JP7260121B2 - Method for manufacturing bodily fluid collection container and capping device - Google Patents

Description

The present invention relates to a method for manufacturing a bodily fluid collection container. The present invention also relates to a stoppering device used for manufacturing a bodily fluid collection container.

2. Description of the Related Art Bodily fluid collection containers (for example, blood collection tubes) fitted with plugs are widely used to collect bodily fluids such as blood. The plug generally includes a plug body such as a rubber plug and a cap member attached to the plug body.

Such a bodily fluid-collecting container, for example, as shown in Patent Document 1 below, is obtained by inserting the plug body into the inside of the cap member to obtain the plug, and then inserting the obtained plug into the body fluid-collecting container body by vacuum. Produced by capping.

JP-A-11-321986

As a combination of the plug main body and the cap member, a combination in which the maximum diameter of the plug main body is larger than the inner diameter of the open end of the cap member is sometimes used.

However, when the maximum diameter of the plug body is larger than the inner diameter of the open end of the cap member, the plug body is compressed at the open end portion of the cap member when the plug body is inserted into the cap member. and the compressed plug body tends to tilt.

Therefore, when the plug main body and the cap member are capped using a conventional capping device, the cap member is likely to be deformed or damaged, resulting in poor fitting between the plug main body and the cap member. When the plug body and the cap member are capped on the body fluid collection container body using a conventional capping device, the body fluid is obtained by capping the body fluid collection container body with the plug body slightly tilted. The internal pressure of the collection container is likely to change, and the internal pressures of a plurality of bodily fluid collection containers are likely to vary. When liquid is collected using such a body fluid collection container, the amount of liquid collected varies depending on the body fluid collection container.

SUMMARY OF THE INVENTION An object of the present invention is to provide a body fluid collection container capable of suppressing poor fitting between a plug body and a cap member and suppressing variations in the amount of sampled fluid when the obtained body fluid collection container is used to collect fluid. It is to provide a manufacturing method and a capping device.

According to a broad aspect of the present invention, there is provided a method for manufacturing a bodily fluid-collecting container comprising a stopper body including a cap member and a stopper main body, and a bodily fluid-collecting container main body, wherein the cap member has a top plate portion at one end and a top plate portion at the other end. The plug body has a gripping portion and a small diameter portion smaller in diameter than the gripping portion, and the maximum diameter of the plug body is equal to the inner diameter of the open end of the cap member. Using a first jig having a recess on a first surface larger than A second jig having a through hole in which a tapered portion, a small diameter portion, and a large diameter portion having a larger diameter than the small diameter portion are provided in this order. a fitting step of fitting the large-diameter portion of the second jig to the projecting portion of the cap member using a a step of press-fitting into the cap member to obtain a plug body in a state in which the plug body protrudes from the open end of the cap member; and a plug in a state in which the plug body protrudes from the open end of the cap member. a first plugging step comprising both steps of plugging the body into the open end of the body fluid collection container main body; or plugging the plug body into the open end of the body fluid collection container body. and obtaining a connecting body between the bodily fluid-collecting container main body and the plug main body; and a second plugging step comprising both a step of plugging the cap member into the plug main body of the connecting body, wherein the tapered portion of the second jig is the same as the second jig. and the diameter of the small diameter portion of the second jig is smaller than the inner diameter of the open end of the cap member. is provided.

A specific aspect of the method for manufacturing a bodily fluid-collecting container according to the present invention includes the first capping step.

A specific aspect of the method for manufacturing a bodily fluid-collecting container according to the present invention includes the second capping step.

In another specific aspect of the method for manufacturing a bodily fluid-collecting container according to the present invention, the tapered portion of the second jig is 15 degrees or more and 30 degrees with respect to the penetrating direction of the through hole of the second jig. It is tilted at the following tilt angles.

In still another specific aspect of the method for manufacturing a bodily fluid-collecting container according to the present invention, the ratio of the depth of the tapered portion of the second jig to the depth of the small-diameter portion of the second jig is 0.5. It is 75 or more and 3.5 or less.

According to a broad aspect of the present invention, there is provided a plugging device used for attaching a plug body comprising a plug body and a cap member to an open end of a bodily fluid collection container body, the first surface having a concave portion on the first surface. 1 jig, and a second jig having a through hole in which a tapered portion, a small diameter portion, and a large diameter portion having a larger diameter than the small diameter portion are provided in this order, wherein the first jig includes the cap A jig for arranging a member inside the recess so as to protrude with respect to the first surface, and the second jig is a jig for moving the plug body with respect to the through hole. There is provided a plugging device, wherein the taper portion of the second jig is inclined so that the diameter thereof decreases toward the small diameter portion of the second jig.

In a specific aspect of the plugging apparatus according to the present invention, the tapered portion of the second jig has an inclination angle of 15 degrees or more and 30 degrees or less with respect to the penetrating direction of the through hole of the second jig. and is slanted.

In another specific aspect of the plugging apparatus according to the present invention, the ratio of the depth of the taper portion of the second jig to the depth of the small diameter portion of the second jig is 0.75 or more3. 5 or less.

A method for manufacturing a bodily fluid-collecting container according to the present invention is a method for manufacturing a bodily fluid-collecting container including a stopper including a cap member and a stopper main body, and a bodily fluid-collecting container main body. In the method for manufacturing a bodily fluid-collecting container according to the present invention, the cap member has a top plate portion at one end and an open end at the other end, and the stopper body has a grip portion and a diameter larger than that of the grip portion. The maximum diameter of the plug body is greater than the inner diameter of the open end of the cap member. In the method for manufacturing a bodily fluid-collecting container according to the present invention, a first jig having a concave portion on the first surface is used, and the opening end side of the cap member is positioned against the first surface of the first jig. An arranging step is provided for arranging the cap member inside the recess of the first jig so as to protrude. The method for manufacturing a bodily fluid-collecting container according to the present invention uses a second jig having a through hole in which a tapered portion, a small-diameter portion, and a large-diameter portion larger in diameter than the small-diameter portion are provided in this order. 2, a fitting step of fitting the large-diameter portion of the jig to the projecting portion of the cap member. A method for manufacturing a bodily fluid-collecting container according to the present invention includes the following first capping step, or includes the following second first capping step. First plugging step: The plug body is press-fitted into the cap member from the taper portion side of the second jig, and the plug body protrudes from the opening end of the cap member. a step of obtaining a body, and a step of plugging the plug body, in which the plug body protrudes from the open end of the cap member, into the open end of the bodily fluid collection container body. Second plugging step: a step of plugging the plug body onto the open end of the bodily fluid collection container body to obtain a connecting body between the bodily fluid collection container body and the plug body, and the plug body in the connecting body. plugging the cap member into the plug main body of the connector so that the cap member is press-fitted into the cap member from the tapered portion side of the second jig. In the method for manufacturing a bodily fluid-collecting container according to the present invention, the tapered portion of the second jig is inclined so that the diameter becomes smaller toward the small-diameter portion of the second jig, and the tapered portion of the second jig is tapered. The diameter of the small diameter portion of the jig is smaller than the inner diameter of the open end of the cap member. In the method for manufacturing a bodily fluid-collecting container according to the present invention, since the above configuration is provided, it is possible to suppress a fitting failure between the plug main body and the cap member, and when the obtained bodily fluid-collecting container is used to collect fluid, In addition, it is possible to suppress variations in the amount of sampled liquid.

