JPH1179258A - Medical partition wall bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make peel characteristics of an easy peel part constant to prevent the generation of an inferior product such that the easy peel part is peeled carelessly. SOLUTION: A medical partition wall bag 1 comprises one drug housing part 2 and other drug housing part 3 mutually isolated by a partition wall part 4 consisting of an easy peel part 5 having easy peel properties and the strong fusion parts 6 connected to both ends of the peel part 5 in the longitudinal direction thereof. This medical partition wall bag 1 is obtained by integrally molding one drug housing part 2 and the other drug housing part 3 mutually connected by a non-fused easy peel part preforming part and the strong fusion parts 6 connected to both ends in the longitudinal direction thereof by blow molding and thermally fusing the easy peel part preforming part to form the easy peel part 5. A ratio a/L of a length (a) in the longitudinal direction of the easy peel part 5 and a length L in the longitudinal direction of the partition wall part 4 is within a range of 0.2-0.6.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for storing different types of drugs such as high-calorie infusions for medical use (hereinafter referred to as "drugs") so as not to be mixed with each other. TECHNICAL FIELD The present invention relates to a medical bulkhead bag devised so that mixing can be performed by aseptic operation such as pressing with a squeeze.

[0002]

2. Description of the Related Art FIG. 4 shows an example of a conventional medical container.
The medical container 101 is integrally formed by blow molding, and has a plurality of chambers separated from each other by a peelable inner wall welding zone 104 and a strong welding portion 102 following both ends thereof. Resin reservoir 1 in 102
03, the strongly welded part 10 during blow molding
No pinholes are generated near the boundary of No. 2 (see JP-A-7-155363).

[0003]

However, according to the above-mentioned conventional technique, the peeling characteristics of the peelable inner wall welding zone (hereinafter referred to as "easy peel portion") are not constant, and the palm is pressed when used. When peeling the easy peel part by the aseptic operation, the peel strength of the easy peel part is too large and it does not peel easily, or conversely, the easy peel part is inadvertently peeled when filling or transporting the drug However, there is a problem that a defective product in which the stored medicines are mixed occurs.

The present invention has been made in view of the above-mentioned problems of the prior art, and is a defective product in which the peeling characteristic of the easy peel portion is constant and the easy peel portion is inadvertently peeled. It is an object of the present invention to realize a medical bulkhead bag that does not have the possibility of occurrence of cracks.

[0005]

In order to achieve the above-mentioned object, a medical bulkhead bag according to the present invention comprises an easy-peel portion having easy peelability and a strong welding portion continuously provided on both longitudinal sides thereof. In a medical-partition bag made of a thermoplastic resin having a plurality of medicine storage parts separated from each other by a partition part, an unpeeled easy-peel part pre-formed part and the strong-welded part continuously provided on both longitudinal sides thereof. After integrally forming the plurality of medicine storage parts connected to each other by blow molding, the partition part is formed by forming the easy peel part by heat welding the easy peel part preformed part, Moreover, the ratio a / L of the longitudinal length a of the easy peel portion to the longitudinal length L of the partition portion is within the range of 0.2 to 0.6. Is shall.

[0006]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The reason why the peeling characteristic of the easy peel portion is not constant in the above-mentioned conventional technique was examined, and the following findings were obtained.

In the above prior art, a parison is sandwiched between divided molds which are closed at the time of blow molding, thereby simultaneously forming a peelable inner wall welded portion (easy peel portion) and a strong welded portion following both ends thereof. Therefore, at this time, a time difference occurs in the portion of the parison that comes into contact with the cavity surface of the split mold, and the parison is wrinkled or wavy.
In other words, as the mold closing progresses, the amount of elongation of the part of the parison that abuts at a later time than the part of the parison that abuts the cavity surface of the split mold earlier increases, and the wall thickness of the parison increases. It has been found that the easy peel portion and the strongly welded portion are formed in a state where the thickness of the parison is varied, and the peel strength of the easy peel portion varies.

