JP2003180663A - Device for measuring body fluid component - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a device for measuring body fluid component having a puncture tool and a body fluid component measuring part, which can surely collect the leaked body fluid within a short time and can successively perform puncturing, collection of the body fluid, measurement and display of the result. <P>SOLUTION: The device for measuring body fluid component comprises a puncture needle, a body fluid collecting means for collecting the body fluid leaked from the skin by puncturing the skin with the puncture needle, and a body fluid component measuring means for measuring the body fluid component. The device for measuring body fluid component is characterized by that it further contains a position adjusting means for adjusting the body fluid collecting position of the body fluid collecting means. <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 specific components 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 configured body fluid component measuring device.

[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-
As described in Japanese Patent No. 309905 and Japanese Patent Laid-Open No. 2000-116626, those in which a puncture device and a blood glucose meter are integrated 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 an apparatus capable of measuring a single blood sampling amount with a small amount such as several μl, and as another method, WO97-43962 discloses voting with an arm with less pain. 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, in the device described in Japanese Patent Laid-Open No. 2001-309905, a method of sucking using an electric pump is disclosed. 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.

Further, in such patients, there are large individual differences in blood properties and human body shapes, and there are some people who can make good measurements with the same device, and others who fail to make measurements. There is also a case where it is necessary to puncture, which is a factor of lowering compliance.

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

[0010]

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. A body fluid component measuring device, comprising: a position adjusting means for adjusting a body fluid collecting position of the body fluid collecting means.

The present invention is also a means for collecting body fluid from the body fluid collecting port by capillarity,
A body fluid component measuring device characterized in that the position adjusting means comprises means for moving the body fluid collecting port to the vicinity of the blood sampling portion of the skin, and as an example, an elastic means for constantly urging the body fluid collecting portion. .

Further, according to the present invention, in the position adjusting means, the body fluid collecting means includes a tubular body fluid collecting portion, and when the body fluid collecting direction is opposite to gravity, the position adjusting means forms the body fluid collecting portion. It is a means for adjusting the angle with the skin contact surface to 10 degrees to 50 degrees, and conversely, when the body fluid collecting direction is the direction of gravity, the position adjusting means sets the angle between the body fluid collecting portion and the skin contact surface to 1
It is intended to provide a body fluid component measuring device characterized by being a means for adjusting to 0 to 90 degrees.

Further, according to the present invention, the position adjusting means moves the position of the body fluid collecting port of the body fluid collecting means to a contact position when a body fluid amount measurable by the body fluid measuring means leaks from the skin. The present invention provides a body fluid component measuring device characterized by the above.

[0014]

BEST MODE FOR CARRYING OUT THE INVENTION A preferred embodiment of the body fluid component measuring device 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 measuring instrument of the present invention is constructed such that a puncture needle which is detachable 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 by puncturing the body fluid. Is a measuring instrument for collecting and measuring a specific component contained therein. In the main body part, a puncture mechanism for instantaneously protruding the puncture needle of this folder,
And a detection mechanism for detecting the state of the measuring chip before and after the adherence of body fluid, a measuring mechanism for measuring a specific component in the body fluid from the detection result by the detecting mechanism, and a display mechanism for displaying the measurement result by the measuring mechanism. Have.

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 above-mentioned folder is provided with a mechanism for moving the tip of the measuring tip to a blood sampling site. Further, the sampling port of the measuring tip is always skin regardless of the condition of the user's skin swelling or the nature of blood. A mechanism for urging the puncture needle in a protruding direction by an elastic body such as a spring is provided so as to come into contact with.

When the body fluid comes into contact with the tip of the measuring tip, a part of the body fluid is sucked by the capillary phenomenon. Therefore, the above-mentioned measuring tip is provided with a position adjusting means for adjusting the position manually or automatically so that the tip end portion comes close to the blood sampling portion.

As another embodiment, it is also possible to sense the surface of the skin with an optical sensor and adjust the position with a small actuator so that the body fluid sampling port is near the blood sampling portion of the skin surface.

The term "vicinity" as used herein means the distance at which a body droplet grown to a certain size by puncturing immediately contacts the body fluid suction port. If the body droplet required for measurement is, for example, a hemisphere, the radius of the hemisphere is calculated from the volume thereof. FIG. 6 shows the result of calculation of the relationship between the required body fluid volume and the body droplet radius. For example, if the body fluid required for measurement is 2 μL, the radius of the body droplet is 1 mm as shown in FIG. 6, so it is necessary to place a body fluid suction port at that position. Bodily fluid is required, which is not preferable because the burden on the patient becomes large. Conversely, if it is within 1 mm, it may not be possible to continuously aspirate the required test amount, which is not preferable. further,
It is necessary to arrange the above-mentioned measuring chip in consideration of the rise of the skin which varies greatly among individuals. Therefore, the folder is provided with a mechanism for moving the measuring tip up and down and to the left and right so as to keep the distance between the liquid discharge site and the body fluid suction port optimal so that the rise of the skin that varies greatly among individuals can be taken into consideration.

