 shipped from the same batch during production, and may generally be a temperature sensor 4 prepared by the same batch of products under the same process. Thereby, systematic errors measured between different temperature sensors 4 can be reduced.
In some examples, as described above, the processing module may store sensitive information of the implanted portion 2.
In some examples, the sensitivity information may be a sensitivity versus temperature of the implanted portion 2. Specifically, in some examples, the sensitivity of the implanted portion 2 may be a variation value of the sensitivity of the implanted portion 2 at the reference temperature.
In some examples, the change in sensitivity of the implanted portion 2 may be obtained from a response current versus temperature of the implanted portion 2 at a reference temperature.
Fig. 5A is a graph showing a linear regression simulation result of the response current versus temperature of the implant part 2 according to the embodiment of the present disclosure, and fig. 5B is a table showing correspondence with the linear regression simulation result graph of fig. 5A.
In some examples, the analyte sensor 1 may sense a concentration of glucose. The implanted portion 2 of the analyte sensor 1 is placed in a glucose solution. In some examples, the concentration of the glucose solution may be 5mmol/L to 25mmol/L. In some examples, the temperature of the glucose solution is varied to obtain a response signal output by the implanted portion 2 when the temperature of the glucose solution is 30 ℃, 34 ℃, 37 ℃, and 40 ℃ (see fig. 5B). In some examples, the response signal may be a response current (see fig. 5B). In other examples, the response signal may be a response voltage.
In some examples, the relationship of the response current and temperature is analyzed, and the response current and temperature may be linearly related (see fig. 5A). In other examples, the relationship between the response current and temperature is analyzed, and the response current and temperature may be non-linearly related.
In some examples, the change in sensitivity of the implanted portion 2 at the reference temperature may be a ratio of a slope (k value) of a linear regression equation of the linear simulation result to the response signal (see fig. 5A and 5B in combination). For example, in connection with fig. 5A and 5B, the variation value of the sensitivity of the implant part 2 at 30 ℃ may be 12.59% (0.428/3.40) when 30 ℃ is selected as the reference temperature, 8.82% (0.428/4.85) when 34 ℃ is selected as the reference temperature, 6.95% (0.428/6.16) when 37 ℃ is selected as the reference temperature, and 5.56% (0.428/7.70) when 40 ℃ is selected as the reference temperature.
In some examples, the variation value of the sensitivity of the implanted portion 2 at the reference temperature may be an average value of the results of a plurality of repeated measurements of the same implanted portion 2. In other examples, the variation in sensitivity of the implanted portion 2 at the reference temperature may be an average of the measurements of the plurality of implanted portions 2. In both cases, the calculation of the average value can reduce the systematic error and improve the accuracy of the calculation result, and thus can be advantageous in improving the accuracy of the obtained analyte concentration.
In some examples, as described above, the processing module may store a second mapping of response signals of the implanted portion 2 as a function of analyte concentration at a predetermined temperature.
In some examples, the predetermined temperature includes a plurality of temperature values. For example, in some examples, the predetermined temperature includes 34 ℃, 35 ℃, 36 ℃, 36.5 ℃, 37 ℃, 37.5 ℃, 38 ℃, 39 ℃,40 ℃, and 41 ℃. In some examples, the reference temperature may be selected from one of a plurality of temperature values. For example, in some examples, the reference temperature may be 34 ℃, 35 ℃, 36 ℃, 36.5 ℃, 37 ℃, 37.5 ℃, 38 ℃, 39 ℃,40 ℃, or 41 ℃.
Fig. 6 is a second map showing response current versus analyte concentration in accordance with an embodiment of the present disclosure.
In some examples, the analyte sensor 1 may sense a concentration of glucose. 37 ℃ was chosen as the reference temperature. The implanted portions 2 of the analyte sensor 1 are placed in glucose solutions of different concentrations, respectively. In some examples, the concentration of the glucose solution may be 0 to 25mmol (see fig. 6). The implanted portion 2 senses glucose solutions of different concentrations and outputs a corresponding response signal. In some examples, the response signal may be a response current (see fig. 6). In other examples, the response signal may be a response voltage.
