WO2014049704A1

WO2014049704A1 - Measuring tip

Info

Publication number: WO2014049704A1
Application number: PCT/JP2012/074680
Authority: WO
Inventors: 笠井正秋; 落合庄司; 森内健行
Original assignee: テルモ株式会社
Priority date: 2012-09-26
Filing date: 2012-09-26
Publication date: 2014-04-03

Abstract

A measuring tip (10) comprises: a molded body (18) provided with an inlet (20) into which a body fluid can flow, and a body fluid channel (22) connected to the inlet (20) and in which the body fluid can flow; a body fluid spreading section (24) provided in region in the middle of the body fluid channel (22) and having a plurality of projections (25); and a measuring unit (26) in the body fluid channel (22) that is provided further on the downstream side of the body fluid flow than the body fluid spreading section (24) and on which light for measuring components is irradiated. A reagent (32) for measuring a component is applied in the body fluid spreading section (24).

Description

Measuring chip

The present invention relates to a measuring chip used for component measurement in which a reagent and a body fluid are reacted to optically measure a coloration degree to quantify a predetermined component in the body fluid.

2. Description of the Related Art Conventionally, component measuring devices that detect components in body fluids such as blood and urine and measure the amount and properties of the components have been widely used. For example, a simple blood glucose meter for diagnosing diabetes and determining an insulin dose is widely used. The principle of blood glucose measurement is that the reagent is fixed on the electrode and the electrical change is measured, and the degree of coloration when the reagent soaked in a porous membrane reacts with blood. Two “colorimetric methods” for optically measuring the light are widely adopted.

Among these, the colorimetric blood glucose meter adopting the colorimetric method has advantages such as easy correction using the hematocrit value when calculating the blood glucose level, and a simple manufacturing process. When measuring a blood glucose level using a colorimetric blood glucose meter, a blood glucose measuring chip having a test paper carrying a reagent (enzyme, coloring reagent, etc.) in a porous membrane such as polysulfone or polyethersulfone The blood glucose level is measured by optically detecting the color of the test paper that is colored by the reaction between glucose and the reagent in the blood. For example, refer to JP 2011-64596 A).

In the case of a blood glucose measurement chip having a structure in which a reagent is supported in a porous membrane, the structure control of the porous membrane is important in order to obtain a blood glucose measurement chip having a certain performance. However, it is difficult to control the structure of the porous membrane, and it is impossible to produce a blood glucose measuring chip with a certain performance unless a good quality porous membrane is selected while performing an intermediate test or the like in the production process, and the production cost remains high. There are problems such as being.

Many of the conventional colorimetric blood glucose meters have received light intensity when light is applied to the test paper before blood soaks, and light is received when light is applied to the test paper after the reagent and blood sugar are reacted. The blood sugar level is calculated based on the absorbance obtained from the intensity and a calibration curve prepared in advance. However, some reagents change the color of the reagent itself over time. When such a reagent is used, a color change with time of the reagent appears as a difference in the received light intensity when detecting the received light intensity from the test paper before the blood permeates. That is, the color of the test paper is different between the case where no change with time of the reagent occurs and the case where the change with time of the reagent occurs. For this reason, the change with time of the reagent may affect the measurement accuracy of the blood glucose level, and improvement is required. Although there is a blood glucose measurement chip made of only a molded product without using a porous film, it takes time until color development and improvement is required.

The present invention has been made in consideration of such problems, and provides a measuring chip that can be manufactured at low cost, is less affected by changes in the reagent over time, and can perform accurate and rapid measurement. For the purpose.

In order to achieve the above object, a measuring chip according to the present invention is a molded product body provided with an inflow port through which bodily fluid can flow and a bodily fluid passage through which the bodily fluid can flow. A bodily fluid developing portion provided in the bodily fluid passage and having a plurality of protrusions; and in the bodily fluid passage, provided downstream of the bodily fluid developing portion in the flow direction of the bodily fluid and irradiated with light for component measurement A component for measuring a component is applied to the body fluid developing unit.

According to the above configuration, unlike the conventional measurement chip in which the reagent is supported on the porous membrane, the reagent is applied to the body fluid development part provided in the body fluid passage in the molded product body, so that the constant It is possible to manufacture a measuring chip having the following performance at low cost. In other words, the dimensional control of the molded product is easier than the structure control of the porous membrane, and there is little variation in the amount of reagent applied due to the difference in the amount of the reagent solution penetrating into the porous membrane. A measuring chip can be easily manufactured. In addition, a measurement unit that is irradiated with light for measurement is provided where the bodily fluid in which the reagent is dissolved after passing through the body fluid development unit is provided, so that the measurement is affected by the color change of the reagent over time. It is difficult to perform measurement with little influence of changes with time of the reagent. Furthermore, since the reagent is applied to the body fluid development portion where a plurality of protrusions are formed, the reaction between the reagent and the predetermined component in the body fluid when the body fluid flows into the body fluid development portion is promoted, so that the measurement time Can be shortened.

In the measurement chip, the plurality of protrusions are provided in the body fluid development portion with an interval in the extending direction of the body fluid passage, and the plurality of protrusions with an interval in the width direction of the body fluid passage. May be provided. According to this configuration, by providing a large number of protrusions, the reagent can be applied with a uniform thickness at the body fluid developing portion. In addition, the contact area between the reagent and the body fluid can be increased, and there is also an effect of causing a turbulent flow effect on the flow of the body fluid. can do.

In the measuring chip, the plurality of protrusions may include ones having different heights. According to this configuration, the turbulent flow effect can be further enhanced due to the presence of the portions having different projection heights in the body fluid developing portion.

In the measurement chip, the intervals between the plurality of protrusions may be partially different. According to this configuration, since there is a portion where the interval between the protrusions is different in the body fluid deployment part, a change occurs in the deployment speed of the body fluid in the body fluid deployment part, so that the turbulent flow effect can be further enhanced.

In the measuring chip, the bodily fluid developing section may include a plurality of protrusion groups each including the plurality of protrusions and arranged at intervals in the extending direction of the bodily fluid passage. According to this configuration, when the body fluid develops from the upstream side to the downstream side of the adjacent protrusion groups, the flow velocity changes, so that the turbulent flow effect can be further enhanced. In the measurement chip, an auxiliary protrusion may be provided on the measurement unit. According to this configuration, the turbulent effect of body fluid can be enhanced in the measurement unit.

In the measurement chip, the molded product body includes a first member provided with the measurement unit, and a second member overlapped and coupled to the first member, and the first member and the first member The bodily fluid passage may be formed between two members, and the bodily fluid deployment part may be provided in the first member or the second member. According to this configuration, the measuring chip can be easily manufactured through a series of steps of applying the reagent to the body fluid development portion and then overlapping the first member and the second member and joining them together.

