JP2006280390A - Medical container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical container with an opening which is formed by breaking a medical agent container and a discharge port and has least chance of being closed by a member separated from the medical agent container. <P>SOLUTION: The medical container 1 is equipped with a soft bag 2 with a medical agent chamber, a medical solution, and a cylindrical body. The cylindrical body is equipped with a cylindrical portion, a breakaway portion, and both a first stress imparting portion 34 and a second stress imparting portion 36 which are provided to interpose the breakaway portion between them and are fixed on the inner surface of the soft bag. The breakaway portion breaks and opens by the expansion of the first and second stress imparting portions 34, 36. The container 1 extends to get over an outer surface of the proximal end portion of the breakaway portion and is equipped with an extension part for retaining the stress imparting portion after the breaking which retains a proximal end portion 33a of a separating portion 33 of the side of the first stress imparting portion and a proximal end portion 35a of a separating portion 35 of the side of the second stress imparting portion after the breaking with an inner surface of the soft bag. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a medical container such as an infusion container filled with a chemical solution such as an infusion.

The medical container is provided with a cylindrical body that has a closed tip and can be opened. Examples of the cylindrical body include a discharge port used at the time of administration of a drug solution and a drug container storing a drug added to the drug solution in a medical container.
Prior to infusion of the patient, mix and dissolve drugs that are difficult to pre-mix into the infusion, such as vitamins and antibiotics, in a vial or soft bag containing the infusion. Preparation of a chemical solution has been carried out. In order to prepare such a chemical solution aseptically and with a simple operation, a drug container containing a drug mixed with the chemical solution is attached to a soft bag containing the chemical solution, and the drug container is infused during infusion. There has been proposed a medical container in which a drug container and a soft bag are communicated to mix a drug and a drug solution by bending and breaking the provided weak part through a soft bag.
The applicant of the present application has proposed the one disclosed in JP 2000-5275 A (Patent Document 1).
The infusion container includes a first drug chamber, at least a second drug chamber partitioned from the first drug chamber, and a communicable portion formed between the first drug chamber and the second drug chamber. The closed drug solution outlet connected to the first drug chamber and the suspension hole for suspending the container are provided, and the second drug chamber enters the suspension hole.
For this reason, two or more kinds of medicines can be mixed aseptically in a container with a simple operation when necessary, and there is an effect that there is little risk of forgetting to mix even if the volume is small.

Also, there is one disclosed in Japanese Patent Laid-Open No. 2003-305107 (Patent Document 2). In the thing of Unexamined-Japanese-Patent No. 2003-305107, as shown to the Fig.8 (a), in the chemical | medical agent discharge member of a medical multi-chamber container, the one end part of the main-body part is equipped with the communication part, and this communication part is The first tube portion connected to the main body portion and the second tube portion connected to the first tube portion and having a tapered outer peripheral surface are formed, and the tip of the second tube portion is sealed with a lid member. A plurality of communication holes communicating with the inside are formed on the outer peripheral surface of the second pipe portion. Moreover, this communication part is connected to the container main body. For this reason, the peripheral part of a container main body is heat-sealed to the outer peripheral surface of a 1st pipe part and a 2nd pipe part. The peripheral edge of the container body is firmly fused to the first tube portion to form a strong seal portion, while the second tube portion is weaker than this and melted with a stronger strength than the weak seal portion for partition. The weak seal part (adhesion part) to be worn is configured. And after pressing a 1st storage chamber and opening the weak seal part for a partition, the whole storage chamber connected is pressed. That is, as shown in FIG. 8B of Japanese Patent Application Laid-Open No. 2003-305107, the weak seal part is peeled off from the second pipe part when the pressure in the storage chamber increases. Thereby, the chemical | medical agent in a storage chamber flows in in a main-body part via a communicating hole. Since the strong seal portion is firmly fused to the first tube portion, the drug does not flow out from this portion.
In the above-mentioned Patent Document 2, although it is a weak seal, the soft resin sheet forming the container main body is sealed so as to seal the communication hole in the second pipe portion that is sufficiently harder than that. In order to securely seal the communication hole, a certain degree of peel strength is required. And when peeling a sheet | seat from a 2nd pipe part, since stress is added to a sheet | seat, there exists a high risk of fracture | rupture in the sealing part of a sheet | seat, especially in the case of sealing. Therefore, in the one shown in Patent Document 2, it is difficult to maintain sufficient sealing performance, and if a seal capable of maintaining sufficient sealing performance is performed, there is a risk that the sheet constituting the container body may break during opening. There is.
JP 2000-5275 A JP 2003-305107 A

Therefore, the applicant of the present application has applied for a medical container or a medical container provided with a discharge port that solves the above problems (Japanese Patent Application No. 2004-245695). The drug container or discharge port of this application has a closed tip and is an openable drug container or discharge port that can reliably distinguish between the drug container or discharge port and the medical container. In addition, when necessary, the medicine container or the discharge port can be communicated with the medical container easily and reliably. This application is not publicly known.
The drug container 100 of this application is formed of a hard or semi-rigid material, as shown in FIGS. 32 to 37 of the above application, and further includes a cylindrical portion 7 whose tip is closed, A first stress applying portion 59 which is provided so as to sandwich at least the breakable portion 58 provided at the tip portion and the breakable portion 58 of the tubular portion 7 and is fixed to one inner surface of the soft bag 2; And the second stress applying portion 60 fixed to the other inner surface of the soft bag 2, and the breakable portion 58 is broken by the spread between the first stress applying portion 59 and the second stress applying portion 60. The front end side part is separated from the breakable part 58 and the cylindrical part 7 is opened.

Further, as shown in FIGS. 38 to 42 of the above application, the discharge port 86 of this application is formed of a hard or semi-rigid material, and further has a cylindrical portion 88 whose tip is closed, and a cylindrical portion. The first stress applying portion that is provided so as to sandwich the breakable portion 91 provided at least at the distal end portion of the 88 and the breakable portion 91 of the tubular portion 88 and is fixed to one inner surface of the soft bag 2. 89 and the second stress applying portion 90 fixed to the other inner surface of the soft bag 2, and the breakable portion 91 is spread by the spread between the first stress applying portion 89 and the second stress applying portion 90. The tubular portion 88 is opened by breaking and separating the tip side portion from the breakable portion 91.
However, as shown in FIG. 29 of the above application, by pressing the soft bag 2 of the medical container 1 85 including the drug container 100 and the discharge port 86, the breakable portion 58 of the drug container 100 or the discharge port 86 When the breakable portion 91 is broken and the first stress applying portion side portion and the second stress applying portion side portion are separated from the breakable portions 58, 91, the opening of the tubular portion formed by the break is Although rare, it is feared that it will be blocked again by the separated member.
Therefore, the present invention solves the above-described problems, and is a medical container having a drug container or a discharge port, and the opening formed by the breakage of the drug container or the discharge port is a drug container or a discharge port. It is an object of the present invention to provide a medical container that is extremely unlikely to be closed again by a more separated member.

What achieves the above object is as follows.
(1) A soft bag formed of a soft resin sheet, a drug chamber formed in the soft bag, a drug solution filled in the drug chamber, and a hollow body for a medical container attached to the soft bag The hollow body for medical container is formed of a hard or semi-rigid material and has a cylindrical portion with a closed tip portion, and a proximal end from the distal end portion of the cylindrical portion. A first stress applying portion fixed to one inner surface of the soft bag and the other inner surface of the soft bag. A second stress applying portion fixed thereto, and the breakable portion breaks due to a spread between the first stress applying portion and the second stress applying portion, and a distal end side is separated from the breakable portion, and the cylinder The shape part opens, and Further, the medical container extends from the proximal end side of the hollow body for medical container to the distal end side so as to get over the outer surface of the proximal end portion of the breakable portion, and the first stress applying portion after breaking A medical container comprising: a post-breaking stress applying part holding extension part that holds the base end part of the side separating part or the base end part of the second stress applying part side separating part between the soft bag inner surface .
(2) The hollow body for a medical container includes the cylindrical portion, the breakable portion, the first stress applying portion, and the second stress applying portion, and a cylindrical shape having an open rear end portion. The medical device according to (1), comprising a body, a lid member for sealing the rear end portion of the cylindrical body, and a medicine accommodated in the cylindrical body, and constituting a medicine container. container.
(3) The hollow body for a medical container includes the cylindrical portion, the breakable portion, the first stress applying portion, and the second stress applying portion, and a cylindrical shape having an open rear end portion. The medical container according to (1) above, which has a body and a sealing member that seals the rear end portion of the cylindrical body and can be punctured with a needle tube, and constitutes a discharge port.
(4) The breakable portion of the medical container hollow body extends from the tip of the cylindrical portion to the vicinity of the fixing portion with the soft bag, according to any one of (1) to (3). Medical container.

(5) The hollow body for a medical container includes a ring-shaped member attached to the proximal end side of the tubular portion, and the post-breaking stress applying portion holding extension portion is formed on the ring-shaped member. The medical container according to any one of (1) to (4) above.
(6) The medical container includes a medical container hollow body attaching member for attaching the medical container hollow body to the soft bag, and the post-breaking stress applying portion holding extension portion includes The medical container according to any one of the above (1) to (4), which is formed on a member for attaching a hollow body for a medical container.
(7) The medical container hollow body mounting member is for the medical container so as to expose the breakable portion of the medical container hollow body except for the extension portion for holding the post-breakage stress applying portion. The medical container according to the above (6), which encloses the cylindrical portion of the hollow body and includes an attachment member cylindrical portion fixed to the soft bag.
(8) The medical extension according to any one of (1) to (7), wherein the extension portion for holding the post-breakage stress applying portion is an annular portion that encloses the proximal end portion of the breakable portion. container. (9) The post-breaking stress applying portion holding extending portion extends from the one end of the ring-shaped member or the medical container hollow body mounting member so as to get over the outer surface of the base end portion of the breakable portion. The medical container according to any one of the above (5) to (8), comprising:
(10) The medical container according to any one of (1) to (9), wherein an inner corner of a distal end portion of the post-breaking stress applying portion holding extension portion has an edge standing. (11) The medical container according to any one of (1) to (10), wherein an outer surface of a distal end portion of the post-breaking stress applying portion holding extension portion is chamfered.
(12) The soft bag is partitioned into a first drug chamber and a second drug chamber by a partition weak seal part from which an internal space can be peeled, and the first drug chamber and the second drug chamber The medical container according to any one of (1) to (11), wherein the chamber is filled with a chemical solution.

The present invention relates to a soft bag formed of a soft resin sheet, a drug chamber formed in the soft bag, a drug solution filled in the drug chamber, and a hollow for a medical container attached to the soft bag. A hollow body for a medical container, which is formed of a hard or semi-rigid material and has a cylindrical portion with a closed end portion, and a base portion from the distal end portion of the cylindrical portion. A breakable portion extending to the end side, a first stress applying portion that is provided so as to sandwich the breakable portion of the tubular portion and is fixed to one inner surface of the soft bag, and the other inner surface of the soft bag A second stress applying portion fixed to the first stress applying portion, and the breakable portion is broken by a spread between the first stress applying portion and the second stress applying portion, and a tip side is separated from the breakable portion, and The cylindrical part opens, Further, the medical container extends from the base end side of the medical container hollow body to the distal end side so as to get over the outer surface of the base end part of the breakable part, and the first stress is applied after the break. A post-breaking stress applying part holding extension part for holding the base end part of the part side separating part or the base end part of the second stress applying part side separating part with the inner surface of the soft bag. .
For this reason, according to the medical container of the present invention, the opening formed by the breakage of the drug container or the discharge port is very unlikely to be closed again by a member separated from the drug container or the discharge port.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In particular, the medical container hollow body used in the medical container of the present invention will be described using an example in which a drug container is formed.
1 is a front view of a medical container according to an embodiment of the present invention, and FIG. 2 is an explanatory diagram for explaining the inside of the medical container shown in FIG. 1 (a soft bag is cut along the central axis of the drug container). 3 is an enlarged view of the lower part of the medical container shown in FIG. 2, FIG. 4 is a front view of the drug container used in the medical container shown in FIG. 1, and FIG. 4 is a side view of the drug container shown in FIG. 4, FIG. 6 is a cross-sectional view of the drug container shown in FIG. 1, and FIG. 7 is a cross-sectional view of the drug container shown in FIG. FIG. 4 is a top view of the medicine container of FIG. 4, and FIGS. 9 and 10 are explanatory views for explaining a method of using the medical container shown in FIG.

  The present invention includes a soft bag 2 formed of soft resin sheets 2a and 2b, drug chambers 3 and 4 formed in the soft bag 2, and drug solutions 5 and 6 filled in the drug chambers 3 and 4, A medical container 1 comprising a medical container hollow body (in this embodiment, a drug container) attached to a soft bag 2, wherein the medical container hollow body is formed of a hard or semi-rigid material, In addition, the tubular portion 31 whose distal end portion is closed, the breakable portion 32 extending from the distal end portion of the tubular portion 31 to the proximal end side, and the breakable portion 32 of the tubular portion 31 are provided and sandwiched therebetween, respectively. The breakable portion 32 includes a first stress applying portion 34 fixed to one inner surface 2c of the bag 2 and a second stress applying portion 36 fixed to the other inner surface 2d of the soft bag 2. Between the applying portion 34 and the second stress applying portion 36. The tubular portion 31 is opened by breaking by the burrs and the distal end side is separated from the breakable portion 32. Further, the medical container 1 is breakable from the proximal end side of the hollow body for medical containers. The base end part 33a of the first stress applying part side separating part 33 or the base end part 35a of the second stress applying part side separating part 35 after extending to the distal end side so as to get over the outer surface of the base end part of the And a post-breaking stress applying portion holding extension portion 38 that is held between the inner surface of the soft bag.

A medical container 1 of the embodiment shown in FIG. 1 includes a soft bag 2, a drug container 10 attached to the soft bag 2, and a discharge port 7 attached to the soft bag 2. In this embodiment, the medical container hollow body constitutes the drug container 10. Specifically, the hollow body for a medical container includes a cylindrical portion 31, a breakable portion 32, a first stress applying portion 34, and a second stress applying portion 36, and a cylinder whose rear end is open. The cylindrical body 31, the lid member 40 that seals the rear end portion of the cylindrical body 31, and the medicine stored in the cylindrical body 31 constitute a medicine container.
As shown in FIG. 1, the medical container 1 includes a soft bag 2, drug solutions 5 and 6, a drug container 10, a drug 3 stored in the drug container 10, a discharge port 7, and a mixed injection port 11. I have.
Moreover, the soft bag 2 of this invention is divided into the 1st chemical | medical agent chamber 3 and the 2nd chemical | medical agent chamber 4 by the weak seal part 13 for a partition which can be peeled, as shown in FIG. Further, the soft bag 2 is formed with a communication restricting weak seal portion 18 provided around the discharge port 7 for restricting the communication between the soft bag 2 and the discharge port 7. The first drug chamber 3 stores a first drug solution 5, and the second drug chamber 4 stores a second drug solution 6.

