WO2022064966A1 - Appareil de mesure de composants - Google Patents

Appareil de mesure de composants Download PDF

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Publication number
WO2022064966A1
WO2022064966A1 PCT/JP2021/031666 JP2021031666W WO2022064966A1 WO 2022064966 A1 WO2022064966 A1 WO 2022064966A1 JP 2021031666 W JP2021031666 W JP 2021031666W WO 2022064966 A1 WO2022064966 A1 WO 2022064966A1
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WO
WIPO (PCT)
Prior art keywords
measuring device
unit
housing
puncture
contact surface
Prior art date
Application number
PCT/JP2021/031666
Other languages
English (en)
Japanese (ja)
Inventor
隆行 杉山
浩明 佐藤
健行 森内
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2022551224A priority Critical patent/JPWO2022064966A1/ja
Publication of WO2022064966A1 publication Critical patent/WO2022064966A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

Definitions

  • the present invention relates to a component measuring device for measuring components in body fluid such as blood.
  • test strip test strip having a reagent
  • the user punctures the skin such as a finger using the attached puncture device, and a small amount of blood exuded from the skin is instilled on the inspection part (sample chamber) of the test strip.
  • the instrument measures the amount of glucose (concentration) in the blood by reacting the blood (whole blood) instilled on the test strip with the reagent based on the electrochemical or colorimetric method, and the result is the blood glucose level. Is displayed on the display unit.
  • the instrument used in the system disclosed in Patent Document 1 is provided on the lid of the container for accommodating the test strip, and the puncture device is integrally attached to the side surface of the container, so that the instrument can be carried on the go.
  • the user can measure the blood glucose level by himself / herself. Therefore, in this type of device including the instrument of Patent Document 1, it is required to improve the portability so that it can be easily carried on the go.
  • At least one embodiment of the present invention has been made in view of the above circumstances, and specifically, in a configuration including a puncture device for blood sampling and a measurement device for measuring the amount of a predetermined component in a body fluid. It is an object of the present invention to provide a component measuring device having excellent portability and design.
  • the component measuring device is a puncture device configured to pierce the surface of a living body to exude body fluid, and a predetermined component contained in the body fluid by introducing the body fluid into a test medium.
  • a component measuring device comprising a measuring device configured to measure a component amount, wherein the piercing device is a surface of at least one of a first housing and an outer surface of the first housing.
  • the measuring device is provided on at least one surface of the second housing and the outer surface of the second housing.
  • the piercing device and the measuring device have a second contact surface and a second connecting portion that can be connected to the first connecting portion, and the first contact surface and the second contact surface face each other.
  • the first housing and the second housing are integrated to form a housing of the component measuring device.
  • the first contact surface and the second contact surface become separate surfaces with the puncture device.
  • the measuring device is configured to be a separate body, and the first housing and the second housing have a portion protruding from the outer surface of the housing in a region to be the outer surface of the housing. do not have.
  • a component measuring device having excellent portability and design is provided in a configuration including a puncture device for blood sampling and a measuring device for measuring the amount of a predetermined component in a body fluid. Can be done.
  • XYZ coordinates are set as shown in the figure. That is, the "Z direction” is a direction along the vertical direction, the "X direction” is one direction orthogonal to the Z direction and parallel to the horizontal plane, and the “Y direction” is orthogonal to the Z direction and parallel to the horizontal plane. Of the other directions (directions orthogonal to the X direction), the direction is orthogonal to the X direction.
  • the Z direction coincides with the thickness direction (vertical direction) of the housing 110
  • the X direction coincides with the longitudinal direction (front-back direction) along the long axis direction of the housing 110.
  • the Y direction coincides with the lateral direction (width direction) of the housing 110.
  • the component measuring device 100 punctures the living body surface (for example, skin) of the user as the puncture site to exude body fluid, and measures the component amount of a predetermined component contained in this body fluid. It is a device.
  • the component measuring device 100 is a self-monitoring blood glucose (self-monitoring of blood glucose; SMBG) device that measures the amount (blood glucose level) of the glucose component contained in the body fluid (blood) by the user himself / herself. This will be described as the form adopted in.
  • SMBG self-monitoring of blood glucose
  • the component measuring device 100 is not limited to the SMBG device, but can also be used as a POCT (Point of Care Testing) device mainly operated by a medical worker. Further, since the component measuring device 100 is a device for measuring the specific amount of the component contained in the body fluid, the type of the body fluid and the amount of the component of the component to be measured are not limited to the configuration of the present embodiment.
  • POCT Point of Care Testing
  • the component measuring device 100 punctures the puncture site of the user to exude blood (whole blood), and a predetermined component contained in the blood exuded by the puncture device 10.
  • a measuring device 20 for measuring the amount of components of the above is provided.
  • the component measuring device 100 has a configuration in which the puncture device 10 and the measuring device 20 are separably integrated along a separation surface 101 extending along the axial direction (X direction).
  • the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measurement device 20 are brought into contact with each other to bring them into contact with each other.
  • the component measuring device 100 shown in FIGS. 1 and 2 shows an aspect when not in use.
  • the contact state between the first contact surface 10a and the second contact surface 20a is released during use (during puncture and measurement).
  • the first contact surface 10a is exposed as a part of the housing of the puncture device 10
  • the second contact surface 20a is exposed as a part of the housing of the measurement device 20.
  • the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measuring device 20 form a separation surface 101 that functions as a split surface of the component measuring device 100.
  • the separation surface 101 is provided at least along the longitudinal direction of the component measuring device 100, and is a surface on which the puncture device 10 and the measuring device 20 are separated.
  • the separation surface 101 may be, for example, a vertical surface extending perpendicular to the width direction of the component measuring device 100.
  • the separation cross-sectional end 102 which is the end surface of the separation surface 101 when the component measuring device 100 is viewed from the side of the needle mounting unit 12 (or the side of the needle eject operation unit 14), coincides with the Z direction and is separated at this time.
  • the area of the surface 101 is minimized.
  • the separated cross-sectional end 102 may be tilted in the axial direction by a predetermined angle when viewed from the side of the needle mounting portion 12 (or the side of the needle eject operating portion 14). .. More specifically, the separation surface 101 is an inclined surface that inclines in the width direction toward the thickness direction. When the separation surface 101 is an inclined surface inclined with respect to the Z direction, the separation surface 101 can be wider than when it is a vertical surface, so that the holding force of the puncture device 10 and the measurement device 20 can be appropriately maintained. Further, when connecting the puncture device 10 and the measurement device 20, the user can visually recognize the correct connection direction.
  • the position of the separation surface 101 with respect to the width direction (Y direction) of the component measuring device 100 may be appropriately determined according to the sizes of the puncture device 10 and the measurement device 20, but the separation surface 101 is the puncture device 10 and the like. When they come into contact with the measuring device 20, they are configured to complement each other.
  • the shape of the separation surface 101 may be a flat surface, a curved surface, or a combination of irregularities, but the separation surface 101, that is, the first contact surface 10a and the second contact surface 20a is a flat surface or a surface in consideration of hygiene.
  • a smooth curved surface is preferable, and a flat surface is more preferable. It is preferable that the footprints of the first contact surface 10a and the second contact surface 20a are substantially the same.
  • first contact surface 10a and the second contact surface 20a are both configured to have the same shape and the same size. Thereby, when the puncture device 10 and the measurement device 20 are combined, the portion protruding from the outer surface of the housing 110 can be eliminated.