The present invention has been devised on the basis of the above findings so as not to generate wrinkles and undulations in the parison portion serving as the partition wall. Hereinafter, an embodiment of a medical bulkhead bag according to the present invention will be described.

First, an embodiment of a medical bulkhead bag according to the present invention will be described.

As shown in FIG. 1, a medical septum bag 1
Is made of a thermoplastic resin and has an easy-peeling portion 5 which can be peeled off by the above-described aseptic operation and a strong welding portion 6 provided continuously on both longitudinal sides thereof.
A drug storage section 2 and a drug storage section 3 separated from each other by a partition section 4 made of a resin. The free end side of the one drug storage section 2 has a plate-shaped hanging member 7 and a cylindrical mouth. 8 is provided continuously, and a cylindrical mouth 9 is continuously provided on the free end side of the other medicine storage section 3.

A hole 7a for suspension is formed in the suspending tool 7, and the mouths 8, 9 are crushed and filled after filling the medicine.
It is closed by welding or by welding the plug 10.

As shown in FIG. 2, the medical bulkhead bag 1 has an unwelded easy-peel portion preformed portion 15 having a gap 15a between opposing wall surfaces and a strongly welded portion 6 provided continuously on both longitudinal sides thereof. After the one medicine storage part 2 and the other medicine storage part 3 connected to each other are integrally formed by blow molding, the easy-peel part preforming part 15 is heat-welded to form the easy-peel part 5, thereby forming the partition part. 4, and the ratio a / L of the longitudinal length a of the easy peel portion 5 to the longitudinal length L of the partition portion 4 is within the range of 0.2 to 0.6. By doing so, it is configured such that the peeling characteristics become constant.

Subsequently, the medical partition bag 1 shown in FIG.
Will be described.

(1) As shown in FIG.
The split molds 22 and 23 each having a cavity that regulates the outer surface of the preform 11 shown in (1) are mounted on a blow molding machine and opened.

Here, the cavity for regulating the outer surface of the preform 11 has a shape for regulating the outer surface of the preform 11 shown in FIG. One of the medicine container molding surfaces 22a and the other medicine container molding surface 23 for regulating the outer surface of the third medicine container 3.
a, Easy peel portion preformed portion forming surfaces 22d and 23 for regulating the outer surface of the easy peel portion preformed portion 15
d, strong welding portion forming surfaces 22c and 23c for regulating the outer surface of the strong welding portion 6, in addition to the hanging tool 7 and the mouth portion 8 which are continuously provided on the free end side of the one medicine storage portion 2, and the other. It has a molding surface (not shown) for regulating the outer surface of the mouth 9 continuously provided on the free end side of the medicine container 3.

(2) After the above (1), after the molten cylindrical parison 21 is pushed out from the extrusion die (not shown) between the opened molds 22 and 23, the mold closing is started.

Prior to the start of mold closing, the Paris 21
So-called pre-blowing, in which a predetermined amount of pressurized fluid is introduced by a blowing means or the like provided inside the extrusion die, by closing the lower end side opening of the extrusion die.

(3) After the above (2), as the mold closing progresses, first, the cylindrical parison 21 comes into contact with the illustrated central portions of the easy-peel part preformed part forming surfaces 22d and 23d, and the parison 21 Is flattened, the contact area of the parison expands to both sides toward the mating surfaces 22b and 23b. At this time, the mold mating surface 22
Since the deformation of the paris 21 in the direction parallel to the b and 23b is not hindered, the paris 21 is flattened without wrinkles or waving, and as shown in FIG. After contacting the entire surfaces of the forming surfaces 22d and 23d, the surface is deformed so as to come into contact with the strong welding portion forming surfaces 22c and 23c.

(4) After the above (3), the mold closing is completed, and as shown in FIG. 3 (c), the easy peel portion preformed portion 15 having the gap 15a where the opposing wall surface is not welded, and both sides thereof. To form a strongly welded portion 6 connected continuously to

(5) Following the completion of the mold closing in (4) above,
A pressurized fluid is introduced into the parison 21 by blowing means (not shown) to expand along the cavity, and the preform 11 shown in FIG. 2 described above is integrally formed by blow molding.

