Monitoring probe and monitoring system

Abstract

The invention provides a monitoring probe and a monitoring system, the monitoring probe comprises a first electrode provided with a sensing layer and a polymer film, the polymer film comprises a protection layer and an isolation layer, the polymer film at least covers the sensing layer, the protection layer is used for separating the sensing layer from the isolation layer, and the isolation layer is used for separating the sensing layer from the isolation layer. The isolation layer is configured to reduce the influence of sterilization gas on the sensing layer when the monitoring probe performs gas sterilization, the isolation layer is prepared from a first solution, the first solution comprises a first polymer and an organic solvent, the first polymer is polyurethane, the mass fraction of the first polymer in the first solution can be 0.1-15%, and the mass fraction of the organic solvent in the first solution can be 0.1-15%. The organic solvent is a substance which has an adverse effect on the sensing layer when the organic solvent is in direct contact with the sensing layer. According to the present disclosure, it is possible to provide a monitoring probe and a monitoring system that are resistant to sterilization gas.

Description

[0001] This application is filed on February 01, 2024 、Application No. 202410144883.7 、The name of the invention is biology Sensor and polymer film thereof and analyte monitoring device A divisional application for a patent application. Technical Field

[0002] The present disclosure relates to the field of new chemical materials, and in particular to a monitoring probe and a monitoring system. Background Art

[0003] Biosensors are analytical devices that tightly combine biological materials, bio-derived materials, or biomimetic materials with optical, electrochemical, temperature, piezoelectric, magnetic, or micromechanical physical and chemical sensors or sensing microsystems. They can usually be used to quickly detect certain specific chemicals in the human body, such as glucose, ketone bodies, and uric acid.

[0004] Biosensors are usually used in conjunction with electronic devices to form a monitoring system. During detection, the probe of the biosensor containing sensitive substances that can sense analytes (such as enzymes, antibodies and ligands, etc.) is generally placed under the host's skin for detection, and the detected signal is then transmitted to the electronic device for analysis or transmission. Therefore, for the health and safety of the host, the probe needs to be fully sterilized and disinfected before use. Common sterilization methods include gas sterilization and radiation sterilization. Since electronic devices may be damaged during radiation sterilization, gas sterilization is usually used to sterilize electronic devices. However, the sterilizing gas (such as ethylene oxide) in the gas sterilization method may affect the sensitive substances on the probe and the performance of the probe itself (for example, causing the sensitive substances to degrade, denature, or undergo undesirable chemical reactions or decomposition, etc.), resulting in a significant decrease in the sensitivity of the biosensor after sterilization by gas sterilization, so that it cannot be used normally.

[0005] Therefore, in the existing processing technology, the electronic device in the monitoring system is usually separated from the biosensor, and the biosensor is sterilized by irradiation sterilization. However, this separate sterilization method is not conducive to the "integrated" product design, and the processing technology of separate sterilization is relatively complicated. After separate sterilization, the electronic device and the biosensor need to be assembled before use, which is relatively complicated. Summary of the invention

[0006] The present disclosure is made in view of the above-mentioned prior art conditions, and its object is to provide a biosensor resistant to sterilization gas, an isolation layer thereof, and an analyte monitoring device.

[0007] To this end, the first aspect of the present disclosure provides a biosensor, which is a biosensor for monitoring an analyte, the biosensor comprising a first electrode provided with a sensing layer, and a polymer film, the polymer film at least covering the sensing layer and the first electrode, the polymer film comprising a protective layer and an isolation layer, the protective layer being closer to the first electrode than the isolation layer, the isolation layer being configured to reduce the effect of the sterilization gas on the sensing layer when the biosensor is subjected to gas sterilization, the isolation layer being made of a first solution, the first solution comprising a first type of polymer and an organic solvent, the first type of polymer being polyurethane.

[0008] In the first aspect of the present disclosure, the polymer film of the biosensor includes a protective layer and an isolation layer. By providing an isolation layer including polyurethane, the penetration of sterilization gas can be limited when the biosensor is sterilized by gas, forming an isolation barrier to reduce the influence of the sterilization gas on the sensing layer, especially the influence of gaseous ethylene oxide on the active substances in the sensing layer, so that the biosensor can be sterilized by gas sterilization. Compared with the biosensor without an isolation layer, the biosensor disclosed in the present disclosure has a greatly reduced sensitivity decrease before and after sterilization, and can still maintain a high sensitivity after sterilization; and the isolation layer with polyurethane has good biocompatibility, which can improve the safety of the biosensor when it is located under the skin of the host; in addition, the isolation layer also has a limiting effect on the penetration of specific analytes (such as glucose), and can play the role of a semipermeable membrane; in addition, the provision of a protective layer can separate the isolation layer from the internal structure (sensing layer and the first electrode), and reduce the adverse effects of the organic solvent in the isolation layer on the sensing layer and the first electrode (such as corrosion leading to damage to the integrity of the internal structure and loss of functionality). Thus, a biosensor resistant to sterilization gas can be provided.

[0009] In the biosensor involved in the first aspect of the present disclosure, optionally, in the first solution, the mass fraction of the first type of polymer is 0.1% to 15%, thereby helping the isolation layer to limit the penetration of sterilization gas during gas sterilization.

[0010] In the biosensor involved in the first aspect of the present disclosure, optionally, the first type of polymer has a soft segment, and in the first type of polymer, the soft segment accounts for 5% to 50%. Since the proportion of the soft segment will affect the performance of the polyurethane material, in this case, by selecting a suitable soft segment proportion, the polyurethane material can have good mechanical properties and biocompatibility.

[0011] In the biosensor involved in the first aspect of the present disclosure, optionally, the first type of polymer has a hydrophilic group, and in the first type of polymer, the hydrophilic group accounts for 1% to 30%. The proportion of the hydrophilic group in the polyurethane will affect the performance of the polyurethane material. In this case, by selecting a suitable proportion of the hydrophilic group, the polyurethane material can have good hydrophilicity and biocompatibility.

[0012] In the biosensor according to the first aspect of the present disclosure, optionally, the organic solvent is a mixed solvent of any one or more of tetrahydrofuran, dichloromethane and N,N-dimethylacetamide, so that the first type of polymer can be dissolved by the organic solvent.

[0013] In the biosensor of the first aspect of the present disclosure, optionally, the thickness of the isolation layer is 1 μm to 40 μm. In this case, selecting an isolation layer of appropriate thickness can effectively serve as an isolation barrier, thereby facilitating improving the resistance of the biosensor to sterilization gas.

