CN115704799A

CN115704799A - Miniature analyte sensor

Info

Publication number: CN115704799A
Application number: CN202110903325.0A
Authority: CN
Inventors: 杨翠军
Original assignee: Medtrum Technologies Inc
Current assignee: Medtrum Technologies Inc
Priority date: 2021-08-06
Filing date: 2021-08-06
Publication date: 2023-02-17

Abstract

The invention discloses a miniature analyte sensor, comprising: a substrate comprising an in vivo portion and an in vitro portion; a first set of electrodes and a second set of electrodes located on a surface of the internal body portion, each set of electrodes including at least one working electrode and at least one additional electrode; pins corresponding to the electrodes are arranged at the outer part of the body and are respectively and electrically connected with the working electrode and the additional electrode through leads; the first electrode set and the second electrode set are configured such that, in use, the first electrode set detects the analyte at a first frequency and provides a first detection signal, the second electrode set detects the analyte at a second frequency and provides a redundant detection signal, the first frequency being not less than the second frequency, thereby improving the reliability of the detection apparatus and enhancing the user experience.

Description

Miniature analyte sensor

Technical Field

The invention mainly relates to the field of medical instruments, in particular to a miniature analyte sensor.

Background

The pancreas in a normal human body can automatically monitor the glucose content in the blood of the human body and secrete the required insulin/glucagon automatically. The function of pancreas of diabetics is abnormal, and insulin required by human bodies cannot be normally secreted. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic functions of a human body, and is a lifelong disease. At present, the medical technology can not cure the diabetes radically, and only can control the occurrence and the development of the diabetes and the complications thereof by stabilizing the blood sugar.

Diabetics need to test their blood glucose before injecting insulin into their body. At present, most detection methods can continuously detect blood sugar and send blood sugar data to remote equipment in real time, so that a user can conveniently check the blood sugar data. The method needs the detection device to be attached to the surface of the skin, and the probe carried by the detection device is penetrated into subcutaneous tissue fluid to finish detection. However, the analyte sensor currently acquires parameter information by using a single electrode group, so that detection signal distortion or failure is easy to occur, and the reliability is not high.

Thus, there is a need in the art for a highly reliable miniature analyte sensor.

Disclosure of Invention

In view of the above shortcomings of the prior art, a first aspect of embodiments of the present invention discloses a miniature analyte sensor comprising a first electrode set and a second electrode set disposed on a sensor substrate, the first electrode set providing a first detection signal at a first frequency and the second electrode set providing a redundant detection signal at a second frequency, which improves reliability of use and enhances user experience.

The invention discloses a miniature analyte sensor, comprising: a substrate comprising an in vivo portion and an in vitro portion; a first set of electrodes and a second set of electrodes located on a surface of the internal body portion, each set of electrodes including at least one working electrode and at least one additional electrode; pins corresponding to the electrodes are arranged at the outer part of the body and are respectively and electrically connected with the working electrode and the additional electrode through leads; the first and second electrode sets are configured such that, in use, the first electrode set provides a first detection signal at a first frequency and the second electrode set provides a redundant detection signal at a second frequency, the first frequency being no less than the second frequency.

According to one aspect of the invention, the additional electrode comprises a counter electrode.

According to one aspect of the invention, the additional electrode further comprises a reference electrode.

According to one aspect of the invention, the first and second electrode sets comprise two working electrodes.

According to one aspect of the invention, the first frequency is between 6 and 3600 times/h and the second frequency is between 0.01 and 60 times/h.

According to one aspect of the invention, the first frequency is an integer multiple of the second frequency.

According to an aspect of the invention, the first electrode group has an area not smaller than that of the second electrode group.

According to one aspect of the invention, upon early end of life of the first electrode set, the second electrode set is switched to the first frequency to take over providing the detection signal.