An upper end side seal portion 24 and a lower end side seal portion 22 are provided at the upper end portion and the lower end portion of the flexible bag 2. The upper end side seal portion 24 and the lower end side seal portion 22 are wide seal portions. Further, as shown in FIG. 1, the lower end side seal portion 22 of the soft bag 2 is provided with a chemical solution injection portion 20 for injecting a chemical solution into the second drug chamber 4. Further, the upper end side seal portion 24 is provided with a mixed injection port mounting portion 19 for attaching the mixed injection port 11, and the lower end side seal portion 22 is provided with a drug container mounting portion 21 for attaching the drug container 10, and the discharge port 7. A discharge port mounting portion 25 for attaching the is formed. The mixed injection port mounting part 19, the drug container mounting part 21, and the discharge port mounting part 25 are formed by not sealing a part of the upper end side seal part 24 and the lower end side seal part 22.
As shown in FIG. 1, the soft bag 2 is partitioned into a first drug chamber 3 and a second drug chamber 4 by a partitionable weak seal portion 13 that can be peeled off. As shown in FIG. 1, the partition weak seal portion 13 is provided so as to cross the entire lateral direction of the drug chamber of the soft bag 2. The partition weak seal portion 13 is formed by fusing the sheet material of the soft bag 2 in a band shape. In the embodiment of the present invention, strong seal portions 14 that do not substantially peel are formed at both ends of the partition weak seal portion 13. The partition weak seal portion 13 of the embodiment peels off when the second drug chamber 4 is strongly pressed with a finger or the like (when squeezed or gripped), and is separated from the first drug chamber 3 and the second drug chamber. 4 can be communicated.

In the embodiment of the present invention, when the second drug chamber 4 is pressed, the partition weak seal part 13 is opened (peeled) from the breakable part 32 of the drug container 10 and the communication blocking weak seal part 18. It is preferable that it is easy. Moreover, it is preferable that the partition weak seal portion 13 is easily peeled off from the communication inhibiting weak seal portion 18 and the breakable portion 32 of the drug container 10 when the first drug chamber 3 is pressed. The medical container 1 according to the embodiment of the present invention is a medical multi-chamber container in which the first drug chamber 3 and the second drug chamber 4 are partitioned by the partition weak seal 13. It may be a single-chamber medical container 1 that is not divided into weak seal portions 13.
The peeling strength of the partition weak seal portion 13 is preferably such that it does not peel off due to the pressure applied to the soft bag 2 during transportation but peels when the soft bag 2 is strongly pressed with a finger or the like. The partition weak seal portion 13 is preferably formed by fusing the soft bag 2. The fusion is preferably thermal fusion, high frequency fusion or the like. Since the soft bag 2 has the two drug chambers 3 and 4 partitioned by the partition weak seal portion 13 in this manner, drugs of different components can be mixed aseptically in the soft bag 2. it can. Further, in the embodiment shown in FIG. 1, the partition weak seal portion 13 is formed in a strip shape horizontally with respect to the soft bag 2, but is not limited thereto.

The peel strength (initial peel strength) of the partition weak seal portion 13 is preferably 0.1 to 5 N / 10 mm, and more preferably 0.3 to 3 N / 10 mm. If the peel strength is within this range, the partition weak seal 13 is not accidentally peeled off during transportation or storage, and the partition weak seal 13 can be easily peeled off. If it is about this level, when the second drug chamber 4 or the first drug chamber 3 is pressed, the partition weak seal portion 13 peels after the breakable portion 32 and the communication blocking weak seal portion 18. There is nothing.
As a method of measuring the peel strength, a portion including each measurement target seal portion of a medical container is cut to a length of 10 mm in the width direction of the container, and the seal portion on each cut side is peeled off at a pulling speed of 300 mm / min. This is done by calculating the average value of the measured values.
The volume ratio between the first drug chamber 3 and the second drug chamber 4 partitioned by the partition weak seal portion 13 is preferably 1: 1 to 1: 1.5. The second drug chamber 4 of the medical container 1 preferably has a larger volume and liquid volume than the first drug chamber 3. If it is such, when the 2nd chemical | medical agent chamber 4 is pressed, the weak seal part 13 for a partition, the breakable part 32 of the chemical | medical agent container 10, and the weak seal part 18 for communication inhibition will be reliably fractured by one action. It becomes easy.

  Further, the amount of fluid to be filled (including the medicine and the head space (gas)) is 20 to 50% by weight of the total capacity of the multi-chamber container (capacity in a state where the partitioning weak seal portion 13 is peeled to be one chamber). If it exists, it will become easy to peel the breakable part 32 of the chemical | medical agent container 10, and the weak seal part 18 for communication inhibition by one action following peeling of the weak seal part 13 for a partition (one action property will improve). In medical containers such as infusion bags, other drugs are co-injected. For this reason, it is bag-made in the medical container in anticipation of a reserve capacity of the same amount to several times the amount of fluid to be filled. The amount of fluid in the medical container having the partition weak seal portion is 20 to 50% by volume. However, even with such a small fluid filling amount, according to the present invention, the drug container 10 and the communication inhibiting weak seal are used. It is easy to apply stress to the portion 18, and both seal portions can be opened more reliably by a single opening operation.

  The soft bag 2 is a soft synthetic resin having a certain degree of heat resistance, such as polyolefin (for example, a mixture containing polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-propylene copolymer, a mixture of polypropylene and polyethylene or polybutene), and these Partially cross-linked product, ethylene-vinyl acetate copolymer (EVA), polyester (polyethylene terephthalate, polybutylene terephthalate, etc.), soft vinyl chloride resin, polyvinyl acetate, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyester elastomer, Various thermoplastic elastomers such as styrene elastomers such as styrene / ethylene / butylene / styrene copolymer or any combination of these ( Resin, polymer alloy, laminate, etc.), a resin layer of a hard material such as polyethylene terephthalate, polyester such as polyethylene naphthalate, polyamide such as nylon, and the above-mentioned soft material (for example, , Polyethylene) resin layers are used. By forming the soft bag 2 with the soft resin, the opening operation of the medicine container 10 and the weak seal portion 18 for inhibiting communication can be easily performed.

A preferred soft resin material is soft polyvinyl chloride. This soft polyvinyl chloride has heat resistance that can withstand the high temperatures of autoclave sterilization, and is excellent in handleability because of its high flexibility. Furthermore, there is an advantage in that it can be easily fixed to the soft bag 2 by molding, processing, and fusion of the drug container 10 and the manufacturing cost can be reduced. Moreover, as a suitable constituent material of the soft bag 2, the soft resin which blended the polypropylene and the styrene-butadiene copolymer can be mentioned. This material is preferable in that it is excellent in water resistance, heat resistance, flexibility and processability. The thickness of the sheet material which comprises the soft bag 2 is not specifically limited, For example, in the case of the sheet material made from a soft polyvinyl chloride, it is preferable that it is about 20-500 micrometers. As the soft bag 2, it is desirable to use an extruded film or a blown tube having a tensile elastic modulus of 500 MPa or less, preferably 50 to 300 MPa.
The soft bag 2 is produced by blow molding using the above resin, formed by fusing the peripheral edges of two sheets formed by the resin, and one sheet formed by the resin. Any of the one formed by folding the sheet and fusing the peripheral edge, or the one formed by extrusion molding using the above resin and fusing the peripheral edge of the opening may be used. The one sheet 2a or the other sheet 2b constituting the soft bag 2 in the present invention is either a front side sheet or a back side sheet constituting the soft bag 2.

In the drug chambers 3 and 4 of the soft bag 2, infusion agents (chemical solutions) 5 and 6 are stored, respectively. The drug chambers 3 and 4 preferably contain different components. As such an infusion, for example, two or more solutions such as peritoneal dialysis solution, transcentral vein infusion, transperipheral vein infusion, transperipheral vein injection, liquid nutrient, etc. Those that need to be mixed are preferred. Examples of the infusion include physiological saline, electrolyte solution, Ringer's solution, high calorie infusion, glucose solution, water for injection, amino acid electrolyte solution, and the like, but are not limited thereto. For example, a glucose electrolyte solution is stored in one of the drug rooms, and an amino acid solution is stored in the other, and water-soluble vitamins such as vitamin B1, vitamin B2, vitamin B6, vitamin C, panthenol, and nicotinamide are stabilized in both chambers. Can be appropriately sorted and stored. In this case, a vitamin-containing high-calorie total infusion solution can be obtained by storing a liquid preparation mainly composed of fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, and vitamin K in a drug container attached to a drug room described later. .
Further, the upper end side seal portion 24 of the soft bag 2 is provided with a hole (hanging portion) 23 for hanging on a hanger or the like. Furthermore, a film such as an aluminum foil may be laminated on the soft bag 2 to provide oxygen barrier properties, light shielding properties, etc., in order to maintain the quality of the chemicals. Further, a thin film such as a vapor deposition film made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide may be formed on the surface of the soft bag 2 in order to impart oxygen barrier properties. Or you may provide the resin film which has these thin films as an intermediate | middle layer.

The communication-inhibiting weak seal portion 18 is formed so as to surround the upper portion of the discharge port 7. A fourth chamber 26 isolated from the first drug chamber 3 is formed by the weak seal portion 18 for inhibiting communication. The fourth chamber 26 is an empty room in the embodiment of the present invention. However, a predetermined liquid (for example, physiological saline) may be placed in the fourth chamber. The fourth chamber may be in a dry state, but may be filled with a small amount of liquid for sterilization. Further, a passage through which some water vapor or medicine passes through the weak seal portion 18 for inhibiting communication may be formed so as to communicate with the second medicine chamber 4 at the above level. The weak seal portion 18 for inhibiting communication can be formed by heat-sealing the sheet material in a band shape (thermal fusion, high frequency fusion, ultrasonic fusion, etc.).
In the embodiment shown in FIG. 1, the weak seal portion 18 for inhibiting communication is formed in an inverted U shape. Further, the weak seal portion 18 for preventing communication has a trapezoidal shape with the short side on the upper side, a triangular shape with the discharge port at the top, a triangular shape with the discharge port at the bottom, a polygonal shape such as a quadrangle, a substantially semicircular shape, A substantially semi-elliptical shape may be used.
In the embodiment of the present invention, the communication-inhibiting weak seal portion 18 is more difficult to peel off than the partition weak seal portion 13 and the breakable portion 32 of the drug container 10. Moreover, the weak seal part 18 for communication inhibition may have the same breakability as the breakable part 32. Specifically, it is preferable that the peel strength of the weak seal portion 18 for inhibiting communication is substantially equal to or greater than the break strength of the breakable portion 32 of the drug container 10. Moreover, it is preferable that the peel strength of the weak seal portion 18 for inhibiting communication is slightly larger than the break strength of the breakable portion 32 of the drug container 10. With the configuration as described above, the medicine is prevented from being administered before the medicine in the soft bag 2 and the medicine 12 in the medicine container 10 are mixed.

As peeling strength of the weak seal part 18 for communication inhibition, it is preferable that it is 1-25N / 10mm, especially 2-20N / 10mm. Moreover, it is preferable that the width | variety (band width) of the weak seal part 18 for communication inhibition is 2-20 mm, especially 4-12 mm.
As shown in FIG. 1, the drug container 10 is attached to a drug container mounting part 21 formed in the lower end side seal part 22 of the soft bag 2. In particular, in this embodiment, the drug container mounting portion 21 is provided at a position closer to the left side than the vicinity of the center of the lower end side seal portion 22. The medicine container 10 may be attached to the soft bag 2 via a medicine container attachment member. Moreover, the discharge port 7 is attached to the discharge port mounting part 25 formed in the lower end side seal part 22 of the soft bag 2, as shown in FIG. The discharge port mounting portion 25 is provided at a position closer to the right side than the center of the lower end side seal portion 22. The medicine container 10 and the discharge port 7 are attached to the soft bag 2 by high frequency fusion, heat fusion, or the like.
The medical container 1 also includes a mixed injection port 11 for mixing chemical solutions. The mixed injection port 11 is attached to a mixed injection port mounting portion 19 formed in the upper end side seal portion 24 of the soft bag 2. In the embodiment, the mixed injection port mounting portion 19 is provided at a position close to the left side of the upper end side seal portion 24.

As shown in FIG. 1, it is preferable to use a known port as the discharge port 7. For example, it is preferable that the discharge port 7 includes a cylindrical port member and a seal member that seals the opening and can be inserted through the needle tube. Specifically, the port is preferably composed of a cylindrical member 7a having both ends opened and a lid portion 7b having a seal member 7c that seals the opening on one end of the cylindrical member 7a. With such a configuration, first, the chemical solution can be injected through the cylindrical member 7 a attached to the soft bag 2.
Moreover, it is preferable that the sealing member has a self-occlusion property, and after the needle tube is extracted from the elastic body, the puncture hole is closed to prevent the leakage of the chemical solution. Examples of the constituent material of the sealing material include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer, polyester, polyvinyl chloride, polyurethane, Flexible polymer materials such as polyamide, thermoplastic resins such as polyamide elastomer and polyester elastomer (thermoplastic elastomer), natural rubber, isoprene rubber, silicone rubber, butadiene rubber, various rubber materials such as styrene-butadiene rubber, etc. An elastic material or a combination of any two or more of these materials can be used, and those containing an elastic material are preferable from the viewpoint of sealing performance and resealability. Moreover, as a port, it is preferable that it is a cylindrical and elliptical cylinder-shaped molded article. The constituent material of the discharge port 7 is preferably the same as that of the drug container.

  As shown in FIG. 1, it is preferable to use a well-known port for the mixed injection port 11. For example, it is preferable to include a cylindrical port member and a seal member that seals the opening and can be inserted through the needle tube. Specifically, the port preferably has the same configuration as that of the discharge port 7, and includes a cylindrical member 11a having both ends opened and a seal member 11c for sealing the opening on one end of the cylindrical member 11a. It is preferable that it consists of the cover part 11b. With such a configuration, first, the chemical solution can be injected through the cylindrical member 11 a attached to the soft bag 2.

Next, the drug container 10 to which the medical container hollow body is applied will be described. As illustrated in FIGS. 4 to 8, the medicine container 10 includes a cylindrical body 30 and a lid portion 40 that seals the rear end portion of the cylindrical body 30.
Hereinafter, the drug container 10 will be described with the “upper side” in FIGS. 4 to 8 as the “front end side” and the “lower side” in FIGS. 4 to 8 as the “base end side”.
As shown in FIGS. 4 to 8, the cylindrical body 30 includes a cylindrical portion 31, a first stress applying portion 34, a second stress applying portion 36, and a post-breaking stress applying portion holding extension portion 38. And have.
The tubular portion 31 is provided with a breakable portion 32. The inside of the cylindrical part 31 is hollow and can be accommodated in the medicine 12. As shown in FIGS. 6 and 7, a medicine storage portion 29 is formed by the inside of the tubular portion 31 and the tip portion of the lid portion 40.
Moreover, the cylindrical part 31 has the soft bag attaching part 43 for attaching the chemical | medical agent container 10 to the soft bag 2, as shown in FIG. 4, FIG. In the embodiment shown in FIGS. 4 and 5, the soft bag attachment portion 43 is provided on the proximal end side of the breakable portion 32 of the tubular portion 31.

