JPH09168530A - Body fluid collecting tool and body fluid analyzer using the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a body fluid collecting tool capable of collecting body fluid not by suction and displaying data, by setting a member capable of transmitting body fluid so as to be penetrated with a penetrating needle. SOLUTION: A base body 2 must comprise a material with rigidity and a penetrating needle holding member 31 a material with elasticity. The penetrating needle holding member 31 is hit by a hammer, etc., connected with a spring to be deformed downward, and a penetrating needle 3 is pushed out downward therewith. The pushed out penetrating needle 3 penetrates through a body fluid transmission member 4 and a finger mounted thereunder, then returns to the original position by the elasticity of the penetrating needle holding member 31. Though the finger penetrated bleeds, the bled blood is absorbed by the body fluid transmission member 4 and reaches an electrode 41 (42) by the capillary phenomenon, etc. Detected matters in the blood are converted to electric signals and transmitted to a sensor set in this body fluid analyzer through a lead wire 43 and measured values are displayed on a display part.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a body fluid collecting device capable of collecting body fluid such as blood or intercellular exudate, and a body fluid analyzer capable of analyzing a substance to be detected contained in the collected body fluid. .

[0002]

2. Description of the Related Art Currently, test systems utilizing the specificity of biomaterials such as enzymes and antibodies are used for clinical test materials, food tests,
Widely used for environmental measurement. Among them, oxidoreductase such as GOD causes electron transfer due to the redox reaction of the substance to be detected before and after the reaction, and is therefore widely used as a sensor material for reading with an electric signal.

As a typical example of such an inspection system, there is a portable blood glucose level sensor used for diabetic patients and the like. Conventionally, to measure blood glucose levels using this blood glucose sensor, a puncture device (lancet) was used to scratch the fingertip, squeeze blood droplets from the wound, remove it from the packaging material, and attach it to the sensor. It was done by attaching the blood drop to the. However, if the puncture device and the sensor are separated as described above, many steps are required for performing a series of operations, which is complicated, and there is a problem of erroneous operation. In addition, in this blood glucose sensor measuring chip, in order to bring the required minimum amount of blood into contact with the electrode part, a film is attached via a spacer, a slit is formed on the electrode, and blood is introduced into the slit by capillary action. However, it was difficult to manufacture it.

Therefore, a medical system in which a puncture needle, a capillary tube and a sensor are integrated (see Japanese Patent Laid-Open No. 61-286738), a blood sampling device in which a puncture needle, a suction tool and a blood reservoir are integrated (Japanese Patent Laid-Open No. Hei 10 (1999) -26498) 5-111476, JP-A-6-311980, JP-A-6-327655, JP-A-7-51251) and a blood sampler in which a puncture needle, a suction tool, a blood reservoir and a sensor are integrated. (See JP-A-5-95937 and JP-A-5-95938).

However, all of the blood collecting methods using these devices are based on a method of decompressing with a syringe, a dropper or the like to suck blood, and in the former case, the pressure cannot be reduced unless the bottom surface of the cylinder is brought into close contact with the skin. When a cylinder with a diameter of φ1.5 mm or less is used, there is a drawback that blood blocks the hole and bleeding stops, and the latter has a drawback that the structure of the dropper is complicated.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide a body fluid collecting device which has a mechanism for collecting body fluid by a method that does not rely on suction and is easy to manufacture, and the body fluid collecting device and the amount of body fluid discharged. The object of the present invention is to provide a convenient body fluid analyzer which is provided with a means for increasing the amount and a display unit.

[0007]

As a result of earnest research in view of the above problems, the inventors of the present invention easily provided a member capable of transmitting body fluid so that a puncture needle could penetrate therethrough, without the need for a suction method. The present invention has been completed based on the finding that a body fluid can be collected and that the body fluid can be easily and quickly analyzed.

That is, the present invention is a body fluid collecting device comprising at least a body fluid transmitting member capable of transmitting a body fluid to a desired position and a puncturing member capable of penetrating the body fluid transmitting member. is there. Further, the present invention comprises at least the body fluid collecting device, means for increasing the discharged amount of body fluid, and a display unit for displaying an analysis result of the collected body fluid. Is.

[0009]

[Function] A body fluid transmission member made of a material having water absorption,
In the body fluid collecting device of the present invention having the puncture member capable of penetrating the body fluid transmitting member, the discharged body fluid moves in the body fluid transmitting member due to a capillary phenomenon or the like and comes into contact with the enzyme electrode. Further, in the body fluid collecting device of the present invention which has a body fluid transmitting member made of a non-water-absorbing material and a puncture member capable of penetrating the body fluid transmitting member, in the body fluid collecting device of the present invention, the discharged body fluid is a space between the skin and the body fluid transmitting member. At, it moves by capillary phenomenon and contacts the enzyme electrode.

Therefore, according to the body fluid collecting device of the present invention,
Problems with the method of collecting blood by suction, that is, the pressure cannot be reduced unless the bottom surface of the cylinder is in close contact with the skin, and when using a cylinder of φ 1.5 mm or less, body fluid blocks the hole and bleeding stops It is possible to solve the problems such as the problem of being complicated and the problem that the structure of the dropper is complicated. Further, it is not necessary to provide a special means for bringing the body fluid into contact with the enzyme electrode or the like, and the series of operation steps required for analysis can be reduced.

