JP2019118690A - Sensor manufacturing method - Google Patents

Abstract

To provide a sensor manufacturing method with which the risk of sensor electrodes coming into contact with a needle member can be reduced in a simplified manner.SOLUTION: A sensor manufacturing method according to the present invention includes: an insertion step of inserting a linear elongate member into a hollow portion defined within a tubular needle member from a proximal end side of the needle member; a protruding step of protruding the elongate member from the distal end of the needle member; a coating step of forming a coating layer on a surface of the protruded portion of the elongate member to process the elongate member into a linear sensor electrode; and an accommodating step of moving the sensor electrode to the proximal end side of the needle member to accommodate the distal end of the sensor electrode into the hollow portion.SELECTED DRAWING: Figure 4

Description

  The present disclosure relates to a method of manufacturing a sensor.

  Conventionally, a sensor is inserted or embedded in the body of a subject such as a patient, and a substance to be measured (for example, glucose, pH, physiologically active substance, protein, etc.) in body fluid such as blood or interstitial fluid of the subject Detection is performed by the sensor. Specifically, the sensor electrode is disposed in the hollow portion partitioned into the needle member, and the substance to be measured in the body fluid introduced into the hollow portion is detected by the sensor electrode in a state where the needle member is punctured by the body surface. Sensors are known.

  In the above-described conventional sensor, when the sensor electrode contacts the inner peripheral wall of the needle member or the like when the sensor electrode is disposed in the hollow portion of the needle member, the sensor electrode may be damaged and the measurement accuracy may be reduced. there were. For example, Patent Document 1 describes a sensor in which sensor electrodes are fixed in advance to a holding member provided with a holding section for holding sensor electrodes, and these are arranged on a needle member.

U.S. Patent Application Publication No. 2009/0178923

  In the sensor described in Patent Document 1, the risk of the sensor electrode coming into contact with the inner peripheral wall of the needle member can be reduced, but it has been necessary to fix the sensor electrode to the holding member in advance.

  In view of the above problems, an object of the present disclosure is to provide a method of manufacturing a sensor capable of reducing the risk of the sensor electrode coming in contact with the needle member by a simple method.

  A method of manufacturing a sensor according to a first aspect of the present invention includes an inserting step of inserting a linear long member into the hollow portion from a proximal end side of a tubular needle member partitioning the hollow portion; A projecting step of causing the member to project from the tip end of the needle member, a coating step of forming a coating layer on the surface of the projecting portion of the elongated member and processing the elongated member into a linear sensor electrode; And moving the sensor electrode to the proximal end side of the needle member to store the tip of the sensor electrode in the hollow portion.

  In the method of manufacturing a sensor according to one embodiment of the present invention, in the inserting step, each of the plurality of elongated members is inserted into the hollow portion from the proximal end side of the needle member, and in the projecting step, the plurality of elongated members The long members are projected so that the lengths of protruding from the tip of the needle member are different from each other, and in the covering step and the housing step, the surface of the most projecting long member of the plurality of long members A coating layer is formed on the substrate to be processed into a sensor electrode, and the tip of the sensor electrode is housed in the hollow portion, which is sequentially repeated to house the tip of each of the plurality of sensor electrodes in the hollow portion.

  In a method of manufacturing a sensor according to an embodiment of the present invention, the total lengths of the plurality of elongated members are different from each other, and after the storing step, the plurality of sensor electrodes have different lengths according to the total lengths. The method further includes a connecting step of connecting the proximal end of each of the plurality of sensor electrodes to a connection member that protrudes from the proximal end of the needle member and has a connection portion corresponding to each of the plurality of sensor electrodes.

  In the method of manufacturing a sensor according to one embodiment of the present invention, in the covering step, a support member for supporting the plurality of elongated members is fixed to the needle member.

  In the method of manufacturing a sensor according to one embodiment of the present invention, in the connection step, the support member is fitted to the connection member.

  In the method of manufacturing a sensor according to one embodiment of the present invention, in the covering step, the covering layer is formed by immersing the projection of the elongated member in a covering liquid.

  According to the method of manufacturing a sensor of the present disclosure, the risk of the sensor electrode contacting the needle member can be reduced by a simple method.

It is a schematic diagram showing a sensor manufactured using a manufacturing method of a sensor as one embodiment of the present invention, and a communication device. It is sectional drawing in alignment with the orthogonal direction orthogonal to the extension direction of the linear sensor electrode with which the sensor shown in FIG. 1 is provided. It is a perspective view which shows the needle member and hub with which the sensor shown in FIG. 1 is provided. It is a flowchart which shows each process of the manufacturing method of the sensor shown in FIG. It is a figure which shows typically the insertion process of the manufacturing method of the sensor shown in FIG. It is a figure which shows typically the protrusion process of the manufacturing method of the sensor shown in FIG. It is a longitudinal cross-sectional view which shows the needle member to which the valve body which supports several elongate members was fixed. It is a figure which shows typically the coating process of the manufacturing method of the sensor shown in FIG. It is a figure (the 1) which shows typically the covering process and accommodation process of the manufacturing method of the sensor shown in FIG. It is a figure (the 2) which shows typically the covering process and accommodation process of the manufacturing method of the sensor shown in FIG. It is a figure (1) which shows typically the connection process of the manufacturing method of the sensor shown in FIG. It is a figure (the 2) which shows typically the connection process of the manufacturing method of the sensor shown in FIG. It is a figure (the 3) which shows typically the connection process of the manufacturing method of the sensor shown in FIG. It is a figure which shows typically after the protrusion process of the modification of the manufacturing method of the sensor shown in FIG. 4, and before a coating process. It is a figure (1) which shows typically the connection process of the modification of the manufacturing method of the sensor shown in FIG. It is a figure (the 2) which shows typically the connection process of the modification of the manufacturing method of the sensor shown in FIG. It is a figure (the 3) which shows typically the connection process of the modification of the manufacturing method of the sensor shown in FIG.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. The same reference numeral is given to a common member in each drawing.