Compared with the prior art, the technical scheme of the invention has the following advantages:

the invention discloses a miniature analyte sensor.A first electrode group and a second electrode group are arranged in an in-vivo part on a substrate, each electrode group comprises at least one working electrode and at least one additional electrode, so that at least two working electrodes and two additional electrodes are arranged on the sensor, and all the electrodes are electrically connected with corresponding pins arranged in the in-vitro part through leads. The first electrode group provides a first detection signal according to the first frequency, the second electrode group provides a redundant detection signal according to the second frequency, when the first detection signal is distorted or invalid due to reasons such as excessive background noise, the sensor can still output the redundant detection signal as an analyte detection signal, the empty window period of the analyte detection signal is avoided, and the reliability and the user experience of the sensor are improved.

Further, the first frequency is not less than the second frequency, the analyte detection signal is provided at a higher first frequency when the first detection signal is normally provided, user experience is met, and the second frequency is slightly lower, so that the sensitivity degradation rate of the second electrode set can be slowed down, and a redundant detection signal with high confidence level can be provided.

Furthermore, the first frequency is an integral multiple of the second frequency, and the first electrode group provides the first detection signal while the second electrode group provides the redundant detection signal, so that time difference of signals provided by the two electrode groups is prevented, inconsistency of detection environments is prevented, and detection reliability is improved.

Further, the miniature analyte sensors disclosed herein can be divided into three-electrode systems, a counter electrode, a reference electrode and at least one working electrode, and two-electrode systems, a counter electrode and at least one working electrode. In addition, the present invention can be divided into two cases according to the number of working electrodes: 1) Single working electrode: only one working electrode is provided; 2) Double working electrodes: the working electrode has two, one of which undergoes an electro-redox reaction with the analyte to produce an electrical signal, referred to as the "working electrode", and the other of which is generally responsible for detecting the response signal of the interferent or background solution, referred to as the "auxiliary electrode". The above electrode composition modes have unique advantages, wherein the three-electrode system has one more reference electrode, so that the detection potential can be effectively controlled, the potential drift can be prevented, and the reliability of the parameter information of the detected analyte can be improved; the two-electrode system has simple structure and lower manufacturing cost.

Furthermore, the area of the first electrode group is not smaller than that of the second electrode group, and the area is reasonably distributed according to the use frequency of the electrode groups, so that the service life of the first electrode group is consistent with that of the second electrode group.

Furthermore, the redundant detection signal is also used for calibrating/diagnosing the first detection signal, the sensitivity of the first detection signal is degraded along with the use of the first electrode group, the detection parameter needs to be adjusted at any time, and on the other hand, when the oxygen concentration in the host body changes or the enzyme on the sensor is deficient, the first electrode group can be calibrated or diagnosed in real time by using the detection data of the second electrode group, so that the first electrode group can keep a high-reliability detection state.

Furthermore, when the service life of the first electrode group is terminated early, the second electrode group is switched to the first frequency to take over the first electrode group to provide a detection signal, so that the service life of the sensor is prolonged, and the user experience is enhanced.

A second aspect of an embodiment of the present invention discloses a continuous analyte monitoring device, comprising: a bottom shell for mounting on a skin surface of a host; a sensor unit comprising a base and at least one miniature analyte sensor as described hereinbefore, the miniature analyte sensor being secured to the base, the sensor unit being mounted on the base via the base for providing an analyte detection signal in the host; the sensor comprises a sensor unit, an emitter unit and a control unit, wherein the sensor unit comprises a sensor unit, a sensor unit and a control unit, the sensor unit comprises a sensor unit and a control unit, the sensor unit is electrically connected with the sensor unit, the sensor unit is used for sensing the analyte parameter information, the emitter unit comprises an internal circuit, an emitter and an electric connection area, the electric connection area is electrically connected with the sensor unit, the internal circuit triggers an electrode group according to a preset frequency, and the emitter is used for sending the analyte parameter information to the outside; the battery is used for providing electric energy; and the receiver is used for receiving the detection signal and indicating the detection signal to a user.

