JPS6032610Y2 - Serum or plasma separation container - Google Patents

Description

[Detailed explanation of the idea] This invention relates to a serum or plasma separation container.

More specifically, this invention includes at least two thin tube portions that have openings at their upper ends and extend nearly vertically in close proximity, and a locking device that includes a thin tube insertion hole that is partially provided in the vicinity of the openings of these thin tube portions. It is composed of a sealing plug for the opening provided with a connecting handle that connects the disease and the locked disease, and a communicating body part that integrally connects the lower ends of the thin tube part, and is used for centrifugation of a predetermined amount of blood. Serum in which the volume dimensions of each part are set so that the interface between the serum or plasma located in the upper layer and the blood cells located in the lower layer is above the vicinity of the connecting part between the communicating body part and the tubule part. or relating to plasma separation containers.

In recent years, the number of clinical tests has increased significantly, and the number of clinical tests in particular is said to increase by at least 10 to 20% every year.

In contrast, the rapid progress in automation and systemization of biochemical tests in recent years is a natural requirement of the times.

However, as the automation of biochemical tests has made it possible to process multiple samples in a short time, the time wastage such as the complicated operations required for pre- and post-processing has come into sharp focus, and interest in simplifying the process is rapidly increasing. be.

One of the issues related to pre-processing and pre-processing is the serum or plasma separation operation, but this operation is the first step in analysis, and it is now clear that it is an important operation that greatly affects the accuracy and reliability of test data. There is no need to explain it.

This is an operation that requires considerable caution and skill.

Looking at the procedures that are commonly performed at present, from blood collection to serum (or plasma) separation, first, blood is collected using a blood collection syringe, placed in a glass tube, covered with a rubber stopper or parafilm, and submitted. .

After applying this to a centrifuge to separate it into blood cell and serum components, the serum is sucked up with a pipette and placed in another glass tube.

Furthermore, the serum is dispensed from the spirane into each sample cup using a pipette, and automatic analysis or manual testing is started.

On the other hand, the remaining blood cell components and a portion of the separated serum should be stored in a refrigerator for at least one week after being covered with a rubber stopper, parafilm, etc. using separate spiranes, and used for data confirmation, reexamination, additional tests, etc. at a later date. You need to be prepared.

For this storage, two bottles of Spiran are required for each sample, and if the lid is covered with parafilm, it cannot be laid flat and there is a risk of damage, so a considerable amount of space is required. Due to the increase, all facilities are being forced to expand their space year by year.

In addition, looking at the necessary equipment from blood collection to serum separation, the following numbers are required per specimen.

Syringe for blood collection: 1 Spiran: 3 Pipette: 1 to 2 Parafilm (or cap):・・3～
4 Judging from this number, it is clear that an increase in the number of specimens will lead to a huge increase in the number of instruments.

Although there is no economic problem if these instruments are reused, they require a lot of labor and time, which not only greatly hinders the labor-saving effect, but also poses a problem in terms of infection with HB antigens and the like.

If all of these devices were made disposable, this problem would be solved, but the economic aspect would become an issue.

In terms of operations, there are two pipette operations per sample.
~3 times are required, and in particular the pipetting operation for the initial separation from blood cell components requires very careful operation and skill in order to obtain as much serum as possible with a small amount of blood sample, and in some cases separation may be difficult. Blood cells may be mixed into the serum, which may distort the data or require re-centrifugation, which wastes a considerable amount of time.

In addition, the same serum has to be separated into 4 to 5 locations using a pipette, including the sample cup, which is not only complicated but also leads to the problem of taking the wrong sample, so some kind of improvement is needed. It is a place where you can

Furthermore, this serum separation process is not entirely performed in a closed state, and it is thought that the time the specimen is left in the open state becomes longer as the number of specimens increases.

As a result, the frequency of contamination with foreign substances will increase, and concentration due to evaporation of specimens will become a non-negligible factor.In particular, as automatic analysis advances to reduce the amount of specimens and improve accuracy, data It is thought that the impact on

Therefore, performing serum separation in a completely sealed state is ideal not only from the standpoint of maintaining data accuracy but also from the standpoint of preventing infections such as seroantigens.

This device can ideally solve these current problems in separating serum (or plasma), and one of its main structural features is that the portion occupied by serum (or plasma) is By making the tube into a thin tube, the serum after separation (
By making the contact area between serum (or plasma) and blood cells extremely small (for example, several fractions of a liter) compared to spiran,
This method has the advantage that the separation efficiency of blood (or plasma) can be increased, leading to a corresponding reduction in the amount of blood to be collected.