By providing a plurality of different types of enzyme electrodes in the body fluid collecting device of the present invention, various substances to be detected can be measured by a single test. According to the body fluid analyzer of the present invention including the body fluid collecting device, means for increasing the amount of body fluid discharged, and the display unit, general users can collect body fluid easily and quickly without requiring skill. The substance to be detected can be analyzed with one touch.

If the above-mentioned body fluid collecting device is made into a cartridge type, it can be disposable, and infection of bacteria and the like can be prevented. If the body fluid collecting device is packaged, it is safer in terms of hygiene. Further, if a plurality of the body fluid collecting devices are combined into one cartridge, the body fluid collecting devices can be successively fed out, and the body fluid can be continuously analyzed.

[0013]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail with reference to the drawings. Here, the body fluid in the present invention refers to a liquid that can be discharged from a living body by puncturing, such as blood or intercellular exudate.

A perspective view of a body fluid collecting device according to an example of the present invention is shown in FIG. In addition, A of the body fluid collecting device 1 in FIG.
2A is a sectional view taken along the line A, and FIG. 3 is an exploded perspective view of the body fluid collecting device 1. This body fluid collecting device 1 has holes 21, 22, 23
A plate-shaped base 2 having a puncture needle 3 and a puncture needle 3 attached to the base 2 via a puncture needle holding member 31 and housed in a hole 21.
And a body fluid transmission member 4 provided on the bottom surface of the base 2. An enzyme electrode is provided on the upper surface of the body fluid transmitting member 4, and the enzyme electrode is composed of a working electrode 41 and a control electrode 42. A lead wire 43 is connected to each of the electrodes 41 and 42 and is housed in the holes 22 and 23 of the base 2.

The body fluid collecting device having such a structure has an advantage that the size thereof can be made compact. Moreover, since the electrodes can be made flat, the electrodes can be easily formed. The base body 2 may be made of any material, but when it is made of a material having rigidity, in order to project the puncture needle 3,
The puncture needle holding member 31 needs to be formed of a material having elasticity. On the other hand, when the base body 2 is made of a material having elasticity, the puncture needle holding member 31 can be made of a material having rigidity. The size and shape of the substrate 2 is not particularly limited as long as it can be installed in the body fluid analyzer, but considering the operability at the time of installation, the storage property of the puncture needle 3, etc., the thickness in the puncture direction is 2 to 50 mm. Yes, and one side of the cross section perpendicular to the puncture direction is 3
~ 50mm polygon, 3 ~ 50mm diameter circle or oval,
Alternatively, the shape is preferably a combination of a polygon and a circle / oval.

Examples of the rigid material forming the base 2 include plastics, ceramics and metals, and examples of the elastic material include polyurethane rubber, synthetic rubber and the like, and woven and non-woven fabrics made of these materials. , And surgical tape materials. In addition, examples of the elastic material forming the puncture needle holding member 31 include an adhesive tape and the like, and examples of the material having rigidity include plastic and the like.

The puncture needle 3 is made of a material harmless to the human body. Such materials include stainless steel (S
US) is preferred. The length of the puncture needle 3 is the body fluid transmission member 4
And preferably 2 to 30 mm for penetrating the stratum corneum of the skin. In the present embodiment, the puncture needle 3 is housed in the hole 21 of the base body 2 except when puncturing, so that it is possible to prevent an injury or the like due to an erroneous operation during installation or disposal in the body fluid analyzer. .

The body fluid transmitting member 4 may be made of any material as long as it can penetrate the puncture needle 3, and either a water-absorbing material or a non-water-absorbing material can be selected. As the water-absorbing material, any material can be used as long as it can absorb the body fluid discharged from the human body by puncture and can transfer the absorbed body fluid to the enzyme electrode by a capillary phenomenon or the like. As such a material, for example, paper, woven cloth, non-woven cloth, porous body or the like can be used. Examples of the paper include cellulose filter paper and the like, and examples of the woven fabric and the non-woven fabric include those made of cellulose, regenerated cellulose, cellulose acetate, silk, cotton, polyamide, polyester, polyacryl, polyolefin, polyurethane, nylon, and the like. Examples of the porous body include a glass filter, a nylon membrane, a nitrocellulose membrane, a cellulose acetate membrane, a polyvinylidene fluoride membrane, a regenerated cellulose membrane, and a foamed cellulose sheet. Among these water absorbent materials, cellulose filter paper, glass filter and polyester non-woven fabric are preferable from the viewpoints of rigidity, water absorption performance and the like.

When a water-absorbent material is used, the amount of body fluid is limited to the water-absorption capacity of the water-absorbent material, so that the test can be performed with a fixed amount of the sample liquid. Moreover, since the surface area of the electrode can be increased, the sensitivity can be improved. Since such a water absorbent material can be penetrated by the puncture needle 3, it is not necessary to provide a special punching step, but in some cases, a hole for passing the puncture needle 3 may be provided. When the bodily fluid transmission member 4 is made of a water-absorbent material, the thickness of the bodily fluid transmission member 4 may be appropriately set in consideration of the length of the puncture needle 3, the amount of bodily fluid discharged, the distance from the puncture portion to the electrode, and the like. It is sufficient, and specifically, about 2 to 2000 μm is preferable.

