HK1092039A - Body fluid sampling implement and body fluid sampling method - Google Patents

Description

Body fluid extraction tool and body fluid extraction method

Technical Field

The present invention relates to a body fluid extraction tool and a body fluid extraction method.

Background

In recent years, with the increase in diabetic patients, self-blood glucose measurement in which daily blood glucose level fluctuations are monitored by the patients themselves has been favored.

The measurement of the blood glucose level is performed by using a blood glucose measuring apparatus in which a test strip capable of changing color according to the amount of glucose in blood is mounted, the test strip is changed in color by supplying and diffusing blood to the test strip, and the degree of the change in color (color measurement) is optically measured to quantify the blood glucose level.

Before the measurement is performed, the patient should extract his or her blood as a method of extracting blood. Blood can be expressed by puncturing the skin of a fingertip with a puncture device provided with a puncture needle or a knife, and then pressing the periphery of the puncture site with a finger or the like.

However, while the fingertip capillaries are concentrated and suitable for blood extraction, on the other hand, the nerves are also concentrated on the fingertips and pain is caused, so that the pain and burden are large for the patient, and the fear caused by the puncture is caused, so that many patients cannot continuously perform self-blood glucose measurement.

As a device capable of solving such problems, there has been developed a blood glucose measuring device described in Japanese patent application laid-open No. 2001-309905, that is, a blood glucose measuring device in which a puncture device is integrated with a measuring device and a suction mechanism for squeezing out blood is attached.

In using the blood glucose measuring device described in japanese patent application laid-open No. 2001-309905, first, a strip containing test paper is loaded into the device body, and the tip of the strip is pressed against the tip of the strip to close the tip opening and maintain airtightness.

Then, after the fingertip is punctured with the puncture needle protruding from the distal opening, the suction mechanism is operated in this state (the pressure is reduced), and blood is aspirated from the puncture site to extract the blood. Then, the blood glucose level of the extracted blood is measured by the measuring device.

However, in such a blood glucose measuring device, although the tip end of the insert piece is pressed by the fingertip during use, it is not easy to keep the force with which the fingertip presses the tip end of the insert piece constant every time the blood glucose level is measured. Therefore, in the conventional blood glucose measuring device, since the piercing depth of the fingertip pierced by the piercing needle varies, if the extracted blood does not reach the amount necessary for measuring the blood glucose level, the blood glucose level cannot be accurately measured.

Disclosure of Invention

The invention aims to provide a body fluid extraction tool and a body fluid extraction method which can extract body fluid more reliably.

In order to achieve the above object, in the body fluid extraction tool of the present invention

A puncture needle is mounted on the body fluid extraction device, and the puncture needle punctures a body fluid extraction part to take out body fluid when in use, and the body fluid extraction device is characterized by comprising:

a main body which accommodates the puncture needle and has an opening through which the puncture needle can pass;

an abutting part fixedly provided on the body and having an outer peripheral shape surrounding the opening, the abutting part pressing the body fluid collecting part when the body fluid collecting part is punctured by the puncture needle,

the inner surface of the abutting portion has a portion inclined closer to the opening than to the center line of the opening.

Thus, if the body fluid extraction site is pressed, the vicinity of the body fluid extraction site is deformed along the shape of the inner surface of the contact portion, and a part of the vicinity is projected into the main body through the opening. Therefore, the puncture depth of the puncture needle at the body fluid extraction site can be made substantially constant. This makes it possible to suppress variation in the puncture depth of the puncture needle and to extract the body fluid more accurately.

In the body fluid collecting tool according to the present invention, the inner surface of the abutting portion is preferably shaped like a truncated cone.

In the body fluid collecting tool according to the present invention, it is preferable that the puncture needle is attached to the body fluid collecting tool in the form of a patch accommodated in a patch main body having an opening through which the puncture needle passes,

when the body fluid collecting part is pressed against the contact part in a state where the insert sheet is attached to the body fluid collecting tool, the body fluid collecting part is brought into contact with the opening edge of the insert sheet main body.

In the body fluid collecting device according to the present invention, it is preferable that the opening area of the opening of the insert main body is smaller than the opening area of the opening of the main body.

In the body fluid collecting device according to the present invention, it is preferable that the opening edge of the tip main body is positioned substantially on an extension of the inclined portion of the inner surface of the contact portion in a state before the body fluid collecting site is punctured by the puncture.

The body fluid extraction tool of the present invention is preferably used in a state where the body is disposed so that the opening is directed vertically upward.

The body fluid extraction method of the present invention is a body fluid extraction method for extracting a body fluid by puncturing the body fluid extraction site with the puncture needle, the body fluid extraction method including:

a main body which accommodates a puncture needle and has an opening through which the puncture needle can pass;

an abutting portion fixedly provided to the body so as to surround an outer periphery of the opening, the abutting portion pressing the body fluid extraction site when the body fluid extraction site is punctured by the puncture needle,

the inner surface of the abutting portion has a portion inclined closer to the center line of the opening, wherein,

the body fluid extraction site is punctured by the puncture needle and the body fluid is taken out in a state where the body fluid extraction site is pressed against the abutting portion.

