JP2597948Y2 - Liquid biological sampling tool - Google Patents

Description

[Detailed description of the invention]

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a liquid biological sample collecting tool for collecting a liquid biological sample used for a clinical test. More specifically, the present invention relates to a liquid biological sample collecting device capable of easily and quantitatively collecting secretory liquid biological samples such as vaginal fluid and cervical mucus.

[0002]

2. Description of the Related Art Serum, plasma, and urine are commonly used as specimens for clinical tests, and secretory liquid biological samples such as vaginal fluid, cervical mucus, saliva, and nipple fluid are used. The collection was complicated and its use was limited. That is, when a secretory liquid biological sample is used for a clinical test, a small amount of a sample is usually collected once using a dropper or a capillary tube, stored in a sample storage tube, and then the sample is analyzed using a quantitative pipette. Quantitative sampling,
Alternatively, it is necessary to perform an operation such as dilution, and it is difficult to collect a required amount of sample and the operation is complicated.

[0003] Saliva is a relatively large secretory liquid biological sample, and vaginal fluid, cervical mucus and C is used as a small amount for predicting rupture of water.
The nipple secretion used for the measurement of EA is exemplified.

[0004] For example, as a method of using a nipple discharge for a clinical test, a method disclosed in Japanese Patent Application Laid-Open No. 2-176466 is cited as an example. In this method, a method is proposed in which a small amount of a sample is subjected to an inspection without using a quantitative pipette, but a method of quantitatively collecting the sample is not mentioned.

[0005] On the other hand, the collection of vaginal fluid is generally performed by using a syringe,
Although a dropper or cotton swab is used, the amount of vaginal fluid is not large, so it is difficult to collect it with a syringe or a dropper. The inconvenience of not being able to do so has arisen.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to solve the above-mentioned problems of the prior art, which is simple in operation and controls the amount of a small amount of secretable liquid biological sample to be controlled. It is an object of the present invention to provide a liquid biological sample collection tool that enables efficient collection.

[0007]

In order to achieve the above object, according to the present invention, a collection member formed of a flexible water-absorbing material for collecting a liquid biological sample is provided at one end thereof. A liquid having a collecting rod having an inner cylinder smaller than the outer diameter of the collecting member and having a shorter overall length than the collecting rod, and an outer cylinder capable of storing the collecting member. A biological sampling device is provided.

It is preferable that a stopper having an outer diameter larger than the inner diameter of the outer cylinder is provided at an end of the collecting rod opposite to the collecting member.

Further, it is preferable that the collecting member is formed of a fibrous material and / or a porous material.

[0010]

The liquid biological sample collecting tool of the present invention basically has a sampling member made of a flexible water-absorbing material for collecting a liquid biological sample, which is fixed to one end thereof. It comprises a rod and a cylindrical outer cylinder capable of storing the collecting member, having a shorter overall length than the collecting rod, and having a smaller inner diameter than the collecting member.

[0011] When a liquid biological sample is collected by the liquid biological sample collecting tool of the present invention, the collecting member is housed in an outer cylinder, and the collecting member is brought into close proximity to the inside and outside of the living body for collecting the liquid biological sample. Then, the collection rod is pushed or the outer cylinder is moved to make the collection member protrude from the outer cylinder, and the collection member is brought into contact with the liquid biological sample collection site to absorb and collect the liquid biological sample. . After a sufficient amount of liquid biological sample is collected by the sampling member, the sampling member is stored in the outer cylinder again, then the sampling rod is pulled out of the outer cylinder, and the sample is diffused and dissolved in the test solution by immersing the sampling member in the test solution. By doing so, the liquid biological sample is subjected to a clinical test.