The measurement chip includes a gas permeable film that covers at least the body fluid development part and the measurement part, and the molded article body has a gas permeable film on a side opposite to a film surface with which the body fluid contacts. A gas passage that faces the film surface and communicates with the outside of the molded product body may be provided. According to this configuration, since oxygen can be supplied to a site where the body fluid and the reagent react, the body fluid and the reagent can be appropriately reacted even in the case of a reagent that requires oxygen for the reaction with the body fluid.

In the measurement chip, the molded product body includes a first member provided with the measurement unit, and a second member overlapped and coupled to the first member, and the first member and the first member The body fluid passage is formed between two members, and the body fluid development part is provided in the first member or the second member, and the first member is disposed on both sides of the measurement part in the width direction. The one end of the gas permeable film has an arrangement base on which one end and the other end of the gas permeable film are respectively arranged, and the second member is located between the arrangement base and the one end of the gas permeable film at a position facing the arrangement base. You may have a protrusion part which pinches | interposes a part and the said other end part. Alternatively, after the gas permeable film is fixed to the placement base of the first member by a method such as ultrasonic fusion or thermal fusion, the second member may be overlapped and bonded. According to this structure, a gas-permeable film can be suitably arrange | positioned in the form which covers a bodily fluid expansion | deployment part.

In the measurement chip, the molded product body may be provided with a groove surrounding the measurement unit from both sides in the width direction of the measurement unit and from the side of the measurement unit opposite to the body fluid development unit. According to this configuration, since the measurement unit is formed in an island shape by a groove formed in the periphery, the body fluid in which the reagent is dissolved can be held on the measurement unit with a substantially uniform thickness, and the measurement accuracy Can be improved.

In the measuring chip, the groove may communicate with the outside of the molded product body. According to this configuration, air escapes through the groove, so that the body fluid can smoothly flow into the body fluid passage. Further, the measurement chip may be a blood glucose measurement chip.

1 is a perspective view of a measurement chip according to an embodiment of the present invention. FIG. 2 is an exploded perspective view of the measurement chip shown in FIG. 1. FIG. 3 is a cross-sectional view taken along line III-III in FIG. FIG. 4 is a sectional view taken along line IV-IV in FIG. 3. It is an expansion perspective view of the base part which comprises the chip | tip for a measurement. FIG. 6A is an enlarged perspective view of a base member having a blood deployment part according to a modified example, and FIG. 6B is an enlarged perspective view of the base member having a measuring part according to the modified example. It is a perspective view which shows the blood glucose meter with which the chip | tip for a measurement shown in FIG. 1 was mounted | worn. FIG. 8 is a partially omitted cross-sectional view of the measurement chip and the blood glucose meter shown in FIG. 7. It is a perspective view which shows the blood glucose meter with which the chip | tip for a measurement which concerns on a modification was mounted | worn. It is a disassembled perspective view of the measuring chip which concerns on a comparative example. It is a figure explaining each position in a blood expansion | deployment part. It is a figure which shows the time change of the reflection intensity about a comparative example and an Example.

Hereinafter, preferred embodiments of the measurement chip according to the present invention will be described with reference to the accompanying drawings, but the present invention is not limited to these embodiments.

FIG. 1 is a perspective view of a measuring chip 10 according to an embodiment of the present invention. FIG. 2 is an exploded perspective view of the measurement chip 10. This measuring chip 10 is used to measure a predetermined component in a body fluid by being attached to a component measuring device. Hereinafter, blood will be described as a representative example of body fluid to be measured using the component measuring apparatus and the measuring chip 10, and glucose (blood sugar) in blood as a predetermined component will be described as representative examples.

As shown in FIGS. 1 and 2, the measuring chip 10 includes a base member 12 (first member), a cover member 14 (second member) overlapping the base member 12, and the base member 12 and the cover member 14. A gas permeable film 16 disposed therebetween. The base member 12 and the cover member 14 constitute a molded product body 18 of the measuring chip 10. In the present embodiment, the measurement chip 10 is configured in a disc shape, but the shape is not particularly limited, and may be configured in another shape such as an ellipse or a polygon.

As shown in FIG. 3, which is a cross-sectional view taken along the line III-III in FIG. 1, the molded product body 18 has an inlet 20 through which blood can flow, an introduction path 58 communicating with the inlet 20, and an introduction. A blood passage 22 (body fluid passage) through which blood can flow while communicating with the path 58, a blood deployment section 24 (body fluid deployment section) having a plurality of protrusions 25, and a measurement section irradiated with light for component measurement 26 is formed. The measurement unit 26 is disposed on the downstream side of the blood deployment unit 24. The blood spreader 24 is coated with a reagent 32 (coloring reagent) that reacts with blood sugar to develop a color corresponding to the blood sugar concentration. The molded product body 18 is formed with a communication passage 28 that allows the blood passage 22 to communicate with the atmosphere.

By combining the base member 12 and the cover member 14, a predetermined volume of space 30 for reacting the reagent 32 and blood glucose is formed inside the molded product body 18. Before the base member 12 and the cover member 14 are combined, the reagent 32 is applied to a large number of protrusions 25 (blood development portions 24) formed on the base member 12, and held for a predetermined time for drying. When oxygen is required for the reaction between the reagent 32 and blood glucose, the gas permeable film 16 is sandwiched between the base member 12 and the cover member 14, and the base member 12 and the cover member 14 are overlapped to bond both. As a result, a predetermined volume of space 30 for reacting the reagent 32 and blood sugar is formed on the blood passage 22. When using the measuring chip 10, blood is introduced into the space 30, where the reagent 32 reacts with blood glucose, and the color (color density) developed thereby is detected by the blood glucose meter 60 (see FIG. 7). Thus, the blood glucose level can be measured.

In a colorimetric blood glucose meter, the intensity of color development according to the blood glucose level is detected by irradiating light of a specific wavelength and detecting the transmitted light amount value or reflected light amount value, and based on a calibration curve prepared in advance. Calculate blood glucose level. Therefore, at least one of the base member 12 and the cover member 14 is made of a material having good transparency (such as resin) for light irradiation / light reception.

When the irradiation source and the light receiving element provided in the colorimetric blood glucose meter are arranged with the measurement chip 10 in between, a material with good transparency is used for both the base member 12 and the cover member 14. When the irradiation source and the light receiving element are arranged on the same side with respect to the measuring chip 10, one of the base member 12 or the cover member 14 may be transparent and the other may be colored so as to reflect light. Alternatively, a reflection film may be inserted between the base member 12 and the cover member 14 while using a resin having good transparency for both the base member 12 and the cover member 14, and the ratio at which the measuring chip 10 is mounted. A reflective surface may be provided inside the color blood glucose meter.

