JP2011078518A - Blood testing instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To refrain from compressing skin because its compressing a sensor prevents the blood from exuding, or from being collected into the sensor in the case of a large swell of the skin and interferes correct measurement. <P>SOLUTION: The blood testing instrument has a holder on which the skin to be punctured is set, a sensor holder arranged lyingly over the holder and to set a blood sensor to measure collected blood on the side opposite to the side where the skin is set, a puncture unit to puncture the skin sequentially passing from the blood sensor to the holder in that order, and urges the blood sensor to the holder to such an extent that the blood sensor does not compress the skin and permits the blood sensor to be displaced in the direction opposite to the holder side. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a blood test apparatus that collects blood exuded from punctured skin with a sensor and measures components of the collected blood.

  A general blood test will be described with diabetes as an example. Carbohydrates ingested by meals and the like are broken down in the small intestine to become glucose, bind to insulin, pass through the cell membrane, and are taken up as energy. In diabetes, the amount of insulin secreted decreases, blood sugar increases and becomes abnormal.

  Therefore, the patient needs to regularly measure the blood glucose level, inject insulin based on the blood glucose level, and keep the blood glucose level normal. Therefore, the patient must collect a small amount of blood from a fingertip or the like and measure the blood glucose level of the blood with a blood glucose level measuring device. Conventionally, using a puncture device for collecting blood, after the skin is opened and blood is exuded, in order to measure blood components, the exuded blood is attached to a part of the sensor set in the blood glucose level measuring device. As a result, blood was taken into the sensor by the capillary phenomenon and the blood glucose level was measured.

  A conventional apparatus 100 is shown in FIG. FIG. 20 shows in detail the A part of FIG. 19, but in FIG. 20, the cap 101 is in an open state. The sensor holder 103 is disposed so as to overlap the holder 102, and the sensor 104 is inserted into the sensor holder 103 and set.

  A through hole 105 is formed in the sensor 104, and the puncture unit 106 punctures the skin set from the corresponding hole of the cap 101 through the through hole 105, and the exuded blood is taken into the sensor 104 and measured. . FIG. 21 shows the internal mechanism of FIG.

In FIG. 21, a spring 107 and a spring 108 are for positioning the sensor 104 inserted in the sensor holder 103 at a predetermined position of the holder 102, and this positioning can be performed by rotating and setting the sensor holder 103. It is said. Thereby, the puncture unit 106 can be accurately positioned at the opening position of the set sensor 104.
As prior art document information related to the invention of this application, for example, Patent Document 1 is known.

Special table 2003-534088 gazette

  However, in the conventional apparatus 100, when the position of the sensor 104 is fixed and the skin bulges is large, the skin is crushed by the contact with the sensor 104, and the skin punctured by the puncture unit 106 In some cases, blood does not ooze out. In such a case, blood cannot be collected and blood measurement cannot be performed despite the puncture of the cut-off skin.

  Accordingly, the present invention has been made to solve such problems, and an object thereof is to provide a device in which the sensor 104 and the skin are brought into contact with each other with an appropriate pressure even when the skin swells is large. Is.

In order to achieve this object, the blood test apparatus of the present invention exposes the first surface with which the skin abuts, the second surface opposite to the first surface, and the skin of the portion to be punctured. A holder having an opening;
A sensor holder that holds the sensor in a state of being biased toward the second surface of the holder;
A puncture unit that punctures the skin through the sensor in the order of the holder, and
When the skin comes into contact with the sensor through the opening, the skin contact position of the sensor is displaced by the pressing of the skin. Thereby, the intended purpose can be achieved.

  As described above, the present invention does not excessively press the skin against the sensor even when the skin swell is large, and therefore, it is possible to eliminate the problem that blood does not ooze out from the skin. A small number of blood test apparatuses can be provided.