[0014] In the biosensor involved in the first aspect of the present disclosure, optionally, the protective layer includes a second type of polymer, and the second type of polymer is a copolymer formed by anionic and cationic polymers or neutral monomers. In this case, the protective layer will not react with the two polymers in the isolation layer, and a protective layer that can separate the isolation layer from the internal structure (sensing layer and the first electrode) can be formed; and a low-corrosive or non-corrosive solvent can be used to dissolve the second type of polymer, so that the formed protective layer will not damage the internal structure when it is in direct contact with the internal structure; in addition, the protective layer has extremely little restriction on the permeability of the analyte, which can facilitate the analyte to pass through the protective layer and contact the sensing layer.

[0015] In the biosensor according to the first aspect of the present disclosure, optionally, the thickness of the protective layer is 1 μm to 20 μm, so that the isolation layer can be effectively separated from the internal structure by the protective layer.

[0016] In the biosensor involved in the first aspect of the present disclosure, optionally, the polymer film further includes a biocompatible layer, the isolation layer is located between the biocompatible layer and the protective layer, and the biocompatible layer includes a third type of polymer, and the third type of polymer is a polyurethane containing a hydrophilic group or a cross-linked water-soluble polyurethane. In this case, the third type of polymer is also a polyurethane, which can further improve the biocompatibility of the biosensor on the one hand; on the other hand, it can also partially block the entry of sterilization gas during the sterilization process of the biosensor, further improving the protective effect of the polymer film on the biosensor.

[0017] In the biosensor involved in the first aspect of the present disclosure, optionally, when the third type of polymer is the polyurethane containing the hydrophilic group, in the third type of polymer, the hydrophilic group accounts for 20% to 50%. Thus, the biocompatible layer containing the third type of polymer can have good biocompatibility, thereby further improving the biocompatibility of the biosensor.

[0018] In the biosensor according to the first aspect of the present disclosure, optionally, the biocompatible layer has a thickness of 1 μm to 30 μm, which can help improve the biocompatibility of the biosensor.

[0019] In the biosensor involved in the first aspect of the present disclosure, optionally, the sensing layer includes one or more of glucase, lactase and hydroxybutyrate dehydrogenase. Thus, a suitable sensitive substance can be selected according to the type of analyte.

[0020] In the biosensor involved in the first aspect of the present disclosure, optionally, the biosensor further includes a second electrode different from the first electrode, and the polymer film also covers the second electrode, thereby enabling the second electrode to be protected by the polymer film.

[0021] A second aspect of the present disclosure provides an isolation layer of a biosensor, the biosensor comprising a first electrode provided with a sensing layer, the isolation layer at least covering the sensing layer and the first electrode, the isolation layer being configured to reduce the effect of sterilization gas on the sensing layer when the biosensor is subjected to gas sterilization, the isolation layer being made of a first solution comprising a first type of polymer and an organic solvent, the first type of polymer being polyurethane.

[0022] In the second aspect of the present disclosure, the isolation layer including polyurethane can limit the penetration of sterilization gas when the biosensor is sterilized by gas, forming an isolation barrier to reduce the impact of the sterilization gas on the sensing layer, especially the impact of gaseous ethylene oxide on the active substances in the sensing layer, so that the biosensor can be sterilized using gas sterilization. Compared with the biosensor without an isolation layer, the biosensor with an isolation layer has a greatly reduced sensitivity drop before and after sterilization, and can still maintain a high sensitivity after sterilization; and the isolation layer with polyurethane has good biocompatibility, which can improve the safety of the biosensor when it is located under the host's skin; in addition, the isolation layer also has a limiting penetration effect on specific analytes (such as glucose), and can play the role of a semipermeable membrane. Thus, an isolation layer with an isolation effect on sterilization gas can be provided, and when the isolation layer is set on the biosensor, it can make the biosensor resistant to sterilization gas.

[0023] The third aspect of the present disclosure provides an analyte monitoring device, comprising an electronic component and the biosensor according to the first aspect of the present disclosure, wherein the electronic component is electrically connected to the biosensor. In the third aspect of the present disclosure, the biosensor is resistant to sterilizing gas, and the biosensor and the electronic component can be assembled together for gas sterilization without radiation sterilization of the biosensor separately. The analyte monitoring device can be assembled into one piece at the time of shipment, and the user does not need to assemble the electronic component and the biosensor separately when using it, thereby facilitating use.

[0024] According to the present disclosure, a biosensor resistant to sterilization gas and an isolation layer thereof and an analyte monitoring device can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a diagram showing an application scenario of the biosensor involved in the example of the present disclosure.

[0026] Figure 2 is a schematic diagram showing a biosensor according to an example of the present disclosure.

[0027] Figure 3 Schematic diagram showing a polymer film according to an example of the present disclosure.

[0028] Figure 4 Schematic diagram showing a polymer film covering an implanted portion according to an example of the present disclosure.

[0029] Figure 5 1 is a diagram showing the appearance of the biosensor of Example 1 of the present disclosure after sterilization.

[0030] Figure 6 3 is a diagram showing the appearance of the biosensor of Comparative Example 1 of the present disclosure after sterilization.

[0031] Description of reference numerals: 100…analyte monitoring device, 1…sensor, 11…implantation portion, 12…connection portion, 13…first electrode, 14…sensing layer, 2…electronic component, 3…polymer membrane, 31…isolation layer, 32…protective layer, 33…biocompatible layer. DETAILED DESCRIPTION

[0032] Hereinafter, the preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same symbols are assigned to the same components, and repeated descriptions are omitted. In addition, the accompanying drawings are only schematic diagrams, and the ratio of the dimensions of the components or the shapes of the components may be different from the actual ones.

[0033] It should be noted that the terms "including" and "having" and any variations thereof in the present disclosure, such as a process, method, system, product or device that includes or has a series of steps or units, are not necessarily limited to those steps or units clearly listed, but may include or have other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0034] The first aspect of the present disclosure relates to a biosensor, which is a biosensor for monitoring an analyte. The biosensor of the present disclosure is resistant to sterilizing gas and can be sterilized by gas sterilization. The biosensor of the present disclosure can be referred to as a sensor, a monitoring probe, a sensing probe, an electrode probe, etc.

[0035] In the present disclosure, the analyte may be one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glutamine, hormones, ketone bodies, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. This is only an example, and the analyte may also be other substances not shown.

