JP2001074731A - Assembly with lancet and humor ingredient detection part - Google Patents

Abstract

PROBLEM TO BE SOLVED: To maintain a detection function while maintaining the sterility of a centesis needle by airtightly blocking a cylindrical part before moving a lancet in a first housing, performing sterility treatment while being sealed, and performing fixing to a second housing. SOLUTION: The tip of a lancet 4 has a centesis needle 41, and a base edge has a connection part 42 with a centesis mechanism 91 in a humor constituent- measuring device 9. The lancet 4 travels in a cylindrical part 21 of a first housing 2, and the tip and the base edge have a first opening 22 and a base edge opening 23, respectively. The centesis needle 41 projects from the first opening 22 and makes connection to the centesis mechanism 91 at the base edge opening 23. A third housing 3 is provided with test paper 32 at a humor constituent measurement part, and a second opening that overlaps with the first opening 22 for forming a tip opening. Before the lancet 4 travels, the lancet 4 is fixed so that it airtightly blocks the base edge opening 23 near the base edge of the cylindrical part 21, and sterility treatment is made while the first opening 22 is sealed by a sealing member, thus preventing the test paper 32 from deteriorating due to the sterility treatment.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an assembly provided with a lancet for use in connection with a body fluid component measuring device for performing a clinical test of a body fluid such as blood.

[0002]

2. Description of the Related Art With the increase in the number of diabetic patients in recent years, self-monitoring of blood glucose, which monitors daily fluctuations in blood glucose, has been recommended. -339473 and JP-A-9-27
No. 6,235, U.S. Pat. No. 4,787,398, and the like disclose a device in which a puncture device and a measuring device are integrated.
However, Japanese Patent Application Laid-Open Nos. Hei 6-339473 and Hei 9-276
No. 235 is an integrated device, but the puncture mechanism and the measurement mechanism are separate, and the lancet including the puncture needle and the detection unit including the test paper must be set separately, which makes operation difficult. Requires some effort. Further, US Pat. No. 4,787,398 discloses that a puncture mechanism and a measurement mechanism are integrated, and the operation is easily performed by setting one adapter having a lancet including a puncture needle and a detection unit including a test paper. However, if the adapter is sterilized before use, reagents and the like impregnated in the test paper will be denatured, making it difficult to provide a product with the sterilized state of the puncture needle maintained. Was.

[0003]

SUMMARY OF THE INVENTION An object of the present invention is to provide a lancet including a puncture needle and a detection unit including a test strip for use in an apparatus in which a puncture mechanism and a measurement mechanism are integrated. Another object of the present invention is to provide an adapter that maintains the function of a detection unit such as a test paper while maintaining sterilization of a puncture needle.

[0004]

The above object is achieved by the present invention described below. (1) The present invention relates to an assembly provided with a lancet and a body fluid component detection unit which are used by being connected to a body fluid component measurement device.
A lancet having a puncture needle at a distal end and a connection portion with a puncture mechanism in the bodily fluid component measuring device at a proximal end, and a first end forming a distal end opening through which the lancet moves and the puncture needle projects. An opening, and a first housing having a cylindrical portion provided with a base end opening for connecting a connection portion of the lancet and a puncture mechanism in the body fluid component measurement device, and a body fluid component measurement detection unit, And a second housing having a second opening overlapping with the first opening and forming the tip opening, and a sealing member for sealing the first opening, wherein the first housing includes the lancet. Before the movement, the lancet is fixed so as to hermetically close the base end opening near the base end of the cylindrical portion, and sterilized in a state where the first opening is sealed with the sealing member. Processed And an assembly including a lancet and a body fluid component detection unit in which the first housing and the second housing are fixed such that the first opening and the second opening form a distal end opening. .

(2) The lancet and the body fluid component detecting section according to the above (1), wherein the entire assembly including the lancet and the body fluid component detecting section is sealed by a protective member. It is an assembly provided with.

(3) In the present invention, the sealing member is connected to the protection member, and the sealing member can be removed from the first opening simultaneously with removing the protection member. An assembly including the lancet and the body fluid component detection unit according to 2).

(4) The lancet according to the above (1) to (3), wherein the sterilization state of the puncture needle is maintained until the sealing member is removed from the first opening. It is an assembly provided with a body fluid component detection unit.

(5) According to the present invention, the flow path provided in the second housing is such that one flow path and another flow path intersect at an angle, and the intersection is formed near the intersection. The above (1), which has a convex portion extending toward the inside of the flow path portion and contacting the meniscus generated near the intersection.
An assembly including the lancet and the body fluid component detection unit according to any one of (4) to (4).

(6) The present invention is an assembly comprising the lancet and the body fluid component detecting section according to the above (1) to (5), wherein the first housing is provided with a mechanism for preventing a lancet from dropping after use. .

(7) The present invention is an assembly including the lancet and the body fluid component detecting unit according to the above (1) to (6), wherein the falling-off prevention mechanism also functions as a sealing mechanism for the base end opening. .

(8) The present invention relates to an assembly provided with a lancet and a body fluid component detecting section used in connection with a body fluid component measuring device, wherein a puncture needle is provided at a distal end, and a puncturing mechanism in the body fluid component measuring device is provided at a proximal end. A lancet provided with a connection portion, a first opening portion in which the lancet moves inside, and a tip opening portion from which the puncture needle projects, and a connection portion of the lancet and puncturing in the body fluid component measuring device A first housing having a tubular portion provided with a base end opening for connecting to a mechanism, a body fluid component measurement detection unit, and a second opening overlapping with the first opening to form the distal end opening A second housing having a portion, a first sealing member for sealing the first opening, and a second sealing member for sealing the base end opening, wherein the first housing is the lancet Is stored in the tubular part The first opening is the first sealing member, the base opening is sterilized in a state sealed with the second sealing member, the first opening and the first opening An assembly comprising a lancet and a bodily fluid component detection unit in which the first housing and the second housing are fixed such that the second opening forms a distal end opening.