[Configuration of sensor 1]
First, an example of a sensor manufactured using a method of manufacturing a sensor according to an embodiment of the present invention will be described. FIG. 1 is a schematic view showing a sensor 1 as an example of a sensor manufactured using a method of manufacturing a sensor according to an embodiment of the present invention, and a communication device 100 used with the sensor 1.

  As shown in FIG. 1, the sensor 1 includes a needle member 10, a hub 70, a working electrode 20 as a sensor electrode, a reference electrode 30 and a counter electrode 40, and a base plate 50.

  The needle member 10 is a tubular hollow needle that defines the hollow portion 11. The needle member 10 extends in the axial direction A, and is disposed such that its tip projects from the lower surface 56 of the base plate 50. As a material of the needle member 10, metal materials, such as stainless steel, aluminum, an aluminum alloy, titanium, a titanium alloy, can be used, for example. The needle member 10 of the present embodiment has an outer diameter of about 0.25 mm to about 0.40 mm (27 gauge to 31 gauge), and a protruding length of the base plate 50 from the lower surface 56 of about 4 to 7 mm.

  The hub 70 is fixed to the proximal end of the needle member 10. The hub 70 is a tubular member defining a hollow portion 71 communicating with the hollow portion 11 of the needle member 10. The outer diameter along the direction orthogonal to the axial direction A of the hub 70 is larger than the outer diameter of the needle member 10. The hub 70 fixes the needle member 10 to the base plate 50 in a state of being fitted to a hub fitting portion 52 of the base plate 50 described later.

  Each of the working electrode 20, the reference electrode 30, and the counter electrode 40 as a sensor electrode is a linear member, and is in the through hole 53 of the base plate 50, the hollow portion 71 of the hub 70, and the hollow portion 11 of the needle member 10 described later. Inside, it extends along the axial direction A of the needle member 10, and its tip is located in the hollow portion 11 of the needle member 10. The base end of the working electrode 20 is connected to a first connection portion 51 a located on the upper surface 57 of the base plate 50 described later. The base end of the reference electrode 30 is connected to a second connection portion 51 b located on the upper surface 57 of the base plate 50 described later. The base end of the counter electrode 40 is connected to a third connection portion 51 c located on the upper surface 57 of the base plate 50 described later. The working electrode 20, the reference electrode 30, and the counter electrode 40 cooperate with each other to detect an electrical signal corresponding to the amount or concentration of the substance to be measured. The diameter of each of the working electrode 20, the reference electrode 30, and the counter electrode 40 in the present embodiment is about 0.1 mm.

  FIG. 2 is a cross-sectional view taken along a direction (hereinafter, referred to as “orthogonal direction”) orthogonal to the extending direction of the sensor electrodes included in the sensor 1. Specifically, FIG. 2 (a) is a cross-sectional view along the orthogonal direction of the working electrode 20 as the sensor electrode, FIG. 2 (b) is a cross-sectional view along the orthogonal direction of the reference electrode 30 as the sensor electrode, FIG. (C) shows a cross-sectional view along the orthogonal direction of the counter electrode 40 as a sensor electrode. As shown in FIG. 2A, the working electrode 20 includes a core 21, a conductive layer 22, a reagent layer 23, and a protective layer 24.

  The core material 21 is a linear member, and it is preferable that the linear shape be easily maintained. Specifically, the core material 21 is not deformed or deformed even by the viscosity of the coating liquid 29 (see FIG. 8 etc.) in the coating step S3 (see FIG. 4) in the method of manufacturing the sensor 1 described later. It is preferable to have elasticity to return to the original linear shape. By using the linear member as the core material 21, the covering layer 27 (see FIG. 8 and the like) can be formed to have a more uniform thickness. As a material of core material 21, super elastic wire, such as nickel titanium and titanium alloy, is preferred, for example. The diameter of the core 21 of the present embodiment is about 80 μm.

  As shown to Fig.2 (a), the conductive layer 22 is formed in a tubular form so that the outer peripheral surface of the core material 21 may be covered. Specifically, the conductive layer 22 is formed over the entire area along the extending direction of the core material 21 and the entire area in the circumferential direction of the core material 21. Examples of the material of the conductive layer 22 include materials such as highly conductive metals, such as gold, silver, and platinum. The thickness along the orthogonal direction of the conductive layer 22 of the present embodiment is about 1 μm.