[0036] The second aspect of the present disclosure relates to an isolation layer of a biosensor, which can limit the penetration of sterilization gas when the biosensor is sterilized by gas, forming an isolation barrier to reduce the impact of the sterilization gas on the sensing layer of the biosensor. The isolation layer of the biosensor of the present disclosure can also be called an isolation membrane, a spacer layer or a sterilization layer, etc.

[0037] The third aspect of the present disclosure relates to an analyte monitoring device, which may include an electronic component and a biosensor. In the analyte monitoring device of the present disclosure, the biosensor is resistant to sterilizing gas, and the biosensor and the electronic component can be assembled together for gas sterilization without radiation sterilization of the biosensor separately. The analyte monitoring device of the present disclosure may also be referred to as a continuous monitoring device or a monitoring system, etc.

[0038] Hereinafter, the biosensor (hereinafter referred to as the sensor) involved in the present disclosure will be described by taking glucose as an example in conjunction with the accompanying drawings.

[0039] Figure 1 is a diagram showing an application scenario of the sensor 1 involved in the example of the present disclosure. Figure 2 is a schematic diagram showing a sensor 1 according to an example of the present disclosure.

[0040] In some examples, the sensor 1 can be used to monitor an analyte. In some examples, the sensor 1 can be used in conjunction with the electronic component 2. Specifically, see Figure 1, the sensor 1 can be combined with the electronic component 2 to form the analyte monitoring device 100, so that the analyte monitoring device 100 is located on the body surface of the host, and the sensor 1 is partially located under the skin of the host, so that the analyte can be monitored by the sensor 1. It should be noted that although the application scenario of the sensor 1 is described as monitoring the analyte in the host body in cooperation with the electronic component 2, the sensor 1 can also be placed in other different test environments to detect the analyte, and it is not necessary to be combined with the electronic component 2 to form the analyte monitoring device 100 to be used. For example, the sensor 1 can also be electrically connected to an external test circuit for monitoring.

[0041] In some examples, the sensor 1 may include an implantable portion 11 (see Figure 2 ). The implantation portion 11 can be implanted under the skin of the host. When in use, the implantation portion 11 can be located under the skin of the host and contact the analyte. Thus, the analyte in the host can be monitored by the sensor 1. In some examples, the sensor 1 may include a connection portion 12 (see Figure 2 ). The implanted portion 11 can be electrically connected to the electronic component 2 via the connecting portion 12. When in use, the implanted portion 11 can be located subcutaneously, and the connecting portion 12 can be located outside the body, so the connecting portion 12 can also be referred to as an external portion.

[0042] In some examples, the sensor 1 may include a first electrode 13 (see Figure 2 ). A sensing layer 14 may be provided on the first electrode 13. The sensor 1 may generate a current signal by reacting the sensing layer 14 on the first electrode 13 with the analyte, and the analyte concentration signal may be obtained by analyzing and processing the current signal. That is, the first electrode 13 may also be referred to as a working electrode.

[0043] In some examples, the sensor 1 may include a second electrode. The second electrode may be the same as or different from the first electrode 13. For example, the second electrode may be a reference electrode or a counter electrode. For another example, the second electrode may be a second working electrode, and the analyte detected by the second working electrode may be the same as or different from the first electrode 13. In some examples, the sensor 1 may include a third electrode. The third electrode may be a reference electrode or a counter electrode and is different from the second electrode. Thus, a sensor 1 having a three-electrode system can be formed to monitor the analyte.

[0044] In some examples, the sensing layer 14 may include a sensitive substance that can promote the reaction of the analyte. For example, the sensing layer 14 may include one or more of glucurase, lactase, and hydroxybutyrate dehydrogenase. Thus, it is possible to select a suitable sensitive substance according to the type of analyte. In some examples, the glucurase may be glucose oxidase or glucose dehydrogenase.

[0045] In some examples, the sensor 1 may include a polymer membrane 3 (shown later). The polymer membrane 3 may control the diffusion of the analyte. That is, the polymer membrane 3 may have selective permeability to the analyte. In some examples, the polymer membrane 3 may at least cover the sensing layer 14. Thus, the amount of analyte permeation can be controlled by the polymer membrane 3, that is, the amount of analyte entering the sensing layer 14 can be controlled, so that the size of the current signal generated by the contact between the analyte and the sensing layer 14 falls within the response linear range of the sensor 1.

[0046] In some examples, the polymer film 3 may be biocompatible. In some examples, the polymer film 3 may cover the implantation portion 11 (shown later) of the sensor 1. Thus, the sensor 1 may be biocompatible.

[0047] In some examples, the polymer membrane 3 can limit the penetration of sterilization gas when the sensor 1 is gas sterilized. For example, the polymer membrane 3 can limit the penetration of ethylene oxide (hereinafter referred to as EO). Thus, a sensor 1 resistant to sterilization gas can be provided. That is to say, the sensor 1 of the present disclosure can be sterilized by gas sterilization, and compared with the sensor 1 without the polymer membrane 3, the decrease in sensitivity of the sensor 1 of the present disclosure before and after sterilization is greatly reduced, and a high sensitivity can still be maintained after sterilization. In some examples, the polymer membrane 3 can cover at least the sensing layer 14 and the first electrode 13. Thus, the erosion of the internal structure (sensing layer 14 and the first electrode 13) by the sterilization gas during sterilization can be reduced, and the internal structure can be protected.

[0048] In some examples, ethylene oxide may be used to sterilize the sensor 1 of the present disclosure. The polymer membrane 3 of the present disclosure is described below by taking ethylene oxide as an example of a sterilizing gas.

[0049] Figure 3 is a schematic diagram showing a polymer film 3 according to an example of the present disclosure.

[0050] In some examples, the polymer film 3 may include an isolation layer 31 (see Figure 3 ). The isolation layer 31 can be configured to reduce the effect of the sterilization gas on the sensing layer 14 when the sensor 1 is sterilized by gas. In some examples, the isolation layer 31 can be made of a first solution. For example, the first solution can be applied to the implanted portion 11 to form the isolation layer 31. In some examples, the first solution can be applied to the target position by spraying, spin coating, or dip coating to form the isolation layer 31. The target position refers to the place where the isolation layer 31 is desired to be formed.