  • the separated cross-sectional end 102 is located between the first opening 12a and the second opening 22a, which will be described later, or between the medium eject operation unit 23 and the needle eject operation unit 14.
  • the separated cross-sectional end 102 may have a straight line, a curved line, or a combination thereof as long as it does not interfere with the functions of the medium eject operation unit 23 and the needle eject operation unit 14.
  • the housing of the puncture device 10 (first housing 11) and the housing of the measurement device 20 (second housing 21) are the first contact surface 10a of the puncture device 10 and the measurement device 20.
  • the component is measured by connecting the first connecting portion 15 of the puncture device 10 (see FIGS. 5A and 5B) and the second connecting portion 24 of the measuring device 20 in a state where the second contact surface 20a is brought into contact with the puncture device 10.
  • the housing 110 of the device 100 is configured.
  • the first connecting portion 15 of the puncture device 10 and the second connecting portion 24 of the measuring device 20 function as a connecting portion of the component measuring device 100. Through this connecting portion, the puncture device 10 and the measuring device 20 are connected so that the user can arbitrarily attach / detach and connect them.
  • the component measuring device 100 does not have a portion protruding from the outer surface of the housing 110 in a state where the puncture device 10 and the measuring device 20 are connected (that is, when not in use). Specifically, in a state where the puncture device 10 and the measurement device 20 are connected, the outer surface regions of the first housing 11 and the second housing 21 constituting the housing 110 have an outwardly convex shape (convex shape toward the outside). Does not have a bulge).
  • the outer shape of the component measuring device 100 has a pillar shape having a substantially rounded rectangular cross section in a state where the puncture device 10 and the measuring device 20 are integrated, and has a convex shape on the outer surface. It is configured so that there is no such thing.
  • the component measuring device 100 does not have a convex shape on the outer surface of the housing 110 when not in use, it is prevented from being caught by other parts around it when it is carried, and the portability is improved. Further, in the component measuring device 100, when both devices are connected to each other when not in use, the outer surface of the housing 110 does not have a convex shape and becomes a smooth surface. Therefore, the component measuring device 100 is difficult to be recognized as a medical device in appearance and has excellent design. Further, in the component measuring device 100, the puncture device 10 and the measuring device 20 can be separated by the user at the time of use. Therefore, the operability of each device is improved.
  • FIGS. 4 to 8 are diagrams mainly for explaining the configuration of the puncture device 10
  • FIGS. 7 and 8 are diagrams mainly for explaining the configuration of the measurement device 20.
  • FIG. 4 is a diagram for explaining a control system of the measuring device 20.
  • the puncture device 10 punctures the needle mounting portion 12 on which the puncture needle cartridge N is mounted and the puncture needle cartridge N mounted on the needle mounting portion 12 in the first housing 11.
  • the puncture operation unit 13 that advances and retreats the needle N2 to puncture the puncture site of the user, and the needle eject operation unit that is operated when removing (ejecting) the used puncture needle cartridge N attached to the needle mounting unit 12.
  • a first connecting portion 15 for maintaining the connected state of the 14 and the measuring device 20, and a depth adjusting portion 16 for adjusting the puncture depth of the puncture needle N2 with respect to the puncture site are provided.
  • the first housing 11 of the puncture device 10 includes a first contact surface 10a.
  • the first contact surface 10a faces the second contact surface 20a of the measurement device 20 when connected to the measurement device 20.
  • the first contact surface 10a functions as a separation surface 101 of the component measuring device 100, and the state of contact with the second contact surface 20a of the measuring device 20 is maintained when the component measuring device 100 is not used.
  • the puncture device 10 is connected to the measuring device 20 to form the housing 110 of the component measuring device 100, the gap between the first housing 11 and the second housing 21 is eliminated as much as possible.
  • the sense of unity of the housing 110 can be enhanced. Therefore, it is preferable that the first contact surface 10a is formed so as not to have a portion protruding from the surface. Further, the first contact surface 10a can be configured so as not to have a convex portion protruding from the first contact surface 10a, so that the contact state with the second contact surface 20a can be stabilized.
  • the first housing 11 is provided with a first flat portion 11a made of a flat surface at least a part of the outer surface. Therefore, the puncture device 10 can prevent rolling that may occur when the puncture device 10 is placed on a mounting surface such as a table in a state of being separated from the measuring device 20.
  • the first flat portion 11a may be arranged at a part or a plurality of places on the outer surface other than the first contact surface 10a in the first housing 11. Further, when the first contact surface 10a is formed substantially flat, it may function as the first flat portion 11a.
  • the needle mounting portion 12 has a first opening 12a, and the puncture needle cartridge N is inserted and mounted.
  • the puncture needle cartridge N is a medical device for collecting blood provided with a puncture needle N2 that is retractably accommodated from a hole provided on the front end side of the needle holder N1.
  • the puncture needle cartridge N is used in contact with the puncture site. Examples of the puncture site include the surface of the user's body (skin, mucous membrane, etc.) such as the fingertip, palm, upper arm, abdomen, thigh, and earlobe. Therefore, the puncture needle cartridge N is considered to be single-use in order to prevent risks such as infectious diseases, and is removed from the puncture device 10 and discarded after use.
  • the puncture device 10 is used repeatedly.
  • the needle mounting portion 12 has a needle engaging portion 12b.
  • the rear end portion of the puncture needle cartridge N (the rear end portion of the needle holder N1) engages with the needle engaging portion 12b, so that the puncture needle cartridge N is held by the puncture device 10.
  • the needle engaging portion 12b holds the rear end portion of the hub of the puncture needle N2 in the puncture needle cartridge N so as to be able to move forward and backward along the axial direction.
  • the needle engaging portion 12b includes an elastic member (coil spring or the like) that can expand and contract along the axial direction, and based on the operation of the puncture operation portion 13, puncture in the puncture needle cartridge N by utilizing the urging force of the elastic member.
  • the needle N2 is moved forward and backward along the axial direction.
  • the needle mounting portion 12 includes a puncture spring for advancing the needle tip of the puncture needle N2 of the puncture needle cartridge N by a predetermined length (predetermined puncture depth), and a needle of the advanced puncture needle N2. It has a return spring as an elastic member for retracting the tip to the original position (standby position).
  • the puncture operation unit 13 is composed of a mechanical switch that causes the puncture needle cartridge N to perform a puncture operation.
  • the puncture operation unit 13 may be configured by a button-type switch mechanism for causing the puncture needle cartridge N to execute the puncture operation by using the pressing operation of the puncture operation unit 13 as a trigger.
  • the puncture operation unit 13 is preferably arranged in the first contact surface 10a region, for example, so as not to protrude from the outer surface of the housing 110 of the component measuring device 100 in the first housing 11. By arranging the puncture operation unit 13 on the first contact surface 10a, the operation surface is not exposed to the outer surface of the housing 110 when not in use, and the aesthetic appearance of the component measuring device 100 is not spoiled.
  • the needle eject operation unit 14 is operated when the used puncture needle cartridge N is removed from the puncture device 10.
  • the needle eject operation unit 14 may be composed of a lever member for the user to perform an eject operation by pressing along the major axis direction.