Here, in the liquid biological sample collecting tool of the present invention, the collecting member is formed of a flexible water-absorbing material, and the outer cylinder has an inner diameter smaller than that of the collecting member. Therefore, after the liquid biological sample is absorbed by the sampling member, the sampling member is compressed by the outer cylinder and contracted with a certain force by storing the sampling member in the outer cylinder and pulling the sample out of the outer cylinder. Removed. Therefore, according to the liquid biological sample collecting device of the present invention, if the size of the collecting member and the outer cylinder and the material of the collecting member are respectively constant, a substantially constant amount of liquid biological sample can always be collected. , By the simple sampling operation described above,
It is possible to stably carry out quantitative sampling of a liquid biological sample, which is particularly advantageous when collecting a liquid biological sample from the body such as vaginal fluid. Moreover, before the collection of the liquid biological sample and after the collection of the liquid biological sample from inside and outside the body, the sampling member is housed in the outer cylinder. Thus, contamination of the collection member and the liquid biological sample can be suitably prevented, and the inspection can be performed accurately.

[0013]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a liquid biological sampling device according to the present invention.

FIG. 1 is a schematic partial cross-sectional view of the liquid biological sampling device of the present invention. A liquid biological sample collection device 10 (hereinafter, referred to as a collection device 10) of the present invention shown in FIG. 1 includes a collection rod 12 for fixing a collection member 14 to one end and an outer cylinder capable of storing the collection member 14. 16. In a preferred embodiment, the sampling tool 10 in the illustrated example includes a stopper 18 at the end of the sampling rod 12 opposite to the sample material 14.

In the illustrated example of the collection tool 10, a collection rod 12
Is a rod having a sampling member 14 at one end, and a shaft 20
The sampling member 14 is fixed to one end of the substrate, and the stopper 18 is fixed to the other end.

The length of the sampling rod 12 varies depending on the site where a liquid biological sample (hereinafter, referred to as a sample) is collected.
It can be of any length depending on the site of collection. For example, when collecting a sample from the body, the length of the collection rod 12 may be determined according to the distance from the insertion site of the collection tool 10 to the body to the collection site. The length should be about 5 cm to 30 cm when performing saliva, and about 5 cm to 15 cm when collecting saliva. When a sample is collected from the outside of the body, such as a nipple secretion, it may be arbitrarily determined according to operability or the like.

The material for forming the shaft 20 of the sampling rod 12 is not particularly limited, and a material that can secure the rigidity that can reliably perform an operation such as the projection of the sampling member 14 from the outer cylinder 16 is used. It is preferable to select the above.
For example, when a sample can be collected without inserting the collection tool 10 into the body, a metal,
It is also possible to use a hard material such as wood, plastic, or the like. When a sample is collected by inserting a collection tool 10 for collecting vaginal fluid into the body, paper, paper, A soft material such as a soft plastic can be selected.

When the shaft 20 is formed of a material having high water absorbability, the sample may be absorbed by the shaft 20, which may obstruct the collection of a certain amount of the sample which is the object of the present invention.
Therefore, it is preferable that the shaft 20 has no water absorption or is sufficiently low.

The sampling rod 12 has a sampling member 14 at one end. The collection member 14 contacts (collects) a biological fluid sample with a sample collection site inside and outside the body, and is made of a water-absorbing material having a certain degree of flexibility.

As a material for forming the sampling member 14, a fiber material or a porous material is suitably used.
4 is made of woven fabric, nonwoven fabric, absorbent cotton, or the like made of cotton, chemical fiber, or a mixture thereof, sponge, porous polymer such as resin foam, paper, or the like. More specifically, for example, when collecting the vaginal fluid, absorbent cotton or a blend of absorbent cotton and rayon is preferably used.

The shape of the sampling member 14 is not particularly limited.
Various shapes can be used according to the shape of the outer cylinder 16 described later, and in particular, a cylindrical shape, a spherical shape, or a cocoon shape around the shaft 20, that is, a cross-sectional shape (a direction orthogonal to the axial direction of the shaft 20) Is preferably circular.

The size of the sampling member 14 is not particularly limited. However, as will be described in detail later, in the sampling tool 10 of the present invention, the diameter of the sampling member 14 and the outer cylinder 16
Has a large effect on the amount of sample collected and its quantification. The difference in the length of the sampling member 14 (the axial direction of the shaft 20) causes the amount of sample to be sampled to increase or decrease in proportion. Therefore, the size of the collecting member 14 depends on the type of the sample (collecting site inside or outside the body) and the amount of the sample required for the clinical test using the biological fluid sample. It is necessary to determine it appropriately in consideration of the water absorption of the material for forming the member 14 and the like. In addition, the sampling tool 10 of the present invention includes:
Since the purpose is basically not to collect a large amount of sample, the diameter of the sampling member 14 is usually 2 mm to 20 mm and the length is 5 mm.
mm to about 30 mm, and may be determined in this range in consideration of the above requirements.