The body fluid extraction method of the present invention extracts body fluid using the following body fluid extraction means, which includes:

a main body for accommodating the puncture needle and having an opening for allowing the puncture needle to pass therethrough

An abutting portion fixedly provided to the body so as to surround an outer periphery of the opening, the abutting portion pressing the body fluid extraction site when the body fluid extraction site is punctured by the puncture needle,

the inner surface of the contact part has a part which is closer to the opening and is inclined closer to the central line of the opening, wherein, the body fluid extracting method comprises the following steps,

pressing the body fluid extraction site into close contact with the inner surface of the abutment portion;

a step of operating the puncture needle to puncture a portion of the body fluid collection site protruding from the opening into the main body by the puncture needle; and

and a step of extracting the body fluid from the puncture site of the body fluid extraction site.

In the method for extracting body fluid of the present invention, the inner surface of the abutting portion is preferably shaped like a truncated cone.

In the body fluid collecting method of the present invention, it is preferable that the puncture needle is mounted in the body fluid collecting tool in the form of a patch accommodated in a patch main body having an opening through which the puncture needle passes,

when the body fluid collecting part is pressed against the contact part in a state where the insert sheet is attached to the body fluid collecting tool, the body fluid collecting part is brought into contact with the opening edge of the insert sheet main body.

In the body fluid collecting method according to the present invention, it is preferable that the opening area of the opening of the insert main body is smaller than the opening area of the opening of the main body.

In the body fluid collecting method according to the present invention, it is preferable that the opening edge of the tip main body is positioned substantially on an extension of the inclined portion of the inner surface of the contact portion in a state before the body fluid collecting site is punctured by the puncture.

In the body fluid collecting method according to the present invention, it is preferable that the body is used in a state where the opening is vertically upward.

Drawings

Fig. 1 is a perspective view showing an embodiment (state in which a lid is opened) when the body fluid collection implement of the present invention is used in a component measurement device.

Fig. 2 is a side view of the component measuring apparatus shown in fig. 1 (in a state where the lid is opened).

FIG. 3 is a longitudinal sectional view showing the configuration of the main part of the component measuring apparatus of the present invention.

FIG. 4 is a longitudinal sectional view showing the configuration of the main part of the component measuring apparatus of the present invention.

Fig. 5 is a block diagram showing a circuit configuration of the component measuring apparatus shown in fig. 1.

FIG. 6 is a block flow diagram showing the control operation (a part including the operation of the operator) of the control mechanism of the component measuring apparatus shown in FIG. 1.

Detailed Description

The body fluid collection implement and the body fluid collection method of the present invention will be described in detail below with reference to preferred embodiments shown in the drawings.

Fig. 1 is a perspective view showing an embodiment (a state in which a lid is opened) when a body fluid collection implement of the present invention is used in a component measuring device, fig. 2 is a side view of the component measuring device shown in fig. 1 (a state in which the lid is opened), fig. 3 and 4 are longitudinal sectional views showing the configuration of the main part of the component measuring device of the present invention, fig. 5 is a block diagram showing the circuit configuration of the component measuring device shown in fig. 1, and fig. 6 is a block diagram showing the control operation (including the operation of a part of the operator) of the control means of the component measuring device shown in fig. 1. In fig. 1 to 4, the upper side is referred to as "top" or "upper" and the lower side is referred to as "base" or "bottom" in the description.

The component measuring apparatus (blood component measuring apparatus) 1 shown in each figure is an apparatus for extracting a body fluid (hereinafter, in the present embodiment, blood is described as a representative example) and measuring the amount of a predetermined component of the body fluid.

The parts from which blood is extracted by the component measuring apparatus 1 include, for example, the palm, the back of the hand, the side of the hand, the fingers (fingertips), the wrist, the abdomen, the thighs, and the earlobe, but in the following embodiments, the side of the hand is typically punctured.

As shown in fig. 1 and 2, the component measuring apparatus 1 has: a main body 2; a lid 20 provided rotatably (openably and closably) with respect to the main body 2; a housing 5 provided in the main body 2; a measuring means 7 that detects the extraction of blood and measures a prescribed component in the blood; a decompression mechanism 8 for bringing the inside of the casing 5 into a decompressed state; a control mechanism 11 provided on a circuit board not shown in the figure; a display unit 12. The component measuring apparatus 1 is used by attaching the insert 13 to an insert loading portion (insert loading space) 50 formed in the housing 5. The following describes each constituent element.

The main body 2 is formed in a box shape, and houses a case 5, a measuring mechanism 7, a decompression mechanism 8, a battery (power supply unit) 9, a control mechanism 11, a display unit 12, and the like therein.

An opening 212 is formed in a wall portion 211 on the distal end side (upper side) of the main body 2, and the opening 212 has a substantially circular cross-sectional shape and penetrates the inside and outside of the main body 2. The component measuring apparatus 1 of the present embodiment is of a vertical type used in a state where the opening 212 is vertically upward, and the insert 13 is loaded (held) in the insert loading portion 50 formed in the housing 5 through the opening 212.

The abutting portion 3 of the blood collection site (body fluid collection site) 900 on the side of the hand is fixed (or bonded) to the distal end side surface of the wall portion 211 so as to surround the outer periphery of the opening 212, for example, by fitting, screwing, or bonding with an adhesive. The abutment 3 may be formed integrally with the body 2.

