JP2007222243A - Infusion container - Google Patents

Abstract

To provide a transfusion container that prevents a soft bag from being damaged by a break end of the breakable portion during a break operation of a breakable portion of a drug container, and prevents the soft bag from being damaged later.
An infusion container (1) includes a soft bag (2) and a drug container (3) for storing a drug (11) to be mixed with a drug solution (9) in the soft bag (2). The medicine container 3 includes a medicine container 30, a breakable part 33 that can discharge the medicine 11 in the medicine container 30 by breaking, and an operation part 34 for performing a breaking operation of the breakable part 33. 5 and a cylindrical portion that is coaxially encapsulated in the distal end portion 63 without contacting the breakable portion 33 and fixed to the drug container main body 5 on the proximal side from the distal end portion 63. 6, the tip of which is located at a predetermined length operation portion side from the breakable portion, and prevents the breakable portion from being exposed to the tubular portion when the breakable portion is broken by the operation portion.
[Selection] Figure 1

Description

  The present invention relates to an infusion container in which a drug can be prepared and blended in a drug solution such as an infusion solution.

Prior to infusion to the patient, a drug that is difficult to pre-mix in the infusion, such as vitamins or antibiotics, is mixed and dissolved in a vial or soft bag containing the infusion. Has been prepared. 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 an infusion container in which a breakable portion (fragile portion) provided is folded and broken through a soft bag so that the drug container communicates with the soft bag to mix the drug and the drug solution.
As such an infusion container, Japanese Patent Application Laid-Open No. 2003-010285 (Patent Document 1) discloses a breaking operation in which the strength of the breaking operation portion is large (rigid), and has excellent gripping and operability during the breaking operation. An infusion container having a portion is disclosed.

Japanese Patent Application Laid-Open No. 2003-159309 (Patent Document 2) proposes an infusion container including a drug container that can reliably break a fragile portion by a single bending operation.
JP2003-010285A JP 2003-159309 A

The above-mentioned infusion container has a sufficient effect. However, as a result of investigations by the present inventors, there is a possibility that the breakable part (breaking end) of the breakable part may damage the soft bag and cause liquid leakage at the time of the breaking operation of the breakable part of the drug container. I found out.
Therefore, the present invention is an infusion container including a drug container having a breakable portion, and for infusion that reliably suppresses damage to a soft bag caused by a breakable portion break end during a breaking operation of the breakable portion. A container is provided.

What achieves the above object is as follows.
(1) An infusion container comprising a soft bag in which a drug solution is stored and a hard drug container that is attached to the soft bag and stores a drug for mixing with the drug solution, A hollow medicine container that contains a medicine, a breakable part that is formed on the distal end side of the medicine container and can discharge the medicine inside the medicine container by breaking, and is provided on the distal side from the breakable part. A drug container body portion having an operation portion for performing a breaking operation of the breakable portion, and encircling the breakable portion coaxially at a tip portion without contacting the breakable portion, and the tip portion A cylindrical portion fixed to the drug container main body and / or the soft bag is provided on the proximal end side, and the distal end of the cylindrical portion is positioned on the operation portion side by a predetermined length from the breakable portion. In addition, the operation unit An infusion container for preventing the breakable portion of the breakable portion from being exposed from the tubular portion during the breaking operation of the breakable portion.

Moreover, what achieves the said objective is as follows.
(2) An infusion container comprising a soft bag in which a drug solution is stored, and a hard drug container that is attached to the soft bag and stores a drug for mixing with the drug solution, A hollow medicine container that contains a medicine, a breakable part that is formed on the distal end side of the medicine container and can discharge the medicine inside the medicine container by breaking, and is provided on the distal side from the breakable part. A drug container body portion having an operation portion for performing a breaking operation of the breakable portion, and encircling the breakable portion coaxially at a tip portion without contacting the breakable portion, and the tip portion A cylindrical portion fixed to the drug container main body part and / or the soft bag on the more proximal side, and an outer diameter of the breakable part or a central axis of the drug container main body part in the breakable part Outside the minimum through When the outer diameter of the diameter portion is Amm, the distal end of the cylindrical portion is an infusion container located 0.4 Amm to Amm on the operation portion side from the breakable portion.

