JP2003210437A - Body fluid component analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a body fluid component analyzer capable of sequentially performing puncture, body fluid sampling, measurement, and display of the result, improving the sureness of the measurement by surely sampling discharged body fluid in a short period of time, and having high portability and cost performance. <P>SOLUTION: This body fluid component analyzer is provided with a puncture needle for puncturing the skin, body fluid sampling means sampling body fluid leaked by puncturing the skin by the puncture needle, body fluid component measuring means measuring the amount of the body fluid component. This body fluid component analyzer is characterized in that the body fluid sampling means is provided with a tubular body fluid sampling part and means moving a body fluid sampling hole of the body sampling part to the skin puncture part. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention enables measurement of a specific component contained in body fluid such as blood glucose level, and also enables puncture, collection of body fluid, measurement, and display of results in an integrated operation. The present invention relates to a body fluid component analyzer.

[0002]

2. Description of the Related Art In recent years, the number of diabetic patients has rapidly increased due to changes in living environment. Diabetic patients are required to keep their daily fluctuations in blood glucose within a normal range, and self-blood glucose measurement (SMBG) in which the patient himself monitors his own blood glucose level is recommended.

One of the methods for measuring the blood sugar level is to convert blood into a blood sugar level by allowing blood to penetrate into a test strip that changes color depending on the amount of glucose in the blood and optically measuring the degree of color change. Widely used. As another method, an enzyme electrode is used, and a method of converting an anode current value generated through an electrochemical reaction into a blood glucose level by causing an enzyme reaction by bringing blood into contact with a test piece is used. .

In the colorimetric measurement, the patient punctures the skin such as a fingertip with a puncture device such as a lancet, and then permeates the test blood with the blood that has come out. The test paper is attached to the measuring device to determine the blood glucose level. Since the conventional self-blood glucose measuring device has a puncture device and a blood glucose measuring device separately, it is necessary to perform two operations, an operation of puncturing the skin and an operation of penetrating blood into the test strip. This is extremely difficult for patients with low vision. Therefore, as an attempt to solve the above problems, Japanese Patent Laid-Open No. 13-
A puncture tool and a blood glucose meter as described in JP-A-309905 and JP-A-2000-116626 have been developed.

On the other hand, in order to secure the blood necessary for the measurement, blood collection is generally performed at the fingertip where the capillaries are concentrated. However, the fingertip is also the site where nerves are concentrated, and it is painful, so that the patient's blood is collected. This may be a burden, and the patient may have problems in health management, such as arbitrarily reducing the number of measurements. Therefore, Japanese Unexamined Patent Publication No. 9-304329 discloses a device capable of measuring a single blood sampling amount with a small amount such as several μl. As another method, WO97-43962 discloses blood sampling with a less painful arm. A blood collection device that can be used is also disclosed.

[0006]

Blood glucose is often measured several times every day, and in order to improve patient compliance, pain reduction is the most important issue. How to reduce blood volume and how Efficient collection of blood from the less painful area is an important issue.

For example, a device disclosed in Japanese Patent Application Laid-Open No. 13-309905 discloses a method of sucking by using an electric pump. However, since it is necessary to mount a suction pump, the device becomes large in size and heavy in weight, which is not preferable in terms of portability. Further, a battery is used as a power source of the electric pump, which is not preferable in terms of cost.

[0008] Further, in such a patient, there are large differences in blood characteristics and human body shapes between individuals, and some people can make good measurements with the same device, some people fail to make measurements, and two measurements are performed once. There is also a case where it is necessary to puncture, which is a factor of lowering compliance.

Further, in the conventional measuring device, the shape of the blood is very important when collecting the blood. Wrinkles on the skin,
Or, when blood is spread on the surface of the skin due to hair laying on the skin, it is impossible to suck blood. For example, JP 2000-
The device described in Japanese Patent No. 221121 discloses a method of scraping while moving regardless of the blood shape. However, since the contact surface between the device and the skin is large, it is not preferable because there is pain when moving the device in contact with the skin, and blood may get into the gap between the device and the skin. Further, if it is made of an elastic member as a countermeasure, it is a member that is thrown away after each measurement, which is not preferable in terms of cost.

An object of the present invention is to provide a puncture device and a body fluid component measuring unit, which can continuously perform puncture, body fluid collection, measurement, and result display, and collect the discharged body fluid in a short time and reliably. To increase the certainty of measurement, portability,
Another object of the present invention is to provide a body fluid component analyzer which is excellent in cost.

[0011]

Means for Solving the Problems The inventors of the present invention have made intensive studies to solve the above problems, and have found the following device. That is, the present invention provides a puncture needle for puncturing the skin, a bodily fluid collection means for collecting a bodily fluid leaked by puncturing the skin with the puncture needle, and a bodily fluid component measuring means for measuring the bodily fluid component amount. An apparatus for analyzing a body fluid component, characterized in that the body fluid collecting means has a tubular body fluid collecting portion, and comprises means for moving a body fluid collecting port of the body fluid collecting portion to a skin puncture portion. .

Further, the present invention is characterized in that the body fluid collecting means is means for moving the body fluid collecting portion at a speed equal to or lower than the speed at which body fluid is collected from the body fluid collecting port by capillarity. An analyzer is provided.

Further, the present invention is a cartridge in which the body fluid collecting means and the body fluid component measuring means are detachable, and the skin contact side of the apparatus housing portion is made of transparent resin and / or the puncture position can be confirmed. The present invention provides a body fluid component analyzer characterized by having a large opening.

[0014]

BEST MODE FOR CARRYING OUT THE INVENTION A preferred embodiment of the body fluid component analyzer of the present invention will be described by taking a blood glucose measuring device as an example. Such a device is applicable not only to blood glucose measurement but also to various body fluid component measuring devices.