A plugging device according to the present invention is a plugging device used for attaching a plug body comprising a plug body and a cap member to an open end of a bodily fluid collection container main body, wherein the first surface has a concave portion. 1 jig and a second jig having a through hole in which a tapered portion, a small diameter portion, and a large diameter portion larger in diameter than the small diameter portion are provided in this order. In the plugging apparatus according to the present invention, the first jig is a jig for arranging the cap member inside the recess so as to protrude from the first surface, and the second jig is a jig. is a jig for moving the plug body with respect to the through hole. In the plugging apparatus according to the present invention, the taper portion of the second jig is inclined so that the diameter thereof becomes smaller toward the small diameter portion of the second jig. Since the stoppering device according to the present invention has the above configuration, it is possible to suppress the fitting failure between the stopper body and the cap member, and when the obtained body fluid collection container is used to collect the fluid, the Fluctuations in liquid volume can be suppressed.

FIGS. 1(a) and 1(b) are perspective views for explaining a plugging method using a plugging device according to an embodiment of the present invention. 2(a) and 2(b) are respectively a plan view and a cross-sectional view of the first jig. 3(a) and 3(b) are respectively a plan view and a cross-sectional view of the second jig. FIG. 4 is a diagram for explaining the inclination angle of the taper portion of the second jig. 5(a) and 5(b) are cross-sectional views for explaining the arranging step and the fitting step, respectively. 6(a) and 6(b) are cross-sectional views for explaining the step of arranging the plug body at the open end of the tubular body in the first plugging step. 7(a), (b) and (c) are cross-sectional views for explaining the step of obtaining a plug body in a state in which the plug body protrudes from the open end of the cap member in the first plugging step. . FIGS. 8(a) and 8(b) show, in the first plugging step, a step of plugging the plug body, which protrudes from the open end of the cap member, into the open end of the bodily fluid collection container body. FIG. 4 is a cross-sectional view for explanation; 9(a), (b) and (c) are cross-sectional views for explaining the second plugging step. 10(a) and 10(b) are a front view and a front cross-sectional view showing a cap member used in a method for manufacturing a bodily fluid-collecting container and a capping device according to an embodiment of the present invention; 1 is a front cross-sectional view showing a plug body used in a method for manufacturing a bodily fluid-collecting container and a capping device according to an embodiment of the present invention; FIG.

The present invention will be described in detail below.

Hereinafter, specific embodiments of the present invention will be described with reference to the drawings.

First, the cap member and the plug main body used in the method for manufacturing a bodily fluid-collecting container and the capping device according to the present invention will be described.

10(a) and 10(b) are a front view and front cross-sectional view showing a cap member used in the method for manufacturing a bodily fluid-collecting container and the capping device according to one embodiment of the present invention. FIG. 10(c) is a front cross-sectional view showing a plug body used in the method for manufacturing a bodily fluid-collecting container and the capping device according to one embodiment of the present invention.

The cap member 4 has a top plate portion 4a at one end and an open end 4b at the other end. The cap member 4 has a side portion extending downward from the peripheral edge of the top plate portion 4a. The top plate portion 4a has a circular opening 41a in the center. Therefore, the outer shape of the top plate portion 4a is annular.

The cap member 4 has a protrusion 4c on its inner surface. The convex portion 4c is annularly provided on the inner surface of the cap member 4 and is an annular convex portion. By having the projection on the cap member, it is possible to make it difficult for the plug body to come off from the cap member.

The cap member does not have to have a convex portion. Also, a plurality of protrusions may be provided at the same height position on the cap member. When a plurality of protrusions are provided at the same height position on the cap member, the protrusions are different from the annular protrusion.

The cap member 4 has a plurality of ribs 4d protruding radially outward of the cap member 4 on the outer surface of the side portion. Since the cap member has ribs, it is possible to prevent the cap member and the stopper from rolling, thereby improving the handleability.

The plug body 5 has a grip portion (large diameter portion) 5a on one end side and a small diameter portion 5b on the other end side. The diameter of the grip portion 5a is larger than the diameter of the small diameter portion 5b. A step is formed by the grip portion 5a and the small diameter portion 5b. The plug body 5 has a maximum diameter at the grip portion 5a. The plug body 5 has a surface with a recess 51a at one end. That is, the grip portion 5a has a concave portion 51a on its upper surface.

In this specification, the direction connecting the one end (top plate portion 4a) and the other end (opening end 4b) of the cap member 4 is the length direction of the cap member 4. The direction orthogonal to the direction is the radial direction of the cap member 4 . Further, in this specification, the direction connecting the one end and the other end of the plug body 5 is the length direction of the plug body 5, and the direction perpendicular to the length direction of the plug body 5 is the direction of the plug body 5. radial direction.

The maximum diameter of the plug body 5 is larger than the inner diameter of the open end 4b of the cap member 4 before manufacturing the bodily fluid collection container. The maximum diameter of the plug body 5 itself is larger than the inner diameter of the open end 4 b of the cap member 4 .

In the cap member 4, the thickness of the side surface portion at the opening end 4b is the smallest. Therefore, the cap member 4 has the maximum inner diameter at the open end 4b. In the method for manufacturing a bodily fluid-collecting container according to the present invention, even if the cap member 4 has the maximum inner diameter at the open end 4b, it is possible to suppress the fitting failure between the plug main body and the cap member.

Note that the cap member 4 does not have to have the maximum inner diameter at the open end 4b.

The inner diameter of the open end 4b of the cap member 4 is preferably 13 mm or more, more preferably 14 mm or more, preferably 18 mm or less, and more preferably 17 mm or less. When the inner diameter of the open end 4b of the cap member 4 is equal to or more than the lower limit and equal to or less than the upper limit, deformation and breakage of the cap member can be effectively suppressed. It can be used favorably as a stopper for blood collection tubes of various sizes, such as blood collection tubes.

From the viewpoint of improving the handleability of the cap member, the length of the cap member 4 is preferably 11 mm or longer, more preferably 15 mm or longer, preferably 25 mm or shorter, and more preferably 20 mm or shorter.

From the viewpoint of improving the handleability of the cap member, the thickness of the top plate portion 4a of the cap member 4 is preferably 0.5 mm or more, more preferably 1 mm or more, preferably 3 mm or less, and more preferably 2 mm or less. .

From the viewpoint of effectively suppressing deformation and breakage of the cap member, the maximum thickness of the side portion of the cap member 4 is preferably 0.3 mm or more, more preferably 0.4 mm or more, preferably 2 mm or less, and more preferably 1 mm. It is below.

From the viewpoint of effectively suppressing deformation and breakage of the cap member, the maximum diameter of the plug body 5 is preferably 0.1 mm or more, more preferably 0.5 mm or more, than the inner diameter of the open end 4b of the cap member 4. A large size is more preferable, a large size of 3 mm or less is preferable, and a large size of 2 mm or less is more preferable.

From the viewpoint of effectively suppressing deformation and breakage of the cap member, the maximum diameter of the plug body 5 is preferably larger than the minimum inner diameter of the cap member 4 by 0.5 mm or more, and more preferably by 1 mm or more. , preferably 4 mm or less, and more preferably 3 mm or less.