The reliability of the sensor is often a key factor limiting the reliability of the continuous analyte monitoring device, and the reliability of the sensor detection signal is now enhanced by providing a first set of electrodes providing the first detection signal and a second set of electrodes providing the redundant detection signal. The redundant detection signal can also be used for calibrating or diagnosing the first detection signal, and meanwhile, when the service life of the first electrode group is terminated early, the second electrode group can be used for providing the detection signal in a replacing manner, so that the use reliability of the sensor is further improved.

Drawings

FIG. 1 is a top view of a sensor according to an embodiment of the present invention;

FIG. 2 is a side view of the sensor of the embodiment of FIG. 1;

FIG. 3 is a cross-sectional view of an electrode according to an embodiment of the present invention;

FIG. 4 is a schematic diagram of a system according to an embodiment of the invention;

FIG. 5 is a schematic view of a continuous analyte monitoring device according to an embodiment of the present invention.

Detailed Description

As mentioned above, the analyte sensor of the prior art uses a single set of electrode sets, and the background noise in the host is too high, or the sensitivity of the electrode is reduced, or the life of the electrode is terminated early, which may result in distortion or failure of the sensor detection signal and reduced reliability of use.

In order to solve the problem, the invention provides a miniature analyte sensor, wherein a first electrode group and a second electrode group are arranged in a body part of a sensor substrate, each electrode group comprises at least one working electrode and at least one additional electrode, because all the electrode groups are penetrated into a host body, a thermal switching process does not exist, the body fluid environments of the electrodes are consistent, the electrode groups are configured in a way that when the miniature analyte sensor is used, the first electrode group provides a first detection signal according to a first frequency, the second electrode group provides a redundant detection signal according to a second frequency, and a user can use the redundant detection signal as a follow-up detection signal to continuously acquire in-vivo analyte parameter information when the first detection signal is distorted or failed, or use the redundant detection signal to calibrate/diagnose the first detection signal, so that the reliability of the parameter data of the measured analyte is improved, and the user experience is enhanced.

Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangement of parts and steps, numerical expressions, and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention unless it is specifically stated otherwise.

Further, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to scale, for example, the thickness, width, length or distance of some elements may be exaggerated relative to other structures for ease of illustration.

The following description of the exemplary embodiment(s) is merely illustrative and is not intended to limit the invention, its application, or uses in any way. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail herein, but are intended to be part of the specification as applicable.

It should be noted that like reference numerals and letters refer to like items in the following figures, and thus, once an item is defined or illustrated in one figure, further discussion thereof will not be required in subsequent figure descriptions.

Furthermore, it is to be understood that one or more method steps mentioned in the present invention does not exclude that other method steps may also be present before or after the combined steps or that other method steps may also be inserted between these explicitly mentioned steps, unless otherwise indicated; it is also to be understood that a combined connection between one or more devices/apparatus as referred to in the present application does not exclude that further devices/apparatus may be present before or after the combined device/apparatus or that further devices/apparatus may be interposed between two devices/apparatus explicitly referred to, unless otherwise indicated. Moreover, unless otherwise indicated, the numbering of the method steps is only a convenient tool for identifying each method step, and is not intended to limit the order of the method steps or the scope of the invention, and changes or modifications in the relative relationship thereof may be regarded as the scope of the invention without substantial change in the technical content.

FIG. 1 is a top view of a sensor according to an embodiment of the present invention; fig. 2 is a side view of the sensor of the embodiment of fig. 1.

The sensor 11 includes a substrate 111, and the substrate 111 is divided into an extracorporeal portion X and an intracorporeal portion Y, with a dotted line shown in fig. 1 as a boundary. Electrodes are laid on the internal part Y and comprise at least one working electrode 1131 and at least one additional electrode, and obviously, in the present embodiment, the additional electrode comprises a counter electrode 1231 and a reference electrode 1331, so as to form a three-electrode system, the counter electrode 1231 is the other electrode opposite to the working electrode 1131 and forms a closed loop with the working electrode 1131, so that the current on the electrodes can be normally conducted, and the reference electrode 1331 is used for providing a reference potential for the working electrode 1131, so that the detection potential can be effectively controlled. In another embodiment of the present invention, the additional electrode may include only the counter electrode 1231 to form a two-electrode system, and the effective areas of the working electrode 1131 and the counter electrode 1231 may be increased in a limited area of the internal portion Y as compared to a three-electrode system, thereby extending the lifespan of the electrodes, and the manufacturing process is simpler because one electrode is reduced, but the reliability of the information detected by the analyte may be reduced because the working electrode 1131 does not have the detection potential of the reference electrode as a reference. In another embodiment of the present invention, the working electrode 1131 has two electrodes, one of which performs an electro-redox reaction with the analyte to be detected to generate an electrical signal, and the other of which is used to detect the response signal of the interferent or background solution in the body fluid of the host, and this electrode is the auxiliary electrode.