On the other hand, as the non-water-absorbing material, as long as the body fluid discharged from the human body by puncturing can be transferred to the electrode with the human body by a capillary phenomenon or the like,
Any may be used. Examples of such materials include polyethylene, polyethylene terephthalate, polystyrene, triacetyl cellulose and the like. By forming such a non-water-absorbing material so that the puncture needle 3 can penetrate therethrough, it is not necessary to provide a special punching step, but when the puncture needle 3 cannot penetrate, a hole for passing the puncture needle 3 is formed. It is necessary to provide a part (puncture hole).

When the body fluid transmission member 4 is formed of a non-water-absorbing material, the thickness of the body fluid transmission member 4 may be set appropriately in consideration of the length of the puncture needle 3, and specifically, it is about 2 to 2000 μm. preferable. The reference electrode 42 is formed of a conductive material, whereas the working electrode 41 contains a conductive substance, as well as a redox enzyme and an electron transfer substance as a substance to be detected. Examples of the conductive material (substance) include metals such as gold, silver, platinum and copper, metal pastes such as gold paste, silver paste and copper paste, carbon paste, metal fine particles such as gold colloid and silver colloid, indium oxide and the like. Can be mentioned. The conductive substance in the working electrode 41 has a role of transmitting an electrochemical change due to an enzymatic reaction to the lead wire 43.

The redox enzyme recognizes a substance to be detected and causes an electrochemical change through a redox reaction. The oxidoreductase used in the present invention is not particularly limited as long as it can carry out an oxidoreduction reaction of a substance to be detected, but it is preferable that it is stable in terms of storage in a dry state from the production process to the use of the enzyme electrode. In some cases, thermostable enzymes such as those derived from thermophiles are preferred. Major redox enzymes include glucose oxidase, glucose oxidase, pyruvate oxidase, D- or L-amino acid oxidase, amine oxidase, cholesterol oxidase, choline oxidase, urate oxidase, ascorbate oxidase, alcohol dehydrogenase, pyruvate dehydrogenase, folate. Dehydrogenase etc. are mentioned.

The electron transfer substance has a function of transferring the local transfer of electrons generated at the reaction site of the enzyme to the conductive substance through the electron transfer substance. Such electron transfer materials include polypyrrole, ferrocene, ferrocene derivatives, nicotinamide derivatives, flavin derivatives, quinones,
Examples include quinone derivatives. These electron transfer substances mediate electron transfer between the enzyme and the conductive substance by being mixed with the enzyme solution or directly modified with the enzyme.

In addition to the above components, the working electrode 41 and the reference electrode 42 stabilize salts, for example, salts having a buffering action, binder components such as PVP, PVA and carrageenan for fixing the electrode to the substrate, and enzymes. BSA to let
Proteins such as casein, saccharides, surfactants for improving the permeability of the sample liquid, phospholipids and the like may be contained. Regarding the body fluid transmission member 4 as a base material, in order to improve the water absorption and the permeability of the sample liquid, the body fluid transmission member 4 is immersed in a surfactant, phospholipid or the like and then dried. Processing may be performed.

The electrodes 41 and 42 can be formed by applying or sticking an electrode material to the body fluid transmitting member 4. In particular, in order to form the working electrode 41 on the body fluid transfer member 4, a method of mixing a conductive material, an electron transfer material and a redox enzyme and applying the mixture in one step, and after forming an electrode substrate with the conductive material, There is a method of fixing an electron transfer material and a redox enzyme. In any case, a screen printing method, a roll coating method, a dispenser, an inkjet method, a vapor deposition method, an electroless plating method, or the like can be used for patterning. However, when using a metal paste that requires high-temperature sintering, or in an environment in which the enzyme is difficult to stabilize, such as the vapor deposition method and the electroless plating method, in order not to deactivate the enzyme, after forming the electrode substrate, It is preferable to immobilize the enzyme. The immobilization of the enzyme can be performed by a screen printing method, a roll coating method, a dispenser, an inkjet or the like.

In the one-step coating method, a conductive material such as carbon black, a redox enzyme such as GOD, and an electron transfer material such as polypyrrole are kneaded together with an organic solvent such as ethyl alcohol. The working electrode 41 can be formed by a screen printing method or the like.

Alternatively, metal sol particles are used as a conductive material, and an enzyme is immobilized on the metal sol particles in an aqueous solution, and then a working electrode 41 is prepared together with an electron transfer substance by a dispenser, ink jet, roll coating, screen printing method or the like. Can be formed. If the electrode is prepared in an aqueous solution system, it can be formed in one step while maintaining the activity of the enzyme. In the case of gold colloid, for example, the metal sol particles can be prepared by reducing chloroauric acid with a suitable reducing agent. The particle size of the metal sol particles can be adjusted by the reaction time with the reducing agent and the concentration of the reducing agent. In order to immobilize the enzyme on the metal sol particles, after preparing the metal sol particles, the unreacted liquid contained in the supernatant is removed by centrifugation, and then BS is used in a buffer solution having a pH of appropriate reaction conditions.
A, by adding the enzyme in the presence of a stabilizer such as sugar,
Can be immobilized.

An enlarged view of FIGS. 4A and 4B shows a state in which the electrodes are formed on the body fluid transmitting member made of a water absorbing material as described above. In FIG. 4A, the electrode 40 is coated on the surface of the tissue 4t of the water-absorbent material, and in FIG. 4B, the electrode 40 is coated on the surface of the tissue 4t and is filled in the voids of the tissue 4t.