  As shown in FIG. 2A, the reagent layer 23 is formed in a tubular shape so as to cover the outer peripheral surface of the conductive layer 22. Specifically, the reagent layer 23 is formed in the entire circumferential direction of the conductive layer 22 at least near the tip where the working electrode 20 is located in the hollow portion 11 of the needle member 10. The reagent layer 23 chemically reacts with the substance to be measured to change the current value between the working electrode 20 and the reference electrode 30 and / or the counter electrode 40. The reagent layer 23 contains a reagent such as an enzyme that reacts with the substance to be measured.

  As shown in FIG. 2A, the protective layer 24 is formed in a tubular shape so as to cover the outer peripheral surface of the reagent layer 23. Specifically, the protective layer 24 is formed at least in the vicinity of the tip where the working electrode 20 is located in the hollow portion 11 of the needle member 10 and in the entire circumferential direction of the reagent layer 23. The protective layer 24 is preferably made of a selectively permeable material which transmits the substance to be measured and does not transmit other substances, and preferably covers the outer peripheral surface of the reagent layer 23 without any gap. Examples of materials having such selective permeability include polyethylene oxide, polyvinyl pyrrolidone, acrylamide, silicone, cellulose acetate, perfluorocarbon (Nafion (registered trademark)), methacrylate polymer (pHEMA and the like), primary amine polymer, Polydimethylsiloxane (PDMS), polyurethane, polyurethane urea, polyurea cellulose acetate, polyester sulfonic acid, other water-soluble gel, hydrophilic membrane and the like can be used in arbitrary combination. Alternatively, the protective layer 24 may be made of a material having an arbitrary insulating property, have a region that does not cover the outer peripheral surface of the reagent layer 23, and expose a part of the reagent layer 23 to the outside. In a region where the protective layer 24 does not cover the outer peripheral surface of the reagent layer 23, for example, after the protective layer 24 is processed to cover the outer peripheral surface of the reagent layer 23 without gaps, a part of the protective layer 24 is removed Can be formed by

  As shown in FIG. 2 (b), the reference electrode 30 includes a core 31, a conductive layer 32, and a protective layer 34. The configuration of the core 31 is the same as that of the core 21 of the working electrode 20 described above, and thus the description thereof is omitted here. Moreover, since the structure of the conductive layer 32 is the same as that of the conductive layer 22 of the working electrode 20 mentioned above, description is abbreviate | omitted here.

  The protective layer 34 is formed in a tubular shape so as to cover the outer peripheral surface of the conductive layer 32. Specifically, the protective layer 34 is formed in the entire circumferential direction of the conductive layer 32 at least near the tip where the reference electrode 30 is located in the hollow portion 11 of the needle member 10. The other configuration of the protective layer 34 is the same as that of the protective layer 24 of the working electrode 20 described above, and thus the description thereof is omitted here.

  As shown in FIG. 2C, the counter electrode 40 includes a core material 41, a conductive layer 42, and a protective layer 44. The configurations of the core 41, the conductive layer 42, and the protective layer 44 of the counter electrode 40 are the same as those of the core 31, the conductive layer 32, and the protective layer 34 of the reference electrode 30 described above, respectively.

  The core 21 of the working electrode 20, the core 31 of the reference electrode 30, and the core 41 of the counter electrode 40 are preferably made of the same material. The conductive layer 22 of the working electrode 20, the conductive layer 32 of the reference electrode 30, and the conductive layer 42 of the counter electrode 40 may be made of the same material or different materials.

  As shown in FIG. 1, the base plate 50 internally divides the hub fitting portion 52 communicating with the upper surface 57 and the through hole 53 communicating with the hub fitting portion 52 and the lower surface 56. The base plate 50 has, on the upper surface 57, a first connection portion 51a for connecting the working electrode 20, a second connection portion 51b for connecting the reference electrode 30, and a third connection portion 51c for connecting the counter electrode 40. And a connecting member. The base plate 50 connects the working electrode 20, the reference electrode 30, and the counter electrode 40 to the communication device 100 through the first connection portion 51a, the second connection portion 51b, and the third connection portion 51c. The dimensions of the base plate 50 of the present embodiment are about 3 cm in outer diameter in plan view and less than 1 cm in thickness.

  The lower surface 56 of the base plate 50 is coated with an adhesive that produces an adhesive force to the extent that the base plate 50 can be attached to the body surface of the subject. Specifically, the adhesion of the lower surface 56 to the body surface is such that the sensor 1 does not come off the body surface of the subject during a period (for example, several days to several weeks) in which the subject uses the sensor 1 It is preferably strong and stronger than ordinary wound bandages and the like. The adhesion to the body surface at the lower surface 56 gives pain to the subject when peeling off the sensor 1 from the body surface while maintaining constant adhesion to the body surface over the period in which the subject uses the sensor 1 It is preferable that the degree is low.

  As a pressure-sensitive adhesive applied to the lower surface 56, for example, a silicone-based pressure-sensitive adhesive, an acrylic pressure-sensitive adhesive, or a rubber-based (natural rubber, synthetic rubber or the like) pressure-sensitive adhesive can be used. However, the pressure sensitive adhesive is not limited to those listed here. The lower surface 56 is covered with release paper or the like in a state before using the sensor 1 and is peeled off in use.