When using either the base member 12 or the cover member 14 as a reflecting surface, the member to be reflected must be colored. The color to be colored is not particularly limited as long as it can be efficiently reflected without absorbing light having an irradiation wavelength, but white is most preferable. The resin to be colored can be selected from many plastics such as polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, and polyethylene terephthalate. If necessary, the resin can be mixed with pigments such as titanium oxide and barium sulfate. May be.

Further, a reflective surface can be obtained by depositing a metal such as aluminum or zinc or an oxide such as titanium oxide or silicon dioxide on at least a part of a member used as the reflective surface by means of vacuum deposition or sputtering. . If such a vapor deposition method is used, the reflecting surface can be made into a mirror surface, and light can be reflected more efficiently.

Specifically, in this embodiment, when the measurement chip 10 is attached to the blood glucose meter 60 (see FIGS. 7 and 8), the irradiation source 72 and the light receiving element 74 provided in the blood glucose meter 60 are for measurement. The base member 12 is disposed on the same side with respect to the chip 10, and is disposed to face the irradiation source 72 and the light receiving element 74. For this reason, in this embodiment, the base member 12 is made of a material with good transparency, and the cover member 14 is made of a material colored so as to reflect light.

Examples of the resin material having good transparency include polymethyl methacrylate, polystyrene, cyclic polyolefin, and polycarbonate. Since blood flows through the blood passage 22 with surface tension, the base member 12 and the cover member 14 are optimally made of polymethyl methacrylate having high hydrophilicity, but at least the blood passage 22 is used even if the resin is poor in hydrophilicity. Hydrophilic treatment may be performed on the portion forming the film by a known method.

Examples of the hydrophilic treatment method include immersion of an aqueous solution containing a hydrophilic polymer such as polyacrylic acid, polyvinyl pyrrolidone, and polyacrylamide in addition to surfactant, polyethylene glycol, polypropylene glycol, hydroxypropyl cellulose, water-soluble silicone, and the like. Examples thereof include a method of coating by a method or a spray method, a method of plasma irradiation, glow discharge, corona discharge, ultraviolet irradiation and the like, and these methods may be used alone or in combination.

The space 30 through which the blood flows is obtained by combining a precisely designed base member 12 and cover member 14. The shape of the space 30 is arbitrary, but the height H (thickness: see FIG. 4) of the space 30 is such that blood flows smoothly, blood glucose levels can be measured over a wide range, and the required blood volume is small. For example, about 20 to 100 μm is desirable. Regarding the size (area) of the space 30, the width W of the space 30 (see FIG. 5) is about 0.2 to 5 mm so that the necessary blood volume can be reduced within the optical measurement range. It is desirable that the length L (see FIG. 5) is about 1 to 10 mm.

If the height H of the space 30 is smaller than 20 μm, the amount of blood necessary for blood glucose level measurement can be reduced, but the development of blood on the blood deployment unit 24 becomes slow, and it takes time to reach the measurement unit 26. It is expected that. If the height H of the space 30 exceeds 100 μm, the amount of blood necessary for blood glucose level measurement increases, and the amount of reflected light is difficult to obtain due to the thick blood layer. In this case, in order to obtain the reflected light amount, it can be dealt with by increasing the irradiation light amount, but the power consumption in the blood glucose meter 60 increases.

If the width W of the space 30 is smaller than 0.2 mm, it is not desirable because optical measurement becomes difficult. If the width W of the space 30 is larger than 0.2 mm, there is no particular limitation on the measurement system and there is no limit. However, since the amount of blood necessary to fill the measurement unit 26 increases, the width W of the space 30 is preferably 5 mm or less. .

The length L of the space 30 is preferably 1 mm or more in order to mix the reagent 32 applied to the blood spreader 24 and the blood that has flowed. If the length L of the space 30 is shorter than 1 mm, mixing may be insufficient and an accurate blood sugar level may not be obtained. On the other hand, when the length L of the space 30 is longer than 10 mm, not only the blood volume necessary to fill the measuring unit 26 increases, but also the measuring chip 10 itself becomes large.

Next, a specific configuration of the base member 12 and the cover member 14 constituting the molded product body 18 of the measuring chip 10 will be described.

As shown in FIG. 2, the base member 12 is a disk-shaped member in the illustrated example, and a plurality of (four in the illustrated example) mounting protrusions 43 for detachably mounting the blood glucose meter 60 on the lower surface thereof. Is provided. The base member 12 is formed with a plurality of (two in the illustrated example) fitting holes 36 that fit into fitting protrusions 34 provided on the lower surface of the cover member 14.

A first passage forming portion 38 that extends toward the center of the base member 12 and a first passage forming portion 38 that is narrower than the first passage forming portion 38 are formed at locations near the outer surface of the base member 12. A second passage forming portion 40 extending from the inner end of the first passage forming portion 38 in the extending direction of the first passage forming portion 38.

As shown in FIG. 5, on the upper surface of the base member 12, both sides in the width direction of the second passage forming portion 40 and the tip side of the second passage forming portion 40 (opposite side to the first passage forming portion 38). ), The groove 42 surrounding the second passage forming portion 40 is provided. As shown in FIG. 3, the groove 42 extends along the extending direction of the first passage forming portion 38 and opens at the outer surface of the base member 12.

The blood spreader 24 is provided in the middle of the blood passage 22. As shown in FIG. 5, in this embodiment, a part of the blood deployment part 24 is provided in the first passage forming part 38 and the other part is provided in the second passage forming part 40. Of the first passage forming portion 38, a region on the downstream side of the region where the blood deployment portion 24 is provided constitutes the measuring portion 26. Since the measurement unit 26 is formed in an island shape by the surrounding grooves 42, the blood in which the reagent 32 is dissolved can be held on the measurement unit 26 with a substantially uniform thickness, and the measurement accuracy can be improved.

In the blood deployment part 24, a plurality of protrusions 25 are provided at intervals in the extending direction of the blood passage 22, and a plurality of protrusions 25 are provided at intervals in the width direction of the blood passage 22. In the illustrated example, a large number of protrusions 25 are arranged in a substantially rectangular region having a long axis in the extending direction of the blood passage 22. In the present embodiment, the blood deployment unit 24 and the measurement unit 26 are provided on the base member 12, but may be provided on the cover member 14. Moreover, the blood deployment part 24 may be provided on both the base member 12 and the cover member 14.