In some examples, the relationship between the response current and the analyte concentration is analyzed, and the response current may be linearly related to the glucose concentration (see fig. 6), i.e., the second mapping relationship is a linear relationship. In other examples, the relationship between the response current and the analyte concentration is analyzed, and the response current and the analyte concentration may be non-linearly related, i.e., the second mapping relationship is a non-linear relationship.
In some examples, the processing module is configured to obtain a subcutaneous temperature. For example, the processing module is configured to obtain the subcutaneous temperature based on the body surface temperature and the first mapping. In some examples, the processing module is configured to select the reference temperature. In some examples, the processing module is configured to obtain calibration information. For example, the processing module is configured to obtain calibration information based on the sensitivity information, the subcutaneous temperature, and the reference temperature. In some examples, the processing module is configured to calibrate the response signal. For example, the processing module is configured to calibrate the response signal obtained by the implanted portion 2 based on the calibration information. In some examples, the processing module is configured to obtain the analyte concentration. For example, the processing module is configured to obtain the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping.
In some examples, as described above, the processing module is configured to obtain the subcutaneous temperature based on the body surface temperature and the first mapping. Specifically, the temperature sensor 4 may transmit the sensed body surface temperature to the processing module, and the processing module obtains the subcutaneous temperature based on the body surface temperature and the first mapping relationship according to the first mapping relationship preset in the processing module.
In some examples, as described above, the processing module is configured to select the reference temperature. In some examples, the reference temperature selected by the processing module configuration may be 37 ℃. In this case, the reference temperature is relatively close to the average body temperature of the human body, whereby the effect of calibrating the analyte concentration in consideration of temperature compensation can be improved. In other examples, the reference temperature may be other temperatures as well. For example, the reference temperature may be 35 ℃, 36 ℃, 36.5 ℃, 37.5 ℃, 38 ℃, or the like.
In some examples, as described above, the processing module is configured to obtain the calibration information based on the sensitivity information, the subcutaneous temperature, and the reference temperature. Specifically, in some examples, the processing module is configured to calculate a difference between the reference temperature and the subcutaneous temperature, and then calculate a product of the difference and a change in sensitivity of the implanted portion 2 at 37 ℃, thereby obtaining calibration information.
In some examples, as described above, the processing module is configured to calibrate the response signal obtained by the implanted portion 2 based on the calibration information. Specifically, in some examples, the response signal generated by the implanted portion 2 can be transmitted through the contact 40 to a processing module configured to mathematically calculate the calibration information and the response signal to calibrate the response signal obtained by the implanted portion 2.
In some examples, the calibration formula for the response signal obtained by the implanted portion 2 may be b=a (1+Δt×z). Where Δt represents the difference between the reference temperature and the subcutaneous temperature, Z represents the variation value of the sensitivity of the implanted part 2 at the reference temperature, a represents the response signal output from the implanted part 2 to the processing module, and b represents the calibrated response signal.
In some examples, as described above, the processing module is configured to obtain the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping. Specifically, in some examples, the processing module is configured to calculate the calibrated analyte concentration from the second mapping relationship at the reference temperature preset by the processing module and the calibrated response signal.
In some examples, the temperature sensor 4 and implanted portion 2 (particularly during the fasting and post-meal periods) may transmit signals to the processing module at intervals, and the processing module may output the calibrated analyte concentration at intervals outwardly so that the user may learn the trend of the change in the analyte concentration in time to control the change in the analyte concentration.
In some examples, the analyte concentration signal obtained by the processing module may be transmitted via wireless communication means, such as bluetooth, wifi, or the like. An external reading device, such as a cell phone, computer (not shown), may receive the analyte concentration signal from the processing module and display the concentration of the analyte.
In the analyte sensor 1 according to the present disclosure, the implanted portion 2 is placed subcutaneously and the applied portion 3 having the temperature sensor 4 is placed on the body surface, the body surface temperature is obtained by the temperature sensor 4, and the subcutaneous temperature is obtained based on the body surface temperature. The processing module is configured to obtain a subcutaneous temperature based on the body surface temperature and the first mapping, to select a reference temperature, to obtain calibration information based on the sensitivity information, the subcutaneous temperature and the reference temperature, to calibrate a response signal obtained by the implanted portion 2 based on the calibration information, and to obtain an analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping. The analyte concentration can thus be obtained taking into account the temperature compensation, increasing the accuracy of the analyte concentration sensing by the analyte sensor 1.