[0051] In some examples, the first solution may include a first type of polymer. The first type of polymer may limit the permeation of sterilization gas (eg, ethylene oxide). Thus, the isolation layer 31 formed by the first solution including the first type of polymer may limit the permeation of sterilization gas.

[0052] In some examples, the first type of polymer may be polyurethane. Polyurethane is a material with good physical and mechanical properties, blood compatibility and biocompatibility, and ethylene oxide generally does not cause structural changes or denaturation of polyurethane when it comes into contact with polyurethane at room temperature and pressure. In this case, by providing an isolation layer 31 including polyurethane, the penetration of sterilization gas can be limited when the sensor 1 is sterilized by gas, forming an isolation barrier to reduce the effect of sterilization gas on the sensing layer 14, especially the effect of gaseous ethylene oxide on the active substances (such as sensitive substances) in the sensing layer 14; and the isolation layer 31 having polyurethane has good biocompatibility, which can improve the safety of the sensor 1 when implanted subcutaneously in the host; in addition, the isolation layer 31 also has a limiting effect on the penetration of specific analytes (such as glucose), which can enable the polymer membrane 3 to act as a semipermeable membrane. In some examples, the first type of polymer may have a carbamate group.

[0053] In some examples, the first type of polymer may have a soft segment, and in the first type of polymer, the proportion of the soft segment may be 5% to 50%. In this case, the properties of the first type of polymer can be adjusted by adjusting the proportion of the soft segment. In some examples, preferably, the proportion of the soft segment is 10% to 25%. In some examples, when the first type of polymer is polyurethane, the polyurethane may have a soft segment. Since the proportion of the soft segment will affect the performance of the polyurethane material, in this case, by selecting a suitable proportion of the soft segment, the polyurethane material can have good mechanical properties and biocompatibility. In some examples, the elasticity, modulus, softness and water absorption of the polyurethane can be adjusted by adjusting the proportion of the soft segment in the polyurethane, thereby adjusting the permeability of the isolation layer 31 to the analyte and the biocompatibility of the isolation layer 31 itself. In some examples, the soft segment may include a component containing an epoxy functional group. For example, the soft segment may include polyethylene oxide (PEO).

[0054] In some examples, the polyurethane may be a block copolymer consisting of a soft segment and a hard segment. In some examples, in the polyurethane, the soft segment may be composed of hydroxyl-containing molecules such as polyester polyols, polyether alcohols, polycaprolactones, polylactic acid-glycolic acid copolymers, etc. of varying molecular weights. In some examples, in the polyurethane, the hard segment may be composed of compounds such as diisocyanates and low molecular weight short chain extenders. In some examples, the diisocyanate may be an aliphatic isocyanate. For example, the diisocyanate may be 1,6-hexamethylene diisocyanate (HDI), 4,4'-dicyclohexylmethane diisocyanate (HMDI), or isophorone diisocyanate (IPDI), etc. In some examples, the short chain extender may be 1,4-butanediol.

[0055] In some examples, the polyurethane may be a polycarbonate polyurethane, a polyether polyurethane and / or a polyester polyurethane. In some examples, the polyurethane may include one or more of aliphatic polyether polyurethane, aliphatic polyether polyurethane urea, cycloaliphatic polyether polyurethane, cycloaliphatic polyether polyurethane urea, aromatic polyether polyurethane, aromatic polyether polyurethane urea, aliphatic polyester polyurethane, aliphatic polyester polyurethane urea, cycloaliphatic polyester polyurethane, cycloaliphatic polyester polyurethane urea, aromatic polyester polyurethane, and aromatic polyester polyurethane urea.

[0056] In some examples, the first type of polymer may be a zwitterionic polyurethane. In this case, this type of polyurethane has the softness and scalability of a polyether chain, and at the same time has the characteristics of a zwitterionic group, and can introduce zwitterionic groups with different characteristics as needed to adjust the properties of the isolation layer 31. In some examples, the zwitterionic groups in the zwitterionic polyurethane may include amine groups, carboxyl groups and / or sulfonic acid groups, etc. In this case, the hydrophilicity and biocompatibility of the isolation layer 31 can be improved by introducing specific zwitterionic groups.

[0057] In some examples, the first type of polymer may have a hydrophilic group. Thus, the first type of polymer can have a certain hydrophilicity, which is beneficial to improve the biocompatibility of the isolation layer 31; and ethylene oxide can react with some types of hydrophilic groups, that is, the first type of polymer containing a type of hydrophilic group that can react with ethylene oxide can adsorb ethylene oxide to a certain extent, thereby further improving the isolation effect of the isolation layer 31 on ethylene oxide. In some examples, the hydrophilic group may include a hydroxyl group, a carboxyl group, and / or an ether group, etc.

[0058] In some examples, in the first polymer, the hydrophilic group may account for 1% to 30%. For example, in the first polymer, the hydrophilic group may account for 1%, 2%, 5%, 6%, 8%, 10%, 12%, 13%, 15%, 16%, 17%, 18%, 20%, 22%, 25%, 26%, 27%, 28%, 29% or 30%. The proportion of the hydrophilic group in the first polymer may affect the performance of the first polymer. In this case, the relevant properties of the first polymer may be adjusted by adjusting the proportion of the hydrophilic group, thereby adjusting the performance of the isolation layer 31.

[0059] In some examples, when the first type of polymer is polyurethane, the proportion of hydrophilic groups can be 1% to 30%. In this case, by selecting a suitable proportion of hydrophilic groups, the polyurethane material can have good hydrophilicity and biocompatibility, etc.; and the polyurethane containing hydrophilic groups of the type that can react with ethylene oxide can absorb part of the ethylene oxide to introduce epoxy groups during sterilization, further improving the isolation effect of the isolation layer 31 on the sterilization gas. In some examples, preferably, in the first type of polymer, the proportion of hydrophilic groups can be 10% to 25%. In some examples, the permeability coefficient of the isolation layer 31 to the analyte can be adjusted by adjusting the hydrophilic groups in the polyurethane. For example, by increasing the proportion of hydrophilic groups in the polyurethane, the dispersibility of the polyurethane in the liquid phase can be increased, thereby helping to improve the permeability of the isolation layer 31 to the analyte. Conversely, the permeability of the isolation layer 31 to the analyte can be reduced by reducing the proportion of hydrophilic groups in the polyurethane. In some examples, the hydrophilicity of the polyurethane can be improved by introducing a block containing a hydrophilic group.