With continuing reference to fig. 1 and fig. 2, pins are laid on the external portion X, the pins correspond to the electrodes one by one and are electrically connected through wires, that is, the first pin 1111 corresponding to the working electrode 1131 is electrically connected through a wire 1121; a second pin 1211 electrically connected to the counter electrode 1231 through a wire 1221; and a third lead 1311 corresponding to reference electrode 1331, electrically connected through wire 1321. Different pins, wires and electrodes are insulated from each other, so that the electric signals are prevented from being interfered.

Since the sensor 11 has a planar structure, there are two opposite surfaces, i.e., a surface and a B surface. Working electrode 1131, counter electrode 1231 and reference electrode 1331 are laid on the a surface of the sensor as a first electrode group 31, and are opposite to each other, and on the B surface of the sensor, a second electrode group is laid, which may be a two-electrode system, a three-electrode system, or a double-working electrode, preferably, the second electrode group is consistent with the a surface electrode group, that is, the second electrode group includes working electrode 1132, counter electrode 1232 and reference electrode 1332, and similarly, pins are also laid on the B surface, the pins correspond to the electrodes on the B surface one by one, and are electrically connected through wires, that is, the fourth pins 1112 corresponding to the working electrodes 1132 are electrically connected through wires 1122; a fifth lead 1212 corresponding to the counter electrode 1232 and electrically connected by a wire 1222; and a sixth lead 1312 corresponding to the reference electrode 1332, which is electrically connected through a lead 1322. Therefore, when any electrode of the first electrode group 31 on the surface A is in end of life or fails in advance, the same electrode of the second electrode group 32 on the surface B can be switched to the same working frequency as the first electrode group to take over the working state, so that the reliability of the parameter data of the detected analyte is improved, and the service life of the sensor is prolonged.

It should be understood by those skilled in the art that the order and location of the pins, leads and electrodes laid on the surface of the sensor, whether it is the A-side or the B-side, are not limited. The pins, leads and electrodes on both faces may be arranged symmetrically or asymmetrically. The corresponding pins, the corresponding wires and the corresponding electrodes are laid on the same surface, and can also be laid on different surfaces. For example, working electrode 1131 on side a can be replaced with counter electrode 1231, or counter electrode 1231 on side a can be replaced with reference electrode 1332 on side B, regardless of the sequence and position of the pins, leads and electrodes on side a and side B, it is only necessary that the pins, leads and electrodes have a one-to-one, insulated relationship.

In other embodiments of the present invention, although the planar structure sensor has only a surface a and a surface B opposite to each other, the number of electrode groups can be increased by increasing the area of the sensor or decreasing the area of the electrodes, thereby further increasing the service life of the sensor. However, an excessively large sensor area may increase rejection response of the host, causing discomfort to the host; too small an electrode area may reduce the sensitivity of the electrode and reduce the reliability of the detection parameters. An excessive number of electrode sets also increases the complexity of the manufacturing process, e.g., the wires may become very densely routed. Therefore, it is preferable that the number of the electrode groups is two.

In other embodiments of the present invention, the electrode groups may also be distributed on the same surface of the sensor, such as the a surface or the B surface, which is not limited herein.

In other embodiments of the present invention, the sensor may also be a cylindrical or conical structure, with the electrodes being arranged in a surrounding manner on the substrate surface.