As shown in FIGS. 6 and 7, the cylindrical portion 31 is a cylindrical portion whose front end portion is closed and whose proximal end portion is opened. In this embodiment, the flange portion 31 a and the first portion are sequentially formed from the proximal end side. One cylindrical portion (soft bag attaching portion) 31b, a tapered portion 31c that is continuous with the first cylindrical portion 31b and decreases in a tapered shape toward the distal end side, and a second cylindrical portion 31d that is continuous with the tapered portion 31c. And a closed portion (tip portion) 31e continuous with the second cylindrical portion 31d. The shape of the tip 31e is a truncated cone shape in the embodiment of the present invention. The shape of the tip may be a dome shape, a cone shape, or the like.
The volume of the medicine container 29 is preferably 1 to 30 mm. The length of the medicine container 29 is preferably 20 to 70 mm. Moreover, the cover part attachment part 31f which attaches the cover part 40 is formed in the base end side of the flange part 31a.
As shown in FIGS. 6 and 7, the lid part 40 includes a disk part 40 a and a sealing part 40 b that seals an opening provided on the bottom surface side of the disk part 40 a. The blocking portion 40b is a cylindrical portion (cylindrical portion) whose proximal end is provided on the disc portion 40a and whose distal end is closed. When the lid portion 40 is attached to the proximal end portion of the tubular portion 31, the blocking portion 40 b is formed in a shape that is in close contact with the inner surface of the proximal end portion of the tubular portion 31. With such a configuration, after the medicine is stored in the cylindrical portion 31, the lid portion 40 is fitted into the lid mounting portion 31f and fixed by ultrasonic fusion, high frequency fusion, heat fusion, or the like. The part 31 can be reliably sealed.

  Examples of the medicine stored in the cylindrical portion 31 include those that are mixed and dissolved in an infusion solution. For example, antibiotics, vitamins (general vitamins), various amino acids, antithrombotic agents such as heparin, insulin, Antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, correction electrolytes, antiviral agents, immunostimulants, and the like. Further, the inside of the cylindrical portion 31 of the cylindrical body 30 may be normal pressure, but may be reduced pressure or vacuum. Thus, when the inside of the cylindrical portion 31 is in a reduced pressure or vacuum state, the effect of preventing degradation, degradation, degradation, etc. of the drug is improved, and when the breakable portion 32 is broken, an infusion solution (chemical solution) is sucked, It can introduce into the cylindrical part 31 more rapidly.

  Moreover, it is preferable that the part (soft bag attaching part 43 in the Example of this invention) joined to the soft bag 2 of the cylindrical part 31 is formed with resin compatible with the soft bag 2. FIG. Thereby, the cylindrical body 30 and the soft bag 2 are easily adhered. In the embodiment of the present invention, a resin layer compatible with the forming material of the soft bag 2 (particularly, the forming material forming the inner surface side of the soft bag 2) is provided on the outer surface of the cylindrical portion 31 (see FIG. Not shown). Specifically, the resin layer is formed on the circumference of the outer peripheral surface of the cylindrical portion 31. Examples of compatible resins include polyolefins (eg, polyethylene, polypropylene, polybutadiene, ethylene-propylene copolymer, a mixture containing polyolefin such as a mixture of polypropylene and polyethylene or polybutene), and partially crosslinked products thereof, ethylene-vinyl acetate. A copolymer (EVA), polyester (polyethylene terephthalate, polybutylene terephthalate, etc.), soft vinyl chloride resin, polyvinyl acetate, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyester elastomer and the like are preferable. In addition, the compatible resin is preferably a material that is the same as or similar to the sheet material constituting the soft bag 2. The compatible resin may be coated on the cylindrical portion 31 by two-color molding. In addition, you may produce the whole chemical | medical agent storage part with resin compatible with a soft bag. You may attach to the soft bag 2 via the member for chemical | medical agent attachment. In this case, it is not necessary to provide a compatible resin layer on the outer surface of the cylindrical portion 31.

  The breakable portion 32 can vertically cut a portion constituting the medicine storage portion 29 of the cylindrical portion 31 when stress is applied by the first stress applying portion 34 and the second stress applying portion 36. It is preferable that it is a simple structure. It is preferable that the breakable portion 32 extends from the tip portion of the cylindrical portion 31 to the vicinity of the fixing portion with the soft bag 2. Since the breakable portion 32 is provided up to the vicinity of the fixing portion of the soft bag 2, when the breakable portion 32 is broken, the medicine in the medicine storage portion 29 can be reliably discharged. Specifically, as shown in FIG. 5, the breakable portion 32 is provided from the distal end of the medicine storage portion 29 to the vicinity of the distal end portion of the first cylindrical portion 31b. The breakable portion 32 may be formed only at the tip side portion of the cylindrical portion 31. As shown in FIG. 5, the breakable portion 32 is provided so as to pass between the first stress applying portion 34 and the second stress applying portion 36 in the vicinity of the distal end portion of the cylindrical portion 31, and the distal end side portion 32 a. And a first stress applying portion side portion 32b and a second stress applying portion side portion 32c that branch from the vicinity of the proximal end portion of the distal end portion 32a and extend in the side surface direction of the cylindrical portion 31. And the 1st stress application part side part 32b and the 2nd stress application part side part 32c are provided so that the base end parts of the front end side part 32a may be connected. By comprising in this way, when the 1st stress provision part 34 and the 2nd stress provision part 36 are expanded, the fracture | ruptureable part 32 fractures | ruptures and the cylindrical part 31 is opened.

  Further, the first stress applying part 34 extends from the one sheet 2 a side part in the vicinity of the tip part of the cylindrical part 31, and the second stress applying part 36 is the other sheet in the vicinity of the tip part of the cylindrical part 31. It extends from the 2b side portion. When the second drug chamber 4 is pressed, the breakable portion 32 has a fixed portion 46 of the first stress applying portion 34 to the soft bag 2 and a vicinity of the fixing portion 48 of the second stress applying portion 36 to the soft bag 2. By swelling, it breaks to the one sheet 2a side and the other sheet 2b side. Further, as shown in FIG. 5, the distal end side portion 32 a preferably passes between the first stress applying portion 34 and the second stress applying portion 36 and extends toward the proximal end side. The distal end side portion 32a passes through the vicinity of the middle between the first stress applying portion 34 and the second stress applying portion 36 of the cylindrical portion 31, and passes through the vicinity of the middle between the one sheet 2a side and the other sheet 2b side. Thus, it extends to the vicinity of the proximal end portion of the medicine container. The distal end side portion 32 a is formed in the vertical direction along the outer surface of the tubular portion 31 from the distal end portion to the proximal end side of the tubular portion 31. The distal end side portion 32 a is formed continuously from the distal end portion of the cylindrical portion 31 to the proximal end side. With such a configuration, as shown in FIG. 9, when the second drug chamber 4 is pressed to inflate the first drug chamber 3, the drug container 10 (cylindrical portion 31) is placed on one sheet 2 a side and It can be torn to the other sheet 2b side.

  As shown in FIG. 5, the first stress applying portion side portion 32 b and the second stress applying portion side portion 32 c of the breakable portion 32 are provided so as to be orthogonal to the distal end side portion 32 a of the breakable portion 32. Yes. Further, the first stress applying portion side portion 32b and the second stress applying portion side portion 32c of the breakable portion 32 are formed in a substantially arc shape. Since the breakable portion 32 is configured as in the embodiment shown in FIGS. 4 and 5, the tip side is separated from the breakable portion 32 by breakage as shown in FIG. 9. In other words, the distal end portion of the cylindrical portion 31 is separated from the proximal end portion of the cylindrical portion 31 from the first cylindrical portion 31 b. The breakable portion 32 is a fragile portion that can be broken as described above. Specifically, the breakable part is preferably a thin part. The breakable portion 32 is preferably produced by forming a groove on the outer surface of the tubular portion 31. Further, the first stress applying portion side portion 32b and the second stress applying portion side portion 32c may be formed in a substantially arc shape, a substantially elliptic arc shape, or a U-shape. Specifically, the breakable portion of the embodiment of the present invention is produced by forming a groove portion having a V-shaped cross section. Specifically, the angle of the groove is preferably 30 to 120 °, particularly 40 to 60 °, and the minimum thickness is preferably 0.05 to 0.3 mm, particularly 0.08 to 0.2 mm. By producing the groove forming portion at such an angle, when the soft bag 2 is inflated, the stress concentrates at the center of the breakable portion, and the groove is reliably broken. Further, the groove portion may have any shape as long as it is easily broken, and is not limited to the V shape as in the embodiment, and may be a semicircular shape, a semielliptical shape, or the like. Moreover, although the breakable part of the present invention can be broken by forming a thin part by forming a groove part, it is not limited to this. The breakable portion may be produced by, for example, forming a portion forming the breakable portion of the medicine storage portion with a material more fragile than the other portions. Specifically, it is preferable that a part forming the breakable part is made of an easily breakable material by multicolor molding, and the other part is made of a material that is not easily broken.

Further, the breakable portion 32 is anything as long as it can break the cylindrical portion 31 (drug storage portion 29) by the stress applied by the first stress applying portion 34 and the second stress applying portion 36. There may be.
In this embodiment, the first stress applying portion 34 and the second stress applying portion 36 extend with the vicinity of the distal end portion of the cylindrical portion 31 as the base end, as shown in FIGS. Is the free end. With such a configuration, when the first stress applying unit 34 and the second stress applying unit 36 are given a force to open them, the force is converted into stress for breaking the breakable portion 32. It has a function to do. The first stress applying part 34 and the second stress applying part 36 are preferably formed to face each other. Further, the main body portions of the first stress applying portion 34 and the second stress applying portion 36 are preferably formed in a vertically long rectangular shape. With such a configuration, when the soft bag 2 is pressed and inflated, the first stress applying portion 34 and the second stress applying portion 36 reliably apply the breaking stress to the breakable portion 32.
Specifically, as shown in FIGS. 4 to 8, the first stress applying portion 34 and the second stress applying portion 36 are provided on each of the vertically long flat plate portions 34 a and 36 a and both sides of the flat plate portions 34 a and 36 a. The formed side wall portions 34b and 36b, the bonding portions 34d and 36d for bonding to the sheet constituting the flexible bag 2, the ribs 34e and 36e formed on the side wall portions, and the inner surfaces of the flat plate portions 34a and 36a. Ribs 34c and 36c and reinforcing ribs 34f and 36f are provided.

It is preferable that the first stress applying part 34 and the second stress applying part 36 are provided so as to face each other and be slightly separated from each other. Since it has such a structure, even if it presses between the 1st stress provision part 34 and the 2nd stress provision part 36 at the time of fixation to the soft bag 2, the 1st stress provision part 34 and the 1st The deformation amount allowed for the second stress applying portion 36 is small, and the breakable portion 32 is not likely to break. In the embodiment of the present invention, the flat plate portions 34a and 36a are preferably arranged so as to face each other. The side wall portions 34b and 36b of the embodiment of the present invention are formed such that the tip end portion is high and the base end portion is low. As shown in FIGS. 5, 6, and 7, ribs 34e and 36e are formed at the front end portions of the side walls 34b and 36b. The rib 34e and the rib 36e are provided at positions facing each other. With such a configuration, the first stress applying part 34 and the second stress applying part 36 are slightly separated from each other. The ribs are preferably separated from each other by 0.1 to 3.0 mm, particularly 0.3 to 1.5 mm.
The ribs 34 c and 36 c are provided on the respective surfaces of the first stress applying part 34 and the second stress applying part 36 that face each other. In the embodiment of the present invention, the ribs 34c and 36c are provided from the tip of the cylindrical portion 31 of the flat plate portions 34a and 36a to the tip of the flat plate portions 34a and 36a near the center of the inner surface of the flat plate portions 34a and 36a. Yes. Further, the ribs may be arranged at positions where they do not contact each other (not shown). Specifically, the first stress applying unit 34 and the second stress applying unit 36 are staggered from the center in the axial direction of the first stress applying unit 34 or the second stress applying unit 36 to the side surface side. It may be provided at a position. For this reason, the ribs 34c and 36c do not contact each other. With such a configuration, since the tensile stress or tear stress applied to the first stress applying part 34 and the second stress applying part 36 is reliably transmitted to the breakable part 32, the breakable part 32 is broken. It becomes easy. The heights of the ribs 34c and 36c increase from the distal end toward the proximal end side.

As shown in FIGS. 4 and 5, the reinforcing ribs 34f and 36f are provided on the outer surface of the flat plate portions 34a and 36a from the distal end portion of the cylindrical portion 31 to the vicinity of the middle portion of the flat plate portions 34a and 36a. The reinforcing ribs 34f and 36f are reduced in diameter from the distal end portion of the cylindrical portion 31 toward the distal end side. By having the reinforcing ribs 34 f and 36 f, the first stress applying portion 34 and the second stress applying portion 36 can reliably apply stress to the vicinity of the tip portion of the cylindrical portion 31.
The joining portions 34d and 36d are portions that can be joined to the inner surface of the flexible bag 2 on the outer surfaces of the flat plate portions 34a and 36a. The joint portions 34d and 36d are formed in a rectangular shape and are flat. The joint portions 34 d and 36 d are formed at the tip side portions of the first stress applying portion 34 and the second stress applying portion 36.

  In the embodiment of the present invention, it is preferable that at least a part of the outer surface of the first stress applying part 34 and the second stress applying part 36 is formed of a material that can be fixed to the inner surface of the soft bag 2. Specifically, at least a part of the joint portions 34 d and 36 d is formed of a material that can be fixed to the inner surface of the soft bag 2. Specifically, the joint portions 34d and 36d to be joined to the inner surface of the soft bag 2 are partly or wholly formed of a material for forming the soft bag 2 (particularly, a material for forming the inner surface side of the soft bag 2). It is preferably formed of a compatible resin. With such a configuration, the first stress applying part 34 and the second stress applying part 36 can be reliably bonded to the inner surface of the flexible bag 2. The compatible resin of the soft bag 2 is preferably the above-described resin. The compatible resin is preferably a material that is the same as or similar to the constituent material of the soft bag. In the embodiment of the present invention, the compatible resin layer is preferably produced by two-color molding. Note that all of the first stress applying part or the second stress applying part may be made of a resin container compatible with the soft bag. The compatible resin layer is preferably made flat so as to be easily joined to the inner surface of the soft bag.

As shown in FIGS. 1, 2, and 3, the whole or a part of the joining portion 34 d of the first stress applying portion 34 is joined to the inner surface of the sheet 2 a of the flexible bag 2 in the medical container 1. Thus, the first fixing portion 46 is formed, and similarly, the whole or a part of the joining portion 36d of the second stress applying portion 36 is joined to the inner surface of the sheet 2b of the flexible bag 2 to form the first fixing portion 46. Two fixing portions 48 are formed. For this reason, the first stress applying part 34 and the second stress applying part 36 are fixed to the first stress applying part 34 and the second stress applying part 36 of the soft bag 2 when the drug chamber is pressed, It spreads following the spread between 48, and a breakable portion, which will be described later, opens to one sheet 2a side and the other sheet 2b side and breaks.
The bonding between the bonding portion 34d of the first stress applying portion 34 and the bonding portion 36d of the second stress applying portion 36 and the inner surface of one sheet 2a, 2b of the soft bag 2 is performed by ultrasonic fusion, high frequency fusion, It is preferably performed by heat fusion or the like. Specifically, after the drug container 10 is arranged at a position as shown in FIG. 1, it is sandwiched from both sides of the surface of the one sheet 2 a and the other sheet 2 b of the flexible bag 2 by a sealing mold and heat sealed. Preferably, it is done.
Moreover, it is preferable that the 1st stress provision part 34 or the 2nd stress provision part 36 is the structure which can carry | support and spread from the exterior of the soft bag 2. FIG.

