JPH0461660B2 - - Google Patents

Description

BACKGROUND OF THE INVENTION (Technical Field) This invention relates to medical containers and methods of manufacturing the same. (Prior art and its problems) The discharge ports and mixed injection ports of medical containers such as blood bags and infusion bags are equipped with internal passages with a closing membrane that can isolate them from the outside so that the inside of the container is maintained in a sterile state until just before use. In preparation for this, during use, communication with the outside is made possible by piercing this occlusive membrane with a puncture needle or the like. Conventionally, tubular bodies such as such discharge ports and mixed injection ports are made by injection molding the tubular part of the tubular body using thermoplastic synthetic resin such as soft vinyl chloride resin, and then molding the tubular body with resin of the same material in advance. The thin films produced were conventionally fused and molded using high-frequency fusion, but the process was complicated and the sealing stability was lacking. In addition, when a tubular body with an occlusion membrane is integrally molded by injection molding, the occlusion membrane is molded so thick that when a plastic puncture needle or the like is used to pierce the occlusion membrane, the puncture needle may bend. In addition, there were problems such as high puncturing resistance, making puncturing operations difficult.
Furthermore, in order to solve these problems, the present inventors have tried to make a prototype of what is shown in FIGS. 5 to 7. Obstruction membrane 2 provided for the internal passage of section 1
The wall thickness of the tubular part 1 is, for example, about 0.5 mm.
For example, since the wall thickness is significantly thinner than that of about 1 mm, the gate part to the mold cavity, which is the empty part to be filled with resin, is the tubular part 1a in contact with the closing membrane 2.
Even if the resin is located at the closing membrane 2 portion of the mold cavity, it is difficult for the resin to flow smoothly into the closing membrane 2 portion of the mold cavity, and there is a problem that molding defects called so-called membrane cracking in which the membrane is not completely closed are likely to occur. That is, in the method of molding a tubular body with such a closing membrane inside, the molten resin first flows from the gate to the tubular part 1 with a large gap, whereas the resin flows around the closing membrane 2 part. The process was slow and insufficient, and furthermore, gas ended up remaining in the slow closing membrane 2 around the resin, resulting in membrane cracking. Purpose of the Invention The present invention has been made in view of the above circumstances, and provides a new method of injection molding as described above that allows forming a thin film, prevents film cracking, and facilitates puncturing operations. The main object of the present invention is to provide a tubular body equipped with an occluding membrane therein, a method for manufacturing the same, and a medical container equipped with this tubular body. That is, the present invention provides a medical container having a container body and a mouth tubular body protruding from the container body, wherein the mouth tubular body includes an injection molded tubular part;
penetrably blocks the internal passage of the tubular portion, and
an occlusion membrane integrally injection molded with the tubular section, further comprising a plurality of gate positions formed substantially coplanar with the occlusion membrane forming section, and a plurality of gate positions of the tubular section and the occlusion membrane formed thereon; so that the thickness of the nearby side wall is equal to or less than the thickness of the occlusion membrane,
