JP2000254111A - Device for measuring body fluid component - Google Patents

Abstract

PROBLEM TO BE SOLVED: To surely measure the component of a body fluid even when the amount of the body fluid which flows out is the small one by providing a body fluid introducing guide to introduce the body fluid to a suck port in the circumference of the port. SOLUTION: A body fluid component measuring device 1 is constituted of a housing 2, an opening part 7 formed in the housing 2, a suck port 4 arranged in the circumference of the opening part 7, test paper 6 being one of the configuration elements of a measurement detecting part, a flow passage part 3 communicating with the port 4 and the paper 6 and a body fluid introducing guide 5 introducing the body fluid which flows out into the opening part 7 to the suck port 4. Then the fluid is guided by the flow passage part 3 from the suck port 4 to the paper 6. Besides, the guide 5 is provided with a function for introducing the body fluid to the suck port 4 when the fluid is brought into contact with it. The guide 5 can be formed by a material being the same as that in the housing 2 and the flow passage part 3 but it is favorable that the material with high hydrophilicity in the same way as in the part 3 is used or a front surface of the guide 5 is worked to have hydrophilicity.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a bodily fluid component measuring device for collecting a bodily fluid, particularly blood, and measuring its component.

[0002]

2. Description of the Related Art With the increase in the number of diabetic patients in recent years, autologous blood glucose measurement for monitoring daily fluctuations in blood glucose level has been recommended. Conventionally, a method for measuring blood glucose level is to squeeze the blood by squeezing the skin of the fingertip with a puncture tool having a needle-like or lancet-like lancet and pressing around the puncture area with a finger or the like. . Then, since the puncture device and the blood glucose measurement device are separate, the puncture device is replaced with a blood glucose measurement device, and the blood is contacted with a test piece for reaching the test paper containing a reagent that reacts with glucose in blood.
The reaction in the test paper section is optically measured as a color reaction, or is electrically measured by an electrode provided on the test paper, and is converted into a blood glucose level. This method is disadvantageous from the viewpoint of hygiene because of poor operability.

In order to solve the problems of operability and hygiene, Japanese Patent Application Laid-Open Nos. Hei 6-339473 and Hei 9-2762 have been proposed.
No. 35 discloses a device in which a puncture device and a blood glucose measuring device are integrated. However, in these devices, since the operating portion of the puncture needle of the puncture device and the member of the measurement system are not on the same straight line, the distance between the puncture position and the test paper is separated. Therefore, in order for the bodily fluid that has flowed out from the puncture position of the epidermis to reach the test paper, it is necessary to flow a large amount of bodily fluid, which imposes a greater burden on the operator,
In addition, the presence of a body fluid that is not necessary for measurement is not hygienic. In addition, when the amount of the bodily fluid to be discharged is small, the bodily fluid does not reach the test paper, and the reliability of the measurement may be inferior.

[0004]

SUMMARY OF THE INVENTION It is an object of the present invention to integrate a mechanism for puncturing the epidermis, a collecting mechanism for collecting body fluid, and a measuring mechanism for measuring a component of body fluid, and that a small amount of body fluid is discharged. Another object of the present invention is to provide a body fluid component measuring device capable of reliably measuring a component of a body fluid.

[0005]

The above object is achieved by the present invention described below. (1) The present invention provides a collection mechanism for collecting a body fluid from the epidermis,
In an apparatus in which a measurement mechanism for measuring a component of the bodily fluid is integrated, a housing, a measurement detecting unit provided in the housing for measuring a component in the bodily fluid, and a flow for introducing the bodily fluid to the measurement detecting unit are provided. And a suction port provided for guiding the bodily fluid into the flow channel portion, and a bodily fluid introduction guide portion for guiding the bodily fluid to the suction port is provided around the suction port. It is a body fluid component measuring device.

(2) The present invention provides an apparatus in which a collecting mechanism for collecting body fluid from the epidermis and a measuring mechanism for measuring a component of the body fluid are integrated, a housing having at least one opening, and a housing inside the housing. A measurement detection unit that measures a component in the body fluid provided in, a flow path unit that introduces the body fluid to the measurement detection unit, and a measurement unit that is provided around the opening to guide the body fluid into the flow path unit. The body fluid component measuring device according to the above (2), further comprising a body fluid introduction guide for guiding the body fluid to the body around the suction port.