In addition, the 1st stress provision part of this invention and the 2nd stress provision part are not limited to the thing of the structure mentioned above, It can join with the one sheet | seat inner surface and the other sheet | seat inner surface which comprise the soft bag 2. In addition, any configuration may be used as long as it has a configuration capable of applying stress to the breakable portion in conjunction with the swelling of the soft bag. For example, it may not be formed to extend in the axial direction of the medicine container, but may be formed obliquely with respect to the medicine container.
Further, the base end portions 33a, 35a of the first stress applying portion side separating portion 33 or the second stress applying portion side separating portion 35 are the post-breaking stress applying portion holding extension portion 38 and the soft bag inner surfaces 2c, 2d. It is preferable that at least the vicinity of the base end portion of the breakable portion 32 is not fixed to the soft bag 2 so that it can easily enter between. In the embodiment of the present invention, the distal end portion of the drug container 10 relative to the breakable portion 32 is the soft bag 2 only at the joint portion 34d of the first stress applying portion 34 or the joint portion 36d of the second stress applying portion 36. It is joined to.

  As a constituent material of the drug container of the present invention, a hard resin or a semi-hard resin is used. Specifically, rigid polyvinyl chloride, polyethylene, polypropylene, polybutadiene, cyclic polyolefin [specifically, ZEONEX (manufactured by ZEON Corporation), APEL (manufactured by Mitsui Chemicals, Inc.)], polypropylene homopolymer, high density polyethylene Such as polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene -Styrene copolymers, polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), butadiene-styrene copolymers, aromatic or aliphatic polymers. Amides of various resins, or those in which any combination of these and the like. Among these, hard polyvinyl chloride, polyethylene, polypropylene, and polyester are preferable because they are highly safe and have excellent adhesion to the soft bag 2. Further, the above-mentioned hard or semi-hard resin is preferable as the constituent material of the lid and the drug container mounting member.

When the second medicine chamber 4 is pressed, the breakable portion 32 is more difficult to peel off than the partition weak seal portion 13 and more likely to peel from the communication inhibiting weak seal portion 18. Further, the breakable portion 32 may be as easily peeled as the communication blocking weak seal portion 18. Specifically, the breaking strength of the breakable portion 32 is preferably larger than the peeling strength of the partition weak seal portion 13 and equal to or smaller than the peeling strength of the communication inhibiting weak seal portion 18.
The breakable portion 32 of the tubular portion 31 is broken by the spread between the first stress applying portion 34 and the second stress applying portion 36, and the distal end side is separated from the breakable portion 32 so that the tubular portion 31 opens. I am doing.
In the embodiment of the present invention, as the first drug chamber 3 expands, as shown in FIG. 9, the first stress applying part 34 and the second stress applying part 36 fixed to the inner surface of the soft bag 2 are outside. First, the distal end side portion 32a of the breakable portion 32 is broken, and then the first stress applying portion side portion 32b and the second stress applying portion side portion 32c of the breakable portion 32 are broken. Then, the first stress applying part side separating part 33 and the second stress applying part side separating part 35 are separated from the medicine container 10.
In the embodiment of the present invention, the drug container 10 is fixed to the inner surface of the soft bag at the attachment portion 43. The fixing is preferably performed by thermal fusion, high frequency fusion, ultrasonic fusion or the like.

The post-breaking stress applying portion holding extending portion 38 including the medical container hollow body (in this embodiment, the drug container 10) has a base end portion of the breakable portion 32 from the base end side of the cylindrical body 30. Extending to the distal end side so as to get over the outer surface, and the base end portion 33a of the first stress applying portion side separating portion 33 after breaking or the base end portion 35a of the second stress applying portion side separating portion 35 is connected to the inner surface of the soft bag. It has the function to hold between. By having such a configuration, the base end part 33a of the first stress applying part side separating part 33 or the base end part 35a of the second stress applying part side separating part 35 separated by breaking of the breakable part 32 is Since the post-breakage stress applying portion holding extension portion 38 is held between the outer surface and the soft bag, the opening formed by the breakage of the drug container is closed again by the member separated from the drug container. Very unlikely.
In the embodiment of the present invention, as shown in FIGS. 4 and 6, the drug container 10 includes a ring-shaped member 37 attached to the proximal end side of the cylindrical portion 31, and extends for holding the stress applying portion after breaking. The part 38 is formed by a ring-shaped member 37. Further, as shown in FIGS. 4 and 5, the post-breaking stress applying portion holding extension portion 38 is an annular portion that encloses the base end portion of the breakable portion 32 (the same reference numerals as the extension portions are attached). 38. The annular portion 38 is formed by the tip side portion of the ring-shaped member 37 in the embodiment of the present invention. In the embodiment of the present invention, the annular portion 38 is formed so as to enclose the first stress applying portion side portion 32b and the second stress applying portion side portion 32c. In the embodiment of the present invention, the ring-shaped member 37 is attached to the cylindrical portion 31 at the base end side portion from the extended portion forming portion. Specifically, a fitting portion 37 a that fits the outer surface of the tubular portion 31 is provided on the proximal end side from the extended portion forming portion of the ring-shaped member 37. In addition, a fitting portion 31 g that fits the ring-shaped member 37 is formed on the proximal end side of the tubular portion 31 with respect to the breakable portion 32.

In the embodiment of the present invention, the ring-shaped member 37 is integrally formed, but a ring-shaped member may be formed by combining a plurality of members.
In the embodiment of the present invention, the post-breaking stress applying portion holding extension portion 38 is manufactured as a separate member from the drug container main body, but is not limited thereto, and is integrated with the drug container main body. It may be produced.
As shown in FIGS. 4 and 6, the annular portion 38 extends to the distal end side so as to get over the outer surface of the proximal end portion of the breakable portion 32. The annular portion 38 is provided around the proximal end portion of the breakable portion 32, and extends from the proximal end side to the distal end side from the proximal end portion of the breakable portion 32 from the proximal end portion of the breakable portion 32. Specifically, the annular portion 38 is formed so as to enclose the first stress applying portion side portion 32 b and the second stress applying portion side portion 32 c of the breakable portion 32. With such a configuration, the base end part 33a of the first stress applying part side separating part 33 or the base end part 35a of the second stress applying part side separating part 35 separated by breakage gets over the tip part of the annular part 38. Thus, it is reliably held between the extending portion 38 and the inner surface of the soft bag.
Moreover, it is preferable that the inner corner | angular of the front-end | tip part of the post-breaking stress-applying part holding extension part 38 has an edged state. By doing in this way, the base end part 33a of the first stress applying part side separating part 33 or the base end part 35a of the second stress applying part side separating part 35 overcoming the base end part of the extending part 38 is obtained. It becomes difficult to return to the inside of the extension part 38.

Furthermore, it is preferable that the outer corner of the distal end portion of the post-breaking stress applying portion holding extension portion 38 is chamfered. The chamfering may be either a chamfering that forms a slope on the outer surface of the tip, such as a C chamfering, or a chamfering that forms a curved surface such as an R chamfering. Preferably, it is chamfering in which an inclined surface is formed. In the illustrated embodiment, the outer surface of the distal end portion of the extending portion 38 is chamfered to form an inclined surface 38a, specifically, the outer surface of the extending portion is formed in a tapered shape whose diameter decreases toward the distal end side. By doing in this way, the separation parts 33 and 35 which got over the front-end | tip part of the extension part 38 become easy to approach between a soft bag inner surface and the outer surface of an extension part.
Furthermore, an edge projecting in the radial direction may be provided at the base end portion at the chamfered portion at the chamfered outer corner of the distal end portion of the post-breaking stress applying portion holding extension portion 38. By doing in this way, the base end part 33a of the first stress applying part side separating part 33 or the base of the second stress applying part side separating part 35 that has entered between the inner surface of the soft bag and the outer surface of the extending part. The separation of the end portion 35a is suppressed.
Further, the post-breaking stress applying part holding extension part 38 is a breakable part so as not to disturb the breaking of the breakable part 32 when the first stress applying part 34 and the second stress applying part 36 are expanded. It is preferably formed at a position spaced apart to some extent (specifically, slightly) from the outer surface of the base end portion of 32.

Further, as shown in FIG. 3, the outer surface of the post-breaking stress applying portion holding extension portion 38 is not fused to the inner surface of the soft bag. With such a configuration, a gap 39 is formed between the outer surface of the post-breaking stress applying portion holding extension portion 38 and the soft bag inner surfaces 2c and 2d. Further, the post-breaking stress applying portion holding extension portion 38 of the present invention is not limited to the entire outer surface, but is not limited to this, and the first stress applying portion side separating portion 33 is not limited thereto. If the base end part 33a or the base end part 35a of the second stress applying part side separating part 35 can penetrate between the inner surface of the soft bag and the extension part for holding the stress applying part after breaking, the entire outer surface is soft. It may not be fixed to the inner surface of the bag. For example, only the distal end portion of the outer surface of the extension portion may not be fixed.
Further, as the post-breaking stress applying portion holding extending portion 42, as shown in FIGS. 11, 12, and 13, the outer surface of the base end portion of the breakable portion 32 is overcome from the tip (one end) of the ring-shaped member 41. You may be comprised by the protrusion part extended like this. The ring-shaped member 41 provided with the breakable portion providing portion holding extension portion 42 is different from the ring-shaped member 37 described above only in the extension portion forming portion. For the same configuration, refer to the ring-shaped member 37 described above.

The extending portion 42 includes a first protrusion 42a and a second 42b arranged in a direction in which the breakable portion 32 is broken (a direction in which the first stress applying portion 34 and the second stress applying portion 36 spread). It is formed by. Specifically, as shown in FIGS. 12 and 13, the extending portion 42 includes a first projecting portion 42 a and a second stress applying portion side portion disposed outside the first stress applying portion side portion 32 b. It is comprised by the 2nd protrusion part 42b arrange | positioned on the outer side of 32c. As shown in FIG. 13, the protrusions 42a and 42b are protrusions having a circular cross section. Further, the outer surfaces of the protrusions 42a and 42b are not fused to the inner surface of the soft bag as described above. Further, the outer surfaces of the tip portions of the protruding portions 42 a and 42 b are chamfered in the same manner as the extending portion 38.
Even with the above-described configuration, the base end portion 33a of the first stress applying portion side separating portion 33 or the base end portion 35a of the second stress applying portion side separating portion 35 separated by the break of the breakable portion 32 is provided. As shown in FIG. 10, the protrusions 42 a and 42 b are held between the outer surface and the soft bag inner surface.

Further, as shown in FIGS. 14, 15, and 16, the post-breaking stress applying portion holding extension portion 45 has either one of the directions in which the breakable portion 32 is broken (the first stress applying portion 34 or The protrusion part arrange | positioned in the any direction which the 2nd stress provision part 36 spreads may be sufficient. Specifically, the protruding portion 45 of the embodiment of the present invention is disposed outside the first stress applying portion side portion 32b. As shown in FIGS. 15 and 16, the projecting portion 45 is a projecting portion having an arcuate cross section. Further, the outer surface of the extending portion 45 is not fused to the inner surface of the soft bag as described above. In addition, the ring-shaped member 44 provided with this breakable part providing part holding extension part 45 is different from the structure of the ring-shaped member 37 described above only in the extension part forming part. Further, the outer surface of the distal end portion of the protruding portion 45 is chamfered in the same manner as the extending portion 38. For the same configuration, refer to the ring-shaped member 37 described above.
Also with the above configuration, as shown in FIG. 17, the base end portion 33 a of the first stress applying portion side separating portion 33 or the second stress applying portion side separating portion 35 separated by breaking the breakable portion 32. The base end portion 35a (in this embodiment, the base end portion 33a of the first stress applying portion-side separation portion 33) gets over the protrusion 45 and is held between the outer surface of the protrusion and the inner surface of the soft bag. .

Further, as shown in FIGS. 18 and 19, the post-breaking stress applying portion holding extending portion 50 is formed by a plurality of protruding portions 50 a arranged so as to surround the base end portion of the breakable portion 32. It may be. The shape of the protrusion 50a in this embodiment is the same as the protrusions 42a and 42b and the protrusion 45 described above. The protrusions 50a are preferably formed at almost equal angles with respect to the central axis. In the embodiment shown in FIG. 18, six protrusions 50a are formed at the tip of the ring-shaped member. Further, the outer surface of the distal end portion of the protruding portion 50 a is chamfered in the same manner as the extending portion 38. Note that the ring-shaped member 49 provided with the breakable portion providing portion holding extension portion 50 is different from the configuration of the ring-shaped member 37 described above only in the shape of the portion constituting the holding extension portion 50. For the same configuration, refer to the ring-shaped member 37 described above.
Further, the medicine container 10 of the medical container 1 of the present invention is attached to the first medicine chamber 3, the discharge port 7 communicates with the first medicine chamber 3, and the soft bag 2 is the first medicine chamber. 3 is provided with a weak seal portion 18 for inhibiting communication between the discharge port 7 and when the second drug chamber 4 or the first drug chamber 3 is pressed, the partition weak seal portion 13 and the drug container It is preferable that the ten breakable portions 32 and the weak seal portion 18 for inhibiting communication are peeled or broken in this order.

As such a medical container 1, specifically, it is preferable that the peeling strength or breaking strength increases in the order of the partition weak seal portion 13, the breakable portion 32, and the communication blocking weak seal portion 18.
The medical container 1 is peeled or broken in the order of the partition weak seal portion 13, the breakable portion 32, and the communication blocking weak seal portion 18 in one order by pressing the second drug chamber 4. It is preferable that By having such a configuration, before the first medicine 5 in the first medicine chamber 3 and the second medicine 6 in the second medicine chamber 4 are mixed, and in the medicine chamber The medicine can be prevented from being administered before the medicine in the medicine container 10 is mixed, and preparation for medicine administration can be easily performed.

Next, the manufacturing method of the medical container 1 of this invention is demonstrated using FIG. The method is not limited to this method.
First, a tube body formed of a soft synthetic resin is prepared. And the upper end side seal part 24 which has one partial unsealed part (mixed injection port mounting part 19) in this tube body, three partial unsealed parts (discharge port mounting part 25, chemical | medical agent container mounting part 21, chemical | medical solution) The soft bag 2 is formed by forming the lower end side seal portion 22, the partition weak seal portion 13, and the communication blocking weak seal portion 18 that the injection portion 20) has. Subsequently, the cylindrical member 7a of the discharge port 7 is inserted and fixed to the discharge port mounting portion 25 that is a partially unsealed portion of the lower end side seal portion 22, and the lid member 7b is fixed to the cylindrical member 7a. Then, the medicine container 10 is inserted into the medicine container mounting portion 25, and the attachment portion 43 of the medicine container 10 is fixed to the soft bag. And the chemical | medical solution injection | pouring part 20 is sealed in the state which inject | poured the 1st chemical | medical agent 5 from the chemical | medical solution injection | pouring part 20 to the 1st chemical | medical agent chamber 3, and was fixed so that the lower end part 22 of the medical container 1 might become upper. To do.
Next, the cylindrical member 11a of the co-injection port 11 is fixed to the partially unsealed portion of the upper end side seal portion 24, the second medicine 6 is injected through the cylindrical member 11a, and the cylindrical member 11a is placed upward. In a state where the container is fixed, the cap member 11b having an elastic member attached to the cylindrical member 11a is fixed and sealed. In this manner, a medical container filled with a medicine as shown in FIG. 1 is produced. The injection of the first drug 5 and the sealing operation of the first drug chamber 3 may be performed before the injection of the second drug 6 and the sealing operation of the second drug chamber.