  • the needle eject operating unit 14 has a first operating body 14a formed along the outer shape of the first housing 11. That is, the first operating body 14a does not protrude from the outer shape of the first housing 11 when not in use.
  • the first operating body 14a is provided so as to be movable along the axial direction by a predetermined eject operation (pushing operation) by the user, and is provided via an engaging member (not shown) housed in the first housing 11. Remove the puncture needle cartridge N from the needle mounting portion 12.
  • the engaging member is a member that engages with the puncture needle cartridge N and moves in conjunction with the axial direction according to the amount of operation of the first operating body 14a.
  • the first operating body 14a is provided with an elastic member (coil spring or the like) (not shown), and when an eject operation is performed when the puncture needle cartridge N is removed, the first operating body 14a moves from the initial position to the eject position, and the puncture needle cartridge N is removed. After that, it moves to the initial position by the urging force of the elastic member.
  • the first connecting portion 15 is connected to the second connecting portion 24 to maintain the connected state of the puncture device 10 and the measuring device 20.
  • the first connecting portion 15 is configured by, for example, a first magnetic member 15a made of a magnetic material or a magnet.
  • the constituent material of the first connecting portion 15 can be appropriately selected according to the form of the second connecting portion 24. That is, when the second magnetic member 24a that functions as the second connecting portion 24 is made of a magnetic material, the first magnetic member 15a may be made of a magnet so that it can be connected to the second magnetic member 24a.
  • the first magnetic member 15a is composed of a magnetic material or a magnet having a magnetic pole different from that of the second magnetic member 24a so as to be connectable to the second magnetic member 24a. good.
  • the first connecting portion 15 is arranged inside the first housing 11 in the vicinity of the first contact surface 10a so as to face the second connecting portion 24 arranged on the second contact surface 20a of the measuring device 20. Will be done. As a result, when the puncture device 10 and the measurement device 20 are connected, the connected state of both devices is maintained without disturbing the contact state between the first contact surface 10a and the second contact surface 20a. Can be done.
  • the length at which the puncture needle N2 of the puncture needle cartridge N mounted on the needle mounting portion 12 advances is the depth adjusting portion 16.
  • the depth adjusting unit 16 adjusts the amount of advancement (puncture depth) of the puncture needle N2 of the puncture needle cartridge N.
  • the depth adjusting unit 16 adjusts the length at which the puncture needle N2 advances from the opening of the needle holder N1, that is, the puncture depth from the surface of the living body, according to the individual difference of the user who is the blood sampler and the puncture site. It is operated when you do.
  • the puncture depth (advancement amount of the puncture needle N2) by the depth adjusting unit 16 can be adjusted in multiple stages by an adjustment dial or the like.
  • the puncture device 10 is operated when the blood sampling device 10 is used to collect blood necessary for measuring the blood glucose level.
  • the puncture needle cartridge N is mounted on the needle mounting portion 12 by the user. At this time, the rear end portion of the puncture needle cartridge N engages with the needle engaging portion 12b. Subsequently, as shown in FIG. 6B, when the puncture operation unit 13 is operated by the user, the needle mounting unit 12 advances the needle tip of the puncture needle cartridge N to a predetermined advance position by the urging force of the puncture spring. .. As shown in FIG. 6C, when the operation of the puncture operation unit 13 is completed, the needle tip of the advanced puncture needle cartridge N is retracted to the original position (standby position) by the urging force of the return spring. In this way, in the puncture needle cartridge N mounted on the needle mounting portion 12, the puncture needle N2 reciprocates along the axial direction between the standby position and the advance position by operating the puncture operation portion 13. Puncture the user's predetermined biological surface.
  • the user presses the first operating body 14a along the axial direction to displace the engaging member inside the first housing 11 along the axial direction. It is moved to the side to release the engagement state between the needle mounting portion 12 (specifically, the needle engaging portion 12b) and the puncture needle cartridge N.
  • the puncture device 10 is in the state shown in FIG. 6E (that is, the state before use) by removing the puncture needle cartridge N after use from the puncture device 10 without the user touching it.
  • the puncture needle cartridge N is detached from the puncture device 10
  • the first operating body 14a returns from the eject position to the initial position before the operation due to the urging force of the elastic member.
  • the measuring device 20 is attached to the medium mounting portion 22 on which the disposable type inspection medium T is mounted and the medium mounting portion 22 in the second housing 21.
  • the medium eject operation unit 23, which is operated when the used inspection medium T is removed, and the second connection unit 24 for maintaining the connection state with the puncture device 10 are provided.
  • the measuring device 20 communicates with the measuring unit 31, the temperature detecting unit 32, and the device detecting unit 33 as a control system in order to execute various processes related to the measurement of the amount of components in the body fluid. It includes a unit 34, a notification unit 35, a display unit 36, a power supply unit 37, a storage unit 38, and a control unit 39.
  • the second housing 21 of the measuring device 20 has a second contact surface 20a facing the first contact surface 10a of the puncture device 10 when connected to the puncture device 10. .
  • the second contact surface 20a functions as a separation surface 101 of the component measuring device 100, and the state of contact with the first contact surface 10a of the puncture device 10 is maintained when the component measuring device 100 is not used.
  • the second contact surface 20a is formed so as not to have a portion protruding from the surface, like the first contact surface 10a.
  • the second contact surface 20a is formed so as not to have a convex shape on the surface, the contact state with the first contact surface 10a can be stabilized, and the second contact surface 20a is formed on the outer surface of the housing 110.
  • the gap to be obtained can be eliminated as much as possible.
  • the second housing 21 is provided with a second flat portion 21a made of a flat surface at least a part of the outer surface. Therefore, the measuring device 20 can prevent rolling that may occur when the measuring device 20 is placed on a mounting surface such as a table in a state of being separated from the puncturing device 10.
  • the second flat portion 21a may be arranged at a part or a plurality of places on the outer surface other than the second contact surface 20a in the second housing 21. Further, when the second contact surface 20a is formed substantially flat, it may function as the second flat portion 21a. Alternatively, two second flat portions 21a may be provided and arranged as a pair of surfaces facing each other.
  • the second flat portion 21a is preferably arranged on the same surface as the first flat portion 11a in the housing 110. That is, the first flat portion 11a and the second flat portion 21a form one surface of the housing 110. By arranging the first flat portion 11a and the second flat portion 21a on the same surface of the housing 110, both flat portions function as mounting surfaces and the mounting stability of the component measuring device 100 can be improved. ..
  • the medium mounting portion 22 has a second opening 22a, and the inspection medium T is inserted into the medium mounting portion 22.
  • the inspection medium T is, for example, a disposable type test strip having an inspection unit T1 (see FIG. 8D) having a predetermined reagent at the front end, and is discarded after measurement.
  • the inspection unit T1 holds a reagent (coloring reagent) that specifically reacts with the substance to be measured in blood.
  • the reagent may be held on a carrier such as a porous membrane capable of absorbing blood. By reacting with the reagent, blood develops a color with a color concentration corresponding to the amount of glucose contained in the blood.
  • the opening shape of the second opening 22a may be formed according to the shape (cross-sectional shape) of the inspection medium T to be mounted.
  • the opening shape of the second opening 22a is set according to the shape of the inspection medium T to be mounted. Therefore, when the inspection medium T is not a plate shape like a test strip but a substantially columnar chip, the second opening 22a has a shape to which the chip can be mounted.