In the following, a method of obtaining an analyte concentration with temperature compensation in mind is described in connection with the above described analyte sensor 1.
The method of obtaining the analyte concentration in consideration of temperature compensation according to the present embodiment may be also referred to as a calibration method for the analyte concentration, a method of calibrating the analyte concentration by temperature compensation, or the like. The names are used to indicate a method of improving the accuracy of the obtained analyte concentration in consideration of temperature compensation according to the present embodiment, and should not be construed as limiting.
Fig. 7 is a flow chart illustrating a method of obtaining an analyte concentration with temperature compensation in mind in accordance with an embodiment of the present disclosure.
In connection with fig. 7, a method of obtaining an analyte concentration with temperature compensation in mind according to the present disclosure may include obtaining sensitive information of an implanted portion 2 prior to wearing an analyte sensor 1 (step S100), obtaining a body surface temperature, obtaining a subcutaneous temperature based on the body surface temperature (step S200), selecting a reference temperature (step S300), obtaining calibration information, calibrating a response signal based on the calibration information (step S400), and obtaining an analyte concentration based on the reference temperature and the calibrated response signal (step S500).
In step S100, as described above, sensitive information of the implanted part 2 may be obtained before wearing the analyte sensor 1. In some examples, sensitive information of the implanted portion 2 may be obtained with a predetermined analyte concentration prior to wearing the analyte sensor 1.
In some examples, in step S100, the predetermined analyte concentration may be a known and same analyte concentration. In some examples, implant portion 2 may be placed in an analyte, and a response signal output by the analyte concentration sensed by implant portion 2 to obtain sensitive information of implant portion 2.
In some examples, in step S100, the sensitivity information may be a sensitivity versus temperature relationship of the implanted portion 2.
In some examples, in step S100, the sensitivity of the implanted portion 2 may increase with an increase in temperature. Specifically, in some examples, the sensitivity of the implanted portion 2 may increase with an increase in temperature within a predetermined temperature range. Wherein in some examples the sensitivity of the implanted portion 2 may be linearly related to temperature. In other examples, the sensitivity of the implanted portion 2 may also be non-linearly related to temperature.
In other examples, in step S100, the sensitivity of the implanted portion 2 may decrease with an increase in temperature. Specifically, in some examples, in step S100, the sensitivity of the implanted portion 2 may decrease with an increase in temperature within a predetermined temperature range. Wherein in some examples the sensitivity of the implanted portion 2 may be linearly related to temperature. In other examples, the sensitivity of the implanted portion 2 may also be non-linearly related to temperature.
In some examples, as previously described, the sensitivity information may be a variation value of the sensitivity of the implanted portion 2 at the reference temperature. For example, in some examples, as previously described, the sensitivity information may be a variation in the sensitivity of the implanted portion 2 at 37 ℃, i.e., 6.95%.
In some examples, in step S100, the implanted portion 2 may be placed in a reagent containing an analyte, by changing the temperature of the reagent and measuring the change in sensitivity of the implanted portion 2 with the temperature of the reagent, to obtain sensitive information of the implanted portion 2. That is, the relationship between the sensitivity of the implanted portion 2 and the temperature of the environment (location) in which the implanted portion 2 is located is obtained by changing the temperature of the reagent to change the temperature of the environment (location) in which the implanted portion 2 is located. In this case, the sensitivity of the implanted portion 2 is measured in relation to the temperature by using a reagent containing an analyte before wearing the analyte sensor 1, whereby the sensitivity information of the implanted portion 2 can be easily obtained in advance.
In some examples, in step S100, the concentration of the analyte in the reagent is maintained as the temperature of the reagent is changed. In this case, when the temperature of the reagent is changed, the change in temperature does not affect the change in analyte concentration, whereby the accuracy of sensitivity sensing of the implanted portion 2 can be improved.
