JP6615464B2 - Paper test tube stand and paper test tube stand enclosing bag sealing device - Google Patents

Description

It relates to the storage of inspected clinical specimens, and the transportation and disposal of specimens after the storage period.

In the medical field, residual samples such as blood, serum, and plasma after clinical tests are valuable specimens that are used for additional tests, confirmation tests, clinical studies, etc., but these specimens are dangerously infectious. It is also a sample.
The specimen after the test is sealed with a cap or a film to prevent the component from being denatured due to concentration or the like, and stored in a refrigerated state in a test tube stand. Test tube stands used for clinical tests are required to have chemical resistance, water resistance, and heat resistance, so they are made of stainless steel and plastic molding and are durable and can withstand long-term use. However, since these test tube stands are expensive and robust, they are repeatedly used after being cleaned.

On the other hand, in recent years, the automation of examinations has progressed, and the required functions of test tube stands have changed from inspection instruments to specimen transport instruments and storage instruments. For this reason, in the reusable test tube stand, cleaning work, storage management, and securing of a storage management place are major problems.
Moreover, although the specimen sealing work is usually performed manually, there is an example in which an automatic stopper is introduced. However, the introduction of an automatic closing machine requires extremely high capital investment costs, and the facilities that can be introduced are limited.

The manual cap closure method that is routinely performed in many medical facilities has a high risk of infection because there are many opportunities for humans to come into contact with the specimen. As another specimen sealing method, a capless test tube stand sealing method manufactured by Asia Equipment Co., Ltd. is well known, but this method is poor in airtightness and is not suitable for long-term storage of specimens. Samples that have passed the storage period are manually removed from the test tube holder one by one by workers wearing disposable products such as gloves, masks, goggles, and gowns, and processed as medical waste. However, contact between the worker and the sample is unavoidable, such as an operator accidentally touching the test tube stand in which the sample inside the test tube is scattered and attached, which threatens the safety of medical workers. The development of a safe specimen disposal method is also strongly desired for hospital infection control.

Reference 1: Utility Model Registration No. 3102034 “Foldable Test Tube Stand”
Reference 2: JP-A-1996-057329 “Simple inspection table assembly sheet”
Reference 3: Japanese Patent Laid-Open No. 2006-167469 “Test tube tray and test tube stand”

Since the serum and plasma used for the inspection are light yellow and transparent liquids, it is difficult to visually check the serum with the test tube stand even if serum, plasma, or the like scatters and adheres to the test tube stand.
In addition, there are many manual methods for sealing and storing specimens according to the prior art, and there are many manual methods that can easily cope with a small number of specimens. However, this method has a high risk of occupational infection because workers often have direct contact with the specimen.

Capless test tube stands (manufactured by Asia Equipment Co., Ltd.) are known as a method for reducing the contact opportunity between the operator and the specimen, and can be said to be a relatively safe specimen storage method. There are problems with airtightness and the weight of the test tube holder.
A heat sealing apparatus is sold as a specimen sealing method that has a small chance of contact with a specimen and has excellent airtightness during storage. However, there is a problem that the apparatus is expensive, a dedicated installation space is required, and once the seal is peeled off, the adhesiveness is weakened and the airtightness is lowered during re-storage.
In addition, some automatic sample transfer systems have an automatic capping device that automatically closes the cap, but there are problems such as high cost, installation space required, and high cost of consumable caps. Is difficult to introduce.

Note that the automatic sample transport system is a test system that can be fully automated without human intervention in all steps of sample pretreatment, analysis, and sample removal. The sample tube is manually transferred to a test tube holder, and then manually processed and stored in a refrigeration facility. Therefore, even in the automatic sample transport system, the worker who is engaged in the sample removal operation always has an opportunity to contact the sample.
On the other hand, specimens that have passed the storage period in the refrigeration facility are taken out from the test tube stand one by one and discarded as medical waste, and the test tube stand is washed and used repeatedly. However, ordinary test tube stands are difficult to clean in terms of shape, and scratches and cracks are easily formed by repeated use, making complete cleaning difficult.

The present invention is a paper test tube stand that can be made disposable in terms of cost, can be hermetically sealed without the operator directly touching the test tube opening, and the scattering of the sample inside the test tube stand In case of adhering to paper, a paper test tube stand is proposed that can easily visually confirm the adhering.