[0060] In some examples, the first solution may include an organic solvent. The first type of polymer may be dissolved in the organic solvent. Thus, it is easy to form the first solution and then form the isolation layer 31. In some examples, the organic solvent may be a mixed solvent of any one or more of tetrahydrofuran, dichloromethane and N,N-dimethylacetamide. Thus, the first type of polymer can be dissolved by the organic solvent.

[0061] In some examples, in the first solution, the mass fraction of the first type of polymer may be 0.1% to 15%. For example, in the first solution, the mass fraction of the first type of polymer may be 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14% or 15%. Thus, it can help the isolation layer 31 to limit the penetration of the sterilizing gas during gas sterilization. In some examples, preferably, in the first solution, the mass fraction of the first type of polymer may be 0.1% to 5%. In this case, the isolation layer 31 can have a suitable analyte permeability coefficient while having the effect of limiting the penetration of the sterilizing gas.

[0062] In some examples, the thickness of the isolation layer 31 may be 1 μm to 40 μm. For example, the thickness of the isolation layer 31 may be 1 μm, 5 μm, 8 μm, 10 μm, 12 μm, 15 μm, 18 μm, 20 μm, 22 μm, 25 μm, 28 μm, 30 μm, 32 μm, 35 μm, 38 μm or 40 μm. In this case, selecting an isolation layer 31 of suitable thickness can effectively act as an isolation barrier, thereby facilitating improving the resistance of the sensor 1 to sterilization gas; in addition, the isolation layer 31 can also have a suitable analyte permeability coefficient. In some examples, preferably, the thickness of the isolation layer 31 may be 10 μm to 30 μm. In this case, it is convenient to balance the isolation effect of the isolation layer 31 on the sterilization gas and the analyte permeability coefficient.

[0063] In some examples, the polymer film 3 may include a protective layer 32 (see Figure 3 ). In some examples, the protective layer 32 can be used to separate the sensing layer 14 from the isolation layer 31. That is, the protective layer 32 can be closer to the first electrode 13 than the isolation layer 31. Thus, the adverse effects of the organic solvent in the isolation layer 31 on the sensing layer 14 and the first electrode 13 (such as corrosion leading to damage to the internal structural integrity and loss of functionality) can be reduced.

[0064] In some examples, the protective layer 32 may be made of a second solution. In some examples, the second solution may be applied to the implant portion 11 to form the protective layer 32. In some examples, the second solution may be applied to the target location by spraying, spin coating, or dip coating to form the protective layer 32. In some examples, the second solution may include a second type of polymer. In other words, the protective layer 32 may include a second type of polymer. The second type of polymer may not react with the first type of polymer. Thus, a protective layer 32 that can separate the isolation layer 31 from the internal structure (sensing layer 14 and the first electrode 13) can be formed.

[0065] In some examples, the second type of polymer can be a copolymer formed by anionic and cationic polymers or neutral monomers. In this case, the protective layer 32 will not react with the two polymers in the isolation layer 31; and a low-corrosive or non-corrosive solvent can be used to dissolve the second type of polymer, so that the formed protective layer 32 will not damage the internal structure (sensing layer 14 and first electrode 13) when it is in direct contact with the internal structure; and the formed protective layer 32 has extremely small permeability restrictions on the analyte, which can facilitate the analyte to pass through the protective layer 32 and contact the sensing layer 14; in addition, the second type of polymer is insoluble in the organic solvent in the first solvent, which can reduce the possibility of the formed film layer falling off and inhibit the interaction between the two film layers, thereby improving the overall stability of the polymer film 3.

[0066] In some examples, the second polymer can be chitosan or carboxymethylacrylate.

[0067] In some examples, the second type of polymer can be selected from one or more of polyethylene glycol-block-polystyrene, polyacrylic acid-block-polystyrene, polyacrylic acid-co-polystyrene, polyacrylamide-block-polystyrene, polyacrylamide-co-polystyrene, poly2-vinylpyridine-block-polystyrene, poly4-vinylpyridine-co-polystyrene, poly4-vinylpyridine-co-polyvinylpyrrolidone, poly2-vinylpyridine-co-polystyrene, poly4-vinylpyridine-block-polystyrene, poly4-vinylpyridine-co-polyacrylamide, polyethoxyethyl acrylate-co-polyhydroxyethyl acrylate, and polyethoxypropyl acrylate-co-polyvinyl alcohol.

[0068] In some examples, the solvent of the second solution can be a lower alcohol solution, an inorganic salt buffer solution, or a mixed solution of a lower alcohol and an inorganic salt buffer solution. Thus, the second polymer can be dissolved, which facilitates the subsequent coating of the second solution. In some examples, the solvent of the second solution can be methanol, ethanol, or a mixed solution of ethanol and phosphate buffer solution.

[0069] In some examples, the thickness of the protective layer 32 may be 1 μm to 20 μm. For example, the thickness of the protective layer 32 may be 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm or 20 μm. Thus, the isolation layer 31 can be effectively separated from the internal structure (sensing layer 14 and first electrode 13) by the protective layer 32. In some examples, preferably, the thickness of the protective layer 32 may be 8 μm to 15 μm. In some examples, preferably, the thickness of the protective layer 32 may be not less than 10 μm.

[0070] In some examples, the thickness ratio of the protective layer 32 to the isolation layer 31 may be 1:1 to 1:10. For example, the thickness ratio of the protective layer 32 to the isolation layer 31 may be 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:3.5, 1:4, 1:4.5, 1:5, 1:5.5, 1:6, 1:6.5, 1:7, 1:7.5, 1:8, 1:8.5, 1:9, 1:9.5 or 1:10. Thus, it is beneficial to separate the isolation layer 31 from the internal structure (sensing layer 14 and first electrode 13) by the protective layer 32. In some examples, preferably, the thickness ratio of the protective layer 32 to the isolation layer 31 may be 1:1 to 1:5.

[0071] In some examples, the polymer film 3 may include a biocompatible layer 33 (see Figure 3 The biocompatible layer 33 may be biocompatible and serve as the outermost layer of the polymer film 3 (ie, the film layer farthest from the first electrode 13 ). In this case, the biocompatibility of the sensor 1 can be improved.

[0072] In some examples, the isolation layer 31 may be located between the biocompatible layer 33 and the protective layer 32. It should be noted that in the present disclosure, the isolation layer 31 is adjusted to have good biocompatibility, and the additional biocompatible layer 33 is added for the purpose of further improving the biocompatibility and reliability of the sensor 1, and the biocompatible layer 33 is not necessarily required.