  The communication device 100 can be connected to the sensor 1. The communication device 100 includes a circuit unit 101, and three connection units 102a, 102b, and 102c electrically connected to the circuit unit 101. Depending on the number of electrodes of the sensor 1 and the measurement method, the number of connections may be two or more than three. The circuit unit 101 includes a processor, a communication device, a memory, and the like. When the communication device 100 is connected to the sensor 1, the connection portion 102 a contacts the first connection portion 51 a of the sensor 1 and is electrically connected to the first connection portion 51 a. The connection unit 102b is in contact with the second connection unit 51b of the sensor 1 in a state where the communication device 100 is connected to the sensor 1, and is electrically connected to the second connection unit 51b. The connection unit 102c is in contact with the third connection unit 51c of the sensor 1 when the communication device 100 is connected to the sensor 1, and is electrically connected to the third connection unit 51c.

  FIG. 3 is a perspective view showing the needle member 10 and the hub 70 included in the sensor 1. A blade surface 15 is formed at the tip of the needle member 10. The blade surface 15 defines the tip opening 12. The needle member 10 can pierce the body from the body surface such as the skin of the subject through the blade surface 15. In the peripheral wall 13 of the needle member 10, a plurality of through holes 14 for introducing the body fluid of the subject into the hollow portion 11 are defined. The hollow portion 11 communicates with the outside of the needle member 10 through the through hole 14 and the tip opening 12.

  As shown in FIG. 1, when the needle member 10 is punctured into the body surface of the subject using the sensor 1 and the communication device 100 connected to each other, the working electrode 20 as a sensor electrode, the reference electrode 30, and the counter electrode 40. Detects an electrical signal corresponding to the amount or concentration of the substance to be measured contained in the body fluid of the subject introduced into the hollow portion 11. The detected electrical signal is transmitted to the communication device 100 through the first connection portion 51 a to the third connection portion 51 c of the base plate 50. The communication apparatus 100 can generate a communication signal according to the received electrical signal, and can transmit the signal to an external display device or the like.

[Method of Manufacturing Sensor 1]
Next, a method of manufacturing the sensor 1 will be described. FIG. 4 is a flowchart showing each step of the method of manufacturing the sensor 1. As shown in FIG. 4, the method of manufacturing the sensor 1 includes an insertion step S1, a protrusion step S2, a covering step S3, a storage step S4, and a connection step S5.

  FIG. 5 is a view schematically showing the insertion step S1 of the method of manufacturing the sensor 1. As shown in FIG. As shown in FIG. 5, in the insertion step S1, each of the plurality of linear elongated members, ie, each of the first elongated member 25, the second elongated member 35, and the third elongated member 45, is in the axial direction. Along the A, the hollow portion 11 is inserted from the proximal end side of the needle member 10 to which the hub 70 is connected.

  The first elongated member 25 is a member of the working electrode 20 of the sensor 1 in which the reagent layer 23 and the protective layer 24 are not formed. That is, the first long member 25 includes the core 21 and the conductive layer 22, and the conductive layer 22 covers the entire outer peripheral surface of the core 21 along the extending direction of the core 21, and the core 21. Is a member that covers the entire area in the circumferential direction. The second elongated member 35 is a member of the reference electrode 30 of the sensor 1 where the protective layer 34 is not formed. That is, the second long member 35 includes the core 31 and the conductive layer 32, and the conductive layer 32 covers the entire outer peripheral surface of the core 31 along the extending direction of the core 31, and the core 31 Is a member that covers the entire area in the circumferential direction. The third elongated member 45 is a member of the counter electrode 40 of the sensor 1 where the protective layer 44 is not formed. That is, the third long member 45 includes the core material 41 and the conductive layer 42, and the conductive layer 42 covers the entire outer peripheral surface of the core material 41 along the extending direction of the core material 41, and the core material 41 Is a member that covers the entire area in the circumferential direction.

  The first elongated member 25, the second elongated member 35, and the third elongated member 45 have different overall lengths. Specifically, the total length of the first long member 25 is longer than that of the second long member 35, and the total length of the second long member 35 is longer than that of the third long member 45. The total length of the first elongated member 25 is, for example, about 5 cm. The total length of the second elongated member 35 is, for example, about 4 cm. The total length of the third elongated member 45 is, for example, about 3 cm. In this case, the total length difference L1 between the first elongated member 25 and the second elongated member 35 is about 1 cm. The total length difference L1 corresponds to 10 to 35% of the total length of the second long member 35. Moreover, the full length difference L2 of the 2nd elongate member 35 and the 3rd elongate member 45 is about 1 cm. The total length difference L2 corresponds to 15 to 50% of the total length of the third long member 45.

  As shown in FIG. 5, before the insertion step S1, each of the plurality of elongated members, ie, the first elongated member 25, the second elongated member 35, and the third elongated member 45, has different lengths on the distal end side. The relative positional relationship between the respective elongated members may be fixed by using the valve body 60 as a support member for supporting the respective elongated members in a state of being protruded at a short distance. In the present embodiment, with the positions of the proximal ends of the first elongated member 25, the second elongated member 35, and the third elongated member 45 aligned, the relative position of the elongated members is determined by the valve body 60. Fixed positional relationship. Thereby, each elongate member maintains the state protruded to the front end side by different length according to each full length. That is, the first long member 25 protrudes by the full length difference L 1 more than the second long member 35, and the second long member 35 protrudes by the full length difference L 2 more than the third long member 45. Maintain the state. Although details will be described later, the valve body 60 is formed with three slits 61a, 61b and 61c (see FIG. 7), and each long member is passed through each slit one by one to make each long The relative positional relationship of the members can be maintained.

