Component Measuring Device

Abstract

A component measurement apparatus (100) comprising a puncture device (10) configured so as to puncture a living body surface and cause a body fluid to exude therefrom, and a measurement device (20) configured so as to measure the quantity of a prescribed component included in the body fluid using an examination medium (T) into which the body fluid can be introduced, the component measurement apparatus (100) being configured such that when the apparatus is not in use, when a first connecting part (15) and a second connecting part (24) are connected in a state in which a first contacting surface (10a) of the puncture device (10) and a second contacting surface (20a) of the measurement device (20) are butted against each other, and the puncture device (10) and the measurement device (20) are integrated, a casing (110) of the component measurement apparatus (100) is formed by a first casing (11) and a second casing (21), and when the apparatus is in use, the puncture device (10) and the measurement device (20) can be separated by disconnection of the first connecting part (15) and the second connecting part (24).

Description

[Technical field]

[0001] The present invention relates to a component measuring device that measures components in body fluids such as blood. [Background technology]

[0002] 2. Description of the Related Art As a component measuring device for measuring components in body fluids such as blood, for example, a technique for measuring blood glucose levels as disclosed in Patent Document 1 below is known.

[0003] When measuring blood glucose levels using the system of Patent Document 1 below, the user first attaches a testing medium (test strip) having a reagent to the meter. Next, the user punctures the skin of a finger or the like using an attached puncturing device, and deposits a small amount of blood that seeps out from the skin onto the testing portion (sample chamber) of the test strip. The meter measures the amount (concentration) of glucose in the blood by reacting the blood (whole blood) deposited on the test strip with the reagent based on an electrochemical or colorimetric method, and displays the result as a blood glucose level on the display. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2007-520699 Summary of the Invention [Problem to be solved by the invention]

[0005] Incidentally, the meter used in the system disclosed in Patent Document 1 is provided on the lid of a container that contains a test strip, and a lancing device is integrally attached to the side of the container, so that the user can carry it when going out and measure their own blood glucose level. Therefore, there is a demand for improved portability of this type of device, including the meter of Patent Document 1, so that it can be easily carried when going out.

[0006] However, in the instrument of Patent Document 1, the puncture device is attached in an exposed state to the container, so when carrying the instrument, the protruding part (convex-shaped part) of the puncture device easily gets caught on other surrounding parts (for example, the user's clothing, clothing accessories such as a bag, etc.), leaving room for improvement in terms of portability.

[0007] Furthermore, the instrument of Patent Document 1 has an exposed puncture device attached to the container, giving it an appearance resembling that of a medical instrument, and there is a need for design improvements.

[0008] At least one embodiment of the present invention has been made in consideration of the above-mentioned circumstances, and specifically, an object of the present invention is to provide a component measuring device that is highly portable and has an excellent design, in a configuration including a puncture device for collecting blood and a measuring device for measuring the amount of a specified component in a body fluid. [Means for solving the problem]

[0009] The component measuring device according to the present embodiment is a component measuring device including a puncturing device configured to puncture a biological surface to cause a body fluid to exude, and a measuring device configured to measure the amount of a predetermined component contained in the body fluid by introducing the body fluid into a test medium, the puncturing device having a first housing, a first contact surface provided on at least one of the outer surfaces of the first housing, and a first connecting part, and the measuring device having a second housing, a second contact surface provided on at least one of the outer surfaces of the second housing, and a second connecting part connectable to the first connecting part. the pricking device and the measuring device are configured such that the first housing and the second housing are integrated to form the housing of the component measuring device by connecting the first connecting part and the second connecting part with the first abutment surface and the second abutment surface facing each other, and the first housing and the second housing are configured such that the first abutment surface and the second abutment surface become separation surfaces and the pricking device and the measuring device become separate entities by releasing the connection between the first connecting part and the second connecting part, and the first housing and the second housing have portions protruding from the outer surface of the housing in an area that becomes the outer surface of the housing. The measuring device further includes a power supply unit that controls the supply of driving power to the measuring device, and a device detection unit that detects a separated state and a connected state of the pricking device and the measuring device., and a control unit that controls the power supply unit to change the driving power supplied based on a result of detection by the device detection unit. Effect of the Invention

[0010] According to one embodiment of the present invention, a component measuring device that is highly portable and has a stylish design can be provided, in a configuration that includes a puncture device for collecting blood and a measuring device for measuring the amount of a specific component in a body fluid. [Brief description of the drawings]

[0011] [Figure 1] 1 is a schematic perspective view of a component measuring device according to an embodiment of the present invention, seen from the front side. [Diagram 2] 1 is a schematic perspective view of a component measuring device according to an embodiment of the present invention, seen from the rear side. [Diagram 3] FIG. 2 is a schematic perspective view showing a state in which the puncture device and the measuring device of the component measuring device according to the present embodiment are separated. [Figure 4] FIG. 2 is a functional block diagram of the measuring device according to the embodiment. [Figure 5A] FIG. 2 is a schematic perspective view of the component measuring device according to the present embodiment, as viewed from the needle attachment side of the puncture device. [Figure 5B] FIG. 2 is a schematic perspective view of the component measuring device according to the present embodiment, as viewed from the needle ejection operation unit side of the puncture device. [Figure 6A] 1 is a conceptual diagram showing a state in which a puncture needle cartridge is attached to a puncture device of a component measuring apparatus according to the present embodiment. FIG. [Figure 6B] 4 is a conceptual diagram showing a state in which a puncture needle is advanced by a puncture device of the component measuring apparatus according to the present embodiment. FIG. [Figure 6C] 4 is a conceptual diagram showing a state in which a puncture needle is retracted by the puncture device of the component measuring apparatus according to the present embodiment. FIG. [Figure 6D] 10 is a conceptual diagram showing a state in which the pricking device of the component measuring device according to the present embodiment has been subjected to an ejection operation. FIG. [Figure 6E] 4 is a conceptual diagram showing a state in which a puncture needle cartridge has been removed from the puncture device of the component measuring device according to the present embodiment. FIG. [Figure 7A]2 is a schematic perspective view of the measuring device of the component measuring device according to the present embodiment, as viewed from the medium mounting portion side. FIG. [Figure 7B] 2 is a schematic perspective view of the component measuring device according to the present embodiment, as viewed from the medium ejection operation unit side of the puncture device. FIG. [Figure 8A] 1 is a conceptual diagram showing a state in which a test medium is attached to a measurement device of a component measuring device according to the present embodiment. FIG. [Figure 8B] 3 is a conceptual diagram showing a measurement state by a measurement device of the component measuring apparatus according to the present embodiment. FIG. [Figure 8C] FIG. 4 is a conceptual diagram showing a state in which the measuring device of the component measuring device according to the present embodiment is subjected to an ejection operation. [Figure 8D] 4 is a conceptual diagram showing a state in which a test medium is removed from the measurement device of the component measuring device according to the present embodiment. FIG. [Figure 9] 4 is a flowchart showing an example of a series of operations when the component measuring device according to the present embodiment is used. [Figure 10A] FIG. 11 is a schematic perspective view of a puncture device of a component measuring device according to the present embodiment, which is a modified example, viewed from the first contact surface side. [Figure 10B] FIG. 11 is a schematic perspective view of a measuring device of a component measuring device according to the present embodiment, which is a modified example, viewed from the second contact surface side. [Figure 11] FIG. 11 is a schematic perspective view showing a state in which the puncture device and the measuring device of the component measuring device according to the present embodiment, which is a modified example, are connected. [Figure 12A] FIG. 13 is a conceptual diagram showing a state before the puncture device and the measuring device of the component measuring device according to the present embodiment, which is a modified example, are connected to each other. [Figure 12B] FIG. 13 is a conceptual diagram showing a state in which the puncture device and the measuring device of the component measuring device according to the present embodiment, which is a modified example, are being connected to each other. [Figure 12C] FIG. 13 is a conceptual diagram showing a state after the puncture device and the measuring device of the component measuring device according to the present embodiment, which is a modified example, are connected. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Hereinafter, the embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely illustrative in order to embody the technical idea of ​​the present invention, and do not limit the present invention. Furthermore, all other possible embodiments, examples, and operating techniques that can be conceived by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the inventions described in the claims and their equivalents.