In the embodiment of the present invention, the substrate 111 is a material with excellent insulating properties, mainly derived from inorganic non-metallic ceramics, silica glass, organic polymer, and the like, and the substrate material is required to have high water impermeability and mechanical strength in consideration of the application environment of the implanted electrode. Preferably, the material of the substrate is selected from one or more of polytetrafluoroethylene (Teflon), polyethylene (PE), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), polymethyl methacrylate (PMMA), polycarbonate (PC), polyimide (PI), and the like.

Fig. 3 is a cross-sectional view of an electrode. In one embodiment of the invention, the working electrode (auxiliary electrode), counter electrode and reference electrode comprise at least an electron conducting layer a, a interference rejection layer b, an enzyme layer c, a modulating layer d and a biocompatible layer e.

Electron conductive layer:

the electron-conducting layer a is made of a material having good electrical conductivity and strong chemical inertness. Preferably, the working electrode and the counter electrode are selected from one of graphite electrode, glassy carbon electrode, noble metal and the like, and the reference electrode is selected from one of Ag/AgCl or calomel. In view of the requirements of good ductility and stability of the surface structure, noble metal electrodes such as gold electrodes, platinum electrodes, silver electrodes, etc. are preferred, and it is further preferred that both the working electrode and the counter electrode are platinum electrodes.

An anti-interference layer:

the interference rejection layer b is located between the enzyme layer and the electron-conducting layer. Interferents are molecules or substances that electrochemically reduce or electrochemically oxidize at the electrode surface, either directly or indirectly through an electron transfer agent, to produce a false signal that interferes with analyte detection. For example, for the determination of glucose as the analyte, common interferents in the body are urea, ascorbic acid, acetaminophen, and the like.

In a preferred embodiment, the interference rejection layer b may prevent the penetration of one or more interferents into the electrolyte surrounding the electrodes. For example, the interference rejection layer b may allow passage of an analyte (e.g., hydrogen peroxide) to be measured at the electrode while preventing passage of other species (e.g., potentially interfering species). In a preferred embodiment, the tamper resistant layer b may be a very thin film intended to limit the diffusion of those substances with a molecular weight of more than 340 Da.

In another preferred embodiment, the interference rejection layer b may be an organic polymer, which may be prepared from an organosilane and a hydrophilic copolymer. Hydrophilic copolymers, more preferably polyethylene glycol (PEG), poly (2-hydroxyethyl methacrylate) and polylysine. In a preferred embodiment, the thickness of the tamper resistant layer b may range from 0.1 microns or less to 10 microns or more. A more preferred thickness range is 0.5 to 5 microns.

Enzyme layer:

the enzyme layer c is coated with an active enzyme, and the corresponding active enzyme is coated according to the type of the analyte to be detected. The active enzyme can enable the analyte to be detected to generate certain chemical reaction to generate electrons, the quantity of the generated electrons is different according to the concentration of the analyte to be detected, the electrons are collected by the electron conduction layer, so that different current intensities are formed, and therefore the current intensity information can be used for representing parameter information of the analyte.

Preferably, the enzyme layer c is coated with glucose oxidase (GOx).

A regulating layer:

the regulating layer d is positioned above the enzyme layer. In the embodiment of the present invention, when glucose oxidase is coated on the enzyme layer, the regulating layer d is mainly used to regulate the permeability of oxygen and glucose transferred to the enzyme layer. The glucose content (molarity) in body fluids is an order of magnitude higher than the oxygen content. However, for enzyme-based sensors that require oxygen to participate, excess oxygen needs to be supplied to ensure that oxygen does not become a limiting species, so that the sensor can respond linearly to changes in glucose concentration without being affected by oxygen partial pressure. That is, when oxygen content becomes a limiting factor, the linear range of glucose oxygen monitoring reactions does not reach the expected concentration range. Without a semi-permeable membrane over the enzyme layer to regulate oxygen and glucose permeation, the upper limit of the linear response of the sensor to glucose can only reach about 40mg/dL. However, in clinical situations, the upper limit of the linear response of blood glucose levels needs to reach about 500mg/dL.