  FIG. 6 is a view schematically showing the projecting step S2 of the method of manufacturing the sensor 1. As shown in FIG. As shown in FIG. 6, in the projecting step S2, a plurality of elongated members, that is, the first elongated member 25, the second elongated member 35, and the third elongated member 45 are protruded from the tip of the needle member 10. The lengths are projected to be different from one another. In the present embodiment, as described above, with the positions of the base ends of the first elongated member 25, the second elongated member 35, and the third elongated member 45 aligned, the valve body 60 By fixing the relative positional relationship of the length members, a state in which it protrudes from the tip end of the needle member 10 is maintained with a length that differs according to the total length of each of the long members. That is, the first long member 25 protrudes by the full length difference L 1 more than the second long member 35, and the second long member 35 protrudes by the full length difference L 2 more than the third long member 45. It is maintaining the state.

  As shown in FIG. 6, in the projecting step S2, a valve body as a supporting member for supporting a plurality of elongated members, that is, the first elongated member 25, the second elongated member 35, and the third elongated member 45. 60 may be fixed relative to the needle member 10. FIG. 7 is a longitudinal sectional view showing the needle member 10 to which the valve body 60 supporting the first elongated member 25, the second elongated member 35, and the third elongated member 45 is fixed. As shown in FIG. 7, the valve body 60 is formed with three slits 61 a, 61 b and 61 c. Each of the first elongated member 25, the second elongated member 35, and the third elongated member 45 passes through any one of the three slits 61a, 61b, and 61c. As a result, the first elongated member 25, the second elongated member 35, and the third elongated member 45 are pressed inward in the orthogonal directions by the restoring force of the valve body 60 and supported by the valve body 60. Further, as shown in FIG. 7, when the valve body 60 is moved from the base end side to the tip end side of the needle member 10 in the axial direction A, the peripheral wall 72 and the bottom wall 73 are formed in the hollow portion 71 of the hub 70. And is fixed to the hub 70. Since the hub 70 is fixed to the needle member 10, the valve body 60 is fixed to the needle member 10. Thus, by fixing the valve body 60 supporting the first elongated member 25, the second elongated member 35, and the third elongated member 45 to the needle member 10, the first elongated member 25, the second elongated member Protruding lengths from the tip of the needle member 10 of the long member 35 and the third long member 45 can be fixed.

  Although the example which fixes the valve body 60 to the needle member 10 simultaneously with protrusion process S2 was shown in FIG. 6, the valve body 60 is used for the needle member 10 at any time just before covering process S3 from insertion process S1. It may be fixed. For example, when fixing the valve body 60 to the needle member 10 before the insertion step S1, in the insertion step S1, each of the first long member 25, the second long member 35, and the third long member 45 is a needle It is inserted into the hollow portion 11 by passing through any one of the three slits 61 a to 61 c of the valve body 60 fixed to the member 10 one by one.

  FIG. 8 is a view schematically showing the covering step S3 of the method of manufacturing the sensor 1. As shown in FIG. FIG. 9 is a diagram (part 1) schematically showing the covering step S3 and the storing step S4 of the method of manufacturing the sensor 1. FIG. 10 is a diagram (part 2) schematically showing the covering step S3 and the storing step S4 of the method of manufacturing the sensor 1.

  First, as shown in FIG. 8, the projecting portion of the first elongated member 25 which is the most projecting elongated member of the first elongated member 25, the second elongated member 35, and the third elongated member 45. The coating layer 27 is formed on the surface of the protrusion 26 by immersing the coating 26 in the coating solution 29, and the coating layer 27 is processed into the working electrode 20. Here, the coating liquid 29 is a coating liquid for the first long member 25. In detail, the coating solution 29 is of two types, and the projections 26 are sequentially dipped in the respective coating solutions 29 to form a coating layer 27 composed of two layers. By immersing the protrusion 26 in the first type of coating solution 29, the reagent layer 23 as the first layer of the coating layer 27 is formed. Next, the protrusion 26 is immersed in the second type of coating liquid 29 to form the protective layer 24 as the second layer of the coating layer 27. At this stage, the elongated members other than the first elongated member 25, that is, the second elongated member 35 and the third elongated member 45 are not immersed in the coating liquid 29. Therefore, the region in which the covering layer 27 can be formed is a partial region of the protrusion 36 in which the first elongated member 25 protrudes more than the second elongated member 35, and in the present embodiment, the first length It is in the range from the tip of the scale member 25 to the position on the base end side by the total length difference L1.

  As shown in FIG. 9, in the housing step S 4, the working electrode 20 as a processed sensor electrode is moved to the proximal end side of the needle member 10, and the tip of the working electrode 20 is housed in the hollow portion 11. At this time, the region of the working electrode 20 where the reagent layer 23 as the covering layer 27 and the protective layer 24 are formed is located in the hollow portion 11.