(9) The lancet and the body fluid component detecting section according to the above (8), wherein the entire assembly including the lancet and the body fluid component detecting section is sealed by a protective member. It is an assembly provided with.

(10) In the present invention, the first sealing member and the second sealing member are connected to the protection member,
The lancet according to any one of (8) to (9), wherein the first sealing member can be removed from the first opening at the same time as the protection member is removed, and the second sealing member can be removed from the base opening. And a body fluid component detection unit.

(11) In the present invention, the sterilization state of the puncture needle may be changed until the first sealing member is removed from the first opening and the second sealing member is removed from the base opening. An assembly comprising the lancet and the body fluid component detection unit according to (8) to (10) held.

(12) According to the present invention, the flow path portion provided in the second housing is such that one flow path and another flow path intersect at an angle, and the vicinity of the intersecting point is the flow path section. An assembly provided with the lancet and the body fluid component detection unit according to the above (8) to (11), which has a convex portion extending toward the inside of the flow passage portion and contacting the meniscus generated near the intersection. .

(13) In the present invention, the first housing is provided with a mechanism for preventing a lancet from falling off after use.
An assembly including the lancet and the body fluid component detection unit according to any one of (12) to (12).

(14) According to the present invention, a lancet having a puncture needle at the distal end, a puncture mechanism connecting portion at the proximal end, and a body fluid component detecting unit are integrated, and the lancet is sealed in a sterilized state. 9 is an assembly including a packaged lancet and a body fluid component detection unit.

(15) According to the present invention, there is provided the lancet according to the above (14), wherein the entire assembly including the lancet and the body fluid component detecting unit is packaged with a protective member. It is.

(16) In the present invention, a part of the sealed package of the lancet and a part of the protective member are connected,
An assembly comprising the lancet and the body fluid component detection unit according to the above (14) to (15), wherein the hermetically sealed package is removed at the same time as the protection member is removed.

It is to be noted that the meniscus means that the liquid in the capillary stays due to the surface tension inside the capillary, and the surface of the liquid rises or falls along the tube wall as compared with the central portion due to the capillary phenomenon, and the curved surface is formed. Refers to the phenomenon that forms In particular, this phenomenon is likely to occur around a capillary when an angle is provided in the capillary.

[0021]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A first embodiment of the present invention will be described with reference to the drawings. FIG. 1 shows a cross section of an assembly 1 according to a first embodiment of the present invention. The assembly 1 includes a first housing 2 and a second housing 3. As shown in FIG. 2 which is a cross section of the first housing 2, the first housing 2 has a tubular portion 21, and the tubular portion 21 is provided with a first opening 22 at a distal end and a proximal opening 23 at a proximal end. The lancet 4 moves inside. The second housing 3 is provided with a second opening 31 and a test paper 32 as a body fluid component measurement / detection unit, as shown in FIG. 3 showing a plane and FIG. 4 which is a cross section taken along line XX. .

The first housing 2 and the second housing 3 are
The first opening 22 and the second opening 31 are overlapped and fixed so as to form the distal end opening 5, thereby forming the assembly 1. The first housing 2 and the second housing 3 are fixed by the engagement of the engaging portions 24a and 24b of the first housing 2 and the engaging portions 35a and 35b of the second housing 3. The contact surface between the first housing 3 and the second housing 3 may be bonded or fused. With this structure, it is not necessary for the operator to set the first housing 2 and the second housing 3 separately in the body fluid component measuring device 9 at the time of use, and the operator can set the first housing 2 and the second housing 3 at the same time as the assembly 1. It is possible to remove the assembly 1 from the body fluid component measuring device 9 as a single assembly 1 instead of separately.

The first housing 2 has a cylindrical portion 21,
A movable lancet 4 is housed inside. The shape of the cylindrical portion 21 may be a cylinder or a square, but a cylinder is preferable because it is structurally easy to manufacture. The lancet 4 is provided with a puncture needle 41 at a distal end, and a connection portion 42 for connecting to a puncture mechanism 91 in the body fluid component measuring device 9 at a proximal end. The shape of the connecting portion 42 is not limited to the convex shape shown in the drawing, and may be any shape as long as it corresponds to the shape of the puncturing mechanism 91, and does not need to protrude from the proximal end opening 23.

The lancet 4 is fixed in the vicinity of the base end of the tubular portion 21, that is, at a position where at least the puncture needle 41 does not protrude from the first opening 22. The fixing force of this fixing is
Before use, the puncture needle 41 does not protrude from the first opening portion 22 and the work can be performed when the puncture mechanism 91 and the connection portion 42 are connected. In use, that is, when the lancet 4 moves, the puncture mechanism 91 The pushing force requires a fixing force enough to release the fixing. The fixing method is not particularly limited, and the inner surface of the tubular portion 21 and / or the lancet 4 may be fixed.
A locking means may be provided on the outer surface, the frictional force of the contact surface between the inner surface of the cylindrical portion 21 and the outer surface of the lancet 4 may be used, or the contact surface may be weakly adhered or fused.

When the base opening 23 is not sealed with a second sealing member to be described later, the lancet 4 before use is fixed near the base opening 23 so as to seal the base opening 23. . The sealing method is basically the same as the lancet 4 described above.
The fixing method is the same as that described above, but specifically, as shown in the drawing, a circumferentially extending convex portion 25 provided on the inner surface of the cylindrical portion 21.
A method for fitting the lancet 4 to the lancet 4 is not limited to this, but is not limited to this. The lancet 4 is fitted to the projection provided on the
A method of keeping the inner surface near the base end and the outer surface near the base end of the lancet 4 in an airtight manner can be used.