When the measuring chip incorporated in the folder has a small attachment angle to the skin, the body fluid may not be able to be sucked into the gap formed between the skin and the measuring tip, which is not preferable. Further, when the body fluid collection direction is opposite to gravity, the measurement tip is not preferable because the attachment angle to the skin becomes large and the speed of penetrating the capillaries decreases due to the effect of the body weight of the body fluid, which requires time for body fluid suction. . Further, when the body fluid collecting direction is the same as gravity, the speed of penetrating the capillaries due to the effect of the body weight of the body fluid has almost no effect on the attachment angle of the measurement tip to the skin.

For patients with impaired visual acuity or handicap, the resting time is limited to 20 seconds.
For this purpose, the body fluid suction time is preferably within 20 seconds. Considering that the body fluid does not enter the gap formed between the skin and the measurement tip and that the time required for suctioning the body fluid is within 20 seconds, the attachment angle of the measurement tip from FIG. In the opposite direction (FIG. 5, solid line), 10 degrees to 50 degrees is preferable, and when the body fluid collection direction is the same direction as gravity (FIG. 5, broken line), the blood inhalation time is always within 20 seconds regardless of the angle. Therefore, the mounting angle is preferably 10 to 90 degrees.

As shown in the schematic diagram (a) of FIG. 7, the relationship between the attachment angle of the body fluid sampling port and the body fluid suction time is considered to be an axisymmetric flow in a capillary tube in which blood sampling is set in the upward direction, and laminar flow is considered. Considering that it is a flow, analysis is performed based on the following equation of motion (dimensionless).

[0024]

[Equation 1]

On the contrary, when the direction of gravity and the direction of collecting body fluid are the same, and when blood flows downward from the upper end of the capillary as shown in FIG.

[0026]

[Equation 2]

A preferred embodiment of the body fluid component measuring device 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 tip mounting portion of the folder is provided with a distance adjusting dial 7 for adjusting the horizontal position, and the position of the measurement tip 4 is moved to the vicinity of the bleeding portion in consideration of the degree of skin rise of the user. Specifically, as shown in FIG. 4, the position of the blood sampling port of the measurement chip is set near the blood drop or from the puncture position as shown in 11 before moving the measuring chip (broken line) and 12 after moving the measuring chip (solid line). Adjust the position to a radius of 1 mm. In such a device, the movement is manually performed by the distance adjusting dial 7. A small actuator may be used for distance adjustment.

Even if the left and right positions are aligned, the tip of the blood sampling port of the measuring chip may be blocked depending on how the skin rises. In the device of the present invention, the measuring tip is always biased toward the skin by the elastic body 6 made of spring. The tip of the measuring tip comes into contact with the surface of the skin as shown in FIG. 4, depending on the balance between the degree of skin rise of the user and the elastic body 6. The folder portion of the measurement chip was configured such that the angle between the blood collection port of the measurement chip and the skin contact surface of the main body was 30 degrees.

Puncture is performed in this state, and the main body is held as it is. Blood is sucked from the tip of the measuring chip arranged near the bleeding site, and the test paper discolors. 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.

[Brief description of drawings]

FIG. 1 is an overall external view of a body fluid component measuring device of the present invention.

FIG. 2 is a vertical sectional view of a folder portion of the body fluid component measuring device according to 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.

FIG. 5 is a diagram showing the relationship between the attachment angle of the measurement tip and the blood suction time.

FIG. 6 is a diagram showing the relationship between the required body fluid amount and the body droplet radius.

FIG. 7 is a schematic diagram for analyzing the relationship between the body fluid suction time and the body fluid sampling port attachment angle of the measurement tip.

[Explanation of symbols]

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

Claims (7)

[Claims] 1. A body fluid component measurement device comprising: a puncture needle for puncturing the skin; a body fluid collecting means for collecting 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. 1. A body fluid component measuring device, comprising a position adjusting means for adjusting a body fluid collecting position of the body fluid collecting means. 2. The body fluid collecting means is means for collecting body fluid from the body fluid collecting opening by capillarity, and the position adjusting means is means for moving the body fluid collecting opening to the vicinity of the blood collecting portion of the skin. The body fluid component measuring device according to claim 1. 3. The position adjusting means, wherein the body fluid collecting means comprises a tubular body fluid collecting portion, and a body fluid collecting direction is opposite to a gravity direction, and the position adjusting means makes skin contact with the body fluid collecting portion. The body fluid component measuring device according to claim 1 or 2, which is a means for adjusting an angle with the surface to 10 to 50 degrees. 4. The position adjusting means, wherein the body fluid collecting means includes a tubular body fluid collecting portion, and the body fluid collecting direction is a gravitational direction, and the position adjusting means connects the body fluid collecting portion and the skin contact surface. The body fluid component measuring device according to claim 1 or 2, which is a means for adjusting the angle to 10 to 90 degrees. 5. The position adjusting means is means for moving the position of the body fluid collecting port of the body fluid collecting means to a contact position at the time when a body fluid amount measurable by the body fluid measuring means leaks from the skin. The body fluid component measuring device according to claim 1. 6. The body fluid component measuring device according to claim 1, wherein the body fluid collecting means and the body fluid component measuring means are removable cartridges. 7. The body fluid component measuring device according to claim 1, wherein a skin contact side of a body of the body fluid component measuring device is made of a transparent resin and is provided with an opening through which a puncture position can be confirmed. .