In step S200, as described above, the body surface temperature is obtained, and the subcutaneous temperature is obtained based on the body surface temperature. Specifically, in some examples, in step S200, the implanted portion 2 may be placed subcutaneously and the applied portion 3 placed on the body surface, the body surface temperature is obtained by the temperature sensor 4, and the subcutaneous temperature is obtained based on the body surface temperature.
In some examples, in step S200, when the application portion 3 is placed on the body surface, the temperature sensor 4 provided in the application portion 3 is placed on the body surface. Thereby, the temperature sensor 4 can sense the temperature of the body surface and output the body surface temperature.
In some examples, in step S200, as previously described, there may be a first mapping relationship between the body surface temperature and the subcutaneous temperature. When the body surface temperature is obtained, the subcutaneous temperature can be obtained by the first map.
In some examples, in step S200, the body surface temperature and the subcutaneous temperature of the simulated living body may be sensed simultaneously at different ambient temperatures, thereby obtaining a first mapping relationship of the body surface temperature and the subcutaneous temperature.
In some examples, in step S200, the body surface temperature and the subcutaneous temperature are affected by both the ambient temperature and the in-vivo temperature. The body surface temperature is more influenced by the ambient temperature than the subcutaneous temperature is influenced by the ambient temperature, and the body surface temperature is less influenced by the internal temperature than the subcutaneous temperature is influenced by the internal temperature, so that the body surface temperature and the subcutaneous temperature can be in nonlinear correlation. I.e. the first mapping may be a non-linear mapping.
In some examples, in step S200, the implanted portion 2 may be placed 3mm to 20mm subcutaneously. It will be appreciated that the distance between 3mm subcutaneously and 20mm subcutaneously is small and the temperatures are approximately equal, without causing statistical differences in the response signals output by the implanted portion 2.
In step S300, as described above, a reference temperature may be selected.
In some examples, in step S300, 37 ℃ may be selected as the reference temperature. In this case, the reference temperature is relatively close to the average body temperature of the human body, whereby the effect of calibrating the analyte concentration by temperature compensation can be improved. In other examples, the reference temperature may be other temperatures as well. For example, the reference temperature may be 35 ℃, 36 ℃, 36.5 ℃, 37.5 ℃,38 ℃, or the like.
In step S400, as described above, calibration information may be obtained based on the sensitivity information, the reference temperature, and the subcutaneous temperature, and the response signal obtained by the implanted portion 2 may be calibrated based on the calibration information.
In some examples, in step S400, the sensitivity information may be a relationship of the sensitivity of the implanted portion 2 to a temperature change as described above. In some examples, the sensitivity information may specifically be the sensitivity of the implanted portion 2 at a reference temperature. Further, the sensitivity information may be a variation value of the sensitivity of the implanted portion 2 at the reference temperature.
In some examples, in step S400, calibration information may be obtained based on the difference between the subcutaneous temperature and the reference temperature, and the sensitivity information. In this case, temperature compensation can be facilitated by taking into consideration the relationship between the sensitivity of the implanted portion 2 and the temperature, and the relationship between the subcutaneous temperature at which the implanted portion 2 is located and the reference temperature.
Specifically, in some examples, the calibration information may be the difference between the reference temperature and the subcutaneous temperature, multiplied by the sensitivity of the implanted portion 2 at the reference temperature. Further, the calibration information may be a product of a difference between the reference temperature and the subcutaneous temperature and a change value of the sensitivity of the implanted portion 2 at the reference temperature.
In other examples, in step S400, calibration information may be obtained based on the sensitivity information and the ratio of subcutaneous temperature to the reference temperature. Specifically, in some examples, the calibration information may be a ratio of the reference temperature to the subcutaneous temperature, multiplied by the sensitivity of the implanted portion 2 at the reference temperature. Further, the calibration information may be a product of a ratio of the reference temperature to the subcutaneous temperature and a variation value of the sensitivity of the implanted portion 2 at the reference temperature.
In some examples, in step S400, the post-calibration response signal may be the product of the pre-calibration response signal and the calibration information, plus the pre-calibration response signal. That is, the calibrated response signal may be the product of the calibration information added one and the response signal before calibration.