The invention according to claim 1 is an invention of a paper test tube stand in which, when liquids (serum and plasma) stored in the test tube are scattered and attached to the paper test tube stand, the attached portion changes color.
Thereby, the operator who handles a test tube and a test tube stand can work without directly touching the discolored portion. In addition, when the adhesion is in a wide range, disposal such as incineration is easy, and contact with the specimen can be avoided.
In addition, the paper test tube stand can be easily created by using a method of manufacturing an origami type paper box, which is frequently used, and a method of folding a sheet developed on one or two sheets.

The invention described in claim 2 is a paper test tube stand whose surface is coated with an indicator showing a protein error, and the liquid stored in the test tube is human serum or plasma.
This gives the paper test tube the same function as a well-known urine test paper coated with an indicator that indicates protein error, and when the scattered human serum or plasma adheres to the paper test tube, the color change reaction occurs immediately. Occurs and disperses and discolors only the attached part. The operator can easily confirm this discoloration visually.

The invention described in claim 3 is an invention in which the paper test tube stand is a box having a two- to four-stage structure formed by cutting or bending cardboard. In the case of a four-stage structure, the uppermost part is the first stage, the bottom surface serving as the lowermost part is the fourth stage, and the second and third stages are provided between them. The first stage and the second stage are provided with a plurality of through holes into which the test tubes can be easily inserted in a grid pattern. In the third stage, holes that do not penetrate the test tube are provided in a grid pattern, and abut the bottom surface of the test tube to stabilize the insertion position of the test tube. Further, the third stage supports and absorbs the pressure acting on the test tube by elastic deformation when the inserted test tube release port is pressed downward by an external force. It is not necessary to provide a hole in the fourth layer, and the bottom surface of the box is formed.

The first layer of the three-layer sealing sheet is a protective sheet. The second layer is a sealing film cut into a circle that individually closes the test tube opening, and a silicone adhesive is applied to the contact surface with the test tube opening. By positioning and placing the circular pattern so as to cover the test tube release port inserted and placed in the paper test tube stand, the test tube release port can be covered and sealed. The third layer is a release sheet that protects the surface of the second layer of silicone adhesive. Cutting is performed on the release sheet, and one of the strips separated by cutting is removed immediately before use, and then the remaining portions are sequentially removed to expose the circular pattern.
As a result, a sealing film having a grid-like circular pattern in which the application surface of the silicon adhesive is exposed is prepared. That is, the third layer of the sealing sheet having the three-layer structure according to the present invention is adjusted to a second layer circular pattern sealing film and a first layer protective sheet immediately before use.

Next, the release sheet of the third layer of the three-layer structure sealing sheet held on the press lid portion of the apparatus is peeled off to expose the second layer sealing film. The grid-like circular pattern is then aligned to individually seal the test tube opening and then the press lid of the sealer body is closed. At this time, the press lid presses the test tube port through the first layer protective sheet and the second layer sealing film. The third stage of the paper test tube stand is elastically deformed by receiving a pressure acting on the test tube. By this pressing, the test tube opening is sealed with the second layer sealing film. Further, by the operation of closing the press lid, the protective sheet of the first layer and the flange portion of the encapsulating bag are pressed against the press lid and are adhesively sealed.

In consideration of the reuse of stored specimens, the adhesive film method with excellent peelability and re-adhesiveness is suitable for the sealing method of the encapsulated bag, but sometimes the disposal of specimens that are strongly suspected to be infectious, or When it is necessary to consider measures for mitigating the collapse of the specimen container, the heat seal method may be adopted.

A paper test tube stand coated with an indicator showing a protein error is instantly discolored when albumin in the sample comes into contact with it, so that the adhesion status (contamination status) of a sample with infectivity can be visually confirmed in real time.
Further, by visually checking the contaminated area, it is possible to take quick safety measures such as discarding the paper test tube stand or sterilizing the contaminated portion.

Overview of paper test tube holder Development status of paper test tube stand before assembly Sectional view of a paper test tube stand with a test tube inserted and placed Cross-sectional view of a three-layer sealing sheet Plan view of a three-layer sealing sheet Explanatory drawing of sealing and sealing work on the test tube opening with a circular sealing film Discoloration due to scattered serum Discoloration test results

<About the structure of the paper test tube stand>
FIG. 1 shows an external appearance of the paper test tube stand of the present invention, FIG. 2 shows a development state before assembly of the paper test tube stand, and FIG. 3 shows a cross-sectional configuration of the paper test tube stand of the present invention. The paper test tube stand 10 is made of cardboard except for the third stage 13 in a four-stage box. The thickness of the cardboard used for the first stage 11, the second stage 12, and the fourth stage 14 serving as the bottom of the box is 450 g / m ² ± 15 g / m from the standpoint of maintaining stable strength and ease of assembly. ² is preferred. Corrugated paper is used for the third stage 13. The diameters of the through holes formed in the first stage 11 and the second stage 12 of the test tube stand are second from the through holes of the first stage 11 in order to prevent rolling when the test tube is inserted and placed. The through hole of the step 12 is narrowed by 3% to 5%.