(3) The infusion container according to (1) or (2), wherein a distal end of the cylindrical portion is located 4 to 10 mm closer to the operation portion than the breakable portion.
(4) The infusion container according to (1) or (2), wherein a distal end of the cylindrical portion is located 5 to 8 mm closer to the operation portion than the breakable portion.
(5) The ruptureable portion starts the rupture operation with the rupture operation of the operation portion as a fulcrum by a rupture operation of the operation portion, starts rupture from a portion facing the fulcrum, and breaks the breakable portion. The operation part is separated from the drug container main body part in the breakable part when the breakage operation proceeds with the contact between the operation part and the cylindrical part as a second fulcrum by the progress ( The container for infusion according to any one of 1) to (4).
(6) Any of the above (1) to (5), wherein the operation portion near the breakable portion where the breakage is started does not substantially contact the cylindrical portion during the breaking operation of the operation portion A container for infusion according to crab.
(7) The said operation part is provided with the recessed part or notch part for avoiding contact | abutting to the said operation part of the front-end | tip part of the said cylindrical part at the time of fracture | rupture operation of the said breakable part by this operation part. (1) thru | or the container for infusion in any one of (6).
(8) The grooves (1) to (7) are formed on the inner surface of the cylindrical portion so as to extend from the tip of the cylindrical portion to a position beyond the breakable portion of the drug container main body portion. An infusion container according to any one of the above.
(9) The infusion container according to any one of (1) to (8), wherein the breakable portion is a fragile portion provided at a boundary portion between the drug storage portion or the drug storage portion and the operation portion. .
(10) The infusion container according to (9), wherein the fragile portion is an annular groove forming portion formed on an outer surface of the medicine storage portion.
(11) The infusion container according to (10), wherein the edge portion on the operation portion side of the annular groove forming portion is chamfered.
(12) The infusion container according to any one of (1) to (11), wherein the infusion container includes a discharge port for discharging the drug solution in the soft bag or a mixed solution of the drug solution and the drug. Infusion container.
(13) The infusion solution according to any one of (1) to (11), wherein the drug container is a discharge port for discharging the drug solution in the soft bag or a mixed solution of the drug solution and the drug. Container.
(14) The infusion container according to any one of (1) to (13), wherein the drug container is attached to the soft bag via the cylindrical portion.

The infusion container of the present invention includes a hollow medicine container containing a medicine, a breakable part formed on the distal end side of the medicine container, and a breakable part capable of discharging the medicine inside the medicine container by breaking. A drug container main body having an operation portion for performing a breaking operation of the breakable portion provided on the distal end side, and a cylinder in which the distal end and the base end are opened and into which the drug container main body is inserted A distal end portion of the tubular portion envelops the breakable portion without contacting the breakable portion, and the distal end of the tubular portion is formed from the breakable portion. Since it is located on the operation part side for a predetermined length and prevents the breakable portion of the breakable part from being exposed to the tubular part during the breaking operation of the breakable part by the operation part, Of the breakable part during the breaking operation of the breakable part The stump, to prevent the flexible bag is damaged.
Prevents the soft bag from being damaged later.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
1 is a front view of an infusion container according to an embodiment of the present invention, FIG. 2 is a front view of a drug container used in the infusion container of FIG. 1, and FIG. 3 is a side view of the drug container of FIG. 4 is a cross-sectional view taken along line AA of the drug container of FIG. 2, FIG. 5 is an enlarged cross-sectional view of line BB of the drug container of FIG. 2, and FIG. 6 is a CC line of the drug container of FIG. FIG. 7 is an enlarged cross-sectional view, FIG. 7 is a front view of a drug container main body used in the drug container of FIG. 2, FIG. 8 is a side view of the drug container main body of FIG. FIG. 10 is an enlarged view of the vicinity of the breakable portion of the drug container main body of FIG. 9, FIG. 11 is an enlarged bottom view of the drug container main body of FIG. 7, and FIG. Fig. 13 is a bottom view of the lid portion of Fig. 12, Fig. 14 is a side view of the lid portion of Fig. 12, and Fig. 15 is a lid portion of Fig. 12. EE sectional view of FIG. 1, FIG. Is a front view of the cylindrical portion to be used for the drug container of FIG. 2, FIG. 17 is a sectional view taken along line F-F of the cylindrical portion of FIG.