Next, the usage method of the medical container 1 of this invention is demonstrated.
First, when the second drug chamber 4 of the medical container 1 is strongly pressed with fingers or the like, the partition weak seal 13 is broken and the second drug 6 and the first drug chamber 3 in the second drug chamber 4 are broken. The first drug 4 is mixed. Next, by further pressing the second drug chamber 4, as shown in FIG. 9, the first drug chamber 3 expands, whereby the first stress applying part 34 and the second stress applying of the drug container 10 are applied. First, the distal end portion 32a of the breakable portion 32 is broken, and then the first stress applying portion side portion 32b and the second stress applying portion side portion 32c are broken to form the tubular portion 31. Opens. Then, as shown in FIG. 10, the base end part 33a of the first stress applying part side separating part 33 separated from the medicine container 10 and the base end part 35a of the second stress applying part side separating part 35 are It enters the gap 39 between the outer surface of the stress applying portion holding extension portion 38 and the inner surface of the soft bag. For this reason, before the medicine 12 in the medicine container 10 and the medicine in the soft bag 2 are mixed, the opening of the cylindrical portion 31 is not blocked.
Then, the weak seal portion 18 for inhibiting communication is peeled off almost simultaneously with or slightly later than the breakable portion 32 of the drug container 10 to complete preparation for drug administration. Then, the needle tube is inserted into the discharge hole 7d of the discharge port 7 to perform drug administration.
In addition, a medical container having a drug container including the post-breaking stress applying part holding extension parts 42, 45, and 50 can be prepared for drug administration in the same manner as the medical container 1.
As described above, the medical container 1 of the present invention has the drug container 10 of the present invention, so that the inside of the drug container 10 and the medical container 1 can be surely separated, and easily and reliably when necessary. In addition, the inside of the medicine container 10 can communicate with the inside of the medical container 1.

Next, a medical container according to another embodiment of the present invention will be described with reference to the accompanying drawings. In this embodiment as well, the medical container hollow body used in the medical container of the present invention constitutes a drug container.
20 is a front view of the medical container of the embodiment of the present invention, FIG. 21 is an explanatory diagram for explaining the inside of the medical container shown in FIG. 20 (a soft bag is cut along the central axis of the drug container) FIG. 22 is an enlarged view of the upper part of the medical container shown in FIG. 20, and FIG. 23 is a drug container (member for attaching a cylindrical body for a medical container) used in the medical container shown in FIG. 24 is a front view of the drug container shown in FIG. 23, FIG. 25 is a side view of the drug container shown in FIG. 24, and FIG. 26 is a C- of the drug container shown in FIG. 27 is a sectional view taken along the line DD of the drug container shown in FIG. 25, FIG. 28 is a bottom view of the drug container shown in FIG. 24, and FIG. 29 is a front view of the mounting member shown in FIG. 30 is a bottom view of the mounting member shown in FIG. 29. FIGS. 30 and 31 are views of the medical container shown in FIG. Use method is an explanatory view for explaining the.

  The medical container 60 of this embodiment was filled in the soft bag 62 formed by the soft resin sheets 62a and 62b, the drug chambers 3 and 4 formed in the soft bag 62, and the drug chambers 3 and 4. A medical container 60 comprising medicinal solutions 5 and 6 and a medical container hollow body attached to a soft bag 62, wherein the medical container hollow body is formed of a hard or semi-rigid material and has a tip Of the flexible bag 62 and a cylindrical portion 71 with a closed portion, a breakable portion 72 extending from the distal end portion of the tubular portion 71 to the proximal end side, and a breakable portion 72 of the tubular portion 71. The first stress applying portion 74 fixed to one inner surface 62 c and the second stress applying portion 76 fixed to the other inner surface 62 d of the soft bag 62 are provided. And with second stress The cylindrical portion 71 is opened by breaking by the spread between the portions 76 and the distal end side is separated from the breakable portion 72, and the medical container 60 is further from the proximal end side of the hollow body for medical containers, The base end portion 73a of the first stress applying portion side separating portion 73 or the base portion of the second stress applying portion side separating portion 75 after extending to the front end side so as to get over the outer surface of the base end portion of the breakable portion 72. A post-breaking stress applying portion holding extending portion 69 for holding the end portion 75a with the inner surface of the soft bag is provided.

The medical container 60 of the embodiment shown in FIGS. 20 to 31 includes a soft bag 62 and a cylindrical member mounting member for a medical container attached to the soft bag 62 (in the embodiment of the present invention, a member for mounting a drug container). ) 78, a medicine container 68 attached to the cylindrical member attaching member 78 for medical containers, and a discharge port 7 attached to the soft bag 62. In this embodiment, the medical container hollow body constitutes the drug container 68. Specifically, the hollow body for a medical container includes a cylindrical portion 71, a breakable portion 72, a first stress applying portion 74, and a second stress applying portion 76, and a cylinder having an open rear end portion. A medicine container 68 is configured by including a cylindrical body 71, a lid member 80 that seals the rear end portion of the cylindrical body 71, and a medicine stored inside the cylindrical body 71.
The medical container 60 of this embodiment is provided with a cylindrical member mounting member 78 for a medical container (a member for mounting a drug container in the embodiment of the present invention) 78 for attaching the drug container 68 to the soft bag 62, and after being broken. The stress applying portion holding extension portion 69 is formed in the cylindrical member mounting member 78 for medical containers.

Unlike the medical container 1, the medical container 60 of the present invention has a drug container 68 attached to the flexible bag 62 via a medical container tubular member attaching member 78.
As shown in FIG. 20, the medical container 60 of the present invention includes a soft bag 62, a first medicine 5 contained in the soft bag 62, a second medicine 6, a medicine container 68, and a medicine container 68. The medicine 92 accommodated in the container and the discharge port 7 are provided.
As shown in FIG. 20, the soft bag 62 includes a partition weak seal portion 13, a communication blocking weak seal portion 18, a spread suppressing sheet fixing portion 86, a first drug chamber 3, and a second drug chamber. 4 is provided. The first drug chamber 3 stores a first drug solution 5, and the second drug chamber 4 stores a second drug solution 6.
The basic configuration of the soft bag 62 is the same as the basic configuration of the soft bag 2. The difference is that the shape of the upper end side seal portion 82 and the lower end side seal portion 84, the position of the weak seal portion 18 for inhibiting communication, and the soft bag 62 includes an inter-sheet fixing portion 86 for suppressing spread.

As shown in FIG. 20, the soft bag 62 of the present invention is partitioned into a first drug chamber 3 and a second drug chamber 4 by a partitionable weak seal portion 13 for separation. An upper end side seal portion 82 and a lower end side seal portion 84 are provided at the upper end portion and the lower end portion of the flexible bag 62. The upper end side seal portion 82 and the lower end side seal portion 84 are wide seal portions. Further, the upper end side seal portion 82 is provided with a drug container attachment member mounting portion 64 for attaching the drug container attachment member 78, and the lower end side seal portion 84 is attached with a discharge port for attaching the discharge port 7. A portion 65 is formed. The medicine container mounting member mounting portion 64 and the discharge port mounting portion 65 are formed by not sealing a part of the upper end side seal portion 82 and the lower end side seal portion 84.
The partition weak seal portion 13 of the soft bag 62 of the present invention is preferably easier to peel than the communication inhibiting weak seal portion 18 and more difficult to peel than the breakable portion 72 of the drug container 68. Specifically, the peel strength (initial peel strength) of the partition weak seal portion 13 is smaller than the peel strength (initial peel strength) of the communication inhibiting weak seal portion 18 and larger than the breakable portion 72 of the drug container 68. preferable. The peel strength (initial peel strength) of the partition weak seal portion 13 is preferably 0.1 to 5 N / 10 mm, and more preferably 0.3 to 3 N / 10 mm. If the peel strength is within this range, the partition weak seal 13 is not accidentally peeled off during transportation or storage, and the partition weak seal 13 can be easily peeled off. Also, if this is the case, when the second drug chamber 4 or the first drug chamber 3 is pressed, the partition weak seal portion 13 peels after the breakable portion 72 and the communication blocking weak seal portion 18. There is nothing.

Further, as shown in FIGS. 20, 21, and 22, the spread sheet suppressing sheet fixing portion 86 is provided in the vicinity of the distal end portion of the drug container 68 on the drug chamber side, and the first stress applying portion 74 is a soft bag. The first fixing portion 90 and the second stress applying portion 76 that are fixed to the 62 restrain the spread between the sheets 62a and 62b fixed by the second fixing portion 91 that is the portion that is fixed to the soft bag 62. It can be peeled off. In the medical container 60 of this embodiment, as shown in FIG. 20, the peelable spread suppressing means for fixing the portion between the sheets located around the first stress applying portion 74 and the second stress applying portion 76. An inter-sheet fixing portion 86 is provided.
In the embodiment shown in FIG. 20, the spread suppressing inter-sheet fixing portion 86 is formed in an arc shape in the vicinity of the distal ends of the first stress applying portion 74 and the second stress applying portion 76 of the drug container 68. It is preferable that the inter-sheet fixing portion for suppressing spread is not peeled off by pressure applied to the soft bag 62 before use during transportation or the like, and is peelable when the soft bag 62 is strongly pressed with a finger. The sheet-to-sheet fixing portion 86 is preferably an arc-shaped one that is continuous with a position near the tip of the stress applying portions 74 and 76 and inside the drug chamber, as in the illustrated embodiment. Note that the inter-sheet fixing portions 86 may be scattered instead of being continuous. Further, the inter-sheet fixing portion 86 may be provided in the vicinity of the tip portion of the stress applying portions 74 and 76 and on the side surface thereof, or two so as to sandwich the stress applying portions 74 and 76 therebetween. Further, as shown in FIG. 20, the spread suppressing sheet fixing portion 86 preferably does not form a chamber partitioned from the second drug chamber 4.

The inter-sheet fixing portion 86 is preferably formed by fusing the soft bag 62 in the same manner as the partition weak seal portion 13. The fusion is preferably thermal fusion, high frequency fusion or the like. By having the inter-sheet fixing portion 86, there is no possibility that the soft bag 62 is inflated during transportation and the first stress applying portion 74 and the second stress applying portion 76 are cleaved. The shape of the inter-sheet fixing portion 86 may be any shape as long as the tubular portion 71 can be prevented from being broken before use such as during transportation.
The communication-inhibiting weak seal portion 18 is formed so as to surround the upper portion of the discharge port 7. The basic configuration of the communication inhibiting weak seal portion 18 is the same as that of the communication inhibiting weak seal portion 18 described above. A fourth chamber 26 isolated from the first drug chamber 3 is formed by the weak seal portion 18 for inhibiting communication. The fourth chamber 26 is an empty room in the embodiment of the present invention. However, a predetermined liquid (for example, physiological saline) may be placed in the fourth chamber. The fourth chamber may be in a dry state, but may be filled with a small amount of liquid for sterilization. Further, a passage through which some water vapor or medicine passes through the weak seal portion 18 for inhibiting communication may be formed so as to communicate with the second medicine chamber 4 at the above level. The weak seal portion 18 for inhibiting communication can be formed by heat-sealing the sheet material in a band shape (thermal fusion, high frequency fusion, ultrasonic fusion, etc.).

In the embodiment of the present invention, the communication-inhibiting weak seal portion 18 is more difficult to peel off than the partition weak seal portion 13 and the breakable portion 72 of the drug container 68. Specifically, the peel strength (initial peel strength) of the weak seal portion 18 for inhibiting communication is greater than the peel strength (initial peel strength) of the partition weak seal portion 13 and the break strength of the breakable portion 72. Thereby, when the 1st chemical | medical agent chamber 3 or the 2nd chemical | medical agent chamber 4 is pressed, the chemical | medical agent administration before mixing a chemical | medical agent can be prevented. The peel strength (initial peel strength) of the weak seal portion 18 for inhibiting communication is preferably 1 to 25 N / 10 mm, and particularly preferably 2 to 20 N / 10 mm. Moreover, it is preferable that the width | variety (band width) of the weak seal part for communication inhibition is 2-20 mm, especially 4-12 mm.
Next, the medicine container 68 will be described. As shown in FIGS. 24 to 28, the drug container 68 includes a drug container cylindrical body 70 and a lid 80 that seals the rear end of the drug container cylindrical body 70. Hereinafter, the drug container 68 will be described with the “upper side” in FIGS. 24 to 28 as the “front end side” and the “lower side” in FIGS.
As shown in FIGS. 24 to 28, the medical container hollow body includes a cylindrical portion 71, a first stress applying portion 74, and a second stress applying portion 76. Moreover, in the Example of this invention, the outer peripheral surface (except a front-end | tip part) of the cylindrical part 71 becomes a part with which the cylindrical body attachment member 78 for medical containers is mounted | worn.

The tubular portion 71 is provided with a breakable portion 72. The inside of the cylindrical part 71 is hollow and can accommodate the medicine 92. As shown in FIGS. 26 and 27, a medicine storage portion 89 is formed by the inside of the tubular portion 71 and the tip portion of the lid portion 80.
As shown in FIGS. 26 and 27, the cylindrical portion 71 is a cylindrical portion whose distal end portion is closed and whose proximal end portion is opened. In this embodiment, the flange portion 71a and the first portion are sequentially formed from the proximal end side. One cylindrical portion (soft bag attaching portion) 71b, a tapered portion 71c that is continuous with the first cylindrical portion 71b and decreases in a tapered shape toward the distal end side, and a second cylindrical portion 71d that is continuous with the tapered portion 71c And a closed portion (tip portion) 71e continuous with the second cylindrical portion 71d. The tip 71e has a dome shape in the embodiment of the present invention. Further, the shape of the tip portion may be a truncated cone shape, a conical shape, or the like.
The volume of the medicine container 89 is preferably 1 to 30 mm. The length of the medicine container 89 is preferably 20 to 70 mm. Moreover, the cover part attaching part 71f which attaches the cover part 80 is formed in the base end side of the flange part 71a.

As shown in FIGS. 26 and 27, the lid 80 includes a disk part 80 a and a sealing part 80 b that seals an opening provided on the bottom surface side of the disk part 80 a. The blocking portion 80b is a cylindrical portion (cylindrical portion) whose proximal end is provided on the disk portion 80a and whose distal end is closed. With this configuration, after the medicine is stored in the cylindrical portion 71, the lid portion 80 is fitted into the lid mounting portion 71f and fixed by ultrasonic fusion, high frequency fusion, heat fusion, or the like. The part 71 can be reliably sealed.
Examples of the medicine stored in the cylindrical portion 71 are those that are mixed and dissolved in an infusion solution. For example, antibiotics, vitamins (general vitamins), various amino acids, antithrombotic agents such as heparin, insulin, Antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, correction electrolytes, antiviral agents, immunostimulants, and the like. Further, the inside of the cylindrical portion 71 of the drug container cylindrical body 70 may be normal pressure, but may be in a reduced pressure or vacuum state. Thus, when the inside of the cylindrical portion 71 is in a reduced pressure or vacuum state, the effect of preventing degradation and degradation of the drug is improved, and when the breakable portion 72 is ruptured, an infusion solution (chemical solution) is sucked, It can introduce into the cylindrical part 71 more rapidly.

