Analyte sensor and preparation and application methods thereof

Abstract

The invention relates to an analyte sensor (1), to a method for the production thereof, and to the use thereof. The analyte sensor (1) comprises a sensing probe (10), an auxiliary needle (20) and a pharmaceutical preparation (30). Wherein the sensing probe (10) comprises a probe substrate (11) and an electrode (12); the auxiliary needle (20) comprises a needle tip (21), a side wall (22) and a bottom wall (23), the needle tip (21) is connected with the bottom wall (23), the side wall (22) and the bottom wall (23) are connected to form a containing groove (24), and the containing groove (24) is used for containing the sensing probe (10); and the pharmaceutical preparation (30) is arranged on the auxiliary needle (20) and / or the sensing probe (10).

Description

Analyte sensor and preparation and application method thereof Technical Field

[0001] The present application relates to the field of sensor technology, and in particular to an analyte sensor and a preparation and application method thereof. Background Art

[0002] Analyte sensors are a type of sensor used for subcutaneous analyte measurement or transcutaneous testing. By implanting a sensor probe into the target area under the skin, analyte sensors can continuously and in-situ monitor the target analyte and provide external feedback on the monitoring data.

[0003] In the related art, the wound caused by the analyte sensor during the implantation process can cause acute inflammatory reactions and bleeding, making the analyte sensor less accurate for a period of time after implantation. In addition, the sensing probe of the analyte sensor will cause inflammatory reactions, foreign body giant cell formation, fibrosis and other foreign body reactions (FBR) after implantation into the human body, and eventually collagen wrapping will form around the implanted probe, preventing the transfer and communication of substances between the probe and the surrounding tissues, that is, preventing the target analyte from being transmitted to the sensing probe, affecting the long-term sensitivity, accuracy, stability and other functions of the analyte sensor. In addition, the sensor, adhesive tape, other components and the glue that may be used can cause skin irritation and lead to allergies.

[0004] In related technologies, researchers have focused on reducing the thickness of the fibrotic layer around implantable medical devices by providing surface coatings that reduce protein contamination and cell attachment. Alternatively, they have applied a drug-containing film to the exterior of the working electrode functional area of ​​analyte sensor probes to achieve anti-inflammatory and anti-fibrotic effects. However, these technologies do not address the problem of targeted drug delivery to different target sites.

[0005] Therefore, there is an urgent need to provide an analyte sensor that can deliver drug preparations to different target sites.

[0006] Summary of the Invention

[0007] According to various embodiments of the present application, an analyte sensor and methods for preparing and using the same are provided.

[0008] In a first aspect, an analyte sensor includes a sensing probe, an auxiliary needle, and a pharmaceutical agent. The auxiliary needle includes a needle tip, a side wall, and a bottom wall, the needle tip being connected to the bottom wall. The side wall and the bottom wall are connected to form a receiving groove for accommodating the sensing probe. The pharmaceutical agent is disposed on the auxiliary needle and / or the sensing probe.

[0009] In some embodiments, the side wall includes a first portion, which is disposed at an end of the side wall close to the needle tip, and a height of the first portion relative to the bottom wall decreases in a direction close to the needle tip.

[0010] In some embodiments, a first protrusion is further provided on the outer surface of the side wall of the auxiliary needle.

[0011] In some embodiments, the sensing probe includes a probe substrate and an electrode, the probe substrate includes an electrode region and a blank region, and the electrode is disposed on the electrode region of the probe substrate.

[0012] In some embodiments, the blank area includes a first blank area, a second blank area, a third blank area, a fourth blank area, and a fifth blank area. The first blank area is located at the end of the probe base near the tip of the auxiliary needle; the second blank area is located on both sides of the electrode area on the probe base; the third blank area is located on both sides of the probe base; the fourth blank area is located at the end of the probe base away from the tip of the auxiliary needle; and the fifth blank area is located on the side opposite to the side of the probe base where the electrode is located.

[0013] In some embodiments, the sensing probe includes a probe base, the probe base further includes a second protrusion, and the second protrusion is located between the probe base and a sidewall of the auxiliary needle.

[0014] In some embodiments, the pharmaceutical formulation includes a functional component.

[0015] In some embodiments, the functional component comprises at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, a pro-angiogenic component, and an anti-allergic component.

[0016] In some embodiments, the anti-inflammatory component includes: at least one of curcumin, dexamethasone, prednisone, methylprednisone, betamethasone, beclomethasone dipropionate, prednisolone, hydrocortisone, and methylprednisolone; the anticoagulant component includes: at least one of heparin sodium, heparin calcium, enoxaparin sodium, dalteparin sodium, nadroparin calcium, argatroban, bivalirudin, warfarin (coumarin sodium), dabigatran etexilate, rivaroxaban, apixaban, dipyridamole, aspirin, clopidogrel bisulfate, urokinase, and antithrombin; the anti-fibrotic component includes: at least one of heparin sodium, heparin calcium, enoxaparin sodium, dalteparin sodium, nadroparin calcium, argatroban, bivalirudin, warfarin (coumarin sodium), dabigatran etexilate, rivaroxaban, apixaban, dipyridamole, aspirin, clopidogrel bisulfate, urokinase, and antithrombin; The vascularization component includes: at least one of macrophage colony stimulating factor-1 receptor inhibitor, colchicine, interferon, endothelin receptor antagonist, pirfenidone, nintedanib, anifate, asiaticoside, D-penicillamine, tretinoin, 5-fluorouracil, and relaxin peptide analog B7-33; the pro-angiogenesis component includes: at least one of vascular endothelial growth factor and platelet-derived growth factor; and the anti-allergic component includes: at least one of mometasone furoate, desonide, triamcinolone acetonide, fluticasone propionate, and halometasone.

[0017] In some embodiments, the pharmaceutical formulation further comprises at least one of an excipient and a penetration enhancer.

[0018] In some embodiments, the excipient includes at least one of collagen, bovine serum albumin, gelatin, chitosan, hyaluronic acid, chondroitin sulfate, sodium alginate, polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, polylactic acid-glycolic acid copolymer, triglycerides, dextrin, sodium hydroxymethylcellulose, petrolatum, propylene glycol, glycerin, stearic acid, glyceryl monostearate, lanolin, beeswax, paraffin, liquid paraffin, triethanolamine, Span 80, and emulsifier OP-10.