From the viewpoint of enhancing the pierceability of the bodily fluid collection needle, the distance between the lower end of the recess 51a provided on the upper surface of the grip portion 5a and the lower end of the plug body 5 is preferably 3 mm or more and preferably 7 mm or less.

From the viewpoint of effectively suppressing bodily fluid splashing when the bodily fluid sampling needle is pulled out of the plug body, the depth of the concave portion 51a provided on the upper surface of the grip portion 5a is preferably 4 mm or more and preferably 8 mm or less.

Next, a method for manufacturing a bodily fluid-collecting container and a capping device will be described with reference to FIGS. 1 to 9. FIG.

FIGS. 1(a) and 1(b) are perspective views for explaining a plugging method using a plugging device according to an embodiment of the present invention. FIG. 1(a) shows the state during plugging, and FIG. 1(b) shows the state after plugging.

As shown in FIG. 1( a ), the plugging device 10 includes a first jig 1 , a second jig 2 and a rack member 3 . A bodily fluid collection container main body 7 is arranged on the rack member 3 . As will be described later, the first jig 1 has a recess on the first surface (the surface on the side of the second jig 2 in FIG. 1(a)), and the second jig 2 has a tapered portion and a small diameter A portion and a large-diameter portion having a larger diameter than the small-diameter portion have through holes provided in this order. At the time of plugging, the first jig 1 is arranged on the large diameter side of the second jig 2 . At the time of plugging, the rack member 3 is arranged on the taper portion side of the second jig 2 . As will be described later, a cap member and a plug body are arranged inside the first jig 1 and inside the second jig 2, and the first jig 1 and the second jig 2 move downward. As a result, the bodily fluid collection container main body is capped. This plugging is vacuum plugging. After plugging, the second jig 2 moves downward to the surface of the rack member 3 .

As shown in FIG. 1(b), by removing the first jig 1, a bodily fluid-collecting container 20 is obtained in which a stopper 9 comprising a stopper body and a cap member is attached to the open end of the bodily fluid-collecting container main body 7. be able to.

A conventional capping device does not have a second jig. In the present invention, since the second jig having a specific structure is used, even if the maximum diameter of the plug body is larger than the inner diameter of the open end of the cap member, it is possible to suppress the fitting failure between the plug body and the cap member. In addition, variation in the amount of fluid sampled can be suppressed when fluid is sampled using the obtained body fluid-collecting container. Moreover, in general, when the thickness of the cap member is thin, the plug body and the cap member are likely to fit together poorly. Insufficient fitting between the plug body and the cap member can be effectively suppressed.

[First Jig]
2(a) and 2(b) are respectively a plan view and a cross-sectional view of the first jig. FIG. 2(b) is a cross-sectional view taken along line AA in FIG. 2(a).

The first jig 1 has a recess 11a on the first surface 1a. The first jig 1 is a jig for arranging the cap member inside the recess 11a so as to protrude from the first surface 1a. The first jig 1 is a jig for arranging the opening end side of the cap member so as to protrude from the first surface 1a.

The first jig 1 has a cylindrical recess 11a on the first surface. The first jig 1 has 24 recesses 11a on the first surface 1a. The number of recesses in the first jig is not particularly limited. The number of recesses in the first jig is preferably plural. The larger the number of recesses, the more bodily fluid-collecting containers can be manufactured at the same time.

The shape of the recess of the first jig is not particularly limited as long as the cap member can be arranged inside the recess. The shape of the concave portion of the first jig may be a polygonal prism shape.

The diameter and depth of the concave portion of the first jig can be appropriately changed according to the size of the cap member. When the concave portion of the first jig has a polygonal prismatic shape, the diameter of the concave portion of the first jig means the diameter of a circle inscribed in the polygon in the polygonal columnar shape.

The diameter of the recess 11a is preferably larger than the maximum outer diameter of the cap member.

The diameter of the concave portion 11a of the first jig 1 is preferably larger than the maximum outer diameter of the cap member by 0.1 mm or more, more preferably by 0.5 mm or more, and preferably by 1.5 mm or less. It is preferably 1.0 mm or less, and more preferably as large as possible. When the diameter of the recessed portion 11a of the first jig 1 is equal to or greater than the above lower limit, the cap member can be satisfactorily arranged inside the recessed portion 11a of the first jig 1 . When the diameter of the concave portion 11a of the first jig 1 is equal to or less than the above upper limit, it is possible to effectively prevent the cap member from wobbling after the cap member is placed inside the concave portion 11a of the first jig 1.

The depth of the concave portion 11a of the first jig 1 is preferably 5 mm or more, more preferably 7 mm or more, preferably 20 mm or less, and more preferably 15 mm or less. When the depth of the recessed portion 11a of the first jig 1 is equal to or greater than the above lower limit, the cap member can be satisfactorily arranged inside the recessed portion 11a of the first jig 1 . When the depth of the concave portion 11a of the first jig 1 is equal to or less than the upper limit, it is possible to effectively suppress the cap member from wobbling after the cap member is placed inside the concave portion of the first jig.

The ratio of the depth of the recess 11a of the first jig 1 to the length of the cap member (depth of the recess of the first jig/length of the cap member) is preferably 0.25 or more, more preferably 0. 0.3 or more, preferably less than 1, more preferably 0.75 or less. When the ratio (depth of the concave portion of the first jig/length of the cap member) is equal to or greater than the lower limit, the cap member can be favorably arranged inside the concave portion of the first jig. When the ratio (depth of the recess of the first jig/length of the cap member) is equal to or less than the upper limit (or less than the upper limit), the cap member is placed inside the recess of the first jig. Wobble of the cap member can be effectively suppressed.

The direction orthogonal to the depth direction of the recess 11a of the first jig 1 is the radial direction of the recess 11a.

[Second Jig]
3(a) and 3(b) are respectively a plan view and a cross-sectional view of the second jig. FIG. 3(b) is a cross-sectional view taken along line AA in FIG. 3(a).

The second jig 2 has a through hole 21 . The through hole 21 is a hole passing through the first surface 2a and the second surface 2b of the second jig 2, and has a tapered portion 21a, a small diameter portion 21b, and a large diameter portion 21c. The diameter of the large diameter portion 21c is larger than the diameter of the small diameter portion 21b. In the through hole 21, the tapered portion 21a is a substantially truncated cone-shaped hole, the small diameter portion 21b is a substantially cylindrical hole, and the large diameter portion 21c is a substantially cylindrical hole.

The through hole 21 is provided with a tapered portion 21a, a small diameter portion 21b, and a large diameter portion 21c in this order. A tapered portion 21a is provided on the second surface b side of the second jig 2, a large diameter portion 21c is provided on the first surface a side of the second jig 2, and the tapered portion 21a and the large diameter portion 21c are provided. A small diameter portion 21b is provided between.

The second jig 2 is a member for moving the plug body with respect to the through hole 21 . More specifically, the second jig 2 is a jig for moving the plug body with respect to the through hole 21 from the tapered portion 21a toward the large diameter portion 21c. A cap member is accommodated in a space defined by the recessed portion 11a of the first jig 1 and the large diameter portion 21c of the second jig 2. As shown in FIG. The plug main body moved with respect to the through-hole 21 is press-fitted inside the cap member accommodated in the space.