The regulating layer d mainly functions as a semipermeable membrane for regulating the permeation amount of oxygen and glucose delivered to the enzyme layer, more specifically, making the excess of oxygen a non-limiting factor. The upper limit of the linear response to glucose of the sensor comprising the modulating layer can be reached at a higher level than without the modulating layer. In a preferred embodiment, the oxygen-glucose permeability of the regulation layer d can be up to a ratio of 200, which ensures that there is sufficient oxygen for the enzyme-based reaction to proceed for the various glucose and oxygen concentrations that may occur subcutaneously.

In a preferred embodiment, the conditioning layer d may be an organic polymer, which may be prepared from an organosilane and a hydrophilic copolymer. Hydrophilic copolymers, more preferably, copolymerized or grafted polyethylene glycol (PEG). Other hydrophilic copolymers that may be used include, but are not limited to, other glycols such as propylene glycol, esters, amides, carbonates, and polypropylene glycol. By using the organic silicon polymer, the transmission of oxygen can be obviously improved, and the permeation of glucose can be effectively controlled. In a preferred embodiment, the thickness of the adjustment layer d may range from 1 micron or less to 50 microns or more, with a more preferred thickness range of 1 micron to 10 microns.

A biocompatible layer:

the biocompatible layer e is located on the outermost surface of the electrode and is intended to eliminate the body's rejection of foreign bodies and to reduce the formation of a layer of shielding cells around the implanted electrode.

In a preferred embodiment, the biocompatible layer e may be prepared from an organosilane and a hydrophilic copolymer. Hydrophilic copolymers, more preferably, copolymerized or grafted polyethylene glycol (PEG). Other hydrophilic copolymers that may be used include, but are not limited to, other glycols such as propylene glycol, esters, amides, carbonates, and polypropylene glycol.

In a preferred embodiment, the thickness of the biocompatible layer e may range from 1 micron or less to 100 microns or more. A more preferred thickness range is 10 to 30 microns.

In the embodiment of the present invention, the substrate 11 has a thickness of 0.01 to 0.8mm, each electrode has a rectangular shape, a width of 0.01 to 1mm, and an area of 0.1 to 2mm ² 。

In other embodiments of the present invention, a carbon nanotube layer modification layer is further disposed on the surface of each electrode. The carbon nano tube is modified on the surface of the formed electrode by physical adsorption, embedding or covalent bond and other modes by utilizing the specific mechanical strength, high specific surface area, rapid electron transfer effect and chemical stability of the carbon nano tube so as to improve the electron transfer speed, and meanwhile, the carbon nano tube can be used as an excellent catalyst (enzyme) carrier due to the large specific surface area. The carbon nanotube layer modification layer can be fixed on the surface of the electrode by a Nafion solution dispersion method, a covalent fixation method and the like.

FIG. 4 is a system diagram according to an embodiment of the present invention.

After the sensor enters the host body, voltage is applied to the pins, the electrodes corresponding to the pins are activated, and the sensor enters a working state. I.e. the first electrode on the A-planeSet 31 (comprising working electrode 1131, counter electrode 1231, and reference electrode 1331) and second set of electrodes 32 (comprising working electrode 1132, counter electrode 1232, and reference electrode 1332) on the B-side are activated simultaneously upon entry into the host, with first set of electrodes 31 at first frequency f ₁ Providing a first detection signal, the second electrode set 32 being at a second frequency f ₂ A redundant detection signal is provided. The first detection signal and the redundant detection signal are both sent to a device (e.g., the receiver 105) that can be observed by the user, and normally, the receiver 105 displays the first detection signal and the redundant detection signal is not displayed, thereby avoiding confusion caused by reading the dual signals by the user. When the background noise of the environment where the sensor is located is too large, or the sensitivity of a certain electrode of the first electrode group is reduced, or the life of a certain electrode is terminated early, or the like, the first electrode group is distorted or fails, the receiver 105 does not display the first detection signal of the first electrode group 31 any more, but displays the redundant detection signal of the second electrode group 32, and thus, the situation that a user reads distorted or failed detection data is avoided.