[0073] In some examples, the biocompatible layer 33 may be made of a third solution. In some examples, the third solution may be applied to the implant portion 11 to form the biocompatible layer 33. In some examples, the third solution may be applied to the target position by spraying, spin coating, or dip coating to form the biocompatible layer 33. In some examples, the third solution may include a third type of polymer. In other words, the biocompatible layer 33 may include a third type of polymer. Among them, the third type of polymer may be a biocompatible polymer. Thus, a biocompatible layer 33 with biocompatibility can be formed, thereby helping to improve the biocompatibility of the sensor 1.

[0074] In some examples, the third type of polymer may be polyurethane. In this case, the third type of polymer is also polyurethane, which can further improve the biocompatibility of the sensor 1 on the one hand, and can also partially block the entry of sterilization gas during the sterilization process of the sensor 1 on the other hand, further improving the protective effect of the polymer film 3 on the sensor 1.

[0075] In some examples, the third type of polymer may be polyurethane containing hydrophilic groups. In this case, the biocompatible layer 33 containing the third type of polymer can have good biocompatibility; in addition, the polyurethane containing hydrophilic groups of the type that can react with ethylene oxide can react with ethylene oxide during sterilization, absorb part of the ethylene oxide and introduce epoxy groups, further improving the hydrophilicity of the biocompatible layer 33, thereby improving the biocompatibility of the polymer film 3.

[0076] In some examples, in the third type of polymer, the proportion of hydrophilic groups can be 20% to 50%. For example, in the third type of polymer, the proportion of hydrophilic groups can be 20%, 22%, 25%, 28%, 30%, 32%, 35%, 37%, 40%, 42%, 45%, 48% or 50%. As a result, the biocompatible layer 33 containing the third type of polymer can have good biocompatibility, thereby further improving the biocompatibility of the sensor 1. In some examples, preferably, in the third type of polymer, the proportion of hydrophilic groups can be 30% to 50%. In some examples, preferably, in the third type of polymer, the proportion of hydrophilic groups can be not less than 30%.

[0077] In some examples, the third type of polymer may be a cross-linked water-soluble polyurethane. In this case, the water-soluble polyurethane has good biocompatibility, thereby enabling the formed biocompatible layer 33 to have good biocompatibility. In some examples, the third type of polymer may be polyethylene glycol block polyurethane, polymethacrylate block polyurethane, polyvinyl alcohol block polyurethane, or polypropylene alcohol block polyurethane.

[0078] In some examples, the solvent of the third solution may be an organic solvent or other mixed solvent. The third type of polymer may be dissolved in an organic solvent. Thus, it is easy to form the third solution, and then form the biocompatible layer 33. In some examples, the organic solvent may be a mixed solvent of any one or more of tetrahydrofuran, dichloromethane, and N,N-dimethylacetamide. Thus, the third type of polymer can be dissolved by an organic solvent. In some examples, the solvent of the third solution may include water. Thus, it is conducive to dissolving the third type of polymer.

[0079] In some examples, in the third solution, the mass fraction of the third type of polymer may be 0.1% to 15%. For example, in the third solution, the mass fraction of the third type of polymer may be 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14% or 15%. Thus, a biocompatible layer 33 with good biocompatibility can be formed. In some examples, preferably, in the first solution, the mass fraction of the first type of polymer may be 0.1% to 5%.

[0080] In some examples, the thickness of the biocompatible layer 33 may be 1 μm to 30 μm. For example, the thickness of the biocompatible layer 33 may be 1 μm, 3 μm, 5 μm, 6 μm, 8 μm, 10 μm, 12 μm, 14 μm, 15 μm, 16 μm, 18 μm, 20 μm, 22 μm, 25 μm, 26 μm, 28 μm, or 30 μm. Thus, it can help improve the biocompatibility of the sensor 1. In some examples, preferably, the thickness of the biocompatible layer 33 may be 10 μm to 20 μm.

[0081] Figure 4 is a schematic diagram showing that the polymer film 3 according to the example of the present disclosure covers the implant part 11. Figure 4 In the figure, for a clearer illustration, the proportion of the polymer film 3 is magnified and the structure of the implant part 11 is simplified, but this should not be construed as a limitation to the present disclosure.

[0082] In some examples, the polymer film 3 may cover the implant portion 11 (see Figure 4 ). In some examples, the polymer film 3 may cover each electrode on the implant part 11. For example, the polymer film 3 may cover the first electrode 13 and the second electrode. Thus, the first electrode 13 and the second electrode can be protected by the polymer film 3. For another example, the polymer film 3 may cover the first electrode 13, the second electrode and the third electrode on the implant part 11. Thus, each electrode can be protected by the polymer film 3. In some examples, the polymer film 3 may completely cover the implant part 11. Thus, the safety of the sensor 1 when implanted subcutaneously in the host can be improved.

[0083] In some examples, the thickness of the polymer film 3 may be no greater than 100 μm. In this case, the polymer film 3 can be stably adhered to the implant part 11, and the implant part 11 occupies less space as a whole, which can reduce the discomfort after implantation under the host's skin, thereby improving the wearing comfort.

[0084] In summary, in the first aspect of the present disclosure, a sensor 1 resistant to sterilization gas can be provided.

[0085] As mentioned above, the second aspect of the present disclosure provides an isolation layer 31 of a sensor 1. The isolation layer 31 can limit the penetration of sterilization gas when the sensor 1 is sterilized by gas, forming an isolation barrier to reduce the impact of the sterilization gas on the sensing layer 14 of the sensor 1.

[0086] The isolation layer 31 involved in the second aspect of the present disclosure is consistent with the isolation layer 31 in the sensor 1 described in the first aspect of the present disclosure. The specific components and proportions can be found in the description of the first aspect and will not be repeated here.

[0087] In some examples, the isolation layer 31 can be configured to reduce the effect of the sterilization gas on the sensing layer 14 when the sensor 1 is subjected to gas sterilization. In some examples, the isolation layer 31 can cover the first electrode 13 and the sensing layer 14 of the sensor 1. Thus, the first electrode 13 and the sensing layer 14 can be protected.