The collecting member 14 may be treated with a protein, a surfactant, or the like, if necessary, to increase its water absorption or to prevent the substance to be measured from adsorbing to the collecting member 14. .

In a preferred embodiment of the sampling tool 10 shown in the drawing, a stopper 18 is provided at an end of the sampling rod 12 on the opposite side of the sampling member 14. The stopper 18 is shown in FIG.
As shown in (b), when the sampling member 14 protrudes from the outer cylinder 16, the separation between the sampling rod 12 and the outer cylinder 16 is prevented, and the collection rod 12 is prevented from protruding more than necessary from the outer cylinder 16. It is a stop for doing. The material for forming the stopper 18 is not particularly limited. Also, the stopper 18
May be formed integrally with the shaft 20, or may be formed by fitting or fixing another member to the shaft 20.

The sampling tool 10 of the present invention comprises such a sampling rod 12 and an outer cylinder 16 for accommodating the sampling member 14. The inner diameter a of the outer cylinder 16 is the diameter b of the sampling member 14.
Is smaller (the diameter of the sampling member 14 is larger than the inner diameter of the outer cylinder 16), and the entire length thereof is shorter than the sampling rod 12, and in the illustrated example, the cylindrical shape satisfies this condition. Have. The outer cylinder 16 together with the protective cover of the sampling member 14 regulates the amount of the sample to be absorbed and collected by the sampling member 14 and enables the sample to be quantitatively collected.

As described above, in the sampling tool 10 of the present invention, as shown in FIG.
Is smaller than the diameter b of the sampling member 14. The sampling member 14 is a flexible water-absorbing material. For this reason, after the sampling rod 12 is pushed (or the outer cylinder 16 is moved) to make the sampling member 14 protrude from the outer cylinder 16 and the sample is sufficiently absorbed by the sampling member 14, FIG. As shown in FIG. 1, the sampling member 14 is housed in the outer cylinder 16 and
As shown in (c), by extracting the sampling rod 12 from the outer cylinder 16, the outer cylinder 16 having an inner diameter a smaller than the diameter b of the sampling member 14 compresses and contracts the sampling member 14, that is, the sampling member 14. Is squeezed by the outer cylinder 16, the excess sample is removed, and the inner diameter a of the outer cylinder is reduced.
Then, a predetermined amount of the liquid biomaterial corresponding to the diameter b and the length in the axial direction of the collection member 14 (and the water absorption of the collection member 14) is held by the collection member 14.

Therefore, if the size (diameter b and length in the axial direction) of the sampling member 14 and the forming material and the inner diameter a of the outer cylinder 16 are constant, respectively, the sampling member 1 formed by the outer cylinder 16 is used.
Since the shrinkage (restricted state) of the sample 4 is always constant, a substantially constant amount of sample can be always collected by a simple operation of storing the sampling member 14 in the outer tube 16 and extracting it after sampling the liquid biomaterial. In particular, when collecting a sample from the body such as a vaginal fluid, the workability can be greatly improved. In particular, in the case of the disposable collection tool 10, if the collection tool 10 having a uniform size and material of the collection member 14 and the inner diameter of the outer cylinder 16 is manufactured, an almost quantitative sample can be stably obtained in a large number of samples. Can be collected. In addition, since it has a simple configuration including the sampling rod 12 and the sampling member 14 and can be manufactured using inexpensive materials, it is extremely economical.

Further, since the sampling member 14 is housed in the outer cylinder 16 as shown in FIG. 1A before use and after sampling of the sample, the sampling member 1 is brought into contact with the outside or the like.
4 and contamination of the sample can be prevented, and an accurate clinical test can be performed.