The body fluid component analyzer of the present invention is constructed such that a puncture needle that can be attached to and detached from the body and a detachable measuring tip are attached to a folder portion of the body for use, and the body fluid is pierced to pierce the body fluid. Is a measuring device for collecting and measuring a specific component contained therein. The body part has a puncture mechanism for instantaneously projecting the puncture needle of this folder, a detection mechanism for detecting the state of the measuring chip before and after body fluid adheres, and a body fluid based on the detection result of this detection mechanism. It has a measurement mechanism for measuring a specific component therein and a display mechanism for displaying the measurement result by this measurement mechanism.

In the blood glucose measuring apparatus which is one of the embodiments of the present invention, a disposable lancet (puncture needle) and a measuring chip which is a disposable colorimetric quantitative cartridge are attached to a folder portion of the apparatus main body, and spring force is applied. Puncture the skin by protruding the lancet and collect blood from the skin. The tip of the measuring chip incorporated in the above-mentioned folder is provided with a tube-shaped blood suction port to suck blood by a capillary phenomenon. The quantification method is not limited to the colorimetric method, but can be applied to the electrode method.

The folder is provided with a mechanism for moving the tip of the measuring tip to the blood sampling site. Therefore, regardless of the shape and position of the blood drop, a mechanism for bringing the tubular blood suction port into contact with the blood drop is provided. Further, the movable speed thereof is the same as the speed at which blood is collected from the tube-shaped blood suction port by the capillary phenomenon, and / or a mechanism for moving the tube-shaped blood suction port at a low speed.

A preferred embodiment of the body fluid component measuring apparatus of the present invention will be further described with reference to the drawings. FIG. 1 shows an outline of a blood glucose measuring device, which includes a disposable puncture needle (not shown), a driving mechanism therefor, and a measuring chip 4 for measuring a blood glucose colorimetric color. An optical system for measurement, a calculation function, and a display unit 1 for displaying the result are provided. In the case of self-blood glucose measurement or the like, the patient attaches the measuring tip 4 and the puncture needle 5 to the folder 3 provided on the skin puncture side at the lower part of the main body. A sectional view of the folder 3 is shown in FIG. In such a device, the folder portion is removable, and the folder shown in FIG. 2 with the measuring tip 4 and the puncture needle 5 attached is attached to the main body shown in FIG. 1 and pressed against the skin as shown in FIG. . Further, in order to enable observation of the puncture site and the state of blood, the folder is made of transparent resin and further has an opening.

As shown in FIG. 3, the measuring chip comprises a resin cartridge having a cylindrical blood sampling port and a test paper which causes a color reaction in the rectangular parallelepiped part. The measurement chip mounting portion of the folder is moved horizontally by the motor 6.

Puncture is performed in this state, and the body is held as it is. After the puncture, the computer-controlled motor 6 is actuated to move the measurement tip mounting portion of the folder in the horizontal direction and suck blood from the tip of the measurement tip. By moving in the horizontal direction, the tip of the measurement tip is brought into contact with the blood droplet regardless of the shape and position of the blood droplet. In addition, the moving speed is set to the same speed as or a low speed at which blood is sampled by the capillarity to prevent blood from adhering to the side surface of the measurement chip. For example, the capillary dimensions are 0.53 mm inner diameter, 8.00 mm length, and the contact angle with the skin.
In case of 30 °, the calculated time for drawing blood by capillary action is
Since it is 7.4 seconds and the blood suction speed is 0.93 mm / s, the measurement tip is moved at a speed lower than that.

When blood is sucked, the test paper is discolored, and the discoloration is optically measured, converted into a blood glucose level, and the result is displayed. Separate the body from the skin, taking care not to allow blood to adhere to the above folder along with the alarm for the end of measurement.

As another embodiment, a drive mechanism using a shape memory alloy fiber may be used instead of the above motor.
This is a drive mechanism that utilizes the property that the shape memory alloy contracts when electricity is applied. The use of shape memory alloy fiber enables downsizing and weight reduction of the device.

[Brief description of drawings]

FIG. 1 is an overall external view of a body fluid component analyzer according to the present invention.

FIG. 2 is a vertical sectional view of a folder portion of the body fluid component analyzer of the present invention.

FIG. 3 is a perspective view of a measurement chip.

FIG. 4 is a vertical sectional view showing a movable mechanism of a measuring chip.

[Explanation of symbols]

1 Display mechanism 2 Measurement start switch 3 folders 4 measuring chips 5 puncture needle 6 motor 7 Light emitting element 8 Light receiving element 9 substrates 10 Guide rail 11 Moving part (before moving) 12 Moving part (after moving)

Claims (4)

[Claims] 1. A body fluid component measurement comprising a puncture needle for puncturing the skin, a body fluid collecting means for collecting a body fluid leaked by puncturing the skin with the puncture needle, and a body fluid component measuring means for measuring the amount of the body fluid component. The apparatus for analyzing body fluid according to claim 1, wherein the body fluid collecting means has a tubular body fluid collecting section, and means for moving the body fluid collecting port of the body fluid collecting section to the skin puncturing section. 2. The body fluid collecting means is means for moving the body fluid collecting part at the same speed as or at a lower speed than the speed at which the body fluid is collected from the body fluid collecting port by capillarity. Body fluid component analyzer. 3. The body fluid component analyzer according to claim 1, wherein the body fluid collecting means and the body fluid component measuring means are removable cartridges. 4. The body fluid according to claim 1, wherein the housing of the body fluid component measuring device has a transparent resin on the skin contact side, and / or has an opening through which the puncture position can be confirmed. Component analyzer.