  • the medium mounting portion 22 holds the mounted inspection medium T, and also holds the medium holding portion (not shown) for advancing the rear end portion of the inspection medium T from the second opening 22a at the time of removal. ) Is provided.
  • the medium holding portion is provided so as to be movable along the axial direction inside the second housing 21 of the measuring device 20.
  • the medium holding portion is a position (measurement position) in which at least a part (particularly near the tip portion) of the inspection medium T is held and measured in the second housing 21 and a position (eject position) in which the inspection medium T is removed. ) And move along the axial direction.
  • the medium holding unit holds the inspection medium T inserted from the second opening 22a, and when the medium eject operation unit 23 is operated after the measurement is completed, the medium holding unit holds the inspection medium T and is far away in the long axis direction. Move toward the end side. Since the inspection medium T is extruded from the second opening 22a of the second housing 21 by a predetermined length, the inspection medium T after measurement can be removed from the measurement device 20 without being touched by the user. ..
  • the amount of extrusion of the inspection medium T by the medium holding unit (corresponding to the operation amount of the medium eject operation unit 23) is the size of the second housing 21, the length of the inspection medium T in the longitudinal direction, and the second required for gripping. Although it is appropriately determined by the amount of protrusion (exposed length) from the opening 22a, it is preferable that the inspection medium T is at least long enough to be detached from the second opening 22a.
  • the medium eject operation unit 23 is operated when the used inspection medium T is removed from the measuring device 20.
  • the medium eject operation unit 23 may be composed of a lever member provided so that the user can move along the axial direction.
  • the medium eject operation unit 23 has a second operation body 23a formed along the outer shape of the second housing 21 and operated by the user.
  • the second operating body 23a is provided so as to be movable along the axial direction by a predetermined eject operation (pressing operation) by the user, and is engaged with the medium holding portion in the second housing 21.
  • the medium holding portion moves toward the front end side in the long axis direction in the second housing 21 as the second operating body 23a moves in the long axis direction.
  • the inspection medium T held in the medium holding portion gradually increases in the amount of protrusion (exposure amount) from the second opening 22a as the second operating body 23a moves.
  • the inspection medium T is separated from the measuring device 20.
  • the medium holding portion moves toward the rear end side in the axial direction as the second operating body 23a moves. And return to the original position (measurement position).
  • the return operation of the second operating body 23a may be performed manually by the user, or may be moved by the urging force of an elastic member (coil spring or the like) (not shown).
  • the second connecting portion 24 brings the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measuring device 20 into contact with each other to maintain the connected state.
  • the second connecting portion 24 is configured by, for example, a second magnetic member 24a made of a magnetic material or a magnet.
  • the constituent material of the second connecting portion 24 may be appropriately selected according to the form of the first connecting portion 15. That is, when the first magnetic member 15a is made of a magnetic material, the second magnetic member 24a may be made of a magnet so that it can be connected to the first magnetic member 15a.
  • the second magnetic member 24a is composed of a magnetic material or a magnet having a magnetic pole different from that of the first magnetic member 15a so that the first magnetic member 15a can be connected to the first magnetic member 15a. good.
  • the second connecting portion 24 is arranged inside the second housing 21 in the vicinity of the second contact surface 20a so as to face the first connecting portion 15 arranged on the first contact surface 10a of the puncture device 10. Will be done. As a result, when the puncture device 10 and the measurement device 20 are connected, the connected state of both devices is maintained without disturbing the contact state between the first contact surface 10a and the second contact surface 20a. Can be done.
  • the measuring unit 31 measures the amount of the component of the body fluid to be measured.
  • the measuring unit 31 optically measures the amount of the glucose component component in the blood.
  • the measuring unit 31 has a light emitting element and a light receiving element (not shown), and is an optical system measuring device that irradiates the blood spread in the inspection unit T1 with the irradiation light from the light emitting element and detects the transmitted light by the light receiving element. It is configured.
  • the measurement unit 31 is arranged in the second housing 21 at a position where the inspection medium T held at the measurement position by the medium holding unit can be inspected (for example, above the inspection unit T1 at the measurement position).
  • the measuring unit 31 intermittently emits light of a single or a plurality of predetermined wavelengths from the light emitting element, receives the light transmitted through the inspection unit T1 by the light receiving element, and outputs an electric signal proportional to the amount of the received light.
  • the control unit 39 captures the electric signal as a digitized measured value. Since this measured value changes depending on the state, it is a data series for each wavelength.
  • the inspection medium T is mounted on the medium mounting unit 22 by the operation of the user.
  • the measuring unit 31 detects that the inspection medium T has been mounted on the medium mounting unit 22 by acquiring a change in the amount of light before and after mounting the inspection medium T in the measuring device 20, and via the control unit 39. Then, the notification unit 35 and the display unit 36 of the device are notified and displayed to urge the user to instill blood.
  • the user applies 0.5 to 10 ⁇ L of blood obtained by the puncture device 10 to the spotting port T2 at the distal end of the test medium T.
  • blood is introduced along a capillary channel (not shown) provided inside the test medium T, it is mixed with a reagent and the reaction with glucose proceeds.
  • the color is developed in an amount corresponding to the glucose level in the blood.
  • the inspection unit T1 is in a position corresponding to the measurement unit 31 when the inspection medium T is attached to the measurement device 20.
  • the blood mixed with the reagent spreads along the capillary tract and reaches the examination unit T1.
  • the inspection medium T may have an air vent hole (not shown) for promoting blood introduction into the capillary passage, and the air vent hole is provided at the end opposite to the spotting port T2 in the capillary passage. It will be provided.
  • the measurement unit 31 emits light having a predetermined wavelength from the light emitting element and the reagent corresponding to the glucose value in the blood.
  • the reagent reaction amount based on the reaction is measured from the amount of light transmitted through the inspection unit T1.
  • the inspection unit T1 is transmitted until the blood mixed with the reagent flows into the inspection unit T1 from the state where there is no sample and the reaction proceeds.
  • a time-series electric signal corresponding to the amount of light is output, and the control unit 39 captures it as a data series of measured values.
  • the control unit 39 detects that blood mixed with the reagent has flowed in from a state where there is no sample (blood) in the inspection unit T1, and the measurement process is started using this as a trigger.
  • the measurement end is processed when the control unit 39 determines from the passage of a predetermined time or the passage of the measured value (for example, when the change of the measured value reaches the plateau). From the start of measurement to the end of measurement
  • the control unit 39 notifies and displays the notification unit 35 and the display unit 36 of the device from the start of measurement to the end of measurement.
  • the measuring unit 31 is configured to perform measurement by a colorimetric method that optically detects the blood glucose level in blood
  • other measuring methods can also be applied.
  • a method for measuring the blood glucose level for example, an enzyme electrode method in which a reagent is applied around an electrode to detect an electrical change accompanying a reaction between the reagent and blood, that is, a current generated between a detection electrode and a counter electrode is used.
  • a current generated between a detection electrode and a counter electrode is used.
  • the measuring unit 31 since the measuring unit 31 only needs to be able to measure the amount of the component in the body fluid to be measured, it is possible to appropriately change the device configuration according to the component to be measured.
  • the temperature detection unit 32 is composed of a known thermometer that measures the environmental temperature at the time of measurement.
  • the temperature detection unit 32 outputs a temperature value based on the measured environmental temperature to the control unit 39.