In a state where the insert 13 is loaded on the insert loading portion 50 (hereinafter referred to as an "insert loading state"), the component measuring apparatus 1 is operated while the blood sampling site 900 is brought into contact with the contact portion 3. Thus, the surface (skin) of the blood extraction site 900 is punctured, and the amount of a predetermined component (hereinafter, glucose is described as a representative example in the present embodiment) in the extracted blood is measured. Wherein the provision of the abutment 3 is a big feature of the invention, which is described in detail below.

The lid body 20 is rotatably supported by a shaft (rotation shaft) 213 at the distal end (upper portion) of the main body 2.

When the lid 20 is closed, the top end of the main body 2 and the abutting portion 3 are covered with the lid 20. On the other hand, as shown in fig. 1 and 2, if the lid 20 is opened, the distal end of the main body 2 and the abutting portion 3 are exposed to the outside, and the insert 13 can be attached and detached, measured, or the like.

A display window (opening) 219 penetrating the inside and outside of the main body 2 is formed on the front surface side of the main body 2, and the display window 219 is closed by a plate-like member made of a transparent material. A display unit 12 is provided inside the display window 219. Therefore, various information displayed on the display unit 12 can be confirmed via the display window 219.

The display unit 12 is constituted by, for example, a liquid crystal display element (LCD). The display unit 12 can display, for example, on/off of a power supply, a power supply voltage (remaining battery), a measurement value, a measurement date, an error display, an operation instruction, and the like.

A recess 215 is formed on the front surface of the main body 2 at the tip end (upper side), and an operation button 216 is provided in the recess 215. In the component measuring apparatus 1 of the present embodiment, the pump 80 of the puncturing mechanism and the pressure reducing mechanism 8, which will be described later, is operated sequentially or substantially simultaneously by pressing the operation button 216. However, the power of the component measuring apparatus 1 may be turned on by pressing the operation button 216.

The control means 11 is constituted by, for example, a microcomputer, and controls various operations of the component measuring device 1 to determine whether or not blood is extracted. The control means 11 incorporates an arithmetic unit for calculating the amount of glucose in blood (blood glucose level) based on a signal from the measuring means 7.

The housing 5 has a tab loading portion 50 in which the tab 13 is loaded. An annular seal ring (sealing member) 55 is fitted to the distal end of the housing 5, that is, the outer peripheral portion of the distal end opening of the insert piece loading portion 50. Thus, if the tab 13 is attached to the tab loading portion 50, the flange 164 of the tab 13 is in close contact with the gasket 55, thereby maintaining the airtightness of the tab loading portion 50.

The seal ring 55 is made of an elastic body (elastic material). Examples of such elastomers include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, epichlorohydrin rubber, urethane rubber, silicone rubber, and fluororubber, and various thermoplastic elastomers such as styrenes, polyolefins, polyvinyl chlorides, polyurethanes, polyesters, polyamides, polybutadienes, and fluororubbers.

A measuring mechanism 7 is provided on the side of the housing 5. The measurement means 7 optically detects the supply (extraction) of blood onto the test paper 18 of the patch 13, and optically measures the amount of glucose in the blood diffused on the test paper 18. The measuring mechanism 7 is constituted by an optical module, and is disposed at a position facing the test strip 18 (near a side position of the test strip 18) in the tab-loaded state.

In this way, since the measurement means 7 has both a function of detecting the extraction of blood and a function of measuring the amount of glucose (predetermined component) in blood diffused on the test strip 18, the number of parts can be reduced, the structure can be simplified, and the number of assembly steps of the apparatus can be reduced as compared with a case where these means are provided separately.

The measuring mechanism 7 includes: the module body 70 includes a light emitting element (light emitting diode) 71 and a light receiving element (photodiode) 72 fixed to the module body 70.

A seal ring 56 similar to the seal ring 55 is provided between the block 70 and the housing 5 to maintain the airtightness of the tab loading portion 50.

The light emitting element 71 is electrically connected to the control means 11, and the light receiving element 72 is electrically connected to the control means 11 via the amplifier 24 and the a/D converter 25 (see fig. 5).

The light emitting element 71 operates in response to a signal from the control means 11 to emit light. The light is preferably pulsed light that intermittently emits light at predetermined time intervals.

When the light emitting element 71 is turned on in the state where the insert is loaded, the test paper 18 is irradiated with light emitted from the light emitting element 71, and the reflected light is received by the light receiving element 72 and photoelectrically converted. An analog signal corresponding to the amount of received light is output from the light receiving element 72, amplified to a desired level by the amplifier 24, converted into a digital signal by the a/D converter 25, and input to the control mechanism 11.

The control means 11 determines whether or not blood is extracted, that is, whether or not blood is spread on the test paper 18 of the patch 13, based on the input signal.

The control means 11 performs predetermined arithmetic processing based on the input signal, and performs correction calculation as necessary to obtain the amount of glucose in blood (blood glucose level). The obtained blood glucose level is displayed on the display unit 12.

Next, the structure of the tab 13 loaded in the tab loading portion 50 will be described. As shown in fig. 3, the insert sheet 13 includes: a puncture needle 14; an inner cylinder 15 which houses the puncture needle 14 and is slidable therebetween; an outer cylinder 16 provided on the outer periphery of the inner cylinder 15; a strip fixing portion 17 provided on the outer periphery of the outer cylinder 16; and a test strip 18 fixed to the test strip fixing portion 17. The insert body 130 is composed of an inner cylinder 15 and an outer cylinder 16.

