JP3648081B2 - Body fluid component measuring device - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a body fluid component measuring instrument for measuring a body fluid component such as blood.
[0002]
[Prior art]
As the number of diabetic patients increases in recent years, self-blood glucose measurement for monitoring daily fluctuations in blood glucose level has been recommended. The method for measuring blood glucose level is to squeeze the skin of the fingertip using a puncture tool equipped with a needle-like or sword-like lancet, squeeze the blood around the puncture part with a finger, etc., and squeeze the blood Touch a test piece to reach a test paper containing a reagent that reacts with glucose in it, and optically measure the reaction at the test paper part as a color reaction or use an electrode provided on the test paper. Measured and converted to blood glucose level. Examples of such test pieces for collecting blood and body fluid include those in which blood or the like is dropped on the test pieces, and test papers such as those disclosed in JP-A-4-264246, JP-A-7-55801, and JP-A-8-247946. There are types that transfer body fluid by capillary action. In the latter, the squeezed body fluid is temporarily held in a part of the test piece, and introduced to the test paper through the capillary.
[0003]
[Problems to be solved by the invention]
However, in such a conventional method of dripping blood or the like, the measured value varies because the time for dripping is not fixed for a fixed time. Even the type using the capillary phenomenon does not contribute to the reaction, and an object that remains in the capillary is made. Therefore, the burden on the patient is reduced by reducing the volume of the capillary as much as possible. However, if the volume of the capillary part is reduced, the opening part of the test piece is also reduced, and the operation for the patient to collect blood becomes difficult. In addition, when a body fluid is accidentally attached to a part other than the capillary mouthpiece, the suction to the capillary is deteriorated due to the influence of the surface tension at that part. Even when the liquid holding portion is provided, the structure is the same if the structure does not guide the periphery of the mouthpiece. Furthermore, if such a holding part is flush with the test piece body, the effect of the fingerprint will cause the test piece body to move from between the finger and the holding part unless the blood drop is pressed more strongly when scooping off the finger. Since blood wraps around on the back side, more blood volume is required, making it more uncertain and unsanitary, putting a burden on the patient.
[0004]
[Means for Solving the Problems]
The above-mentioned subject is achieved by the following present invention.
(1) The present invention relates to a bodily fluid component measuring instrument having a body fluid inlet, a measurement test paper capable of measuring components in the body fluid, and a flow path section for guiding the body fluid from the suction port to the measurement test paper. The body fluid component measuring instrument is provided with a body fluid introduction guide part for guiding the body fluid to the inlet without holding or holding the body fluid around the inlet. The body fluid whose component is measured in the present invention particularly refers to blood, but lymph fluid, urine, sweat and the like can also be measured.
[0005]
(2) The present invention provides the body fluid component measuring instrument according to (1), wherein the body fluid introduction guide portion is two or more protrusions provided around the suction port. The body fluid component measuring instrument according to the above (1) is particularly preferably provided with two protrusions.
(3) The present invention provides the body fluid component measuring instrument according to the above (1) to (2), wherein the surface tension in the body fluid introduction guide part is smaller than the surface tension in the flow path part.
[0006]
(4) The present invention provides the body fluid component measuring instrument according to any one of the above (1) to (3), wherein the body fluid introduction guide portion has a hem that expands as the distance from the suction port increases.
(5) In the present invention, the body fluid introduction guide section includes a body fluid suction port, a measurement test paper capable of measuring components in the body fluid, and a flow path section for guiding the body fluid from the suction port to the measurement test paper. The body fluid component measuring instrument according to any one of the above (1) to (4), which is provided with an angle with respect to the longitudinal axis direction of the housing having the.
[0007]
(6) The present invention provides the body fluid component measuring instrument according to the above (1) to (5), wherein the flow path section introduces body fluid to the measurement test paper by capillary action.
(7) The present invention relates to a body fluid component measuring instrument having a body fluid inlet, a measurement test paper capable of measuring components in the body fluid, and a flow path section for guiding the body fluid from the suction port to the measurement test paper. The body fluid component measuring instrument is provided with two protrusions extending outwardly around the suction port.
[0008]
(8) The present invention provides the body fluid component measuring instrument according to the above (7), wherein each of the two protrusions facing each other has a shape that widens as the distance from the suction port increases.
(9) In the present invention, the two protrusions include a body fluid suction port, a measurement test paper capable of measuring components in the body fluid, and a flow path portion for guiding the body fluid from the suction port to the measurement test paper. The body fluid component measuring instrument according to any one of (7) to (8), wherein the instrument is provided with an angle with respect to a longitudinal axis direction of the housing.