  Further, as shown in FIG. 9, after the tip of the working electrode 20 formed by processing the first elongated member 25 is accommodated in the hollow portion 11, the second elongated member 35 and the third elongated member 45 are formed. The coating layer 37 is formed on the surface of the projecting portion 36 by immersing the projecting portion 36 of the second long member 35 which is the longest projecting member among them into the coating liquid 39, and is processed into the reference electrode 30. Do (coating step S3). Here, the coating solution 39 is a coating solution for the second long member 35. In detail, the protective layer 34 as the covering layer 37 is formed by immersing the protrusion 36 in the covering liquid 39. At this stage, the long members other than the second long member 35, that is, the first long member 25 and the third long member 45 are not immersed in the coating liquid 39. Therefore, the region where the covering layer 37 can be formed is a partial region of the protrusion 36 where the second elongated member 35 protrudes more than the third elongated member 45, and in the present embodiment, the second length It is within the range from the tip of the scale member 35 to the position on the proximal side by the total length difference L2.

  As shown in FIG. 10, the processed reference electrode 30 as a sensor electrode is moved to the proximal end side of the needle member 10, and the tip of the reference electrode 30 is accommodated in the hollow portion 11 (accommodating step S4). At this time, the region of the reference electrode 30 in which the protective layer 34 as the covering layer 37 is formed is located in the hollow portion 11.

  Further, as shown in FIG. 10, after the tip of the reference electrode 30 formed by processing the second elongated member 35 is accommodated in the hollow portion 11, a third elongated member which is one remaining elongated member. A coating layer 47 is formed on the surface of the projecting portion 46 by immersing the 45 projecting portions 46 in the coating liquid 49, and processed into the counter electrode 40 (coating step S3). Here, the coating solution 49 is a coating solution for the third long member 45. In detail, the protective layer 44 as the covering layer 47 is formed by immersing the protrusion 46 in the covering liquid 49. At this stage, the elongated members other than the third elongated member 45, that is, the first elongated member 25 and the second elongated member 35 are not immersed in the coating liquid 49. The area in which the covering layer 47 can be formed is the entire protrusion 46 of the third elongated member 45. Thereafter, the counter electrode 40 as a processed sensor electrode is moved to the proximal end side of the needle member 10, and the tip of the counter electrode 40 is accommodated in the hollow portion 11 (accommodating step S4). At this time, the region of the counter electrode 40 in which the protective layer 44 as the covering layer 47 is formed is located in the hollow portion 11.

  As described above, in the covering step S3 and the housing step S4, the covering layer is formed on the surface of the most projecting long member of the plurality of long members and processed into a sensor electrode, and the tip of the sensor electrode is hollow The tip end of each of the plurality of sensor electrodes is accommodated in the hollow portion 11 by sequentially repeating the operation of being accommodated in the portion 11. In addition, as a formation method of a coating layer, not only an immersion method but a spray coating method is employable. At this time, in a state in which the long member protrudes from the tip end of the needle member 10 by the covering length, a coating layer is formed on the protruding portion by a spray coating method and processed into a sensor electrode. Thereafter, the sensor electrode is moved to the proximal end side of the needle member 10, and the tip of the sensor electrode is accommodated in the hollow portion 11 in the needle member 10.

  FIG. 11 is a diagram (part 1) schematically showing the connection step S5 of the method of manufacturing the sensor 1. FIG. 12 is a diagram (part 2) schematically showing the connection step S5 of the method of manufacturing the sensor 1. FIG. 13 is a diagram (part 3) schematically showing the connection step S5 of the method of manufacturing the sensor 1.

  As shown in FIG. 11, after the accommodation step S4, the working electrode 20, the reference electrode 30, and the counter electrode 40 as a plurality of sensor electrodes are positioned at the proximal end of the needle member 10 with different lengths according to their total lengths. Project from the hub 70. In the present embodiment, by aligning the positions of the tips of the working electrode 20, the reference electrode 30, and the counter electrode 40, they project with different lengths according to their total lengths. That is, the first long member 25 protrudes by the full length difference L1 more than the second long member 35, and the second long member 35 protrudes by the full length difference L2 more than the third long member 45. At this time, the valve body 60 may be removed while maintaining the protruding length of each sensor electrode.

  As shown in FIG. 11, in the connection step S5, first, the hub 70 is fitted from the upper surface 57 of the base plate 50 to the hub fitting portion 52 partitioned in the base plate 50. Thus, the needle member 10 is fixed to the base plate 50 in a state of protruding from the lower surface 56 of the base plate 50 through the through hole 53. At this time, as shown in FIG. 12, the base end sides of the working electrode 20, the reference electrode 30, and the counter electrode 40 as a plurality of sensor electrodes have different lengths according to their total lengths, It projects from the upper surface 57 through the joint portion 52. Thereby, the sensor electrode can be identified by the protrusion length from the upper surface 57. In the present embodiment, since the total length of the working electrode 20 is the longest, the total length of the reference electrode 30 is the second longest, and the total length of the counter electrode 40 is the shortest, the operator projects the sensor electrode that protrudes most. It can be identified that the second projecting sensor electrode is the reference electrode 30 and the third projecting sensor electrode is the counter electrode 40. The total length difference L1 and the total length difference L2 are differences such that the difference in length of each sensor can be identified on the proximal end side of each sensor when the positions on the distal end side of each sensor are substantially matched.