  • the device detection unit 33 is in a state where the puncture device 10 is connected or separated from the measuring device 20, that is, a state in which the puncturing device 10 is connected to the measuring device 20 (when the component measuring device 100 is not used, the first contact surface 10a is used. And the second contact surface 20a are in contact with each other and connected to each other) and the separated state of the puncture device 10 (when the component measuring device 100 is used, the first contact surface 10a and the second contact surface 20a are separated from each other). State) is detected.
  • the device detection unit 33 can adopt a method corresponding to the method of connecting the puncture device 10 and the measurement device 20 as a method of detecting the attachment / detachment state of both.
  • the puncture device 10 and the measuring device 20 are magnetically connected. Therefore, the device detection unit 33 may be configured by, for example, a magnetic sensor using a Hall element or the like that can detect the presence or absence of a magnetically connected state.
  • the device detection unit 33 punctures a state in which the first contact surface 10a and the second contact surface 20a are in contact with each other and the puncture device 10 is connected, and the first contact surface 10a and the second contact surface 20a are separated from each other. The separated state of the device 10 is magnetically detected.
  • the device detection unit 33 outputs the detected state information (connection state information, separation state information) indicating the detected connection state or separation state to the control unit 39.
  • the device detection unit 33 since the device detection unit 33 only needs to have a configuration capable of detecting the connection and separation state (detachment state) of the puncture device 10 with respect to the measurement device 20, the method of detecting the attachment / detachment state of both is limited to the above configuration. Not done.
  • the communication unit 34 is wired or connected to another device (for example, an external server of a medical facility, various mobile terminals owned by a doctor in charge, etc.) connected via a communication network according to a predetermined protocol. It is a network interface that controls wireless communication (including short-range wireless communication).
  • the communication unit 34 transmits transmission data including a measured value indicating the measured component amount (blood glucose level) to the communication destination.
  • the notification unit 35 is composed of a notification device such as a speaker that outputs a notification sound such as a voice or a buzzer, a light emitting device that lights or blinks in various colors, a vibrator that generates a predetermined vibration, and the like. (For example, the start or end of a predetermined operation, a warning when an error occurs, a procedure guide, etc.) are notified to the user in an identifiable manner. Further, the notification unit 35, under the control of the control unit 39, performs notification from the medium mounting unit 22 to prompt the removal of the inspection medium T, notification to prompt the connection between the puncture device 10 and the measurement device 20, and the like. This prevents the user from forgetting to remove the inspection medium T or misplaceing the component measuring device 100.
  • a notification device such as a speaker that outputs a notification sound such as a voice or a buzzer, a light emitting device that lights or blinks in various colors, a vibrator that generates a predetermined vibration, and the like.
  • the display unit 36 is composed of a display device such as an LCD (Liquid Crystal Display), an OLED (Organic Light Emitting Diode), or a micro LED (Micro Light Emitting Diode) display, and the display content is visible to the user (characters). , Numbers, figures, and other symbols).
  • the display unit 36 displays, for example, the amount of components in the body fluid measured by the measurement unit 31 (specifically, the value calculated by the calculation unit 39b of the control unit 39), and the notification content required for operation. It also displays (guidance display, measurement start / end display, etc.).
  • the display content (display data) displayed on the display surface 36a of the display unit 36 is output from the control unit 39.
  • the display surface 36a of the display unit 36 is arranged on the second contact surface 20a. Therefore, in the component measuring device 100, the display surface 36a is not exposed to the outside of the housing 110 when not in use. For this reason, the design is improved and it becomes difficult for the surroundings to recognize it as a medical device. It is suitable when the user wants to make it difficult for others to notice that he / she is carrying a glucose meter.
  • the power supply unit 37 is housed in the second housing 21, and stores and mounts the battery that is the power source of the component measuring device 100.
  • the battery is preferably a small battery such as a button battery in consideration of the portability of the component measuring device 100.
  • the battery used in the power supply unit 37 may be either a primary battery or a secondary battery. Further, the power supply unit 37 may use a physical battery such as a solar cell in combination with a chemical battery such as a button battery. Further, the power supply unit 37 may be provided with a function capable of supplying power or charging by connecting to an external power source (commercial power source or the like) by wire or wirelessly.
  • the power supply unit 37 is a unit (measurement unit 31, temperature detection unit 32, communication unit 34, notification unit 35, display unit 36) that constitutes the measurement device 20 based on the separated state and the connected state of the puncture device 10 and the measuring device 20. , The amount of power supplied to the circuits of the storage unit 38 and the control unit 39) can be changed, which contributes to power saving.
  • the storage unit 38 is a measuring device 20 such as various control programs necessary for driving the measuring device 20, data transmitted to a communication destination including the measured values measured by the measuring unit 31, and past values related to measurements for a predetermined period. It is composed of a known storage medium for storing various data used.
  • the control unit 39 is composed of various processors including, for example, a CPU (Central Processing Unit), a ROM (Read only memory), a RAM (Random Access Memory), and the like.
  • the control unit 39 controls each unit constituting the measurement device 20 in an integrated manner while activating a predetermined processing program to execute a predetermined processing.
  • the control unit 39 includes, for example, a time measuring unit 39a composed of an RTC (Real-Time Clock), and measures the time according to a reference clock having a predetermined cycle supplied from a clock unit (not shown).
  • the time clock by the time measuring unit 39a is used for generating the date and time when the measurement was performed and for measuring from the start of the measurement to the end of the measurement.
  • control unit 39 calculates the component amount (blood glucose level) of the component in the body fluid to be measured based on the detection value (color concentration and light amount in the case of the specific color type) detected by the measurement unit 31.
  • a calculation unit 39b is provided.
  • the calculation unit 39b has a function of appropriately performing correction processing in consideration of measured value fluctuation factors such as the environmental temperature (temperature value by the temperature detection unit 32) at the time of calculation processing. As a result, the calculation unit 39b can obtain a value closer to the true value with less measurement error. The calculation unit 39b outputs the calculated measured value to the display unit 36.
  • control unit 39 controls ON / OFF of power supply to each unit by the power supply unit 37 based on the state information from the device detection unit 33.
  • the control unit 39 outputs a control signal for stopping the power supply to the power supply unit 37.
  • the power of the measuring device 20 is turned off.
  • the control unit 39 outputs a control signal for starting the power supply to the power supply unit 37. As a result, the measuring device 20 is turned on and becomes an idle state.
  • control unit 39 outputs a control signal to the measurement unit 31 when the power is turned on and becomes an idle state. Using this control signal as a trigger, the measuring unit 31 starts controlling light emission / reception and outputting an electric signal proportional to the amount of light. The control unit 39 starts a process of capturing an electric signal as a digitized measured value. This control continues intermittently until the device detection unit 33 detects the connection between the puncture device 10 and the measurement device 20 and the power is turned off.
  • control unit 39 includes a determination unit 39c that makes a predetermined determination (determination of connection of the puncture device 10, determination of attachment of the inspection medium T, determination of measurement start / end).
  • the control unit 39 takes in as a data series of measured values according to the amount of transmitted light of the inspection unit T1 from the measurement unit 31 that continues the intermittent measurement.
  • the determination unit 39c detects that blood has flowed in from the state where there is no blood in the examination unit T1, it determines that the measurement has started, and starts the measurement process using this as a trigger.
  • the judgment unit 39c Judges that the measurement is completed.