Further, the penetrating corrugated cardboard installed in the third stage 13 of the test tube stand has a buffering action against an impact when the test tube is inserted and placed, and abuts against the curved surface of the bottom of the tube to stabilize the insertion position. The thickness of the corrugated paper is 2mm ± 1mm and the diameter of the through hole is 5-10mm, which is sufficiently smaller than the outer diameter of the test tube. It is not necessary to limit to a numerical value, and if it is smaller than the outer diameter of the test tube, no major problem will occur. In addition, it is possible not only to make a simple circle but also to make a cross-shaped cutting.

The fourth stage 14 of the test tube stand has no through hole and forms the bottom surface of the box.
In the present invention, the paper test tube stand 10 has a four-stage configuration, but functionally, the paper test tube stand has a two-stage configuration corresponding to the first stage 11 and the third stage 13 of the present invention. It performs the same function as the present invention. Similarly, there is no problem with a three-stage paper test tube stand. In the case of a three-stage paper test tube stand, there is no problem even if either the second stage 12 or the fourth stage 14 of the present invention is omitted.

In order to enhance the effect of preventing hand injury when assembling the test tube holder, avoid sharpening the cut surface of the test tube holder, and dare cut the cut surface.
The test tube holder may be coated with ink, logo / character printing, etc., taking advantage of the characteristics of paper. In addition, a barcode or a two-dimensional barcode may be printed or pasted for handling an automatic transfer machine or automatically managing management in refrigerated storage. Furthermore, an IC tag may be attached and sample information may be recorded on the IC tag for management.

The test tube stand (also referred to as a sample rack) is provided with a hook on the side of the test tube stand in consideration of removal or transfer by the handling arm when used in the sample carry-out device of an automatic carrier. Alternatively, an insertion hole for an arm may be provided.
An example of a method for assembling a four-stage paper test tube stand will be described with reference to FIG.
In the case of FIG. 2, the paper test tube stand 10 is composed of two members, a box body 16 having an insertion port 15 formed in a grid pattern on the surface and an intermediate test tube receiver 19, and is assembled in the following procedure.
(1) Insert the middle test tube receiver 19 into the bottom surface of the box body 16.
(2) The side folding part 17 is folded inside the box body 16 according to the crease.
(3) Fold the top fold 18 into the inside of the box body 16 according to the crease.

<Discoloration by specimen>
The protein detection solution to be coated on the paper test tube holder 10 of the present invention comprises a buffer solution made of citric acid and sodium citrate, tetrabromophenol blue which is an indicator showing a protein error, and acetone which is a solvent for the indicator. Used and created.
The protein detection solution forms a complex by contact between albumin and an indicator showing the protein error adjusted to the acidic side, and turns from pale yellow, which is an acidic color, to blue-green, which is a basic color. Since the degree of discoloration is proportional to the albumin concentration, the detection sensitivity and discoloration rate, the influence of temperature, and the discoloration stability were measured using a protein detection solution.

A protein detection solution, detection equipment, and a dropped sample were prepared by the following procedure.
(1) The first solution of the protein detection solution dissolves tetrabromophenol blue with acetone,
For the second solution, a buffer solution was prepared with citric acid and sodium citrate, and the first and second solutions were mixed 1: 1 to obtain a protein detection solution.
(2) A test paper test tube stand (one piece) and a test protein detection paper (four pieces) were coated with a protein detection solution to prepare test equipment.
(3) Place the test protein detection paper after preparation in a room at 25 ° C. and a refrigerator at 4 ° C. for 1 week (Table 1,
Table 2), and stored in a 25 ° C. room and a 4 ° C. refrigerator for 12 weeks (Tables 3 and 4), respectively.
(4) The test sample was prepared by diluting human serum with physiological saline to 4.00 g / dL,
2.00 g / dL, 1.00 g / dL, 0.80 g / dL,
0.70 g / dL, 0.50 g / dL, 0.02 g / dL,
The albumin concentration was adjusted to 0.00 g / dL.
(5) One drop of each adjusted test sample at each concentration was dropped on a detection paper for protein detection test using a pipette.
(6) The color change degree was determined with reference to a color tone table manufactured by Eiken Chemical Co., Ltd.