[0009]
DETAILED DESCRIPTION OF THE INVENTION
An embodiment of a body fluid component measuring instrument of the present invention will be described with reference to the drawings. FIG. 1 is a plan view of the body fluid component measuring instrument 1 according to this embodiment, and FIG. 2 is a longitudinal sectional view thereof. A rectangular housing 2, a measurement test paper 6 attached on the plane of the housing 2, a flow path portion 3 for introducing body fluid to the measurement test paper 6, and the body fluid are guided to the suction port 4 of the flow path portion 3. It consists of a body fluid introduction guide part 5. Note that the shape of the housing 2 is not particularly limited as long as the other components can be provided.
[0010]
The flow path unit 3 is a path for guiding body fluid from the suction port 4 to the measurement test paper 6 by capillary action. Although the cross-sectional shape and length depend on the amount of body fluid required for measurement, it is preferable to design so that the dead volume does not increase. Specifically, the cross-sectional shape may be a tube, a V-shaped groove, or a rectangle, but a thin rectangle is preferable in view of the dead volume. The thickness is preferably about 0.05 to 0.5 mm, and the width is preferably about 0.5 to 3 mm. Although the length depends on the position arrangement of the optical member used for measurement, it is preferably as short as possible, and is preferably about 1 mm to 15 mm. The flow path part 3 can be obtained by fixing a tubular body or a groove member even if the flow path part 3 is integrally formed with the housing 2 by injection molding, or provided integrally with the housing 2 by notching or pressing the housing 2. It may be a thing.
[0011]
Housing 2 is made of ABS, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene Thermosetting such as thermoplastic resin used in injection molding such as terephthalate, phenol resin, epoxy resin, silicone resin, and unsaturated polyester may be used. Further, in the optical measurement in which the detection principle captures the color reaction on the test paper, a non-transparent material is preferable so that it is less susceptible to the influence of disturbance light due to the measurement accuracy. A translucent colored resin may be used so that the patient can see the suction.
[0012]
The material used for the flow path portion 3 may be the same as that of the housing 2, but it is preferable to increase the suction force by making the surface of the material highly hydrophilic such as acrylic resin or the surface hydrophilic. Examples of hydrophilic means include physical treatment such as ozone treatment, plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation, and application of surfactants, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol, etc. Can be done.
[0013]
The body fluid introduction guide portion 5 has a function of guiding body fluid to the suction port 4 when body fluid comes into contact with the tip portion thereof. In terms of shape, if the body fluid once led to the inlet 4 spreads to the distal end portion 7 of the housing 2, the suction force is reduced and the amount of body fluid increases unnecessarily, causing a burden on the patient. Alternatively, it is desirable to have a structure that does not hold and does not allow other body fluids to flow out. Specifically, two protrusions 51a and 51b are provided in a rail shape around the inlet 4 so as to protrude outward. Two or more protrusions may be provided, or the protrusions may be continuous in a circumferential shape. Further, when the angle α is provided with the housing 2 as will be described later, it may be a semicircular shape or a dome shape that covers the patient's skin. The height of the body fluid introduction guide part 5 is such that body fluid spreads from between the body fluid introduction guide parts 5 (between the two protrusions 51a and 51b) when an excessive amount of body fluid flows into the body fluid introduction guide part. In order to prevent this, it is desirable that the height be from the upper surface to the lower surface of the front end portion 7 of the housing 2 as shown in the front view 3. The material may be the same as that of the housing 2 or the flow path part 3, and it is desirable to perform a hydrophilic treatment like the flow path part 3.
[0014]
When the body fluid is actually measured by the body fluid component measuring instrument 1, the body fluid introduction guide unit 5 is brought closer to the body fluid drop, and the body fluid introduction guide unit 5 is brought into contact with the body fluid. At that time, it is expected that the tip of the body fluid introduction guide unit 5 is brought close to the skin of the patient, and when the body fluid introduction guide unit 5 and the housing 2 are on the same plane, the body fluid introduction guide unit 5 If the tip is not touched, the gap between the patient's skin and the back surface 8 of the housing is small, so that there is a risk that bodily fluid will accidentally adhere to the back surface 8 of the housing, making it difficult to suck the bodily fluid. Therefore, it is desirable to provide an angle α between the body fluid introduction guide portion 5 and the housing 2. This is because providing the angle α between the body fluid introduction guide portion 5 and the housing 2 increases the gap between the patient's skin and the housing back surface 8 so that the body fluid does not go around the housing back surface 8.