[0013] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product; however, these are merely examples and are not intended to limit the interpretation of the present invention.

[0014] In this specification, for convenience of explanation, 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 a direction perpendicular to the Z direction and parallel to the horizontal plane, and the "Y direction" is a direction perpendicular to the X direction among another direction perpendicular to the Z direction and parallel to the horizontal plane (direction perpendicular to the X direction). In the component measuring device 100 according to this embodiment, the Z direction coincides with the thickness direction (up-down direction) of the housing 110, the X direction coincides with the longitudinal direction (front-rear direction) along the long axis direction of the housing 110, and the Y direction coincides with the short side direction (width direction) of the housing 110.

[0015] In the following description, when ordinal numbers such as "first" and "second" are used, unless otherwise specified, they are used for convenience and do not dictate any order.

[0016] The component measuring device 100 according to one embodiment of the present invention is a device that punctures the surface of a user's body (e.g., skin) as a puncture site to exude bodily fluid and measures the amount of a predetermined component contained in the bodily fluid. In the following embodiment, the component measuring device 100 will be described as being adopted in a self-monitoring of blood glucose (SMBG) device that measures the amount of glucose (blood glucose level) contained in bodily fluid (blood) by the user himself.

[0017] The component measuring device 100 is not limited to an SMBG device, but can also be used as a POCT (Point of Care Testing) device operated mainly by medical personnel. In addition, since the component measuring device 100 is a device that measures the amount of a specific component contained in a body fluid, the type of body fluid and the amount of the component to be measured are not limited to the configuration of this embodiment.

[0018] [composition] First, the configuration of a component measuring device 100 according to this embodiment will be described with reference to Figs. 1 to 8 as appropriate.

[0019] As shown in Figure 1 or 2, the component measuring device 100 comprises a puncturing device 10 that punctures the user's puncture site to allow blood (whole blood) to seep out, and a measuring device 20 that measures the amount of a specified component contained in the blood exuded by the puncturing device 10.

[0020] The component measuring device 100 has a configuration in which the pricking device 10 and the measuring device 20 are separably integrated along a separation surface 101 extending along the axial direction (X direction). When the component measuring device 100 is not in use (such as when it is carried after measurement), the first contact surface 10a of the pricking device 10 and the second contact surface 20a of the measuring device 20 are brought into contact with each other to connect the two devices. The component measuring device 100 shown in Figs. 1 and 2 shows a state when not in use.

[0021] 3, when the component measuring device 100 is used (during puncturing and measurement), the contact state between the first contact surface 10a and the second contact surface 20a is released. At this time, the first contact surface 10a is exposed as a part of the housing of the puncturing device 10, and the second contact surface 20a is exposed as a part of the housing of the measuring device 20. This allows the user to separate the puncturing device 10 and the measuring device 20 and use them independently. The first contact surface 10a of the puncturing device 10 and the second contact surface 20a of the measuring device 20 form a separation surface 101 that functions as a separation surface of the component measuring device 100.

[0022] In the component measuring device 100 according to this embodiment, the separation surface 101 is provided at least along the longitudinal direction of the component measuring device 100, and is a surface where the puncture device 10 and the measuring device 20 are separated. The separation surface 101 may be, for example, a vertical surface extending perpendicularly to the width direction of the component measuring device 100. In this case, the separation cross-section end 102, which is the end face of the separation surface 101 when the component measuring device 100 is viewed from the needle mounting part 12 (or the needle ejection operation part 14) side, coincides with the Z direction, and at this time, the area of ​​the separation surface 101 is minimized. Alternatively, as shown in FIG. 1 and FIG. 2, the separation cross-section end 102 can be inclined by a predetermined angle in the axial direction when viewed from the needle mounting part 12 side (or the needle ejection operation part 14 side). More specifically, the separation surface 101 is an inclined surface that inclines in the width direction as it approaches the thickness direction. When separation surface 101 is an inclined surface inclined with respect to the Z direction, separation surface 101 can be made wider than when it is made a vertical surface, and therefore the holding force of puncturing device 10 and measuring device 20 can be appropriately maintained. Furthermore, when connecting puncturing device 10 and measuring device 20, the user can visually confirm the correct connection direction.

[0023] The position of the separation surface 101 in 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 measuring device 20, but the separation surface 101 is configured to be complementary to each other when the puncture device 10 and the measuring device 20 come into contact with each other. The shape of the separation surface 101 may be a flat surface, a curved surface, or a combination of convex and concave surfaces, but the separation surface 101, i.e., the first contact surface 10a and the second contact surface 20a, are preferably flat surfaces or smoothly curved surfaces, more preferably flat surfaces, in consideration of hygiene. The footprints of the first contact surface 10a and the second contact surface 20a are preferably almost the same. It is more preferable that the first contact surface 10a and the second contact surface 20a are configured to have the same shape and size. This makes it possible to eliminate any part protruding from the outer surface of the housing 110 when the puncture device 10 and the measuring device 20 are combined. The separated cross-sectional end 102 is located between the first opening 12a and the second opening 22a described below, or between the medium ejection operation unit 23 and the needle ejection operation unit 14. The separated cross-sectional end 102 may be straight, curved, or a combination thereof, as long as it does not interfere with the functions of the medium ejection operation unit 23 and the needle ejection operation unit 14.

[0024] 3, the housing (first housing 11) of the puncturing device 10 and the housing (second housing 21) of the measuring device 20 are connected by a first connecting part 15 (see FIGS. 5A and 5B) of the puncturing device 10 and a second connecting part 24 of the measuring device 20 in a state where a first contact surface 10a of the puncturing device 10 and a second contact surface 20a of the measuring device 20 are in contact with each other, thereby forming a housing 110 of the component measuring device 100. The first connecting part 15 of the puncturing device 10 and the second connecting part 24 of the measuring device 20 function as a connecting part of the component measuring device 100. The connecting part connects the puncturing device 10 and the measuring device 20 so that the user can detach and connect them as desired.

[0025] The component measuring device 100 has no portion protruding from the outer surface of the housing 110 when the puncturing device 10 and the measuring device 20 are connected (i.e., when not in use). Specifically, when the puncturing device 10 and the measuring device 20 are connected, the outer surface areas of the first housing 11 and the second housing 21 constituting the housing 110 do not have an outward convex shape (protrusion). In this embodiment, the outer shape of the component measuring device 100 is configured such that, when the puncturing device 10 and the measuring device 20 are integrated, the cross section of the component measuring device 100 is a columnar shape having a substantially rounded rectangular shape, and there is no convex shape on the outer surface.

[0026] In this way, the component measuring device 100 has no convex shape on the outer surface of the housing 110 when not in use, so that it is prevented from getting caught on other parts around it when it is carried, and portability is improved. In addition, when the component measuring device 100 is not in use, the outer surface of the housing 110 is smooth without a convex shape because the two devices are connected. Therefore, the component measuring device 100 is not easily recognized as a medical instrument in appearance, and has excellent design. Furthermore, when the component measuring device 100 is in use, the puncture device 10 and the measuring device 20 can be separated by the user. Therefore, the operability of each device is improved.

[0027] Next, each part constituting the component measuring device 100 will be described with reference to Fig. 4 to Fig. 8 as appropriate. Fig. 5 and Fig. 6 are diagrams mainly for explaining the configuration of the puncture device 10, and Fig. 7 and Fig. 8 are diagrams mainly for explaining the configuration of the measuring device 20. Fig. 4 is a diagram for explaining the control system of the measuring device 20.

[0028] <Puncture device> As shown in Figure 5A or 5B, the puncture device 10 is provided within a first housing 11 with a needle mounting section 12 on which a puncture needle cartridge N is attached, a puncture operation section 13 that moves the puncture needle N2 of the puncture needle cartridge N attached to the needle mounting section 12 back and forth to puncture the site to be punctured of the user, a needle ejection operation section 14 that is operated when removing (ejecting) a used puncture needle cartridge N attached to the needle mounting section 12, a first connection section 15 for maintaining the connection with the measurement device 20, and a depth adjustment section 16 for adjusting the puncture depth of the puncture needle N2 relative to the site to be punctured.