The lancet 4 is fitted in the vicinity of the base end of the tubular portion 21 and seals the base end opening 23. Therefore, the lancet 4 has the same cross-sectional shape as that of the tubular portion 21. The same as the housing 2 and the second housing 3 may be used, but it is preferable to use a flexible one among them.

The first housing 2 is sterilized in a state where the lancet 4 is accommodated in the cylindrical portion 21 and the base opening 23 is sealed, or at least the cylindrical portion 21 in which the inside is sterilized. After the sterilized lancet 4 is stored under aseptic conditions, the inside of the tubular portion 21 is maintained in a sealed state until use, thereby maintaining the sterilized state. The sterilization method is not particularly limited.
G sterilization, γ-ray sterilization, electron beam sterilization and the like can be mentioned. The first housing 2 is combined with the second housing 3 to form the assembly 1 after the inside of the tubular portion 21 is maintained in a state capable of maintaining a sterilized state until use as described above.

The material of the first housing 2 is ABS,
Injection molding of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluorine resin, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, etc. Thermosetting resins such as thermoplastic resins, phenol resins, epoxy resins, silicone resins, and unsaturated polyesters are used.

The inside of the cylindrical portion 21 is maintained in a sealed state by sealing the first opening 22 and the base end opening 23. The first opening 22 is sealed by the first sealing member 6. As shown, the first sealing member 6 is in the form of a film, and is fixed to the periphery of the first opening 22 by adhesion or fusion. The first sealing member 6 is preferably in the form of a film so as to be easily adhered or fused and easily peeled off, but may be in the form of a lid or a plug. As described above, the proximal opening 23 is preferably fixed to the lancet 4 and kept in a sealed state, but may be sealed with a second sealing member (not shown) similar to the first sealing member 6. .

The second housing 3 has a second opening 31 and
A test paper 32 is provided as a body fluid component measurement / detection unit. Note that the body fluid component measurement and detection unit is not limited to the test paper, and a medium suitable for the body fluid component measurement unit of the body fluid component measurement device 9 can be used. In the present embodiment, a bodily fluid inlet 33a and a flow path 33 for guiding the bodily fluid from the bodily fluid inlet 33a to the test paper 32 by capillary action are provided on the periphery of the second opening 31. The constituent material of the second housing 3 is the same as that of the first housing 2 described above. However, the body fluid component measuring unit of the body fluid component measuring device 9 is an optical measuring unit that captures a color reaction on a test paper. In some cases, it is desirable to use a non-transparent material to reduce the influence of disturbance light from the viewpoint of measurement accuracy.
The translucent colored resin may be used to confirm the movement of the body fluid.

Although the cross-sectional shape and length of the channel 33 vary depending on the amount of body fluid required for measurement, it is desirable to design the channel 33 so as to reduce the remaining amount of body fluid. Specifically, the cross-sectional shape may be tubular, V-shaped groove, rectangular groove,
A thin rectangular shape is preferable because the remaining amount of body fluid can be reduced. The thickness is about 0.05-0.5mm, the width is 0.5-3m
m is preferable. The length is preferably as short as possible, preferably about 5 mm to 15 mm, depending on the position and arrangement of the body fluid component measuring means 93 of the body fluid component measuring device 9.

The body fluid is supplied to the body fluid inlet 33a of the flow path 33.
In the closed system, the capillary phenomenon may stop halfway and the bodily fluid may not reach the test paper 32 when it is guided from the test paper 32 to the test paper 32. Therefore, it is necessary to vent the air. Specifically, the test paper fixing portion 36 provided in a concave shape on the inner surface of the second housing 3 is provided.
Is desirably a structure as shown in FIG. That is, the test paper 32 is fixed so as to form a gap 39 a between the periphery of the test paper 32 and the periphery of the test paper fixing part 36 and a gap 39 b between one surface of the test paper 32 and the plane of the test paper fixing part 36. In order to achieve this (the state shown in FIG. 4), it is desirable to adopt a structure having the measurement test paper fixing table 38 and the air vent 37 at the flow path test paper side end 33b. The test paper 32 is composed of a measurement test paper fixing table 38 and a flow path test paper side end 3.
3b.

The material of the flow path 33 may be the same as that of the second housing 3, but is preferably a material having high hydrophilicity such as acrylic resin. When the material is not made of an acrylic resin or the like, the surface may be subjected to a hydrophilic treatment to increase the suction force. Examples of the hydrophilic treatment include physical activation treatment such as ozone treatment, plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation, and application of a surfactant, water-soluble silicon, hydroxypropyl cellulose, polyethylene glycol, polypropylene glycol, and the like. And the like. The channel 33 may be formed integrally with the second housing 3 by injection molding, or may be provided integrally with the second housing 3 by notching or pressing the second housing 3. It may be obtained by fixing.

It is desirable to provide a bodily fluid introduction guide section 34 at the edge of the bodily fluid introduction port 33a. Body fluid introduction guide part 3
4 has a function of guiding the body fluid to the body fluid inlet 33a when the body fluid comes in contact therewith. The constituent material is the second housing 3
It may be the same as the channel section 4 and it is desirable that the channel section 33 has been subjected to a hydrophilic treatment like the channel 33. In terms of shape, a large amount of body fluid that cannot be sucked in through the body fluid inlet 33a spreads around the second opening 31 and becomes unsanitary, and the flow path 3
Since the suction force of 3 is reduced and the amount of body fluid required for measurement increases and the burden on the user increases, the body fluid is quickly guided to the body fluid introduction port 33a, and a large amount of body fluid is retained and does not flow out to other parts. Is desirable. Specifically, a rail-shaped guide 34a, b may be provided on both the left and right sides of the periphery of the body fluid inlet 33a so as to protrude.