A reagent 32 is applied to the blood development part 24 having such a large number of protrusions 25. The reagent 32 is applied and held on the blood deployment part 24 having a large number of protrusions 25 formed by molding before combining the base member 12 and the cover member 14. The blood spreader 24 to which the reagent 32 is applied is arranged on the front side (upstream side in the blood flow direction) instead of the measurement unit 26 irradiated with light having a specific wavelength in order to measure the blood glucose level. The

In the measurement chip 10, when blood flows into and develops in the blood development unit 24 and blood in which the reagent 32 is dissolved flows into the measurement unit 26, color development in the measurement unit 26 is measured. Since the blood in which the reagent 32 is dissolved flows into the measuring unit 26, the influence of the undissolved reagent is eliminated during the measurement. In addition, since the measurement location (the location where the light is irradiated) and the location where the reagent 32 is held are different, even if the reagent 32 is slightly discolored over time, the measurement before the measurement for checking the measurement system on the blood glucose meter 60 side is performed. Does not affect the light intensity measurement.

By appropriately providing a large number of protrusions 25, the solution-like reagent 32 is held at a predetermined position by the capillary force, and the outer periphery of the applied reagent 32 becomes thicker than that near the center even after drying, so-called coffee stain. There is no coating unevenness such as a phenomenon, and there is an advantage that the reagent 32 can be applied uniformly and highly in the thickness direction of the space 30. In addition, the contact area between the reagent 32 and the blood is increased, and the blood flow has an effect of causing a turbulent flow effect (stirring effect). Can be shortened.

The shape of the protrusion 25 is not particularly limited, and any of a cylindrical shape, an elliptical shape, a polygonal shape such as a triangular shape and a quadrangular shape, a polygonal shape such as a cone, a triangular shape and a quadrangular shape, and a hemispherical shape may be adopted. These shapes may be used alone or in combination of two or more. From the viewpoint of producing a mold for forming a part, a cylindrical shape is most easily produced.

When the protrusion 25 has a cylindrical shape, the outer diameter is preferably about 10 to 200 μm. If the size of the protrusion 25 is small, a large number of protrusions 25 can be erected with respect to a certain area, which is advantageous in that the surface area of the reagent application is widened. It becomes difficult to obtain the protrusion 25. On the other hand, when the outer diameter of the protrusion 25 is larger than 200 μm, the number of the protrusions 25 that can be provided with respect to the area of the blood spreading portion 24 is reduced, and the surface area of the reagent application is reduced and the blood turbulence effect is reduced. This is not desirable.

The height of the protrusion 25 is desirably 30 to 100% with respect to the height H of the space 30 where blood is developed, and the height may be partially changed within this range. If the height of the protrusion 25 is smaller than 30% with respect to the height H of the space 30, the blood turbulence effect may not be sufficiently obtained, and the reaction end point between the blood sugar and the reagent 32 may become unstable. Moreover, by providing the protrusions 25 having different heights among the many protrusions 25, the blood deployment speed is changed, and the turbulence effect can be further enhanced.

The arrangement of the protrusions 25 is not particularly limited as long as the protrusions 25 are arranged widely in the width direction within a range that does not hinder the inflow and development of blood. A large number of protrusions 25 may be arranged on the entire surface of the space 30 at regular intervals. In the blood spreading part 24, the interval between the protrusion 25 and the protrusion 25 may be partially changed. By partially changing the interval between the protrusions 25, a change occurs in the blood development speed in the blood development part 24, so that the turbulence effect can be enhanced.

Further, as shown in FIG. 6A, in the blood expansion part 24, the protrusions 25 may be divided into a plurality of parts, and the components of each reagent 32 may be applied separately according to the stage of the reaction. Specifically, in FIG. 6A, blood deployment part 24 includes a plurality of projection groups 44 each including a plurality of projections 25 and spaced in the extending direction of blood passage 22 (see FIG. 3). The number of protrusions 25 included in these protrusion groups 44 may be the same as or different from each other. Since the plurality of projection groups 44 are arranged at intervals in this way, when blood moves from the upstream side to the downstream side of the projection groups 44 adjacent to each other, a change occurs in the flow velocity. The effect can be further enhanced.

In order to further enhance the turbulent flow effect of the blood mixed with the reagent 32, in addition to the protrusions 25 provided in the blood spreading part 24, a plurality of auxiliary protrusions 46 are provided in the measurement part 26 as shown in FIG. 6B. Also good. When the auxiliary protrusion 46 is disposed on the measurement unit 26, irregular reflection of light by the auxiliary protrusion 46 may occur. However, if the irradiation source 72 and the light receiving element 74 on the blood glucose meter 60 side are appropriately disposed, such irregular reflection is not caused. It is not a problem, and it is possible to perform measurement appropriately.

As shown in FIGS. 1 to 3, a tip-side tapered blood collection nozzle 56 protruding from the cover member 14 is provided at a location near the upper surface of the cover member 14. An inlet 20 is provided at the tip of the blood collection nozzle 56. As shown in FIG. 3, the cover member 14 is provided with an introduction path 58 that communicates the inlet 20 and the blood passage 22. Accordingly, when blood is spotted on the tip of the blood collection nozzle 56, blood flows from the inflow port 20 and is guided to the blood passage 22 via the introduction path 58 by capillary action.

When oxygen is required for the reaction system, such as when GOD (glucose oxidase) is used as the enzyme of the reagent 32, the combination of only two parts of the base member 12 and the cover member 14 provides sufficient oxygen supply to the reagent 32. May not be. In this case, as in the measurement chip 10 according to the present embodiment, a gas permeable film having good oxygen permeability so as to cover at least the blood deployment part 24 and the measurement part 26 between the base member 12 and the cover member 14. 16, and a gas passage 48 between a film surface opposite to the film surface in contact with blood (the side not in contact with blood) and a member constituting the molded product body 18 (cover member 14 in the illustrated example). (See FIGS. 3 and 4). With this configuration, oxygen can be supplied to the site where the blood sugar reacts with the reagent 32. Therefore, even in the case of the reagent 32 containing an enzyme that requires oxygen for the reaction with blood, the color reaction can be reliably performed.

In FIG. 2, the gas permeable film 16 is rectangular, but may be any shape such as a square, a circle, an ellipse, etc. as long as it can cover at least the blood spreading part 24 and the measuring part 26. When the gas permeable film 16 is a quadrangle as shown in FIG. 2, the manufacturing is easy and the positioning when the gas permeable film 16 is disposed between the base member 12 and the cover member 14 is easy.

Examples of the gas permeable film 16 include nonporous films such as polystyrene and polymethylpentene, and microporous films such as polyethylene and polypropylene used for battery separators. Depending on the combination of the arrangement of the light emitting element and the light receiving element 74 described above, these films are colored even if they are transparent or appear white due to light scattering unless they absorb light of the measurement wavelength. It may be.