(3) In the present invention, the body fluid introduction guide is provided around the suction port, and projects from the suction port, specifically, two or more protrusions projecting toward the center of the opening. The body fluid component measuring device according to (1) or (2) above. (4) The present invention is the body fluid component measuring device according to any one of (1) to (4), wherein the flow channel unit introduces a body fluid to the measurement and detection unit by capillary action.

(5) The present invention is the humor component measuring device according to the above (1) to (4), wherein the surface tension in the humor introduction guide portion is smaller than the surface tension in the flow passage portion. (6) In the present invention, the bodily fluid component measurement according to any one of (1) to (5), wherein the inside of the bodily fluid introduction guide portion is flared toward the center of the opening portion as the distance from the suction port increases. Device.

(7) The present invention is the body fluid component measuring device according to any one of (1) to (6), further comprising a puncturing means from which a puncture needle projects. Desirably, the humor component measuring device according to any one of the above (2) to (6), further comprising a puncturing means in which a puncturing needle projects from the opening. (8) The present invention is the body fluid component measurement device according to any one of (2) to (7), further including a suction unit configured to reduce a pressure inside the housing and suck a part of the epidermis or the body fluid from the opening. .

(9) The present invention is the body fluid component measuring device according to any one of (2) to (8), wherein a part of the housing protrudes and the opening is provided at a protruding tip. (10) In the present invention, the housing has a tapered structure having an angle with respect to the epidermis when the opening is pressed against the epidermis to collect the body fluid from the epidermis. The body fluid component measuring device according to any one of (1) to (9).

(11) According to the present invention, when the puncture needle projects, the puncture needle passes through the bodily fluid introduction guide.
It is a body fluid component measuring device according to 0). In particular, the body fluid introduction guide portion is provided around the suction port, and is two or more projections projecting from the suction port toward the center of the opening, wherein the two or more projections pass between the two or more projections. The body fluid component measuring device according to any one of (1) to (10). (12) In the present invention, the measurement / detection unit comprises a test paper containing a reagent that undergoes a color reaction with the body fluid, and means for optically measuring the color produced by the color reaction. The body fluid component measuring device according to any one of the above (1) to (10), which quantitatively or qualitatively measures a target body fluid component from data obtained by optically measuring a color.

(13) The present invention provides a body fluid component measuring device having a sampling mechanism for sampling a body fluid from the epidermis and a measuring mechanism for measuring a component of the body fluid, which is detachably provided. A measurement detection unit that measures a component in the body fluid provided, a flow channel unit that introduces the body fluid to the measurement detection unit, and an intake port that is provided to guide the body fluid into the flow channel unit, The body fluid storage container is provided with a body fluid introduction guide for guiding the body fluid to the suction port around the suction port.

(14) According to the present invention, there is provided a body fluid component measuring device having a sampling mechanism for sampling a body fluid from the epidermis and a measuring mechanism for measuring a component of the body fluid, the detachable mechanism having at least one opening. A housing, a measurement detection unit provided in the housing for measuring a component in the body fluid, a flow channel unit for introducing the body fluid to the measurement detection unit, and the opening for guiding the body fluid into the flow channel unit. The body fluid storage container according to the above (13), further comprising a suction port provided around the portion, and a body fluid introduction guide portion for guiding the body fluid to the suction port is provided around the suction port. is there.

(15) The invention is characterized in that the body fluid introduction guide portion is provided around the suction port and is at least two projections projecting from the suction port toward the center of the opening. 4. The body fluid storage container according to item 1. (16) The present invention is the body fluid storage container according to any one of (13) to (15), wherein the flow channel unit introduces a body fluid to the measurement detection unit by capillary action.

(17) The present invention is the body fluid storage container according to any one of (13) to (16), wherein a surface tension in the body fluid introduction guide portion is smaller than a surface tension in the flow passage portion. (18) The present invention is the humor component measuring device according to any one of (14) to (17), wherein the inside of the humor introduction guide portion is flared from the suction port toward the center of the opening.