[0019] In some embodiments, the penetration enhancer includes at least one of lecithin, ethanol, propylene glycol, ethyl acetate, dimethyl sulfoxide, laurocapram, oleic acid, lauryl alcohol, urea, salicylic acid, dimethyl amino acid ester, and limonene.

[0020] In some embodiments, the form of the pharmaceutical preparation includes at least one of a coating, a gel, an emulsion, a paste, and a microcapsule.

[0021] In some embodiments, the drug preparation is disposed in the receiving groove of the auxiliary needle at one end close to the needle tip.

[0022] In some embodiments, the pharmaceutical formulation comprises a functional component comprising at least one of an anti-inflammatory component, an anticoagulant component, and an anti-fibrotic component.

[0023] In some embodiments, the drug formulation is disposed on an inner surface of a side wall of the auxiliary needle; and / or, the drug formulation is disposed on an inner surface of a bottom wall of the auxiliary needle.

[0024] In some embodiments, the pharmaceutical preparation comprises a functional component comprising at least one of an anti-inflammatory component and an anti-allergic component.

[0025] In some embodiments, the drug formulation is disposed on an outer surface of a sidewall of the auxiliary needle.

[0026] In some embodiments, the pharmaceutical preparation comprises a functional component comprising at least one of an anti-inflammatory component and an anti-allergic component.

[0027] In some embodiments, the drug formulation is disposed on the first protrusion away from the needle tip.

[0028] In some embodiments, the pharmaceutical formulation comprises a functional component comprising at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, and a pro-angiogenic component.

[0029] In some embodiments, the electrodes include a working electrode, a reference electrode, and a counter electrode, and the drug preparation is disposed on at least one of the surface of the working electrode, the surface of the reference electrode, the surface of the counter electrode, the first blank area, the second blank area, the third blank area, the fourth blank area, and the fifth blank area.

[0030] In some embodiments, the drug formulation is disposed on at least one of the surface of the reference electrode, the surface of the counter electrode, the first blank area, the second blank area, the third blank area, the fourth blank area, and the fifth blank area.

[0031] In some embodiments, the drug preparation is disposed on the outer surface of the side wall of the auxiliary needle and the fifth blank area.

[0032] In some embodiments, the pharmaceutical formulation includes a functional component comprising at least one of an anti-inflammatory component and an anticoagulant component.

[0033] In a second aspect, the present application also provides a preparation method based on the above-mentioned analyte sensor, comprising the following steps: preparing a drug preparation; placing the drug preparation on an auxiliary needle and / or a sensing probe; and placing the sensing probe in a receiving groove of the auxiliary needle.

[0034] In some embodiments, the drug formulation is disposed on the auxiliary needle by at least one of in-hole spot coating, surface spot coating, dip coating, spin coating, and spray coating.

[0035] In some embodiments, the drug formulation is disposed on the sensing probe by at least one of in-hole spot coating, surface spot coating, dip coating, spin coating, and spray coating.

[0036] In a third aspect, the present application also provides an application method based on the above-mentioned analyte sensor, comprising the following steps: percutaneously inserting the analyte sensor into a target location; and withdrawing the auxiliary needle and leaving the sensing probe at the target location.

[0037] The details of one or more embodiments of the present application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present application will become apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the following briefly introduces the drawings required for use in the embodiments or the conventional technology descriptions. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the disclosed drawings without any creative work.

[0039] FIG1 is a schematic diagram of a partial structure of an analyte sensor in one embodiment of the present application.

[0040] FIG2 is a schematic diagram of a partial structure of an analyte sensor in one embodiment of the present application.

[0041] FIG3 is a schematic diagram of a partial structure of an analyte sensor in one embodiment of the present application.

[0042] FIG. 4 is a schematic diagram of the auxiliary needle of the analyte sensor in FIG. 3 when withdrawing along the x direction in the figure.

[0043] FIG5 is a schematic diagram of a partial structure of an analyte sensor in one embodiment of the present application.

[0044] FIG6 is a schematic diagram of an auxiliary needle of an analyte sensor according to an embodiment of the present application when inserted along the y direction in the figure.

[0045] FIG. 7 is a schematic diagram of an auxiliary needle of an analyte sensor according to an embodiment of the present application when withdrawing along the x direction in the figure.

[0046] FIG8 is a schematic diagram of the needle insertion of the analyte sensor along the y direction in one embodiment of the present application.

[0047] FIG9 is a front view of a sensing probe in one embodiment of the present application.

[0048] FIG10 is a left side view of the sensing probe in one embodiment of the present application.

[0049] FIG11 is a front view of a sensing probe in one embodiment of the present application.

[0050] FIG12 is a cross-sectional view of the sensor of FIG11 along line BB.

[0051] FIG13 is a front view of a sensing probe in one embodiment of the present application.

[0052] FIG14 is a cross-sectional view of the sensor of FIG13 taken along CC.

[0053] FIG15 is a front view of a sensing probe in one embodiment of the present application.

[0054] FIG16 is a cross-sectional view of the sensor of FIG13 along DD.

[0055] Among them, 1. analyte sensor; 10. sensing probe; 11. probe base; 111. electrode area; 112. blank area; 1121. first blank area; 1122. second blank area; 1123. third blank area; 1124. fourth blank area; 1125. fifth blank area; 113. second protrusion; 12. electrode; 121. counter electrode; 122. working electrode; 123. reference electrode; 13. wire; 20. auxiliary needle; 21. needle tip; 22. side wall; 221. first part; 222. second part; 223. first protrusion; 23. bottom wall; 24. receiving groove; 30. drug preparation; 31. drug preparation placed in the target area; A. skin. DETAILED DESCRIPTION

[0056] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0057] In this application, when a component is referred to as being "fixed to" or "disposed on" another component, it may be directly on the other component or there may be a central component. When a component is referred to as being "connected to" another component, it may be directly connected to the other component or there may be a central component. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in the specification of this application are for illustrative purposes only and do not represent the only implementation method.