  The infusion container 1 of the present invention includes a soft bag 2 in which a drug solution is stored, and a hard drug container 3 in which a drug 11 that is attached to the soft bag 2 and is mixed with the drug solution is stored. The drug container 3 includes a hollow drug container 30 in which the drug 11 is stored, and a breakable part 33 that is formed on the distal end side of the drug container 30 and can discharge the drug 11 inside the drug container 30 by breakage. And the medicine container main body 5 having an operation portion 34 for performing a breaking operation of the breakable portion 33 provided on the distal end side from the breakable portion 33, and the breakable portion 33 without contacting the breakable portion 33. The portion 63 is coaxially encapsulated and includes a cylindrical portion 6 fixed to the drug container main body 5 and / or the soft bag 2 on the proximal side from the distal end 63. The distal end of the tubular portion 6 is positioned on the side of the predetermined length operation portion 34 with respect to the breakable portion, and the tubular portion 6 of the breakable portion 33 of the breakable portion 33 when the breakable portion 33 is broken by the operation portion 34. It is intended to prevent exposure from.

Moreover, in the infusion container 1 of the present invention, the drug container 3 includes a hollow drug container 30 in which the drug 11 is stored, and a drug inside the drug container 30 formed at the distal end side of the drug container 30 by breakage. The drug container main body 5 having a breakable portion 33 that can discharge 11 and an operation portion 34 that is provided on the distal end side of the breakable portion 33 and performs a breaking operation of the breakable portion 33, and a distal end and a proximal end It has an open cylindrical shape and includes a cylindrical portion 6 into which the drug container main body portion 5 is inserted. The distal end portion 63 of the cylindrical portion 6 encapsulates the breakable portion 33 without contacting the breakable portion 33, and the outer diameter of the breakable portion 33 or the drug container in the breakable portion 33. When the outer diameter of the smallest outer diameter portion passing through the central axis of the main body portion is Amm, the tip 63a of the tubular portion 6 is located on the 0.4Amm to Amm operation portion 34 side from the breakable portion 33. It has become.
Further, the infusion container 1 includes a discharge port 4 for discharging the chemical solution in the soft bag 2 or the mixed solution of the chemical solution and the drug 11.

As shown in FIG. 1, the infusion container 1 includes a soft bag 2, a drug container 3, and a discharge port 4.
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 copolymers or any combination thereof Blended resin, polymer alloy, laminate, etc.), a resin layer of a hard material such as a polyester such as polyethylene terephthalate and polyethylene naphthalate, a polyamide such as nylon, and the soft material described above (for example, , Polyethylene) resin layers are used. By molding with these soft resins, it is possible to easily perform an operation of communicating the drug solution storage unit 10 and the drug storage unit 30 from the outside of the soft bag 2.

  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 that it is easy to be fixed by molding and processing to the soft bag 2 and fusion of the drug container 3 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.
Inside the soft bag 2, a chemical solution storage unit 10 is formed to store an infusion solution (chemical solution). 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.

  Further, as shown in FIG. 1, an upper end side seal portion 23a and a lower end side seal portion 23b are provided on the upper end side and the lower end side of the soft bag 2, and the seal portions 23a and 23b are respectively hung on hangers or the like. A hole (hanging part) 25 is provided. Further, the soft bag 2 includes a drug container fixing part 27 (non-seal part) for fixing the drug container 3 at a position near the end of the seal part 23a, and the discharge port 4 is provided at the central part of the seal part 23b. A discharge port fixing portion 28 (non-seal portion) for fixing is provided. Furthermore, in order to maintain the quality of the chemical solution, a film such as an aluminum foil may be laminated on the soft bag 2 in order to impart oxygen barrier properties, light shielding properties, and the like. 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. Since these oxide films are transparent, the transparency of the soft bag 2 can be maintained, and the state of communication when the chemical solution storage unit 10 and the drug storage unit 30 are communicated with each other can be confirmed. This is preferable because the mixing / dissolving state and the like of the (chemical solution) and the drug are easily visible.