The puncture needle 14 includes a needle body 141 and a hub 142 fixed to the proximal end side of the needle body 141, and the puncture needle 14 is housed in the inner cavity of the inner tube 15.

The needle body 141 is made of a hollow member or a solid member made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy, and has a sharp cutting edge (needle point) formed at its distal end. The blade edge pierces the surface (skin) of the blood collection part 900 on the side of the hand.

The bushing 142 is formed of a substantially cylindrical or columnar member.

A hole 151 having a circular cross-sectional shape is formed in a substantially central portion of the distal end of the inner cylinder 15.

The needle body 141 passes through the hole 151 when puncturing the blood extraction site 900. Further, the bore diameter of the hole 151 is set smaller than the tip outer diameter of the bush 142. Therefore, when the puncture needle 14 moves in the distal direction of the inner cylinder 15, the hub 142 does not pass through the hole 151 and touches the periphery of the hole 151, and therefore, the puncture needle 14 is prevented from moving in the distal direction. Therefore, the length of the needle body 141 protruding from the distal end of the insertion piece 13 is kept constant when puncturing the blood collection site 900.

On the outer circumference of the inner cylinder 15, next to the outer cylinder 16. The outer cylinder 16 is formed of a substantially cylindrical member, and has an inner cavity 161 therein.

An abutment 163 projecting annularly is formed at the distal end of the outer cylinder 16. A distal end opening (opening) 162, which opens the inner cavity 161 of the outer cylinder 16 (the inner cavity of the blade main body 130), is formed inside the contact portion 163.

As described later, in the present embodiment, when the blood extraction site 900 is punctured, if the contact portion 3 is pressed against the blood extraction site 900, the blood extraction site 900 also comes into contact with the contact portion 163, and the distal end opening 162 is closed by the blood extraction site 900.

The distal end outer peripheral edge (edge of the distal end opening 162) of the contact portion 163 is shaped so as to stimulate the periphery of the puncture site and provide an effect of alleviating pain during puncture when it is pressed against the blood collection site 900. Further, it is also in a shape that can suppress as much as possible the inflow of air from between the tip of the abutting portion 163 and the surface of the blood collection part 900 when the insert piece loading portion 50 is brought into a depressurized state by the action of the depressurizing mechanism 8 described later.

Further, an annular flange 164 protruding outward is formed on the outer peripheral portion of the outer cylinder 16 in the vicinity of the base end of the abutting portion 163. In the tab-loaded state, the flange 164 has a base end surface abutting against the top end of the housing 5, and the tab 13 is positioned with respect to the housing 5 (positioned in the vertical direction in fig. 3 and 4).

A strip fixing portion (strip fixing member) 17 is provided on the outer periphery of the outer cylinder 16, and a strip 18 is fixed to the strip fixing portion 17.

Further, a blood introduction guide 166 protruding toward the center of the lumen portion 161 is formed on the inner peripheral surface of the outer tube 16. The blood introducing guide 166 has a function of receiving blood (specimen) that has bleeded from the hand (blood extraction site 900) and flowed into the lumen 161 after puncturing.

Further, the insert 13 is formed with a blood passage 19 formed to penetrate the outer cylinder 16 and the strip fixing portion 17. The blood passage 19 is a channel for guiding blood obtained by puncturing to the test paper 18, and has a passage opening 191 that opens to the inner chamber 161 and a passage opening 192 that opens to the outside of the insert piece 13. The access opening 192 is located in the center of the test strip 18.

Further, passage opening 191 is formed near the base of blood introduction guide 166. Therefore, the blood caught by the blood introducing guide 166 is effectively introduced from the passage opening 191 to the blood passage 19. The blood reaches the passage opening 192 by capillary action, is supplied to the center of the test piece 18 provided in a shape covering the passage opening 192, and spreads radially on the test piece 18.

The test paper 18 is a product in which a reagent is attached to a carrier capable of absorbing and diffusing blood.

Examples of the carrier include sheet-like porous bodies such as nonwoven fabrics, woven fabrics, and stretched sheets. The porous body is preferably hydrophilic.

The reagent to be loaded on the carrier can be determined appropriately according to the component to be measured in blood (specimen). For example, in the case of measuring blood glucose level, there may be mentioned a color-changing agent (color-changing reagent) such as Glucose Oxidase (GOD), Peroxidase (POD), e.g., 4-aminoantipyrine, N-ethyl N- (2-hydroxy-3-sulfopropyl) m-toluidine, and the like, and there may be mentioned a substance which reacts with blood components such as ascorbate oxidase, alcohol oxidase, cholesterol oxidase, and the like, and a color-changing agent (color-changing reagent) similar to the above, depending on the measurement components. Further, a buffer such as phosphate buffer may be contained. Of course, the kind and composition of the reagent are not limited to these.

Further, a decompression mechanism (suction mechanism) 8 capable of decompressing the inside of the case 5 (insert piece loading portion 50) is provided in the main body 2. The decompression mechanism 8 includes: a pump 80, a pipeline 81, a branch pipe 82 which branches from the middle of the pipeline 81 and has an open end, and an electromagnetic valve 83 provided in the middle of the branch pipe 82.