[0058] In this application, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include at least one of such features. In the description of this application, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0059] In this application, unless otherwise expressly specified or limited, when a first feature is "above" or "below" a second feature, it can mean that the first feature is directly in contact with the second feature, or the first feature and the second feature are indirectly in contact through an intermediary. Furthermore, when a first feature is "above," "above," or "above" a second feature, it can mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is higher in level than the second feature. When a first feature is "below," "below," or "below" a second feature, it can mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is lower in level than the second feature.

[0060] In this application, "skin" refers to the area where the skin contacts the outside world, "subcutaneous" refers to the area within the skin, and "transcutaneous" refers to the area through the skin. "Target site" refers to the area where the sensor probe is implanted and / or the drug formulation takes effect.

[0061] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification are for the purpose of describing specific embodiments only and are not intended to limit the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0062] With reference to FIG1 , the present application discloses an analyte sensor 1 comprising a sensing probe 10, an auxiliary needle 20, and a pharmaceutical agent 30. The auxiliary needle 20 comprises a needle tip 21, a sidewall 22, and a bottom wall 23. The needle tip 21 is connected to the bottom wall 23. The sidewalls 22 and bottom wall 23 are connected to form a receiving groove 24 for accommodating the sensing probe 10. The pharmaceutical agent 30 is disposed on the auxiliary needle 20 and / or the sensing probe 10.

[0063] In the analyte sensor 1 provided in the present application, the provision of an auxiliary needle 20 helps protect the sensing probe 10 and smoothly delivers the sensing probe 10 percutaneously to the target location. At the same time, different drug preparations 30 can be provided on the sensing probe 10 and / or the auxiliary needle 20 as needed, depending on the type, dosage form, and function of the drug preparations 30, thereby delivering different drug preparations 30 to different target locations, thereby specifically exerting anti-inflammatory, anticoagulant, anti-allergic, and anti-fibrotic effects, thereby achieving the purpose of improving the accuracy, stability, and sensitivity of the analyte sensor 1, extending the service life of the analyte sensor 1, and improving the comfort of the user.

[0064] In some embodiments, sidewall 22 includes a first portion 221, which is disposed at one end of sidewall 22 proximal to needle tip 21. The height of first portion 221 relative to bottom wall 23 decreases as it approaches needle tip 21. This configuration facilitates the insertion of auxiliary needle 20 into subcutaneous tissue. In some embodiments of the present application, first portion 221 may be wedge-shaped or have other shapes, as long as first portion 221 facilitates the insertion of auxiliary needle 20 into subcutaneous tissue.

[0065] In some embodiments, the first portion 221 may extend to the needle tip 21. This configuration can better protect the sensing probe 10 and facilitate delivery of the drug preparation to the target site under the skin.

[0066] In some embodiments, the sidewall 22 of the auxiliary needle 20 further includes a second portion 222, which is disposed at an end of the sidewall 22 away from the needle tip 21. In some embodiments, the second portion 222 may be rectangular. In some embodiments of the present application, the second portion 222 may also have other shapes, as long as the second portion 222 facilitates delivery of the drug formulation 30 to the target site and protects the sensing probe 10.

[0067] In some embodiments, as shown in FIG3 , the outer surface of the side wall 22 of the auxiliary needle 20 is further provided with a first protrusion 223. During the withdrawal of the auxiliary needle 20, the first protrusion 223 provided on the outer surface of the side wall 22 of the auxiliary needle 20 helps to assist the skin tissue in retaining the drug preparation 30 subcutaneously.

[0068] In some embodiments, a first protrusion 223 is disposed on the outer surface of each side wall 22 of the auxiliary needle 20 .

[0069] In some embodiments, the first protrusion 223 is disposed between the first portion 221 and the second portion 222. In this case, during the needle withdrawal process, the first protrusion 223 helps to place the drug preparation 30 subcutaneously.

[0070] In some embodiments, the angle of the needle tip 21 of the auxiliary needle 20 is 20°-50°. In some embodiments, the angle of the needle tip 21 of the auxiliary needle 20 is 30°-45°. The thickness of the auxiliary needle 20 is 0.05mm-0.2mm. In some embodiments, the thickness of the auxiliary needle 20 is 0.06mm-0.12mm. In some embodiments, the width of the auxiliary needle 20 is 0.4mm-0.8mm. In some embodiments, the width of the auxiliary needle 20 is 0.45mm-0.65mm. With such a configuration, while ensuring the drug delivery area and stability of the analyte sensor 1, it is convenient for the auxiliary needle 20 to smoothly penetrate the subcutaneous tissue and cause a smaller wound on the skin, thereby helping to reduce the impact of acute inflammatory reactions and bleeding on the analyte sensor 1.

[0071] In some embodiments of the present application, the side wall 22, bottom wall 23 and needle tip 21 of the auxiliary needle 20 can be integrally formed; or, the auxiliary needle 20, bottom wall 23 and needle tip 21 can be separately set and combined together by welding, bonding, etc.

[0072] In some embodiments of the present application, the auxiliary needle 20 is made of stainless steel, titanium, tantalum, magnesium, nickel-titanium alloy, cobalt alloy, ceramics, and the like.

[0073] 9 and 10 , the sensing probe 10 includes a probe substrate 11 , an electrode 12 , and a wire 13 . The probe substrate 11 includes an electrode region 111 and a blank region 112 . The electrode 12 is disposed in the electrode region 111 of the probe substrate 11 .

[0074] In some embodiments, the blank area 112 includes a first blank area 1121, a second blank area 1122, a third blank area 1123, a fourth blank area 1124, and a fifth blank area 1125. The first blank area 1121 is located at the end of the probe base 11 near the needle tip 21 of the auxiliary needle 20; the second blank area 1122 is located on both sides of the electrode area 111 on the probe base 11; the third blank area 1123 is located on both sides of the probe base 11; the fourth blank area 1124 is located at the end of the probe base 11 away from the needle tip 21 of the auxiliary needle 20; and the fifth blank area 1125 is located on the side opposite the probe base 11 where the electrode 12 is provided.