The present invention provides a medical container characterized by being formed thinner than the surrounding tubular portion. Furthermore, the present invention is directed to the production of a medical container having a container body and a mouth tubular body which is protruded from the container body and has a closing membrane that can be pierced into an internal passage surrounded by the tubular part. The method comprises: providing a gate position to a mold cavity at a tubular part portion in contact with the occlusive membrane; and a mold cavity at this gate position and a mold of a tubular part forming part in the vicinity thereof in the mold cavity of the tubular part forming part. By injection molding using a mold in which the thickness of the cavity is locally made thinner than the periphery so that the thickness of the cavity is equal to or less than the thickness of the mold cavity in the part where the occlusive membrane is formed, the tubular body for the mouth part is manufactured. Provided is a method for manufacturing a medical container, which comprises: molding the mouth tube, and then fusing the molded mouth tubular body to the peripheral edge of the container body so as to communicate with the inside of the container body. It is something to do. Further, as an embodiment of the medical container of the present invention, the medical container is formed by injection molding using a mold in which the thickness of the entire circumference of the side wall of the tubular portion in contact with the occlusion membrane is equal to or less than the thickness of the occlusion membrane. The present invention provides a tubular body provided with an occlusive membrane therein, and a medical container provided with this tubular body. DETAILED DESCRIPTION OF THE INVENTION The present invention will be described in detail below with reference to the drawings. The medical container 3 of the present invention is formed as shown in FIG. Here, the container 3 is one used for medical purposes, such as a blood bag or an infusion bag,
It consists of a body 4 such as a flexible bag. This main body 4 is made by overlapping a pair of preferably transparent sheets of synthetic resin (preferably soft vinyl chloride resin, ethylene-vinyl acetate copolymer, etc.) and fusing their peripheral edges to form a bag-shaped structure. is formed. In this case, the main body 4 accommodates an anticoagulant solution, etc., if necessary, and also includes a known structure connected to a medical container such as a voting tube 9 having a voting needle 95 at the tip, if necessary. provided. On the other hand, the main body 4 is provided with one or a plurality of tubular bodies 10 for discharge or mixed injection in fluid-tight connection. The tubular body 10 usually has a hollow cylindrical shape, is generally made of synthetic resin (preferably soft vinyl chloride resin, ethylene-vinyl acetate copolymer, etc.), and has one end communicating with the main body 4 through an opening, and the other end. The end opens to the outside of the main body 4. In this case, as shown in FIG. 7, a closed chain 2 is provided in the middle of the tubular body to prevent the contents, such as blood and transfusion fluid, from flowing out. Further, a part of the tubular body protrudes outside the main body, and a part is fused and fitted so as to communicate with the inside of the main body 4. The protruding portion of the tubular body 10 is hermetically covered with a protective bag 5 preferably made of a transparent, fusible synthetic resin (preferably soft vinyl chloride resin or ethylene-vinyl acetate copolymer resin). wrapped. The protective bag 5 usually includes a pair of sheets 5.
1 and 55 are joined together to form a bag body that airtightly encloses the protruding end of the tubular body 10. One end of the sheet 51 on one side of the protective bag 5 is fused to the protruding end side of the protective bag 5,
Also, with the free tip 65 remaining at the other end, an openable seal is formed and made of synthetic resin that can be fused (preferably soft vinyl chloride resin or ethylene-vinyl acetate copolymer resin). opening tab 6
are joined. Next, the tubular body provided with an occlusion membrane inside according to the present invention will be described in more detail. FIG. 1 is a partial cross-sectional view of a mold 11 for injection molding a tubular body having an occluding membrane therein;
The core pin 20 is slidable up and down, and the mold is shown in a closed state. This mold 11 forms a cavity 12 that conforms to the desired shape of the tubular body. That is, a space is formed for the occluding membrane part 14 that blocks the internal passage of the tubular part 13. The mold 11 has a pair of gates 1 for introducing molten resin into the cavity 12.
5, as shown in FIGS. 1 and 2, the occlusive membrane part 1