As shown in FIGS. 4 and 5, two placement pedestals 50 on which one end and the other end of the gas permeable film 16 are respectively arranged are provided on both sides in the width direction of the blood deployment part 24 and the measurement part 26. It is done. The groove 42 described above extends along the extending direction of the blood passage 22 between the first passage forming portion 38 and the placement base 50. Each placement base 50 of the base member 12 used as the embodiment this time is a flat bottom portion 50a, and is inclined to be higher (approaching the cover member 14 side) from the bottom portion 50a toward the blood deployment portion 24 side (blood passage 22 side). Although it has the portion 50b, it may be configured by only a flat surface.

Further, in each placement base 50, a positioning portion 50c formed in a concave shape is provided at the outer end in the width direction of the blood passage 22, and one end portion and the other end portion of the gas permeable film 16 are provided in the positioning portion 50c. Is placed. Thereby, between the base member 12 and the cover member 14, the gas permeable film 16 can be appropriately arrange | positioned in a predetermined position, and the state can be hold | maintained stably.

As shown in FIG. 4, a projecting portion 52 that sandwiches one end portion and the other end portion of the gas permeable film 16 between the cover base 14 and the placement base 50 is provided at a position facing the placement base 50 of the cover member 14. Thus, in a state where the gas permeable film 16 is disposed between the base member 12 and the cover member 14 (in a sandwiched state), the gas permeable film 16 covers the blood deployment part 24 and the measurement part 26. Between the arrangement bases 50. As a result, a space 30 having a predetermined height H (see FIG. 3) is formed between the base member 12 and the gas permeable film 16.

As shown in FIG. 4, a groove-like gas passage 48 facing the gas permeable film 16 is provided on the surface of the cover member 14 on the side in contact with the gas permeable film 16. In the illustrated example, two gas passages 48 are arranged side by side, and an intermediate convex portion 54 is provided therebetween. By providing the intermediate convex portion 54, the height from the base member 12 of the portion spanned between the two arrangement bases 50 in the gas permeable film 16 is regulated to a predetermined height. Therefore, a space for supplying oxygen is appropriately formed between the cover member 14 and the gas permeable film 16, and the thickness of the space 30 can be appropriately regulated to a desired height H.

As shown in FIG. 3, the gas passage 48 extends to the outer surface of the cover member 14 and communicates with the outside (atmosphere). Accordingly, air (oxygen in the air) can be reliably supplied from the outside of the measurement chip 10 to the blood deployment unit 24 and the measurement unit 26 via the gas passage 48 and the gas permeable film 16.

As shown in FIG. 7, the measurement chip 10 is used in a state where it is mounted on the blood glucose meter 60. The blood glucose meter 60 includes a housing 62 made of, for example, a resin, a display 64 and

operation units

66a and 66b (power buttons, etc.) provided on the housing 62, and a measurement provided on the tip of the housing 62. The chip | tip 10 is equipped with the chip | tip mounting part 68 which can attach or detach. The casing 62 in the illustrated example is formed in a rectangular shape with rounded corners, but any shape can be adopted as long as it can be easily held by a human hand and necessary components can be provided on the outside and inside. Can do.

Further, inside the housing 62, a photometry unit including an irradiation source 72 and a light receiving element 74 (see FIG. 8), a control unit for controlling the photometry unit and the display, a storage unit for storing information, a photometry unit, A battery for supplying power necessary for driving the display 64 is provided.

FIG. 8 is a partially omitted sectional view of the measurement chip 10 and the blood glucose meter 60 shown in FIG. In FIG. 8, only the components necessary for explanation are shown in the blood glucose meter 60, and other components (lens, control board, etc.) are not shown. As shown in FIG. 8, the chip mounting portion 68 provided at the tip of the housing 62 is provided with a mounting hole 70 that can be fitted into the mounting protrusion 43 provided in the measurement chip 10. The measurement chip 10 is attached to the blood glucose meter 60 by the fitting of 43 and the attachment hole 70.

The mounting structure of the measuring chip 10 to the blood glucose meter 60 is not limited to the fitting structure. For example, the measurement chip 10 is provided with a plurality of claws made of elastic pieces, and the blood glucose meter 60 is provided with a recess or projection that can be engaged with the nail, and the measurement chip is engaged by the engagement between the nail and the recess or projection. 10 may be configured to be attached to the blood glucose meter 60.

The irradiation source 72 includes a first light emitting element 72a that irradiates the measurement unit 26 with light having a first wavelength, and a second light emission that irradiates the measurement unit 26 with light having a second wavelength different from the first wavelength. And an element 72b. The first light emitting element 72 a and the second light emitting element 72 b are disposed at a position facing the opening 76 provided at the tip of the housing 62. The light emitted from the first light emitting element 72 a and the second light emitting element 72 b is irradiated to the measurement unit 26 through the opening 76.

In FIG. 8, the first light emitting element 72a and the second light emitting element 72b are juxtaposed in a direction perpendicular to the paper surface. The 1st light emitting element 72a and the 2nd light emitting element 72b may be comprised by a light emitting diode (LED), for example. The first wavelength is a wavelength for detecting the color density of the reagent 32 according to the blood glucose level, and is, for example, 620 to 640 nm. The second wavelength is a wavelength for detecting the concentration of red blood cells in blood, and is, for example, 510 to 540 nm.

The light receiving element 74 is disposed at a position facing an opening 76 provided at the front end of the housing 62, and receives reflected light from the measurement chip 10 (specifically, the cover member 14). For example, it may be composed of a photodiode (PD). The reflected light from the measuring chip 10 reaches the light receiving element 74 through the opening 76.

In order to measure the blood glucose level using the measurement chip 10 and the blood glucose meter 60, first, the blood glucose meter 60 is turned on, and the measurement chip 10 is mounted on the chip mounting portion 68 of the blood glucose meter 60. Then, the first light emitting element 72a and the second light emitting element 72b provided in the blood glucose meter 60 alternately irradiate light to the measuring unit 26 of the measuring chip 10 and from the measuring chip 10 before collecting blood. The reflected light is detected by the light receiving element 74. In this case, since the reflected light is detected by irradiating light to the measurement unit 26 not applied with the reagent 32 instead of the blood spreading unit 24 applied with the reagent 32, the color of the reagent 32 changes over time. Even if this occurs, the blood glucose level measurement accuracy is not affected. The reflection intensity detected at this time (hereinafter referred to as “first reflection intensity”) is stored in the storage unit. The 1st light emitting element 72a and the 2nd light emitting element 72b continue irradiation with respect to the measurement part 26 after that.

Next, a part of the subject's body (eg, fingers) is punctured with a puncture device (not shown), and a small amount of blood (eg, about 0.3 to 1.5 μL) is allowed to flow out onto the skin. Then, the tip of the blood collection nozzle 56 of the measurement chip 10 is brought into contact with the blood that has flowed out. Then, blood flows from the inflow port 20 into the introduction path 58 by the capillary phenomenon, and further flows through the blood path 22 toward the measurement unit 26.