[0075] In some embodiments, the electrodes 12 of the sensing probe 10 include a counter electrode 121 , a reference electrode 123 , and a working electrode 122 .

[0076] In some embodiments, as shown in Figure 7 , the probe base 11 further includes a second protrusion 113, which is located between the probe base 11 and the sidewall 22 of the auxiliary needle 20. In some embodiments, the probe base 11 includes two second protrusions 113, one on each side of the probe base 11. The provision of the second protrusions 113 helps retain the drug formulation 30 at the implantation site of the sensing probe 10 during the withdrawal of the auxiliary needle 20.

[0077] In some embodiments, the sensing probe 10 is positioned within the receiving groove through the engagement and positioning of structural members. In some embodiments, the fifth blank area 1125 does not contact the bottom wall 23 of the auxiliary needle 20. This arrangement of the sensing probe 10 facilitates placement of the drug formulation 30 within the receiving groove and / or within the sensing probe 10, while also facilitating the removal of the auxiliary needle 20.

[0078] In some embodiments, pharmaceutical formulation 30 includes a functional component.

[0079] In some embodiments, the functional component includes at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, a pro-angiogenic component, and an anti-allergic component. In some embodiments, pharmaceutical preparations 30 containing different functional components can be placed at different locations on the analyte sensor 1 according to different needs, thereby more specifically exerting the effects of the functional components.

[0080] In some embodiments, the anti-inflammatory component includes at least one of curcumin, dexamethasone, prednisone, methylprednisone, betamethasone, beclomethasone dipropionate, prednisolone, hydrocortisone, and methylprednisolone.

[0081] In some embodiments, the anticoagulant component includes at least one of: heparin sodium, heparin calcium, enoxaparin sodium, dalteparin sodium, nadroparin calcium, argatroban, bivalirudin, warfarin (warfarin sodium), dabigatran etexilate, rivaroxaban, apixaban, dipyridamole, aspirin, clopidogrel bisulfate, urokinase, and antithrombin.

[0082] In some embodiments, the anti-fibrotic component includes at least one of a macrophage colony-stimulating factor-1 receptor inhibitor, colchicine, interferon, an endothelin receptor antagonist, pirfenidone, nintedanib, anifate, asiaticoside, D-penicillamine, tretinoin, 5-fluorouracil, and the relaxin peptide analog B7-33. The macrophage colony-stimulating factor-1 receptor inhibitor includes at least one of GW2580, BLZ945, PLX3397, ARRY-382, PLX7486, and JNJ-40346527.

[0083] In some embodiments, the pro-angiogenic component includes at least one of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF).

[0084] In some embodiments, the anti-allergic component includes at least one of mometasone furoate, desonide, triamcinolone acetonide, fluticasone propionate, and halometasone.

[0085] In some embodiments, the functional component comprises at least one of dexamethasone, macrophage colony stimulating factor-1 receptor inhibitor, enoxaparin sodium, interferon, VEGF, and mometasone furoate.

[0086] In some embodiments, the drug formulation 30 further comprises at least one of an excipient and a penetration enhancer.

[0087] In some embodiments, the excipients include at least one of collagen, bovine serum albumin, gelatin, chitosan, hyaluronic acid, chondroitin sulfate, sodium alginate, polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, poly(lactic-co-glycolic acid) copolymer (PLGA), triglycerides, dextrin, sodium hydroxymethylcellulose, petrolatum, propylene glycol, glycerol, stearic acid, glyceryl monostearate, lanolin, beeswax, paraffin, liquid paraffin, triethanolamine, Span-80 (the chemical composition is sorbitan fatty acid ester), and emulsifier OP. Emulsifier OP can be emulsifier OP-10 (the chemical composition is alkylphenol polyoxyethylene ether).

[0088] By adding excipients, it is helpful to prepare the drug preparation 30 containing different functional components into dosage forms with different shapes, and then it is helpful to set the drug preparation 30 containing different functional components at different positions of the analyte sensor 1 according to needs, so as to achieve the purpose of delivering the drug preparation 30 containing different functional components to different target positions.

[0089] In some embodiments, the penetration enhancer comprises at least one of lecithin, ethanol, propylene glycol, ethyl acetate, dimethyl sulfoxide, laurocapram, oleic acid, lauryl alcohol, urea, salicylic acid, dimethyl amino acid ester, and limonene. The addition of the penetration enhancer helps to promote skin absorption of the pharmaceutical preparation 30, thereby allowing the functional components in the pharmaceutical preparation 30 to better function.

[0090] In some embodiments, the form of the drug preparation 30 includes at least one of a coating, a gel, an emulsion, a paste, and a microcapsule.

[0091] In some embodiments, as shown in Figure 2, the drug preparation 30 is positioned within the receiving groove of the auxiliary needle 20, near the needle tip 21. Upon withdrawal of the auxiliary needle 20, the drug preparation 30 is deposited subcutaneously with the assistance of the sensing probe 10. In some embodiments, the drug preparation 30 may be in the form of a gel or microcapsule. In some embodiments, the functional components of the drug preparation 30 include at least one of an anti-inflammatory component, an anticoagulant component, and an anti-fibrotic component.

[0092] In some embodiments, as shown in FIG5 , the drug formulation 30 can be disposed on the inner surface of the sidewall 22 of the auxiliary needle 20, the inner surface of the bottom wall 23, and the outer surface of the sidewall 22 of the auxiliary needle 20. In some embodiments, the drug formulation 30 can be one or more of a coating, a gel, an emulsion, or a paste. The functional components of the drug formulation 30 include at least one of an anti-inflammatory component and an anti-allergic component.

[0093] In some embodiments, as shown in Figure 6 , the drug formulation 30 can be disposed on the inner surface of the sidewall 22 of the auxiliary needle 20; and / or, the drug formulation 30 can be disposed on the inner surface of the bottom wall 23 of the auxiliary needle 20. In some embodiments, the drug formulation 30 can be at least one of a coating, a gel, an emulsion, and a paste. The functional components of the drug formulation 30 include at least one of an anti-inflammatory component and an anti-allergic component.