The breakable portion 72 can vertically cut a portion constituting the medicine storage portion 89 of the cylindrical portion 71 when stress is applied by the first stress applying portion 74 and the second stress applying portion 76. It is preferable to have such a configuration. The breakable portion 72 of the present invention is provided at the distal end portion of the medicine storage portion 89 (tubular portion 71).
The breakable portion 72 is provided so as to pass between the first stress applying portion 74 and the second stress applying portion 76 in the vicinity of the distal end portion of the tubular portion 71 as shown in FIGS. A distal end portion 72a, and a first stress applying portion side portion 72b and a second stress applying portion side portion 72c branched from the vicinity of the proximal end portion of the distal end portion 72a and extending in the side surface direction of the tubular portion 71 ing. And the 1st stress application part side part 72b and the 2nd stress application part side part 72c are provided so that the base end parts of the front end side part 72a may be connected. By comprising in this way, when the 1st stress provision part 74 and the 2nd stress provision part 76 are expanded, the fracture | ruptureable part 72 fractures | ruptures and the cylindrical part 71 is opened.
The first stress applying portion 74 extends from the one sheet 62 a side portion near the front end portion of the cylindrical portion 71, and the second stress applying portion 76 is the other sheet near the front end portion of the cylindrical portion 71. 62b extends from the side portion. When the second drug chamber 4 is pressed, the breakable portion 72 has a fixing portion 90 of the first stress applying portion 74 to the soft bag 62 and a fixing portion 91 of the second stress applying portion 76 in the vicinity of the fixing bag 91. By swelling, it breaks to the one sheet 62a side and the other sheet 62b side. Further, as shown in FIG. 23, the distal end side portion 72a preferably passes between the first stress applying portion 74 and the second stress applying portion 76 and extends toward the proximal end side. The leading end portion 72a passes through the vicinity of the middle between the first stress applying portion 74 and the second stress applying portion 76 of the cylindrical portion 71, and passes through the vicinity of the middle between one sheet side and the other sheet side. It is provided at the tip of the cylindrical part 71 (medicine storage part 89).

The distal end side portion 72 a is formed in the vertical direction along the outer surface of the tubular portion 71 from the distal end portion to the proximal end side of the tubular portion 71. The distal end side portion 72 a is formed continuously from the distal end portion of the cylindrical portion 71 to the proximal end side. With such a configuration, as shown in FIG. 31, the second drug chamber 4 or the first drug chamber 3 is pressed to inflate the second drug chamber 3, so that the drug container 68 (cylindrical portion 71. ) To one sheet 62a side and the other sheet 62b side.
As shown in FIG. 25, the first stress applying portion side portion 72b and the second stress applying portion side portion 72c of the breakable portion 72 extend respectively obliquely to the distal end side portion 72a of the breakable portion 72. It is provided as follows. The first stress applying part side portion 72b and the second stress applying part side part 72c of the breakable part 72 are formed in a substantially arc shape. Since the breakable portion 72 is configured as in the embodiment shown in FIGS. 24 and 25, the tip side portion is separated from the second cylindrical portion 71d of the cylindrical portion 71 by breakage as shown in FIG. To do. The breakable portion 72 is a fragile portion that can be broken as described above. Specifically, the breakable part is a thin part. The breakable portion 72 is preferably produced by forming a groove on the outer surface of the cylindrical portion 71. Further, the first stress applying part side portion 72b and the second stress applying part side part 72c may be formed in a substantially arc shape, a substantially elliptic arc shape, or a U-shape.

Specifically, the breakable part of the embodiment of the present invention is produced by forming a groove part having a V-shaped cross section. Specifically, it is preferable that the angle of the groove is 68 to 120 °, particularly 40 to 60 °, and the minimum thickness is 0.05 to 0.3 mm, particularly 0.08 to 0.2 mm. By producing the groove forming portion at such an angle, when the soft bag 62 is inflated, the stress concentrates on the center of the breakable portion, and the groove is reliably broken. Further, the groove portion may have any shape as long as it is easily broken, and is not limited to the V shape as in the embodiment, and may be a semicircular shape, a semielliptical shape, or the like. Moreover, although the breakable part of the present invention can be broken by forming a thin part by forming a groove part, it is not limited to this. The breakable portion may be produced by, for example, forming a portion forming the breakable portion of the medicine storage portion with a material more fragile than the other portions. Specifically, it is preferable that a part forming the breakable part is made of an easily breakable material by multicolor molding and the other parts are made of a material that is not easily broken.
Further, the breakable portion 72 is anything as long as it can break the cylindrical portion 71 (drug storage portion 89) by the stress applied by the first stress applying portion 74 and the second stress applying portion 76. There may be.

In this embodiment, the first stress applying portion 74 and the second stress applying portion 76 extend with the vicinity of the distal end portion of the cylindrical portion 71 as the base end, as shown in FIGS. Is the free end. With such a configuration, when the first stress applying unit 74 and the second stress applying unit 76 are given a force to open them, the force is converted into stress for breaking the breakable portion 72. It has a function to do. The first stress applying part 74 and the second stress applying part 76 are preferably formed so as to face each other. The main body portions of the first stress applying portion 74 and the second stress applying portion 76 are preferably formed in a vertically long rectangular shape. With such a configuration, when the soft bag 62 is pressed and inflated, the first stress applying portion 74 and the second stress applying portion 76 reliably apply the breaking stress to the breakable portion 72.
Specifically, as shown in FIGS. 24 to 27, the first stress applying part 74 and the second stress applying part 76 are provided on each of the vertically long flat plate parts 74a and 76a and on both sides of the flat plate parts 74a and 76a. The formed side wall portions 74b and 76b, the bonding portions 74d and 76d for bonding to the sheet constituting the soft bag 62, the ribs 74e and 76e formed on the side wall portions, and the inner surfaces of the flat plate portions 74a and 76a. And ribs 74c and 76c.

The first stress applying part 74 and the second stress applying part 76 are preferably provided so as to face each other and slightly apart. Since it has such a structure, even if it presses between the 1st stress application part 74 and the 2nd stress application part 76 at the time of fixation to the soft bag 62, the 1st stress application part 74 and the 1st The amount of deformation allowed for the second stress applying portion 76 is small, and the breakable portion 72 is not likely to break. In the embodiment of the present invention, the flat plate portions 74a and 76a are preferably arranged so as to face each other. The side wall portions 74b and 76b of the embodiment of the present invention are formed such that the tip end portion is high and the base end portion is low. As shown in FIGS. 25 and 27, ribs 74e and 76e are formed at the front end portions of the side walls 74b and 76b. The rib 74e and the rib 76e are provided at positions facing each other. With such a configuration, the first stress applying unit 74 and the second stress applying unit 76 are slightly separated from each other. The ribs are preferably separated from each other by 0.1 to 3.0 mm, particularly 0.3 to 1.5 mm.
The ribs 74 c and 76 c are provided on the respective surfaces of the first stress applying part 74 and the second stress applying part 76 that face each other. In the embodiment of the present invention, the ribs 74c and 76c are provided on the inner surfaces of the flat plate portions 74a and 76a from the tip of the cylindrical portion 71 of the flat plate portions 74a and 76a to the tip of the flat plate portions 74a and 76a. In the embodiment of the present invention, the ribs 74c and 76c may be arranged at positions where they do not contact each other (not shown). Specifically, the first stress applying unit 74 and the second stress applying unit 76 are staggered from the center in the axial direction of the first stress applying unit 74 or the second stress applying unit 76 to the side surface side. In the position. With such a configuration, since the tensile stress or tear stress applied to the first stress applying part 74 and the second stress applying part 76 is reliably transmitted to the breakable part 72, the breakable part 72 is broken. It becomes easy.

The joining portions 74d and 76d are portions provided on the outer surfaces of the flat plate portions 74a and 76a and joined to the inner surface of the soft bag 62. The joining portions 74d and 76d are formed in a rectangular shape and are flat. The joining portions 74d and 76d are formed from the distal end portions of the first stress applying portion 74 and the second stress applying portion 76 to the vicinity of the proximal end portion.
In the embodiment of the present invention, it is preferable that at least a part of the outer surfaces of the first stress applying portion 74 and the second stress applying portion 76 be formed of a material that can be fixed to the inner surface of the soft bag 62. Specifically, at least a part of the joining portions 74 d and 76 d is formed of a material that can be fixed to the inner surface of the soft bag 62. Specifically, the joint portions 74d and 76d to be joined to the inner surface of the soft bag 62 are partly or wholly formed of a material for forming the soft bag 62 (particularly, a material for forming the inner surface side of the soft bag 62). It is preferably formed of a compatible resin. With such a configuration, the first stress applying part 74 and the second stress applying part 76 can be reliably bonded to the inner surface of the soft bag 62. The compatible resin of the soft bag 62 is preferably the above-described resin. The compatible resin is preferably a material that is the same as or similar to the constituent material of the soft bag. In the embodiment of the present invention, the compatible resin layer is preferably produced by two-color molding. Note that all of the first stress applying portion or the second stress applying portion may be made of a resin that is compatible with the soft bag in the entire drug container. The compatible resin layer is preferably made flat so as to be easily joined to the inner surface of the soft bag.

Then, as shown in FIGS. 21 and 23, the whole or a part of the joining portion 74 d of the first stress applying portion 74 is joined to the medical container 60 with the inner surface 62 c of the sheet 62 a of the flexible bag 62. Similarly, the first fixing portion 90 is formed, and similarly, the whole or a part of the joint portion 76d of the second stress applying portion 76 is joined to the inner surface 62d of the sheet 62b of the soft bag 62, thereby the second portion. The fixed portion 91 is formed. For this reason, the first stress applying part 74 and the second stress applying part 76 are fixed to the first stress applying part 74 and the second stress applying part 76 of the soft bag 62 when the drug chamber is pressed, It spreads following the spread between 91, and a breakable portion, which will be described later, opens to one sheet 62a side and the other sheet 62b side and breaks.
The joining between the joining portion 74d of the first stress applying portion 74 and the joining portion 76d of the second stress applying portion 76 and the inner surfaces 62c and 62d of the one sheet 62a and 62b of the soft bag 62 is performed by ultrasonic fusion or high frequency. It is preferably performed by fusion, heat fusion, or the like. Specifically, after the drug container 68 is arranged at a position as shown in FIG. 18, it is sandwiched from both sides of the surface of the one sheet 62a and the other sheet 62b of the flexible bag 62 by a sealing mold and heat sealed. Preferably, it is done.

Moreover, it is preferable that the 1st stress provision part 74 or the 2nd stress provision part 76 is a structure which can carry | support and spread from the exterior of the soft bag 62. FIG.
The first stress applying portion and the second stress applying portion of the present invention are not limited to those having the above-described configuration, and can be joined to one sheet inner surface and the other sheet inner surface constituting the soft bag 62. In addition, any configuration may be used as long as it has a configuration capable of applying stress to the breakable portion in conjunction with the swelling of the soft bag. For example, it may not be formed to extend in the axial direction of the medicine container, but may be formed obliquely with respect to the medicine container.
Further, the breakable portion 72 of the tubular portion 71 breaks due to the spread between the first stress applying portion 74 and the second stress applying portion 76 and the distal end side is separated from the breakable portion 72 so that the tubular portion 71 is opened. To do. In the embodiment of the present invention, the second drug chamber 4 or the first drug chamber 3 is fixed to the inner surface of the soft bag 62 as shown in FIG. 31 due to the expansion of the second drug chamber 4 when the second drug chamber 4 or the first drug chamber 3 is pressed. The first stress applying portion 74 and the second stress applying portion 76 spread outward, the tip side portion 72a of the breakable portion 72 is first broken, and then the first stress applying portion side of the breakable portion 72 The part 72b and the second stress applying part side part 72c are broken. Thereby, the front end side is separated from the breakable portion 72 of the medicine container 68.

The drug container 68 is attached to the soft bag 62 by being inserted into an attachment member 78 fixed to the drug container mounting portion 64 and fixed by high frequency fusion, ultrasonic fusion, or the like. When the medicine container 68 is attached to the medicine container attachment member 78, the breakable portion 72 is exposed from the tip of the attachment member cylindrical portion 79 of the attachment member 78.
As shown in FIGS. 23, 29, and 30, the mounting member 78 includes a mounting member cylindrical portion 79 and a post-breakage stress applying portion holding extension portion 69.
The member 78 for attaching the medicine container according to the embodiment of the present invention covers the cylindrical portion 71 of the medicine container 68 so as to expose the breakable portion 32 of the medicine container 10 except for the extending portion 69 for holding the post-breaking stress applying portion. The mounting member cylindrical portion 79 is provided to be wrapped and fixed to the soft bag 62.
As shown in FIGS. 23 and 29, the attachment member tubular portion 79 is a tubular portion and has an internal shape corresponding to the external shape of the medicine container 68. Specifically, as shown in FIG. 29, the mounting member cylindrical portion 79 is reduced in diameter to the flange portion 79 a, the first cylindrical portion 79 b, and the distal end side provided in order from the proximal end side to the distal end side. A tapered portion 79c and a second cylindrical portion 79d are formed.

The post-breaking stress applying portion holding extension portion 69 is an annular portion that encloses the base end portion of the breakable portion 72. As shown in FIG. 29, the annular portion 69 is provided at the distal end portion of the drug container mounting member 78 (the distal end of the second cylindrical portion 79d).
As shown in FIG. 23, the annular portion 69 extends to the distal end side so as to get over the outer surface of the base end portion of the breakable portion 32. The annular portion 69 is provided around the proximal end portion of the breakable portion 32 and extends from the proximal end side to the distal end side from the proximal end portion of the breakable portion 72 from the proximal end portion of the breakable portion 72. Specifically, the annular portion 69 is formed so as to enclose the first stress applying portion side portion 72 b and the second stress applying portion side portion 72 c of the breakable portion 72. With such a configuration, the base end portion 73a of the first stress applying portion side separating portion 73 or the base end portion 75a of the second stress applying portion side separating portion 75 separated by breaking breaks over the tip end portion of the annular portion 69. Thus, it is securely held between the annular portion 69 and the inner surface of the soft bag.
Moreover, it is preferable that the inner corner | angular of the front-end | tip part of the stress application part holding extension part 69 after a fracture | rupture has an edged state. By doing in this way, the base end part 73a of the first stress applying part side separating part 73 or the base end part 75a of the second stress applying part side separating part 75 that has overcome the base end part of the extending part 69 is provided. It becomes difficult to return to the inside of the extension part 69.

Furthermore, it is preferable that the outer corner of the distal end portion of the post-breaking stress applying portion holding extension portion 69 is chamfered. The chamfering may be either a chamfering that forms a slope on the outer surface of the tip, such as a C chamfering, or a chamfering that forms a curved surface such as an R chamfering. Preferably, it is chamfering in which an inclined surface is formed. In the illustrated embodiment, the outer surface of the distal end portion of the extending portion 69 is chamfered to form an inclined surface 69a, specifically, the outer surface of the extending portion is formed in a tapered shape whose diameter decreases toward the distal end side. By doing in this way, the separation parts 73 and 75 which got over the front-end | tip part of the extension part 69 become easy to approach between the soft bag inner surface and the outer surface of the extension part.
Furthermore, an edge projecting in the radial direction may be provided at the base end portion at the chamfered portion at the chamfered outer corner of the distal end portion of the post-breaking stress applying portion holding extension portion 69. By doing so, the base end portion 73a of the first stress applying portion side separating portion 73 or the base of the second stress applying portion side separating portion 75 that has entered between the inner surface of the soft bag and the outer surface of the extending portion. The separation of the end portion 75a is suppressed.
Further, the post-breakage stress applying portion holding extension portion 69 is located at a position (specifically, slightly) away from the outer surface of the base end portion of the breakable portion 72 so as not to hinder the breakage of the breakable portion 72. It is preferable to be formed.