In this case, the blood flows into the blood expansion part 24 provided in the middle of the blood passage 22 before reaching the measurement part 26. In the blood spreader 24, blood sugar in the blood that has flowed starts to react with the reagent 32 and is colored according to the amount of blood sugar. Since the reagent 32 is applied to the blood development part 24 in which the plurality of protrusions 25 are formed, the reaction between the reagent 32 and blood glucose when blood flows into the blood development part 24 is promoted. That is, by providing a large number of projections 25, blood is rapidly developed on the blood deployment part 24 by capillary force, and a turbulent blood effect occurs, so that the reaction between the reagent 32 and blood sugar is efficiently performed. Done. The blood reaches the measuring unit 26 after the reagent 32 is dissolved in the blood developing unit 24.

Then, the light from the first light emitting element 72a and the second light emitting element 72b is irradiated to the measurement unit 26 where the blood in which the reagent 32 is dissolved has arrived, and the reflected light is detected by the light receiving element 74, and the reflection intensity ( The color density is measured based on the amount of reflected light. Specifically, the reflection intensity (hereinafter referred to as “second reflection intensity”) after a predetermined time has elapsed (for example, after 10 seconds) from the time when the reaction intensity between the reagent 32 and blood sugar has advanced and the reflection intensity has changed greatly. Call). Then, the absorbance is obtained from the first reflection intensity and the second reflection intensity, and the blood glucose level is calculated with reference to a calibration curve (stored in the storage unit) indicating the relationship between the absorbance and the blood glucose level. .

In this case, the pigment produced by the reaction between the reagent 32 and blood glucose is detected by the light emitted from the first light emitting element 72a, and the color density corresponding to the amount of blood glucose is measured. Further, red blood cells are detected by the light emitted from the second light emitting element 72b, and the red blood cell concentration is measured. Then, the blood sugar level obtained from the color density is corrected using the hematocrit value obtained from the red blood cell concentration to obtain the blood sugar level. Note that the measurement wavelength may be further increased in order to estimate the height H of the space 30 or to correct individual differences in red blood cell color.

As described above, according to the measurement chip 10, unlike the conventional measurement chip in which the reagent 32 is carried on the porous film, the blood development part provided in the middle of the blood passage 22 in the molded product body 18. Since the reagent 32 is applied to 24, the measurement chip 10 having a certain performance can be manufactured at low cost. That is, the control of the dimensions of the molded product is easier than the control of the structure of the porous membrane, and there is little variation in the amount of the reagent 32 applied due to the difference in the amount of the reagent solution penetrating into the porous membrane. Can be easily manufactured.

In addition, since the measurement unit 26 that is irradiated with the measurement light is provided where the blood in which the reagent 32 is dissolved passes through the blood spreading unit 24, the color change of the reagent 32 over time during measurement is provided. Therefore, it is possible to perform measurement with little influence of the change of the reagent 32 over time.

Furthermore, since the reagent 32 is applied to the blood development part 24 in which the plurality of protrusions 25 are formed, the reaction between the reagent 32 and blood glucose when blood flows into the blood development part 24 is promoted, so that measurement is performed. Time can be shortened.

FIG. 9 is a perspective view showing a blood glucose meter 60a to which a measuring chip 10a according to a modification is attached. The measurement chip 10a shown in FIG. 9 is for measurement in which a blood collection nozzle 56 is provided on the upper surface of the cover member 14 of the molded product body 18 in that a blood collection nozzle 80 is provided on the outer surface of the molded product body 18. Different from the chip 10. Further, the mounting tip 43 (see FIG. 1 and the like) is not provided on the measuring chip 10a. The tip of the blood glucose meter 60a is provided with a chip mounting portion 82 in the form of an opening into which the measuring chip 10a can be inserted and mounted.

Inside the blood glucose meter 60a, an irradiation source for irradiating light having a specific wavelength to the measurement unit 26 of the measurement chip 10a attached to the blood glucose meter 60a, and reflected light from the measurement chip 10 are detected. A light receiving element is provided. In the measuring chip 10a shown in FIG. 9, the base member 12 is made of a material having good transparency, and the cover member 14 is made of a material colored so as to reflect light. For this reason, in the blood glucose meter 60a, both the irradiation source and the light receiving element are arranged on the side facing the base member 12 of the measuring chip 10a mounted on the blood glucose meter 60a. The irradiation source and the light receiving element provided in the blood glucose meter 60a are configured in the same manner as the irradiation source 72 and the light receiving element 74 in the blood glucose meter 60, except that their arrangement is different.

When both the base member 12 and the cover member 14 of the measurement chip 10a are made of a highly transparent member, the measurement chip 10a faces the one surface side of the measurement chip 10a attached to the blood glucose meter 60a. An irradiation source may be disposed, and a light receiving element may be disposed to face the other surface side of the measurement chip 10a. In the case of such a configuration, light is irradiated from the irradiation source to the measuring unit 26, and the light transmitted through the measuring unit 26 is received by the light receiving element.

Also with the measurement chip 10a according to the modification, the same effect as the measurement chip 10 described above can be obtained.

Hereinafter, the effects of the present invention will be described in comparison between the examples of the present invention and comparative examples, but the present invention is not limited to these examples.

[Comparative Example]: Measurement Chip Using a Molded Product without Protrusions in the Blood Deployment Part FIG. 10 is an exploded perspective view of a measurement chip according to a comparative example. Reagent solutions shown in Table 1 were prepared as blood glucose measurement reagents. As shown in FIG. 10, a transparent portion having a measuring portion 26 having a width of 1.3 mm and a length of 1.5 mm at the tip of a blood deployment portion 24 a having a width of 1.3 mm and a length of 2.0 mm, which is not provided with a protrusion. A base member 12a made of polymethyl methacrylate is molded, and using a dispenser (SMP-III: manufactured by Musashi Engineering Co., Ltd.), 0.1 μL of the reagent solution shown in Table 1 is spotted and applied, and a dry desiccator And stored at room temperature protected from light. After the reagent 32 is completely dried, a polypropylene microporous film hydrophilized with polyether-modified silicone (NF sheet NN100: Tokuyama Corporation) is used as the gas permeable film 16 so that the thickness of the space 30 becomes 50 μm. The cover member 14 made of white polypropylene by blending titanium oxide was attached to the base member 12a to obtain a measurement chip according to a comparative example as shown in FIG.

MAOS: N-ethyl-N- (2-hydroxy-3-sulfopropyl) -3, 5-dimethylalanine sodia salt

[Example 1]: Standard Form A measurement chip according to Example 1 is configured in the same manner as the measurement chip 10 shown in FIG. 2 and the like, and specifically, manufactured as follows.