When the body fluid transmitting member 4 is made of a water-absorbing material, the electrodes 41 and 42 may be provided on either the upper surface or the lower surface of the body fluid transmitting member 4, but when it is made of a non-water-absorbing material. As shown in FIG. 2 (b), it must be provided on the lower surface of the body fluid transmission member 4. Each electrode is preferably formed at a position as close as possible to the puncture portion in order to suppress the amount of bodily fluid discharged, and in order to reduce the resistance value due to bodily fluid, the working electrode 41 and the control electrode 42 are brought close to each other. It is preferable to form it.

In the body fluid collecting device of the present invention, as shown in FIGS.
As shown in, the water absorbing layer 4a and the sheet 4b made of a non-water absorbing material may be laminated so that the body fluid transmitting member (water absorbing layer) 4a made of a water absorbing material is on the lower side. In this case, the enzyme electrodes 41 and 42 need only be provided between the two, and may be formed on either side of the water absorbing layer 4a or the sheet 4b. The water absorbing layer 4a and the sheet 4b are laminated by a method of pressure bonding using an adhesive, a binder such as PVP, or a method of applying a water absorbing powder such as carboxymethyl cellulose or microcrystalline cellulose to the sheet 4b. be able to.

The body fluid collecting device of the present invention may have a plurality of enzyme electrodes. By using different types of enzymes depending on the substance to be detected, it is possible to detect multiple items at the same time. A plurality of enzyme electrodes may be provided on the same base material, or as shown in FIG. 6, the body fluid transmission member is composed of a plurality of layers 4n, 4n '... Of water-absorbing material, and each layer has a different type of enzyme. The electrodes 41, 42, 41 ', 42' may be provided. In the former case, even if the substrate is made of a water-absorbing material,
It may be made of a non-water-absorbing material, or may be provided between the sheet made of the non-water-absorbing material and the water-absorbing layer. In the latter case, the body fluid sequentially permeates into each layer and reaches the enzyme electrode provided in each layer, but in order to prevent the electrodes from contacting each other, as shown in FIG. It is preferable to provide water-absorbing spacer layers 4m, 4m '... Between 4n, 4n', 4n ''.

FIGS. 8A and 8B are schematic views showing an example of collecting body fluid (here, blood) by the body fluid collecting device 1 using the body fluid transmitting member 4 formed of a water-absorbing material. In this embodiment, the base 2 is made of a rigid material, and the puncture needle holding member 31 is made of an elastic material. The puncture needle holding member 31 is hit by a hammer or the like connected to a spring to be deformed downward, and the puncture needle 3 is pushed downward with it. The pushed out puncture needle 3 is a body fluid transmission member 4
After piercing through and puncturing a finger attached below it, the puncture needle holding member 31 returns to its original position by the elasticity. The punctured finger bleeds, but the blood is absorbed by the body fluid transmitting member 4,
The electrodes reach the electrodes 41, 42 due to a capillary phenomenon or the like. The substance to be detected in the blood is converted into an electric signal and sent to a sensor provided in the body fluid analyzer through the lead wire 43.

FIGS. 9 (a) and 9 (b) are schematic views showing an example of blood collection by the body fluid collecting device 1 using the body fluid transmitting member 4 formed of a non-water absorbent material. In this embodiment, the base 2
Is made of an elastic material, and the puncture needle holding member 31 is made of a rigid material. Puncture needle holding member 31
Is hit by a hammer or the like connected to a spring, and the base 2
Transform. The puncture needle 3 is pushed downward by the deformation of the base body 2 and penetrates the body fluid transmission member 4. Then, after puncturing a finger mounted below the body fluid transmission member 4, the elastic force of the base body 2 returns the original position. The punctured finger bleeds,
The blood moves between the body fluid transmission member 4 and the finger due to the capillary phenomenon or the like, and reaches the electrodes 41 and 42. The substance to be detected in the blood is converted into an electric signal and sent to a sensor provided in the body fluid analyzer through the lead wire 43.

Although the electrodes are provided on the body fluid transmitting member in the present embodiment, the present invention is not limited to this, and means for extracting an electric signal from the body fluid transmitting member may be provided on the body fluid analyzer side. For example, if a cylindrical conductive member corresponding to the holes 22 and 23 of the base body 2 is installed in the body fluid analyzer and driven so as to come into contact with the body fluid transmitting member when the body fluid collecting device is attached, The substance to be detected can be measured without providing electrodes and lead wires as in the embodiment. Further, although the method of electrochemically measuring the substance to be detected has been described as an example in the present embodiment, a means for optically detecting using a GOD-coloring substrate or the like can be applied.

This body fluid collecting device 1 can be used in a body fluid analyzer in the form of a cartridge. As a result, it can be disposable and prevent bacterial infection and the like. In addition, if the body fluid collecting device 1 is packaged, it becomes safer in a hygienic manner, and inactivation of the enzyme can be prevented. FIG. 10 shows a cross-sectional view of the body fluid collecting device 1 wrapped with the package 11. The package 11 may be made of any material as long as it has airtightness, and for example, a laminate film in which a plurality of aluminum foils and polyethylene, nylon, polypropylene or the like are laminated can be used. The packaging is preferably performed under aseptic conditions.