Another major structural feature of this device is that two or more of the thin tube portions are used, and their lower ends are communicated through a hollow body mainly occupied by blood cells. A sufficient amount of serum (or plasma) can be separated without increasing the height, so conventional centrifugal separators can be used as is.

Furthermore, another major structural feature of this device is that the sealing stopper at the opening of the capillary section has a locking mechanism that holds the stopper and locks it to the capillary section, and in order to increase the overall structural strength. This is because a connecting handle is attached to connect the locking joints.

A capillary tube insertion hole is provided in the locking disease.

The thin tube portion can be locked by inserting the opening of the thin tube portion into the thin tube insertion hole.

The locking tube is connected to a sealing stopper and must be flexible so that the stopper can be freely attached to and removed from the capillary opening while the sealing stopper is locked in the capillary portion.

The connecting handle is used to mechanically fix the capillary portions that are locked in the locking device, particularly by connecting the capillary insertion holes thereof to each other.

This serves to prevent twisting or other deformation of the thin tube portion during centrifugation or the like.

Therefore, it must be mechanically hard to some extent, but as will be described later, it will be separated after centrifugation, so it must be made of a material that can be cut or have a structure that allows it to be separated.

It is effective to integrally mold the sealing stopper, the locking valve, and the connecting handle.

In addition, it is desirable that the material used be one that is hard and flexible to some extent and can be cut.

Next, the present invention will be explained in more detail based on the embodiments shown in the figures.

However, this invention is not limited to this.

First, in FIGS. 1 to 4, the serum separation container 1 is integrally formed with a cylindrical connecting body part 2, a serum tubule part 3 extending in parallel upwardly from the upper surface thereof, and a serum tubule part 4 thinner than this. It is composed of a connecting joint 11, a locking joint 9, 10, and a sealing stopper 12, 13.

Hereinafter, the binding disease 11, the locking disease 9, 10, and the sealing plug 12, 13 will be collectively referred to as the frame portion 1B.

The cylindrical connecting body part 2 is a semi-hard transparent ionomer resin hollow body, the bottom surface 16 is flat so as to stand upright and have good stability, and a small opening 14, 15 is provided in the upper part to connect with the thin tube. .

The edges of these small openings and the corners of the bottom surface 16 are rounded to facilitate fluid movement.

For the same purpose, the ceiling surface 17 is rounded and convex downward.

The serum capillary tube part 3 is a vertically extending hollow cylindrical body made of semi-rigid transparent ionomer resin, and its lower end opening is integrally communicated with the small opening 14 of the cylindrical connecting body part 2 .

The opening 5 at the upper end is provided with a bulging ring-shaped part 23 whose inner diameter is slightly larger in order to fit the protrusion 20 of the sealing stopper into it, and whose outer diameter is also slightly larger in order to lock the locking ring 9 at the same time. It is.

Note that 22 is a scale at equal intervals.

On the other hand, the serum capillary tube section 4 is a vertically extending hollow cylindrical body made of semi-rigid transparent ionomer resin, has a diameter smaller than that of the serum capillary tube section 3, and its lower end opening is integrally communicated with the small opening 15.

The opening 6 at the upper end is shaped to match the shape of the tip of a syringe for blood injection.

Further, the inner diameter is slightly increased in order to accommodate the protrusion 21 of the sealing stopper, and at the same time, a bulging annular portion 19 is provided which has a slightly increased outer diameter in order to lock the locking member 10.

The frame portion 18 has a connecting disease 11 and a locking disease 9 as shown in FIG.
, 10 and sealing plugs 12 and 13 are integrally formed.

The locking sockets 9 and 10 have locking holes 7 and 8, and are locked to the thin tube portion by passing through the neck portions of the upper end openings 5 and 6 of the thin tube portion.

In this case, both the thin tubes 3 and 4 are mechanically connected to each other by the bonding disease 11, and deformation such as twisting of both tubes can be prevented.

Due to the flexibility of the locking mechanism 9゜10, the sealing plugs 12 and 13 are
Since it can be inserted into and removed from the upper end opening while being locked in the thin tube section, there is no need to remove it once it is locked, and it is convenient because it can be handled essentially as one with the thin tube section.

