JPH07155362A - Rupturing and communicating device - Google Patents

Abstract

PURPOSE:To improve adhesiveness to vessels composed of polyolefin polymers for blood, medicinal liquid, etc. CONSTITUTION:A substantial communicating part (1) which is used for connecting the vessels for preserving liquids, such as blood and medicinal liquid, and tubes transporting these liquids, tubes to each other and the vessels to each other and consists of a polypropylene material having >=30 melt flow rate measured under conditions of 230 deg.C and a load (2) of 160g communicates the liquids by rupture of a closing part 4 at a brittle part 3.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is installed in a connecting portion between a liquid conveying tube and a container, a connecting portion between containers and a container, and a liquid conveying tube which are handled in the medical field such as blood and medical liquid. The present invention relates to a rupture communication device capable of maintaining communication between a tube or tubes and a container or between containers and a container by maintaining a closed state and breaking.

[0002]

2. Description of the Related Art In the medical field dealing with liquids such as medical liquids and blood, it does not come into contact with the outside air unlike a closing member disclosed in Japanese Patent Publication No. 2-37780 as means for aseptically communicating liquids with each other. A breaking communication device having a breaking communication tube that breaks and opens by a force applied from the outside in a state is often used.

On the other hand, as materials for the infusion container, the blood component storage container and the tube used by connecting to them in the medical field as described above, at present, drainage in a closed system, operability, impact resistance, etc. In this respect, soft polyvinyl chloride, which is highly transparent and flexible, is the mainstream, and other soft plastics such as low density polyethylene and ethylene vinyl acetate copolymer are often used.

However, in recent years, soft polyvinyl chloride has been pointed out to have problems such as elution, coloring, and disposal of plasticizers. In order to solve these problems, the transition to polyethylene-based materials such as polyethylene and polypropylene is rapidly progressing. It is well known that the progress has been made, but in spite of this, new problems have arisen regarding the material of the connection parts,
The current situation is that no consideration has been made.

The problem here is that when the container or tube is made of soft polyvinyl chloride, a rigid polyvinyl chloride containing a relatively small amount of plasticizer (rich in brittleness and easy to break) is used as the connecting pipe. However, when the container / tube is made of a polyolefin-based polymer, it is difficult to bond and bond with hard polyvinyl chloride. Further, hard polyvinyl chloride itself has the same reasons as soft polyvinyl chloride (elution of plasticizer, disposal treatment, etc.), and needless to say, it is desired to avoid using it.

Besides hard polyvinyl chloride, polycarbonate, polystyrene and the like can be cited as candidates for the material, but these are also difficult to bond to polyolefins such as polyethylene and polypropylene like hard polyvinyl chloride.

[0007]

SUMMARY OF THE INVENTION In order to provide a breakage communication device in which the above-mentioned problems of the prior art have been solved, the present invention substantially changes the material of the communication pipe itself to an adhesive property with a polyolefin polymer. The point is to select a material that is both excellent and easy to dispose of.

[0008]

DISCLOSURE OF THE INVENTION The gist of the present invention is to provide a break communication including a liquid transfer tube and a liquid transfer tube and / or a liquid storage container and a communication pipe provided in the liquid storage container. In the device, the communication pipe has a hollow shape with one end closed, and the communication pipe is not in contact with the inner wall surface of the liquid transport tube or the inner surface of the liquid storage container. An outer wall surface, an inner wall surface of the liquid transfer tube, and an outer peripheral wall portion that is in close contact with the entire circumference in the circumferential direction or the sealing portion of the liquid storage container. The outer wall surface on the closed portion side and the outer wall on the open portion side. An annular thin portion that separates the closed portion side by a force applied from the outside of the liquid transport tube and / or the liquid storage container near the boundary with the portion and connects both ends of the communication pipe , The temperature of the communicating pipe is 230 ℃, the load Melt flow rate was measured under the conditions of 160g is breaking communication apparatus of 30 or more polypropylene, by adopting such a configuration,
It is a rupture communication device that has excellent adhesiveness to a tube and / or container made of a polyolefin-based polymer and is easy to dispose of.

The polypropylene (hereinafter referred to as PP) used in the present invention generally has a hinge property remarkably superior to other polymers, but has a high melt flow rate (hereinafter referred to as MFR). In the (low molecular weight range), brittleness increases, and it becomes possible to break. The present invention skillfully utilizes this property, and if the container or tube is made of PP-based polymer, it is possible to easily join and bond, and the effect is great.