  As shown in FIG. 2, the drug container 3 includes a drug container main body 5 and a cylindrical part 6. As shown in FIG. 1, the drug container 3 is liquid-tightly fixed to the soft bag 2 by a drug container bonding member 51 disposed between the soft bag 2 and the drug container 3. The medicine container 3 is fixed to the soft bag 2 so that the operation part 34 protrudes into the medicine solution storage part 10. The drug container 3 may be directly sandwiched between the sheet materials constituting the flexible bag 2 and fixed by fusion. Moreover, it is preferable that the medicine container 3 is attached to the soft bag 2 via the cylindrical part 6. Specifically, the cylindrical part 6 of the drug container 3 is liquid-tightly attached to the drug container fixing part 27 of the soft bag 2 by ultrasonic fusion, high-frequency fusion, heat fusion, or the like. By attaching the drug container 3 via the cylindrical part 6 in this way, it is possible to prevent the influence of energy such as heat generated during fusion from reaching the drug 11 in the drug container 30.

The drug container main body 5 is a container body that can store a drug including a drug storage unit 30, a breakable unit 33, an operation unit 34, and a lid 35.
As shown in FIGS. 7, 8, and 9, the medicine storage unit 30 includes a cylindrical main body 31 having a distal end (lower side shown in FIG. 7) closed by a proximal end portion of the operation unit 34, and a cylindrical main body. After the medicine 11 is stored in the part 31, the cover part 35 is configured to seal the proximal end opening of the cylindrical main body part 31.
The internal shape at the distal end side of the medicine storage unit 30 (the base end portion of the operation unit 34) is formed in a truncated cone shape. The tip internal shape is not limited to the truncated cone shape, and may be a dome shape, a substantially hemispherical shape, a polygonal truncated cone shape, or the like. The cylindrical main body 31 includes an enlarged diameter portion 31a that gradually increases in diameter from the distal end to the vicinity of the proximal end portion, a cylindrical portion 31b having the same outer diameter provided on the proximal end side of the enlarged diameter portion 31a, and a base of the cylindrical portion 31b. It consists of a flange portion 36 provided at the end.

  It is preferable that the taper of the enlarged diameter portion 31a is made at a somewhat large angle with respect to the central axis. Specifically, the diameter-expanded portion 31a is preferably made such that the diameter / length ratio is 3/8 or more and 1/1 or less at the maximum diameter portion and 1/5 or more and 3/8 or less at the minimum diameter portion. . Moreover, it is preferable that the tip inner diameter (the inner diameter of the fractured portion) of the medicine container 30 is made large to some extent. Specifically, the inner diameter is preferably 5 to 15 mm. Moreover, it is preferable that a medicine storage part volume is 1-30 ml. Moreover, it is preferable that the length of a chemical | medical agent storage part is 20-70 mm. As described above, the medicine storage part includes a diameter-expanding part that expands from the distal end toward the base end, and the inner diameter of the fracture portion is made large to some extent, so that the medicine and / or the mixed solution with the medicine liquid can It can prevent remaining in a storage part. Further, the base end side of the flange portion 36 is a lid portion attachment portion 37 to which a lid portion 35 is attached which is formed in a concave shape.

12 and 13, the lid portion 35 is formed in a disc shape, and includes a cylindrical portion 39 formed on the bottom surface side so as to be close to the inner surface of the base end opening of the cylindrical portion 31 b of the cylindrical main body portion 31. ing. The outer diameter of the disc-shaped portion of the lid portion 35 is made to be approximately the same as the inner diameter of the lid portion attachment portion 37 formed in a concave shape. Further, an annular convex portion 42 such as a semi-elliptical section, a semi-circular section, or a triangular section, which becomes a margin when fused to the lid mounting portion 37, is located at the outer periphery of the cylindrical portion 39 on the bottom surface of the lid portion 35. Is provided. With this configuration, after the drug 11 is stored in the drug storage unit 30, the lid 35 is fixed to the lid mounting portion 37 by ultrasonic fusion, high frequency fusion, heat fusion, or the like. The storage part 30 can be reliably sealed.
Although not shown in the embodiment of the present invention, an elastic member that can be pierced with a needle tube or the like is attached to at least a part of the lid at the base end of the medicine container, and the medicine and / or medicine liquid mixed solution from the medicine container May be discharged, that is, it may be used also as a discharge port.

  As the drug 11 stored in the drug storage unit 30, the drug 11 is blended 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. Moreover, although the inside of the chemical | medical agent storage part 30 of the chemical | medical agent container 3 may be a normal pressure, it is good also as a pressure reduction or a vacuum state. As described above, when the medicine container 30 is in a reduced pressure or vacuum state, the effect of preventing degradation / degradation and the like of the medicine is improved, and the infusate (medical solution) is sucked when the breakable portion 33 is broken. It can be quickly introduced into the medicine container 30.