In other examples, in step S400, the post-calibration response signal may be the quotient of the pre-calibration response signal and the calibration information. In further examples, in step S400, the post-calibration response signal may be the sum/difference of the pre-calibration response signal and the calibration information.
In some examples, in step S400, the subcutaneously inserted implanted portion 2 may simultaneously sense the subcutaneous analyte concentration output response signal when the temperature sensor 4 senses the temperature of the body surface to output the body surface temperature. In this case, the subcutaneous temperature, that is, the temperature at the position of the implanted part 2, and the response signal output by the implanted part 2 sensing the analyte concentration can be obtained at the same time, whereby the response signal of the implanted part 2 can be temperature-compensated in real time, so that the accuracy of the analyte concentration calibration can be improved.
In some examples, in step S400, there is no time delay between the implant portion 2 outputting the response signal and the temperature sensor 4 outputting the body surface temperature. In this case, the subcutaneous temperature (i.e., the temperature at the position where the implanted portion 2 is located) is obtained based on the body surface temperature, and the response signal output from the implanted portion 2 at this subcutaneous temperature can be obtained without time delay, whereby the accuracy of the analyte concentration calibration can be further improved.
In step S500, the analyte concentration may be obtained based on the reference temperature, as well as the calibrated response signal, as described above.
In some examples, in step S500, a relationship of the response signal of the implanted portion 2 to the analyte concentration may be obtained at a reference temperature. In some examples, at the reference temperature, there may be a second mapping relationship between the response signal of the implanted portion 2 and the concentration of the analyte.
In some examples, in step S500, the response signal of the implanted portion 2 and the analyte concentration may be linearly related. That is, the second mapping relationship may be a linear mapping relationship. In other examples, the response signal of the implanted portion 2 and the analyte concentration may be non-linearly related. That is, the second mapping relationship may be a nonlinear mapping relationship.
In some examples, in step S500, implant portion 2 is placed in analyte solutions of different concentrations, respectively, at a reference temperature, and the response signal output by implant portion 2 is measured to obtain a second mapping of the response signal of implant portion 2 to the analyte concentration.
In some examples, in step S500, the maximum concentration of the analyte used to detect that the second mapping relationship is obtained is lower than the maximum sensed concentration of the implanted portion 2. In some examples, the concentration gradient for detecting the analyte for which the second mapping is obtained is incremented. In some examples, the concentration of the analyte used to detect the second mapping is near the concentration of the subcutaneous analyte. In this case, the proximity of the concentration of the analyte may make the systematic error of detection relatively small, thereby enabling to improve the accuracy of detection.
In some examples, in step S500, the calibrated analyte concentration may be obtained based on the relationship of the response signal of the implanted portion 2 to the change in analyte concentration at the reference temperature, and the calibrated response signal. That is, the calibrated analyte concentration can be obtained by the second mapping relationship and the response signal of the implant part 2 after the calibration of step S400.
In the method according to the present disclosure, before wearing the analyte sensor 1, sensitive information of the implanted part 2 is obtained in the case of a predetermined analyte concentration, i.e. the relation of the sensitivity of the implanted part 2 to the temperature change is obtained. The implanted portion 2 is placed subcutaneously and the applied portion 3 having the temperature sensor 4 is placed on the body surface, the body surface temperature is obtained by the temperature sensor 4, and the subcutaneous temperature is obtained based on the body surface temperature. The reference temperature is selected, calibration information is obtained based on the sensitivity information, the reference temperature, and the subcutaneous temperature, and the response signal obtained by the implanted portion 2 is calibrated based on the calibration information, whereby a calibrated response signal can be obtained. Based on the reference temperature and the calibrated response signal, the analyte concentration is calibrated, whereby the accuracy of the obtained analyte concentration can be improved.
While the disclosure has been described in detail in connection with the drawings and embodiments, it should be understood that the foregoing description is not intended to limit the disclosure in any way. Modifications and variations of the present disclosure may be made as desired by those skilled in the art without departing from the true spirit and scope of the disclosure, and such modifications and variations fall within the scope of the disclosure.
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| EP2720612B1 (en) * | 2011-06-16 | 2019-02-06 | Abbott Diabetes Care, Inc. | Temperature-compensated analyte monitoring devices, systems, and methods thereof |
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