A discoloration test was conducted using test protein detection paper stored under the following four conditions.
(1) Table 1 shows the protein detection sensitivity test results of the test protein detection paper stored at 25 ° C. for 1 week.
(2) Table 2 shows the protein detection sensitivity test results of the test protein detection paper stored at 4 ° C. for 1 week.
(3) Table 3 shows the protein detection sensitivity test results of the test protein detection paper stored at 25 ° C. for 12 weeks.
(4) Table 4 shows the protein detection sensitivity test results of the test protein detection paper stored at 4 ° C. for 12 weeks.

From the results in Tables 1, 2, 3, and 4 above, the time required for the color change after the serum contacted the paper test tube stand 10 coated with the protein detection solution for 1 week and 12 weeks was as follows. It was instantaneous within 1 second with room temperature storage and refrigerator storage, and the fading time (discolored state) was stable at 240 hours or more.
FIG. 7 shows the discolored portion of the test paper test tube stand into which the serum of the actual specimen was dropped.
The detection paper for protein detection test (FIG. 8) in which the sample adjusted to each concentration was dropped,
In order to represent the light yellow color of the indicator, the detection paper was cut out and pasted on a white mount.

From the first stage left, storage conditions 25 ° C, storage for 1 week: 4.00 g / dL, 2.00 g / dL
1.00 g / dL, 0.80 g / dL, 0.070 g / dL, 0.50 g / dL, 0.02 g / dL, 0.00 g / dL
From the second stage left, storage conditions 4 ° C, 1 week storage: 4.00 g / dL, 2.00 g / dL
1.00 g / dL, 0.80 g / dL, 0.070 g / dL, 0.50 g / dL, 0.02 g / dL, 0.00 g / dL

From the third stage left, storage conditions 25 ° C., 12 weeks storage: 4.00 g / dL, 2.00 g / dL, 1.00 g / dL, 0.80 g / dL, 0.070 g / dL, 0.50 g / dL , 0.02 g / dL, 0.00 g / dL
4th stage from left, storage condition 4 ° C, 12 weeks storage: 4.00 g / dL, 2.00 g / dL
1.00 g / dL, 0.80 g / dL, 0.070 g / dL, 0.50 g / dL, 0.02 g / dL, and 0.00 g / dL, respectively, indicate the degree of discoloration.

Since the albumin concentration in human serum and human plasma is 200 times or more higher than the detection sensitivity of 0.02 g / dL concentration of the protein detection solution, a paper test tube stand 10 coated with the protein detection solution and Discoloration due to contact with human serum and human plasma is more sensitive and easy to visually check.
In addition, since the protein detection solution used in the present invention can be easily coated on general-purpose general paper, it can be widely used for applications other than paper test tube stands. For example, it can be used as a sample contamination detection indicator near a sample handling table, a sample probe of an analyzer, or a place where sample scattering is likely to occur, such as a sample dispensing device or a capping device of a transport machine.

<Sealing of test tube with sealing sheet>
As shown in FIG. 4, the sealing sheet 30 includes three layers. The first layer is a protective sheet 31, the second layer is a sealing film 32, and the third layer is a release sheet 33.
An easily peelable adhesive layer 34 is applied to the surface of the sealing film 32 of the protective sheet 31, and the protective sheet 31 and the sealing film 32 are lightly bonded. A silicon adhesive layer 35 is applied to the side surface of the release sheet 33 of the sealing film 32, and the silicon adhesive layer 35 can be adhered to the test tube release port 21 in a state where the release sheet 33 is peeled off. Further, when the adhesive layer 34 of the protective sheet 31 is set in the sealing device 40 shown in FIG. 6 with the release sheet 33 peeled off, it adheres to the flange portion 44 of the enclosing bag 43 and is placed on the test tube. The stand 10 is hermetically sealed.

The sealing film 32 is a transparent, milky white, or colored seal that is cut into 10 to 200 circular shapes and coated with a silicone adhesive that can maintain adhesive strength even if silicone oil remains in the opening of the vacuum blood collection tube. A test tube having an outer diameter of 10 mm to 18 mm, which is a film, is sealed together.
The release sheet 33 exposes the sealing film 32 by a two-stage peeling means, peels the band release sheet 33a in the first stage, and peels the base release sheet 33b in the second stage. The exposed sealing film 32 is pressed and brought into close contact with the test tube opening 10 using the sealing device 40. The sealing sheet 30 adheres to the flange portion 44 of the enclosing bag 43 simultaneously with the sealing of the test tube release port 21 by the sealing film 32 by pressing of the sealing device 40.