[0016]

Embodiments of the present invention will be described below in detail with reference to the drawings. FIG. 1 is a cross-sectional view of a part of a body fluid component measuring device 1 according to an embodiment of the present invention, which is cut in a lateral direction and the opening 7 is viewed from there. FIG. 2 is the same as FIG. FIG. 2 is a longitudinal sectional view near an opening 7 of the body fluid component measuring device 1. The body fluid component measuring device 1 includes a housing 2, an opening 7 formed in the housing 2, a suction port 4 provided on a peripheral edge of the opening 7, and a test paper 6 which is one of constituent elements of a measurement detecting unit. And a flow path 3 communicating the suction port 4 and the test paper 6, and a body fluid introduction guide 5 for guiding the body fluid flowing out of the opening 7 to the suction port 4.

The shape of the housing 2 is not particularly limited as long as it has a shape in which other components can be provided. However, as shown in FIG. 2, the vicinity of the opening 7 is a tapered structure having an angle α between the housing back surface 8 and the skin (for example, a fingertip or a stomach) pressed by the opening 7, or the vicinity of the opening. It is desirable to have a projecting structure. This serves as an indication of the position of the opening 7 when operating the body fluid component measuring device 1, and the portion that is pressed against the epidermis can be only the opening 7. Can be reliably contacted. The angle α is not particularly limited as long as the above-described effects can be obtained, but is preferably about 5 to 60 degrees.

The housing 2 is made of ABS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride,
Polyvinylidene chloride resin, polyphenylene oxide,
Thermoplastic polyurethane, polymethylene methacrylate,
Polyoxyethylene, fluororesin, polycarbonate,
Thermosetting resins such as polyamide, acetal resin, acrylic resin, polyethylene terephthalate, and other thermoplastic resins used in injection molding, and phenol resins, epoxy resins, silicone resins, and unsaturated polyesters may be used.
When the measurement detection unit performs an optical measurement that captures the color reaction on the test paper, it is preferable that the measurement detection unit be non-transparent so as not to be easily affected by disturbance light due to measurement accuracy. . Alternatively, a semi-transparent colored resin may be used to check the movement of the bodily fluid in the flow path section 3.

As the measurement / detection unit, besides a unit that performs an optical measurement to capture a color reaction on a test paper, a unit that performs an optical measurement of a body fluid itself without using a color reaction,
A body fluid may be introduced between the electrodes to measure a current value between the electrodes.

The channel section 3 is provided with a test paper 6 through which a bodily fluid flows through an inlet 4.
Lead to. Its cross-sectional shape, length, width, etc.
Although it depends on the amount of body fluid required for the measurement, it is desirable to design so that the dead volume does not increase. Specifically, examples of the cross-sectional shape include a tubular shape, a V-shaped groove, a rectangular groove, and the like. From the viewpoint of dead volume, a thin rectangular groove is preferable. The depth of the groove is
Desirably, the thickness is about 0.05 to 0.5 mm and the width is about 0.5 to 3 mm. The length should be as short as possible, 12m
A distance of about m to 15 mm is appropriate, but not limited thereto.

The material used for the channel portion 3 may be the same as that of the housing 2, but it is possible to use a material having high hydrophilicity such as an acrylic resin or to increase the suction force by making the surface hydrophilic. desirable. Examples of the means for rendering hydrophilic include physical activation treatment such as ozone treatment, plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation, and application of a surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, and polypropylene glycol. Can also be performed. The flow path 3 is formed integrally with the housing 2 by injection molding, or
The housing 2 can be cut or pressed
And a member obtained by fixing a tubular body or a groove member.