[0015]
Furthermore, it is desirable that the body fluid introduction guide unit 5 has a surface tension in the body fluid introduction guide unit 5 that is smaller than the surface tension in the flow channel unit 3, thereby smooth supply of body fluid from the patient's skin, And since all the bodily fluid in the bodily fluid introduction guide part 5 is supplied to the flow path part 3, it becomes unnecessary to consider the dead volume in the bodily fluid introduction guide part 5, and it is possible to reduce the burden on a patient. The shape for that purpose is not particularly limited, but specifically, as shown in FIG. 4, the portions of the two protrusions 51a and 51b facing each other become wider as they move away from the suction port, so that body fluid is spotted. It is desirable to make the side to be widened. The surface tension can also be adjusted by the material and surface treatment of the body fluid introduction guide portion 5.
[0016]
Specifically, each of the body fluid introduction guide portion 5 or the protrusions 51a and 51b has a width of about 1 to 3 mm, a height of about 0.5 to 3 mm, and a length (a distance protruding from the tip surface) of 1. About 3 mm is preferable. This is because when the body fluid is squeezed out about 4 μl, the size is about 3 mm. Therefore, it is desirable that the whole body fluid introduction guide part should have the maximum equivalent to the necessary blood volume. It is done. The angle α with the housing 2 is 10 to 80 degrees, and considering the ease of use of the patient, about 10 to 45 degrees is appropriate.
[0017]
The measurement test paper 6 is fixed on the plane of the housing 2 via measurement test paper fixing bases 10a and 10b. The fixing method is not particularly limited, and examples thereof include adhesion and fusion. In the present embodiment, the measurement test paper side end of the flow path portion 3 is provided at the center of the measurement test paper fixing table 10a. However, the shape is not particularly limited to this, and the measurement test paper fixing table 10a and The measurement test paper side end of the flow path section 3 may be provided separately. The measurement test paper fixing base is not particularly limited as long as it does not require two kinds of 10a and 10b, and the shape can be fixed to the measurement test paper 6.
[0018]
In addition, when the body fluid is introduced from the suction port 4 to the measurement test paper 6 by using the flow path portion 3, it is desirable to provide air escape in the closed system because the capillary phenomenon stops midway. Specifically, as shown in FIG. 5 which is an enlarged view of the insertion portion of the measurement test paper 6 in the housing 2 (the measurement test paper 6 is not inserted), the periphery of the measurement test paper 6 is partially bonded and melted. A measurement test paper fixing base 10b is provided so as to be fixed to the housing 2 by wearing, and a space is formed between the measurement test paper 6 and the housing 2 to secure a passage through which air can escape. The width of the space at that time is preferably about 0.01 to 0.3 mm. Then, the measurement test paper fixing base 10a may be formed with an air escape portion 9 communicating with the measurement test paper side end portion of the flow path portion 3 provided at the center and the space.
[0019]
Further, the air escape is not limited to the shape described above, and the structure thereof is shown in the body fluid component measuring instrument 21 which is another embodiment of the present invention shown in FIG. The measurement test paper 26 may be provided on the side surface in the middle, and the air escape part 29 may be provided as an end part of the flow path part 23 and provided on the plane of the housing 22. In the body fluid component measuring device 21, other components such as the suction port 24 and the body fluid introduction guide portion 25 are the same as those of the body fluid component measuring device 1.
[0020]
For example, when measuring glucose in blood, the measurement test paper 6 is obtained by impregnating a test paper with glucose oxidase, peroxidase, and a color reagent as a reagent and drying them. As the test paper, a porous film is desirable, and examples thereof include a nonwoven fabric, a woven fabric, and a stretched sheet. Examples of the material include polyesters, polyamides, polyolefins, polysulfones, and celluloses. In addition, since a reagent is impregnated or a body fluid is impregnated, a hydrophilic material or a hydrophilic material is desirable. The measurement test paper 6 may be a single layer film or a multilayer structure. In the case of a structure in which body fluid is impregnated from the back end of the measurement test paper 26 as in the body fluid component measuring instrument 21 described later, a multilayer structure is better.
[0021]
In the present invention, even if the measurement test paper is provided with a structure in which body fluid is impregnated from the vicinity of the center of the back of the measurement test paper 6 as in the body fluid component measurement tool 1, the measurement test paper 26 as in the body fluid component measurement tool 21. It may be provided with a structure in which body fluid is impregnated from the back end. Note that, as described above, it is desirable that the measurement test paper is partially stopped when the test paper is fixed, and that a path for air to escape is free. Further, it is desirable that the housings 2 and 22 are provided with steps 11 and 31 so that the mounting positions of the measurement test papers 6 and 26 can be adjusted.