The PP used in the present invention is a crystalline PP produced by a generally known method. Generally, PP is an isotactic crystalline PP, but in the present invention, it is syndiotactic. It goes without saying that even a crystalline PP of the type does not violate the spirit of the present invention. PP
Any of a homopolymer, a random copolymer and a block copolymer may be used, but a homopolymer is particularly preferable. This is because the copolymer has increased flexibility and is less likely to break (especially in the case of a block copolymer, the breakability decreases). Therefore, when a copolymer is used, it is preferable that the amount of comonomer is small (preferably 4 mol% or less). As the comonomer, α-olefins such as ethylene, butene-1, hexene-1, octene-1, 4-methylpentene-1 are usually used.

In the present invention, the melt flow rate of PP (hereinafter referred to as MFR) was measured according to JISK7058. Generally, when the MFR value is low, the brittleness is low, and particularly when PP is used, it has a hinge property and is difficult to break.
On the other hand, if the MFR is too high (as is often the case when the MFR exceeds 80), the moldability and the strength of the molded product may be reduced. Formability in consideration of this point,
When it is used as a material for a communication device that is used after being fractured as in the present invention due to the mechanical properties of the base material, the MFR measured under the conditions of a temperature of 230 ° C. and a load of 2,160 g is preferably 3
A range of 5 to 80, more preferably 40 to 70 is suitable.

The breaking communication device of the present invention will be described below with reference to the drawings.

In the breakage communication device of the present invention, the communication pipe 1 is shown in FIG.
As shown in FIGS. 3 and 4, by disposing the tubes 5 and the liquid storage container 6, respectively, an example of a tube break communication device, a tube liquid storage container break communication device, and a liquid storage container break communication device is shown. It was

FIG. 1 is a partial cross-sectional side view of an example of a communication pipe used in the breakage communication device of the present invention, in which the communication pipe 1 is circumferentially aligned with the inner surface of the tube 5 or the inner surface of the seal portion of the liquid storage container 6. Hollow-shaped portion 2 having an outer surface portion that adheres to the entire surface
A closed portion 4 having an outer surface continuous with the outer surface portion, extending in the axial direction, and having a maximum outer diameter smaller than the outer diameter of the hollow shape portion; It is composed of a thin portion 3 formed so as to be broken by an external force connecting the hollow shape portion 2 and the closing portion 4. The shape of the communication tube used for such an application, particularly the shape of the communication tube, varies somewhat depending on the application, especially the flow rate flowing through the communication tube, but usually the inner diameter of the communication tube is preferably 1 to 15 m.
mφ is preferable, and 2 to 10 mmφ is more preferable. The thickness of the thin portion is preferably 0.2 to
0.7 mm is more preferable, and 0.3 to 0.6 mm is more preferable.

Further, in the case of the use of the present invention, the length of the communicating pipe is ruptured by hand at the time of use, so that the length of both of them is 1 at the thin portion as a boundary.
It is preferably 0 mm or more for its use.

The communicating tube is usually manufactured by injection molding, but it goes without saying that the molding method is not limited.

It goes without saying that the communicating pipe does not depart from the gist of the present invention even if a pigment, a dye or the like is kneaded with the raw material in order to clarify its existence.

FIG. 2 is a partial cross-sectional side view of the tube breaking and communicating device, which is an example of the present invention, in which a part of the communicating pipe 1 and an outer surface part thereof are in close contact with the inner wall of the tube 5. At the time of use, by applying a force from the outside of the tube 5, the thin portion 3 is broken and the closed portion 4 is separated from the communicating pipe main body or is broken while leaving a part thereof, whereby the fluid in the tube can be communicated. It is preferable that the outer surface of the closed portion 4 separated from the main body of the communicating tube has a stripe-shaped concave-convex groove or a matte surface so as not to adhere to the inner surface of the tube.

FIG. 3 is a partial cross-sectional side view of a broken communication device between tube liquid storage containers, which is an example of the present invention, in which a part of the outer surface of the communication pipe 1 is embedded in a seal part of the liquid storage container. There is.