Further, when bodily fluid is introduced from the suction port 4 to the test paper 6 via the flow path 3, it is conceivable that the capillary phenomenon stops halfway in the closed system. Therefore, it is desirable to provide an air vent.
When fixing the test paper 6 to the housing 2, as shown in FIG. 4, the test paper 6 has an end portion on the test paper side of the flow path portion 3 at the center thereof and a groove-shaped air vent 9 around it. Test paper center fixing base 10 which secures air bleeding by air bleeding part 9 when touched
A, or a test paper peripheral fixing base 1 for partially fixing the test paper 6 to the housing 2 by adhesive and fusion.
0B is provided so as to form a space between the housing 2 and the test paper 6, that is, to ensure that the air does not come out of contact with the test paper side end of the flow path 3 and the test paper 6. At this time, the step of the space is preferably about 0.01 to 0.3 mm.

The body fluid introduction guide 5 has a function of guiding the body fluid to the suction port 4 when the body fluid comes into contact. The material may be the same as that of the housing 2 and the flow path unit 3, but it is preferable to use a material having high hydrophilicity similarly to the flow path unit 3 or to treat the surface to be hydrophilic. In terms of shape, the bodily fluid once guided to the inlet 4 spreads around the opening 7 due to surface tension around the opening 7, and the suction force of the bodily fluid in the flow path 3 decreases, and In order to prevent the body fluid from leaking due to the capillary action between the epidermis, a structure in which the body fluid does not flow out from around the suction port 4 is preferable.

Specifically, there is one provided with two protruding guides 51a and 51b from the periphery of the suction port 4. It is desirable that the width and height between the guides 51a and 51b be substantially the same as the height and width of the suction port 4. In addition,
Other shapes of the bodily fluid introduction guide 5 include a tubular shape that covers the entire periphery of the suction port 4 and a shape that includes three or four protruding guides.

The body fluid introduction guide 5 is connected to the guides 51a,
In the case of a projection 51b, as shown in FIG. 3, the inside of the body fluid introduction guide 5 is narrowed on the suction port side and the side on which the body fluid is spotted is widened. By making it wider, the surface tension in the body fluid introduction guide 5 can be made smaller than the surface tension in the flow path portion 3. Therefore, all the bodily fluids are smoothly supplied to the flow path unit 3 and the dead volume in the bodily fluid introduction guide 5 does not need to be considered. That is, even if a small amount of bodily fluid is used, the bodily fluid can be sufficiently supplied to the measurement detection unit or the test paper 6. Since it can be supplied, the burden on the operator is not increased.

The internal size of the body fluid introduction guide 5 is, specifically, about 1 to 3 mm in width, about 0.5 to 3 mm in height, and 1 to 3 mm in length (distance protruding from the suction port).
Degree. This is because when a body fluid of about 4 μl (the amount of body fluid appearing on the epidermis after puncturing) is collected, the size of the body fluid becomes a drop of about 3 mm in diameter. It is because it can demonstrate.

When the body fluid component measuring device 1 has a puncturing means, the puncture needle is inserted into the body fluid introduction guide 5 in the opening 7.
Near the distal end, or the body fluid introduction guide 5 is the guide 51
In the case of a plurality of projections as in a and 51b, it passes between them and punctures the epidermis. When the required amount of bodily fluid that has flowed out of the punctured site becomes a droplet, the bodily fluid comes into contact with the bodily fluid introduction guide 5 and is guided from the suction port 4 to the test paper 6 through the flow path 3. The position through which the puncture needle passes in the opening 7 is desirably about 3 mm from the distal end of the body fluid introduction guide at a distance, more preferably within 1 mm from the distal end or inside the body fluid introduction guide, even in view of the required body fluid volume.

When the glucose in blood is measured, for example, the test paper 6 is obtained by impregnating the test paper with glucose oxidase, peroxidase and a color reagent as reagents and drying the test paper. As the test paper, a porous membrane is desirable, and examples of the form include a nonwoven fabric, a woven fabric, and a stretched sheet. Examples of the material include polyesters, polyamides, polyolefins, polysulfones, and celluloses. Further, since a reagent is impregnated or a body fluid is impregnated, a hydrophilic material or a material subjected to a hydrophilic treatment is preferable. In addition, test paper 6
May be a single-layer film or a multilayer structure.