[0094] In some embodiments, as shown in FIG7 , the probe base 11 further includes a second protrusion 113 , and the drug preparation 30 is disposed on the inner surface of the side wall 22 of the auxiliary needle 20 ; and / or, the drug preparation 30 is disposed on the inner surface of the bottom wall 23 of the auxiliary needle 20 . When the auxiliary needle 20 is withdrawn, the drug preparation 30 is deposited subcutaneously with the assistance of the second protrusion 113 on the probe base 11 under the action of skin A . In some embodiments, the drug preparation 30 can be one or more of a coating, a gel, an emulsion, and a paste. The functional components of the drug preparation 30 include: at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrosis component, and a pro-angiogenic component. In some embodiments, there can be two second protrusions 113 .

[0095] In some embodiments, as shown in Figures 5 and 8 , the drug formulation 30 is disposed on the outer surface of the sidewall 22 of the auxiliary needle 20. During insertion of the auxiliary needle 20, the drug formulation 30 is retained on the surface of the skin A (i.e., drug formulation 31 is retained at the target site) due to the action of the skin A. In some embodiments, the drug formulation 30 can be at least one of a coating, a gel, an emulsion, a paste, and a microcapsule. The functional components of the drug formulation 30 include at least one of an anti-allergic component and an anti-inflammatory component.

[0096] In some embodiments, as shown in FIG3 , the sidewall 22 of the auxiliary needle 20 is further provided with a first protrusion 223 , and the drug preparation 30 is provided on the outer wall of the auxiliary needle 20 at a position away from the needle tip 21 of the analyte sensor 1 on the first protrusion 223 . In this case, when the auxiliary needle 20 is inserted, the drug preparation 30 can be smoothly delivered subcutaneously due to the protection of the first protrusion 223 ; when the auxiliary needle 20 is withdrawn, the drug preparation 30 is retained subcutaneously due to the action of the skin A . In this case, when the auxiliary needle 20 is withdrawn, the drug preparation 30 is retained subcutaneously due to the action of the skin A . In some embodiments, the drug preparation 30 can be at least one of a coating, a gel, an emulsion, a paste, and a microcapsule. The functional components of the drug preparation 30 include at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, and a pro-angiogenic component.

[0097] In some embodiments, as shown in Figures 11-16, the drug preparation 30 is disposed on at least one of the surfaces of the working electrode 122, the reference electrode 123, the counter electrode 121, the first blank area 1121, the second blank area 1122, the third blank area 1123, the fourth blank area 1124 and the fifth blank area 1125 of the sensing probe 10.

[0098] In some embodiments, as shown in Figures 15 and 16, the drug agent 30 is disposed on at least one of the surface of the reference electrode 123, the surface of the counter electrode 121, the first blank area 1121, the second blank area 1122, the third blank area 1123, the fourth blank area 1124, and the fifth blank area 1125. Disposing the drug agent 30 on the electrode region 111 of the non-working electrode 122 of the sensing probe 10 does not impair the function of the analyte sensor 1. Furthermore, based on the sustained release of the drug, a controlled local environment can be provided around the sensor, achieving acute inflammation suppression and sustained local anti-inflammation, thereby bypassing FBR and fibrosis, thereby improving the function, lifespan, and comfort of the analyte sensor 1.

[0099] In some embodiments, multiple drug preparations 30 of different forms can be simultaneously placed at different locations on the analyte sensor 1. In some embodiments, the drug preparations 30 are placed on the outer surface of the sidewall 22 of the auxiliary needle 20 and the fifth blank area 1125. This arrangement allows for simultaneous and targeted delivery of different drug preparations 30 to different target sites, thereby enabling simultaneous delivery of drug preparations 30 containing different functional components, allowing the functional components in the drug preparations 30 to function more effectively.

[0100] In some embodiments, the sensor of the sensing probe 10 is selected from at least one of an electrochemical sensor and a biosensor. In some embodiments, the sensor of the sensing probe 10 is an electrochemical sensor, including an amperometric, voltage-type, capacitive, or impedance-type electrochemical sensor.

[0101] The present application also provides a method for preparing the above-mentioned analyte sensor 1, comprising: preparing a drug preparation 30; placing the drug preparation 30 on the auxiliary needle 20 and / or the sensing probe 10; and placing the sensing probe 10 in the receiving groove of the auxiliary needle 20.

[0102] In some embodiments, the drug preparation 30 is disposed on the auxiliary needle 20 by at least one of in-hole spot coating, surface spot coating, dip coating, spin coating, and spray coating. In some embodiments, the drug preparation 30 is disposed on the sensing probe 10 by at least one of in-hole spot coating, surface spot coating, dip coating, spin coating, and spray coating.

[0103] The present application also provides a method for using the analyte sensor 1, comprising: percutaneously inserting the analyte sensor 1 into a target location; and withdrawing the auxiliary needle 20 and leaving the sensing probe 10 in the target location. In some embodiments, the target location is subcutaneous.

[0104] The raw materials in the examples of this application are all commercially available products.

[0105] Preparation of pharmaceutical preparations

[0106] Example 1

[0107] A 0.5 wt% PVP (K-30) solution was prepared, and the functional component was added and dispersed to obtain a functional component solution. The drug content was controlled to be 0.1 wt% of the coating after drying (i.e., the weight ratio of PVP (K-30) to the functional component was 1000:1). The functional component solution was sprayed onto the surface of the sensing probe under conditions of an ultrasonic sprayer with an ultrasonic frequency of 120 kHz, an ultrasonic nozzle power of 1.5 W, a nozzle movement speed of 20 mm / s, and a carrier gas pressure of 6 kPa. The spraying was repeated 10 times, thereby preparing a sensing probe including a functional component coating.

[0108] In some embodiments, the functional component can be at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, and a pro-angiogenic drug component.

[0109] Example 2

[0110] 0.6 g of sodium hydroxymethylcellulose was added to 10.0 g of deionized water and stirred to dissolve, and then 1.5 g of glycerol was added and stirred evenly to obtain a hydrogel matrix. Functional components were added to the hydrogel matrix to obtain a hydrogel-like pharmaceutical preparation 30.