Further, as shown in FIG. 22, the outer surface of the post-breaking stress applying portion holding extension portion 69 is not fused to the inner surface of the soft bag. With such a configuration, a gap 39 is formed between the outer surface of the post-breaking stress applying portion holding extension portion 69 and the soft bag inner surfaces 62c and 62d. Further, the post-breaking stress applying portion holding extension portion 69 of the present invention is not limited to the entire outer surface of the soft bag inner surface, but is not limited to this. If the base end part 73a or the base end part 75a of the second stress applying part side separating part 75 can enter between the inner surface of the soft bag and the extension part for holding the stress applying part after breaking, the entire outer surface is soft. It may not be fixed to the inner surface of the bag. For example, only the distal end portion of the outer surface of the extension portion may not be fixed.
With the above-described configuration, the gap 39 is formed between the outer surface of the post-breaking stress applying portion holding extension portion 78 and the soft bag inner surfaces 62c and 62d, and is separated by the breakage of the breakable portion 72. The base end part 73a of the stress applying part side separating part 73 or the base end part 75a of the second stress applying part side separating part 75 is between the inner surface of the soft bag and the outer surface of the post stressed stress applying part holding extension part 69. Invades and is retained.
As shown in FIGS. 33, 34, and 35, the post-breaking stress applying portion holding extending portion extends from the one end of the drug container mounting member 78 so as to get over the outer surface of the base end portion of the breakable portion 72. It may be.

The extending portion 100 of this embodiment is provided at the distal end portion of the mounting member 99, and is constituted by projecting portions 100a and 100b that ride over the outer surface of the proximal end portion of the breakable portion 32 to the distal end side. The attachment member 99 provided with the breakable portion providing portion holding extension portion 100 is different from the configuration of the attachment member 78 described above only in the shape of the portion constituting the post-breakage stress applying portion holding extension portion. For the same configuration, refer to the mounting member 78 described above.
As shown in FIG. 33, the extending portion 100 includes protrusions 100 a and 100 b arranged in a direction in which the breakable portion 72 breaks (a direction in which the first stress applying portion 74 and the second stress applying portion 76 spread). It is formed by. Specifically, the extension part 100 includes a projecting part 100a arranged outside the first stress applying part side part 72b and a second stress applying part arranged outside the second stress applying part side part 72b. It is comprised by the side extension part 100b. As shown in FIG. 35, the protrusions 100a and 100b are protrusions having a circular cross section. Further, the outer surfaces of the protrusions 100a and 100b are not fused to the inner surface of the soft bag as described above. Further, the outer surfaces of the tips of the projecting portions 100 a and 100 b are chamfered like an annular portion 69.
The base end part 73a of the first stress applying part side separating part 73 or the base end part 75a of the second stress applying part side separating part 75 separated by the break of the breakable part 72 is also a protruding part. It is held between the outer surface of 100a, 100b and the inner surface of the soft bag.

In addition, as shown in FIGS. 36, 37, and 38, the post-breaking stress applying portion holding extension portion 102 has the first stress applying portion 74 or the second stress applying portion 76 of the breakable portion 72 spread. The protrusion part arrange | positioned only in the position corresponding to the any fracture | rupture direction of the position corresponding to a direction may be sufficient. Specifically, the protrusion 102 according to the embodiment of the present invention is disposed outside the proximal end portion of the first stress applying portion side portion 72b. As shown in FIGS. 37 and 38, the protruding portion 102 is a protruding portion having an arcuate cross section. Further, the outer surface of the extension 102 is not fused to the inner surface of the soft bag as described above. In addition, the ring-shaped member 101 provided with the breakable part providing part holding extension part 102 is different from the structure of the ring-shaped member 78 described above only in the shape of the part constituting the extension part. For the same configuration, refer to the ring-shaped member 78 described above.
With the configuration as described above, the base end portion 73a of the first stress applying portion side separating portion 73 or the base end portion 75a of the second stress applying portion side separating portion 75 separated by the break of the breakable portion 72 is extended. It is held between the outer surface of the portion 102 and the inner surface of the soft bag.
Further, as shown in FIGS. 39 and 40, the post-breaking stress applying portion holding extending portion 104 is formed by a plurality of protruding portions 104a arranged so as to surround the base end portion of the breakable portion 72. It may be. The shape of the protruding portion 104a in this embodiment is the same as that of the protruding portions 100a and 100b and the protruding portion 102 described above. The protrusions 104 are preferably formed at substantially equal angles with respect to the central axis. In the embodiment shown in FIG. 39, six protrusions 104 a are formed at the tip of the ring-shaped member 103. Note that the attachment member 103 provided with the breakable portion providing portion holding extension portion 104 is different from the ring-shaped member described above only in the shape of the portion constituting the holding extension portion 104. For the same configuration, refer to the ring-shaped member 103 described above.

Further, the above-described post-breaking stress applying portion holding extension portions 100, 102, 104 are formed at positions spaced apart from the outer surface of the base end portion of the breakable portion 71 to some extent so as not to hinder the breakage of the breakable portion 72. Preferably it is.
In addition, as a protrusion part, the base end parts 73a and 75a of the separation parts 73 and 75 isolate | separated from the chemical | medical agent container 68 by the fracture | rupture of the breakable part 72 can be hold | maintained between the outer surface of a protrusion part, and the surface without a soft bag. Any shape and position may be used.
In the medical container 60 of the present invention, the medicine container 68 is attached to the second medicine chamber 64, the discharge port 7 communicates with the first medicine chamber 4, and the soft bag 62 is the first medicine. The weak seal portion 18 for inhibiting communication between the chamber 4 and the discharge port 7 is provided. When the second drug chamber 4 is pressed, the breakable portion 72 of the drug container 68 and the weak seal portion 13 for partitioning are provided. It is preferable that the weak seal portion 18 for inhibiting communication is peeled or broken in this order. With such a configuration, it is possible to prevent drug administration before the drug is mixed.

In the medical container 60 of the present invention, the medicine container 68 is attached to the second medicine chamber 4, the discharge port 7 communicates with the first medicine chamber 3, and the soft bag 62 is the first medicine chamber. 3 and a weak seal portion 18 for inhibiting communication between the discharge port 7 and when the first drug chamber 3 is pressed, the partition weak seal portion 13, the breakable portion 72 of the drug container 68, It is preferable that the weak seal portion 18 for inhibiting communication is peeled or broken in this order.
As such a medical container 60, specifically, it is preferable that the peel strength or the break strength is increased in the order of the breakable portion 72, the partition weak seal portion 13, and the communication blocking weak seal portion 18.
Moreover, the medical container 60 peels or breaks in order of the weak seal part 13 for partitioning, the breakable part 72, and the weak seal part 18 for communication inhibition by pressing the second drug chamber 4 in one action. It is preferable that By having such a configuration, before the first medicine 5 in the first medicine chamber 3 and the second medicine 6 in the second medicine chamber 4 are mixed and the medicine in the medicine chamber The medicine can be prevented from being administered before being mixed with the medicine in the medicine container 68, and preparation for medicine administration can be easily performed.

Next, the manufacturing method of the medical container 60 of this invention is demonstrated using FIG. In addition, the manufacturing method of a medical container is not limited to this method.
First, a tube body formed of a soft synthetic resin is prepared. The tube body has an upper seal portion 82 having a partially unsealed portion (drug container mounting member mounting portion 64), and two partially unsealed portions (discharge port mounting portion 65, drug solution injection portion ( The soft bag 62 is formed by forming the lower end side seal portion 84, the partition weak seal portion 13, and the communication inhibiting weak seal portion 18. Subsequently, the drug container mounting member 78 is inserted and fixed to the drug container mounting member mounting portion 64 which is a partially unsealed portion of the upper end side seal portion 82. Then, the second medicine 6 is injected from the attachment member 78, and the medicine container 68 is inserted into and secured to the attachment member 78 in a state where the upper end portion 82 of the medical container 60 is fixed upward.
Next, the cylindrical member 7a of the discharge port 7 is inserted into and fixed to the discharge port mounting portion 65, which is a partially unsealed portion of the lower end side seal portion 84, and the lid member 7b is fixed to the cylindrical member 7a. And the chemical | medical solution injection | pouring part is sealed in the state which inject | poured the 1st chemical | medical agent 5 from the chemical | medical solution injection | pouring part to the 1st chemical | medical agent chamber 3 and fixed so that the lower end part 84 of the medical container 60 may become upper. In this way, a medical container filled with a medicine as shown in FIG. 20 is produced. The injection of the first medicine 5 and the sealing operation of the first medicine chamber 3 may be performed before the injection of the second medicine 6 and the sealing operation of the second medicine chamber 4.

Next, the usage method of the medical container 60 of this invention is demonstrated.
First, when the second drug chamber 4 of the medical container 60 is strongly pressed with a finger or the like, the spread suppressing sheet fixing portion 86 is peeled off due to the spread of the second drug chamber 4, and then, as shown in FIG. As described above, the first stress applying portion 74 and the second stress applying portion 76 of the drug container 68 expand, first, the distal end side portion 72a of the breakable portion 72 is broken, and then the first stress applying portion side. When the portion 72b and the second stress applying portion side portion 72c are broken, the tubular portion 71 is opened. At this time, the base end portion 73a of the first stress applying portion-side separating portion 73 separated from the drug container 68 has a gap between the outer surface of the annular portion 69 and the sheets 62a and 62b as shown in FIG. Enter 39. Thereby, before the medicine 92 in the medicine container 68 and the medicine in the soft bag 62 are mixed, the opening of the cylindrical portion 71 is not closed again. Therefore, medicine mixing can be performed smoothly.
The weak seal portion 13 for partitioning is peeled off almost simultaneously or slightly later than the breakage of the drug container 68, and the weak seal portion 18 for blocking communication is peeled off substantially simultaneously or slightly later than the weak seal portion 13 for partitioning. Preparation is complete. Then, the needle tube is inserted into the discharge hole 7d of the discharge port 7 to perform drug administration.
In addition, a medical container having a drug container including the post-breaking stress applying part holding extension parts 100, 102, and 104 can be prepared for drug administration in the same manner as the medical container 60.

Next, a medical container which is another embodiment of the present invention will be described.
In this embodiment, the medical container hollow body constitutes the discharge port. 41 is a front view of the medical container according to the embodiment of the present invention, and FIG. 42 is an explanatory diagram for explaining the inside of the medical container shown in FIG. 41 (cutting the soft bag along the central axis of the discharge port). 43 is an enlarged view of the lower part of the medical container shown in FIG. 42, FIG. 44 is a front view of the discharge port used in the medical container shown in FIG. 41, and FIG. 44 is a side view of the discharge port shown in FIG. 44, FIG. 46 is a cross-sectional view taken along line EE of the discharge port shown in FIG. 44, and FIG. 47 is a cross-sectional view taken along line FF shown in FIG. FIG. 48 is a top view of the discharge port shown in FIG. 44, and is an explanatory diagram for explaining a method of using the medical container shown in FIGS. 49 and 50.

  The medical container 110 of the present invention includes a soft bag 112 formed of soft resin sheets 112a and 112b, drug chambers 3 and 4 formed in the soft bag 112, and a drug solution filled in the drug chambers 3 and 4. 5 and 6 and a medical container cylindrical body 92 attached to the soft bag 112, the medical container cylindrical body 92 is made of a hard or semi-rigid material, In addition, the cylindrical portion 93 whose distal end portion is closed, the breakable portion 32 extending from the distal end portion to the proximal end side of the tubular portion 93, and the breakable portion 32 of the tubular portion 93 are provided and sandwiched therebetween, respectively. The breakable portion 32 includes a first stress applying portion 34 fixed to one inner surface 112c of the bag 112 and a second stress applying portion 36 fixed to the other inner surface 112d of the soft bag 112. The tubular portion 93 is opened by breaking by the spread between the giving portion 34 and the second stress applying portion 36, and the distal end side is separated from the breakable portion 32. Further, the medical container 110 is for a medical container. From the base end side of the cylindrical body 92, it extends to the tip end side so as to get over the outer surface of the base end portion of the breakable portion 32, and the base end portion 33a or the first end of the first stress applying portion side separating portion 33 after the break And a post-breaking stress applying portion holding extension portion 38 that holds the base end portion 35a of the stress applying portion side separating portion 35 between the inner surface and the inner surface of the soft bag.

The medical container 110 includes a soft bag 112 and a discharge port 87 attached to the soft bag 112. In this embodiment, the hollow body for medical container constitutes the discharge port 87. Specifically, the hollow body for a medical container includes a cylindrical portion 93, a breakable portion 32, a first stress applying portion 34, and a second stress applying portion 36, and a cylinder whose rear end is open. The cylindrical body 92 and the sealing member 94 that seals the rear end portion of the cylindrical body 92 are provided. The seal member 94 includes an elastic member 96 that is at least partially capable of puncturing a needle tube.
The basic structure of the soft bag 112 is the same as that of the soft bag 2, and the differences are the shapes of the upper end side seal portion and the lower end side seal portion, and the soft bag 112 having no weak seal portion for communication inhibition. See above for the same configuration.
As shown in FIG. 41, the soft bag 112 is divided into a first drug chamber 3 and a second drug chamber 4 by a partitioning weak seal portion 13 that can be peeled off. The first drug solution 113 is stored in the first drug chamber 113, and the second drug solution 6 is stored in the second drug chamber 4.

An upper end side seal portion 124 and a lower end side seal portion 122 are provided at the upper end portion and the lower end portion of the flexible bag 112. The upper end side seal portion 124 and the lower end side seal portion 122 are wide seal portions. Further, the lower end side seal portion 122 of the soft bag 112 is formed with a discharge port mounting portion 118 for attaching the discharge port 87. The discharge port mounting portion 118 is formed by not sealing a part of the lower end side seal portion 122.
As shown in FIG. 44, the discharge port 87 includes a cylindrical body 92 for a medical container and a seal member 94 that seals the rear end portion of the cylindrical body 92.
The discharge port 87 of the embodiment of the present invention preferably replaces the configuration of the base end portion of the drug container 10 with the configuration of the base end portion of the discharge port 7 described above and does not fill the inside with the drug. The configuration of the seal member 94 is preferably a configuration of a known discharge port seal member. 44 to 48, the discharge port 87 includes a cylindrical portion 93 having a discharge path 88 or a hollow portion therein, a breakable portion 32 provided in the cylindrical portion 93, and a first stress application. A portion 34, a second stress applying portion 36, and a seal member 94 are provided.