(6) After the above (5), the dies 22, 2
3 and then open the mold to obtain a preform 11
Take out.

(7) After the above (6), the preform 1
The easy-peel portion preformed portion 15 is pressed by heat sealing means and the opposing wall surface is thermally welded to form the easy-peel portion 5 having easy peelability. Get.

In the present invention, the number of the drug storage sections is not limited to the above-mentioned two, but may include three or more drug storage sections separated from each other by a partition wall as necessary. Can be.

The thermoplastic resin constituting the medical bulkhead bag is preferably made of low-density polyethylene, linear low-density polyethylene, high-density polyethylene, ethylene-α-olefin in consideration of water resistance, mechanical strength, moldability and the like. Copolymer,
Ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polypropylene and the like can be used in a single layer or a multilayer.

The following is an example of a two-layer structure of a medical partition back.

As the outer layer, transparency (spectral ray transmittance [J
ISK6714] is 70 or more), flexibility (bending rigidity is 1
000-5000 kg / cm ² ), heat resistance (melting point: DS)
Thermoplastic resin satisfying each condition of melting peak temperature measured by method C: 100 ° C. or higher, preferably 115 ° C., for example, linear low-density polyethylene (melting point: 120 ° C.), ethylene-propylene random copolymer (( Melting point: 145
° C).

Further, as an inner layer for forming an easy peel portion having an easy peeling property which can be easily peeled off by pressing the medicine accommodating portion, a melting point higher than that of the thermoplastic resin used for the outer layer is used. A mixture of other thermoplastic resins is preferred. For example, when linear low-density polyethylene is used for the outer layer, polypropylene (melting point: 160 ° C.) is added to the linear low-density polyethylene by about 50: 5.
What was mixed at the ratio of 0 is used.

An experiment for confirming the effect of the medical bulkhead bag according to the present invention was conducted, and will be described in detail below.

(Experimental example) (1) Step of forming preformed product Set wall thickness of Paris: 0.35 mm (wall thickness in the circumferential direction is constant) Resin material of Paris Outer layer: density 0.92 g / cm ³ Melt index 1 0.4 low density polyethylene Inner layer: Ethylene / propylene random copolymer having a density of 0.90 g / cm ³ melt index 3.3 (ethylene content 2% by weight) (2) Welding step of easy peel part Heat seal bar Under the following conditions, the easy peel portion preformed portion was thermally welded.

Set temperature: 135 ° C., time 1.5 seconds, pressure 3 kg / cm ^{2 The} same as that shown in FIG. 1 by the above-mentioned (1) forming step of the preformed article and (2) welding step of the easy peel portion. Shape, height H is 400 mm, major axis L ₀ is 150 mm
(The length L of the partition wall in the longitudinal direction was 140 mm), and a medical partition bag having a minor axis d of 30 mm was manufactured.

(3) Drug Filling Step After filling glucose solution into one of the drug storage sections from its mouth, the mouth section is crushed and welded and closed, and then the other drug storage section is filled with amino acid from its mouth. After filling the liquid, a stopper was welded to the mouth to close the mouth.

(4) Sterilization Step of Medical Partition Bag The medical-filled medical partition bag was sterilized at 115 ° C. for 30 minutes.

Compression Test The a / L of the drug-filled medical septum bag obtained in the above steps (1) to (4) was changed to produce five samples for each a / L. The sample was placed on the flat surface of the table, and one of the medicine storage sections was pressed with the palm from the upper surface to the lower surface, and the peeling state of the easy peel portion was observed. Table 1 shows the results.

<Evaluation of Compression Test> A: All five samples were successfully peeled. B: One or two of the five samples were difficult to peel.

C: 3 to 5 samples out of 5 were difficult to peel.

D: One or more of the five samples had peeled off the easy peel portion due to an increase in the internal pressure of the bag during the filling, transporting, and sterilizing steps before the compression test.