[0111] In some embodiments, the functional component can be at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, a pro-angiogenic component, and an anti-allergic component.

[0112] Example 3

[0113] Melt 1.2g of stearic acid, 0.35g of glyceryl monostearate, 0.6g of liquid paraffin, 0.1g of petrolatum, and 0.5g of lanolin in a water bath. Maintain the temperature at 80°C after complete melting. Then, add 0.04g of triethanolamine and 10.0g of deionized water preheated to 80°C. Stir continuously clockwise until a milky white semisolid solidifies. Stir again at room temperature until nearly condensed to obtain an emulsion base. Functional components are added to the emulsion base to obtain an emulsion pharmaceutical preparation 30.

[0114] In some embodiments, the functional component may be at least one of an anti-inflammatory component and an anti-allergic component.

[0115] Example 4

[0116] Melt 4.0 g of glyceryl monostearate and 4.0 g of paraffin in a water bath. Add 2.0 g of petrolatum, 20.0 g of liquid paraffin, and 0.1 g of Span 80. Once completely melted, maintain the temperature at 80°C. Then, add 0.2 g of OP emulsifier (preheated at 80°C) and 10.0 g of deionized water while stirring clockwise until the mixture solidifies into a milky white semisolid. This provides a paste base. Functional components are then added to the paste base to obtain a paste-like pharmaceutical preparation 30.

[0117] In some embodiments, the functional component may be at least one of an anti-inflammatory component and an anti-allergic component.

[0118] Example 5

[0119] Sodium alginate with a molecular weight of 80k-120k is prepared as a 40g / L solution and sterilized at 121°C for 15 minutes. A 4g / L solution of low molecular weight chitosan (typically <10k, ≥75% deacetylation) is prepared with 90mL of deionized water. This solution is acidified with 0.4mL of glacial acetic acid and then adjusted to a pH of 5.7-6.0 with 1M NaOH solution. After filtration, deionized water is added to adjust the volume to 100mL and sterilized at 121°C for 15 minutes. A functional component dispersion is prepared by dispersing 1wt% of the functional component in the sodium alginate solution. Sterile 0.1M CaCl2 solution is then added dropwise through a 0.11mm needle as a hardening solution. After gelation for 30 minutes, the solution is rinsed with deionized water. The washed gel beads were then added to 100 mL of chitosan solution and vortexed at 100 rpm, and then washed with deionized water to obtain chitosan-coated microcapsules.

[0120] In some embodiments, the functional component is at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, a pro-angiogenic component, and an anti-allergic component.

[0121] Example 6

[0122] Appropriate amounts of functional components and 50 mg of bovine serum albumin (Sigma, SRE0098) were dissolved in 1 mL of deionized water to form the internal aqueous phase. PLGA (poly(lactic-co-glycolic acid)) was dissolved in dichloromethane to prepare a 50 g / L PLGA solution as the oil phase. Polyvinyl alcohol (PVA) was dissolved in deionized water to prepare a 10 g / L aqueous solution as the external aqueous phase. 100 μL of the internal aqueous phase was added to 2 mL of the oil phase and ultrasonicated in an ice bath at 60% amplitude (75 W ultrasonic power) for 30 seconds to form a primary emulsion. This primary emulsion was then added to 20 mL of the external aqueous phase, and the resulting dispersion was immediately spray-dried using a mini spray dryer at a flow rate of 1 mL / min and inlet and outlet temperatures of 25°C / 23°C. The spray-dried microparticles were washed from the cyclone separator of the spray dryer with 0.05% Poloxamer 188 and collected on a cellulose acetate membrane filter, then dried under vacuum at room temperature and finally stored under desiccating conditions at -20°C.

[0123] In some embodiments, the functional component is at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrotic component, a pro-angiogenic component, and an anti-allergic component.

[0124] Setting method of drug preparation

[0125] Application Example 1

[0126] Dexamethasone-loaded polyvinyl alcohol gel was prepared by physically crosslinking polyvinyl alcohol using the freeze-thaw method. First, polyvinyl alcohol (molecular weight: ~10k) was dissolved by stirring at 85°C to obtain a 15wt% polyvinyl alcohol solution. An appropriate amount of dexamethasone was then added to prepare a 0.1wt% dexamethasone solution, and stirring was continued for 2 hours. After sonication for 30 minutes to remove air bubbles, the solution was frozen at -20°C for 1 hour and then thawed at room temperature (~25°C) for 1 hour. Three freeze-thaw cycles were performed to obtain the dexamethasone-loaded polyvinyl alcohol gel.

[0127] As shown in Figure 2, a certain volume of drug-loaded polyvinyl alcohol gel is applied to the distal end of the receiving groove of auxiliary needle 20 of analyte sensor 1. After the sensor probe 10 is implanted and the auxiliary needle 20 is withdrawn, the drug-loaded gel is retained at the distal end of the sensor probe 10 at the implantation site, continuously releasing dexamethasone, which has an anti-inflammatory effect and improves the function and lifespan of the analyte sensor 1.

[0128] Application Example 2

[0129] VEGF-loaded PLGA microspheres were prepared according to the method of Example 5. Hyaluronic acid and polyethylene glycol were dissolved at 8 wt% and 2 wt%, respectively. At a VEGF concentration of 0.2 wt%, the VEGF-loaded PLGA microspheres were thoroughly mixed with the hyaluronic acid / polyethylene glycol hydrogel to produce the drug-loaded hyaluronic acid / polyethylene glycol hydrogel.

[0130] As shown in Figures 3 and 4, a certain volume of drug-loaded hyaluronic acid / polyethylene glycol hydrogel is applied to the first protrusion 223 of the auxiliary needle 20 of the analyte sensor 1, away from the distal end of the auxiliary needle 20. After the sensing probe 10 is implanted and the auxiliary needle 20 is withdrawn, the drug-loaded hyaluronic acid / polyethylene glycol hydrogel is retained at the implantation site by the subcutaneous tissue, continuously releasing VEGF, promoting angiogenesis and improving sensor function and lifespan.

[0131] Application Example 3

[0132] An emulsion base was prepared according to the method of Example 3, and then mometasone furoate (0.2 wt %) was added to obtain mometasone furoate emulsion. The mometasone furoate emulsion was applied to the outer surface of the auxiliary needle 20 .