[0088] In some examples, the isolation layer 31 may be made of a first solution, and the first solution may include a first type of polymer and an organic solvent. Among them, the first type of polymer may be polyurethane. In this case, the isolation layer 31 including polyurethane can limit the penetration of sterilization gas when the sensor 1 is sterilized by gas, forming an isolation barrier to reduce the impact of the sterilization gas on the sensing layer 14, especially the impact of gaseous ethylene oxide on the active substances in the sensing layer 14, so that the sensor 1 can be sterilized using gas sterilization. Compared with the sensor 1 without the isolation layer 31, the sensor 1 provided with the isolation layer 31 has a greatly reduced sensitivity decrease before and after sterilization, and can still maintain a high sensitivity after sterilization; and the isolation layer 31 with polyurethane has good biocompatibility, which can improve the safety of the sensor 1 when implanted subcutaneously in the host; in addition, the isolation layer 31 also has a limiting penetration effect on specific analytes (such as glucose), which can act as a semipermeable membrane.

[0089] In some examples, the isolation layer 31 can also be used in other scenarios where the penetration of ethylene oxide needs to be limited, and the isolation layer 31 can be set on the predetermined target. That is, the second aspect of the present disclosure can provide an isolation layer 31 that can limit the penetration of sterilization gas.

[0090] In some examples, the method for preparing the isolation layer 31 may include: preparing a first solution; coating the first solution at a predetermined position; and forming the isolation layer 31 after drying.

[0091] As mentioned above, the third aspect of the present disclosure relates to an analyte monitoring device 100 .

[0092] In some examples, the analyte monitoring device 100 may include an electronic component 2 and a sensor 1 electrically connected to the electronic component 2 (see Figure 1 ). Thus, the analyte can be monitored by the sensor 1. The sensor 1 described in the third aspect of the present disclosure is consistent with the sensor 1 of the first aspect of the present disclosure. The specific structure and details can be found in the description of the first aspect of the present disclosure, which will not be repeated here. That is, in some examples, the analyte monitoring device 100 may include an electronic component 2 and the sensor 1 described in the first aspect of the present disclosure.

[0093] In the analyte monitoring device 100 of the present disclosure, the sensor 1 is resistant to sterilizing gas, and the sensor 1 can be assembled with the electronic component 2 for gas sterilization without radiation sterilization of the sensor 1 alone.

[0094] In some examples, the analyte monitoring device 100 can be assembled as a whole at the factory, and the user does not need to perform additional operations to assemble the electronic component 2 and the sensor 1 when using it. This can facilitate the use of the user. It should be noted that although the sensor 1 provided in the present disclosure can be designed as an integral part with the electronic component 2, if necessary, the two can also be set to be separable and matched, and the "integrated design" should not be understood as a limitation on the sensor 1 of the present disclosure.

[0095] In summary, according to the present disclosure, a sensor 1 resistant to sterilization gas and its isolation layer 31 and an analyte monitoring device 100 can be provided.

[0096] In order to further illustrate the present disclosure, the sensor 1 and the isolation layer 31 provided by the present disclosure are described in detail below in conjunction with the embodiments, and the beneficial effects achieved by the present disclosure are fully illustrated in conjunction with the comparative examples.

[0097] It should be noted that, in the embodiments and comparative examples of the present disclosure, unless otherwise specified, the reagents and instruments used are all commercially available products.

[0098] First, a plurality of sensors including a first electrode provided with a sensing layer of glucose enzyme are prepared.

[0099] [Example] According to Table 1-1 and Table 1-2, the first solution, the second solution and the third solution (some embodiments do not have the third solution) are prepared, and the second solution, the first solution and the third solution are sequentially coated on the prepared sensor to obtain the sensor with the polymer film of Embodiment 1 to Embodiment 11. PEO in Table 1-1 and Table 1-2 belongs to the hydrophilic group and the soft segment, PEGDGE refers to polyethylene glycol diglycidyl ether, and the experiment is carried out using the polyurethane containing PEO as an example.

[0100] Table 1-1

[0101] Table 1-2

[0102] [Comparative Example 1] A commercially available continuous glucose monitoring system (Shenzhen Silicon-Based Sensing Technology Co., Ltd., model: GS1) was selected as Comparative Example 1.

[0103] [Comparative Example 2] The sensor of Comparative Example 2 was prepared according to the same steps as Example 1, except that no protective layer was provided.

[0104] [Comparative Example 3] The sensor of Comparative Example 3 was prepared according to the same steps as Example 4, except that the thickness of the isolation layer was 50 μm.

[0105] [Comparative Example 4] The sensor of Comparative Example 4 was prepared according to the same steps as Example 1, except that the polyether polyurethane in the first solution contained 50% PEO.

[0106] Test the performance of the sensor: (1) Cytotoxicity test (biocompatibility test) Taking the sensors of Example 1 and Example 9 as examples, a cytotoxicity test was conducted, specifically: a control group and an experimental group were designed, the control group included a blank group (adding blank control cell culture fluid), a negative control group (adding high-density polyethylene extract (non-toxic substance)) and a positive control group (adding latex glove extract (toxic substance)), the experimental group included different concentrations of the first solution of Example 1 and the third solution of Example 9, see Table 2 for details, cells were inoculated in the experimental group and the control group, the cell survival rate was measured after the cells were incubated, and the cytotoxicity test results are shown in Table 2.

[0107] Table 2

[0108] (2) Sensitivity test The sensors of each embodiment and each comparative example were sterilized using ethylene oxide, and the specific sterilization conditions were as follows: temperature: 52±3°C, humidity: 30-85%, action time: 360 min (minutes), concentration: 600±40 mg / L. Figure 5 is a diagram showing the appearance of the sensor of Example 1 of the present disclosure after sterilization, Figure 6 3 is a diagram showing the appearance of the sensor of Comparative Example 1 of the present disclosure after sterilization.

[0109] The sensitivity of each sensor was tested before and after sterilization, specifically: the sensor was exposed to a standard phosphate buffer (PBS buffer) with different glucose concentrations at 37°C ± 1°C, its response current at different glucose concentrations was measured, and each response current was fitted to obtain a standard curve, so that the sensitivity of each sensor can be obtained based on the fitted standard curve calculation formula. Among them, the glucose concentrations are as follows: 2.2mM (millimoles per liter), 5mM, 10mM, 15mM, 20mM, 25mM. The measured sensitivity is shown in Table 3. In Table 3, the decline = (sensitivity before sterilization-sensitivity after sterilization) / sensitivity before sterilization * 100%. The greater the decline (also known as the attenuation amplitude), the greater the impact of ethylene oxide, and the weaker the sensor's resistance to ethylene oxide; conversely, the smaller the decline, the stronger the sensor's resistance to ethylene oxide.