The tapered portion 21a of the second jig 2 is inclined so that the diameter becomes smaller toward the small diameter portion 21b of the second jig 2 . Therefore, the tapered portion 21 a has the maximum diameter on the second surface b of the second jig 2 .

The second jig 2 has 24 through holes 21 . The number of through holes in the second jig is not particularly limited. The number of through holes in the second jig is preferably plural. The larger the number of through-holes, the more bodily fluid-collecting containers can be manufactured at the same time.

In this specification, the direction orthogonal to the through hole 21 (tapered portion 21a, small diameter portion 21b, and large diameter portion 21c) of the second jig 2 is the through hole 21 (tapered portion 21a, small diameter portion 21b). and the radial direction of the large diameter portion 21c).

The maximum diameter of the tapered portion 21 a of the second jig 2 may be larger or smaller than the diameter of the large diameter portion 21 c of the second jig 2 .

The maximum diameter of the taper portion 21 a of the second jig 2 is preferably larger than the maximum diameter of the plug body 5 .

The maximum diameter of the tapered portion 21a of the second jig 2 is preferably larger than the maximum diameter of the plug body by 0.5 mm or more, more preferably by 1 mm or more, preferably by 4 mm or less, and 3 mm. It is more preferable that it is greater than or equal to. When the maximum diameter of the tapered portion 21a of the second jig 2 is equal to or more than the lower limit and equal to or less than the upper limit, the plug body can be arranged satisfactorily.

The maximum diameter of the tapered portion 21a of the second jig 2 is preferably 16 mm or more, more preferably 18 mm or more, preferably 22 mm or less, and more preferably 20 mm or less. When the maximum diameter of the tapered portion 21a of the second jig 2 is equal to or more than the lower limit and equal to or less than the upper limit, the plug body can be arranged satisfactorily, and a fitting failure between the plug body and the cap member can be suppressed. can.

The diameter of the large-diameter portion 21 c of the second jig 2 is larger than the maximum outer diameter of the cap member 4 .

The diameter of the large-diameter portion 21c of the second jig 2 is preferably larger than the maximum outer diameter of the cap member 4 by 0.1 mm or more, more preferably by 0.5 mm or more, and 1.5 mm or less. A large size is preferable, and a large size of 1.0 mm or less is more preferable. In this case, wobbling of the cap member can be effectively suppressed.

The diameter of the large diameter portion 21 c of the second jig 2 is larger than the diameter of the small diameter portion 21 b of the second jig 2 .

The diameter of the large-diameter portion 21c of the second jig 2 is preferably larger than the diameter of the small-diameter portion 21b of the second jig 2 by 0.5 mm or more, more preferably by 1 mm or more, and 4 mm or less. A large size is preferable, and a large size of 3 mm or less is more preferable. In this case, wobbling of the cap member can be effectively suppressed.

The diameter of the large-diameter portion 21c of the second jig 2 is preferably 16 mm or more, more preferably 17 mm or more, preferably 22 mm or less, and more preferably 20 mm or less. When the diameter of the large-diameter portion 21c of the second jig 2 is equal to or greater than the lower limit and equal to or less than the upper limit, deformation and breakage of the cap member can be effectively suppressed.

The diameter of the small diameter portion 21b of the second jig 2 is smaller than the inner diameter of the open end 4b of the cap member 4 .

The diameter of the small-diameter portion 21b of the second jig 2 is preferably 0.1 mm or more smaller than the inner diameter of the open end 4b of the cap member 4, more preferably 0.3 mm or more, and 1 mm or less. is preferred, and it is more preferred to be as small as 0.8 mm or less. In this case, when the plug body 5 moves from the small-diameter portion 21b of the second jig 2 to the opening end 4b of the cap member 4, the inclination of the plug body 5 can be effectively suppressed, and deformation of the cap member can be prevented. And breakage can be effectively suppressed.

The diameter of the small diameter portion 21 b of the second jig 2 is smaller than the maximum diameter of the plug body 5 .

The small diameter portion 21b of the second jig 2 is preferably smaller than the maximum diameter of the plug body 5 by 0.5 mm or more, more preferably by 1 mm or more, preferably by 3 mm or less, and 2 mm or less. Smaller is more preferred. In this case, the plug body 5 can be effectively deformed, and deformation and breakage of the cap member can be effectively suppressed.

The diameter of the small diameter portion 21b of the second jig 2 is preferably 13 mm or more, more preferably 14.5 mm or more, preferably 18 mm or less, and more preferably 16.5 mm or less. When the diameter of the small-diameter portion 21b of the second jig 2 is equal to or greater than the lower limit and equal to or less than the upper limit, deformation and breakage of the cap member can be effectively suppressed.

FIG. 4 is a diagram for explaining the inclination angle of the taper portion of the second jig.

FIG. 4 shows a cross-sectional view of the second jig 2, showing an enlarged view of one through-hole portion of the second jig 2. As shown in FIG.

In FIG. 4 , P is the penetrating direction of the through hole 21 of the second jig 2 , and Q is the inclination direction of the taper portion 21 a of the second jig 2 . The inclination angle θ of the tapered portion 21 a of the second jig 2 is an angle at which the tapered portion 21 a of the second jig 2 is inclined with respect to the penetrating direction P of the through hole 21 of the second jig 2 . As shown in FIG. 4, the inclination angle .theta. means the smaller one of the angles formed by the straight line in the penetrating direction P and the inclination direction Q of the tapered portion. Therefore, the maximum value of the tilt angle θ is 90 degrees. The inclination angle is 0 degrees when the tapered portion is not inclined. In the present invention, the tilt angle θ is greater than 0 degrees and less than 90 degrees.

It is preferable that the tapered portion 21a is inclined at an inclination angle θ of 15 degrees or more, and is inclined at an inclination angle θ of 18 degrees or more with respect to the penetration direction P of the through hole 21 of the second jig. is more preferably inclined at an inclination angle θ of 30 degrees or less, and more preferably at an inclination angle θ of 25 degrees or less. When the inclination angle θ is equal to or greater than the lower limit and equal to or less than the upper limit, deformation and breakage of the cap member can be effectively suppressed.

In FIG. 4, X is the depth of the tapered portion 21a, Y is the depth of the small diameter portion 21b, and Z is the depth of the large diameter portion 21c. The depth direction of the tapered portion 21 a , the small diameter portion 21 b and the large diameter portion 21 c corresponds to the through direction P of the through hole 21 of the second jig 2 .

The ratio of the depth X of the taper portion 21a of the second jig 2 to the depth Y of the small diameter portion 21b of the second jig 2 (depth X of the taper portion 21a/depth Y of the small diameter portion 21b) is preferably is 0.75 or more, more preferably 1.3 or more, preferably 3.5 or less, more preferably 2.5 or less. When the ratio (depth X of tapered portion 21a/depth Y of small diameter portion 21b) is equal to or more than the lower limit and equal to or less than the upper limit, it is possible to effectively suppress fitting failure between the plug main body and the cap member.