[0133] As shown in FIG8 , when the sensing probe 10 is implanted, the drug-loaded emulsion will remain on the skin of the implantation site and continuously release mometasone furoate to play an anti-allergic role, thereby improving the comfort of sensor use.

[0134] Application Example 4

[0135] According to the method of Example 5, sodium alginate was used as the wall material to embed interferon to prepare microcapsules. 2wt% chitosan solution and 2wt% acid-soluble collagen solution were prepared using 0.1M and 0.02M acetic acid aqueous solutions as solvents, respectively, and 50wt% sodium glycerol phosphate solution was prepared using deionized water as solvent. The three solutions were then stirred at 4°C for 1 hour, and the chitosan solution and acid-soluble collagen solution were mixed in a 1:1 ratio at 4°C, and then the sodium glycerol phosphate solution was added dropwise to make the final concentration of the sodium glycerol phosphate solution 6wt%, and the synthesized sol was stored at 4°C. At 4°C, the interferon microcapsules and GW2580 were fully mixed with the above sol, and the sensing probe 10 was immersed in the above drug-loaded sol, and then the temperature was raised to 37°C.

[0136] As shown in Figures 11 and 12, a gel coating loaded with interferon and GW2580 is obtained. After the sensor probe 10 is implanted, the drug-loaded gel coating and the sensor probe 10 remain at the implantation site, continuously releasing interferon and GW2580, exerting anti-inflammatory and anti-fibrotic effects, thereby improving the function and lifespan of the analyte sensor 1.

[0137] Application Example 5

[0138] A gelatin aqueous solution (1 wt%) was heated and dissolved at 50°C and stirred thoroughly to dissolve it. Then, curcumin (0.05 wt%) and prednisone (0.15 wt%) were added according to the proportion of the drug in the coating. After thorough mixing, the mixture was spot-coated on the first blank area 1121 and the second blank area 1122 on the surface of the sensing probe 10. After drying, a drug-loaded gelatin coating was obtained.

[0139] As shown in Figures 13 and 14, after the sensing probe 10 is implanted, the gelatin drug-loaded coating continuously releases curcumin and prednisone at the implantation site, playing an anti-inflammatory and anti-fibrotic role, thereby improving the function and life of the analyte sensor 1.

[0140] Application Example 6

[0141] A paste base was prepared according to the method of Example 4, and then desonide (0.3 wt %) was added to obtain a desonide paste. The desonide paste was applied to the outer surface of the side wall 22 of the auxiliary needle 20 .

[0142] Polyethylene glycol (molecular weight: 20k) and N,N-methylenebisacrylamide (cross-linking agent) were dissolved in deionized water. Ammonium persulfate was added under nitrogen to produce a 1wt% aqueous solution of ammonium persulfate. The mixture was stirred at 50°C for 3 hours, and the product was extracted with water. The mixture was then mixed with 0.1wt% dexamethasone and 0.5wt% enoxaparin sodium, respectively, to produce a dexamethasone sol and an enoxaparin sodium sol. The dexamethasone sol was spot-coated on the fourth blank sensing area 1124, and the enoxaparin sodium sol was spray-coated on the fifth blank sensing area 1125. After drying, a dexamethasone gel coating was formed on the probe neck, and an enoxaparin sodium gel coating was formed on the back side of the probe where the dot electrode 12 was located.

[0143] As shown in Figures 6, 15 and 16, during the implantation of the sensing probe 10, the desonide paste will remain on the skin of the implantation site and continuously release desonide. The dexamethasone coating and the enoxaparin sodium coating continuously release dexamethasone and heparin sodium at the implantation site, playing an anti-allergic, anti-inflammatory and anticoagulant role, thereby improving the function and life of the analyte sensor 1.

[0144] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0145] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. An analyte sensor (1), characterized in that It comprises a sensing probe (10), an auxiliary needle (20) and a drug preparation (30), The auxiliary needle (20) comprises a needle tip (21), a side wall (22) and a bottom wall (23), wherein the needle tip (21) is connected to the bottom wall (23), the side wall (22) and the bottom wall (23) are connected to form a receiving groove (24), and the receiving groove (24) is used to receive the sensing probe (10); and The drug preparation (30) is arranged on the auxiliary needle (20) and / or on the sensing probe (10).

2. The analyte sensor (1) according to claim 1, wherein: The side wall (22) comprises a first portion (221), the first portion (221) being arranged at one end of the side wall (22) close to the needle tip (21), and the height of the first portion (221) relative to the bottom wall (23) decreasing in a direction close to the needle tip (21).

3. The analyte sensor (1) according to claim 1 or 2, wherein: A first protrusion (223) is also provided on the outer surface of the side wall (22) of the auxiliary needle (20).

4. The analyte sensor (1) according to any one of claims 1 to 3, wherein: The sensing probe (10) comprises a probe base (11) and an electrode (12); the probe base (11) comprises an electrode region (111) and a blank region (112), and the electrode (12) is arranged on the electrode region (111) of the probe base (11).

5. The analyte sensor (1) according to claim 4, wherein: The blank area (112) includes a first blank area (1121), a second blank area (1122), a third blank area (1123), a fourth blank area (1124) and a fifth blank area (1125), The first blank area (1121) is located at one end of the probe base (11) close to the needle tip (21) of the auxiliary needle (20); the second blank area (1122) is located on both sides of the electrode area (111) on the probe base (11); the third blank area (1123) is located on both sides of the probe base (11); the fourth blank area (1124) is located on one end of the probe base (11) away from the needle tip (21) of the auxiliary needle (20); and the fifth blank area (1125) is located on the opposite side of the probe base (11) where the electrode (12) is arranged.

6. The analyte sensor (1) according to any one of claims 1 to 5, wherein: The sensing probe (10) comprises a probe base (11); the probe base (11) further comprises a second protrusion (113), wherein the second protrusion (113) is located between the probe base (11) and a side wall (22) of the auxiliary needle (20).