The inner diameter a of the outer cylinder 16 and the diameter b of the sampling member 14
Although there is no particular limitation on the difference between them, if the difference between them is too small (if the inner diameter a is too large or the diameter b is too small), the effect of restricting the sampling member 14 by the outer cylinder 16 cannot be sufficiently obtained. In addition, it becomes impossible to quantitatively collect a sample with good accuracy. On the other hand, if the difference between the two is too large, the outer cylinder 16 squeezes the collection member 14 too much, reducing the amount of sample to be collected. And a simple operation cannot be realized. Therefore, it is necessary to satisfy the condition that the diameter b of the sampling member 14 is slightly larger than the inner diameter a of the outer cylinder 16. Specifically, the inner diameter a of the outer cylinder 16 is 0.1 mm larger than the diameter b of the sampling member 14. It is preferable to have a configuration that is 1 mm to 5 mm smaller.

More specifically, for example, the vaginal fluid is
When collecting about 1 mg, the sampling member 14 is made of absorbent cotton or a mixed cotton of absorbent cotton and rayon.
4 has a diameter b of 2.8 mm to 3.2 mm and a length of 13 mm
17 mm, while the inner diameter a of the outer cylinder 16 is 2.6 mm
It may be about 3.0 mm. In addition, 40m of vagina contents liquid
To collect about g, the sampling member 14 is made of absorbent cotton or a mixed cotton of absorbent cotton and rayon.
The diameter b is 2.3 mm to 2.7 mm and the length is 10 mm to
14 mm, while the inner diameter a of the outer cylinder 16 is 2.1 mm to 2.
It may be about 5 mm.

The outer diameter of the outer cylinder 16 is not particularly limited, and may be determined as appropriate according to the inner diameter a of the outer cylinder 16 and the material such as the rigidity of the material forming the outer cylinder 16. The outer cylinder 16
Is too thick, that is, if the whole of the sampling tool 10 is too thick, there is a case that the sampling may be hindered particularly when the sample is inserted into the body. Therefore, the outer diameter of the outer cylinder 16 is usually about 2 mm to 20 mm. Further, the length of the outer cylinder 16 depends on the length of the sampling rod 12, as shown in FIG. 1 (b), under the condition that the sampling member 14 completely appears outside the outer cylinder 16 at the time of sample collection. Anything that satisfies is acceptable.

The cross-sectional shape of the outer cylinder 16 may be appropriately determined according to the shape of the sampling member 14 (or the sampling member 14 is determined according to the outer cylinder 16). In consideration of the operability of housing the member 14, it is preferable that both have a circular cross-sectional shape. If necessary, the cross-sectional shapes of the two may be triangular, quadrangular, or even more polygonal, rectangular, or the like. In addition, the axial direction is not limited to a linear shape as in the illustrated example, and may be bent or arbitrarily deformable as necessary.

The material for forming the outer cylinder 16 may be any material as long as it is water-repellent, and is not particularly limited. Specific examples include various metals such as various stainless steels and various resins such as vinyl chloride, Teflon, and polyethylene.

Note that the sampling tool 10 of the present invention having such a configuration is sterilized (sterilized) before being used for sampling.
It is preferably subjected to disinfection and hermetically sealed in a film of paper, synthetic resin or the like.

The sampling device 10 of the present invention basically has the above-described configuration. An example of the operation of the sample collection device 10 for quantitatively collecting a sample will be described below. First, FIG.
As shown in (2), with the sampling member 14 housed in the outer cylinder 16, the sampling member 14 (the tip of the sampling tool 10) is brought close to the sample collection site in the living body or outside the living body. Next, the sampling rod 12 is pushed or the outer cylinder 16 is moved to
(B) The sampling member 14 is made to protrude from the outer cylinder 16, and the sampling member 14 is brought into contact with a sample collection site, whereby the sample is absorbed and collected by the collection member 14.