It is desirable that the internal space of the body fluid introduction guide 34 has a width of about 1 to 3 mm, a height of about 0.5 to 3 mm, and a length of about 1 to 3 mm. This removes body fluids
This is because the size of the droplet when approximately 4 μl is squeezed out is approximately 3 mm, and therefore, it is desirable that the guide has a size equivalent to the maximum required amount of body fluid. It is desirable that the heights of the guides 34a and 34b are substantially the same as the maximum diameter of the body fluid inlet 33a. In addition, two guides 34 shown
In addition to a and b, the cover may cover all four directions of the body fluid introduction port 33a in the up, down, left, and right directions, or may cover the three directions of the bottom, left, and right. The inner surfaces of the two guides 34a, b may not be parallel as shown in the figure, but may be open in a C shape toward the center of the second opening 31.

The puncture needle 41 punctures the body fluid introduction guide 34 near or at the tip thereof. When the required amount of bodily fluid that has flowed out of the puncture position becomes a droplet, the bodily fluid comes into contact with the bodily fluid introduction guide 34 and is guided to the test paper 32 through the flow path 33. The position through which the puncture needle 41 passes is desirably about 3 mm from the distal end of the body fluid introduction guide 34 even if it is far from the point of view of the amount of bodily fluid required for measurement.
mm. When the bodily fluid introduction guide 34 includes the guides 34a and 34b as illustrated, the guide may pass between them.

The second housing 3 is provided with a taper having an angle α from the second opening 31 so as to serve to guide the distal end opening 5 to a puncturing position (for example, a fingertip or a belly). Is desirable. The puncturing position can be applied only to the tip opening 5 and the entire periphery of the puncturing position is not pushed, so that the user can limit the puncturing position by the touch. Is preferably 10 to 45 degrees. The shape may be such that the second opening 31 protrudes from the main body of the second housing 3 instead of the taper having the angle α.

The body fluid component detecting section or test paper 32 is not particularly limited, and a suitable body fluid component measuring means can be selected and used. For example, when the body fluid component measuring means is an optical measuring means that captures the color reaction on the test paper, and when measuring glucose in blood, glucose oxidase, peroxidase as a reagent and a color reagent are impregnated into the test paper. It should be dried. As the test paper, a porous membrane is desirable, and examples of the form include a nonwoven fabric, a woven fabric, and a stretched sheet. Examples of the material include polyesters, polyamides, polyolefins, polysulfones, and celluloses. In addition, since a reagent is impregnated or a body fluid is impregnated, a hydrophilic material or a material subjected to a hydrophilic treatment is preferable.
The test paper may be a single-layer sheet or a multi-layer sheet.

The assembly 1 includes a first housing 2 in which the inside of the cylindrical portion 21 is kept sealed and at least a sterile state of the puncture needle 41 is maintained, and a second housing having the above-described body fluid component measurement / detection section. Are formed so as to form the distal end opening 5, and then the entirety of the protective member 8 is formed.
Is desirably sealed. The form of the protection member 8 is not particularly limited as long as the other structure of the assembly 1 can be sealed. The illustrated form is a sheet-like form, which can be removed from the cut portion 81 by breaking it immediately before use. At this time, the protection member connection portion 61 of the first sealing member 6 is connected to a part of the inner surface of the protection member 8, and if a second sealing member is provided, the protection member connection portion of the second sealing member 6 is connected. Is connected to a part of the inner surface of the protection member 8, thereby removing the protection member 8 and simultaneously removing the first sealing member from the first opening, and further removing the second sealing member from the base opening. can do.

The protective member 8 may be a sheet-shaped member or a hard plastic case. The constituent material of the protective member 8 is not particularly limited. If it is a sheet-like material, it is the same as the first sealing member or the second sealing member described above. The same as the housing and the second housing can be used.

Next, a method of using the assembly 1 will be described. First, when the assembly 1 is sealed with the protection member 8, the protection member 8 is removed, and at the same time, the first sealing member 6 (or the second sealing member when having the second sealing member) is also removed. I do. Next, the assembly 1 is connected to the tip of the body fluid component measuring device 9. At this time, the connection part 42 of the lancet 4 and the puncture mechanism 9
The first concave portion 92 fits and compresses the spring 94 connected to the puncturing means 91. It is desirable that an O-ring 95 or the like be provided at the tip of the body fluid component measuring device 9 in order to increase the fixing force of the connected assembly 1. This completes the preparation before measurement.

The body fluid component measuring device 9 is pressed so that the distal end opening 5 of the assembly 1 hits the puncturing position. Then, the compression of the spring 94 of the button 96 is released, the puncturing means 91 moves in the distal direction, and the lancet 4 is pushed out by the force,
The puncture needle 41 punctures the puncture position. Thereafter, the puncture needle 41 is stored in the assembly 1 by returning the spring 94 to its original length or by being pulled back by another spring (not shown). FIG. 6 shows the state at this time.

After puncturing, when bodily fluid (blood) flows out of the puncturing position, the bodily fluid flows from the bodily fluid introduction guide section 34 to the channel 3.
After that, it is guided to the test paper 32. The body fluid guided to the test paper 32 undergoes a color reaction, and absorbance (or luminescence) is measured by a light-emitting element 93a and a light-receiving element 93b, which are a part of the body fluid component measuring means, to calculate a body fluid component. After a series of operations are completed, the assembly 1 is removed from the tip of the body fluid component measuring device 9. At this time, the lancet 4 and the like can be removed in an integrated state.