4 (that is, the tubular portion 13 in contact with the occlusive membrane portion 14). Here, as the material for the mold, carbon steel for machine structures, carbon tool steel, nickel chrome steel, Swedish soybean steel, etc. are used, and it is preferable to use the above-mentioned steel materials, which have been quenched and annealed as necessary. As the molten resin, a resin heated to a temperature higher than the melting point of various thermoplastic synthetic resins is used, and preferred examples of the various thermoplastic synthetic resins include soft vinyl chloride resin and ethylene-vinyl acetate resin. Furthermore, the thickness "A" of the cavity of the tubular portion 13 around the tip of the gate 15 is thinner than other parts of the tubular portion, and the thickness of the cavity 13 forming the occluding membrane portion 14 is smaller than that of the other portion of the tubular portion.
The thickness is equal to or less than "B". When injection molding is performed using a mold having such a configuration, the flow of the molten resin introduced into the cavity 13 from the gate 15 into the tubular part 13 having a thickness of "A" is suppressed, and the molten resin is suppressed from flowing into the tubular part 13 having a relatively small flow resistance. The resin flows preferentially through the occluding membrane portion 14 having a thickness of “B” and then merges with the molten resin flowing from the tubular portion 13 having a thickness of “A” to fill the entire tubular portion 13 . As a result, as shown in FIG. 3, a tubular body 10 is formed in which the tubular portion 13a in the vicinity of the gate 15 is thinned, but there is no risk of membrane cracking of the closure membrane 16. Note that the thickness of the tubular portion 13 is preferably 0.7
The thickness "A" of the tubular part 13a and the range of the tubular part 13 are not particularly limited as long as they do not pose a problem for the practical use of the molded product (preferably 0.4 mm to 0.6 mm). For example, as shown in Fig. 4, over the entire circumference 17 of the mold cavity in the part corresponding to the tubular part in contact with the occlusive membrane, the thickness "A" is equal to the thickness of the mold cavity in the part where the occlusive membrane is formed. It may be made to be equal to or lower than "B". However, the distance shall be 0.4m/m or more. In a tubular body molded using such a mold, an annular groove is formed on the circumferential surface of the tubular body on the side of the occlusion membrane. The number of gates set in the cavity may be one instead of the two in the above embodiment, or three or more gates may be provided at equal intervals. Next, the present invention will be explained in more detail with reference to Examples. Embodiment A tubular body 10 as shown in FIGS. 2 to 4
A container of the present invention having the following structure and a comparative container having the tubular body 10 shown in FIG. 5 were manufactured. In this case, the tubular body 10 according to the first aspect of the present invention is made of soft vinyl chloride resin, has an inner diameter of 5 mm, an outer diameter of 7 mm, a length of 30 mm in the longitudinal direction of the tubular body 10, and a middle part of the tubular body 10 in the longitudinal direction. The thickness of the occlusion membrane 16 provided at the occlusion membrane 16 was set to 0.5 mm, and the thickness of the portion 13a near the gate in contact with the occlusion membrane was 0.5 mm. It was manufactured by integrally molding it by injection molding. Tubular body 10 as a second aspect according to the present invention
is made of soft vinyl chloride resin and has an inner diameter of 5 mm, an outer diameter of 7 mm, and a length of 30 mm in the longitudinal direction of the tubular body 10.
It was manufactured by injection molding, with a thickness of 0.5 mm for the occlusion membrane 16 provided at the longitudinally intermediate portion, and a wall thickness of 0.4 mm for the side wall portion A of the tubular part extending over the circumference in contact with the occlusion membrane. On the other hand, the tubular body 10 of the comparison container is made of soft vinyl chloride resin and has an inner diameter of 5 mm and dimensions.
The outer diameter is 7 mm, the length in the longitudinal direction of the tubular body 10 is 30 mm, and the thickness of the occlusion membrane 2 provided at the middle part in the longitudinal direction is 0.5 mm.
As in the present invention, the gate positions were manufactured by injection molding using a pair of molds provided at equal intervals. 200 of each of the three types of tubular bodies produced in this manner were observed for the occurrence of membrane cracking defects. These results are shown in Table 1 below.