  • the control unit 39 displays the value calculated by the calculation unit 39b on the display unit 36, and notifies the notification unit 35 of the end of the measurement.
  • the determination unit 39c observes the signal from the measurement unit 31 and determines whether or not the inspection medium T mounted on the medium mounting unit 22 has been removed within a predetermined time (for example, several minutes).
  • a predetermined time for example, several minutes.
  • the determination unit 39c causes the notification unit 35 to execute a notification prompting the user to remove the inspection medium T.
  • the determination of the inspection medium T by the determination unit 39c may be determined, for example, depending on whether or not the medium eject operation unit 23 is operated.
  • the inspection medium T is attached to the measurement unit 31 by comparing the blank signal acquired by the measurement unit 31 before the measurement value acquisition with the signal acquired by the measurement unit 31 after a predetermined time has elapsed from the measurement value acquisition. You may decide whether or not it is.
  • the test medium T usually has an air vent hole at the distal end of the capillary tract to facilitate the introduction of blood. If the blood is left for a long time with the blood introduced into the capillary channel in the test medium T, the blood may seep out of the test medium T through the air vent holes. Therefore, it is preferable to remove the inspection medium T from the measuring device 20 within a predetermined time from the measurement.
  • the determination unit 39c determines whether the puncture device 10 and the measurement device 20 are connected within a predetermined time (for example, several minutes) after the inspection medium T is removed based on the state information from the device detection unit 33. Make a judgment.
  • the determination unit 39c determines that the puncture device 10 is not connected within a predetermined time from the acquisition of the measured value (that is, when the connection state information is waiting to be input)
  • the determination unit 39c measures the puncture device 10 with the user.
  • the notification unit 35 is made to execute the notification for prompting the connection with the device 20. As a result, the user can prevent forgetting to connect the puncture device 10 after the measurement is completed.
  • control unit 39 processes and generates transmission data in which the measurement value calculated by the calculation unit 39b is associated with the measurement condition information (temperature information indicating the environmental temperature, the measurement time required for the measurement, etc.). It is provided with a generation processing unit 39d that performs a process of storing the transmitted data in the storage unit 38 and a process of controlling the transmission of the transmitted data toward the communication destination via the communication unit 34.
  • timekeeping unit 39a, the calculation unit 39b, and the generation processing unit 39d are all described as being included in the control unit 39, they may be configured separately from the control unit 39, respectively. Some of them may be included in the control unit 39.
  • control unit 39 when the control unit 39 is in a state where measurement by the measurement unit 31 is possible (a state in which the puncture device 10 is separated from the measurement device 20) and the inspection medium T is not attached within a predetermined time, the user It is also possible to control the notification unit 35 so as to notify the user to attach the inspection medium T. Further, the control unit 39 may be configured to interrupt the measurement process when an unexpected situation such as the puncture device 10 being attached to the measurement device 20 occurs during measurement or the like. At that time, the control unit 39 may cause the notification unit 35 to execute notification indicating a measurement error.
  • the measuring device 20 is operated when measuring the blood glucose level in the blood collected by using the puncture device 10.
  • the inspection medium T is inserted from the second opening 22a by the user and mounted on the medium mounting portion 22.
  • the blood collected by the puncture device 10 is introduced into the inspection unit T1 of the inspection medium T through the opening of the instillation port T2 through the capillary passage of the inspection medium T.
  • the measuring device 20 starts measuring the mounted inspection medium T.
  • the measurement result (measured value) by the measuring unit 31 is displayed on the display unit 36.
  • the user presses the second operation body 23a of the medium eject operation unit 23 along the long axis direction of the component measuring device 100 by the eject operation, and the inside of the second housing 21
  • the medium holding portion on the side is moved along the long axis direction from the measurement position to the eject position.
  • the inspection medium T is pushed out from the second opening 22a and removed.
  • the second operating body 23a moves to the position (initial position) before the operation. Further, as the second operating body 23a moves, the medium holding portion also moves toward the base end side in the long axis direction and returns to the original position (measurement position).
  • the user when using the component measuring device 100 according to the present embodiment, as a first process, the user separates the puncture device 10 and the measuring device 20 (S1), and powers the measuring device 20. Turn it on (S2).
  • step S1 when the control unit 39 inputs the separation state information indicating that the puncture device 10 has been separated from the measurement device 20, the control unit 39 outputs a control signal for starting the power supply to the power supply unit 37. As a result, the power of the measuring device 20 is turned on and the measuring device 20 is in an idle state.
  • control unit 39 determines whether or not the inspection medium T is mounted on the medium mounting unit 22 (S3).
  • step S3 when the control unit 39 determines that the test medium T is mounted on the medium mounting unit 22 (S3-Yes), the control unit 39 ends the mounting detection process of the test medium T and waits for the detection of blood instillation. Start. On the other hand, when the control unit 39 determines that the inspection medium T is not mounted on the medium mounting unit 22 (S3-No), the control unit 39 displays a display prompting the user to mount the inspection medium T (S4). , The processing of step S3 and step S4 is looped until the inspection medium T is attached.
  • control unit 39 observes the signal from the measurement unit 31 and determines whether or not the blood mixed with the reagent has flowed in from the state where the test medium T has no sample (S5).
  • step S5 when the control unit 39 observes the signal from the measurement unit 31 and detects that the blood mixed with the reagent has flowed in from the state where the test medium T has no sample (S5-Yes), the measurement is performed. It is determined to start, and the measurement process is started using this as a trigger (S7). On the other hand, when the inflow of blood mixed with the reagent cannot be detected (S5-No), the control unit 39 displays a display prompting the user to instill blood (S6), and the instillation of blood is confirmed. The process of step S5 and step S6 is looped until the result is reached.
  • control unit 39 starts the measurement (S7), and determines whether or not the reaction is completed by the follow-up observation of the predetermined time by the timing unit 39a or the follow-up observation of the data series of the measured values by the judgment unit 39c. (S8).
  • the determination unit 39c determines that the measurement is completed, and proceeds to the measurement end process (S10). On the other hand, if the reaction is not completed (S8-No), the measurement state is continued (S9), and the process returns to step S8 again.
  • control unit 39 displays the value calculated by the calculation unit 39b on the display unit 36, stores the measurement result and the measurement date and time in the storage unit 38, and notifies the notification unit 35 of the end of the measurement. S10).
  • control unit 39 observes the signal from the measurement unit 31 and determines whether or not the inspection medium T mounted on the medium mounting unit 22 has been removed within a predetermined time (for example, several minutes). (S11).
  • step S11 when the control unit 39 determines that the inspection medium T has been removed from the medium mounting unit 22 within a predetermined time (S11-Yes), the control unit 39 determines whether or not the puncture device 10 is connected to the measurement device 20. (S13). On the other hand, when the control unit 39 determines that the inspection medium T has not been removed from the medium mounting unit 22 within a predetermined time (S11-No), the control unit 39 transfers the inspection medium T from the medium mounting unit 22 to the user. The notification unit 35 is controlled so as to notify the user to remove it, and the display of the measured value is continued (S12). After that, the control unit 39 loops the processes of steps S11 and S12 until the inspection medium T is removed.
  • step S13 when the control unit 39 determines that the puncture device 10 is connected within a predetermined time (S13-Yes), the control unit 39 outputs a control signal for stopping the power supply to the power supply unit 37 (S15), and ends the process. do. As a result, the power of the measuring device 20 is turned off, and the process ends.