7. The analyte sensor (1) according to any one of claims 1 to 6, wherein: The drug preparation (30) includes functional components, and the functional components include at least one of anti-inflammatory components, anticoagulant components, anti-fibrosis components, pro-angiogenesis components, and anti-allergic components.

8. The analyte sensor (1) according to claim 7, wherein: The anti-inflammatory component comprises at least one of curcumin, dexamethasone, prednisone, methylprednisone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone and methylprednisolone; The anticoagulant component comprises at least one of heparin sodium, heparin calcium, enoxaparin sodium, dalteparin sodium, nadroparin calcium, argatroban, bivalirudin, warfarin, dabigatran etexilate, rivaroxaban, apixaban, dipyridamole, aspirin, clopidogrel bisulfate, urokinase, and antithrombin; The anti-fibrosis component includes: at least one of macrophage colony stimulating factor-1 receptor inhibitor, colchicine, interferon, endothelin receptor antagonist, pirfenidone, nintedanib, anifate, asiatica glycoside, D-penicillamine, retinoic acid, 5-fluorouracil, and relaxin peptide analog B7-33; The angiogenesis-promoting component comprises: at least one of vascular endothelial growth factor and platelet-derived growth factor; and The anti-allergic component comprises at least one of mometasone furoate, desonide, triamcinolone acetonide, fluticasone propionate and halometasone.

9. The analyte sensor (1) according to claim 8, wherein: The pharmaceutical preparation (30) further comprises at least one of an excipient and a penetration enhancer.

10. The analyte sensor (1) according to claim 9, wherein: The excipients include at least one of collagen, bovine serum albumin, gelatin, chitosan, hyaluronic acid, chondroitin sulfate, sodium alginate, polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, polylactic acid-glycolic acid copolymer, triglyceride, dextrin, sodium hydroxymethyl cellulose, vaseline, propylene glycol, glycerol, stearic acid, glyceryl monostearate, lanolin, beeswax, paraffin, liquid paraffin, triethanolamine, Span 80, and emulsifier OP-10; and / or, The penetration enhancer includes at least one of lecithin, ethanol, propylene glycol, ethyl acetate, dimethyl sulfoxide, laurocapron, oleic acid, lauryl alcohol, urea, salicylic acid, dimethyl amino acid ester and limonene.

11. The analyte sensor (1) according to any one of claims 1 to 10, wherein: The form of the drug preparation (30) includes at least one of a coating, a gel, an emulsion, a paste, and a microcapsule.

12. The analyte sensor (1) according to any one of claims 1 to 11, wherein: The drug preparation (30) is arranged in the receiving groove (24) of the auxiliary needle (20) at one end close to the needle tip (21).

13. The analyte sensor (1) according to claim 12, wherein: The drug preparation (30) comprises a functional component, wherein the functional component comprises at least one of an anti-inflammatory component, an anticoagulant component, and an anti-fibrotic component.

14. The analyte sensor (1) according to any one of claims 1 to 11, wherein: The drug preparation (30) is disposed on the inner surface of the side wall (22) of the auxiliary needle (20); and / or the drug preparation (30) is disposed on the inner surface of the bottom wall (23) of the auxiliary needle (20).

15. The analyte sensor (1) according to claim 14, wherein the drug preparation (30) comprises a functional component, wherein the functional component comprises at least one of an anti-inflammatory component and an anti-allergic component.

16. The analyte sensor (1) according to any one of claims 1 to 11, wherein: The drug preparation (30) is arranged on the outer surface of the side wall (22) of the auxiliary needle (20).

17. The analyte sensor (1) according to claim 16, wherein the drug preparation (30) comprises a functional component, wherein the functional component comprises at least one of an anti-inflammatory component and an anti-allergic component.

18. The analyte sensor (1) according to claim 3, wherein: The drug preparation (30) is arranged at a position of the first protrusion (223) away from the needle tip (21).

19. The analyte sensor (1) according to claim 18, wherein: The drug preparation (30) comprises functional components, and the functional components include at least one of an anti-inflammatory component, an anticoagulant component, an anti-fibrosis component, and a pro-angiogenesis component.

20. The analyte sensor (1) according to claim 5, wherein: The electrode (12) includes a working electrode (122), a reference electrode (123) and a counter electrode (121), and the drug preparation (30) is arranged on at least one of the surface of the working electrode (122), the surface of the reference electrode (123), the surface of the counter electrode (121), the first blank area (1121), the second blank area (1122), the third blank area (1123), the fourth blank area (1124) and the fifth blank area (1125).

21. The analyte sensor (1) according to claim 16, wherein: The drug preparation (30) is arranged on at least one of the surface of the reference electrode (123), the surface of the counter electrode (121), the first blank area (1121), the second blank area (1122), the third blank area (1123), the fourth blank area (1124) and the fifth blank area (1125).

22. The analyte sensor (1) according to claim 5, wherein: The drug preparation (30) is arranged on the outer surface of the side wall (22) of the auxiliary needle (20) and the fifth blank area (1125).

23. The analyte sensor (1) according to claim 22, wherein: The pharmaceutical preparation (30) includes a functional component, wherein the functional component includes at least one of an anti-inflammatory component and an anticoagulant component.

24. A method for preparing an analyte sensor (1) according to any one of claims 1 to 23, characterized in that: The following steps are involved: preparing the pharmaceutical preparation (30); The drug preparation (30) is arranged on the auxiliary needle (20) and / or the sensing probe (10); and, The sensing probe (10) is arranged in the receiving groove (24) of the auxiliary needle (20), Wherein, the drug preparation (30) is disposed on the auxiliary needle (20) by at least one of in-hole spot coating, surface spot coating, dip coating, spin coating, and spray coating; and / or, The drug preparation (30) is disposed on the sensing probe (10) by using at least one of the following methods: in-hole spot coating, surface spot coating, dip coating, spin coating, and spray coating.

25. A method for using the analyte sensor (1) according to any one of claims 1 to 23 or the analyte sensor (1) prepared by the preparation method according to claim 24, characterized in that: The following steps are involved: inserting the analyte sensor (1) percutaneously into a target location; and, The auxiliary needle (20) is withdrawn, and the sensing probe (10) is left at the target location.

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