  As shown in FIG. 13, the first connecting portion 51 a, the second connecting portion 51 b, and the third connecting portion 51 c corresponding to the working electrode 20, the reference electrode 30, and the counter electrode 40 as a plurality of sensor electrodes are provided on the upper surface 57. The base ends of the working electrode 20, the reference electrode 30, and the counter electrode 40 are connected to a base plate 50 as a connecting member. Specifically, the base end of the working electrode 20 is connected to the first connection portion 51 a corresponding to the working electrode 20. The proximal end of the reference electrode 30 is connected to the second connection portion 51 b corresponding to the reference electrode 30. The proximal end of the counter electrode 40 is connected to the third connection portion 51 c corresponding to the counter electrode 40. The covering layers 27, 37, 47 are not formed at the base ends of the working electrode 20, the reference electrode 30, and the counter electrode 40, respectively, and the conductive layers 22, 32, 42 are exposed, respectively. Therefore, each of the working electrode 20, the reference electrode 30, and the counter electrode 40 is electrically connected to each connection of the base plate 50. When connecting each of the working electrode 20, the reference electrode 30, and the counter electrode 40 to each connection portion of the base plate 50, a portion including the base end of each of the working electrode 20, the reference electrode 30, and the counter electrode 40 is cut. It may be connected as a proximal end.

  As described above, in the method of manufacturing the sensor 1 according to this embodiment, the linear long member is inserted into the hollow portion 11 from the proximal end side of the tubular needle member 10 that divides the hollow portion 11 and A projecting step S2 of causing the elongated member to project from the tip end of the needle member 10, and a covering step of forming the covering layer on the surface of the projecting portion of the elongated member and processing the elongated member into a linear sensor electrode S3 and an accommodation process S4 which moves the sensor electrode to the proximal end side of the needle member 10 and accommodates the tip of the sensor electrode in the hollow portion 11. Therefore, the tip of the sensor electrode on which the covering layer is formed is easily pulled into the needle member 10 by the operation of pulling the sensor electrode to the proximal end side without having to insert the tip into the needle member 10 from the outside. It can be moved. As a result, the covering layer can be inhibited from contacting the inner peripheral wall of the needle member 10.

  Next, a modification of the method of manufacturing the sensor 1 will be described. As shown in FIG. 4, a modification of the method of manufacturing the sensor 1 includes an insertion step S1, a protrusion step S2, a covering step S3, a storage step S4, and a connection step S5. The insertion step S1, the covering step S3, and the accommodation step S4 of this example are the same as the above-described steps, and thus the description thereof is omitted here.

  FIG. 14: is a figure which shows typically after protrusion process S2 of the modification of the manufacturing method of the sensor 1, and before coating process S3. As shown in FIG. 14, in this example, after the valve body 60 shown in FIG. 6 is fixed to the needle member 10 in the projecting step S2, the hub 70 is fixed to the first base plate piece 58 before the covering step S3. . Here, the first base plate piece 58 constitutes a base plate 50 '(see FIG. 16 etc.) by being fitted with a second base plate piece 59 (see FIG. 15 etc.) described later. The first base plate piece 58 internally defines a hub fitting portion 52a communicating with the upper surface 57a and a through hole 53a communicating with the hub fitting portion 52a and the lower surface 56a. As shown in FIG. 14, the hub 70 is fitted from the upper surface 57 a of the first base plate piece 58 to the hub fitting portion 52 a divided into the first base plate piece 58. Thus, the needle member 10 is fixed to the first base plate piece 58 in a state of being protruded from the lower surface 56a of the first base plate piece 58 through the through hole 53a. The tips of the first elongated member 25, the second elongated member 35, and the third elongated member 45 project from the lower surface 56 a of the first base plate piece 58.

  FIG. 15 is a diagram (part 1) schematically showing the connection step S5 of the modified example of the method of manufacturing the sensor 1. FIG. 16 is a diagram (part 2) schematically showing the connection step S5 of the modified example of the method of manufacturing the sensor 1. FIG. 17 is a diagram (part 3) schematically showing the connecting step S5 of the modified example of the method of manufacturing the sensor 1.

  As shown in FIG. 15, in the connection step S5 of this example, first, the first base plate piece 58 is fitted to the first base plate fitting portion 52b divided by the upper surface 57 'of the second base plate piece 59. Here, the second base plate piece 59 internally divides the first base plate fitting portion 52b communicating with the upper surface 57 'and the through hole 53b communicating with the first base plate fitting portion 52b and the lower surface 56'. . The first base plate piece 58 mates with the second base plate piece 59 to form a base plate 50 'shown generally in FIG. At this time, as shown in FIG. 16, the base end sides of each of the working electrode 20, the reference electrode 30, and the counter electrode 40 as a plurality of sensor electrodes have different lengths according to their total lengths. It projects from the upper surface 57 'through the first base plate fitting portion 52b. Thereby, the sensor electrode can be identified by the protrusion length from the upper surface 57 '. In this example, the total length of the working electrode 20 is the longest, the total length of the reference electrode 30 is the second longest, and the total length of the counter electrode 40 is the shortest. The third sensor electrode protruding can be identified as the reference electrode 30 and the third sensor electrode protruding as the counter electrode 40.