A second embodiment of the present invention will be described with reference to the drawings. FIG. 7 shows a cross section of an assembly 101 which is a second example of the embodiment of the present invention. The assembly 101 includes a first housing 102 and a second housing 103. As shown in FIG. 8 which is a cross section of the first housing 102, the first housing 102 has a cylindrical portion 121, and the cylindrical portion 121 has a first opening 122 at a distal end and a proximal opening 123 at a proximal end. The lancet 104 moves inside. As shown in FIG. 9 showing the front surface and FIG. 10 showing the upper surface, the second housing 103 is provided with a second opening 131 and a test paper 132 as a body fluid component measurement / detection unit.

First housing 102 and second housing 1
03 is fixed so that the first opening 122 and the second opening 131 overlap to form the tip opening 105,
An assembly 101 is obtained. The first housing 102 and the second housing 103 are fixed by press-fitting the first housing 102 into the second housing 103. The contact surfaces of the first housing 102 and the second housing 103 are bonded or fused. And the engaging portion may be formed in the first housing 10.
2 and the second housing 103 may be provided and fitted. With this structure, the operator separates the first housing 102 and the second housing 103 separately from each other during use, and the body fluid component measuring device (not shown. This is the same as that of the body fluid component measuring device 9 of the first embodiment). It is possible to set the same as the assembly 101 at the same time. It can be removed from the device.

The first housing 102 has a cylindrical portion 121 in which a movable lancet 104 is housed. The shape of the cylindrical portion 121 may be a cylinder or a square, but a cylinder is preferable because it is structurally easy to manufacture. The lancet 104 has a puncture needle 14 at its tip.
1. At the base end, there is provided a connection portion 142 for connecting to a puncture mechanism (not shown; similar to the puncture mechanism 91) in the body fluid component measuring device. The shape of the connecting portion 142 is not limited to the convex shape shown in the figure, and may be any shape as long as it corresponds to the shape of the puncturing mechanism.
It does not matter if it does not protrude from 23 or protrudes.

The lancet 104 is provided near the base end of the cylindrical portion 121, that is, at least when the puncture needle 141 is
It is fixed at a position where it does not project from 2. It should be noted that this fixing force can be used when the puncture needle 141 does not protrude from the first opening 122 before use and when the puncture mechanism is connected to the connection portion 142 before use. When the puncture mechanism is moved, the puncturing mechanism needs a fixing force enough to release the fixation. The fixing method is not particularly limited, and a locking means may be provided on the inner surface of the cylindrical portion 121 and / or the outer surface of the lancet 104, or a frictional force of a contact surface between the inner surface of the cylindrical portion 121 and the outer surface of the lancet 104 may be used. The contact surface may be weakly adhered or weakly fused.

When the base opening 123 is not sealed with a second sealing member described later, the lancet 104 before use is fixed near the base opening 123 so as to seal the base opening 123. . The method of sealing is basically the same as the method of fixing the lancet 104 described above, but specifically, as shown in the figure, a protrusion 125 provided on the inner surface of the cylindrical portion 21 and extending circumferentially is provided. There is a method of fitting the lancet 104, but not limited thereto, a method of narrowing the vicinity of the base end of the inner surface of the tubular portion 121 and fitting the lancet 104 there,
A method in which the lancet 104 is fitted to a convex portion partially provided on the inner surface of the cylindrical portion 121, and the inner surface near the proximal end of the cylindrical portion 121 and the outer surface near the proximal end of the lancet 104 are airtightly contacted. And so on.

When the assembly 101 is detached from the body fluid component measuring device, since the lancet 104 is connected to the puncturing mechanism of the body fluid component measuring device by the connecting portion 142, the lancet 104 is pulled back in the proximal direction of the first housing 102. I will go. Then, the lancet 104 has the convex portion 1 extending circumferentially.
By fitting and fixing with the means by the above-described fixing / sealing method such as 25, the connecting portion 142 is detached from the puncture mechanism, and the assembly 101 can be finally removed from the body fluid component measuring device. Further, at this time, the puncture needle 141 is firmly fixed to the tubular portion 121 and the tip of the puncture needle 141 does not come out from the second opening 131, so that erroneous puncture after use can be prevented.

The lancet 104 fits near the base end of the cylindrical portion 121 and seals the base end opening portion 123.
21, and the material may be basically the same as the first housing 102 and the second housing 103 described later, and among them, it is preferable to use a material having flexibility.

The first housing 102 is sterilized with the lancet 104 housed inside the cylindrical portion 121 and the base end opening 123 sealed, or at least the cylindrical portion 121 with its interior sterilized. After the sterilized lancet 104 is stored under aseptic conditions inside the cylindrical part 1,
The sterilization state is maintained by maintaining the sealed state of the inside of 21 until use. The sterilization method is not particularly limited, and examples thereof include EOG sterilization, γ-ray sterilization, and electron beam sterilization. The first housing 102 is assembled with the second housing 103 after the inside of the tubular portion 121 is maintained in a sterilized state until use as described above, and forms the assembly 101.

The material of the first housing 102 is AB
Injection of S, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, etc. Thermoplastic resin, phenolic resin, epoxy resin,
Examples include thermosetting properties of silicone resins, unsaturated polyesters, and the like.