When the sampling member 14 has sufficiently absorbed the sample,
The collecting member 14 is stored in the outer cylinder 16 again to the state shown in FIG. 1A, the collecting tool 10 is separated from the collecting site (or as it is), and the sampling is performed as shown in FIG. The rod 12 is pulled out of the outer cylinder 16. Here, as described above, in the sampling tool 10 of the present invention, the inner diameter a of the outer cylinder 16 is smaller than the diameter b of the sampling member 14, and the sampling member 14 has flexibility. Therefore, by storing and extracting the sampling member 14 in the outer cylinder 16, the outer cylinder 16 squeezes the sampling member 14, and an excess sample is removed from the sampling member 14, and the size of the sampling member 14, the inner diameter a of the outer cylinder 16, and the like are reduced. A certain amount of the sample corresponding thereto is held by the sampling member 14.

After the sampling rod 12 has been pulled out of the outer cylinder 16, the sampling member 14 is immersed in a test solution or a test diluent.
By stirring and sufficiently dissolving and dissolving the sample held by the sampling member 14, a predetermined amount of the sample can be provided for a clinical test.

Although the sampling device of the present invention has been described in detail above, the present invention is not limited to the above embodiment, and various modifications and changes may be made without departing from the gist of the present invention. Of course.

Experimental Example A vaginal fluid sampling device according to the present invention having the shape shown in FIG. 1 was prepared. The collection member 14 was formed by fixing a blended cotton of absorbent cotton and rayon to the tip of the shaft 20 of the collection rod 12. The length of the sampling member 14 in the axial direction is 15 mm, and the diameter b is 3.1 mm to 3 mm.
It was 2 mm. The total length of the sampling rod 12 was 150 mm. On the other hand, the outer cylinder 16 is made of vinyl chloride, and the inner diameter a is 3.
0 mm, and the total length was 105 mm. The outer diameter is 4.0
mm.

Using such a vaginal fluid sampling device, the protein solution was sampled four times for each of five measurers and weighed. The sampling method is the method described above. The results are shown in Table 1 below and FIG. In Table 1 below, the unit of the sampling amount is [mg], and the unit of the variation coefficient is [%].

[0041]

As shown in the above Table 1 and FIG. 3, the sampling device of the present invention has a simple structure and a simple sampling method, and has a necessary and sufficient accuracy (in the above example, the coefficient of variation is small). (5.1%). From the above results, the effect of the present invention is clear.

[0043]

As described in detail above, according to the liquid biological sample collecting tool of the present invention, the collecting member is brought into contact with the sample collecting site, and after collecting the liquid biological sample, the collecting member is stored in the outer cylinder. Then, with a simple operation of pulling out, a substantially constant amount of a sample can always be stably collected. In addition, since it has a simple configuration consisting of a sampling rod and a sampling member and can be manufactured with inexpensive materials, it is extremely economical.

[Brief description of the drawings]

FIGS. 1A, 1B, and 1C are schematic partial cross-sectional views of an example of a liquid biological sample collecting tool of the present invention, respectively. FIG. Is shown.

FIG. 2 is a schematic view of the liquid biological sample collection tool shown in FIG. 1 when viewed from an axial direction.

FIG. 3 is a graph showing the amount of sample collected by the vaginal fluid sampling device according to the liquid biological sample collecting device of the present invention.

[Explanation of symbols]

 Reference Signs List 10 liquid biological sample collection tool (collection tool) 12 sampling rod 14 sampling member 16 outer cylinder 18 stopper 20 shaft

────────────────────────────────────────────────── (5) References JP-A-63-293439 (JP, A) JP-A-63-293440 (JP, A) (58) Fields investigated (Int. Cl. ⁶ , DB name) G01N 33/48 G01N 1/10

Claims (3)

(57) [Scope of request for utility model registration] A collection member formed of a flexible water-absorbing material for collecting a liquid biological sample, a collection rod provided at one end thereof, an inner diameter of which is larger than an outer diameter of the collection member. A liquid biological sample collection tool, comprising: a small cylindrical body having a shorter overall length than the collection rod, and an outer cylinder capable of storing the collection member. 2. The liquid biological sample collecting tool according to claim 1, wherein a stopper having an outer diameter larger than the inner diameter of the outer cylinder is provided at an end of the collecting rod opposite to the collecting member. 3. The liquid biological sample collection tool according to claim 1, wherein the collection member is formed of a fiber material and / or a porous material.