The ratio of the depth X of the taper portion 21a of the second jig 2 to the depth Z of the large diameter portion 21c of the second jig 2 (depth X of the taper portion 21a/depth Z of the large diameter portion 21c) is , preferably 0.2 or more, more preferably 0.3 or more, preferably 1.4 or less, more preferably 1 or less. When the ratio (depth X of tapered portion 21a/depth Z of large diameter portion 21c) is equal to or greater than the lower limit, movement of the second jig can be effectively suppressed during the plugging process. When the ratio (depth X of tapered portion 21a/depth Z of large diameter portion 21c) is equal to or less than the upper limit, it is possible to effectively suppress poor fitting between the plug main body and the cap member.

The sum of the depth of the concave portion 11a of the first jig 1 and the depth Z of the large-diameter portion 21c of the second jig is preferably greater than the length of the cap member 4. The sum of the depth of the concave portion 11a of the first jig 1 and the depth Z of the large-diameter portion 21c of the second jig is preferably longer than the length of the cap member 4 by 0.1 mm or more, and is preferably 0.3 mm or more. , preferably 2 mm or less longer than the length of the cap member 4, and more preferably 1 mm or less longer than the length of the cap member 4 . In this case, it is possible to effectively prevent a fitting failure between the plug body and the cap member.

[Rack material]
Preferably, the capping device comprises a rack member. The rack member is a member for arranging the bodily fluid collection container main body. A conventionally known rack member can be used as the rack member.

Next, with reference to FIGS. 5 to 9, the manufacturing method of the bodily fluid-collecting container and the capping device will be described in further detail.

[Placement process]
A method for manufacturing a bodily fluid-collecting container according to the present invention includes the following placement step.

FIG. 5A is a cross-sectional view for explaining the placement process.

In FIG. 5(a), one concave portion 11a portion of the first jig 1 is shown enlarged.

As shown in FIG. 5A, in the placement step, a first jig 1 having a concave portion 11a on the first surface 1a is used, and the opening end 4b side of the cap member 4 is placed on the first jig 1 side. A cap member 4 is arranged inside the recess 11a of the first jig 1 so as to protrude from the surface 1a. In the arrangement step, the cap member 4 is arranged inside the recess 11 a of the first jig 1 so that the top plate portion 4 a side of the cap member 4 is on the bottom surface side of the recess 11 a of the first jig 1 .

[Mating process]
A method for manufacturing a bodily fluid-collecting container according to the present invention includes a fitting step described below.

FIG.5(b) is sectional drawing for demonstrating a fitting process.

In FIG. 5B, one concave portion 11a portion of the first jig 1 and one through hole 21 portion of the second jig 2 are shown enlarged.

As shown in FIG. 5(b), in the fitting step, a second jig 2 having a through hole 21 in which a tapered portion 21a, a small diameter portion 21b, and a large diameter portion 21c are provided in this order is used. 2, the large-diameter portion 21c of the jig 2 is fitted to the projecting portion of the cap member 4. As shown in FIG. After the fitting step, the cap member 4 is accommodated in the space formed by the recess 11a of the first jig 1 and the large diameter portion 21c of the second jig 2. As shown in FIG.

[Capping process]
The method for manufacturing a bodily fluid-collecting container according to the present invention includes the following first capping step or the following second capping step as the capping step. In the plugging step (first plugging step and second plugging step), the plug body is press-fitted from the tapered portion of the second jig into the cap member to form a bodily fluid collection container. It is a process of obtaining

<First plugging step>
The first plugging step is a step including both steps (1) and (2) below. (1) A step of press-fitting the second jig from the tapered portion side into the inside of the cap member to obtain a plug body in a state in which the plug body protrudes from the open end of the cap member (hereinafter referred to as a press-fitting step). (1A)). (2) A step of plugging the opening end of the bodily fluid-collecting container body with the plug body protruding from the opening end of the cap member (hereinafter sometimes referred to as a plugging step (1A)).

As a result, the plug including the plug body and the cap member can be attached to the open end of the body fluid-collecting container body, and the body fluid-collecting container includes the plug body including the cap member and the plug body and the body fluid-collecting container body. Obtainable. In the first plugging step, the number of times of plugging is one.

6 to 8 are cross-sectional views for explaining the first plugging step.

Press-fitting step (1A):
In the press-fitting step (1A), the plug body before being press-fitted into the cap member is preferably arranged at the open end of the tubular body.

6(a) and 6(b) are cross-sectional views for explaining the step of arranging the plug body at the open end of the tubular body in the first plugging step.

In FIG. 6(a), the plug body 5 is arranged in the through hole 30a of the plate member 30 having the through hole 30a. The through hole 30a is a cylindrical hole. The diameter of the through hole 30a is smaller than the diameter of the grasping portion of the plug body 5 and larger than the diameter of the small diameter portion. Also, the diameter of the through hole 30 a is larger than the outer diameter of the tubular body 40 . The tubular body 40 is different from the body fluid collection container main body.

The tubular body 40 is arranged on the rack member 50 . The inner diameter of the open end 40a of the tubular body 40 is smaller than the diameter of the grip portion of the stopper body and larger than the diameter of the small diameter portion. The inner diameter of the open end 40a of the tubular body 40 is such that the small-diameter portion of the plug body 5 can be inserted into the open end 40a without the plug body 5 being press-fitted.

The through hole 30a of the plate-like member 30 and the open end 40a of the tube 40 are opposed to each other, and the plate-like member 30 on which the plug main body 5 is arranged is moved downward, as shown in FIG. 6(b). The plug body 5 can be placed at the open end 40a of the tubular body 40 at the same time.

The step of arranging the plug main body at the opening end of the tubular body in the first capping step may be performed before the arranging step, may be performed after the arranging step, or may be performed in the fitting step. may be performed before or after the fitting step.

7(a), (b) and (c) are cross-sectional views for explaining the step of obtaining a plug body in a state in which the plug body protrudes from the open end of the cap member in the first plugging step. .

In FIG. 7A, one through-hole 21 portion of the second jig 2 and the like are shown enlarged.

As shown in FIG. 7A, in the structure of the first jig 1, the second jig 2, and the cap member 4 obtained in the fitting step, the tapered portion 21a of the second jig 2 and the tubular body The stopper body 5 arranged at the open end of the 40 is opposed to the stopper body 5, and the structure is moved downward to arrange the grasping part 5a of the stopper body 5 inside the tapered part 21a of the second jig 2. .

Next, as shown in FIG. 7(b), by moving downward the structure consisting of the first jig 1, the second jig 2 and the cap member 4, the tip 51b of the small diameter portion 5b of the plug body 5 is The plug body 5 is press-fitted into the cap member 4 from the tapered portion 21 a of the second jig 2 to a position where the top plate portion is not located relative to the opening end 4 b of the cap member 4 . For example, by installing and operating an air cylinder in the press-fitting direction, the structure of the first jig 1, the second jig 2, and the cap member 4 can be moved downward to a predetermined position.

Thus, as shown in FIG. 7(c), it is possible to obtain a plug in which the plug main body 5 protrudes from the open end 4b of the cap member 4. As shown in FIG. The plug with the plug main body 5 protruding from the opening end 4b of the cap member 4 is housed inside the first jig 1 and the second jig 2 . In the plug body in which the plug body 5 protrudes from the opening end 4b of the cap member 4, the tip 51b of the plug body 5 may be present inside or outside the tapered portion 21a.