[0022]
Next, a method for using the body fluid component measuring device 1 will be described. First, a patient's fingertip or the like is punctured with a needle or a puncture device having a needle, and blood is allowed to flow out onto the skin. Then, the blood is brought close to the droplet while the tip of the body fluid introduction guide portion 5 of the body fluid component measuring instrument 1 is touched to the skin of the patient, and the blood is brought into contact with the body fluid introduction guide portion 5. Then, the blood is guided to the suction port 4 through the body fluid introduction guide portion 5 by the surface tension without being attached to other parts such as the housing back surface 8 of the body fluid component measuring instrument 1 by the surface tension. It is guided to the measurement test paper 6 by the capillary phenomenon through the flow path portion 3 and developed on the measurement test paper 6. Thereafter, the blood spread on the measurement test paper 6 is subjected to quantification of blood components, qualitative analysis, for example, measurement of blood glucose level, etc. by a measuring device or the like. The measuring device includes a light source and a light receiving element, the light receiving element captures the light emitted from the light source and reflected from the measurement test paper 6, measures the degree of coloration, and converts it to a blood glucose level, etc. 6 includes two electrodes that measure body fluid components by an electrode method in which the current is detected by measuring the current value between the electrodes.
[0023]
The body fluid component measuring device 1 may be used by being attached to a puncture device having a needle or a device in which a puncture mechanism and a measurement mechanism are provided integrally. For example, the body fluid component measuring device 1 is attached to the tip of a puncture device or device, and the body fluid introduction guide unit 5 is directly in contact with or close to the patient's skin, and the protrusions 51a and 51b of the body fluid introduction guide unit 5 The needle passes between the blood and the blood that has flowed out of the skin after puncture immediately comes into contact with the body fluid introduction guide 5 and is developed on the measurement test paper 6.
[0024]
【The invention's effect】
The bodily fluid component measuring instrument of the present invention makes it difficult for bodily fluids such as blood to adhere to the front and back surfaces of the housing other than the suction port and the bodily fluid introduction guide, thereby minimizing the risk that the patient or measurer touches bodily fluids, even with less bodily fluids. Effectively, the body fluid can be guided to the measurement test paper quickly and reliably, and the components of the body fluid can be measured.
[Brief description of the drawings]
FIG. 1 is a plan view of a body fluid component measuring device 1. FIG.
FIG. 2 is a longitudinal sectional view of the body fluid component measuring device 1. FIG.
FIG. 3 is a front view of the body fluid component measuring device 1;
FIG. 4 is a plan view of a bodily fluid component measuring instrument 1 having another form of the bodily fluid introduction guide section 5;
FIG. 5 is a plan view of an insertion portion of a measurement test paper 6 of the body fluid component measuring device 1;
FIG. 6 is a longitudinal sectional view of the body fluid component measuring tool 2;
[Explanation of symbols]
1,21 Body fluid component measuring device 2,22 Housing part 3,23 Flow path part 4,24 Suction port 5,25 Body fluid introduction guide part 51a, 51b Projection 6,26 Measurement test paper 7 Tip part 8 Housing back surface 9,29 Air Separation part 10a, 10b Measurement test paper fixing base 11, 31 Step difference

Claims (7)

In a bodily fluid component measuring instrument having a bodily fluid inhalation port, a measurement test paper capable of measuring components in the bodily fluid, and a flow path section for guiding the bodily fluid from the inhalation port to the measurement test paper, around the inhalation port Is a bodily fluid component measuring instrument provided with a bodily fluid introduction guide portion which is two or more protrusions for guiding bodily fluid to the inhalation port. The body fluid component measuring instrument according to claim 1, wherein a surface tension in the body fluid introduction guide part is smaller than a surface tension in the flow path part. The humor component measuring instrument according to claim 1 or 2 , wherein the humor introduction guide portion has a hem that expands as the distance from the suction port increases. The longitudinal direction of the housing in which the body fluid introduction guide has a body fluid inlet, a measurement test paper capable of measuring components in the body fluid, and a flow path section for guiding the body fluid from the suction port to the measurement test paper body fluid component measuring instrument according to claim 1 to 3 is provided at an angle to. In a bodily fluid component measuring instrument having a bodily fluid inhalation port, a measurement test paper capable of measuring components in the bodily fluid, and a flow path section for guiding the bodily fluid from the inhalation port to the measurement test paper, around the inhalation port Is a body fluid component measuring instrument provided with two protrusions extending outward. The humor component measuring instrument according to claim 5 , wherein each of the two protrusions facing each other has a shape that widens as the distance from the suction port increases. The longitudinal direction of the housing in which the two protrusions have a body fluid suction port, a measurement test paper capable of measuring components in the body fluid, and a flow path portion for guiding the body fluid from the suction port to the measurement test paper The body fluid component measuring device according to claim 5 , wherein the body fluid component measuring device is provided with an angle to the body.

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