JPS59194748A - Medical container - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

Detailed Description of the Invention 10. Background of the Invention (Technical Field) The present invention relates to medical containers such as blood bags, infusion bags, and liquid drug containers for peritoneal dialysis, and particularly relates to improvements in the structure of their dispensing or transferring portions. It is something.

(Prior art and its problems) In medical containers having a dispensing or transferring part, such as blood bags, infusion bags, and liquid drug containers for peritoneal dialysis, when dispensing or transferring from one container to another, It is desired that the time required for this process be constant and without variation.

As a typical example, a blood bag will be described below.

Blood bags (double, triple, quadruple) consist of a parent bag and a child bag. After the blood collected in the parent bag is centrifuged, the plasma components are transferred to the child bag. To explain a typical configuration example of a blood bag with reference to FIG. 1, a parent bag 11 and a child bag 14 are connected to a cover tube 12.
It is connected to a connecting tube 13 through a dispensing section A, and blood is collected from a blood collecting needle 16 at the tip of another tube 15.

By the way, as shown in FIGS. 2 and 3 above the dispensing section indicated by A in FIG. The small diameter part 19 of the communicating cylinder 17 that meets the small diameter part 19 and the large diameter part 21 of the opening 20 is separated by bending and cutting off the thin wall part 22 provided at the boundary with the large diameter part 21. , the liquid storage portion 24 of the bag 11 and the connecting tube 13 are configured to communicate with each other. The flattened end 18 floats in the space of the tube 13 and is formed without blocking the tube 13.

Medical containers such as the blood bag mentioned above are sterilized in an autoclave (high-pressure steam sterilization), but at that time, the communication tube 17
The small diameter portion 19 of the tube 12 and the tube 12 may fuse together due to a phenomenon commonly called blocking caused by heat. In this case, even if the small diameter portion (occluding body) 19 of the communicating tube (sealing body) 17 is folded, the passage may not be completely opened, resulting in a problem that variations occur in the separation time of plasma components.

10. Purpose of the Invention The present invention has been made in view of the above-mentioned circumstances, and its purpose is to roughen the closing body of the sealing body to block the gap between the cover tube and the closing body. The object of the present invention is to provide a medical container that eliminates this problem and greatly improves the variation in time required for dispensing or transferring after the closure is cut off.

10 Specific Structure of the Invention According to the present invention, a container body containing a liquid therein;
A tube connected to the container body and having a flow path communicating with a liquid storage portion in the container body, and a flow path sealing body fixed in a liquid-tight state within the tube? Is the sealing body a separable closing body that opens the flow path and allows complete flow of liquid?
A medical container comprising gold on the entire outer surface of the closure,
All of the above objects can be achieved by roughening the surface of the closure so that the surface area that can come into contact with the tube is 50% or less of the total external surface area of the closure.

Hereinafter, a representative example of a medical container whole blood bag according to the present invention will be described in detail with reference to the accompanying drawings.

As explained with reference to FIGS. 1 to 3, the problem is that blocking occurs between the cover tube 12 and the small diameter portion 19 of the communicating tube 17 that is to be separated and floated during autoclave sterilization, which is the cause of Q. Some things are as mentioned above.

Therefore, in the present invention, in order to completely prevent the above-mentioned blocking, the small diameter portion of the communication tube 17 is designed to prevent the above-mentioned blocking. The surface of tube 9 is roughened to prevent it from blocking against tube 12.

In addition, the communication cylinder which is a sealing body and the small diameter part 1 which is a closing body
The structure of 9 is not limited to what is shown in the drawings, and the closing body that is separated from the sealing body is integral with the sealing body to block the communication path before the separation, but after the separation, the two are separated and communicated with each other. It is fine as long as it opens the passage.

FIG. 4 shows the structure of a communicating tube (sealing body) and its small diameter portion (closure body) that meet the purpose of the present invention.

The one shown in Figure 4 is the same as the one shown in Figures 2 and 3, so is it the same number? This is shown using The essential difference between the two is that the entire surface of the small diameter portion 19 of the communicating tube 17 is roughened.

As shown in FIG. 5, the rough surface processing referred to here refers to all processing in which the surface is composed of convex portions 25 and concave portions 26, and only the convex portions 25 can come into contact with the cover tube 12. , Grooved means processed, ribbed means processed, etc., and the arrangement of the convex portions and concave portions is also arbitrary. in short,
By forming the recess 526, the surface area of the small diameter portion 19 of the communication tube 17 that can come into contact with the cover tube 12 is completely eliminated, thereby completely preventing blocking. As a result, as will be described later, variations in plasma separation time can be significantly reduced, achieving the intended purpose.

Generally, soft vinyl chloride resin is used as the material for blood bags and tubes, and therefore blocking tends to occur. The communicating tube is preferably made of a hard material such as hard vinyl chloride or polycarbonate resin that is not made of the same material as the bag or tube. Polycarbonate is particularly suitable for ease of handling when folding and bending. and the proportion of the recess 26, i.e. the contactable surface with the cover tube 12! We carried out all experiments to find out what level of R should be set to prevent blocking and ensure no variation in the time required for dispensing, and the following results were obtained.

Next, using a communicating tube as shown in Figure 4, we created one with countless vertical ribs extending in the axial direction on the entire outer surface of the cylindrical small diameter part of the communicating tube of the polycarbonate shank, and one without. did. Note that the radius of the circle of the cross section of the small diameter portion was the distance from the center to the outer surface of the rib, and was the same as that in the case where no rib was formed. The contact area of the small diameter part with the tube was measured by bringing the small diameter part into close contact with the inner surface of the tube, and the ratio of the small diameter part without ribs to the total external surface area was determined.Six types of zombles were prepared. Prepare a parent bag with each communication cylinder and conduct a test according to the same method as the above-mentioned test method.
The incidence of blocking and the variation in separation time (standard deviation) were measured. All results are shown in Table 1.