Sectional drawing of the principal part of the blood test apparatus in Embodiment 1 of this invention. Cross section of the main part of the device Cross section of the main part of the device Second holder schematic diagram in the apparatus Second holder schematic diagram in the apparatus Plan view and sectional view of the sensor used in the device Sectional drawing which shows the principal part operation | movement in the apparatus Sectional drawing which shows the principal part structure in the apparatus Perspective view of the blood test apparatus Perspective view of the blood test apparatus Explanatory drawing of measurement operation in the blood test apparatus The perspective view of the sensor holder used for the blood test apparatus in Embodiment 2 of this invention. Second holder schematic diagram used in the blood test apparatus The perspective view which shows the principal part of the blood test apparatus Side view showing the main operation of the blood test apparatus The perspective view which shows the principal part structure of the blood test apparatus in Embodiment 3 of this invention. Sectional drawing which shows the principal part structure of the apparatus Sectional drawing which shows the principal part structure of the apparatus Schematic configuration diagram showing a conventional blood test apparatus The perspective view which shows the principal part structure of the apparatus Sectional drawing which shows the principal part structure of a figure apparatus

  The blood test apparatus of the present invention has 1) a holder, 2) a sensor holder, and 3) a puncture unit.

Holder The holder is for fixing a portion for puncturing (skin such as a finger), and has an opening that is a portion of a puncture unit for allowing blood to exude from the skin and a portion through which light passes. Furthermore, the shape of the holder is a material and structure that can hold the finger stably and does not easily deform when pressed by the finger. A shape that can be pressed by applying pressure is desirable, and the opening portion may be circular or oval, and the skin contact portion should not be sharp so that the portion that contacts the holder does not hurt when pressed.

  When sucking the part that has come into contact with the holder, it is necessary to provide packing or the like in the part of the opening that comes into contact with the skin. In addition, it is desirable that the holder can be easily removed from the apparatus, and dirt such as blood that has adhered unexpectedly can be washed.

Sensor holder The sensor holder is used to hold a sensor for testing a blood component. When the sensor is an electrochemical type, a connector may be used instead. The sensor holder of the present invention is arranged so that the held sensor overlaps the holder, and the sensor that overlaps the holder is not separated regardless of the orientation of the apparatus. The sensor holder in the present invention may have a lock mechanism using a magnet or the like. The sensor holder has a rotating shaft for rotation, and in a state where the sensor is held by the sensor holder, a counter balance that can be balanced with respect to the rotating shaft is opposite to the sensor holding portion with respect to the rotating shaft. May have in position.

Puncture unit There are two types of puncture units: needle type and laser type. The needle type is common, and the laser type will be described here. The laser type has a laser rod, a flash lamp, and a lens, and puncture is performed using laser light. Laser puncture is performed using a solid-state laser when the device is small enough to be held with one hand.

  In the solid-state laser, a laser rod doped with a rare earth ion or a transition metal ion serving as a laser active species containing ions such as erbium Er, neodymium Nd, or holonium Ho, and the laser rod active species are excited. A flash lamp for irradiating the light of the light, a lens barrel for efficiently condensing the light of the flash lamp to the laser rod without leaking outside, and a lens for condensing the emitted light at a predetermined position Composed. Examples of the solid-state laser include a ruby laser, a glass laser, a YAG laser, and the like.

  The laser rod for puncturing the skin as in the present invention is preferably a laser rod made of a YAG laser doped with about 50% of erbium Er. The laser rod may be a YAG single crystal or a YAG ceramic.

  The needle or light coming out of the puncture unit hits the skin set in the holder, and blood is exuded from the skin.

(Embodiment 1)
FIG. 1 shows a cross-sectional view of the main part of the blood test apparatus. In FIG. 1, the blood test apparatus includes a holder 1 having an opening 1 a for pressing against the skin 30 and a sensor 2 for measuring blood components so as to contact the holder 1, and a sensor for holding the sensor 2. The puncture unit 4 for puncturing the skin 30 from the holder 3 and the sensor 2 through the opening 1a of the holder 1 and the opening for sandwiching the sensor 2 with the holder 1 and allowing the needle or laser light of the puncture unit 4 to pass through The second holder 5 having 5 a, the sensor 2 acts so as to contact the holder 1, and when the skin 30 rises, the sensor 2 can be bent with such a force that the sensor 2 can bend so that the sensor 2 does not press the skin 30. There is a spring 6 for holding down.

  In the present invention, since the skin 30 to be punctured in a series of operations does not open the gap with the sensor and does not press the skin 30, the sensor 2 does not press the skin 30, but the sensor 2 does not press the skin 30. Needs to be pressed in the direction of the holder 1 so as not to open. In order for the sensor 2 not to press the skin 30, the sensor 2 needs a space that can move in the direction opposite to the skin.