The inside of the cylindrical portion 121 is kept in a sealed state by sealing the first opening 122 and the base end opening 123. The first opening 122 is sealed by the first sealing member 106.
It is performed by As shown, the first sealing member 106 has a plug shape, is press-fitted and fixed in the first opening 122, and keeps the inside of the cylindrical portion 121 airtight. In addition,
The first sealing member 106 may be in the form of a lid, or may be in the form of a film so as to be easily adhered or fused and peeled off. As described above, it is desirable that the base end opening portion 123 fixes the lancet 104 and keeps a sealed state, but a second sealing member (not shown) similar to the first sealing member 106.
May be sealed.

The second housing 103 has the second opening 13
1 and a test paper 132 as a body fluid component measurement / detection unit. In the second example, when the test paper 132 is fixed to the first housing 102 to form the assembly 101 as described later, the surface direction of the test paper 132 is substantially parallel to the axial direction of the tubular portion 121. It is provided so that it becomes. In the second example, the test paper 132 is fixed to the second housing 103 in a state where the test paper 132 is combined with the test paper housing 132a. The body fluid component measurement / detection unit is not limited to the test paper, and a medium suitable for a body fluid component measurement unit of the body fluid component measurement device can be used.

The constituent material of the second housing 103 may be the same as that of the first housing 102 described above. However, the humor component measuring means of the humor component measuring device is used for optical measurement for detecting the color reaction on the test paper. In the case of the means, among them, a non-transparent resin is preferable in order to reduce the influence of disturbance light from the viewpoint of measurement accuracy, but a translucent colored resin is used to confirm the movement of the body fluid in the channel 133. But it is good.

In the present embodiment, the second opening 131
The body fluid introduction port 133a and the flow path 133 that guides the body fluid from the body fluid introduction port 133a to the test paper 132 by capillary action are provided on the periphery of. FIG. 12 is an enlarged cross-sectional view taken along line YY of the second housing 103 in FIG. 10 of the second example. As shown in FIG. 12, the flow path 133 is formed such that a flow path 133 c extending from the body fluid introduction port 133 a and a flow path 133 d extending in the axial direction of the second housing 103 intersect at an angle, and further, the flow path 133 d and the test paper 132 The flow path 133e extending in the direction intersects at an angle. In the second example, the flow path 133 is used when the test paper housing 132a and the second housing 3 are combined.
It is created so as to be formed in the gap.

The cross-sectional shape and length of the channel 133 vary depending on the amount of body fluid required for measurement, but it is desirable to design the channel 133 so as to reduce the remaining amount of body fluid. Specifically, the cross-sectional shape may be a tubular shape, a V-shaped groove, or a rectangular groove, but a thin rectangular shape is preferable because the remaining amount of body fluid can be reduced. The thickness is about 0.05-0.5mm and the width is about 0.5.
About 5 to 3 mm is preferable. The length is preferably as short as possible, preferably about 5 mm to 15 mm, depending on the position and arrangement of the body fluid component measuring means of the body fluid component measuring device.

The body fluid is supplied to the body fluid introduction port 13 of the channel 133.
When the liquid is guided from 3a to the test paper 132, in a closed system, the capillary phenomenon may stop halfway and the body fluid may not reach the test paper 132. Therefore, air must be vented. Specifically, it is desirable that the test paper fixing portion 136 provided in a concave shape on the inner surface of the second housing 103 has a structure as shown in FIG. That is, the test paper 132 is fixed so as to form a gap 139 a between the periphery of the test paper 132 and the periphery of the test paper fixing part 136 and a gap 139 b between one surface of the test paper 132 and the plane of the test paper fixing part 136. 12 (the state shown in FIG. 12).
And a structure having an air vent 137 at the flow path test paper side end 133b. The test paper 132 is supported by the measurement test paper fixing stand 138 and the flow path test paper side end 133b.

In the second example, as shown in FIG.
The channel 133 extends from the body fluid introduction port 133a.
3c and the flow path 13 extending in the axial direction of the second housing 103
3d intersects at an angle, and the flow path 133d intersects at an angle with the flow path 133e extending toward the test paper 132. With such a flow path shape, a liquid having a high viscosity such as a body fluid When the fluid flows through the inside of the tube, the surface tension may cause formation of a medium squash on the end face. Therefore, in the second example, the convex portion 135 extending toward the inside of the flow path 133 near the intersection and contacting the meniscus generated near the intersection.
a, It is desirable that a projection 135b extending toward the inside of the flow path 133 be formed on the test paper 132. Convex part 1
The meniscus is eliminated by the surface tension of the projection 35a and the projection 135b.

The material of the flow path 133 may be the same as that of the second housing 103, but a material having high hydrophilicity such as acrylic resin is desirable. When the material is not made of an acrylic resin or the like, the surface may be subjected to a hydrophilic treatment to increase the suction force. Examples of the hydrophilic treatment include physical activation treatment such as ozone treatment, plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation, and application of a surfactant, water-soluble silicon, hydroxypropyl cellulose, polyethylene glycol, polypropylene glycol, and the like. And the like.

It is desirable to provide a body fluid introduction guide section 134 at the edge of the body fluid introduction port 133a. The bodily fluid introduction guide 134 is provided when the bodily fluid comes in contact therewith.
It has the function of guiding body fluid to a. The constituent material may be the same as that of the second housing 103 or the channel portion 133, and it is preferable that the material is subjected to a hydrophilic treatment like the channel 133. In terms of shape, the amount of body fluid that cannot be sucked through the body fluid inlet 133a due to the large amount spreads around the second opening 131 and becomes unsanitary, and the suction force of the flow channel 133 decreases, and the amount of body fluid required for measurement is reduced. Therefore, it is preferable that the body fluid is quickly introduced to the body fluid inlet 133a, a large amount of the body fluid is retained, and the body fluid is not discharged to other parts. Specifically, a guide in which rail-shaped guides 134a and 134b protrude on both the left and right sides of the peripheral edge of the bodily fluid introduction port 133a can be cited. The inner surfaces of the two guides 134a and 134b are
The shape may be open in a C shape toward the center of the second opening 31 or may be parallel, but in order to perform blood suction more reliably and quickly, it is better to open in a C shape. preferable. Further, it is desirable to provide a lower plate for closing the lower side of the bodily fluid inlet 133a. Further, the body fluid introduction guide section 134
As another shape, the guide may cover all four directions, up, down, left, and right of the bodily fluid inlet 133a.