When the body fluid collecting device 1 is of a cartridge type, if a plurality of body fluid collecting devices 1 are combined into one cartridge, the body fluid collecting device can be fed one after another, and the body fluid can be continuously analyzed. . FIG. 11 shows a package 11
FIG. 5 is a cross-sectional view showing a state in which the five body fluid collection devices 1 packaged in 1 are loaded in one cartridge holder 12.

Next, FIG. 12 is a perspective view of a body fluid collecting device according to another example of the present invention. Further, FIG. 13 is a plan view of the body fluid transmitting member 4 of the body fluid collecting device 1 ′ in FIG. 12, and FIG. 14 is a schematic diagram showing an example of body fluid collecting using the body fluid collecting device 1 ′.
Shown in (a), (b), (c). The body fluid collecting device 1 ′ is provided in a cylindrical cylinder 24, a puncture needle holding member 31 slidable in the cylinder 24, a puncture needle 3 attached to the puncture needle holding member 31, and a lower end of the cylinder 24. Body fluid transmission member 4
And As shown in FIG. 13, the body fluid transmission member 4 is provided with a working electrode 41 and a reference electrode 42, and a wiring 44 is provided on each electrode. The electrodes 41, 42 and the wiring 44 may be provided on either the upper surface or the lower surface of the body fluid transmitting member 4, but if the body fluid transmitting member 4 is made of a non-water-absorbing material, it must be provided on the lower surface.

The size and shape of the cylinder 24 are not particularly limited as long as it can be installed in the body fluid analyzer, but considering the operability during installation and the storage property of the puncture needle 3, the height in the puncture direction is 2 The cross section perpendicular to the puncture direction is preferably a circle or an ellipse having a diameter of 3 to 50 mm, a polygon having a side of 3 to 50 mm, or a combination of the polygon and a circle or an ellipse.

Also in this body fluid collecting device 1 ', a body fluid transmitting member (water absorbing layer) made of a water absorbent material and a sheet made of a non-water absorbent material may be laminated, and a plurality of enzyme electrodes may be provided. It may be provided. The plurality of enzyme electrodes may be provided on the same base material as shown in FIG. 15, or the body fluid transmission member may be composed of a plurality of layers made of a water-absorbing material, and different types of enzyme electrodes may be provided on each layer. Good. Even in the case as shown in FIG. 15, the base material may be made of a water-absorbing material or may be made of a non-water-absorbing material, and also from a body fluid transmission member and a non-water-absorbing material made of a water-absorbing material. An electrode may be provided between the sheet and the sheet.

In the body fluid collecting device 1 ', the puncture needle holding member 3
1 is pushed by a hammer or the like connected to a spring and slides downward. As a result, the puncture needle 3 penetrates the body fluid transmitting member 4 and punctures a finger attached below it. The puncture needle 3 and the puncture needle holding member 31 return to their original positions by a conventional method using the action of a spring or the like. The punctured finger bleeds, but the blood is absorbed by the body fluid transmission member 4 or travels between the body fluid transmission member 4 and the finger and reaches the electrodes 41, 42. The substance to be detected in the blood is converted into an electric signal and the wiring 44
To the sensor provided in the body fluid analyzer.

The body fluid collecting device has been described above. Next, the body fluid analyzer of the present invention using the body fluid collecting device will be described. In this example, the body fluid collecting device is referred to as a measuring chip.

FIG. 16 is a perspective view of a body fluid analyzer according to an example of the present invention. The body fluid analyzer 5 includes a housing 6
And a display unit 6 provided on one side of the housing 6.
1, a tightening switch 62, a puncture needle firing switch 63, a measuring tip installation tool 64, a measuring section 80 and a tightening section 7, and a cartridge holder storage section 8 and a puncture needle driving section 9 provided inside the housing 6. The measurement chip 81a is installed in the measurement unit 80, and the measurement chips 81b and 81 packaged by the package 83 in the cartridge holder storage unit 8.
A cartridge holder 82 including c, 81d and 81e is stored.

As shown in FIGS. 17 (a) and 17 (b), the measuring chips 81 housed in the cartridge holder 82 are sent to the measuring unit 80 one by one by the measuring chip installation tool 64. At this time, the claw portion 80a provided in the measurement unit 80 peels the package 83 from the measurement chip 81, so that the measurement chip
81 is installed in the measuring unit 80 in a hygienic and safe state. The measurement chip installation tool 64 is provided slidably with respect to the cartridge holder 82, and after sending out the measurement chip 81,
The spring 84 returns it to its original position. Measurement chips 81b, 81c, 81 left after the measurement chip 81a is sent out.
The d and 81e are pressed by the spring 85, and the measuring tip 81b moves to a position where it can be delivered by the measuring tip setting tool 64.

The measuring tip installation tool 64 may have any structure as long as it can send the measuring tip 81 to the measuring section 80. For example, in a normal state, the tip of the installation tool is shown.
64a is oriented in the horizontal direction, and the measurement chip 81 can pass under the measurement chip installation tool 64. However, when the measurement chip installation tool 64 is touched, the tip 64a of the installation tool is directed obliquely downward and measured. Abut on the rear end of tip 81,
It is possible to adopt a configuration in which the measuring chip 81 can be sent to the measuring unit 80 by sliding 64.

Although not shown, it is preferable to provide a pushing and discarding function so that the subject can discard the measurement chip without touching it directly after measurement. The package 83 may have any structure as long as it is detached from the measuring chip 81 by a desired means. For example, in the case where it is peeled off by the claw portion 80a provided in the measuring unit 80, Can have a structure in which an ear portion 83a having a broken tip is provided and the claw portion 80a is inserted between the broken portions.