Preferably, the first frequency is not lower than the second frequency, when the electrodes are working normally, the first electrode group 31 provides the first detection signal at the higher first frequency to meet the daily detection requirement of the user, and the second electrode group 32 provides the redundant detection signal at the lower second frequency, so that the sensitivity attenuation is slow to maintain the redundant detection with high confidence level.

In a preferred embodiment of the invention, the first frequency f ₁ 6-3600 times/h, second frequency f ₂ Is 0.01 to 60 times per hour.

Further preferably, the first frequency f ₁ Is the second frequency f ₂ The integral multiple of the first detection signal is provided by the first electrode group 31, and the second electrode group 32 provides the redundant signal, and the first detection signal can be provided by the first electrode group 31 at the same time, so that the detection environment inconsistency caused by the time difference of the detection signals is avoided.

Even more preferably, the first frequency f ₁ =30 times/h, second frequency f ₂ =10 times/h.

In other embodiments of the present invention, the effective working time of the first electrode group after being activated is 1 to 14 days, the enzyme activity on the electrode is reduced after the first electrode group is activated for more than 14 days, and the activated electrode enters the failure state, and meanwhile, the activated electrode may enter the failure state in advance due to the damage of the electrode or the error in the processing process. If a single group of electrode groups are arranged on the sensor, once one electrode enters a failure state, the sensor fails, and a user needs to replace a new sensor, so that the user experience is reduced, and the use cost of the user is increased.

If a plurality of sets of electrodes are provided on the sensor, for example, a first electrode set 31 and a second electrode set 32 are provided, once one of the electrodes of the first electrode set 31 enters a failure state, the working frequency of the same electrode of the second electrode set 32 is changed to f ₁ And the failed electrode in the first electrode group 31 is replaced, so that the sensor can continue to work normally, the service life of the sensor is prolonged, and the detection reliability is improved.

In particular, reference is made to fig. 1 and 2 in combination. After the sensor is inserted into the host, the first pin 1111, the second pin 1211, the third pin 1311 on the a-side, the third pin 1112, the fourth pin 1212, and the fifth pin 1312 on the B-side are applied with voltage by the internal circuit 1031 (see fig. 5 for details), and the working electrode 1131, the counter electrode 1231, and the reference electrode 1331 on the a-side are applied with frequency f ₁ In the active state, the working electrode 1132, counter electrode 1232 and reference electrode 1332 on the B-plane are operated at a frequency f ₂ And entering a working state. Upon premature failure or end of life of any of working electrode 1131, counter electrode 1231, and reference electrode 1331, internal circuit 1031 switches the pin object to which the voltage is applied, e.g., premature failure of working electrode 1131, internal circuit switches the frequency at which the voltage is applied to fourth pin 1112 on side B, and working electrode 1132 on side B operates at a frequency of f ₂ Change to f ₁ The electrode assembly is combined with the counter electrode 1231 and the reference electrode 1331 which are not failed to detect the analyte to be detected to avoid the premature failure of the sensor 11, so that a user does not need to replace the sensor due to the premature failure of the working electrode 1131, the user experience is enhanced, and the use cost of the user for replacing the sensor is reduced. In the embodiment of the present invention, the frequency of the working electrode 1132 is changed for the second electrode group on the B-plane, the second electrode group 32 cannot continuously provide the redundant detection signal, and the internal circuit 1031 does not provide the redundant detection signal to the B-plane any moreThe other electrodes of the second electrode group 32 on, are applied with a voltage, and the other electrodes are thus put into a sleep state.

It will be appreciated by those skilled in the art that the above embodiments are not limited to failure of the working electrode, and that failure of other electrodes, such as the counter electrode, the reference electrode, or failure of both or three electrodes may be accomplished by using the same electrode in the above embodiments to take over for the failed electrode.

In other embodiments of the present invention, there may be a plurality of electrode sets on the sensor, and the electrode sets are not limited to the first electrode set 31 and the second electrode set 32.