  • the control unit 39 determines that the puncture device 10 is not connected within a predetermined time (S13-No)
  • the control unit 39 notifies the user to notify the user to prompt the connection with the puncture device 10.
  • the unit 35 is controlled (S14). After that, the control unit 39 loops the processes of steps S13 and S14 until the puncture device 10 is connected.
  • the component measuring device 100a of the modified example shown below has a different connection form between the puncture device 10 and the measuring device 20 from the above-mentioned form.
  • FIG. 10A shows the configuration of the puncture device 10 as a modified example
  • FIG. 10B shows the configuration of the measuring device 20 as a modified example.
  • the first contact surface 10a of the puncture device 10 is fitted with the measurement device 20 when it is connected to the measurement device 20, so that the first engagement portion functions as the first connection portion 15. 15b is provided.
  • the second contact surface 20a of the measuring device 20 is fitted with the puncturing device 10 when connected to the puncturing device 10, so that the second engaging portion functions as the second connecting portion 24. 24b is provided.
  • the first engaging portion 15b and the second engaging portion 24b form a connecting mechanism composed of members (concave grooves, ridge members) that are fitted to each other.
  • the puncture device 10 and the measurement device 20 have a first engagement portion by sliding at least one device along the axial direction in a state where the first contact surface 10a and the second contact surface 20a are butted against each other.
  • the 15b and the second engaging portion 24b are fitted and connected.
  • the first engaging portion 15b is composed of a pair of concave grooves extending in the axial direction along the longitudinal peripheral edge of the first contact surface 10a.
  • the second engaging portion 24b extends axially along the longitudinal peripheral edge of the second contact surface 20a and protrudes outward from the second contact surface 20a as a pair of protrusions. It consists of strip members. Both the ridge member and the concave groove have the same continuous cross-sectional shape in the axial direction.
  • the ridge member and the concave groove each have a cross-sectional shape having substantially the same shape so that they can be fitted to each other.
  • the first engaging portion 15b is composed of a concave groove and the second engaging portion 24b is composed of a convex member, but the first engaging portion 15b is a convex member.
  • the second engaging portion 24b may be a concave groove.
  • the puncture device 10 is in contact with the first contact surface 10a and the second contact surface 20a, and is slidably moved along the axial direction with the first engaging portion 15b.
  • the second engaging portion 24b By fitting the second engaging portion 24b, it is connected to the measuring device 20.
  • the engagement between the second engaging portion 24b and the first engaging portion 15b provided in the second housing 21 is performed by a predetermined operation (for example, a slide operation). It will be released.
  • the puncture device 10 can be separated from the measurement device 20 by sliding and moving the puncture device 10 in the direction opposite to that at the time of connection in this released state.
  • the first engaging portion 15b and the second engaging portion 24b may be configured such that at least the puncture device 10 and the measuring device 20 can be detachably connected to each other. Therefore, the first engaging portion 15b and the second engaging portion 24b are not limited to the ridge members and the concave grooves that are attached and detached by the slide movement as shown in FIGS. 10A and 10B.
  • the device detection unit 33 is configured to detect the separated state of the puncture device 10 and the measuring device 20 and the connected state by fitting.
  • the device detection unit 33 has a detection piece that moves in a predetermined direction by sliding movement when the puncture device 10 is fitted, and a detection piece in a state where the puncture device 10 is normally fitted to the measurement device 20. It may be a detection mechanism having a detection unit (detection circuit) for electrically detecting the moving position of the above.
  • the device detection unit 33 detects the connection state and the separation state with the puncture device 10 by detecting that the detection piece has moved to a predetermined position, and the state according to the connection state or the separation state between the devices.
  • the information is output to the control unit 39.
  • the configuration of the device detection unit 33 is not limited as long as it has a function of detecting the connection between the puncture device 10 and the measurement device 20.
  • FIG. 12 shows an example of a connection operation between the puncture device 10 and the measurement device 20 in the component measuring device 100a of the modified example.
  • FIG. 12A shows a state in which the measurement by the measuring device 20 is completed and before the puncture device 10 is connected to the measuring device 20.
  • FIG. 12B when the puncture device 10 and the measurement device 20 are connected, the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measurement device 20 face each other.
  • the engaging portion 15b is inserted into the second engaging portion 24b.
  • the puncture device 10 is slid and moved along the axial direction so that the front end portion of the puncture device 10 and the front end portion of the measurement device 20 are parallel to each other in the direction intersecting the axial direction.
  • slide movement for example, one device may be fixed and the other device may be slid.
  • the first engaging portion 15b and the second engaging portion 24b are fitted to each other, and the first contact surface 10a and the second contact surface 20a are in contact with each other.
  • the puncture device 10 and the measurement device 20 are connected.
  • the component measuring device 100 has a piercing device 10 configured to puncture the surface of the living body and exude blood, and the blood exuded from the surface of the living body is contained in the test medium T.
  • a measuring device 20 configured to measure the amount of glucose component (blood glucose level) contained in blood by introducing the puncturing device 10 is provided, and the puncturing device 10 includes a first housing 11 and a first housing 11.
  • the measuring device 20 has a first contact surface 10a and a first connecting portion 15 provided on at least one of the outer surfaces of the above, and the measuring device 20 is a second housing 21 and a second housing 21.
  • the puncture device 10 and the measuring device 20 are in a state where the first contact surface 10a and the second contact surface 20a face each other and are in contact with each other, and the first connecting portion 15 and the second connecting portion are in contact with each other.
  • the first housing 11 and the second housing 21 are integrated to form the housing 110 of the component measuring device 100, and the first connecting portion 15 and the second connecting portion are connected.
  • the first contact surface 10a and the second contact surface 20a become the separation surface 101, and the puncture device 10 and the measurement device 20 are configured to be separate bodies.
  • the housing 11 and the second housing 21 do not have a portion protruding from the outer surface of the housing 110 in the region to be the outer surface of the housing 110.
  • the component measuring device 100 can be attached and detached in a state where the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measurement device 20 are butted against each other when not in use. Since the housing 110 is formed when they are connected and integrated, the device is excellent in portability and design. When the puncture device 10 and the measuring device 20 are integrated, the outer surface of the housing 110 of the component measuring device 100 has no convex shape. Therefore, the component measuring device 100 is prevented from being caught by other parts when being carried, and is difficult to be recognized as a medical device from the surroundings, so that the portability and design are improved. Further, since the component measuring device 100 can separate the puncture device 10 and the measuring device 20 at the time of use, each device can be used separately and the operability is good.
  • the first housing 11 preferably, when the first housing 11 abuts the first contact surface 10a and the second contact surface 20a via the separation surface 101, the first housing 11 is brought into contact with the first contact surface 10a. , May be configured to be connected complementarily to each other and integrated.
  • the device has excellent portability and design.
  • the outer shape of the first contact surface 10a may preferably have the same shape as the outer shape of the second contact surface 20a.
  • the first connecting portion 15 is a first magnetic member provided inside the first housing 11 facing the first contact surface 10a.
  • the second connecting portion 24 is a second magnetic member 24a provided inside the second housing 21 facing the second contact surface 20a, and is the first magnetic member 15a and the second magnetic member.