The tightening portion 7 is provided to increase the amount of body fluid discharged, and a finger is inserted therein. Although the tightening portion 7 has a cylindrical shape in this embodiment, various shapes such as a ring shape and a cylindrical shape can be selected. Since the thickness of the finger of the person to be measured varies from person to person, there are elastic materials,
It is preferable that the inner diameter can be adjusted with a belt or the like.

Inside the tightening portion 7, there is provided a tightening member 71 for pressing and congesting the finger. This tightening member 71 fixes the finger by lightly touching the finger except during measurement.
When necessary (for example, immediately before puncturing or before puncturing to during puncturing), the inner diameter becomes small, the finger is pressed and blood vessels of the finger are congested, and a sufficient amount of body fluid can be obtained at the time of puncturing. Further, by pressing the finger immediately after the puncture, a sufficient amount of body fluid can be squeezed out from the puncture portion. The tightening member 71 may be made of any material as long as it can press and congest the finger, but, for example, a pressure band used to measure blood pressure uses air injection. Alternatively, it is possible to use, for example, a device that uses tightening of a belt by driving a motor or the like.

The puncture needle (see FIGS. 1 to 3 and 8) of the measuring tip 81 installed in the measuring unit 80 is hammered out by the hammer 92 connected to the spring 91 in the puncture needle driving unit 9, and is ejected from the body fluid transmitting member. Project. The hammer 92 may be operated by a conventional method, and a means for operating when the puncture needle firing switch 63 is pressed may be provided. The display portion 61 is preferably formed as large as possible in order to improve visibility, and is preferably provided at a position where the finger is not hidden by the finger when the finger is inserted into the tightening portion 7.

An example of a method for measuring a substance to be detected in blood using the body fluid analyzer 5 will be described. First, the cartridge holder 82 is inserted into the cartridge holder housing portion 8 and the measuring chip 81 is sent out to the measuring portion 80 by the measuring tip installation tool 64. Next, a finger is inserted into the tightening portion 7 (see FIG. 18), and the tightening switch 62 is turned on. Then, the finger is squeezed by the tightening member 71, causing blood stasis. When the puncture needle firing switch 63 is turned on in this state, the puncture needle of the measuring chip 81 is hammered out by the hammer 92 connected to the spring 91, protrudes from the body fluid transmitting member, and punctures the finger. Blood bleeding from the finger is either absorbed by the body fluid transmission member or transmitted between the body fluid transmission member and the finger to reach the electrode, and the substance to be detected in the blood is sent to the sensor as an electric signal for measurement. The value is shown on the display unit 61.

Another example of the method for measuring the substance to be detected in blood using the body fluid analyzer 5 will be described. Cartridge holder 82 in the cartridge holder storage section 8
Is inserted, the measurement tip 81 is sent out to the measurement section 80 by the measurement tip installation tool 64, and then the finger is inserted into the tightening section 7, the same as above, but next, the puncture needle firing switch 63
Insert Then, the puncture needle of the measuring chip 81 is hammered out by the hammer 92 connected to the spring 91, protrudes from the body fluid transmitting member, and punctures the finger. After puncturing, tightening switch 62
Insert Thereby, the tightening member 71 presses the finger, and the blood is squeezed out from the punctured portion. The bleeding blood is either absorbed by the body fluid transmission member or transmitted between the body fluid transmission member and the finger to reach the electrode, and the substance to be detected in the blood is sent to the sensor as an electric signal, and the measured value is It is displayed on the display unit 61.

A perspective view of a body fluid analyzer 5'according to another example of the present invention using the body fluid collecting device 1'is shown in FIG.
As shown in FIGS. 9 and 20, the basic configuration is similar to that of the body fluid analyzer 5, and when the puncture needle firing switch 63 is turned on, a hammer 92 connected to a spring 91 knocks out the puncture needle holding member 31, As a result, the puncture needle 3 is pushed out to penetrate the body fluid transmission member 4 and puncture a finger. In the above examples, the method of electrochemically measuring the substance to be detected has been described as an example. However, in the case of optically detecting using a GOD-coloring substrate or the like, reflection of light incident on the measurement unit, etc. Can be read and digitized.

According to the body fluid analyzer of the present invention as described above, after the measuring chip or the cartridge is mounted, the pressing of the finger, the puncture, the detection and the display of the measured value, or the puncture or the finger is operated by a simple switch operation. A series of operation steps of compression, detection, and display of measured values can be continuously performed, and the inspection can be completed with one touch. Also,
This device is equipped with a puncture member, a body fluid transmission member, a means for extracting an electrode or an electric signal, a means for increasing the amount of body fluid discharged, and a display unit, so that general users do not need to be skilled, and it is easy and quick. Can be used for

Although the present invention has been described in detail with reference to the drawings, the present invention is not limited to this, and various modifications can be made without departing from the concept of the present invention.
For example, instead of the tightening member, two rollers or clothespin-like members may be used to squeeze the body fluid from the skin.