[0029] 5A or 5B, the first housing 11 of the puncture device 10 has a first contact surface 10a. The first contact surface 10a faces a second contact surface 20a of the measuring device 20 when the puncture device 10 is connected to the measuring device 20. The first contact surface 10a functions as a separation surface 101 of the component measuring device 100, and is maintained in contact with the second contact surface 20a of the measuring device 20 when the component measuring device 100 is not in use.

[0030] Furthermore, when 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 minimized, thereby enhancing the sense of unity of the housing 110. For this reason, it is preferable that the first contact surface 10a is formed so as not to have any portion protruding from the surface. Furthermore, by configuring the first contact surface 10a so as not to have any convex portion protruding from the first contact surface 10a, the contact state with the second contact surface 20a can be stabilized.

[0031] The first housing 11 is provided with a first flat portion 11a consisting of a flat surface on at least a part of the outer surface. This makes it possible to prevent the puncture device 10 from rolling when it is placed on a placement surface such as a table while separated from the measuring device 20. The first flat portion 11a may be disposed on a part or a plurality of places on the outer surface of the first housing 11 other than the first contact surface 10a. When the first contact surface 10a is formed to be substantially flat, it may function as the first flat portion 11a.

[0032] The needle mounting section 12 has a first opening 12a, into which the puncture needle cartridge N is inserted and mounted. The puncture needle cartridge N is a medical device for blood collection that includes a puncture needle N2 that is housed so as to be able to advance and retreat from a hole provided on the front end side of the needle holder N1. The puncture needle cartridge N is used by contacting it with a site to be punctured. Examples of the site to be punctured include the surface of the user's body (skin, mucous membrane, etc.) such as the fingertip, palm, upper arm, abdomen, thigh, and earlobe. Therefore, in order to prevent the risk of infection, etc., the puncture needle cartridge N is single-use, and is removed from the puncture device 10 and discarded after use. The puncture device 10 is used repeatedly.

[0033] The needle mounting portion 12 has a needle engagement portion 12b. The puncture needle cartridge N is held in the puncture device 10 by engaging a rear end portion of the puncture needle cartridge N (a rear end portion of the needle holder N1) with the needle engagement portion 12b.

[0034] The needle engagement part 12b holds the rear end of the hub of the puncture needle N2 in the puncture needle cartridge N so that it can advance and retreat in the axial direction. The needle engagement part 12b has an elastic member (such as a coil spring) that is expandable and contractable in the axial direction, and advances and retreats the puncture needle N2 in the puncture needle cartridge N in the axial direction by utilizing the biasing force of the elastic member based on the operation of the puncture operation part 13. In this embodiment, the needle attachment part 12 has, as elastic members, a puncture spring (not shown) 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 return spring for retracting the needle tip of the advanced puncture needle N2 to its original position (standby position).

[0035] The puncture operation unit 13 is configured with a mechanical switch that causes the puncture needle cartridge N to perform a puncture operation. In the component measuring device 100 according to this embodiment, the puncture operation unit 13 may be configured with a button-type switch mechanism that causes the puncture needle cartridge N to perform a puncture operation when the puncture operation unit 13 is pressed. In the first housing 11, the puncture operation unit 13 is preferably disposed, for example, within the first contact surface 10a area so as not to protrude from the outer surface of the housing 110 of the component measuring device 100. By disposing 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 impaired.

[0036] The needle ejection operation unit 14 is operated when removing a used puncture needle cartridge N from the puncture device 10. As one example, the needle ejection operation unit 14 may be configured as a lever member that the user presses along the longitudinal direction to perform an ejection operation. The needle ejection operation unit 14 has a first operation body 14a that is formed along the outer shape of the first housing 11. In other words, the first operation body 14a does not protrude from the outer shape of the first housing 11 when not in use.

[0037] The first operating body 14a is provided so as to be movable along the axial direction by a predetermined ejection operation (pressing operation) by the user, and removes the puncture needle cartridge N from the needle mounting part 12 via an engagement member (not shown) housed in the first housing 11. The engagement member is a member that engages with the puncture needle cartridge N and moves in conjunction with it in the axial direction depending on the amount of operation of the first operating body 14a. The first operating body 14a is provided with an elastic member (such as a coil spring) (not shown), and when an ejection operation is performed to remove the puncture needle cartridge N, it moves from an initial position to an ejection position, and after the puncture needle cartridge N is removed, it moves back to the initial position due to the biasing force of the elastic member.

[0038] The first connecting part 15 connects with the second connecting part 24 to maintain the connection state between the puncture device 10 and the measuring device 20. The first connecting part 15 is, for example, configured with a first magnetic member 15a made of a magnetic material or a magnet. The material of the first connecting part 15 may be appropriately selected according to the form of the second connecting part 24. That is, when the second magnetic member 24a functioning as the second connecting part 24 is made of a magnetic material, the first magnetic member 15a may be configured with a magnet so as to be connectable with the second magnetic member 24a. Furthermore, when the second magnetic member 24a is made of a magnet, the first magnetic member 15a may be configured with a magnetic material or a magnet with a different magnetic pole from the second magnetic member 24a so as to be connectable with the second magnetic member 24a.

[0039] The first connecting portion 15 is disposed inside the first housing 11 near the first contact surface 10a so as to face the second connecting portion 24 disposed on the second contact surface 20a of the measuring device 20. This makes it possible to maintain the connection state of the two devices when the puncture device 10 and the measuring device 20 are connected to each other without disturbing the contact state between the first contact surface 10a and the second contact surface 20a.

[0040] The length to which the puncture needle N2 of the puncture needle cartridge N attached to the needle attachment part 12 advances (the puncture depth when puncturing the puncture site (the biological surface such as the skin) of the user) can be adjusted to any length by the depth adjustment part 16. The depth adjustment part 16 adjusts the amount of advancement (puncture depth) of the puncture needle N2 of the puncture needle cartridge N. The depth adjustment part 16 is operated to adjust the length to which the puncture needle N2 advances from the opening of the needle holder N1, i.e., the puncture depth from the biological surface, depending on the individual differences of the user who is the blood recipient and the puncture site. The puncture depth by the depth adjustment part 16 (the amount of advancement of the puncture needle N2) can be adjusted in multiple stages by an adjustment dial or the like.

[0041] 6A to 6E, an example of how the pricking device 10 can be used will now be described. The pricking device 10 is operated when drawing blood, which is necessary for measuring a blood glucose level using the measuring device 20.

[0042] As shown in FIG. 6A, the puncture needle cartridge N is attached to the needle mounting section 12 by the user. At this time, the rear end of the puncture needle cartridge N engages with the needle engagement section 12b. Next, as shown in FIG. 6B, when the puncture operation section 13 is operated by the user, the needle mounting section 12 advances the needle tip of the puncture needle cartridge N to a predetermined advanced position by the biasing force of the puncture spring. As shown in FIG. 6C, when the operation of the puncture operation section 13 is completed, the advanced needle tip of the puncture needle cartridge N is retreated to its original position (standby position) by the biasing force of the return spring. In this way, when the puncture operation section 13 is operated, the puncture needle cartridge N attached to the needle mounting section 12 reciprocates the puncture needle N2 along the axial direction between the standby position and the advanced position, puncturing a predetermined biological surface of the user.

[0043] Next, as shown in FIG. 6D, the user presses down the first operating body 14a along the axial direction to move the engagement member inside the first housing 11 toward the distal end along the axial direction, thereby releasing the engagement between the needle attachment portion 12 (more specifically, the needle engagement portion 12b) and the puncture needle cartridge N.

[0044] Then, the puncture device 10 returns to the state shown in Fig. 6E (i.e., the state before use) when the user removes the used puncture needle cartridge N from the puncture device 10 without touching it with his or her hands. When the puncture needle cartridge N is removed from the puncture device 10, the first operating body 14a returns from the eject position to the initial position before operation due to the biasing force of the elastic member.

[0045] Measuring Device As shown in either Figure 7A or 7B, the measuring device 20 is provided with a second housing 21, a media mounting section 22 in which disposable type testing medium T is mounted, a media ejection operation section 23 which is operated when removing used testing medium T attached to the media mounting section 22, and a second connection section 24 for maintaining the connection with the puncture device 10.