Next, an example of use of the body fluid component measuring device 1 will be described with reference to FIGS. 5, 6, 7 and 8 showing the use state of the body fluid component measuring device 1. As shown in FIG. 5, the housing 2 is detachably joined to the apparatus main body housing 15, and a seal member 14 such as an O-ring is provided at the joint to maintain airtightness. The measuring and detecting unit is a test paper 6
And a light source 11 provided thereabove, and a light receiving element 1 for capturing light emitted from the light source 11 and reflected from the test paper section 6
2, and the optical data obtained by measuring the degree of coloration of the test paper 6 is used to obtain a blood glucose level or the like by an unillustrated calculation means or conversion means.

When the operator operates the puncturing means,
The puncture needle 13 punctures the skin 16 as shown in FIG. In addition,
The puncture needle 13 passes through an intermediate point between the guides 51a and 51b constituting the bodily fluid introduction guide 5 at the distal end portion of the bodily fluid introduction guide 5 in the opening 7. Thereafter, the bodily fluid 17 that has flowed out of the puncture position of the epidermis 16 becomes droplet-like and comes into contact with the bodily fluid introduction guide 5. The state at that time is shown in FIG. 7 showing a longitudinal section, and a part of the bodily fluid component measuring device 1 is cut in a horizontal direction, and a cross-sectional view in which the opening 7 is viewed from there. FIG. 8 shows a cross section of a part of the horizontal body fluid component measuring device 1 as viewed in the direction. Depending on the operator, it is conceivable that the outflow of bodily fluids is small. Therefore, an auxiliary suction means is provided in the bodily fluid component measuring device 1 to aspirate the epidermis after or simultaneously with the puncture to congest blood, and secure a necessary amount of bodily fluid. You may.
Further, the suction means may suction the epidermis before puncturing and puncture the raised epidermis.

When a large portion of the housing 2 is in contact with the skin 16 during suction, the pressure for pressing the skin 16 is dispersed, and the adhesion between the opening 7 and the skin 16 is deteriorated, and the vicinity of the opening 7 is reduced. Since the airtightness of the housing 2 may not be maintained, the structure of the housing 2 has a structure in which the vicinity of the opening 7 protrudes, that is, a tapered structure having an angle with respect to the skin 16 when the opening 7 is pressed against the skin 16. Alternatively, it is desirable that the structure be such that the vicinity of the opening protrudes. With these suction means and a tapered structure or a structure in which the vicinity of the opening protrudes, a minimum amount of body fluid required for measurement can be collected.

The body fluid 17 flowing out to the epidermis 16 is
Body fluid introduction guide 5 by surface tension between
And flows into the flow path having a higher surface tension through the suction port 4 to be guided to the test paper 6.

In the present invention, the portion shown in FIG. 2, ie, the housing 2, a measurement detecting section provided in the housing 2 for measuring components in the body fluid, and a flow path for introducing the body fluid to the measurement detecting section And a suction port 4 provided to guide the body fluid into the flow path section 3.
A portion provided with a bodily fluid introduction guide portion 5 for guiding the bodily fluid to the suction port 4 may be detachably provided as a bodily fluid storage container. At this time, it is sufficient that the measurement detector has at least a part of its configuration, for example, the test paper 6.

[0034]

The bodily fluid component measuring device of the present invention quickly guides a minimum amount of bodily fluid such as blood necessary for measurement flowing out of the epidermis into a bodily fluid introduction guide by its surface tension,
Immediately thereafter, the liquid can be guided to a flow path having a larger surface tension in the body fluid guide, and can be guided to a test paper or a measurement detector by a capillary phenomenon. In other words, the present invention is a body fluid component measuring device that can quickly and accurately measure even a minimum amount of body fluid such as blood necessary for measurement.

Further, the body fluid component measuring device of the present invention keeps the excess amount in the body fluid introduction guide even if the body fluid such as blood excessively flows out of the amount necessary for the measurement. Excess amount can be prevented from flowing out of the housing due to surface tension between the skin and the skin. That is, it is a body fluid component measuring device capable of performing measurement in a state excellent in hygiene.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of a part of a body fluid component measuring device 1 cut in a lateral direction, and the opening 7 is viewed from there.