[0054]

The present invention will be described in more detail with reference to the following examples, but the scope of the present invention is not limited to these examples. (Example 1) A phosphate buffer (pH 7.3) containing gold sol particles (particle size of about 40 nm) and glucose oxidase was stirred,
Enzyme immobilization was performed. Polypyrrole was mixed with this solution to obtain a working electrode component solution (a). On the other hand, under the same conditions as the working electrode component solution (a), a working electrode component solution (b) was prepared in which cholesterol oxidase was immobilized on gold sol particles instead of glucose oxidase.

As shown in FIG. 21, working electrode component solutions (a) and (b) were respectively dispensed with two glass fiber filter papers 4n and 4n 'on which gold paste was formed by screen printing as reference electrodes 42 and 42'. And dry at 50 ° C for 2 minutes,
Enzyme electrodes (A) and (B) 41,41 'were formed. The glass fiber filter paper 4 thus formed with the enzyme electrodes (A) and (B) 41, 41 '
Two sheets of n and 4n ′ were laminated with a spacer 4m made of the same glass fiber filter paper interposed therebetween to obtain a body fluid transmitting member 4. Using this body fluid transmitting member 4, a body fluid collecting device 1 ″ as shown in FIG. 22 was manufactured.

Each electrode 41, 42, 41 ', 42' was connected to a reader (not shown) through a lead wire 43. The body fluid collecting device 1 ″ was attached to a finger and bleeding with a puncture needle. Blood is transferred from the puncture part to the enzyme electrodes (A) and (B) 41,41 'through the glass fibers 4n, 4n', 4m, and the glucose concentration and cholesterol concentration in the blood can be detected by the reader. It was

Example 2 900 μl of a ferrocene-modified GOD solution in which a ferrocenecarboxylic acid was introduced into the lysine residue of GOD via carbodiimide, and 0.123 g of PVP,
100 μl of ethanol was mixed to obtain an enzyme electrode component solution. As shown in FIG. 23, the substrate of the working electrode 41 and the control electrode 42 were formed on the polystyrene sheet 4b provided with the puncture hole 4h having a diameter of 2 mm by screen printing with silver paste. Further, the enzyme electrode component was applied onto the working electrode substrate by screen printing and dried at 50 ° C. for 5 minutes to obtain an enzyme electrode.

On the polystyrene sheet 4b on the side where the enzyme electrodes were formed, a water absorbing layer solution consisting of microcrystalline cellulose: ethanol: triton X-100 = 1: 1: 0.01 was applied over the entire surface by screen printing, and at 50 ° C. After drying for 5 minutes, it was completely dried by air drying. Using the sheet thus formed with the water absorbing layer 4a, the body fluid collecting device 1 ″ ′ as shown in FIG. 24 was manufactured with the water absorbing layer 4a on the lower surface. In the same manner as in Example 1, each electrode 41, 42 was connected to a reader and measured. As a result, the glucose concentration in the blood could be detected.

[0059]

The body fluid collecting device of the present invention is easy to manufacture, and the body fluid analyzer of the present invention allows the body fluid to be collected easily by a method that does not rely on aspiration, and the body fluid analysis can be carried out easily and quickly. Can be done.

[Brief description of the drawings]

FIG. 1 is a perspective view showing an example of a body fluid collecting device of the present invention.

2 (a) is a sectional view taken along line AA of the body fluid collecting device in FIG. (b) shows a cross-sectional view of a body fluid collecting device according to another example of the present invention.

FIG. 3 shows an exploded perspective view of the body fluid collecting device in FIG.

FIG. 4 is an enlarged view of an electrode formed on a body fluid transmission member made of a water-absorbing material. (a) shows a state where the electrode is coated on the surface of the tissue of the water-absorbing material, and (b) shows a state where the electrode is coated on the tissue surface and is filled in the voids of the tissue. .

FIG. 5 (a) is a perspective view showing a stack of a body fluid transmission member (water absorbing layer) made of a water-absorbing material and a sheet made of a non-water-absorbing material, and FIG. Show.

FIG. 6 is a perspective view showing an example of a body fluid transmission member composed of a plurality of layers.

FIG. 7 is a perspective view showing another example of the body fluid transmission member composed of a plurality of layers.

FIG. 8 is a schematic diagram showing puncture and collection of body fluid using the body fluid collection device according to an example of the present invention. (a) shows a punctured state, and (b) shows a state immediately after puncturing.

FIG. 9 is a schematic diagram showing puncture and collection of body fluid using a body fluid collecting device according to another example of the present invention. (a) shows a punctured state, and (b) shows a state immediately after puncturing.

FIG. 10 is a cross-sectional view showing a packaged body fluid collection device of the present invention.

FIG. 11 is a cross-sectional view showing a body fluid collecting device of the present invention housed in a cartridge holder.

FIG. 12 is a perspective view showing another example of the body fluid collecting device of the present invention.

13 is a plan view showing an example of a body fluid transmitting member in the body fluid collecting device of FIG.

FIG. 14 is a schematic diagram showing puncture and collection of body fluid using a body fluid collecting device according to another example of the present invention. (a) shows the state before puncturing, (b) shows the state after puncturing, and (c) shows the state immediately after puncturing.

15 is a plan view showing another example of the body fluid transmitting member in the body fluid collecting device of FIG. 7. FIG.

FIG. 16 is a perspective view showing an example of a body fluid analyzer of the present invention.

FIG. 17 is a cross-sectional view showing a body fluid collecting device (measurement chip) of the present invention housed in a cartridge holder. (a) shows the state before sending out the measuring chip, and (b) shows the state after sending out the measuring chip.