  In the holder 1 shown in FIG. 1, if the surface of the portion to which the skin to be punctured is A (corresponding to the first surface) and the facing surface is B (corresponding to the second surface), the rotation axis of the holder 1 The angle between the surface A and the surface B becomes narrower toward the tip (the free end side of the sensor) with respect to C. This is set so that the sensor 2 is swung by the raised skin so that it is parallel to the surface A with respect to the raised skin when the skin is applied to the opening of the surface A and pressurized or sucked. ing. The skin swell is about 1.8 mm to 3 mm when the diameter of the opening on the surface A is 9 mm, and about 0.5 mm to 1.5 mm when the diameter of the opening on the surface A is 5 mm. The angle considering this is set to 3 degrees to 12 degrees.

  By providing an angle between the surface A and the surface B of the holder 1, a space in which the sensor 2 can swing is created between the holder 1 and the second holder. As another means for providing a space in which the sensor 2 can move in the direction opposite to the skin 30, there is a means for providing a space in the second holder 5. FIG. 2 shows a view of inserting the sensor 2 into the second holder 5. Furthermore, in FIG. 3, the figure which provided the space D of the grade which the sensor 2 can rock | fluctuate is provided in a part of surface with respect to the sensor 2 of the 2nd holder 5. FIG. The space D allows the sensor 2 to move in the direction opposite to the skin 30 and does not press the skin 30.

Next, it will be described that the sensor 2 has a shape that can swing with respect to the skin swell. FIG. 4 shows a top view and a cross-sectional view of the sensor 2. In FIG. 4, the end of the sensor 2 is thin. The sensor 2 is made of a material such as PET (polyethylene terephthalate) by depositing several electrodes of palladium, carbon, gold, etc. on a base film 7 of 0.1 mm to 0.3 mm which is an insulator such as PET (polyethylene terephthalate). A three-layer structure in which a spacer 8 of 0.1 mm to 0.3 mm which is an insulator such as) is overlapped, and a cover 9 of 0.1 mm to 0.3 mm which is an insulator such as PET (polyethylene terephthalate) is overlapped. It is said. Since the sensor 2 is fixed to the sensor holder 3 by inserting only the end portion of the base film 7 shown in the sensor cross-sectional view, the sensor 2 does not press the skin while touching the skin against the skin bulge. Can be swung.
The sensor 2 is pushed to the holder 1 side by a spring 6 as shown in FIG. 1, but the force that swells the skin is 0.02N ± 0.01N. Therefore, as shown in FIG. 3, the distance from the position where the holding part 32 is held up to the position 33 where the raised skin pushes up the sensor 2 is L1, and the sensor 2 is pressed from the position 32 where the sensor holder 3 is held by the spring 6. If the distance to the current position 33 is L2,
Spring force F = (L1 / L2) × 0.02N ± 0.01N
It becomes.

Since the amount of swelling of the skin 30 differs from 0.5 mm to 3 mm depending on individual conditions, if the spring constant of the spring 6 is small, the spring force does not change with respect to the amount of swelling of the skin. Depending on the size of the constant, it may be necessary to adjust the spring force of the spring 6.
FIG. 6 is a spring adjustment sectional view showing an example of adjusting the spring force of the spring 6. In FIG. 6, the adjusting rod 10 is positioned on the upper portion of the spring 6, and the spring 6 can be compressed and extended by moving the adjusting rod 10 up and down as indicated by arrows in FIG. 6. In this case, a screw is formed at the end of the adjusting rod 10 that is not in contact with the spring 6 and set in a screw receiving portion formed in the second holder 1. When the adjusting rod 10 is rotated in the direction F in FIG. 6, the adjusting rod 10 moves in the direction in which the spring 6 is compressed, and the force pressing the sensor 2 against the holder 1 can be increased. Further, when the adjusting rod 10 is rotated in the direction opposite to the F direction, the adjusting rod 10 moves in the direction in which the spring 6 is extended, and the force pressing the sensor 2 against the holder 1 can be reduced. In the present invention, the spring 6 may be a coil spring, and even if it is rubber, the effect is the same, and these elastic bodies can be used. Any rubber having a spring force such as urethane rubber, natural rubber, or chloroprene rubber may be used.

  Next, a blood glucose measuring device will be described as an example of a blood test apparatus equipped with the present invention. FIG. 7 shows an apparatus when a laser puncture unit is used for the puncture unit 4. In FIG. 7, a casing 11 having a rectangular parallelepiped shape has operation buttons 12, 13, and 14 in the upper front portion, and a laser protective cover 15 in the middle. In FIG. 7, there is a display board 16 made of liquid crystal or the like in the upper part of the housing 11, and a puncture button 17 for executing puncture is in the upper right corner.