Transparent with a blood developing part 24 having a width of 1.3 mm and a length of 2.0 mm having a number of protrusions 25 and a measuring part 26 having a width of 1.3 mm and a length of 1.5 mm at the tip of the blood developing part 24 A base member 12 made of polymethyl methacrylate was molded. The columnar protrusion 25 has a height of 30 μm and a size (outer diameter) of 60 μm, and 11 rows and 10 rows are alternately added in the width direction with a pitch interval of 110 μm in the blood expansion portion 24. Nineteen rows were arranged.

0.1 μL of the reagent solution shown in Table 1 is applied to the protrusion 25 (blood development part 24) of the base member 12 by using a dispenser (SMP-III: manufactured by Musashi Engineering Co., Ltd.), and the room temperature is set in a dry desiccator. Stored under shading. After the reagent 32 is completely dried, a polypropylene microporous film (NF sheet NN100: manufactured by Tokuyama Co., Ltd.) hydrophilized with polyether-modified silicone is bonded so that the thickness of the space 30 becomes 50 μm. A cover member 14 made of white polypropylene by blending titanium was attached to obtain a measurement chip according to Example 1.

[Example 2]: Example in which the thickness of the space is 20 μm The measurement chip according to Example 2 is configured in the same manner as the measurement chip 10 shown in FIG. 2 and the like. In this way, it was produced.

Transparent with a blood developing part 24 having a width of 1.3 mm and a length of 2.0 mm having a number of protrusions 25 and a measuring part 26 having a width of 1.3 mm and a length of 1.5 mm at the tip of the blood developing part 24 A base member 12 made of polymethyl methacrylate was molded. The height of the columnar projection 25 is 12 μm, the size (outer diameter) is 60 μm, and 11 rows and 10 rows are alternately added in the width direction at a pitch interval of 110 μm in the blood expansion part 24. Nineteen rows were arranged.

0.04 μL of the reagent solution shown in Table 1 is applied to the protrusion 25 (blood spreading part 24) of the base member 12 by using a dispenser (SMP-III: manufactured by Musashi Engineering Co., Ltd.), and the room temperature is set in a dry desiccator. Stored under shading. After the reagent 32 is completely dried, a polypropylene microporous film (NF sheet NN100: manufactured by Tokuyama Co., Ltd.) hydrophilized with polyether-modified silicone is bonded so that the thickness of the space 30 becomes 20 μm. A cover member 14 made of white polypropylene by blending titanium was attached to obtain a measurement chip according to Example 2.

[Example 3]: Example in which the space thickness is 100 μm The measurement chip according to Example 3 is configured in the same manner as the measurement chip 10 shown in FIG. 2 and the like. It was made.

Transparent with a blood developing part 24 having a width of 1.3 mm and a length of 2.0 mm having a number of protrusions 25 and a measuring part 26 having a width of 1.3 mm and a length of 1.5 mm at the tip of the blood developing part 24 A base member 12 made of polymethyl methacrylate was molded. The columnar protrusion 25 has a height of 60 μm and a size (outer diameter) of 60 μm, and 11 rows and 10 rows in the width direction are alternately added at a pitch interval of 110 μm in the blood expansion portion 24. Nineteen rows were arranged.

0.2 μL of the reagent solution shown in Table 1 is applied to the protrusion 25 (blood development part 24) of the base member 12 by using a dispenser (SMP-III: manufactured by Musashi Engineering Co., Ltd.), and room temperature is set in a dry desiccator. Stored under shading. After the reagent 32 is completely dried, a polypropylene microporous film (NF sheet NN100: manufactured by Tokuyama Co., Ltd.) hydrophilized with polyether-modified silicone is bonded so that the thickness of the space 30 becomes 100 μm. A cover member 14 made of white polypropylene by blending titanium was attached to obtain a measurement chip according to Example 3.

[Example 4]: Example in which the height of the protrusions was lowered Example 4 was a measurement chip manufactured in the same manner as in Example 1 except that the height of the protrusions 25 was 15 μm.

[Example 5]: Example of changing the arrangement of protrusions with respect to Example 1 The measurement chip according to Example 5 is configured in the same manner as the measurement chip 10a according to the modification shown in FIG. Specifically, it was produced as follows.

Transparent with a blood developing part 24 having a width of 1.3 mm and a length of 2.0 mm having a number of protrusions 25 and a measuring part 26 having a width of 1.3 mm and a length of 1.5 mm at the tip of the blood developing part 24 A base member 12 made of polymethyl methacrylate was molded. The blood spreader 24 has a single protrusion having a columnar protrusion 25 having an outer diameter of 60 μm and a height of 30 μm, in which 11 rows and 10 rows are alternately arranged in the width direction at a pitch interval of 110 μm. A total of four protrusion groups 44 were provided with a distance of 0.22 mm between the protrusion group 44 and the protrusion group 44.

0.1 μL of the reagent solution shown in Table 1 is applied to the protrusion 25 (blood development part 24) of the base member 12 by using a dispenser (SMP-III: manufactured by Musashi Engineering Co., Ltd.), and the room temperature is set in a dry desiccator. Stored under shading. After the reagent 32 is completely dried, a polypropylene microporous film (NF sheet NN100: manufactured by Tokuyama Co., Ltd.) hydrophilized with polyether-modified silicone is bonded so that the thickness of the space 30 becomes 50 μm. A measuring member according to Example 5 was prepared by attaching a cover member 14 made of white polypropylene by blending titanium.

[Measurement results of reagent thickness distribution]
The comparative measurement chip and the measurement chips of Examples 1 to 5 were disassembled, and the thickness distribution of the reagent 32 was evaluated with a laser microscope (LEXT OLS4000: manufactured by Olympus Corporation). The measurement position of the thickness of the reagent 32 is, as shown in FIG. 11, two straight lines that divide the blood deployment part 24 coated with the reagent 32 into three equal parts in the width direction (X direction in FIG. 11), In each of the regions A to L in which the blood spreader 24 is divided into 12 equal parts by three straight lines that divide the blood spreader 24 into four in the extending direction (Y direction in FIG. 11). The thickness of the reagent 32 at a location where there is no 25 was measured. In these regions A to L, the thickness of the reagent 32 can be measured for all of the four-stage projection groups 44 in which the projections 25 are arranged even in Example 5 in which the arrangement of the projections 25 is different from the others. The measured reagent thickness results are shown in Table 2.