[0110] Table 3

[0111] Results Analysis from Figure 5 and Figure 6 It can be seen that the appearance of the sensor of Example 1 did not change significantly after sterilization, while the appearance of the sensor of Comparative Example 1 changed, indicating that the sensor of Comparative Example 1 without an isolation layer was corroded after sterilization.

[0112] It can be seen from Table 3 that the sensitivity of the sensors in each embodiment decreases slightly before and after sterilization, which can indicate that the sensors in each embodiment are resistant to ethylene oxide. However, the sensitivity of the sensors in each comparative example decreases significantly after sterilization, and some cannot detect sensitivity. The following is a specific analysis: In Comparative Example 1, because the commercially available product does not have an isolation layer like the present invention, the sensitivity of the sensor drops significantly after sterilization, so the sensor of Comparative Example 1 cannot be sterilized by ethylene oxide. In Comparative Example 2, because no protective layer is provided, the electrode is corroded after coating the first solution containing an organic solvent, resulting in no sensitivity being detected, which can be explained by the protective layer of the present invention being able to effectively protect the electrode. In Comparative Example 3, because the thickness of the isolation layer is 50 μm, the excessive increase in film thickness causes the diffusion resistance of the isolation layer to glucose to be too large, and effective sensitivity cannot be detected. In Comparative Example 4, the PEO content in the isolation layer is 50%, that is, the content of soft segments and hydrophilic groups is 50%, the overall hydrophilicity of the isolation layer is high, and the diffusion resistance to glucose is small, so that the sensor has a higher sensitivity before sterilization, but it also causes the isolation effect of the isolation layer to ethylene oxide to deteriorate, and the sensitivity of the sensor drops significantly after sterilization.

[0113] By comparing Example 1 and Examples 2-3, it can be found that increasing the film thickness will lead to a decrease in sensitivity, but the attenuation of the sensitivity after sterilization is also reduced, indicating that increasing the thickness of the isolation layer can reduce the damage to the electrode caused by ethylene oxide sterilization.

[0114] By comparing Example 1 and Example 4, it can be found that because the concentration and thickness of the polyether polyurethane in Example 4 are greater than those in Example 1, the attenuation degree of sensitivity after sterilization is reduced, but the overall sensitivity of Example 4 is lower than that of Example 1.

[0115] By comparing Example 1 and Examples 5-6, it can be found that Examples 5-6 respectively use different concentrations of polyether polyurethane to prepare the isolation layer. Due to the different solution concentrations, there is a slight difference in the sensitivity before sterilization and the sensitivity attenuation after sterilization, but there is no significant difference.

[0116] By comparing Example 1 with Examples 7-8, it can be found that Examples 7-8 use different types of polyurethanes, respectively. Since these two types of polyurethanes are more hydrophobic than polyether polyurethanes, the isolation layer has a greater diffusion resistance to glucose and a lower sensitivity. However, the sensitivity attenuation amplitude after sterilization is also reduced accordingly, indicating that different types of polyurethanes can have an isolation effect.

[0117] By comparing Example 1 and Examples 9-11, it can be found that Examples 9-11 are sensors with biocompatible layers of different components added respectively. Due to the increase in the overall film thickness of the polymer film, the sensitivity of the sensors of Examples 9-11 is reduced compared with that of Example 1, but the sensitivity attenuation amplitude after sterilization is also reduced accordingly, which has a stronger protective effect; and the third solution of Example 9 shows stronger biocompatibility than the first solution of Example 1 in the cytotoxicity test, indicating that adding a biocompatible layer helps to improve the biocompatibility of the sensor.

[0118] In summary, the sensors of each embodiment have strong resistance to ethylene oxide (i.e., sterilizing gas). In comparison, the sensors obtained in each comparative example cannot achieve the performance and effect of the sensors obtained in the above embodiments.

[0119] Although the present disclosure is specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the above description does not limit the present disclosure in any form. Those skilled in the art may modify and change the present disclosure as needed without departing from the essential spirit and scope of the present disclosure, and these modifications and changes all fall within the scope of the present disclosure.

Claims

1. A monitoring probe, characterized in that: The monitoring probe comprises a first electrode provided with a sensing layer, and a polymer film, The polymer film comprises a protective layer and an isolation layer, and the polymer film at least covers the sensing layer. The protective layer is used to separate the sensing layer from the isolation layer. The isolation layer is configured to reduce the effect of the sterilization gas on the sensing layer when the monitoring probe is subjected to gas sterilization. The isolation layer is made of a first solution, the first solution includes a first type of polymer and an organic solvent, the first type of polymer is polyurethane, and in the first solution, the mass fraction of the first type of polymer can be 0.1% to 15%, and the organic solvent is a substance that has an adverse effect on the sensing layer when it directly contacts the sensing layer.

2. The monitoring probe according to claim 1, characterized in that: The polymer membrane is biocompatible and has selective permeability to the analyte monitored by the monitoring probe.

3. The monitoring probe according to claim 1, characterized in that: The first type of polymer has a soft segment, and in the first type of polymer, the soft segment accounts for 5% to 50%.

4. The monitoring probe according to claim 1, characterized in that: The first type of polymer is zwitterionic polyurethane, and the zwitterionic groups in the zwitterionic polyurethane include amine groups, carboxyl groups and / or sulfonic acid groups.

5. The monitoring probe according to claim 1, characterized in that: The first type of polymer has a hydrophilic group, and in the first type of polymer, the hydrophilic group accounts for 1% to 30%.

6. The monitoring probe according to claim 1, characterized in that: The polymer film has a thickness of no greater than 100 μm.

7. The monitoring probe according to claim 1, characterized in that: The thickness ratio of the protective layer to the isolation layer is 1:1 to 1:

10.

8. The monitoring probe according to claim 1, characterized in that: The monitoring probe includes a second electrode different from the first electrode, the second electrode is a second working electrode, and the analyte detected by the second working electrode is the same as or different from that of the first electrode.

9. The monitoring probe according to claim 1, characterized in that: The analytes monitored by the monitoring probe are one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glutamine, hormones, ketone bodies, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone and troponin.

10. A monitoring system, characterized in that: It comprises an electronic component and a monitoring probe according to any one of claims 1 to 9, wherein the electronic component and the monitoring probe are designed as an integral whole and are assembled into one body when leaving the factory.

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