This blood glucose level measuring instrument can be operated when the laser protective cover 15 is slid and pulled out. When the operation button 12 of the operation unit is pressed to select the input voltage adjustment for laser output, the level for adjustment is displayed on the display board 16. The level can be selected from 1 to 5, the operation button 13 increases the level in order from 1 to 5, and the operation button 4 decreases on the contrary. When the selection is completed by looking at the level display on the display board 16, the skin can be punctured. As shown in FIG. 7, when the sensor 2 is inserted into the sensor holder 3 and the holder 1 is rotated, the state shown in FIG. 8 is obtained. FIG. 9 shows a state in which the skin of the site where blood glucose level is desired to be measured is set in the opening of the holder 1 (here, the ring finger is set).

  When the puncture button 17 is pressed in the state shown in FIG. 9, a laser is emitted from the puncture unit 4, and the emitted laser light irradiates the finger to exude blood from the finger. The exuded blood is taken into the sensor 2 and the blood glucose level can be measured.

(Embodiment 2)
Another example of a structure in which the skin to be punctured in a series of operations does not open a gap with the sensor and does not compress the skin is shown.

  In the first embodiment, the sensor 2 is bent with respect to the skin swell, but in the second embodiment, the sensor holder 3 is rotated and the sensor 2 is not bent.

FIG. 10 shows a state in which the holder 1 and the sensor holder 3 are closed. In order to make it easy to insert and remove the sensor 2 into and from the sensor holder 3, the holder 1 and the sensor holder 3 can be rotated, and the holder 1 and the sensor holder 3 are opened as shown in FIG. As shown in FIGS. 10 to 11, the holder 1 and the sensor holder 3 are rotated and opened, the sensor 2 is inserted into the sensor holder 3 and returned as shown in FIG. When it is desired to remove the sensor 2, the holder 1 and the sensor holder 3 are rotated and opened as shown in FIGS. 10 to 11, and the sensor 2 is removed from the sensor holder 3 and returned as shown in FIG. FIG. 12 shows a state in which the sensor 2 is inserted into the sensor holder 3. At this time, since the sensor 2 does not bend, it is necessary to move the entire holder and change the position of the finger contact portion of the sensor.
When the sensor 2 is inserted, the sensor holder 3 is provided with a counter balance 19 in order to balance the sensor holder 3 with respect to the rotation axis R1. Further, an electromagnet 21 (shown in FIG. 13) is provided in the second holder 5 to lock the sensor holder 3 so that the sensor holder 3 does not rotate easily. Lock by arriving at.
FIG. 13 shows the second holder. The R1 portion of the sensor holder 3 shown in FIG. 12 is fitted into the P1 portion shown in FIG. 13 so that the sensor holder 3 can rotate. FIG. 14 shows that the sensor holder 3 into which the sensor 2 is inserted and the holder 1 are inserted into the P2 portion shown in FIG. FIG. 15 shows a cross section in the lateral direction of FIG. When the electromagnet 21 disposed in the second holder 5 is operated, the conductor 20 attached to the sensor holder 3 arrives at the electromagnet 21, and the sensor holder 3 is thereby locked. However, the sensor 2 inserted into the sensor holder 3 does not move away from the holder 1. Further, the sensor holder 3 is provided with a spring that urges the sensor 2 inserted into the sensor holder 3 so as not to press the skin 30 against the holder 1 side.

  In the blood test apparatus incorporating the above configuration, there are two types of lock release timings. One is locked until the skin 30 is punctured by the puncture unit 4, and the lock is released immediately after the puncture so that the skin 30 is not compressed. Since the lock is controlled by the electromagnet 21, it can be achieved by electrically operating the electromagnet 21 immediately after the laser irradiation and releasing the lock.

  The other is that when the skin 30 is set in the opening of the holder 1, the lock is released to keep the skin 30 from being pressed, and the skin 30 is punctured by the puncture unit 4. The release timing may be that a skin detection sensor (not shown) is arranged in the vicinity of the opening of the holder 1 and the electromagnet 21 is operated when the skin 30 can be detected to release the lock. A skin detection sensor (not shown) is arranged as a wiring (not shown) on the skin, and when the skin 30 is electrically detected by short-circuiting the wiring, the electromagnet 21 is operated to lock it. You may cancel.