FIG. 4 is a partial cross-sectional side view of a breakage communication device between liquid storage containers according to an example of the present invention, in which a part of the outer surface of the communication pipe 1 forms a first liquid storage container and a second liquid storage container. It is embedded in the defining seal portion, and it becomes possible to mix the liquids in both liquid storage containers by breaking by the external force during use. Although two communication pipes are provided in this figure, it is preferable to have at least two communication passages in order to mix the liquids in both containers. Further, since the closed portion 4 of the communication pipe 1 may float in the container after being broken, it is preferable that the closed part 4 is located on the container side that is not in direct communication with the liquid outlet.

The container / tube is made of a material other than PP,
For example, in the case of polyethylene type, it is possible that the PP and the broken communication pipe are joined and adhered by interposing, for example, an ethylene-propylene copolymer between the container / tube and the broken communication pipe.

[0022]

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited thereto.

(Examples 1 and 2, Comparative Examples 1 and 2) (1) Preparation of Communication Pipe A PP (homopolymer) fracture communication pipe having the shape shown in FIG. 1 was obtained by ordinary injection molding. Except for the thin portion of the broken communication tube, the outer diameter is 6.0 mm and the inner diameter is 3.5 mm, and the wall thickness of the thin portion is 0.4 mm. The total length is 40 mm
The thin-walled portion is located almost in the center.

(2) Evaluation method of communicating tube The communicating tube produced in (1) was held by both hands with the thin portion in the center and "folded" (atmosphere: 25 ° C x 65%).
RH). One communication pipe made for each condition (MFR)
The operation of “folding” each by 0 pieces was performed, and the number of thin pieces that were only bent and did not break (holes could not be opened and communication paths could not be secured) was counted.

Heavy metal and eluate test: In accordance with the Japanese Pharmacopoeia general test method “Plastic container test method for infusion”,
A test was conducted on the communication pipe manufactured in (1).

(3) Experimental results (see Table 1) The injection molding of the communicating pipe was carried out smoothly. No foreign matter, foaming, shrinkage, cracks, etc. were observed in any composition, and the appearance and dimensional accuracy were confirmed. I got something without any problems.

It was confirmed that the results of heavy metals and eluates were compatible with the Japanese Pharmacopoeia in any composition.

As shown in Table 1 showing the relationship between the MFR and the number of unbreakable samples, good results were obtained when the MFR was 30 or more.

[0029]

[Table 1]

[0030]

As described above, the breaking and communicating device of the present invention uses PP as the material and adopts MFR of 30 or more so that the breakage is not impaired and the tube and the container made of polyolefin are not damaged. It is achieved by a communication pipe that enables reliable joining of the products, naturally does not impair the good moldability as in the past, and does not cause elution of plasticizers and is easy to dispose of. Some have high value.

[Brief description of drawings]

FIG. 1 is a half cross-sectional view showing an example of the configuration of a breaking communication pipe portion in a breaking communication device of the present invention.

FIG. 2 is a partial cross-sectional view showing an example of the breaking and communicating device of the present invention incorporated into a tube.

FIG. 3 is a partial cross-sectional view showing an example of the breaking and communicating device of the present invention incorporated into a container.

FIG. 4 is a partial cross-sectional view showing an example of the breaking and communicating device of the present invention incorporated into a container.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Breaking communication pipe 2 Hollow shape part 3 Thin part 4 Closure part 5 Liquid transfer tube 6 Liquid storage container 6A First liquid storage container 6B Second liquid storage container 7 Liquid outlet

Continuation of the front page (51) Int.Cl. ⁶ Identification code Office reference number FI Technical display location A61M 39/02 A61J 3/00 314 B A61M 5/14 459

Claims (1)

[Claims] 1. A breakage communication device comprising a liquid transfer tube and a liquid transfer tube and / or a liquid storage container and a communication pipe provided in the liquid storage container,
The communication pipe has a hollow shape with one end closed, and an outer wall surface of the communication pipe on the closed portion side that does not substantially contact the inner wall surface of the liquid transport tube or the inner surface of the liquid storage container. A boundary portion between the outer wall surface on the side of the closed portion and the outer wall portion on the side of the open portion, which has an outer wall portion on the opening portion side in close contact with the entire circumference of the inner wall surface of the transfer tube in the circumferential direction or the seal portion of the liquid storage container. In the vicinity, there is an annular thin portion that separates the closed portion side by a force given from the outside of the liquid transport tube and / or the liquid storage container, and connects both ends of the communication pipe, A breaking and communicating device made of polypropylene having a melt flow rate of 30 or more measured at a temperature of 230 ° C. and a load of 2,160 g.