  The breakable part 33 is a thin fragile part provided at the boundary between the medicine storage part 30 or the medicine storage part 30 and the operation part 34. In the embodiment, the thin fragile portion (breakable portion) is an annular groove forming portion 38 formed on the outer surface of the distal end portion (the distal end portion of the enlarged diameter portion 31a) of the medicine storage portion 30. For this reason, when the operation part 34 is bent from the outside of the bag, the breakable part 33 is cut and the operation part 34 is separated from the medicine storage part 30. The groove forming portion has a V-shaped cross section. Specifically, the cross-sectional V-shaped angle of the groove forming portion is preferably 30 to 90 °, particularly 40 to 50 °. By producing the groove forming portion at such an angle, when the operation portion 34 is bent, the stress is concentrated at the center of the breakable portion, so that the portion is reliably broken. The groove forming portion may have any shape as long as it can be 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, it is good also as making it easy to fracture | rupture by producing the thickness of a groove formation part relatively thinner than the thickness of the groove formation part vicinity. Further, the breakable part may be made of a material more fragile than other parts. Specifically, it is preferable to make an annular shape with a material that can be easily broken only in the vicinity of the breakable portion by multicolor molding, and make the other portions with a material that is not easily broken. Further, in the embodiment of the present invention, the groove forming portion is an annular groove forming portion and is provided continuously around the entire outer peripheral surface of the medicine storage portion, but is not limited thereto, and may be provided intermittently. .

As shown in FIG. 10, the edge 41 on the operation portion 34 side of the annular groove forming portion 38 is chamfered. Specifically, the distal end side outer surface edge 41 is made to be rounded. For this reason, the inner surface of the chemical solution storage portion 10 is not damaged by the operation portion 34 that has been cut and separated, particularly during the breaking operation. Moreover, generation | occurrence | production of the fragment resulting from the edge of the operation part 34 contacting a cylindrical part at the time of fracture | rupture operation, and the hook at the time of operation can be prevented. In addition, as a chamfering shape, it is not restricted to the shape mentioned above.
As shown in FIGS. 2, 3, 7, and 8, a plurality of operation portions 34 are formed perpendicular to the plate-like main body portion 34a along the axial direction on both surfaces of the plate-like main body portion 34a. The reinforced portion 34b is provided. The reinforcing portion 34b becomes a grip portion that is gripped when performing a breaking operation, and has a diameter reduced from the proximal end toward the distal end. Further, by providing the reinforcing portion 34b, the operation portion 34 is not easily deformed in the bending direction, and the force applied during the breaking operation is surely concentrated on the breakable portion.