The pipe 81 and the branch pipe 82 are formed of, for example, pipes made of a flexible material such as polyolefin, e.g., polyvinyl chloride, polystyrene, polypropylene, ethylene-vinyl acetate copolymer (EVA), polyamide, polyester, silicone rubber, or polyurethane.

The housing 5 is formed with an air passage 59 for communicating the plug loading portion 50 with the outside, and one end of the pipe 81 is connected to the air passage 59. Further, a pump 80 is provided at the other end of the pipe 81.

The electromagnetic valve 83 can open and close (open/close) the flow path of the branch pipe 82.

The battery 9 provided in the main body 2 is electrically connected to the pump 80, the solenoid valve 83, the control mechanism 11, the display unit 12, and the like, and supplies electric power necessary for their operations.

When the pump 80 is operated in a state where the tip opening 162 is closed by the blood collection site 900 in the patch loading state and the electromagnetic valve 83 is closed, air in the patch loading portion 50 is sucked and exhausted by the pump 80 via the ventilation path 59 and the pipe 81, and thereby the inside of the patch loading portion 50 is in a pressure reduction state.

In this state, if the solenoid valve 83 is opened (opened), air (atmospheric air) from the outside is introduced into the inlet filling portion 50 in the reduced pressure state via the branch pipe 82, the pipe 81, and the air passage 59, and the reduced pressure state is released or relaxed.

The pump 80 may be configured to reduce the pressure in the patch loading portion 50 to such an extent that blood can be sucked out from the puncture site of the blood collection site 900 (for example, about 100 to 400 mmHg).

A puncture mechanism (not shown) is provided on the proximal end side of the insert piece 13, and moves the puncture needle 14 in the distal direction, so that the needle point of the needle body 141 passes through the distal opening 162 to puncture the blood collection site 900. The lancing mechanism has, for example, a spring and a plunger to which a force is applied by the spring.

As described above, the present invention is characterized by the abutting portion 3. This point (feature) will be explained in detail below.

The contact portion 3 is formed in a shape surrounding the opening 212 of the main body 2, and thus the contact portion 3 has the opening 30 having a substantially circular cross-sectional shape at a substantially central portion thereof.

The surface facing the opening 30 of the contact portion 3 constitutes a contact surface (inner surface) 31 that presses the blood collection site 900. The contact surface 31 is inclined at a substantially constant angle (θ in fig. 3), and approaches the center line of the opening 212 as the contact surface approaches the opening 212 of the body 2. That is, the contact surface 31 has a side surface shape of a truncated cone (a shape of a portion other than the vicinity of the top of the truncated cone).

With this configuration, if the side portion of the hand (blood extraction site 900) is pressed against the contact portion 3 when puncturing the blood extraction site 900, the vicinity of the blood extraction site 900 deforms along the shape of the contact surface 31, and the shape thereof is defined (see fig. 4). Part of the blood extraction site 900 protrudes into the main body 2 through the opening 212.

At this time, regardless of the magnitude of the force with which the side portion of the handle presses against the contact portion 3, the shape of the vicinity of the blood collection site 900 (particularly, the shape of the portion protruding into the main body 2) is defined to be substantially constant by the contact portion 3. Therefore, the puncture depth of the puncture needle 14 at the blood collection site 900 can be made substantially constant. This ensures an accurate blood volume when measuring the blood glucose level.

This effect can be sufficiently exhibited to the extent that the side portion of the hand is lightly caught by the abutting portion 3. In particular, the component measuring apparatus 1 of the present embodiment is of a vertical type, and the above-described effects can be sufficiently exhibited to the extent that the handle is placed on the abutting portion 3. Therefore, when measuring the blood glucose level, adjustment of the force with which the side portion of the hand presses the contact portion 3 is not necessary, and the convenience of the patient can be improved.

Further, by defining the shape in the vicinity of the blood extraction site 900, an effect of collecting blood at the blood extraction site 900 (blood collection) can be also exhibited. This makes it possible to more reliably ensure blood necessary for measuring the blood glucose level. That is, the contact portion 3 may be a member having a blood collecting function (blood collecting member).

Here, as shown in FIG. 3, when the minimum diameter (diameter at the base end) of the opening 30 is * A [ mm ], and the maximum diameter (diameter at the tip end) of the opening 30 is * B [ mm ], it is preferable that the relation of * B/* A is 1.1 to 2.0, and more preferably 1.2 to 1.6 is satisfied. Specifically, * A is preferably about 5 to 20mm, more preferably about 8 to 15 mm.

The angle θ between the contact surface 31 and the central axis O of the opening 30 (opening 212) is preferably about 45 to 85 °, and more preferably about 65 to 75 °.

The hardness (defined in JIS K6253) of the abutting portion 3 is preferably 30 or more. By making the contact portion 3 harder, deformation when the side portion of the hand is pressed can be prevented, and thus the function of the contact portion 3 to define the shape near the blood collection site 900 can be more effectively exerted.

As shown in the drawing, the contact surface (inner surface) 31 is not limited to a structure that is inclined at a substantially constant inclination angle over the entire length of the opening 30, and may have a portion that is locally substantially parallel to the center line O of the opening 212, or may have an inclination angle that changes in stages.