Peeling test of easy peel part (1) Test piece of easy peel part Cut-out shape of test piece: strip shape of 50 mm in the short direction of the partition part and 15 mm in the long direction However, in the short direction of the easy peel part Length 15mm
Then, it was cut out such that the easy peel portion was located at the center.

Cutting position of test piece: The length a in the longitudinal direction of the easy peel portion is divided into three equal parts, and a 15 mm width at the center of each equally divided part is cut out. However, those that are less than 15 mm wide when divided into three equal parts are divided into two equal parts, and those that are less than 15 mm wide after being divided into two equal parts are not divided into equal parts and are not divided equally, and are 15 m in the center
Cut out m width.

The number of cut test pieces: 330 in total 270 sheets: 10 types of 9 types (Run Nos. 1 to 9) of medical bulkhead bags were prepared, and three test pieces (left, center, right 3) 40 pieces: 10 pieces of 2 types (Run No. 10 and 11) of medical bulkhead bags were prepared, and two test pieces (left and right 2 pieces), respectively.
20 pieces: Two kinds (Run Nos. 12, 13) of medical bulkhead bags are prepared 10 by 10 and one test piece (one place at the center) (2) Peeling test method Peeling strength Testing machine: HEIDON-17 type Peeling speed: 100 mm / min Peeling strength was measured for each of the above test pieces, and each RunN was measured.
o. Table 1 shows the standard deviation of the wall thickness together with the standard deviation of the peel strength obtained for each of Nos. 1 to 13.

[0040]

[Table 1] As is clear from Table 1, those having a ratio a / L of the length a in the longitudinal direction of the easy peel portion to the length L in the longitudinal direction of the partition wall within the range of 0.2 to 0.6 are the peeling properties. Is constant.

[0041]

Since the present invention is configured as described above, the following effects can be obtained.

The peeling characteristics of the easy peel portion in the partition portion are constant, and the easy peel portion can be easily peeled by aseptic operation during use. Further, there is no possibility that the easy peel portion may be inadvertently peeled off at the time of filling or transporting the medicine into the medicine storage section.

[Brief description of the drawings]

FIG. 1 illustrates a medical septum bag according to one embodiment;
(A) is a schematic front view, (b) is a schematic side view seen from the arrow direction of (a).

2A and 2B show a preformed product of the medical bulkhead bag shown in FIG. 1, wherein FIG. 2A is a schematic front view, and FIG. 2B is a schematic partial cross-sectional view taken along line AA of FIG.

FIG. 3 is an explanatory view showing a blow molding step of the preformed product shown in FIG. 2;

FIG. 4 is a schematic front view showing an example of a conventional medical container.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical partition bag 2, 3 Drug storage part 4 Partition part 5 Easy peel part 6 Strong welding part 7 Hanging tool 7a Hole 8, 9 mouth part 10 Plug body 11 Preformed product 15 Easy peel part preformed part 15a Gap 21 Parisin 22, 23 Mold 22a, 23a Molding surface of medicine container 22b, 23b Molding surface 22c, 23c Molding surface of strong welding portion 22d, 23d Molding surface of easy peel part pre-molding part

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Akira Tanaka 26-504 Takahatadai, Misawa 850, Hino-shi, Tokyo

Claims (1)

[Claims] 1. A medical medical device made of a thermoplastic resin having a plurality of medicine accommodating portions separated from each other by an easy peel portion having easy peelability and a partition portion formed of a strong welding portion continuously provided on both longitudinal sides of the easy peel portion. In the bulkhead bag, the unpeeled easy peel part pre-formed part and the plurality of medicine storage parts connected to each other by the strongly welded parts provided on both sides in the longitudinal direction thereof are integrally formed by blow molding, and then the easy peel is performed. The preliminary peeling portion is heat-welded to form the easy peel portion, thereby forming the partition portion, and furthermore, the longitudinal length a of the easy peel portion and the longitudinal length of the partition portion. A medical partition wall bag, wherein the ratio a / L to the height L is within the range of 0.2 to 0.6.