The plug body 5 has a concave portion 51a in the grip portion 5a. In the press-fitting step ( 1 A), since the plug body 5 has the concave portion 51 a , the plug body can be effectively deformed when passing through the small diameter portion 21 b of the second jig 2 .

In the press-fitting step ( 1 A), first, the plug body 5 passes through the tapered portion 21 a of the second jig 2 . Since the plug body 5 is gradually compressed when passing through the tapered portion 21a, the plug body 5 is less likely to tilt. Next, the plug body 5 passes through the small diameter portion 21b of the second jig. The plug body 5 is further compressed when passing through the small diameter portion 21b, and a force is generated from the inside to the outside. However, while the plug body 5 is passing through the small diameter portion 21b, the force directed from the inside to the outside is alleviated to some extent. Next, the plug main body 5 reaches the opening end 4b of the cap member 4, and the tip 51b of the small diameter portion 5b of the plug main body 5 is closer to the top plate than the opening end 4b of the cap member 4. It is press-fitted inside the cap member 4 until it is not positioned. The plug body 5 can be easily inserted straight into the cap member 4, and the force directed from the inside to the outside is relieved to some extent while the plug body 5 is passing through the small-diameter portion 21b. In spite of using the plug body and the cap member having a larger diameter than the opening end 4b of the cap member 4, it is possible to suppress fitting failure between the plug body and the cap member.

Plugging step (1A):
FIGS. 8(a) and 8(b) show, in the first plugging step, a step of plugging the plug in a state in which the plug body protrudes from the open end of the cap member into the open end of the bodily fluid collection container body ( FIG. 10 is a cross-sectional view for explaining the plugging step (1A)).

In FIG. 8( a ), the bodily fluid collection container main body 7 is arranged on the rack member 3 . The rack member 3 is placed on the mounting surface. A serum or plasma separation composition 8 is accommodated in the bottom of the body fluid collection container main body 7 .

As shown in FIG. 8( a ), the plug with the plug main body 5 protruding from the open end 4 b of the cap member 4 is plugged into the open end of the bodily fluid collection container main body 7 . The tapered portion 21a of the second jig 2 in the structure of the first jig 1, the second jig 2, the cap member 4 and the plug body 5 is opposed to the open end of the body fluid collection container body 7, and the By moving the structure downward, it can be plugged.

After plugging, the second jig moves downward under its own weight.

By removing the first jig 1, the second jig 2 and the rack member 3 after the capping, the bodily fluid collection container 20 shown in FIG. 8(b) can be obtained. The body fluid collection container 20 includes a stopper 9 having a cap member 4 and a stopper body 5, and a body fluid collection container body 7. The body fluid collection container body 7 contains a composition 8 for separating serum or plasma. The bodily fluid collection container 20 is a blood collection container and a blood collection tube.

The capping in the capping step (1A) is preferably vacuum capping.

In the method for manufacturing a bodily fluid-collecting container comprising the arranging step, the fitting step, and the first plugging step, the plug body and the cap member are simultaneously capped at the open end of the bodily fluid-collecting container body. The number of times of vacuum plugging is one. Therefore, the manufacturing time can be shortened as compared with the manufacturing method of the bodily fluid-collecting container including the arranging step, the fitting step, and the second capping step.

In the method for manufacturing a bodily fluid-collecting container comprising the arranging step, the fitting step, and the first plugging step, the maximum diameter of the plug body is larger than the inner diameter of the open end of the cap member. In addition, even if the plug body and the cap member are plugged at the same time, it is possible to suppress a fitting failure between the plug body and the cap member. In addition, since the stopper is slanted and capped at an extremely low frequency, the internal pressure of the bodily fluid-collecting container obtained is unlikely to change, and when the bodily fluid-collecting container is used to collect fluid, variations in the amount of collected fluid can be suppressed. can be done.

<Second capping step>
The second plugging step is a step including both steps (1′) and (2′) below. (1′) A step of plugging the plug main body into the opening end of the bodily fluid-collecting container main body to obtain a connecting body between the bodily fluid-collecting container main body and the plug main body (hereinafter referred to as plugging step (2A)). Sometimes). (2′) plugging the cap member into the plug main body of the connecting body so that the plug main body of the connecting body is press-fitted into the cap member from the tapered portion side of the second jig; A step (hereinafter sometimes referred to as a plugging step (2B)).

As a result, the plug including the plug body and the cap member can be attached to the open end of the body fluid-collecting container body, and the body fluid-collecting container includes the plug body including the cap member and the plug body and the body fluid-collecting container body. Obtainable. In the second plugging process, the number of times of plugging is two.

9(a), (b) and (c) are cross-sectional views for explaining the second plugging step.

Plugging step (2A):
In the plugging step (2A), as shown in FIG. 9A, the plug body 5 is plugged into the open end of the body fluid collection container body 7 to form a connecting body between the body fluid collection container body 7 and the plug body 5. obtain. The plugging in the plugging step (2A) is plugging without using the first jig and the second jig. FIG. 9(a) shows the plug main body 5 and the bodily fluid-collecting container main body 7 (the connecting body between the bodily fluid-collecting container main body 7 and the plug main body 5) after being capped. The rack member 3 is placed on the mounting surface. A connecting body between the bodily fluid collection container main body 7 and the plug main body 5 is arranged on the rack member 3 . A serum or plasma separation composition 8 is accommodated in the bottom of the body fluid collection container main body 7 .

As a method for capping the body fluid-collecting container main body 7 with the plug main body 5, a conventionally known capping method can be used. The capping in the capping step (2A) is preferably vacuum capping.

The plugging step (2A) may be performed before the arranging step, after the arranging step, or before the fitting step. may be done after

Plugging step (2B):
In the plugging step (2B), as shown in FIG. 9B, the plug body 5 in the connecting body between the body fluid-collecting container body 7 and the plug body 5 obtained in the plugging step (2A) is replaced with the second The cap member 4 is plugged onto the plug main body 5 of the connector so that the cap member 4 is press-fitted from the tapered portion 21a side of the jig 2 to the inside of the cap member 4 . Specifically, the cap member 4 (FIG. 5(b)) accommodated in the space formed by the concave portion 11a of the first jig 1 obtained in the fitting step and the large diameter portion 21c of the second jig 2. ) is plugged into the plug main body 5 in the connecting body between the bodily fluid collection container main body 7 and the plug main body 5 . The tapered part 21a of the second jig 2 in the structure of the first jig 1, the second jig 2 and the cap member 4 (FIG. 5(b)) and the opening end of the bodily fluid collection container main body 7 are plugged. The cap member 4 can be attached to the plug body 5 at the connecting body between the bodily fluid collection container body 7 and the plug body 5 by facing the plug body 5 and moving the structure downward. In the capping step (2B), a cap member is further capped on the plug main body capped in the capping step (2A).

After plugging, the second jig moves downward under its own weight.