[0046] As shown in FIG. 4, the measuring device 20 is equipped with a control system including a measuring unit 31, a temperature detection unit 32, a device detection unit 33, a communication unit 34, an alarm unit 35, a display unit 36, a power supply unit 37, a memory unit 38, and a control unit 39 to execute various processes related to measuring the amount of components in body fluids.

[0047] 7A or 7B, the second housing 21 of the measuring device 20 has a second contact surface 20a that faces the first contact surface 10a of the puncturing device 10 when connected to the puncturing device 10. The second contact surface 20a functions as the separation surface 101 of the component measuring device 100, and is maintained in contact with the first contact surface 10a of the puncturing device 10 when the component measuring device 100 is not in use.

[0048] Similarly to the first contact surface 10a, the second contact surface 20a is preferably formed so as not to have any portion protruding from the surface. By configuring the second contact surface 20a so as not to have any convex shape on the surface, the contact state with the first contact surface 10a can be stabilized and gaps that may occur on the outer surface of the housing 110 can be minimized.

[0049] In addition, the second housing 21 is provided with a second flat portion 21a consisting of a flat surface on at least a part of the outer surface. Therefore, the measuring device 20 can be prevented from rolling when it is placed on a placement surface such as a table in a state where it is separated from the puncture device 10. The second flat portion 21a may be arranged on a part or a plurality of places on the outer surface of the second housing 21 other than the second contact surface 20a. In addition, when the second contact surface 20a is formed to be 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.

[0050] When the puncture device 10 and the measuring device 20 are connected, the second flat portion 21a is preferably disposed 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 disposing the first flat portion 11a and the second flat portion 21a on the same surface of the housing 110, both flat portions function as a mounting surface, and the mounting stability of the component measuring device 100 can be improved.

[0051] The medium mounting section 22 has a second opening 22a, into which the test medium T is inserted. The test medium T is, for example, a disposable type test strip having a test section T1 (see FIG. 8D) having a predetermined reagent at the front end, and is discarded after measurement. The test section T1 holds a reagent (coloring reagent) that reacts specifically with the substance to be measured in the blood. The reagent may be held on a carrier such as a porous membrane capable of absorbing blood. By reacting with the reagent, the blood develops a color with a color intensity corresponding to the amount of glucose contained in the blood.

[0052] The opening shape of the second opening 22a may be formed to match the shape (cross-sectional shape) of the mounted testing medium T. The opening shape of the second opening 22a is set according to the shape of the mounted testing medium T. Therefore, when the testing medium T is not a plate-like shape like a test strip but a substantially cylindrical chip, the second opening 22a has a shape that allows the chip to be mounted.

[0053] The medium mounting section 22 also has a medium holding section (not shown) that holds the mounted test medium T and allows the rear end of the test medium T to advance through the second opening 22a when it is removed.

[0054] The medium holding part is provided inside the second housing 21 of the measuring device 20 so as to be movable along the axial direction. The medium holding part moves along the axial direction between a position (measurement position) where the medium holding part holds at least a portion of the test medium T (particularly the vicinity of the tip) and performs measurement within the second housing 21, and a position (eject position) where the test medium T is removed.

[0055] The medium holding part holds the test medium T inserted from the second opening 22a, and when the medium ejection operation part 23 is operated after the measurement is completed, the medium holding part moves toward the distal end side in the long axis direction while holding the test medium T. Since the test medium T is pushed out from the second opening 22a of the second housing 21 by a predetermined length, the user can remove the test medium T after the measurement from the measuring device 20 without touching it with his / her hands. The amount of pushing out of the test medium T by the medium holding part (corresponding to the operation amount of the medium ejection operation part 23) is appropriately determined depending on the size of the second housing 21, the longitudinal length of the test medium T, and the protruding amount (exposed length) from the second opening 22a required for gripping, but it is preferable that the length is at least long enough to allow the test medium T to be removed from the second opening 22a.

[0056] The medium eject operation unit 23 is operated when removing the used test medium T from the measurement device 20. As an example, the medium eject operation unit 23 may be configured with a lever member that is provided so as to be movable along the axial direction by the user. The medium eject operation unit 23 is formed along the outer shape of the second housing 21, and has a second operation body 23a that is operated by the user.

[0057] The second operating body 23a is provided so as to be movable along the axial direction by a predetermined ejection operation (pressing operation) by the user, and engages with the medium holding part in the second housing 21. The medium holding part moves to the front end side in the axial direction in the second housing 21 with the movement of the second operating body 23a in the axial direction. The protruding amount (exposed amount) of the test medium T held in the medium holding part from the second opening 22a gradually increases with the movement of the second operating body 23a. When the medium holding part moves to the eject position by the operation of the second operating body 23a, the test medium T is released from the measurement device 20. After the test medium T is removed, the second operating body 23a moves to a position before the operation (initial position), and then the medium holding part moves to the rear end side in the axial direction with the movement of the second operating body 23a to 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 biasing force of an elastic member (such as a coil spring) not shown.

[0058] The second connecting part 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 connection state. The second connecting part 24 is, for example, composed of a second magnetic member 24a made of a magnetic material or a magnet. The second connecting part 24 may be made of a material selected appropriately according to the form of the first connecting part 15. That is, when the first magnetic member 15a is composed of a magnetic material, the second magnetic member 24a may be composed of a magnet so as to be connectable with the first magnetic member 15a. Furthermore, when the first magnetic member 15a is composed of a magnet, the second magnetic member 24a may be composed of a magnetic material or a magnet with a different magnetic pole from the first magnetic member 15a so as to be connectable with the first magnetic member 15a.

[0059] The second connecting portion 24 is disposed inside the second housing 21 near the second abutment surface 20a so as to face the first connecting portion 15 disposed on the first abutment surface 10a of the puncture device 10. This makes it possible, when the puncture device 10 and the measuring device 20 are connected to each other, to maintain the connection state of the two devices without disturbing the abutment state between the first abutment surface 10a and the second abutment surface 20a.

[0060] Next, the control system of the measuring device 20 will be described with reference to FIG.

[0061] The measuring unit 31 measures the amount of a component of the body fluid to be measured. In the component measuring device 100 according to this embodiment, the measuring unit 31 optically measures the amount of glucose in blood. The measuring unit 31 has a light-emitting element and a light-receiving element (not shown), and is configured as an optical measuring instrument that irradiates light from the light-emitting element to the blood spread in the testing unit T1 and detects the transmitted light with the light-receiving element. The measuring unit 31 is disposed in a position (for example, above the testing unit T1 at the measurement position) in the second housing 21 where the testing medium T held at the measurement position by the medium holding unit can be tested. The measuring unit 31 intermittently emits light of a single or multiple predetermined wavelengths from the light-emitting element, receives the light transmitted through the testing unit T1 with the light-receiving element, and outputs an electrical signal proportional to the amount of received light. The control unit 39 captures the electrical signal as a digitalized measured value. This measured value changes depending on the state, so it is a data series for each wavelength.

[0062] The user operates the test medium T to load the test medium T into the medium loading section 22. The measurement section 31 detects that the test medium T has been loaded into the medium loading section 22 by acquiring a change in the amount of light before and after loading the test medium T into the measuring device 20, and issues a notification and display to the notification section 35 and display section 36 of the device via the control section 39 to prompt the user to deposit a spot of blood.

[0063] The user applies 0.5 to 10 μL of blood obtained by the pricking device 10 to the spotting port T2 at the distal end of the test medium T. After the blood is introduced along a capillary channel (not shown) provided inside the test medium T, it is mixed with a reagent and reacts with glucose. This causes the blood to develop a color in an amount corresponding to the glucose level in the blood. In the capillary channel inside the test medium T, the test part T1 is located at a position corresponding to the measurement part 31 when the test medium T is attached to the measurement device 20. The blood mixed with the reagent spreads along the capillary channel and reaches the test part T1. The test medium T may have an air vent hole (not shown) for facilitating the introduction of blood into the capillary channel, and the air vent hole is provided at the end of the capillary channel opposite to the spotting port T2. When the blood mixed with the reagent reaches the test section T1 and spreads into the gap of the test section T1, the measurement section 31 emits light of a predetermined wavelength from the light-emitting element and measures the amount of reagent reaction based on the reagent reaction corresponding to the glucose level in the blood from the amount of light transmitted through the test section T1.