In the comparative example in which the protrusions 25 are not provided in the region where the reagent 32 is applied, the outer periphery of the dried reagent 32 is thick and the central portion (regions E and H) is thin due to the coffee stain phenomenon. On the other hand, Examples 1 to 5 in which the protrusions 25 were provided in the region where the reagent 32 was applied were uniformly applied as is apparent from the standard deviation of the reagent thickness. Among these, in Example 5, the arrangement of the protrusions 25 was widely spaced every three rows, and the thickness of the widely spaced reagent 32 without the protrusions 25 was 1 μm or less. This indicates that the protrusion 25 in the process of drying the reagent solution is absorbed by capillary force, and as a result, the thickness is higher than those of Examples 1 and 4 in which the same amount of reagent solution was applied. It has become.

[Results of reaction rate and simultaneous reproducibility]
On 10 measurement chips according to Comparative Examples and Examples 1 to 5, 0.7 μL of blood prepared in advance with a hematocrit value of 40% and a blood glucose level of 400 mg / dL was spotted, and the change in blood glucose response color was 630 nm. The change in light reflection intensity was measured with a fiber spectrometer (USB-2000: Ocean Optic).

FIG. 12 shows the change over time in the reflection intensity as an indicator of the reaction rate. Absorbance was calculated from the reflection intensity before blood spotting (0-second reflection intensity) and the blood glucose levels of 100 mg / dL and 400 mg / dL (10-second reflection intensity) 10 seconds after blood spotting (Table 3). And a calibration curve based on this was created. Table 3 shows the slope of the created calibration curve and the coefficient of variation (CV%) of the blood glucose level calculated again from the calibration curve as an index of simultaneous reproducibility.
Here, the absorbance and the coefficient of variation are each expressed by the following equations.
Absorbance: A = −log (10-second reflection intensity / 0-second reflection intensity)
Coefficient of variation: CV% = 100 × standard deviation / average value Further, the absorbance slope is a value obtained by multiplying 1000 as a coefficient for convenience.

As understood from the results shown in FIG. 12, the convergence of the reflection intensity of the test chips of Examples 1 to 5 in which the protrusions 25 are provided is larger than that of the measurement chip of the comparative example having no protrusions 25 in the blood deployment part 24a. The reaction is fast and efficient. The results in Table 3 also show that the blood glucose level (BG) 100 mg / dL, 400 mg / dL when the measurement chip of the comparative example was compared with the absorbance of Examples 1, 4, and 5 having the same height of the comparative example and the space 30. Both dL have high absorbance, indicating good reaction efficiency. Even when the coefficient of variation (CV%) is compared, Examples 1 to 5 provided with the protrusions 25 are much smaller than the comparative example without the protrusions 25, and the simultaneous reproducibility is greatly improved.

By the way, although Example 1 and the height of the space 30 differ, about Example 2 and 3 whose height of the protrusion 25 with respect to the height of the space 30 is the same ratio, the light absorbency was implemented according to the height of the space 30, respectively. Example 2 is low and Example 3 is high, and the height of the space 30 can be measured from 20 μm to 100 μm without any problem.

Further, in Example 5 in which the four-step projection group 44 is provided by widening a part of the interval between the protrusions 25, higher absorbance can be obtained compared to Example 1 in which the interval between the protrusions 25 is constant, It shows that the reaction between the blood glucose and the reagent 32 proceeded efficiently.

In the above description, the present invention has been described with reference to preferred embodiments and examples. However, the present invention is not limited to the above-described embodiments and examples, and various modifications can be made without departing from the scope of the present invention. Needless to say, it is possible.

For example, the present invention is not limited to blood glucose measurement, and may be configured as a measurement chip 10 for measuring other components in blood or other body fluids (lymph fluid, spinal fluid, saliva, etc.). Of course. Other components in the blood include cholesterol, uric acid, creatinine, lactic acid, hemoglobin, various alcohols, various sugars, various proteins, various vitamins, various inorganic ions such as sodium, and environmental hormones such as PCB and dioxin. Also good. Furthermore, the measurement is not limited to the measurement of the amount of the predetermined component in the body fluid, and the property of the predetermined component may be measured, or both the amount and the property of the predetermined component may be measured.

Claims

A molded product body (18) provided with an inlet (20) through which body fluid can flow and a body fluid passage (22) through which the body fluid can flow through the inlet (20);
A body fluid development part (24) provided in the body fluid passage (22) and having a plurality of protrusions (25);
A measuring section (26) provided in the body fluid passage (22) downstream of the body fluid developing section (24) in the body fluid flow direction and irradiated with light for component measurement;
The body fluid developing part (24) is coated with a component measuring reagent (32).
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 1,
The bodily fluid deployment part (24) is provided with the plurality of protrusions (25) at intervals in the extending direction of the bodily fluid passage (22), and at intervals in the width direction of the bodily fluid passage (22). And the plurality of protrusions (25) are provided.
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 2,
The plurality of protrusions (25) include ones having different heights.
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 2,
The intervals between the plurality of protrusions (25) are partially different.
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 2,
The body fluid deployment part (24) includes a plurality of projection groups (44) each including the plurality of projections (25) and arranged at intervals in the extending direction of the body fluid passage (22).
A measuring chip (10, 10a) characterized by that.
In the measurement chip (10, 10a) according to any one of claims 1 to 5,
The measurement unit (26) is provided with an auxiliary projection (46).
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 1,
The molded article main body (18) includes a first member (12) provided with the measurement unit (26), and a second member (14) overlapped and coupled to the first member (12). ,
The body fluid passageway (22) is formed between the first member (12) and the second member (14),
The body fluid development part (24) is provided on the first member (12) or the second member (14).
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 1,
A gas permeable film (16) covering at least the body fluid development part (24) and the measurement part (26);
A gas passage that faces the film surface of the gas permeable film (16) opposite to the film surface that contacts the body fluid and communicates with the outside of the molded product body (18) in the molded product body (18). (48) is provided,
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 8,
The molded article main body (18) includes a first member (12) provided with the measurement unit (26), and a second member (14) overlapped and coupled to the first member (12). ,
The body fluid passageway (22) is formed between the first member (12) and the second member (14),
The body fluid development part (24) is provided on the first member (12) or the second member (14),
The first member (12) has an arrangement base (50) in which one end and the other end of the gas permeable film (16) are respectively arranged on both sides in the width direction of the measurement unit (26). ,
The second member (14) sandwiches the one end portion and the other end portion of the gas permeable film (16) between the second member (14) and the arrangement base (50) at a position facing the arrangement base (50). Having a protrusion (52),
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 1,
The molded product body (18) surrounds the measurement unit (26) from both sides in the width direction of the measurement unit (26) and from the opposite side of the measurement unit (26) from the body fluid development unit (24). A groove (42) is provided,
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 10,
The groove (42) communicates with the outside of the molded body (18).
A measuring chip (10, 10a) characterized by that.
The measuring chip (10, 10a) according to claim 1,
The measurement chip (10, 10a) is a blood sugar measurement chip.
A measuring chip (10, 10a) characterized by that.