  Both methods are easier to control if the lock is electrically released, but may be released by a mechanical configuration.

(Embodiment 3)
Another example of a structure in which the skin to be punctured in a series of operations does not open a gap with the sensor and does not compress the skin is shown.

  In the third embodiment, the first embodiment and the second embodiment are combined. That is, the sensor 2 bends and the sensor holder 3 also rotates. Since the specific movement is the same as that described in the first embodiment and the second embodiment, detailed description thereof is omitted.

  FIG. 16 shows an assembly of the sensor holder 3 and the second holder 5 into which the holder 1 and the sensor 2 are inserted. In FIG. 16, the second holder 5 is provided with an electromagnet 21 and an adjusting rod 10. FIG. 17 shows a cross-sectional view in the side direction of FIG. In FIG. 17, the sensor holder 3 is provided with a counter balance 19 and a conductor 20. A state in which the holder 1 and the sensor holder 3 are closed is a fifth sectional view 18. In FIG. 18, the adjusting rod 10 holds the sensor 2, and the electromagnet 21 and the conductor 20 are attracted by the magnet, so the movement of the sensor holder 3 is locked. Since the counter balance 19 is present, the spring of the adjusting rod 10 may have a weaker force and is at a level where adjustment is hardly necessary. Since the swinging width of the sensor 2 may be small, the width for selecting the constituent material of the sensor is widened.

  The blood test apparatus according to the present invention can be applied to a blood test apparatus for inspecting blood properties because blood can be spotted correctly on the sensor even when the skin swells are large.

DESCRIPTION OF SYMBOLS 1 Holder 2 Sensor 3 Sensor holder 4 Puncturing unit 5 Second holder 6 Spring 7 Base film 10 Adjustment rod 19 Counter balance 20 Conductor 21 Electromagnet

Claims (15)

In a device for puncturing the skin, collecting blood exuded from the skin with a sensor, and measuring the components of the collected blood,
A holder having a first surface with which the skin abuts, a second surface opposite to the first surface, and an opening for exposing the skin of the portion to be punctured;
A sensor holder that holds the sensor in a state of being biased toward the second surface of the holder;
A puncture unit that punctures the skin through the sensor in the order of the holder, and
The blood test apparatus is configured such that when the skin comes into contact with the sensor through the opening, the skin contact position of the sensor is displaced by pressing of the skin.   An elastic body for urging the sensor toward the second surface is provided, and the skin contact position of the sensor is displaced against the urging force of the elastic body by the skin contact with the sensor. The blood test apparatus according to claim 1.   The blood test apparatus according to claim 2, wherein the elastic body is a spring or rubber.   The blood test apparatus according to claim 2, wherein an urging force applied to the sensor is 0.02N ± 0.01N.   The blood test apparatus according to claim 2, wherein the second surface of the holder has an inclined surface where the sensor approaches the skin from one end of the sensor held by the sensor holder to a free end of the sensor.   The blood test apparatus according to claim 2, further comprising an adjustment mechanism for adjusting the biasing force.   The sensor holder is supported by the rotating shaft so that the sensor, one end of which is held by the sensor holder, can rotate in a direction in which the sensor contacts or separates from the skin, and the direction in which the sensor contacts the skin 2. The blood test apparatus according to claim 1, wherein the sensor holder is biased and provided so that the skin contact position of the sensor is displaced by rotation of the sensor holder by contact of the skin with the sensor. .   The blood test apparatus according to claim 7, further comprising a lock portion that stops the rotation of the sensor holder.   The blood test apparatus according to claim 8, further comprising a mechanism that releases the lock portion in conjunction with an operation of holding the sensor to the sensor holder. The blood test according to claim 8, further comprising a skin detection sensor that detects contact of the skin with the holder, wherein the skin detection sensor unlocks the lock portion in conjunction with detection of the skin. apparatus.   The blood test apparatus according to claim 15, further comprising a mechanism that unlocks the lock portion in conjunction with a puncturing operation of the puncture unit. The blood test apparatus according to claim 7, further comprising: a weight that applies a rotational force in a direction opposite to a direction in which the sensor rotates in contact with the skin; and a lock unit that stops the rotation of the sensor holder. . The blood test apparatus according to claim 7, further comprising an elastic body that biases the sensor toward the second surface.   The blood test apparatus according to claim 1, wherein the puncture unit uses a laser.   The blood test apparatus according to claim 1, wherein the puncture unit uses a needle.

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