  As shown in FIG. 16, in the present example, each of the first connection portion 51 a ′, the second connection portion 51 b ′, and the third connection portion 51 c ′ is a first base plate fitting portion 52 b of the upper surface 57 ′ of the base plate 50 ′. It is formed in the shape of a circular arc centering on the opening position of. Specifically, the first connection portion 51a ', the second connection portion 51b', and the third connection portion 51c 'are formed at different positions in the circumferential direction, and the upper surface 57' which is the diameter of the first connection portion 51a '. The distance from the opening of the first base plate fitting portion 52b corresponds to the projection length of the working electrode 20, and from the opening of the first base plate fitting portion 52b at the upper surface 57 'which is the diameter of the second connection portion 51b'. Of the reference pole 30 corresponds to the protrusion length of the reference electrode 30, and the distance from the opening of the first base plate fitting portion 52b at the upper surface 57 'which is the diameter of the third connection portion 51c' corresponds to the protrusion length of the counter electrode 40. Thereby, the connection freedom degree of each sensor electrode and the connection part is improved, and each sensor electrode can be easily connected to the corresponding connection part.

  The present invention is not limited to the configuration specified in each embodiment described above, and various modifications can be made without departing from the scope of the invention described in the claims.

  For example, although the above-mentioned embodiment showed an example in which the sensor 1 includes the working electrode 20, the reference electrode 30, and the counter electrode 40 as three sensor electrodes, the sensor 1 may not have the counter electrode 40. That is, two sensor electrodes may be provided. In that case, the needle member 10 may or may not be used as a counter electrode. Also, the sensor 1 may not have the reference electrode 30 and the counter electrode 40 as sensor electrodes. That is, there may be one sensor electrode. In that case, the needle member 10 can be used as a reference electrode. Furthermore, the sensor 1 may include a plurality of working electrodes 20 as sensor electrodes. That is, four or more sensor electrodes may be provided. In that case, by making the components of the reagent layer 23 of each of the plurality of working electrodes 20 different from each other, a plurality of substances to be measured can be detected.

  Moreover, in the above-mentioned embodiment, although the valve body 60 was used as a supporting member which supports each sensor electrode, it may replace with the valve body 60 and may use the hub 70 as a supporting member. Further, in the above-described modified example, the first base plate piece 58 may be used as a support member. In that case, in the connection step S5, the first base plate piece 58 as the support member is fitted to the second base plate piece 59 as the connection member.

  The present disclosure relates to a method of manufacturing a sensor.

1: Sensor 10: Needle member 11: Hollow portion 12: Tip opening 13: Peripheral wall 14: Through hole 15: Blade surface 20: Working electrode 21: Core material 22: Conductive layer 23: Reagent layer 24: Protective layer 25: First Long member 26: Projection 27: Coating layer 29: Coating liquid 30: Reference electrode 31: Core material 32: Conductive layer 34: Protective layer 35: Second long member 36: Projection part 37: Coating layer 39: Coating liquid 40: Counter electrode 41: Core material 42: Conductive layer 44: Protective layer 45: Third elongated member 46: Projection portion 47: Coating layer 49: Coating liquid 50, 50 ': Base plate (connection member)
51a, 51a ': first connection portion 51b, 51b': second connection portion 51c, 51c ': third connection portion 52, 52a: hub fitting portion 52b: first base plate fitting portion 53, 53a, 53b: penetrating Holes 56, 56 ': lower surface 56a of base plate: lower surface 57 of first base plate piece 57, 57: upper surface of base plate 57a: upper surface 58 of first base plate piece 58: first base plate piece 59: second base plate piece 60: valve body Support member)
61a to 61c: slit 70: hub 71: hollow portion 72: peripheral wall 73: bottom wall 100: communication device 101: circuit portions 102a to 102c: connection portion A: axial direction L1 of needle member: first long member and second Total length difference L2 with the long member: Total length difference between the second long member and the third long member

Claims (6)

Inserting the linear elongated member into the hollow portion from the proximal end side of the tubular needle member defining the hollow portion;
Projecting the elongated member from the tip of the needle member;
A covering step of forming a covering layer on the surface of the protruding portion of the long member, and processing the long member into a linear sensor electrode;
And D. moving the sensor electrode to the proximal end side of the needle member to store the tip of the sensor electrode in the hollow portion. In the inserting step, each of the plurality of elongated members is inserted into the hollow portion from the proximal end side of the needle member,
In the projecting step, the plurality of elongated members are projected so that the lengths of projecting from the tip of the needle member are different from each other,
In the covering step and the accommodating step, a covering layer is formed on the surface of the most projecting elongated member of the plurality of elongated members, and processed into a sensor electrode, and the tip of the sensor electrode is accommodated in the hollow portion The method for manufacturing a sensor according to claim 1, wherein the tip of each of the plurality of sensor electrodes is accommodated in the hollow portion by sequentially repeating the operation. The total length of each of the plurality of elongated members is different from each other
After the storing step, the plurality of sensor electrodes project from the proximal end of the needle member with different lengths according to their total length,
The method of manufacturing a sensor according to claim 2, further comprising: a connecting step of connecting a proximal end of each of the plurality of sensor electrodes to a connection member having a connection portion corresponding to each of the plurality of sensor electrodes.   The method according to claim 3, wherein in the covering step, a support member for supporting the plurality of elongated members is fixed to the needle member.   The method of manufacturing a sensor according to claim 4, wherein in the connection step, the support member is fitted to the connection member.   The method for manufacturing a sensor according to any one of claims 1 to 5, wherein in the covering step, the covering layer is formed by immersing the projection of the elongated member in a covering liquid.

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