Table 1: a: Surface area of the small diameter portion of the communicating tube that can be contacted with the cover tube (ii) Total external surface area of the small diameter portion of the communicating tube As a result, the surface area of the small diameter portion of the communicating tube that can be contacted with the tube is 50% of the total external surface area. For the following, the blocking occurrence rate is 3% or less, and the standard deviation of separation time is 2.
．． It was stable at around 4, and in practice, the variation in separation time due to blocking in the small diameter portion was improved.

In the present invention, the contactable surface area of the small diameter portion with the tube can be determined by bringing a sheet of soft polyvinyl chloride or the like into close contact with the outer surface of the small diameter portion and measuring the contact area per unit area. Also, the obturator (small diameter part)
For convenience, the total external surface area of is equal to the total external surface area of a small diameter portion of the same diameter that is not subjected to surface roughening.

(1) Specific Effects of the Invention When using the blood bag of the present invention, the blood bag is centrifuged after surface sampling, and the large diameter portion 21 of the communicating tube 17 is
Then, the small diameter part 19 is folded by hand, and the small diameter part 19 is separated from the large diameter part 21 to form a communication path and the plasma is separated.
). At this time, if there is blocking between the cover tube 12 and the small diameter portion 19, the separated small diameter portion 19 will not float sufficiently within the cover tube 12, and the communication path will not be opened sufficiently, resulting in variations in separation time. Is it blocking between cover tube 12? Therefore, after separation, the small diameter portion 19 easily floats up within the cover tube 12 to form a complete communication path, so that no noise occurs due to variations in plasma separation time. In order to fully confirm this, we conducted the following tests.

(1) Test sample (1-1) Product of the present invention It was less than 0.05%.

(1-2) Comparative Example Using a communicating cylinder made of hard vinyl chloride as shown in Figures 2 and 3, is the small diameter part of the communicating cylinder completely roughened? Not administered.

(2) Confirmation method Using the above sample, approximately 30 cc of air was poured into the parent bag and the child bag, followed by autoclave treatment. Thereafter, all 200 gallons of water was poured into the parent bag, and the air in the child bag was removed. Next, the parent bag was set on the separation stand, and the small diameter part of the communication cylinder was broken to allow communication. The parent bag was pressurized at a predetermined pressure on a separation stand, and the time required for the 150-degree separation transition was measured. The amount of separated liquid was measured by placing the child bag on a top balance and measuring the amount of change in weight. The levitation state of the small diameter part of the separated communication tube at the start of separation was visually confirmed.

(3) Results The above confirmation test results are shown in Table 2. As can be seen from this table, in terms of separation time, the product of the present invention was 3 times longer than the comparative example.
The separation time has been reduced by 0%, and the variation (standard deviation) in separation time has been reduced to about the current value, resulting in a significant improvement in performance. Regarding the mobility of the separated small-diameter portion of the communicating tube, visual observation revealed that all of the products of the present invention floated completely to the end, that is, to the position of the connecting tube 13, but in the comparative example, about 80% of the parts floated halfway. It was confirmed that blocking had occurred.

Table 2 ■1 Specific Effects of the Invention The medical container having a sealing body closure body with a roughened surface according to the present invention has the following advantages compared to a conventional product without a roughened surface. It had such a remarkable effect.

(1) As is clear from the above-mentioned confirmation test, it was pointed out that the separation time was conventionally too long, but according to the present invention, the separation time was sufficiently shortened and the problem was solved.

(2) As is clear from the above-mentioned 2nd test, the variation in separation time was conventionally too wide, but according to the present invention, it has been greatly improved and a homogeneous product can now be obtained.

(3) 1, the buoyancy of the small diameter part of the separated communicating tube is
It was confirmed that the product of the present invention had no problems like the conventional products and was perfect. That is, it was found that no blocking occurred between the cover tube and the communicating tube due to the surface roughening effect.

(4) As described above, all the conventional problems have been solved by the simple and inexpensive process of roughening the communicating cylinder, and it has become possible to obtain a homogeneous layer weight.

[Brief explanation of drawings]

Figure 1 is a plan view showing the double blood bag, Figure 2 is the top view of the double blood bag.
FIG. 3 is a cross-sectional view taken along line 1-■ in FIG. 2, and FIG. 4 is a roughened closure body used in the medical container of the present invention. FIG. 5 is a partial cross-sectional side view of an example of a structure of a sealed body having a structure, and FIG. 5 is a schematic cross-sectional view of a roughened surface. Explanation of symbols 11... Parent bag, 12... Cover tube, 13
... Connecting tube, 14... Child bag, 15...
Blood collection tube, 16...Blood collection needle, 17...Communication tube,
18... Sealed Song end, 19... Small diameter part, 20... Opening, 21... Large diameter part, 22... Thin wall part, 23...
Adhesive, 24--Liquid storage section, 25...Convex portion, 26
... Concave patent applicant Chill Seven Co., Ltd./Lee, "・External patent attorney Watari 2 Nozomi Minoru 1, /-: Country 2 Map
Castle 3

Claims (1)

[Claims] (1) A container body containing a liquid therein, a tube connected to the container body and having a full flow path communicating with the liquid storage portion in the container body, and fixed in a liquid-tight state within the tube. A medical container having a separable closure member that completely opens the flow path to allow full flow of liquid, wherein the entire outer surface of the closure member is A medical container characterized in that the surface of the closure body is roughened so that the surface area that can come into contact with the tube is 50% or less of the total external surface area of the closure body.