In the plugging step ( 2 B), first, the plug body 5 passes through the tapered portion 21 a of the second jig 2 . Since the plug body 5 is gradually compressed when passing through the tapered portion 21a, the plug body 5 is less likely to tilt. Next, the plug body 5 passes through the small diameter portion 21 b of the second jig 2 . The plug body 5 is further compressed when passing through the small diameter portion 21b, and a force is generated from the inside to the outside. However, while the plug body 5 is passing through the small diameter portion 21b, the force directed from the inside to the outside is alleviated to some extent. Next, the plug body 5 reaches the open end 4b of the cap member 4, and the plug body 5 is press-fitted to the inside of the cap member 4. As shown in FIG. The plug body 5 can be easily inserted straight into the cap member 4, and the force directed from the inside to the outside is relieved to some extent while the plug body 5 is passing through the small-diameter portion 21b. In spite of using the plug body and the cap member having a larger diameter than the opening end 4b of the cap member 4, it is possible to suppress fitting failure between the plug body and the cap member.

By removing the first jig 1, the second jig 2 and the rack member 3 after capping, the bodily fluid collection container 20 shown in FIG. 9(c) can be obtained. The body fluid collection container 20 includes a stopper 9 having a cap member 4 and a stopper body 5, and a body fluid collection container body 7. The body fluid collection container body 7 contains a composition 8 for separating serum or plasma. The bodily fluid collection container 20 is a blood collection container and a blood collection tube.

The capping in the capping step (2B) is preferably vacuum capping.

In the method for manufacturing a bodily fluid-collecting container comprising the arranging step, the fitting step, and the second capping step, the capping step (2A) and the capping step (2B) are performed. was performed, and the number of times of vacuum plugging was two.

In the method for manufacturing a bodily fluid-collecting container comprising the arranging step, the fitting step, and the second plugging step, the bodily fluid-collecting container is obtained by previously plugging the body fluid-collecting container body with the plug main body. can be made difficult to change the internal pressure of. In addition, even if the cap member is driven into the plug body despite the fact that the maximum diameter of the plug body is larger than the inner diameter of the open end of the cap member, the fitting failure between the plug body and the cap member is suppressed. be able to. In addition, since the stopper tilts very infrequently, the internal pressure of the bodily fluid-collecting container obtained is less likely to change, and when the bodily fluid-collecting container is used to collect fluid, variations in the amount of collected fluid can be suppressed.

(other details)
The material of the cap member is preferably resin. Only one kind of the above resin may be used, or two or more kinds thereof may be used.

Examples of the resin include polyethylene, polypropylene, polyester, polycarbonate, and the like.

The same material or different materials may be used for the top plate portion, the side surface portion, the convex portion, and the ribs that constitute the cap member. From the viewpoint of facilitating molding, it is preferable that the same material is used for the top plate portion, the side surface portions, the protrusions, and the ribs.

The material of the plug body is preferably an elastomer. If the material of the plug body is an elastomer, the plug body can be well deformed when passing through the tapered portion and the small diameter portion of the second jig. Only one kind of material for the stopper body may be used, or two or more kinds thereof may be used in combination.

Examples of the elastomer include thermosetting elastomers and thermoplastic elastomers. Examples of the thermosetting elastomer include isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene copolymer rubber, and the like. Examples of the thermoplastic elastomer include styrene-based elastomers.

When the material of the plug body is the elastomer, the plug body is a rubber plug. The stopper body is preferably a rubber stopper.

Materials for the first jig and the second jig include polyethylene, polypropylene, polyvinyl chloride, polycarbonate, acrylic resin, polytetrafluoroethylene, and the like. Only one kind of material may be used for each of the first jig and the second jig, or two or more kinds thereof may be used in combination. Moreover, the materials of the first jig and the second jig may be the same or different.

The material of the first jig is preferably polyethylene, polyvinyl chloride, polycarbonate, or polytetrafluoroethylene because of its excellent strength.

The material of the second jig is preferably polyethylene, polyvinyl chloride, polycarbonate, or polytetrafluoroethylene, more preferably polytetrafluoroethylene, because of its excellent strength and slipperiness.

Examples of the bodily fluid collection container include blood collection containers such as blood collection tubes. Examples of the blood collection tube include a 5 cc blood collection tube, a 7 cc blood collection tube, a 10 cc blood collection tube, and the like.

EXAMPLES The present invention will be described in more detail below with reference to examples. The invention is not limited only to the following examples.

(Example 1)
Fabrication of the cap member:
A resin composition (polyethylene) was injected into a mold having the cap member dimensions shown below and molded to produce a cap member having the shape shown in FIG.

Length: 20mm
Top plate thickness: 1.6 mm, side thickness: 0.4 mm
Inner diameter of open end: 16.5mm
Minimum inner diameter: 15.5mm
Maximum outer diameter: 17.2mm
Rib length: 17 mm, rib height: 0.1 mm
Height of annular protrusion: 0.2 mm Width of annular protrusion: 1.8 mm Distance between annular protrusion and top plate 6 mm

Plug body:
A rubber stopper (material: butyl rubber) having the shape shown in FIG. 10 and the dimensions shown below was prepared.

Maximum diameter (maximum diameter of grip): 17mm
Diameter of small diameter part (maximum diameter of small diameter part): 14.2 mm
Depth of recess: 5 mm

Bodily fluid collection container body:
A PET tube (polyethylene terephthalate tube) having an inner diameter of 13.5 mm at the open end was prepared.

Body:
A PET tube (polyethylene terephthalate tube) having an inner diameter of 14.3 mm at the open end was prepared.

Plate-like member:
A plate-like member having 100 through-holes (inner diameter: 16.2 mm) (the cross-sectional outline is shown in FIG. 6A) was prepared.

Fabrication of the first jig:
A resin composition (polycarbonate) was injected into a mold having the following first jig dimensions and molded to prepare a first jig having the shape shown in FIG. .

Diameter of recess: 18.0 mm Depth of recess: 11 mm Number of recesses: 100

Fabrication of the second jig:
A resin composition (polytetrafluoroethylene) was injected and molded into a mold having the second jig dimensions shown below, and the shape shown in FIG. 3 (however, the number of through holes was 100) No. 2 jig was produced.

Maximum diameter of taper part: 19 mm, depth X of taper part: 5 mm, inclination angle θ of taper part: 20 degrees Diameter of small diameter part: 15.8 mm, depth Y of small diameter part: 3 mm
Diameter of large diameter part: 18.0 mm, depth Z of large diameter part: 10 mm
Number of through holes: 100

Rack material:
A rack member was prepared on which the tubular body and the blood collection container body can be arranged.

Placement process:
The cap member was arranged inside the concave portion of the first jig so that the opening end side of the cap member protruded above the upper surface of the first jig (FIG. 5(a)). A cap member was arranged in each of the 100 concave portions of the first jig. The open end side of the cap member protruded upward by about 10 mm with respect to the upper surface of the first jig.

Mating process:
The large-diameter portion of the second jig was fitted to the projecting portion of the cap member (FIG. 5(b)).

First capping step:
(Press-fitting step (1A))
100 tubular bodies (PET tubes) were arranged on the rack member. A plug body was arranged in each of the 100 through-holes of the plate member (Fig. 6(a)). Next, the plate-shaped member on which the plug main body was arranged was moved downward, and the plug main body was arranged at the open end of the tubular body (Fig. 6(b)).

The tapered portion of the second jig in the structure of the first jig, the second jig, and the cap member obtained in the fitting step is opposed to the plug body arranged at the open end of the tubular body, and By moving the structure downward, the gripping portion of the cap member was arranged inside the tapered portion of the second jig (Fig. 7(a)).