A specific size of the internal space of the body fluid introduction guide 134 is about 1 to 3 mm in width and 0.5 to 3 mm in height.
The length and length are desirably about 1 to 3 mm. This is because, when a body fluid is squeezed out to about 4 μl, the size becomes a drop of about 3 mm. Therefore, it is desirable that the guide has a size equivalent to the maximum necessary body fluid volume. Guide 134a,
The height of b is desirably about the same as the maximum diameter of the body fluid inlet 133a.

The puncture needle 141 penetrates the body fluid introduction guide 134 in the vicinity of or at the tip thereof. When the required amount of bodily fluid that has flowed out of the puncture position becomes a droplet, the bodily fluid comes into contact with the bodily fluid introduction guide 134 and is guided to the test paper 132 through the flow channel 133. The position through which the puncture needle 141 passes is desirably about 3 mm from the distal end of the body fluid introduction guide 134, and more desirably within 1 mm from the distal end, considering the amount of bodily fluid required for measurement.

The second housing 103 is provided with
In order to play the role of guiding the 5 to a puncturing position (for example, a fingertip or a stomach), the vicinity of the second opening 131 may be formed in a curved surface portion 105a corresponding to the vicinity of the puncturing position. In FIG. 9, a curved surface portion 105a similar to that of a finger is provided, whereby the distal opening 105 is depressed, and it is easy to match the puncturing position of the finger with the distal opening 105.

The body fluid component detecting section or test paper 132 is not particularly limited, and a suitable one can be selected and used by the body fluid component measuring means. For example, the body fluid component measuring means is an optical measuring means that captures the color reaction on the test paper,
When measuring glucose in blood, for example, glucose oxidase, peroxidase and a coloring reagent as reagents may be impregnated into test paper and dried. As the test paper, a porous membrane is desirable, and examples of the form include a nonwoven fabric, a woven fabric, and a stretched sheet. Examples of the material include polyesters, polyamides, polyolefins, polysulfones, and celluloses. In addition, since a reagent is impregnated or a body fluid is impregnated, a hydrophilic material or a material subjected to a hydrophilic treatment is preferable.
The test paper may be a single-layer sheet or a multi-layer sheet.
In the case of a multi-layer sheet, it is necessary to bring the respective layers into close contact as shown in the figure.

The assembly 101 includes a first housing 102 in which the inside of the tubular portion 121 is kept sealed and at least a sterile state of the puncture needle 141 is kept, and a second housing having the above-mentioned body fluid component measurement / detection section. And the tip opening 1
After being fixedly formed so as to form 05, it is desirable that the entirety be further sealed by the protection member 108. The form of the protection member 108 is not particularly limited as long as the other configuration of the assembly 101 can be sealed.
The illustrated form is a sheet-like shape, and the notch 18
1 can be removed by tearing immediately before use. In addition,
At this time, the protection member connection part 161 of the first sealing member 106 is connected to a part of the inner surface of the protection member 108, and if a second sealing member is provided, the protection member connection part of the second sealing member is protected. By connecting to a part of the inner surface of the member 108, the protection member 108 is removed, the first sealing member is removed from the first opening, and the second sealing member is further removed from the base opening. Can be.

The protective member 108 may be a hard plastic case other than a sheet-like member. Protective member 1
The constituent material of 08 is not particularly limited, and if it is a sheet-like material, a material similar to the above-described first sealing member or the second sealing member, such as an aluminum-coated film, or a hard plastic case may be used. If there is, the same thing as the first housing and the second housing can be used.

The assembly 101 of the second embodiment can be used in substantially the same manner as the first embodiment.

[0069]

As described above, according to the present invention, while the puncture needle is sterilized and maintained in a sterilized state before use, adverse effects due to sterilization of parts other than the puncture needle, for example, test paper reagents by various sterilization treatments, etc. Provided is an assembly having a lancet that does not cause deterioration of the lancet. With the assembly provided with the lancet of the present invention, measurement can be performed safely because the lancet is maintained in sterility, and furthermore, the body fluid component detection unit such as the lancet and test paper can be simultaneously attached to and detached from the body fluid component measurement device, so that it is easy and easy. Operation can be performed reliably.

[Brief description of the drawings]

FIG. 1 is a sectional view of an assembly 1 which is a first example of an embodiment of the present invention.

FIG. 2 is a cross-sectional view of the first housing 2.

FIG. 3 is a plan view of the second housing 3. FIG.

FIG. 4 is a sectional view taken along line XX of the second housing 3 in FIG. 3;

FIG. 5 is a plan view of a test paper fixing portion 36 (without test paper) of the second housing 3.

FIG. 6 is a cross-sectional view illustrating an example of a usage form of the assembly 1 of the present invention.

FIG. 7 shows an assembly 101 according to a second embodiment of the present invention.
2 shows a cross section of FIG.

FIG. 8 is a cross-sectional view of the first housing 102.

FIG. 9 is a front view of the second housing 103.

10 is a top view of the second housing 103. FIG.

FIG. 11 shows a test paper fixing portion 136 of the second housing 103.
It is a top view (state without a test paper).