In the present embodiment, as shown in fig. 3 and 4, the contact portion 163 of the tab 13 is configured not to protrude from the opening 212 of the main body 2 in the tab loading state. With this configuration, in a state where the contact portion 3 (contact surface 31) is pressed by the side portion of the hand (blood extraction site 900), the portion of the blood extraction site 900 protruding into the main body 2 is in contact with the tip (edge of the tip opening 162) of the contact portion 163 of the insertion piece 13. Thus, the blood sampling site 900 is positioned at both the contact portion 3 and the contact portion 163 with respect to the puncture needle 14. Therefore, the variation in depth when the puncture needle 14 punctures the blood sampling site 900 can be more reliably prevented.

Further, the opening area of the tip opening 162 of the tab 13 (tab main body 130) is set smaller than the opening area of the opening 212 of the main body 2. Therefore, the distal end opening 162 of the insertion piece 13 can be reliably closed by the blood collection site 900 in a state where the contact portion 3 is pressed by the side portion of the hand. This makes it possible to more reliably reduce the pressure of the pressure reducing mechanism 8.

In particular, in the present embodiment, the edge of the distal end opening 162 of the insertion piece 13 is set to be positioned substantially on the extended surface of the contact surface (inner surface) 31 of the contact portion 3 (substantially on the same plane as the contact surface 31) in a state before the puncture needle 14 punctures the body fluid extraction site. This can more reliably exhibit the effect of the blood collection site 900 closing the distal end opening 162 of the insert sheet 13.

Next, referring to fig. 1 to 6, a method of using the component measuring apparatus 1, that is, operations of each part and control operations of the control means when puncturing, blood extraction (the body fluid extraction method of the present invention), diffusion, and blood glucose level measurement are performed by the component measuring apparatus 1 will be described.

First, the cover 20 is opened, and the tab 13 is inserted into the tab loading portion 50 of the housing 5 through the opening 212 of the main body 2. Further, if the insert 13 is pushed in the proximal direction, the flange 164 of the insert 13 abuts against the seal ring 55 and the distal end of the housing 5, and the insert 13 is positioned with respect to the housing 5.

Then, the power supply, not shown, is turned on [ 2 ]. Thereby, each part of the component measuring apparatus 1 is started up to be in a measurable state. Wherein the solenoid valve 83 is closed.

Then, the side portion of the hand (blood sampling site 900) is pressed against the contact portion 3. Thereby, the shape near the blood collection site 900 is defined by the contact portion 3, and the portion of the blood collection site 900 protruding into the main body 2 presses the contact portion 163 of the insert sheet 13. However, since the component measuring device 1 of the present embodiment is of a vertical type, the distal end opening 162 of the insert piece 13 can be accurately closed by the blood collection site 900 by a simple operation of placing a hand on the contact portion 3.

Next, the operation button 216 is pressed to puncture the surface (skin) of the blood collection part 900 (step S101 in fig. 6).

When the operation button 216 is pressed, the puncture mechanism is operated to move the puncture needle 14 in the distal direction, and the needle body 141 protrudes from the distal opening 162 through the hole 151 to puncture the surface of the side portion (body fluid collection site) of the hand. Thereby, blood is discharged from the puncture site of the needle body 141.

At this time, since the abutment portion 163 between the abutment portion 3 and the insert piece 13 positions the blood collection site 900 with respect to the puncture needle 14, the blood collection site 900 is punctured at a correct puncture depth.

Further, the operation switches (not shown) of the pump 80 are also turned on substantially simultaneously by the pressing of the operation button 216.

When the needle body 141 pierces the blood collection site 900, the puncture needle 14 is returned in the proximal direction, and the needle tip of the needle body 141 is accommodated in the insert piece 13.

When the operation switch of the pump 80 is turned on, the control means 11 starts the operation of the pump 80 (step S102 in fig. 6).

That is, the pump 80 operates substantially simultaneously with the operation [ 4 ] described above, and starts the suction and exhaust of air in the inlet filling portion 50 of the housing 5. Thereby, the pressure of the tab loading portion 50 (including the inside of the tab 13) is reduced, and a depressurized state is obtained.

At this time, the puncture site of the needle body 141 of the blood collection site 900 is also in a reduced pressure state. Therefore, since blood is sucked out from the puncture site to promote bleeding, a necessary amount of blood can be secured in a short time.

The minimum pressure generated by the pump 80 is preferably about 100 to 400mmHg, for example.

As described above, in the component measuring apparatus 1, the puncture operation and the decompression operation can be performed substantially simultaneously by one-time pressing of the operation button 216, and therefore, the operability is excellent.

In the operation [ 6 ] above, blood that has risen in a granular form at the puncture site on the side of the hand (blood collection site 900) is sucked into the insert piece 13, brought into contact with the blood introduction guide 166 formed inside, guided to the test strip 18 via the blood passage 19, supplied to the center of the test strip 18, and radially diffused.

As the blood is supplied to and diffused over the test strip 18, the glucose (component to be measured) in the blood reacts with the reagent attached to the test strip 18, and the test strip 18 changes color according to the amount of glucose.