[0064] The measurement unit 31 continues to intermittently measure the emitted light and received light intensity, outputting a time-series electrical signal according to the amount of light transmitted through the testing unit T1 from the state in which there is no sample yet in the testing unit T1 until blood mixed with a reagent flows in and the reaction progresses, and the control unit 39 imports this as a data series of the measurement value.

[0065] The control unit 39 detects that blood mixed with a reagent has flowed into the testing unit T1 from a state in which there is no sample (blood), and this triggers the start of the measurement process. The control unit 39 performs measurement termination processing when a preset time has elapsed or when it determines this based on the measured value (for example, when the change in the measured value reaches a plateau). From the start of the measurement to the end of the measurement, the control unit 39 notifies and displays the measurement from the start to the end of the measurement on the notification unit 35 and display unit 36 ​​of the device.

[0066] The measuring unit 31 is configured to perform colorimetric measurement that optically detects the blood glucose level in the blood, but other measurement methods can also be applied. Examples of blood glucose level measurement methods include an enzyme electrode method in which a reagent is applied around an electrode and an electrical change caused by a reaction between the reagent and the blood is detected, that is, a current generated between the detection electrode and the counter electrode. Naturally, the measuring unit 31 only needs to measure the amount of a component in the body fluid to be measured, so the device configuration can be changed appropriately depending on the component to be measured.

[0067] The temperature detection unit 32 is configured with 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.

[0068] The device detection unit 33 detects the connected or separated state of the puncture device 10 relative to the measuring device 20, i.e., the connected state of the puncture device 10 relative to the measuring device 20 (a state in which the first abutment surface 10a and the second abutment surface 20a are abutted and connected when the component measuring device 100 is not in use) and the separated state of the puncture device 10 (a state in which the first abutment surface 10a and the second abutment surface 20a are separated when the component measuring device 100 is in use).

[0069] The device detection unit 33 can adopt a method according to the connection method of the puncture device 10 and the measuring device 20 as a method for detecting the attachment / detachment state of both. In the component measuring device 100 according to this embodiment, the puncture device 10 and the measuring device 20 are configured to be magnetically connected. Therefore, the device detection unit 33 may be configured, for example, with 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 magnetically detects a state in which the first contact surface 10a and the second contact surface 20a are in contact with each other to connect the puncture device 10, and a state in which the first contact surface 10a and the second contact surface 20a are separated from each other to separate the puncture device 10. The device detection unit 33 outputs state information (connection state information, separation state information) indicating the detected connection state or separation state to the control unit 39.

[0070] It should be noted that the device detection section 33 only needs to have a configuration capable of detecting the connected and separated state (attached / detached state) of the puncture device 10 with respect to the measuring device 20, and the method of detecting the attached / detached state of the two is not limited to the above configuration.

[0071] The communication unit 34 is a network interface that controls wired or wireless communication (including short-range wireless communication) with other devices (communication destinations, such as external servers in medical facilities and various mobile terminals owned by doctors in charge) connected via a communication network in accordance with a predetermined protocol. The communication unit 34 transmits transmission data including measurement values ​​indicating the measured amounts of components (blood glucose levels) to the communication destinations.

[0072] The notification unit 35 is composed of an alarm such as a speaker that outputs a notification sound such as a voice or a buzzer sound, a light-emitting device that lights up or flashes in various colors, a vibrator that generates a predetermined vibration, etc., and notifies the user of predetermined notification content (for example, the start or end of a predetermined operation, a warning due to an error occurrence, a procedure guide, etc.) in a manner that allows the user to identify it. Furthermore, under the control of the control unit 39, the notification unit 35 issues notifications such as a notification to prompt the user to remove the testing medium T from the medium mounting unit 22 and a notification to prompt the user to connect the puncturing device 10 and the measuring device 20. This prevents the user from forgetting to remove the testing medium T or leaving the component measuring device 10 behind.

[0073] 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 is an interface that outputs display contents in a format that is visible to the user (characters, numbers, figures, and other symbols). The display unit 36 ​​not only displays, for example, the amounts of components in the body fluid measured by the measurement unit 31 (more specifically, values ​​calculated by the calculation unit 39b of the control unit 39), but also displays notification contents required for operation (guidance display, display of start and end of measurement, etc.). The display contents (display data) displayed on the display surface 36a of the display unit 36 ​​are output from the control unit 39.

[0074] The display surface 36a of the display unit 36 ​​is disposed on the second contact surface 20a. Therefore, the display surface 36a of the component measuring device 100 is not exposed to the outside of the housing 110 when not in use. This improves the design and makes it difficult for others to recognize it as a medical instrument. This is suitable for cases where the user wants to make it difficult for others to notice that they are carrying a blood glucose meter.

[0075] The power supply unit 37 is housed in the second housing 21 and houses and attaches a battery that is the power source of the component measuring device 100. Considering the portability of the component measuring device 100, a small battery such as a button battery is preferable. The battery used in the power supply unit 37 may be either a primary battery or a secondary battery. The power supply unit 37 may also use a physical battery such as a solar cell in addition to a chemical battery such as a button battery. Furthermore, the power supply unit 37 may be provided with a function of being able to supply power or charge by connecting to an external power source (such as a commercial power source) by wire or wirelessly. The power supply unit 37 can change the amount of power supplied to the circuits of each unit (the measuring unit 31, the temperature detection unit 32, the communication unit 34, the notification unit 35, the display unit 36, the memory unit 38, and the control unit 39) that constitutes the measuring device 20 based on the separated state and the connected state of the puncture device 10 and the measuring device 20, which contributes to power saving.

[0076] The memory unit 38 is composed of a known storage medium that stores various data used in the measuring device 20, such as various control programs necessary to operate the measuring device 20, data to be transmitted to a communication destination including measurement values ​​measured by the measurement unit 31, and past values ​​related to measurements for a specified period of time.

[0077] The control unit 39 is composed of various processors including, for example, a CPU (Central Processing Unit), a ROM (Read only memory), and a RAM (Random Access Memory). The control unit 39 executes a predetermined process by controlling each unit constituting the measuring device 20 while starting a predetermined processing program. The control unit 39 includes a clock unit 39a composed of, for example, an RTC (Real-Time Clock), and keeps time according to a reference clock with a predetermined cycle supplied from a clock unit (not shown). The time kept by the clock unit 39a is used to generate the date, time, and minute when the measurement was performed, and to keep time from the start to the end of the measurement.

[0078] The control unit 39 also includes a calculation unit 39b that calculates the amount of a component (blood glucose level) in the body fluid to be measured based on the detection value (color concentration or light amount in the case of a colorimetric method) detected by the measurement unit 31.

[0079] The calculation unit 39b has a function of performing an appropriate correction process in consideration of measurement value fluctuation factors such as the environmental temperature (temperature value detected by the temperature detection unit 32) during the calculation process. This allows the calculation unit 39b to obtain a value closer to the true value with less measurement error. The calculation unit 39b outputs the calculated measurement value to the display unit 36.

[0080] Furthermore, the control unit 39 performs ON / OFF control of the power supply to each unit by the power supply unit 37 based on the status information from the device detection unit 33. When connection status information is input from the device detection unit 33, the control unit 39 outputs a control signal to the power supply unit 37 to stop the power supply. As a result, the power of the measuring device 20 is turned OFF. When separation status information is input from the device detection unit 33, the control unit 39 outputs a control signal to the power supply unit 37 to start the power supply. As a result, the measuring device 20 is powered ON and enters an idle state.

[0081] Furthermore, when the power is turned on and the device enters an idle state, the control unit 39 outputs a control signal to the measurement unit 31. This control signal triggers the measurement unit 31 to start controlling the emission and reception of light and outputting an electrical signal proportional to the amount of light. The control unit 39 starts the process of capturing the electrical signal as a digitized measurement 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.

[0082] The control unit 39 also includes a determination unit 39c that performs predetermined determinations (determination of connection of the pricking device 10, determination of attachment of the test medium T, and determination of start and end of measurement). The control unit 39 takes in, from the measurement unit 31 that continues intermittent measurement, a data series of measured values ​​corresponding to the amount of light transmitted through the test unit T1. When the determination unit 39c detects that blood has flowed into the test unit T1 from a state in which there is no blood, it determines that the measurement has started, and starts the measurement process using this as a trigger. When the reaction between the reagent and blood progresses in the test unit T1 and a predetermined time has elapsed since the start of the measurement in the timing unit 39a, or when the determination unit 39c determines that the measurement has ended due to the passage of the data series of measured values, the determination unit 39c determines that the measurement has ended. As a measurement end process, 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.