The cylindrical body 92 for medical containers includes a ring-shaped member 37 attached to the proximal end side of the cylindrical portion 93, and the post-breaking stress applying portion holding extension portion 38 is formed on the ring-shaped member 37. Yes. As shown in FIGS. 44 to 47, the post-breaking stress applying portion holding extending portion 38 is an annular portion that encloses the proximal end portion of the breakable portion 32. The annular portion 38 is formed by the tip side portion of the ring-shaped member 37 in the embodiment of the present invention. In the embodiment of the present invention, the annular portion 38 is formed so as to enclose the first stress applying portion side portion 32b and the second stress applying portion side portion 32c. In the embodiment of the present invention, the ring-shaped member 37 is attached to the cylindrical portion 93 at the proximal end side from the extended portion forming portion. Specifically, a fitting portion 37 a that fits the outer surface of the tubular portion 93 is provided on the proximal end side from the extended portion forming portion of the ring-shaped member 37. In addition, a fitting portion 31 g that fits with the ring-shaped member 37 is formed on the proximal end side of the breakable portion 32 of the tubular portion 93.
In addition, as a structure of the extension part for stress application part holding | maintenance after a fracture | rupture, any structure of the extension parts 42, 45, 50 as mentioned above may be sufficient.
Further, as in the above-described embodiment, it is preferable that the inner corner of the distal end portion of the post-breaking stress applying portion holding extension portion has an edge. Furthermore, it is preferable that the outer corner of the distal end portion of the post-breaking stress applying portion holding extension portion 69 is chamfered. Furthermore, an edge projecting in the radial direction may be provided at the base end portion at the chamfered portion at the chamfered outer corner of the distal end portion of the post-breaking stress applying portion holding extension portion 69.

A seal member attaching portion 95 to which the seal member 94 is attached is formed at the base end portion (first cylindrical portion 31b) of the cylindrical portion 93 of the embodiment. The seal member 94 is a cylindrical portion whose base end is closed. The distal end portion of the seal member 94 has a shape that can be attached to the seal member attachment portion 95 of the tubular portion 93. An elastic member 96 through which a needle tube (specifically, a discharge needle: not shown) or the like can be inserted is provided at the base end portion (discharge port of the discharge port) of the seal member 94. The elastic member 96 is preferably the same as the elastic member of the discharge port 7. The hollow part of the cylindrical part may contain a powder or solid medicine. The configuration excluding the base end portion of the discharge port of the present invention may be a configuration excluding the base end portion of the medicine container 68.
The medical container 110 of the present invention peels or breaks in order of the partition weak seal portion 13 and the breakable portion 32 of the discharge port 87 when the second drug chamber 4 or the first drug chamber 3 is pressed. It is preferable that As such a medical container 110, specifically, it is preferable that the peel strength or the break strength is increased in the order of the breakable portion 72 and the partition weak seal portion 13.
Further, the medical container 110 may be peeled or broken in order of the weak seal portion 13 for partitioning and the breakable portion 72 of the discharge port 87 by pressing the second drug chamber 4 in one action. preferable. By having such a configuration, the medicine is administered before the first medicine 5 in the first medicine chamber 3 and the second medicine 6 in the second medicine chamber 4 are mixed. This can be prevented.

Next, the manufacturing method of the medical container 110 of this invention is demonstrated using FIG. 41 thru | or FIG. In addition, the manufacturing method of the medical container 110 is not limited to this method.
First, a tube body formed of a soft synthetic resin is prepared. And the upper end side seal part 124 which has one part (chemical solution injection | pouring part: not shown) in this tube body, and two partial unseal parts (discharge port mounting part 118, chemical | medical solution injection | pouring part: figure) A soft bag 112 is formed by forming a lower end side seal portion 122 and a weak sealing portion 13 for partitioning.
Next, the medical container cylindrical body 92 of the discharge port 87 is inserted and fixed to the discharge port mounting portion 118 which is a partially unsealed portion of the lower end side seal portion 124, and the seal member 94 is fixed to the cylindrical body 92. . And the chemical | medical solution injection | pouring part is sealed in the state which inject | poured the 1st chemical | medical agent 5 to the 1st chemical | medical agent chamber 3 from the chemical | medical solution injection | pouring part, and was fixed so that the lower end part of the medical container 110 might become upper.
Next, the second liquid medicine 6 is injected into the second medicine chamber 4 from the liquid medicine injection section on the upper end side seal section, and the medical liquid injection section is sealed in a state where the upper end of the medical container 110 is fixed upward. Stop.

In this way, a medical container filled with a medicine as shown in FIG. 41 is produced. The injection of the first medicine 5 and the sealing operation of the first medicine chamber 3 may be performed before the injection of the second medicine 6 and the sealing operation of the second medicine chamber 4.
Next, the usage method of the medical container 110 of this invention is demonstrated.
First, when the second drug chamber 4 of the medical container 110 is strongly pressed with a finger or the like, first, the partition weak seal 13 is peeled off due to the expansion of the second drug chamber 4, so that the inside of the second drug chamber 4 The medicine 6 and the medicine 5 in the first medicine chamber 3 are mixed. Further pressing further expands the first drug chamber 3, expands the first stress applying portion 34 and the second stress applying portion 36 of the discharge port 87, and breaks the distal end portion 72 a of the breakable portion 72. Then, the first stress applying part side part 72b and the second stress applying part side part 72c are broken, and the cylindrical part 71 is opened. Then, the base end portion 33a of the first stress applying portion side separating portion 33 or the base end portion 35a of the second stress applying portion side separating portion 35 separated from the discharge port 87 by the break of the breakable portion 32 is broken. It enters and is held between the outer surface of the post-stress applying portion holding extension portion 38 and the inner surface of the soft bag. Then, a needle tube is inserted into the discharge hole of the discharge port 87 to perform drug administration. According to the present invention, since the separation part 33 and the separation part 35 are held between the outer surface of the extension part 38 and the inner surface of the soft bag, the opening of the cylindrical part 93 is not re-closed during drug administration.

Further, the medical container 1 includes a medical container tubular body attaching member for attaching the medical container tubular body 92 to the soft bag, and the post-breaking stress applying portion holding extension portion is provided for medical use. You may form in the cylindrical body attachment member for containers. Specifically, the cylindrical member mounting member for a medical container is a cylindrical tube for a medical container so that the breakable part of the cylindrical body for the medical container is exposed except for the extension part for holding the stress applying part after fracture. It is preferable that the cylindrical portion of the cylindrical body is encapsulated and provided with an attachment member cylindrical portion fixed to the soft bag. Moreover, it is preferable that the extension part for holding | maintenance of a stress provision part after a fracture | rupture becomes an annular part which encloses the base end part of a breakable part. In addition, the post-breaking stress applying portion holding extension portion is configured by a protruding portion extending from one end of the above-described medical container tubular member mounting member so as to get over the outer surface of the base end portion of the breakable portion. Is preferred.
Although the medical container of the present invention has been described above, it is not limited to the above-described embodiments.

FIG. 1 is a front view of a medical container according to an embodiment of the present invention. FIG. 2 is an explanatory view for explaining the inside of the medical container shown in FIG. 1. FIG. 3 is an enlarged view of a lower portion of the medical container shown in FIG. FIG. 4 is a front view of a medicine container used for the medical container shown in FIG. FIG. 5 is a side view of the medicine container shown in FIG. 6 is a cross-sectional view of the drug container shown in FIG. 4 taken along line AA. 7 is a cross-sectional view of the drug container shown in FIG. FIG. 8 is a top view of the drug container of FIG. FIG. 9 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 10 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 11 is an explanatory diagram for explaining an extension portion for holding a post-breakage stress applying portion, which is another embodiment. FIG. 12 is an explanatory view for explaining an extension portion for holding a post-breaking stress applying portion according to another embodiment (a side view of a drug container). FIG. 13 is an explanatory diagram for explaining an extension portion for holding a post-breaking stress applying portion according to another embodiment (a top view of a drug container). FIG. 14 is an explanatory diagram for explaining an extension portion for holding a post-breaking stress applying portion, which is another embodiment. FIG. 15 is an explanatory view for explaining an extension part for holding a stress applying part after fracture, which is another example (a side view of a drug container). FIG. 16 is an explanatory view for explaining an extension part for holding a stress applying part after fracture, which is another example (a top view of a drug container). FIG. 17 is an explanatory diagram for explaining the action of the post-breaking stress applying portion holding extension portion which is another embodiment. FIG. 18 is an explanatory view for explaining a post-breaking stress applying portion holding extension portion that is another embodiment (a side view of a drug container). FIG. 19 is an explanatory view for explaining an extension portion for holding a post-breaking stress applying portion according to another embodiment (a top view of a drug container). FIG. 20 is a front view of a medical container according to another embodiment of the present invention. FIG. 21 is an explanatory view for explaining the inside of the medical container shown in FIG. 20 (a view in which a soft bag is cut along the central axis of a drug container used for the medical container). FIG. 22 is an enlarged view of the upper part of the medical container shown in FIG. FIG. 23 is a front view of a medicine container (figure with a medicine container attachment member) used for the medical container shown in FIG. 24 is a front view of the medicine container shown in FIG. FIG. 25 is a side view of the medicine container shown in FIG. 26 is a cross-sectional view of the drug container shown in FIG. 24 taken along the line C-C. 27 is a cross-sectional view of the drug container shown in FIG. 25 taken along the line DD. FIG. 28 is a bottom view of the medicine container shown in FIG. 29 is a front view of the member for attaching a medicine container shown in FIG. FIG. 30 is a bottom view of the member for attaching a medicine container shown in FIG. FIG. 31 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 32 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 33 is an explanatory diagram for explaining an extension portion for holding a post-breakage stress applying portion, which is another embodiment. FIG. 34 is an explanatory view for explaining an extension part for holding a stress applying part after fracture, which is another example (front view of a member for attaching a medicine container). FIG. 35 is an explanatory view for explaining an extension portion for holding a post-breaking stress applying portion according to another embodiment (a bottom view of a member for attaching a drug container). FIG. 34 is an explanatory diagram for explaining a post-breaking stress applying portion holding extension portion which is another embodiment. FIG. 37 is an explanatory view for explaining an extension part for holding a stress applying part after fracture, which is another example (front view of a member for attaching a drug container). FIG. 38 is an explanatory view for explaining an extension part for holding a stress applying part after fracture, which is another example (a bottom view of a member for attaching a medicine container). FIG. 39 is an explanatory view for explaining an extension portion for holding a post-breaking stress applying portion according to another embodiment (a front view of a member for attaching a drug container). FIG. 40 is an explanatory view for explaining an extension part for holding a stress applying part after fracture, which is another example (a bottom view of a member for attaching a drug container). FIG. 41 is a front view of the medical container according to the embodiment of the present invention. FIG. 42 is an explanatory view for explaining the inside of the medical container shown in FIG. 41 (a view in which a soft bag is cut along the central axis of a medicine container used for the medical container). 43 is an enlarged view of the lower part of the medical container shown in FIG. FIG. 44 is a front view of the discharge port used for the medical container shown in FIG. FIG. 45 is a side view of the discharge port shown in FIG. 46 is a cross-sectional view of the discharge port shown in FIG. 44 taken along the line EE. 47 is a cross-sectional view of the discharge port shown in FIG. 45 taken along the line F-F. FIG. 48 is a top view of the discharge port of FIG. FIG. 49 is an explanatory diagram for explaining a method of using the medical container shown in FIG. FIG. 50 is an explanatory diagram for explaining a method of using the medical container shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Medical container 2 Soft bag 3 1st chemical | medical agent chamber 4 2nd chemical | medical agent chamber 5 1st chemical | medical agent 6 2nd chemical | medical agent 10 Pharmaceutical container 13 The weak seal part 31 for partition 31 The cylindrical part 32 Breakable part 33 1st Stress applying part side separating part 33a Base end part 34 of first stress applying part side separating part First stress applying part 35 Second stress applying part side separating part 35a Base end of second stress applying part side separating part Part 36 second stress applying part 38 extension part for holding stress applying part after fracture

Claims (12)

A soft bag formed of a soft resin sheet, a drug chamber formed in the soft bag, a drug solution filled in the drug chamber, and a medical container hollow body attached to the soft bag. A medical container, wherein the hollow body for a medical container is formed of a hard or semi-rigid material and has a cylindrical portion whose distal end is closed, and extends from the distal end of the cylindrical portion to the proximal side. A first stress applying portion fixed to one inner surface of the soft bag and a first stress applying portion fixed to one inner surface of the soft bag 2, the breakable portion breaks due to the spread between the first stress applying portion and the second stress applying portion, and the distal end side is separated from the breakable portion so that the cylindrical portion is Open, and in front The medical container extends from the base end side of the medical container hollow body to the distal end side so as to get over the outer surface of the base end part of the breakable part, and the first stress applying part side separating part after the break A post-breaking stress applying part holding extension part for holding the base end part of the second stress applying part side separating part or the base end part of the second stress applying part side separating part with the inner surface of the soft bag. Container. The hollow body for a medical container includes the cylindrical portion, the breakable portion, the first stress applying portion, and the second stress applying portion, and a cylindrical body having an open rear end portion; The medical container according to claim 1, comprising a lid member that seals a rear end portion of the cylindrical body and a medicine stored inside the cylindrical body, and constituting a medicine container. The hollow body for a medical container includes the cylindrical portion, the breakable portion, the first stress applying portion, and the second stress applying portion, and a cylindrical body having an open rear end portion; 2. The medical container according to claim 1, further comprising: a sealing member that seals the rear end portion of the cylindrical body and that can be punctured with a needle tube, and constitutes a discharge port. The medical container according to any one of claims 1 to 3, wherein the breakable portion of the hollow body for the medical container extends from the tip of the cylindrical portion to the vicinity of the fixing portion with the soft bag. The said medical container hollow body is provided with the ring-shaped member attached to the base end side of the said cylindrical part, The said extension part for stress-applying part holding | maintenance after a fracture | rupture is formed in this ring-shaped member. Item 5. A medical container according to any one of Items 1 to 4. The medical container includes a member for attaching a hollow body for a medical container for attaching the hollow body for the medical container to the soft bag, and the extension portion for holding the post-breakage stress applying portion is the medical container. The medical container according to any one of claims 1 to 4, wherein the medical container is formed on a hollow body mounting member. The medical container hollow body mounting member is formed of the medical container hollow body so as to expose the breakable portion of the medical container hollow body except the extension portion for holding the post-breakage stress applying portion. The medical container according to claim 6, wherein the medical container includes an attachment member cylindrical portion that encloses the cylindrical portion and is fixed to the soft bag. The medical container according to any one of claims 1 to 7, wherein the post-breaking stress applying portion holding extension portion is an annular portion that encloses the base end portion of the breakable portion. The post-breaking stress applying portion holding extension portion is constituted by a protruding portion extending from one end of the ring-shaped member or the medical container hollow body mounting member so as to get over the outer surface of the base end portion of the breakable portion. The medical container according to any one of claims 5 to 8. The medical container according to any one of claims 1 to 9, wherein an inner corner of a distal end portion of the post-breaking stress applying portion holding extension portion has an edge. The medical container according to any one of claims 1 to 10, wherein an outer surface of a tip end portion of the post-breaking stress applying portion holding extension portion is chamfered. The soft bag is partitioned into a first drug chamber and a second drug chamber by a partition weak seal part from which an internal space can be peeled, and in the first drug chamber and the second drug chamber, The medical container according to any one of claims 1 to 11, which is filled with a chemical solution.

Images