On the other hand, after executing step S102 shown in fig. 6, the control means 11 drives the measuring means 7, monitors the color change of the (monitor) strip 18 via the measuring means 7, and determines whether or not blood has been extracted (step S103 in fig. 6).

In step S103, it is determined that blood has been extracted when the voltage of the signal input from the light receiving element 72 of the measurement means 7 exceeds a predetermined threshold value, and it is determined that blood has not been extracted when the voltage of the signal is lower than or equal to the threshold value.

The threshold is set to be sufficiently higher than the voltage of the signal before the test paper 18 changes color and sufficiently lower than the voltage of the signal when the test paper changes color.

When it is determined in the aforementioned step S103 that blood has not been extracted, it is determined whether or not time has elapsed (step S104 in fig. 6).

If it is determined in the aforementioned step S104 that the time has not elapsed, the process returns to the step S103, and the process of the step S103 and thereafter is executed again; when it is determined that the time has elapsed, an error process is performed (step S105 in fig. 6).

In step S105, the pump 80 is stopped, the electromagnetic valve 83 is opened, the pressure reduction state is released, and a display indicating an error (error display) is displayed on the display unit 12.

The operator (user) can grasp the error (presence of a certain trouble) by the error display.

The function of the solenoid valve 83 when opened will be described in detail below.

In step S103, when it is determined that blood has been extracted, the pump 80 is stopped (step S106 in fig. 6).

Subsequently, the solenoid valve 83 is opened to release the reduced pressure state (step S107 in fig. 6).

When the solenoid valve 83 is opened, the outside air (atmosphere) flows into the insert filling part 50 (including the inside of the insert 13) and the puncture site of the blood sampling site 900 via the branch pipe 82, the pipe 81 and the air passage 59, and the pressure is returned to the atmospheric pressure.

The suction feeling around the puncture site on the side of the hand was lost, and after confirming that the atmospheric pressure was returned, the handle was separated from the contact portion 3.

After executing step S107 shown in fig. 6, the control means 11 measures the degree of discoloration of the test strip 18 by the measuring means 7, and performs correction such as calculation of temperature correction and calculation of hematocrit value by performing calculation based on the obtained data. The blood glucose level is quantified (step S108 in fig. 6).

In this case, since the pressure-reduced state of the inlet filling portion 50 (including the inside of the inlet 13), that is, the pressure-reduced state of the housing space of the test strip 18 is released, components in the atmosphere (for example, oxygen, carbon dioxide, water vapor, and the like) necessary for the reaction between the glucose (component to be measured) in the blood and the reagent attached to the test strip 18 are sufficiently supplied, and the blood glucose level can be accurately measured.

Next, the measured blood glucose level is displayed on the display unit 12 (step S109 in fig. 6). This enables the blood glucose level to be grasped.

After the decompression state is released, the solenoid valve 83 is closed again in preparation for the next measurement.

As described above, if the component measuring apparatus 1 is used, the contact portion 163 of the contact portion 3 and the insert piece 13 can position the puncture site of the blood collection site 900, and variation in puncture depth can be suppressed. This makes it possible to extract a sufficient amount of blood necessary for measurement, and thereby accurately and reliably measure the blood glucose level (the amount of a predetermined component in the blood).

Further, since the test piece 18 is provided on the insert 13, puncturing, blood collection, and diffusion to the test piece 18 and measurement (component quantification) can be performed continuously, and blood glucose level measurement (component measurement) can be performed easily and in a short time.

In addition, if the blood collection part is a vertical type, measurement of the blood glucose level can be started only by placing the blood collection part (body fluid collection part) 900 on the contact part 3, and the blood collection part can be used easily, and therefore, the blood collection part is advantageous for periodic or repeated use.

In addition, after the puncture, accidents such as mistaken re-puncture of the surface of the living body can be prevented, and the safety is high. Further, since the puncture needle 14 cannot be seen directly, the fear of the puncture can be reduced.

As described above, the component measuring apparatus 1 is suitable for use by the patient himself/herself in measuring his/her blood glucose level or the like.

Further, the component measuring apparatus 1 is simple in structure, small in size, light in weight, inexpensive, and suitable for mass production.

The body fluid collection tool and the body fluid collection method according to the present invention have been described above with reference to the illustrated embodiments, but the present invention is not limited thereto, and for example, the configuration of each part may be replaced with any configuration that can exhibit the same function.

For example, the measuring means may measure the amount of the predetermined component, but may measure the property of the predetermined component, or may measure the amount and the property of the predetermined component.

The measuring means is not limited to optically measuring the intensity of color change (color measurement) of the test strip that changes in color due to the reaction between the component in the blood and the reagent, and converting the measured value into a measured value to display the measured value, and may be, for example, electrically converting the potential change generated by the measurement of the component in the specimen into a measured value to display the measured value.

Further, the decompression mechanism releases the decompressed state before the measurement, but the decompressed state may be relaxed before the measurement.

The decompression mechanism may be configured to start decompression before puncturing.

The pressure reducing mechanism may be started manually or automatically. In the latter case, for example, a sensor or the like may be provided near the side of the distal end portion of the case 5 so that, when the fingertip is punctured, the movement of the puncture needle in the distal direction is electromagnetically detected, and the decompression mechanism may be operated based on the information of the sensor.