[0083] After the measurement is completed, the determination unit 39c observes the signal from the measurement unit 31 and determines whether the test medium T mounted on the medium mounting unit 22 has been removed within a predetermined time (for example, several minutes). When the determination unit 39c determines that the test medium T has not been removed within the predetermined time, the determination unit 39c causes the notification unit 35 to execute a notification to prompt the user to remove the test medium T. This prevents the user from forgetting to remove the test medium T after the measurement is completed. The determination unit 39c may determine whether the test medium T has been removed, for example, depending on whether the medium eject operation unit 23 has been operated. Alternatively, the determination unit 39c may determine whether the test medium T has been mounted on the measurement unit 31 by comparing a blank signal acquired by the measurement unit 31 before the measurement value is acquired with a signal acquired by the measurement unit 31 after a predetermined time has elapsed since the measurement value was acquired. The test medium T usually has an air vent hole to facilitate the introduction of blood into the distal part of the capillary channel. If blood is left in the capillary channel in the test medium T for a long period of time, there is a possibility that blood will seep out of the test medium T through the air vent hole. For this reason, it is preferable to remove the test medium T from the measuring device 20 within a predetermined time after the measurement.

[0084] Furthermore, the determination unit 39c determines whether the puncture device 10 and the measuring device 20 have been connected within a predetermined time (e.g., several minutes) after the testing medium T has been removed, based on the status information from the device detection unit 33. When the determination unit 39c determines that the puncture device 10 has not been connected within a predetermined time from the acquisition of the measurement value (i.e., when the input of connection status information is awaited), it causes the notification unit 35 to issue a notification to prompt the user to connect the puncture device 10 and the measuring device 20. This prevents the user from forgetting to connect the puncture device 10 after the measurement is completed.

[0085] The control unit 39 also includes a generation processing unit 39d that performs a process of generating transmission data that associates the measurement value calculated by the calculation unit 39b with measurement condition information (temperature information indicating the environmental temperature, the measurement time required for the measurement, etc.), a process of storing the generated transmission data in the memory unit 38, and a process of controlling the transmission of the transmission data to the communication destination via the communication unit 34.

[0086] Although the timing unit 39a, the calculation unit 39b, and the generation processing unit 39d are described as being included in the control unit 39, each of them may be configured separately from the control unit 39, or some of them may be configured to be included in the control unit 39.

[0087] Furthermore, when the measuring section 31 is in a state where measurement is possible (when the pricking device 10 is separated from the measuring device 20) and the testing medium T is not attached within a predetermined time, the control section 39 can also control the notification section 35 to issue a notification urging the user to attach the testing medium T. Furthermore, the control section 39 can also be configured to interrupt the measurement process when an unexpected event occurs, such as the pricking device 10 being attached to the measuring device 20 during measurement. At that time, the control section 39 may cause the notification section 35 to issue a notification indicating a measurement error.

[0088] 8A to 8D, an example of how to use the measuring device 20 will be described. The measuring device 20 is operated when measuring the blood glucose level in blood collected using the pricking device .

[0089] As shown in Fig. 8A, the test medium T is inserted by the user through the second opening 22a and attached to the medium attachment section 22. Blood collected by the pricking device 10 is introduced into the test section T1 of the test medium T through the opening of the drop port T2 and through the capillary channel of the test medium T. Then, the measuring device 20 starts measuring the attached test medium T. As shown in Fig. 8B, the measurement result (measured value) by the measuring section 31 is displayed on the display section 36.

[0090] Next, as shown in FIG. 8C, the user presses the second operating body 23a of the medium eject operating unit 23 along the longitudinal direction of the component measuring device 100 by an eject operation, and moves the medium holding part inside the second housing 21 along the longitudinal direction from the measurement position to the eject position. As a result, as shown in FIG. 8C, the test medium T is pushed out from the second opening 22a and removed. As shown in FIG. 8D, after removing the test medium T, the second operating body 23a moves to the position before the operation (initial position). In addition, as the second operating body 23a moves, the medium holding part also moves toward the base end side in the longitudinal direction and returns to its original position (measurement position).

[0091] [Operation] Next, a series of operations performed when using the component measuring device 100 according to this embodiment will be described with reference to Fig. 9. Note that the operations described below are presented in an exemplary order, and are not limited to the specific order presented. Each process is performed appropriately at a necessary timing when using the component measuring device 100.

[0092] As shown in FIG. 9, when using the component measuring device 100 according to this embodiment, as the first process, the user separates the puncture device 10 and the measuring device 20 (S1) and turns on the power of the measuring device 20 (S2).

[0093] In step S1, when the control unit 39 receives separation state information indicating that the puncture device 10 has been separated from the measuring device 20, it outputs a control signal for starting the power supply to the power supply unit 37. This causes the measuring device 20 to be powered on and enter an idle state.

[0094] As the next process, the control unit 39 determines whether or not the test medium T has been loaded into the medium loading unit 22 (S3).

[0095] In step S3, if the control unit 39 determines that the test medium T has been attached to the medium attachment unit 22 (S3-Yes), it ends the attachment detection process for the test medium T and starts the process of waiting for detection of blood deposition. On the other hand, if the control unit 39 determines that the test medium T has not been attached to the medium attachment unit 22 (S3-No), it displays a message prompting the user to attach the test medium T (S4), and loops the processes of steps S3 and S4 until the test medium T is attached.

[0096] Next, the control unit 39 observes the signal from the measurement unit 31 and determines whether or not blood mixed with a reagent has flowed into the testing medium T from a state in which there was no sample therein (S5).

[0097] In step S5, the control unit 39 observes the signal from the measurement unit 31, and if it detects that blood mixed with a reagent has flowed into the testing medium T from a state in which there was no sample present (S5-Yes), it determines that measurement should be started, and uses this as a trigger to start the measurement process (S7). On the other hand, if the control unit 39 cannot detect the flow of blood mixed with a reagent (S5-No), it displays a message encouraging the user to apply a blood spot (S6), and loops the processing of steps S5 and S6 until application of the blood is confirmed.

[0098] As the next process, the control unit 39 starts the measurement (S7) and determines whether the reaction has ended by observing the passage of a predetermined time using the timing unit 39a or by observing the data series of the measurement values ​​using the judgment unit 39c (S8).

[0099] When the reaction between the reagent and blood progresses in the test section T1, and a predetermined time has elapsed since the start of measurement as measured by the timer section 39a, or when the measurement end condition is met by the judgment section 39c due to the passage of the data series of the measured value (S8-Yes), the judgment section 39c judges that the measurement has ended and proceeds to the measurement end process (S10).On the other hand, if the reaction has not ended (S8-No), the measurement state continues (S9) and the process returns to step S8 again.

[0100] As a measurement end process, the 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 memory unit 38, and notifies the notification unit 35 of the end of the measurement (S10).

[0101] After the measurement end process, the control unit 39 observes a signal from the measurement unit 31 and determines whether the test medium T mounted in the medium mounting unit 22 has been removed within a predetermined time (for example, several minutes) (S11).

[0102] In step S11, if the control unit 39 determines that the test medium T has been removed from the medium mounting unit 22 within the predetermined time (S11-Yes), it determines whether the pricking device 10 is connected to the measurement device 20 (S13). On the other hand, if the control unit 39 determines that the test medium T has not been removed from the medium mounting unit 22 within the predetermined time (S11-No), it controls the notification unit 35 to notify the user to remove the test medium T from the medium mounting unit 22 and continues to display the measurement value (S12). Thereafter, the control unit 39 loops the processes of steps S11 and S12 until the test medium T is removed.

[0103] In step S13, if the control unit 39 determines that the puncture device 10 has been connected within a predetermined time (S13-Yes), it outputs a control signal to the power supply unit 37 to stop the power supply (S15), and ends the process. This turns off the power to the measuring device 20, and ends the process. On the other hand, if the control unit 39 determines that the puncture device 10 has not been connected within a predetermined time (S13-No), it controls the notification unit 35 to issue a notification to the user to prompt connection to the puncture device 10 (S14). Thereafter, the control unit 39 loops the processes of steps S13 and S14 until the puncture device 10 is connected.