  • One of the members 24a may be made of a magnet, and the other may be made of a magnet or a magnetic material having a magnetic pole different from that of the magnet.
  • the puncture device 10 and the measurement device 20 can be magnetically connected to the first connecting portion 15 made of the first magnetic member 15a and the second connecting portion 24 made of the second magnetic member 24a, both devices can be connected.
  • the configuration to be connected is not complicated, and it can be easily separated even during use.
  • the first connecting portion 15 is a first engaging portion 15b provided on the first contact surface 10a
  • the second connecting portion 24 is a second connecting portion 24. It may be a second engaging portion 24b provided on the second contact surface 20a and fitted to the first engaging portion 15b by sliding movement along the axial direction.
  • the puncture device 10 and the measuring device 20 have a connecting structure including a first connecting portion 15 including a first engaging portion 15b and a second connecting portion 24 composed of a second engaging portion 24b, both devices are connected or connected.
  • separating at least one device can be connected and separated by a simple operation of sliding along the axial direction.
  • the measuring device 20 is a display unit 36 that displays a blood measurement result (blood glucose level) on a display surface 36a arranged on the second contact surface 20a. It may be configured with.
  • the display surface 36a is not exposed on the outer surface of the housing 110, so that medical treatment is performed from the surroundings. It becomes difficult to be recognized as an instrument.
  • the first housing and the second housing may preferably have a configuration in which a flat surface is formed at least partially.
  • each device when both devices are placed on a mounting surface such as a table with the puncture device 10 and the measuring device 20 separated, each device may have rolling that may occur when the device is placed on the mounting surface. Be prevented.
  • the measuring device 20 has a power supply unit 37 that controls the supply of driving power to the measuring device 20, and a separated state between the puncturing device 10 and the measuring device 20.
  • the configuration may include a device detection unit 33 that detects the connected state, and a control unit 39 that controls the power supply unit 37 and changes the drive power to be supplied based on the detection result by the device detection unit 33.
  • the component measuring device 100 can change the amount of electric power supplied based on the separated state and the connected state of the puncture device 10 and the measuring device 20, so that power saving can be achieved.
  • the measuring device 20 includes a measuring unit 31 for measuring the component amount of the glucose component contained in blood and a notifying unit 35 for performing predetermined notification.
  • the control unit 39 determines that the inspection medium T has not been removed within a predetermined time after the measurement by the measurement unit 31 is completed, the control unit 39 causes the notification unit 35 to execute a notification prompting the removal of the inspection medium T. It may be configured as.
  • the component measuring device 100 can make the user recognize that the inspection medium T has not been removed after the measurement of the measuring unit 31 is completed, so that the inspection medium T is forgotten to be removed. Can be prevented.
  • the control unit 39 is a puncture device within a predetermined time based on the detection result by the device detection unit 33 after the inspection medium T is removed.
  • the notification unit 35 may be configured to execute a notification prompting the connection between the puncture device 10 and the measuring device 20.
  • the puncture device 10 and the measuring device 20 are separable at the time of use, and both are miniaturized devices, so that it is easy to misplace them somewhere after use. ..
  • the component measuring device 100 gives a notification prompting the connection between the puncturing device 10 and the measuring device 20 at a predetermined timing after the blood component measuring process is completed, it is necessary to prevent the puncturing device 10 and the measuring device 20 from being misplaced. Can be done.
  • the body fluid is preferably the blood of the user, and the component may be a glucose component contained in the blood.
  • the component measuring device 100 is excellent in portability and goes out by being adopted in a blood glucose self-measuring device (SMBG device) that measures a blood glucose level based on the amount of glucose component contained in the user's blood as a component to be measured, for example. It can be a device that is difficult to be recognized as a medical device in the future.
  • SMBG device blood glucose self-measuring device
  • Puncture device (10a first contact surface), 11 First housing (11a first flat portion), 12 needle mounting part (12a opening, 12b needle engaging part), 13 Puncture operation part, 14-needle eject operation unit (14a first operation unit), 15 First connecting portion (15a first magnetic member, 15b first engaging portion), 16 Depth adjustment unit, 20 Measuring device (20a second contact surface), 21 Second housing (21a second flat part), 22 Medium mounting portion (22a second opening), 23 Medium eject operation unit (23a second operation unit), 24 Second connecting portion (24a second magnetic member, 24b second engaging portion), 31 Measuring unit, 32 Temperature detector, 33 Device detector, 34 Communication Department, 35 Notification unit, 36 display unit (36a display surface), 37 Power supply, 38 Memory 39 Control unit (39a timekeeping unit, 39b calculation unit, 39c judgment unit, 39d generation processing unit), 100, 100a component measuring device (101 separation surface, 102 separation cross-section end, 110 housing), N puncture needle cartridge (N1 needle holder, N2 puncture needle), T inspection medium (

Abstract

L'invention concerne un appareil de mesure de composants (100) comprenant un dispositif de ponction (10) configuré de manière à ponctionner une surface de corps vivant et à faire exsuder un fluide corporel de celle-ci, et un dispositif de mesure (20) configuré de manière à mesurer la quantité d'un composant prescrit inclus dans le fluide corporel à l'aide d'un milieu d'examen (T) dans lequel le fluide corporel peut être introduit, l'appareil de mesure de composants (100) étant configuré de sorte que lorsqu'il n'est pas utilisé, alors qu'une première partie de liaison (15) et une seconde partie de liaison (24) sont reliées dans un état dans lequel une première surface de contact (10a) du dispositif de ponction (10) et une seconde surface de contact (20a) du dispositif de mesure (20) sont en butée l'une contre l'autre, et que le dispositif de ponction (10) et le dispositif de mesure (20) sont intégrés, un boîtier (110) de l'appareil de mesure de composants (100) est formé par un premier boîtier (11) et un second boîtier (21), et lorsque l'appareil est utilisé, le dispositif de ponction (10) et le dispositif de mesure (20) peuvent être séparés par séparation de la première partie de liaison (15) et de la seconde partie de liaison (24).
PCT/JP2021/031666 2020-09-23 2021-08-30 Appareil de mesure de composants WO2022064966A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001524680A (ja) * 1997-11-28 2001-12-04 ロシュ ダイアグノスティックス ゲーエムベーハー 切開器具付分析用測定器
JP2002515302A (ja) * 1998-05-20 2002-05-28 ノボ ノルディスク アクティーゼルスカブ 糖尿病の自己薬物治療のために患者が使用するための医療機器
JP2011064597A (ja) * 2009-09-17 2011-03-31 Terumo Corp 血糖計及び血糖値測定方法
JP2016515024A (ja) * 2013-03-14 2016-05-26 ニプロ ダイアグナスティックス，インコーポレーテッド 交換可能なモジュールを備えた測定器

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001524680A (ja) * 1997-11-28 2001-12-04 ロシュ ダイアグノスティックス ゲーエムベーハー 切開器具付分析用測定器
JP2002515302A (ja) * 1998-05-20 2002-05-28 ノボ ノルディスク アクティーゼルスカブ 糖尿病の自己薬物治療のために患者が使用するための医療機器
JP2011064597A (ja) * 2009-09-17 2011-03-31 Terumo Corp 血糖計及び血糖値測定方法
JP2016515024A (ja) * 2013-03-14 2016-05-26 ニプロ ダイアグナスティックス，インコーポレーテッド 交換可能なモジュールを備えた測定器

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