FIG. 18 is a perspective view showing a state in which a finger is attached to the body fluid analyzer according to the example of the present invention.

FIG. 19 is a perspective view showing another example of the body fluid analyzer of the present invention.

FIG. 20 is a perspective view showing a state in which a finger is attached to and punctured by a body fluid analyzer according to another example of the present invention.

FIG. 21 is a perspective view showing a body fluid transmission member according to the first embodiment.

FIG. 22 is a cross-sectional view showing the body fluid collecting device according to the first embodiment.

FIG. 23 is a perspective view showing a body fluid transmission member according to the second embodiment.

FIG. 24 is a cross-sectional view showing a body fluid collecting device according to a second embodiment.

[Explanation of symbols]

 1,1 ', 1' ', 1' '' ... Bodily fluid collection device 11,83 ... Package 12,82 ... Cartridge holder 2 ... Substrate 21,22,23 ... Hole 24 ... Cylinder 3 ... Puncture needle 31 ... Puncture Needle holding member 4, 4n, 4n ', 4n' '... Body fluid transmission member 4m, 4m' ... Spacer layer 4a ... Water absorbing layer 4b ... Sheet 4t ... Water absorbing material tissue 4h ... Puncture hole 40 ... Electrode 41, 41 '... Working electrode 42, 42 '... Control electrode 43 ... Lead wire 44 ... Wiring 5, 5' ... Body fluid analyzer 6 ... Housing 61 ... Display 62 ... Tightening switch 63 ... Puncture needle firing switch 64 ... Measuring tip installation tool 64a ... Installation Tool tip part 7 ... Tightening part 71 ... Tightening member 8 ... Cartridge holder storing part 80 ... Measuring part 80a ... Claw part 81a-e ... Measuring tip 83a ... Package body ear part 84, 85, 91 ... Spring 9 ... Puncture needle driving part 92 ... hammer

Claims (18)

[Claims] 1. A body fluid collecting device comprising at least a body fluid transmitting member capable of transmitting a body fluid to a desired position, and a puncturing member capable of penetrating the body fluid transmitting member. 2. The body fluid collecting device according to claim 1, wherein the body fluid transmitting member is made of a water absorbent material. 3. The body fluid collecting device according to claim 2, wherein the body fluid transmitting member is provided with one or more kinds of enzyme electrodes. 4. The body fluid collecting device according to claim 2, wherein the body fluid transmitting member comprises a plurality of layers, and different types of enzyme electrodes are provided in each layer. 5. The body fluid collecting device according to claim 4, wherein a spacer layer having water absorbability is provided between the layers provided with the enzyme electrodes. 6. A sheet made of a non-water-absorbent material is laminated on the body fluid-transmitting member made of a water-absorbent material, and one or more sheets are provided between the body fluid-transmitting member and the sheet. The body fluid collecting device according to claim 2, wherein a seed enzyme electrode is provided. 7. The body fluid collecting device according to claim 2, wherein the water-absorbent material is paper, woven cloth, non-woven cloth, or a porous body. 8. The woven fabric and the non-woven fabric are cellulose, regenerated cellulose, cellulose acetate, silk, cotton, polyamide,
The body fluid collecting device according to claim 7, which is made of at least one selected from the group consisting of polyester, polyacrylic, polyolefin, polyurethane, and nylon. 9. The porous body comprises at least one selected from the group consisting of a glass filter, a nylon membrane, a nitrocellulose membrane, a cellulose acetate membrane, a polyvinylidene fluoride membrane, a regenerated cellulose membrane and a foamed cellulose sheet. The bodily fluid collection device according to claim 7, wherein 10. The body fluid transmission member is formed of a non-water-absorbing material, and one or a plurality of types of enzyme electrodes are provided on the lower surface of the body fluid transmission member,
The body fluid collecting device according to claim 1. 11. The enzyme electrode comprises a working electrode portion and a control electrode portion, and the working electrode portion contains a redox enzyme as a substance to be detected, an electron transfer substance and a conductive substance. The body fluid collection device according to claim 3, 4, 6, or 10. 12. The body fluid collecting device according to claim 11, wherein the conductive substance is metal sol particles. 13. The working electrode part is formed by immobilizing the redox enzyme on the metal sol particles in an aqueous solution and then, together with the electron transfer substance, by a dispenser, inkjet, roll coating or screen printing method. The bodily fluid collection device according to claim 12, wherein 14. The body fluid collecting device according to claim 1, wherein the body fluid collecting device is packaged in a package. 15. The body fluid collecting device according to claim 1 or 2, at least means for extracting an electric signal from the body fluid transmitting member, means for increasing the amount of bodily fluid discharged, and an analysis result of the collected body fluid. A body fluid analyzer, comprising: 16. At least claim 3, 4, 6 or 1.
0. A body fluid analyzing device comprising: the body fluid collecting device according to any one of 0), a means for increasing the amount of discharged body fluid, and a display unit for displaying an analysis result of the collected body fluid. 17. A body fluid collecting device according to claim 14, means for increasing the amount of bodily fluid discharged, a display section for displaying an analysis result of the collected body fluid, and a packaging body from the body fluid collecting device. A body fluid analyzer comprising a means for desorbing. 18. The body fluid analyzer according to claim 15, wherein one or a plurality of the body fluid collecting devices constitutes one cartridge.