[0104] [Example of modification] Next, modified examples of the component measuring device 100 according to the present invention will be described with reference to Figures 10 to 12 as appropriate. In the modified examples described below, components having the same functions as those in the above-mentioned embodiment are denoted by the same reference numerals, and detailed descriptions thereof will be omitted. In addition, in the modified examples, configurations, members, and methods of use that are not specifically mentioned may be the same as those in the above-mentioned embodiment.

[0105] In a modified component measuring device 100a described below, the connection between the puncture device 10 and the measuring device 20 is different from that described above.

[0106] FIG. 10A shows the configuration of a pricking device 10 which is a modified example, and FIG. 10B shows the configuration of a measuring device 20 which is a modified example.

[0107] As shown in FIG. 10A, the first contact surface 10a of the pricking device 10 is provided with a first engagement portion 15b that functions as a first connection portion 15 for fitting with the measuring device 20 when the pricking device 10 is connected to the measuring device 20. As shown in FIG. 10B, the second contact surface 20a of the measuring device 20 is provided with a second engagement portion 24b that functions as a second connection portion 24 for fitting with the pricking device 10 when the pricking device 10 is connected to the measuring device 20. The first engagement portion 15b and the second engagement portion 24b constitute a connection mechanism made of members that fit with each other (groove and ridge member). The first engagement portion 15b and the second engagement portion 24b are engaged and connected to the measuring device 20 by sliding at least one of the devices along the axial direction with the first contact surface 10a and the second contact surface 20a butted against each other.

[0108] Here, the shapes of the first engagement portion 15b and the second engagement portion 24b will be described in detail. As shown in FIG. 10A, the first engagement portion 15b is composed of a pair of grooves extending in the axial direction along the longitudinal periphery of the first abutting surface 10a. As shown in FIG. 10B, the second engagement portion 24b is composed of a pair of convex members extending in the axial direction along the longitudinal periphery of the second abutting surface 20a and protruding outward from the second abutting surface 20a. The convex members and the grooves each have the same cross-sectional shape in the axial direction. In addition, the convex members and the grooves each have a substantially same cross-sectional shape so that they can be fitted into each other. In the component measuring device 100a according to this embodiment, the first engagement portion 15b is composed of a groove and the second engagement portion 24b is composed of a convex member, but the first engagement portion 15b may be composed of a convex member and the second engagement portion 24b may be composed of a groove.

[0109] 11, the puncture device 10 is connected to the measuring device 20 by fitting the first engagement portion 15b and the second engagement portion 24b while sliding the puncture device 10 along the axial direction with the first contact surface 10a and the second contact surface 20a in contact with each other. The connected state between the puncture device 10 and the measuring device 20 is released by a predetermined operation (for example, a sliding operation) of the engagement between the second engagement portion 24b provided on the second housing 21 and the first engagement portion 15b. In this released state, the puncture device 10 can be separated from the measuring device 20 by sliding the puncture device 10 in the opposite direction to when it was connected.

[0110] It should be noted that the first engagement portion 15b and the second engagement portion 24b may have any configuration as long as they can detachably connect at least the puncture device 10 and the measuring device 20. Therefore, the first engagement portion 15b and the second engagement portion 24b are not limited to a convex member and a concave groove that are detachable by sliding movement as shown in Figs. 10A and 10B.

[0111] Furthermore, in the modified component measuring device 100a, the device detection unit 33 is configured to detect the separated state of the puncturing device 10 and the measuring device 20 and the connected state due to the engagement. As an example, the device detection unit 33 may be a detection mechanism having a detection piece that moves in a predetermined direction due to the sliding movement of the puncturing device 10 when the puncturing device 10 is normally engaged with the measuring device 20, and a detection unit (detection circuit) that electrically detects the movement position of the detection piece when the detection unit detects that the detection piece has moved to a predetermined position, thereby detecting the connected state and separated state of the puncturing device 10, and outputs state information corresponding to the connected state or separated state of the devices to the control unit 39.

[0112] It should be noted that the configuration of device detection section 33 is not limited as long as it has a function capable of detecting the connection between puncture device 10 and measuring device 20.

[0113] FIG. 12 shows an example of the operation of connecting the puncture device 10 and the measuring device 20 in the component measuring apparatus 100a of the modified example.

[0114] FIG. 12A shows a state before the puncture device 10 is connected to the measuring device 20 after the measurement by the measuring device 20 is completed. As shown in FIG. 12B, when the puncture device 10 and the measuring device 20 are connected, the first engagement part 15b is inserted into the second engagement part 24b in a state where the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measuring device 20 face each other. In this inserted state, for example, the puncture device 10 is slid along the axial direction so that the front end of the puncture device 10 and the front end of the measuring device 20 are parallel in a direction intersecting the axial direction. For example, the sliding movement may be performed by sliding one device while fixing the other device. As a result, as shown in FIG. 12C, the first engagement part 15b and the second engagement part 24b are fitted together, and the puncture device 10 and the measuring device 20 are connected in a state where the first contact surface 10a and the second contact surface 20a are in contact with each other.

[0115] [Effects] As described above, the component measuring device 100 of this embodiment comprises a puncturing device 10 configured to puncture the surface of a living body to allow blood to exude, and a measuring device 20 configured to measure the amount of glucose component contained in the blood (blood glucose level) by introducing the blood that has exuded from the surface of the living body into a test medium T, where the puncturing device 10 has a first housing 11, a first abutment surface 10a provided on at least one of the outer surfaces of the first housing 11, and a first connecting portion 15, and the measuring device 20 has a second housing 21, a second abutment surface 20a provided on at least one of the outer surfaces of the second housing 21, and a second connecting portion 24 connectable to the first connecting portion 15. In addition, in the component measuring device 100, the puncture device 10 and the measuring device 20 are configured such that the first connecting portion 15 and the second connecting portion 24 are connected with the first abutment surface 10a and the second abutment surface 20a facing each other and in contact with each other, thereby integrating the first housing 11 and the second housing 21 to form the housing 110 of the component measuring device 100, and when the connection between the first connecting portion 15 and the second connecting portion 24 is released, the first abutment surface 10a and the second abutment surface 20a become separation surfaces 101 and the puncture device 10 and the measuring device 20 become separate entities, and the first housing 11 and the second housing 21 do not have any parts protruding from the outer surface of the housing 110 in the area that becomes the outer surface of the housing 110.

[0116] With this configuration, the component measuring device 100 is excellent in portability and design because the housing 110 is formed when the first contact surface 10a of the puncture device 10 and the second contact surface 20a of the measuring device 20 are detachably connected and integrated in a state where they are butted together when not in use. 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 does not have a convex shape. Therefore, the component measuring device 100 is prevented from getting caught on other parts when carried, and is difficult to be recognized as a medical instrument by the surroundings, improving portability and design. Furthermore, the component measuring device 100 is capable of separating the puncture device 10 and the measuring device 20 when in use, so that each device can be used separately and is easy to operate.

[0117] Furthermore, in the component measuring device 100 of this embodiment, the first housing 11 may preferably be configured so that when the first abutment surface 10a and the second abutment surface 20a are abutted via the separation surface 101, they are complementarily connected to each other and integrated.

[0118] With this configuration, when the puncture device 10 and the measuring device 20 are connected, the first housing 11 and the second housing 21 can be integrated to form the housing 110 of the component measuring device 100, resulting in a device with excellent portability and design.

[0119] In the component measuring device 100 according to this embodiment, the outer shape of the first contact surface 10a may preferably be configured to be the same as the outer shape of the second contact surface 20a.

[0120] With this configuration, when the pricking device 10 and the measuring device 20 are combined, there is no part that protrudes from the outer surface of the housing 110.

[0121] Furthermore, in the component measuring device 100 of this embodiment, preferably, the first connecting portion 15 is a first magnetic member 15a provided inside the first housing 11 facing the first abutment surface 10a, and the second connecting portion 24 is a second magnetic member 24a provided inside the second housing 21 facing the second abutment surface 20a, and either one of the first magnetic member 15a and the second magnetic member 24a may be composed of a magnet, and the other may be composed of a magnet or a magnetic material having a different magnetic pole from the magnet.