Further, as shown in FIGS. 3, 4, and 8, the operation portion 34 avoids contact of the distal end portion of the tubular portion with the operation portion 34 when the breakable portion 33 is broken by the operation portion 34. A recess or notch 34c is provided. As described above, the operation unit 34 of this embodiment includes a plurality of rib-shaped reinforcing portions 34b extending from the plate-shaped main body portion 34a in a direction perpendicular to and parallel to the distal end side of the plate-shaped main body portion. Is provided with a notch 34c formed by partially notching. By having the notch 34 c, the tip of the tubular portion 6 is prevented from becoming an obstacle when the breakable portion 33 is broken by the operation portion 34. In this embodiment, the operation part 34 has a plurality of rib-shaped reinforcing parts as described above. However, the operation part 34 does not have a recess formed between the reinforcing parts, and is near the breakable part. May be a shape that is thickest and thin toward the tip side. In this case, the above-described notch is a recess extending in a direction orthogonal to the axial direction of the operation unit. The recess or notch 34c starts breaking by pressing the operation part 34 from a certain direction, and further completely breaks the operation part by pressing from the opposite direction (so-called folding). In some cases, the fulcrum is formed in cooperation with the cylindrical portion 6. Further, it is sufficient that at least a predetermined distance is provided between the portion of the operation portion that may come into contact with the tip portion of the cylindrical portion, and the present invention is not limited to the concave portion or the notch portion as described above. For example, the thickness may be adjusted by adjusting the thickness of the operation portion, the thickness of the cylindrical portion, or the like.
Moreover, it is preferable that the operation part in the vicinity of the breakable part where the breakage is started does not substantially contact the cylindrical part during the breaking operation of the operation part. Specifically, the operation part 34 in the vicinity of the breakable part 33 for starting the breakage is located on the side of the part 33b facing the inner surface of the tip part of the cylindrical part 6 and the fulcrum 33a of the breakable part 33 during the breaking operation of the operation part 34. It is preferable that the operation unit 34 does not substantially contact. In the embodiment, since the gap is formed between the operation portion 34 side of the breakable portion 33 and the distal end portion of the tubular portion, there is no contact.
Then, the breakable portion 33 is started to break from a portion facing the fulcrum at a certain point of the breakable portion 33 by a break operation of the operation portion 34 and starts to break from the portion facing the fulcrum. The operation portion 34 is preferably separated from the drug container main body portion 5 at the breakable portion 33 when the contact between the operation portion 34 and the cylindrical portion 6 becomes a second fulcrum and the breaking operation proceeds. .
The cylindrical portion 6 has a cylindrical shape with an opening at the distal end and a proximal end, the distal end is located slightly closer to the operating portion 34 than the breakable portion 33, and encloses the vicinity of the breakable portion 33. Protecting the breakable portion 33 from external impacts and assisting the breaking operation by the operation portion 34. With such a configuration, as shown in FIGS. 19 to 21, the breakable portion 33 is started to be broken by a break operation of the operation portion 34 with a certain point of the breakable portion 33 as a fulcrum 33a. The fracture starts from the facing portion 33b. Then, as the breakage of the breakable portion 33 progresses, the contact point between the operation portion 34 and the cylindrical portion 6 becomes a second fulcrum, and stress is applied to the fulcrum 33a. Is separated from the drug container body 5 at the breakable portion 33.

As shown in FIGS. 2 to 4, the cylindrical portion 6 is a cylindrical body having an open front end and a base end. And the front-end | tip part 63 of the cylindrical part 6 encloses the breakable part 33, without contacting the breakable part 33. FIG. Further, the distal end 63a of the tubular portion 6 is positioned on the operation portion side by a predetermined length from the breakable portion 33, and the tubular portion of the breakable portion 33 of the breakable portion 33 when the breakable portion 33 is broken by the operation portion 34. The exposure from 6 is prevented.
Further, in the cylindrical portion of this embodiment, the tip portion 63 of the cylindrical portion 6 encloses the breakable portion 33 without contacting the breakable portion 33 and is outside the breakable portion 33. When the diameter (or the outer diameter of the smallest outer diameter portion passing through the central axis of the drug container main body portion in the breakable portion 33) is Amm, the tip 63a of the tubular portion 6 is 0.4 Amm from the breakable portion 33. It is located on the Amm operation unit 34 side. In particular, it is preferable to be positioned on the side of the operation unit 34 from 0.5 Amm to 0.8 Amm. Specifically, the distal end 63a of the tubular portion 6 is preferably positioned 4 to 10 mm closer to the operation portion than the breakable portion 33, and in particular, 5 to 8 mm closer to the operation portion side than the breakable portion 33. Preferably it is located.
By having the above-described configuration, the soft bag is prevented from being damaged by the break end of the breakable portion during the break operation of the breakable portion of the drug container.

  As shown in FIGS. 16 and 17, the cylindrical portion 6 is reduced in diameter into a first cylindrical portion 60a having the same outer diameter provided at the base end portion and a tapered shape provided at the distal end side of the cylindrical portion 60a. A taper portion 60b, a second cylindrical portion 60c having the same outer diameter provided on the distal end side of the tapered portion 60b, a reduced diameter portion 60d provided on the distal end side of the cylindrical portion 60c, and a base of the first cylindrical portion 60a It consists of a flange portion 61 provided at the end. The proximal end side surface of the flange portion 61 has a semicircular cross section that is a margin when used for ultrasonic fusion, high frequency fusion, and thermal fusion with the distal end side of the flange portion 36 of the drug container body 5. An annular convex portion 62 such as a semi-elliptical shape or a triangular section is provided.