FIG. 12 is a sectional view taken along line YY of the second housing 103 in FIG. 10;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1, 101 Assembly 2, 102 First housing 21, 121 Tubular part 22, 122 First opening 23, 123 Base opening 3, 103 Second housing 31, 131 Second opening 32, 132 Test paper 33 133 flow path 34, 134 body fluid introduction guide 4, 104 lancet 41, 141 puncture needle 42, 142 connection part 5, 105 tip opening part 6, 106 first sealing member 61, 161 protection member connection part 8, 108 protection member 9 Body fluid component measuring device 91 Puncture mechanism

Continued on the front page (72) Inventor Naoki Morikawa 1727 Tsukiji Arai, Showa-cho, Nakakoma-gun, Yamanashi Prefecture F-term (reference) in Terumo Corporation 2G045 AA25 BB19 CA25 CA26 DA31 FA11 FB17 GC10 GC15 JA20

Claims (16)

[Claims] An assembly provided with a lancet and a body fluid component detection unit used in connection with a body fluid component measurement device, comprising a puncture needle at a distal end and a connection portion with a puncture mechanism in the body fluid component measurement device at a base end. A lancet, a first opening forming an end opening through which the lancet moves and the puncture needle projects, and a connection portion of the lancet and a puncture mechanism in the body fluid component measuring device. A first housing having a cylindrical portion provided with a base end opening, a body fluid component measuring and detecting unit, and a second having a second opening overlapping with the first opening to form the distal end opening. A housing, and a sealing member that seals the first opening, wherein the first housing has the base end opening near the base end of the cylindrical portion before the lancet moves. Are fixed so as to seal, and sterilized in a state where the first opening is sealed with the sealing member, and the first opening and the second opening are open at the tip. An assembly comprising a lancet and a bodily fluid component detection unit in which the first housing and the second housing are fixed so as to form a part. 2. The assembly provided with a lancet and a body fluid component detecting unit according to claim 1, wherein the entire assembly including the lancet and the body fluid component detecting unit is sealed by a protective member. 3. The lancet and body fluid according to claim 1, wherein the sealing member is connected to the protection member, and the sealing member can be removed from the first opening at the same time as the protection member is removed. An assembly provided with a component detection unit. 4. A set provided with a lancet and a body fluid component detecting unit according to claim 1, wherein the puncture needle is kept in a sterilized state until the sealing member is removed from the first opening. Three-dimensional. 5. The flow path provided in the second housing is such that one flow path and another flow path intersect at an angle, and near the intersection, the flow path faces the interior of the flow path. The assembly provided with the lancet and the body fluid component detection unit according to claim 1, wherein the assembly has a convex portion that extends and contacts a meniscus generated near the intersection. 6. The assembly according to claim 1, further comprising a mechanism for preventing the lancet from dropping after use in the first housing. 7. An assembly comprising a lancet and a body fluid component detecting unit according to claim 1, wherein said falling-off preventing mechanism also functions as a sealing mechanism for said base end opening. 8. An assembly provided with a lancet and a body fluid component detection unit used in connection with a body fluid component measurement device, comprising a puncture needle at a distal end and a connection portion with a puncture mechanism in the body fluid component measurement device at a base end. A lancet, a first opening forming an end opening through which the lancet moves and the puncture needle projects, and a connection portion of the lancet and a puncture mechanism in the body fluid component measuring device. A first housing having a cylindrical portion provided with a base end opening, a body fluid component measurement / detection unit, and a second having a second opening overlapping with the first opening to form the distal end opening. A housing, a first sealing member that seals the first opening, and a second sealing member that seals the base end opening, wherein the first housing is such that the lancet is the cylindrical portion Is stored in the The opening is the first sealing member, the base end opening is sterilized in a state sealed with the second sealing member, and the first opening and the second opening An assembly provided with a lancet and a bodily fluid component detection unit in which the first housing and the second housing are fixed so that a top opening is formed. 9. The assembly according to claim 8, wherein the entire assembly including the lancet is sealed by a protective member. 10. The first sealing member and the second sealing member are connected to the protection member, and the first sealing member is removed from the first opening simultaneously with the removal of the protection member. The assembly provided with the lancet and the body fluid component detecting unit according to claim 8, wherein the second sealing member can be removed from the base end opening. 11. The sterilization state of the puncture needle is maintained until the first sealing member is removed from the first opening and the second sealing member is removed from the base opening. Item 11. An assembly comprising the lancet according to any one of Items 8 to 10 and a body fluid component detection unit. 12. The flow path provided in the second housing is such that one flow path and another flow path intersect at an angle, and near the intersection, the flow path faces the inside of the flow path. The lancet according to any one of claims 8 to 11, wherein the lancet and the body fluid component detecting unit are provided with a convex portion that extends and contacts a meniscus generated near the intersection. 13. An assembly comprising a lancet and a body fluid component detecting unit according to claim 8, wherein a mechanism for preventing a used lancet from falling off is provided in the first housing. 14. A lancet having a puncture needle at the distal end, a lancet provided at a proximal end thereof and a connection portion with a puncture mechanism, and a body fluid component detecting unit, wherein the lancet is sealed and packaged in a sterilized state. And an assembly provided with a body fluid component detection unit. 15. The whole assembly including the lancet and the body fluid component detecting unit is packaged with a protective member.
An assembly comprising the lancet according to claim 4 and a body fluid component detection unit. 16. The lancet according to claim 14, wherein a part of the sealed package of the lancet and a part of the protective member are connected, and the sealed package is removed simultaneously with the removal of the protective member. And an assembly provided with a body fluid component detection unit.