Next, a method of using the serum separation container 1 having the above structure will be explained.

First, the collected blood is poured into a sealing stopper 12. as shown in FIG.
In the serum separation container 1 with the serum tube 13 removed, the serum is injected from the upper end opening 6 of one of the serum capillary sections 4.

That is, in a state in which the air in the serum separation container 1 can be expelled from the upper end opening 5 of the other serum capillary section 3, the needle of the syringe (not shown) used to collect blood is removed and blood is injected from the upper end opening 6.

When the injection is completed, a sealing plug 1 is inserted into the other upper end opening 5.
2 is applied, and then a sealing plug 13 is applied to the upper end opening 6.

Next, the serum separation container 1 into which the blood has been injected is subjected to a centrifugal separator (not shown), and the blood is separated into a serum part (upper part) and a blood cell part (lower part).

B is the interface between serum and blood cells at this time.

Thereafter, a portion of the thin tube 3 slightly above the boundary surface B is crimped, and further sealed by heat fusion to separate the upper and lower portions of the tube.

In other words, only the serum (part) is separated in the upper part.

If necessary, the upper and lower portions of one of the serum tubule portions 4 are separated in the same manner.

Next, by cutting the sealed portion of the serum tubular portion 3 using scissors or the like, the serum can be completely separated.

Incidentally, at this time, the joint disease 11 is also cut.

Then, on the sample cup (not shown), remove the sealing stopper 12 of the cut serum tube and push out the serum.
Only serum can be introduced into the sample cup and used for analysis without using a pipette or the like.

In other words, serum can be fractionated simply by cutting the tubule.

On the other hand, the separation container 1 from which most of the serum tubule portion 3 has been removed can be stored in a refrigerator or the like as appropriate.

In addition, if data such as the patient's name and the date and time of blood collection are written in the locking area of the sealing stopper, storage will be ensured and space will be saved.

Note that, if it is necessary to divide the centrifuged serum into two equal parts (or three equal parts), the amount of serum to be extruded may be reduced in accordance with the scale 22 of the serum thin tube part 3.

Then, the remaining serum (after another extrusion operation in the case of dividing into three equal parts) may be extruded into another sample cup.

Here, an example of the dimensional specifications of the serum separation container 1 will be given.

Inner radius of cylindrical connecting part 2: 8 mm Minimum height = 11 Inner diameter of serum tubule part 3 x height: 6.5 mmφX9011E
ll Serum tubule part 4 inner diameter x height: 2.5 stage φ x 9oTI
rI4 full height (with sealing stopper): 104 + yoR Blood volume (serum volume): 5.2 mL Unlike the above example, it is possible to make the inner diameters of both serum tubules the same, or to reduce the number of small parts to three It can also be more than that.

Furthermore, the serum tubule portion may be slightly constricted at the location where it is to be cut so that it can be easily cut by hand.

Furthermore, although the above description has mainly been about serum separation, this container can also be used as a plasma separation container.

Of course, in this case, it is sufficient to coat the inner surface of the container with a drug such as heparin.

In that case, it is sufficient to attach a mark or the like to make it clear that it has been coated.

Furthermore, this container can also be used as a container for centrifuging urine, etc.

[Brief explanation of the drawing]

FIG. 1 is a front view including a partial vertical cross-section of the serum separation container according to this invention, FIG. 2 is a right side view thereof, and FIG. 3 is a top view.
FIG. 4 is a perspective view of the pillar portion 18. 1... Serum separation container, 2... Cylindrical connecting body part, 3.4... Serum tubule part, 5, 6...
... Upper end opening, 7.8 ... Thin tube insertion hole, 9,
10...Holding disease, 11...Connection pattern, 1
2,13... Seal stopper, B... Serum or plasma and blood cell interface.

Claims (1)

[Scope of utility model registration request] At least two thin tube portions having an opening at the upper end and extending close to each other almost vertically, and a locking tube portion and a locking tube portion each having a thin tube insertion hole inserted through the vicinity of the opening of the thin tube portions. It is composed of a sealing stopper for the opening with a connecting stem attached thereto, and a communicating body part that integrally communicates and connects the lower ends of the thin tube parts. Alternatively, a serum or plasma separation container in which the volume dimensions of each part are set so that the interface between the plasma and the blood cells located in the lower layer is higher than the vicinity of the connecting part between the communicating body part and the capillary part.