Next, the air cylinder is installed in the press-fitting direction and operated to move the structure consisting of the first jig, the second jig 2 and the cap member downward, so that the tip of the small diameter portion of the plug main body is pushed into the cap member. The plug body is press-fitted into the cap member from the tapered portion of the second jig to a position not located in the top plate portion than the open end of the plug body, and the plug body protrudes from the open end of the cap member. was obtained (FIGS. 7(b) and (c)).

(Capping step (1A))
100 bodily fluid collection container bodies (PET tubes) were placed on the rack member. The tapered portion of the second jig in the structure of the first jig, the second jig, the cap member, and the plug body obtained in the fitting step is opposed to the open end of the body fluid collection container body, The structure was moved downwards. In this way, the stopper body protruding from the opening end of the cap member was vacuum-sealed to the opening end of the body fluid collection container body to manufacture 100 body fluid collection containers (Fig. 8(a)). and (b)).

(Example 2)
In the same manner as in Example 1, the arranging process and the fitting process were performed.

Second capping step:
(Capping step (1B))
100 bodily fluid collection container bodies (PET tubes) were placed on the rack member. 100 stopper bodies were vacuum-sealed to the opening end of the bodily fluid collection container (PET tube) to obtain a connecting body between the bodily fluid collection container body and the stopper body (Fig. 9(a)).

(Capping step (2B))
The tapered portion of the second jig in the structure of the first jig, the second jig, and the cap member obtained in the fitting step is opposed to the plug body that is plugged into the opening end of the body fluid collection container body. to move the structure downward. In this manner, the cap member housed in the space formed by the concave portion of the first jig and the large-diameter portion of the second jig is vacuum-attached to the plug body in the connecting body between the bodily fluid collection container body and the plug body. It was stoppered to produce 100 bodily fluid collection containers (FIGS. 9(b) and (c)).

(Comparative example 1)
100 bodily fluid collection containers were manufactured in the same manner as in Example 2, except that the second jig was not used.

(evaluation)
<Failure to fit between the stopper body and the cap member>
For 100 bodily fluid collection containers thus obtained, the deformed state and damaged state of the cap member were visually checked, and the ratio of occurrence of fitting failure between the plug main body and the cap member was determined.

<Variation in sample volume>
Using the obtained body fluid collection container and a commercially available blood collection holder, hot water was collected from the hot tub into the body fluid collection container. Fluctuations (CV values) in the amount of liquid sampled from 100 body fluid-sampling containers were determined by the following formula. In Comparative Example 1, variation in sampled liquid amount was not evaluated.

CV value (%) = (σ/X) x 100
σ: Standard deviation of the amount of fluid collected into the body fluid collection container X: Average value of the amount of fluid collected into the body fluid collection container

The composition and results are shown in Table 1.

REFERENCE SIGNS LIST 1 first jig 1a first surface 2 second jig 2a first surface 2b second surface 3 rack member 4 cap member 4a top plate portion 4b opening end 4c convex Portion 4d Rib 5 Plug main body 5a Grip portion 5b Small diameter portion 51a Recess 7 Body fluid collection container main body 8 Serum or plasma separation composition 9 Plug 10 Plugging device 11a Recess 20 Body fluid collection Container 21 Through hole 21a Tapered portion 21b Small diameter portion 21c Large diameter portion 30 Plate member 30a Through hole 40 Tubular body 40a Open end 41a Opening 50 Rack member 51a Concave portion 51b Tip

Claims (8)

A method for manufacturing a bodily fluid-collecting container comprising a stopper body including a cap member and a stopper main body, and a bodily fluid-collecting container main body, comprising:
the bodily fluid collection container is a blood collection container,
The cap member has a top plate portion at one end and an open end at the other end,
The plug body has a gripping portion on one end side and a small diameter portion having a diameter smaller than that of the gripping portion on the other end side ,
The stopper body has a maximum diameter at the gripping portion,
the maximum diameter of the plug body is larger than the inner diameter of the open end of the cap member,
Using a first jig having a recess on the first surface, the cap member is moved to the first surface so that the open end side of the cap member protrudes with respect to the first surface of the first jig. an arranging step of arranging inside the recess of the jig;
A second jig having a through hole in which a tapered portion, a small diameter portion, and a large diameter portion having a larger diameter than the small diameter portion are provided in this order is used to replace the large diameter portion of the second jig with the cap. A fitting step of fitting to the protruding portion of the member,
a step of press-fitting the plug body into the cap member from the taper portion side of the second jig to obtain a plug body in a state in which the plug body protrudes from the opening end of the cap member; a first plugging step comprising both steps of plugging the plug body in a state in which the plug body protrudes from the open end of the cap member into the open end of the bodily fluid collection container body;
or
a step of plugging the plug body into the open end of the bodily fluid collection container body to obtain a connecting body between the bodily fluid collection container body and the plug body; a second plugging step comprising both a step of plugging the cap member into the plug main body of the connection body so as to be press-fitted into the cap member from the tapered portion side;
the tapered portion of the second jig is inclined so that the diameter becomes smaller toward the small diameter portion of the second jig;
The method of manufacturing a bodily fluid-collecting container, wherein the diameter of the small-diameter portion of the second jig is smaller than the inner diameter of the open end of the cap member. 2. The method for manufacturing a bodily fluid-collecting container according to claim 1, comprising the first capping step. 2. The method for manufacturing a bodily fluid-collecting container according to claim 1, comprising the second capping step. 4. Any one of claims 1 to 3, wherein the tapered portion of the second jig is inclined at an inclination angle of 15 degrees or more and 30 degrees or less with respect to the penetrating direction of the through hole of the second jig. 2. The method for manufacturing the bodily fluid-collecting container according to item 1. 5. The ratio of the depth of said tapered portion of said second jig to the depth of said small diameter portion of said second jig is 0.75 or more and 3.5 or less. 3. The method for manufacturing the bodily fluid collection container according to 1. A plugging device used for attaching a plug comprising a plug main body and a cap member to an open end of a body fluid collection container main body,
A capping device used to obtain a bodily fluid-collecting container in which a plug body comprising a plug body and a cap member is attached to an open end of a body fluid-collecting container main body,
the bodily fluid collection container is a blood collection container,
The cap member has a top plate portion at one end and an open end at the other end,
The plug body has a gripping portion on one end side and a small diameter portion having a diameter smaller than that of the gripping portion on the other end side,
The stopper body has a maximum diameter at the gripping portion,
a first jig having a recess in the first surface;
a second jig having a through hole in which a tapered portion, a small diameter portion, and a large diameter portion having a larger diameter than the small diameter portion are provided in this order;
The first jig is a jig for arranging the cap member inside the recess so as to protrude from the first surface,
the second jig is a jig for moving the plug body with respect to the through hole,
A plugging device, wherein the taper portion of the second jig is inclined so that the diameter thereof decreases toward the small diameter portion of the second jig. 7. The plugging according to claim 6, wherein the tapered portion of the second jig is inclined at an inclination angle of 15 degrees or more and 30 degrees or less with respect to the penetrating direction of the through hole of the second jig. Device. 8. The plugging according to claim 6 or 7, wherein a ratio of the depth of said taper portion of said second jig to the depth of said small diameter portion of said second jig is 0.75 or more and 3.5 or less. Device.

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