<Sealing work with a sealing device>
The sealing device 40 can store one to five sealing sheets 30 on the press lid 42, and can also set one to five sealing bags 43 on the main body 41. Therefore, the sealing operation is performed five times continuously. Can be implemented.
Since the height (depth) of the sealing device 40 can be adjusted freely, the sealing height is adjusted according to the height of the test tube. The power supply for the device can be driven by a battery as well as a general commercial power supply.

<Procedure from specimen sealing operation to specimen disposal>
(1) Insert and place a test tube in the paper test tube stand 10.
(2) The enclosing bag 43 is set on the main body 41 of the sealing device 40, and the sealing sheet 30 is set on the press portion 42. At this time, the test tube release port 21 and the sealing sheet 30 are aligned.
(3) The test tube stand 10 into which the test tube is inserted and placed is placed on the sealing device 40.
(4) The release sheet 33 of the sealing sheet 30 is peeled off to expose the adhesive layer 35 of the sealing film 32.
(5) The press lid 42 of the sealing device 40 is pushed down and pressed.

(6) After 2 to 3 seconds, the test tube release port 21 is sealed with the sealing film 32, and at the same time, the flange portion 44 of the enclosing bag 43 and the protective sheet 31 are brought into close contact with each other by pressing. The sheet 31 is double-sealed.
(7) The specimen is refrigerated for a predetermined period in a state of being double-sealed and protected.
(8) When the stored specimen is reused, the protective sheet 31 that is in close contact with the flange portion of the encapsulating bag 43 can be easily peeled by hand. Part or all of the protective sheet is peeled off and individually sealed with the sealing film 32. The collected specimen is taken out.
(9) The reused specimen is again sealed with the same sealing film 32, inserted and placed in the paper test tube holder 10, stored in the enclosing bag 43, and the protective sheet 31 and the flange portion 44 of the enclosing bag 43. The product is kept in close contact by hand and stored in the refrigerator.
(10) The specimen whose storage period has passed is discarded without being removed from the paper test tube stand 10 in a sealed state together with the paper test tube stand 10.

A paper test tube stand functions as a test tube stand by being folded and assembled.
Compared to conventional test tube stands, it is easy to transport, store, lightweight, and has excellent convenience and economy, making it suitable for emergency disasters.
A paper test tube stand coated with an indicator showing a protein error makes it possible to instantly visually recognize a contaminated portion of the test tube stand due to scattering of the sample by a color change reaction of the protein error.

It can be said that detecting the contaminated part of the test tube stand and taking sterilization treatment in real time is an effective safety measure for medical staff.
The provision of a sealed specimen storage method with improved airtightness and protection is useful for ensuring the stability of valuable test samples.
Specimens that have passed the storage period are handled as infectious waste by human hands wearing disposable products such as gloves, goggles, masks, gowns, etc. is there.
However, the method for discarding a double sealed stored specimen according to the present invention is an extremely safe disposal method without causing specimen scattering during disposal.

DESCRIPTION OF SYMBOLS 10 Paper test tube stand 11 1st stage 12 2nd stage 13 3rd stage 14 4th stage 15 Insert port 16 Box body 17 Side fold part 18 Top fold part 19 Middle stage test tube receiver 20 Test tube 21 Test tube release port 30 Sealing sheet 31 Protective sheet 32 Sealing film 33 Release sheet 33a Band release sheet 33b Base release sheet 34 Adhesive layer 35 Silicon adhesive layer 40 Sealing device 41 Main body 42 Press lid 43 Encapsulating bag

Claims (3)

A paper test tube stand characterized in that it has a site where an indicator is coated on the surface and the contact part is discolored by contact with a liquid that is serum or plasma of a person stored in the test tube. The paper test tube stand according to claim 1, wherein the indicator coated on the surface of the paper test tube stand is an indicator showing a protein error . When the paper test tube stand is a box having a two-stage to four-stage structure formed by cutting and bending cardboard, and the paper test tube stand has a four-stage configuration, the first stage, the second stage, A plurality of through holes are formed in a grid pattern in the step and the third step, the through hole diameter formed in the first step and the second step is larger than the outer diameter of the test tube, and the test tube can be inserted and removed. can freely through holes of the third stage is smaller than the tube outer diameter, in contact with the bottom curved surface of the inserted tube, positioning is performed in the test tube, fourth stage to form a bottom paper test tube rack according to any one of claims 1 or 2, characterized in that there.