Fig. 5 is a schematic diagram of a continuous analyte monitoring device 100 according to an embodiment of the present invention. Continuous analyte monitoring device 100 includes a bottom housing 101 for mounting to a host skin surface; a sensor unit 102, the sensor unit 102 comprising a base 1021 on which the micro analyte sensor 11 is fixed and the micro analyte sensor 11 as described above, the sensor unit 102 being mounted on the bottom case 101 via the base; a transmitter unit 103, the transmitter unit 103 comprising an internal circuit 1031, a transmitter 1032 and an electrical connection region 1033, the electrical connection region 1033 being electrically connected to the sensor unit 102, the internal circuit 1031 being configured to apply a voltage to each pin at a predetermined frequency such that the corresponding electrode detects the analyte at the frequency and provides a detection signal; emitter 1032 is for transmitting the analyte detection signal to the outside world; a battery 104, the battery 104 being for providing electrical energy; a receiver 105, the receiver 105 being configured to receive the analyte detection signal and indicate to a user.

In summary, the present invention discloses a micro analyte sensor, wherein a first electrode set and a second electrode set are disposed at an internal portion of a sensor substrate, each electrode set comprises at least one working electrode and at least one additional electrode, the first electrode set and the second electrode set are configured such that, in use, the first electrode set detects an analyte at a first frequency and provides a first detection signal, and the second electrode set detects an analyte at a second frequency and provides a redundant detection signal, when the first detection signal is distorted or fails, a user can read the redundant detection signal, thereby improving reliability of the sensor and enhancing user experience.

The invention also discloses a continuous analyte monitoring device using the miniature analyte sensor, and the reliability of the continuous analyte monitoring device is often limited to the reliability of the sensor, so that after the miniature analyte sensor is adopted, the continuous analyte monitoring device can realize redundant detection, the detection reliability is improved, the service life of the sensor is prolonged, the user experience is enhanced, and the use cost of a user is reduced.

Although some specific embodiments of the present invention have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. A miniature analyte sensor, comprising:

a substrate comprising an in vivo portion and an in vitro portion;

a first set of electrodes and a second set of electrodes located on a surface of the internal body portion, each set of electrodes including at least one working electrode and at least one additional electrode;

pins corresponding to the electrodes are arranged on the external part of the body, and the pins are respectively and electrically connected with the working electrode and the additional electrode through leads;

the first and second electrode sets are configured such that, in use, the first electrode set detects the analyte at a first frequency and provides a first detection signal, and the second electrode set detects the analyte at a second frequency to provide a redundant detection signal, the first frequency being no less than the second frequency.

2. The miniature analyte sensor of claim 1 wherein the additional electrode comprises a counter electrode.

3. The miniature analyte sensor of claim 2 wherein the additional electrode further comprises a reference electrode.

4. The microanalyzer sensor of any one of claims 1 to 3, wherein said first electrode group and said second electrode group comprise two working electrodes.

5. The miniature analyte sensor of claim 1 wherein the first frequency is between 6 and 3600 times per hour and the second frequency is between 0.01 and 60 times per hour.

6. The miniature analyte sensor of claim 5 wherein the first frequency is an integer multiple of the second frequency.

7. The micro analyte sensor of claim 1, wherein the first electrode set has an area no smaller than the second electrode set.

8. The microanalyzer sensor of claim 1 wherein upon premature expiration of said first electrode set life, said second electrode set is switched to a first frequency to successively provide a detection signal.

9. A continuous analyte monitoring device, comprising:

a bottom shell for mounting on a skin surface of a host;

a sensor unit comprising a base and at least one miniature analyte sensor of claim 1, said miniature analyte sensor being secured to said base, said sensor unit being mounted to said bottom housing via said base for providing an in vivo analyte detection signal;

an emitter unit comprising an internal circuit, an emitter and an electrical connection area, the electrical connection area being electrically connected to the sensor unit, the internal circuit triggering an electrode set at a predetermined frequency, the emitter being configured to transmit the analyte parameter information to the outside;

a battery for providing electrical energy; and

a receiver for receiving the detection signal and indicating to a user.