[0122] The puncture device 10 and the measuring device 20 can be magnetically connected via a first connecting portion 15 consisting of a first magnetic member 15a and a second connecting portion 24 consisting of a second magnetic member 24a, so that the configuration for connecting the two devices is not complicated and they can be easily separated during use.

[0123] Furthermore, in the component measuring device 100 of this embodiment, preferably, the first connecting portion 15 is a first engagement portion 15b provided on the first abutment surface 10a, and the second connecting portion 24 is a second engagement portion 24b provided on the second abutment surface 20a and engaged with the first engagement portion 15b by sliding movement along the axial direction.

[0124] The puncture device 10 and the measurement device 20 have a connection structure consisting of a first connecting portion 15 consisting of a first engagement portion 15b and a second connecting portion 24 consisting of a second engagement portion 24b, so that when connecting or separating the two devices, they can be connected and separated by a simple operation of sliding at least one of the devices along the axial direction.

[0125] Furthermore, in the component measuring device 100 according to this embodiment, the measuring device 20 may preferably be configured with a display unit 36 ​​that displays the blood measurement results (blood glucose level) on a display surface 36a arranged on the second contact surface 20a.

[0126] With this configuration, when the puncture device 10 and the measuring device 20 are connected and integrated, the display surface 36a is not exposed on the outer surface of the housing 110, making the component measuring device 100 less likely to be recognized as a medical instrument by those around.

[0127] In the component measuring device 100 according to this embodiment, preferably, the first housing and the second housing may be configured so that at least a part of them has a flat surface.

[0128] With this configuration, when the pricking device 10 and the measuring device 20 are placed separately on a support surface such as a table, each device is prevented from rolling, which may occur when placed on the support surface.

[0129] Furthermore, in the component measuring apparatus 100 according to this embodiment, the measuring device 20 may preferably be configured to include a power supply unit 37 which controls the supply of driving power to the measuring device 20, a device detection unit 33 which detects the separated and connected states of the puncture device 10 and the measuring device 20, and a control unit 39 which controls the power supply unit 37 to change the driving power supplied based on the detection results by the device detection unit 33.

[0130] With this configuration, the component measuring device 100 can change the amount of power supplied based on the separated and connected states of the puncture device 10 and the measuring device 20, thereby achieving power saving.

[0131] Furthermore, in the component measuring apparatus 100 according to this embodiment, the measuring device 20 preferably includes a measuring unit 31 that measures the amount of glucose component contained in blood, and an alarm unit 35 that issues a predetermined alarm, and the control unit 39 may be configured to cause the alarm unit 35 to issue an alarm urging the removal of the test medium T when it determines that the test medium T has not been removed within a predetermined time after the measurement by the measuring unit 31 is completed.

[0132] With this configuration, the component measuring device 100 can notify the user that the test medium T has not been removed after the measurement by the measurement section 31 is completed, thereby preventing the user from forgetting to remove the test medium T.

[0133] Furthermore, in the component measuring device 100 of this embodiment, preferably, the control unit 39 may be configured to cause the notification unit 35 to issue a notification prompting the connection of the puncture device 10 and the measuring device 20 when it determines, based on the detection result by the device detection unit 33, that the puncture device 10 and the measuring device 20 have not been connected within a predetermined time after the test medium T has been removed.

[0134] In order to improve portability, the component measuring device 100 is configured such that the puncturing device 10 and the measuring device 20 can be separated during use and are both small-sized devices, so they are easily left behind after use. However, the component measuring device 100 issues a notification to encourage the connection of the puncturing device 10 and the measuring device 20 at a predetermined timing after the blood component measurement process is completed, so that the puncturing device 10 and the measuring device 20 can be prevented from being left behind.

[0135] In addition, in the component measuring device 100 according to this embodiment, the body fluid is preferably the user's blood, and the component may be the glucose component contained in the blood.

[0136] The component measuring device 100 can be used, for example, as a self-monitoring blood glucose measuring device (SMBG device) that measures blood glucose levels based on the amount of glucose contained in the user's blood as the component to be measured, making it highly portable and unlikely to be recognized as a medical instrument when away from home.

[0137] This application is based on Japanese Patent Application No. 2020-158863 filed on September 23, 2020, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0138] 10 puncture device (10a first contact surface), 11 first housing (11a first flat portion), 12 Needle attachment part (12a opening, 12b needle engagement part), 13 Puncture operation part, 14 needle ejection operation unit (14a first operation body), 15 first connecting portion (15a first magnetic member, 15b first engaging portion), 16 Depth adjustment section, 20 Measuring device (20a second contact surface), 21 second housing (21a second flat portion), 22 Media loading section (22a second opening), 23 medium eject operation unit (23a second operation body), 24 second connecting portion (24a second magnetic member, 24b second engaging portion), 31 Measuring part, 32 Temperature detection unit, 33 Device detection unit, 34 Communications Department, 35 Information Department, 36 display section (36a display surface), 37 Power supply section, 38 storage section, 39 control unit (39a time measurement 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 Test medium (T1 test section, T2 application port).

Claims

1. a puncturing device configured to puncture a biological surface to exude bodily fluid; and a measuring device configured to measure an amount of a predetermined component contained in the body fluid by introducing the body fluid into a test medium, The pricking device has a first housing, a first contact surface provided on at least one of outer surfaces of the first housing, and a first connecting portion, The measuring device has a second housing, a second contact surface provided on at least one of outer surfaces of the second housing, and a second connecting portion connectable to the first connecting portion, the pricking device and the measuring device are configured such that the first connecting portion and the second connecting portion are connected in a state in which the first contact surface and the second contact surface are opposed to each other and in contact with each other, whereby the first housing and the second housing are integrated to form a housing of the component measuring device; When the first connecting portion and the second connecting portion are disconnected, the first contact surface and the second contact surface become separation surfaces, and the pricking device and the measuring device become separate bodies. The first housing and the second housing do not have a portion protruding from the outer surface of the housing in a region that becomes the outer surface of the housing, Furthermore, the measuring device a power supply unit that controls the supply of driving power to the measuring device; a device detection unit that detects a separated state and a connected state of the pricking device and the measuring device; A control unit that controls the power supply unit to change the driving power supplied based on a detection result by the device detection unit.

2. The component measuring device of claim 1 , wherein the first housing and the second housing are complementarily connected to each other and integrated when the first abutment surface and the second abutment surface are abutted via the separation surface.

3. The component measuring device according to claim 1 , wherein an outer shape of the first contact surface is the same as an outer shape of the second contact surface.

4. the first connecting portion is a first magnetic member provided inside the first housing and facing the first contact surface, the second connecting portion is a second magnetic member provided inside the second housing and facing the second contact surface, The component measuring device according to any one of claims 1 to 3, wherein one of the first magnetic member and the second magnetic member is composed of a magnet, and the other is composed of a magnet or a magnetic material having a different magnetic pole from the magnet.

5. the first connecting portion is a first engaging portion provided on the first contact surface, The component measuring device according to any one of claims 1 to 3, wherein the second connecting portion is a second engaging portion provided on the second abutment surface and engaged with the first engaging portion by sliding movement along the axial direction.

6. The component measuring apparatus according to any one of claims 1 to 5, wherein the measuring device is provided with a display unit that displays the measurement results of the bodily fluid on a display surface arranged on the second contact surface.

7. The component measuring device according to claim 1 , wherein the first housing and the second housing each have a flat surface formed on at least a portion thereof.

8. The measuring device includes a measuring unit for measuring the amount of the component contained in the body fluid; A notification unit that issues a predetermined notification, A component measuring device as described in any one of claims 1 to 7, wherein the control unit, when determining that the test medium has not been removed within a predetermined time after measurement by the measurement unit is completed, causes the notification unit to issue a notification encouraging the removal of the test medium.

9. The component measuring device of claim 8, further comprising: when the control unit determines, based on the detection result by the device detection unit, that the puncture device and the measuring device are not connected within a predetermined time after the test medium is removed, the control unit causes the notification unit to issue an alert to prompt the puncture device to be connected to the measuring device.

10. 10. The component measuring device according to claim 1, wherein the body fluid is a user's blood, and the component is a glucose component contained in the blood.

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