[Table] Furthermore, the tubular body 10 according to the first aspect of the present invention
and a comparative container with a tubular body in which the side wall thickness 1a of the tubular body was 1.2 mm and the wall thickness of the closing membrane 2 was 1.0 mm to avoid membrane cracking, and a container made of plastic. Perform the puncture operation using a puncture needle (Blood transfusion set type 1 manufactured by Terumo Corporation),
The piercing operability was sensually observed. These results are shown in Table-2.

[Table] From the above results, it can be seen that the container of the present invention is a medical container having a tubular body that not only prevents membrane cracking but also facilitates the puncturing operation. To explain how to use the medical container of the present invention, when using it as a discharge port, the medical container 4
Remove the opening tab 6 provided on the tubular body 10 to expose the tubular body 10, and use a plastic puncture needle provided in a blood transfusion set (sold separately) to penetrate the occlusive membrane of the tubular body 10 and connect it to perform a transfusion of the collected blood. Also, when used as a mixed injection port, the same operation is performed to mixedly inject preservation solution, etc. Effects of the Invention As detailed above, the container body includes a tubular body provided in the container body, and the internal passage of the tubular part is blocked;
In addition, the puncture operation can be facilitated by making the thickness of the pierceable occlusion membrane at least at the side wall near the gate equal to or less than the thickness of the occlusion membrane. Furthermore, by configuring the injection mold with the above-mentioned wall thickness, it is possible to provide a tubular body that has the effect of facilitating the inflow of the injection molding resin from the gate and eliminating the occurrence of membrane cracking in the closing membrane. Furthermore, by providing two or more equally spaced gates that communicate the injection mold with the mold cavity, the injection molding resin can flow more easily through the gates, thereby preventing the occurrence of cracks in the closing membrane. It is possible to provide a tubular body that has disappeared. In addition, over the entire circumference of the side wall of the tubular part in contact with the occlusive membrane,
By making the thickness equal to or less than the thickness of the occluding film, it is possible to stably and easily infuse the resin for injection molding, and the tubular shape has the effect of completely preventing the occurrence of cracks in the occluding film. I can donate my body.

[Brief explanation of drawings]

FIG. 1 is a cross-sectional view of a mold used for molding the tubular body of the present invention, FIG. 2 is a cross-sectional view taken along the - line in FIG. 1, and FIG. FIG. 4 is a cross-sectional view corresponding to FIG. 2, FIG. 5 is a cutaway perspective view of a conventional tubular body, and FIG. 6 is a cross-sectional view of a conventional tubular body. Front view of medical container, Fig. 6
FIG. 3 is a sectional view taken along the line -' in the figure. DESCRIPTION OF SYMBOLS 1...Tubular part, 1a...Tubular part in contact with the occlusive membrane, 2...Occluded membrane, 3...Medical container, 4...Container body, 5...Protective bag, 6...Tab for opening, 10
... Tubular body, 11 ... Mold, 12 ... Cavity, 13 ... Tubular part, 14 ... Occlusion membrane part, 15 ...
...Gate, 16...Closing membrane, 17...Mold cavity entire circumference, 20...Core pin.

Claims (1)

[Scope of Claims] 1. A medical container comprising a container body and a spout tubular body protruding from the container body, wherein the spout tubular body includes an injection-molded tubular part;
penetrably blocks the internal passage of the tubular portion, and
an occlusion membrane integrally injection molded with the tubular section, further comprising a plurality of gate positions formed substantially coplanar with the occlusion membrane forming section, and a plurality of gate positions of the tubular section and the occlusion membrane formed thereon; so that the thickness of the nearby side wall is equal to or less than the thickness of the occlusion membrane,
A medical container characterized in that the wall is thinner than the surrounding tubular portion. 2. A method for manufacturing a medical container having a container body and a mouth tubular body which is provided in a protruding manner on the container body and has an occlusive membrane that can be penetrated into an internal passageway surrounded by a tubular part, the method comprising: The gate position to the mold cavity is provided in the tubular part that contacts the above-mentioned occlusion membrane, and the thickness of the mold cavity in the tubular part forming part at this gate position and in the vicinity of the mold cavity in the tubular part forming part is set as above. The tubular body for the mouth is formed by injection molding using a mold that is locally made thinner than the surrounding area so that the thickness is equal to or less than the thickness of the mold cavity in the area where the occlusive membrane is formed, and then . A method for manufacturing a medical container, characterized in that the molded mouth tubular body is fused to the peripheral edge of the container body so as to communicate with the inside of the container body. 3 Gates are provided at two or more equally spaced locations, and the thickness of the mold cavity in the tubular portion forming portion near each gate is locally thinned to be equal to or less than the thickness of the mold cavity in the above-mentioned occlusive membrane forming portion. 3. The manufacturing method according to claim 2, wherein injection molding is performed using a mold. 4. The manufacturing method according to claim 2, wherein the locally thinned portion of the mold cavity is formed in an annular shape over the entire circumference of the mold cavity in the closing membrane forming portion.