FIG. 2 is a longitudinal sectional view of the body fluid component measuring device 1 in the vicinity of an opening 7 as in FIG.

FIG. 3 is a cross-sectional view similar to FIG. 1 of a body fluid component measuring device 1 of another embodiment.

FIG. 4 is a plan view of a place where a test paper of the body fluid component measuring device 1 in a state where the test paper is not installed is installed.

FIG. 5 is a longitudinal sectional view showing a use state of the body fluid component measuring device 1.

FIG. 6 is a longitudinal sectional view showing a use state of the body fluid component measuring device 1.

FIG. 7 is a longitudinal sectional view showing a use state of the body fluid component measuring device 1.

8 is a cross-sectional view of a part of the bodily fluid component measuring device 1 in the state of FIG. 7 cut in a lateral direction, and the opening 7 is viewed from there.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Body fluid component measuring device 2 Housing 3 Flow path part 4 Suction port 5 Body fluid introduction guide 51a, 51b guide 6 Test paper 7 Opening 8 Housing back surface 9 Air vent 10A Test paper center fixed base 10B Test paper peripheral fixed base 11 Light source 12 Light receiving element 13 Puncture needle 14 Seal member 15 Device housing 16 Skin 17 Body fluid

Claims (12)

[Claims] 1. An apparatus in which a sampling mechanism for sampling a body fluid from an epidermis and a measurement mechanism for measuring a component of the body fluid are integrated, wherein a housing and a component in the body fluid provided in the housing are measured. A measurement detection unit, a flow channel unit that introduces the bodily fluid to the measurement detection unit, and a suction port provided to guide the bodily fluid into the flow channel unit. A bodily fluid component measuring device provided with a bodily fluid introduction guide for guiding to a suction port. 2. An apparatus in which a collection mechanism for collecting body fluid from the epidermis and a measurement mechanism for measuring a component of the body fluid are integrated, a housing having at least one opening, and the housing provided in the housing. From a measurement detection unit that measures a component in a body fluid, a flow channel unit that introduces the body fluid to the measurement detection unit, and an inlet provided around the opening to guide the body fluid into the flow channel unit. The body fluid component measuring device according to claim 1, wherein a body fluid introduction guide unit for guiding the body fluid to the suction port is provided around the suction port. 3. The body fluid component measuring device according to claim 1, wherein the body fluid introduction guide is two or more projections provided around the suction port. 4. The humor component measuring device according to claim 1, wherein the flow channel portion introduces humor to the measurement detecting portion by capillary action. 5. The body fluid component measuring device according to claim 1, wherein a surface tension in the body fluid introduction guide portion is smaller than a surface tension in the flow passage portion. 6. The body fluid component measuring device according to claim 1, wherein the inside of the body fluid introduction guide portion is widened as the distance from the suction port increases. 7. The body fluid component measuring device according to claim 2, further comprising a puncturing means for projecting a puncturing needle from said opening. 8. The humor component measuring device according to claim 2, further comprising suction means for evacuating the inside of the housing and sucking a part of the epidermis or the humor from the opening. 9. A part of the housing is projected,
9. The device according to claim 2, wherein said projecting end has said opening.
The body fluid component measuring device according to claim 1. 10. The housing according to claim 1, wherein the housing has a tapered structure having an angle with respect to the epidermis when the opening is pressed against the epidermis to collect the body fluid from the epidermis. The body fluid component measuring device according to any one of the preceding claims. 11. The body fluid component measuring device according to claim 2, wherein the puncture needle passes through the body fluid introduction guide when protruding from the opening. 12. A body fluid component measuring device having a sampling mechanism for sampling a body fluid from the epidermis and a measuring mechanism for measuring a component of the body fluid, is detachably provided, a housing, and the body fluid provided in the housing. A measurement detection unit that measures components in the flow passage unit that introduces the bodily fluid to the measurement detection unit, and a suction port that is provided to guide the body fluid into the flow passage unit. A bodily fluid storage container provided with a bodily fluid introduction guide for guiding the bodily fluid to the suction port.