In the above-described component measuring apparatus 1, an insert retraction mechanism may be provided in which the insert 13 moves in the proximal direction.

In the above-described embodiment, the body fluid collection implement of the present invention has been described as being applied to a component measurement device having both a function of collecting blood and a function of measuring the amount of a predetermined component in blood.

In the above-described embodiment, the extracted body fluid is represented by blood, but in the present invention, the extracted body fluid is not limited to this, and may be sweat, lymph, interstitial fluid, or medullary fluid, for example.

In the above-described embodiment, the components to be measured are exemplified by glucose (blood glucose level), but in the present invention, the components to be measured are not limited to this, and may be, for example, organic compounds such as protein, cholesterol, uric acid, creatine lactam, and alcohol, and inorganic ions such as sodium, potassium, calcium, chlorine, phosphoric acid, carbonic acid, and pH.

Possibility of industrial utilization

According to the present invention, since the shape of the vicinity of the body fluid extraction site is defined by the contact portion, variation in puncture depth can be suppressed, and body fluid can be extracted more accurately. Further, by attaching the insert piece having the puncture needle and using it, the positional relationship, the dimensional relationship, or the like between the abutting portion and the tip of the insert piece can be set appropriately, and the above-described effects can be further improved. In addition, the body fluid extraction tool of the present invention is simple in structure, small in size, light in weight, inexpensive, and suitable for mass production. Thus, industrial applicability is possible.

Claims (13)

1. A body fluid collecting tool having a puncture needle mounted thereon, and for collecting a body fluid by puncturing a body fluid collecting site with the puncture needle in use,

it includes: a main body which accommodates the puncture needle and has an opening through which the puncture needle can pass;

an abutting part fixedly provided on the body and having an outer peripheral shape surrounding the opening, the abutting part pressing the body fluid collecting part when the body fluid collecting part is punctured by the puncture needle,

the inner surface of the abutting portion has a portion inclined closer to the opening than to the center line of the opening.

2. The body fluid extraction tool of claim 1,

the inner surface of the abutting portion has a truncated cone side shape.

3. The body fluid extraction tool of claim 1 or 2,

the puncture needle is mounted in the body fluid collecting tool in a state of being accommodated in a blade, and an opening through which the puncture needle can pass is provided in a blade main body of the blade,

when the body fluid collecting part is pressed against the contact part in a state where the insert sheet is attached to the body fluid collecting tool, the body fluid collecting part is brought into contact with the opening edge of the insert sheet main body.

4. The body fluid extraction tool of claim 3,

the opening area of the opening of the inserting sheet main body is smaller than that of the opening of the main body.

5. The body fluid extraction tool of claim 3,

in a state before the puncture of the body fluid collection site by the puncture, the opening edge of the tab body is located substantially on an extension of the inclined portion of the inner surface of the contact portion.

6. The body fluid extraction tool of claim 1,

the main body is used in a state that the opening is vertically upward.

7. A body fluid collecting method for collecting a body fluid by puncturing a body fluid collecting site with a puncture needle, the body fluid collecting method comprising:

a main body which accommodates a puncture needle and has an opening through which the puncture needle can pass;

an abutting portion fixedly provided to the body so as to surround an outer periphery of the opening, the abutting portion pressing the body fluid extraction site when the body fluid extraction site is punctured by the puncture needle,

the inner surface of the abutting portion has a portion which is inclined closer to the center line of the opening as it is closer to the opening,

the body fluid extraction site is punctured by the puncture needle and the body fluid is taken out in a state where the body fluid extraction site is pressed against the abutting portion.

8. A body fluid collecting method for collecting a body fluid using a body fluid collecting tool comprising:

a main body for accommodating the puncture needle and having an opening for allowing the puncture needle to pass therethrough

An abutting portion fixedly provided to the body so as to surround an outer periphery of the opening, the abutting portion pressing the body fluid extraction site when the body fluid extraction site is punctured by the puncture needle,

the inner surface of the abutting portion has a portion which is inclined closer to the center line of the opening as it is closer to the opening,

the body fluid extraction method comprises the steps of, i.e.,

pressing the body fluid extraction site into close contact with the inner surface of the abutment portion;

a step of operating the puncture needle to puncture a portion of the body fluid collection site protruding from the opening into the main body by the puncture needle; and

and a step of extracting the body fluid from the puncture site of the body fluid extraction site.

9. The method of taking body fluid of claim 7 or 8,

the inner surface of the abutting portion has a truncated cone side shape.

10. The method of taking body fluid of claim 7 or 8,

the puncture needle is installed in the body fluid extraction tool as an insert which is accommodated in an insert main body having an opening through which the puncture needle passes,

when the body fluid collecting part is pressed against the contact part in a state where the insert sheet is attached to the body fluid collecting tool, the body fluid collecting part is brought into contact with the opening edge of the insert sheet main body.

11. The method of taking body fluid of claim 10,

the opening area of the opening of the inserting sheet main body is smaller than that of the opening of the main body.

12. A method of body fluid sampling as defined in claim 1,

in a state before the puncture of the body fluid collection site by the puncture, the opening edge of the tab body is located substantially on an extension of the inclined portion of the inner surface of the contact portion.

13. The method of taking body fluid of claim 7 or 8,

the opening of the main body is arranged to be vertically upward for use.