  Further, as shown in FIGS. 5 and 17, the cylindrical portion 6 in this embodiment has a breakable portion 33 of the drug container main body portion 31 on the inner surface of the cylindrical portion 6 from the tip 63 a of the cylindrical portion 6. A groove 64 extending to a position exceeding the upper limit is formed. In this embodiment, a plurality of grooves 64 are formed. By providing the groove 64, the medicine in the medicine container 3 is discharged well when the breakable portion 33 of the medicine container 3 is broken. In particular, in the present invention, the distal end portion of the cylindrical portion 6 is positioned at a predetermined distance projecting portion from the breakable portion. By forming this groove, the distal end portion 63 of the cylindrical portion 6 discharges the medicine. Make sure that it is an obstacle.

Further, the operation portion 34 near the breakable portion 33 that starts breakage includes an inner surface of the distal end opening portion of the cylindrical portion 6 (inner surface of the reduced diameter portion 60d) and a fulcrum 33a of the breakable portion 33 during the breaking operation of the operation portion 34 It is preferable that the operation portion 34 on the facing portion 33b side does not substantially contact. In the embodiment, the gap is formed so that a slight gap is formed between the operation portion 34 side of the breakable portion 33 and the inner surface of the cylindrical portion tip opening (the inner surface of the reduced diameter portion 60d), and therefore, no contact is made.
Further, the drug container main body 5 and the cylindrical part 6 are formed by ultrasonic welding, heat fusing, and the distal end side surface of the flange part 36 of the drug container main body part 5 and the proximal end side surface of the flange part 61 of the cylindrical part 6. Liquid-tight bonding is performed by high-frequency fusion or the like.

  The constituent materials of the drug container main body 5 and the cylindrical part 6 are rigid polyvinyl chloride, polyethylene, polypropylene, polybutadiene, cyclic polyolefin (specifically, ZEONEX (manufactured by ZEON Corporation), APEL (Mitsui Chemicals, Inc.). Manufactured), polypropylene homopolymer, polyolefin such as high density polyethylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile , Polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), polyester such as polybutylene terephthalate (PBT), butadiene-styrene Examples thereof include various resins such as copolymers, aromatic or aliphatic polyamides, and combinations thereof, which are hard in that they are highly safe and have excellent adhesion to the soft bag 2. Polyvinyl chloride, polyethylene, polypropylene and polyester are preferred.

  The discharge port 4 is a part for discharging the chemical solution. The discharge port 4 seals a cylindrical member having an open front end (lower side shown in FIG. 1) and a base end (upper side shown in FIG. 1), and a front end opening (mixed solution discharge port) on the front end side of the cylindrical member. An elastic member arranged in this manner and a cap (elastic member support member) for fixing the elastic member. The elastic member can pierce the needle tube, and can pierce the needle tube when necessary to infuse the mixed solution in the drug solution storage unit 10. Further, as shown in FIG. 1, the discharge port 4 is liquid-tightly fixed to the soft bag 2 by a discharge port joining member 52 disposed between the soft bag 2 and the discharge port 4. Note that the discharge port 4 may be directly sandwiched between the sheet materials constituting the soft bag 2 and may be fused and fixed. Further, as the constituent material of the discharge port 4, those described in the drug container main body 5 and the cylindrical portion 6 can be used.

Next, a method for using the infusion container 1 (drug container 3) will be described in detail with reference to the accompanying drawings.
FIG. 18 is a cross-sectional view (before fracture) for explaining the method of using the infusion container according to the embodiment of the present invention, and FIG. 19 is for explaining the method of using the infusion container according to the embodiment of the present invention. FIG. 20 is a sectional view for explaining a method of using the infusion container according to the embodiment of the present invention (under fracture), and FIG. 21 is for infusion according to the embodiment of the present invention. It is explanatory drawing for demonstrating the use condition of a container.
The cylindrical portion 6 of the medicine container 3 is fixed with one hand, and the operation portion 34 is held and bent by the other hand through the soft bag 2. As shown in FIGS. 18 and 19, the fulcrum 33 a located on the folding direction side of the breakable portion 33 serves as a fulcrum, and the operation portion 34 rotates clockwise to be positioned on the opposite side to the folding direction of the breakable portion 33. (Part facing the fulcrum 33a) 33b starts to break. Due to the start of the breakage, the medicine stored in the medicine container main body part 5 passes through the space between the medicine container main body part 5 and the cylindrical part 6 and the groove 64 and flows into the chemical liquid storage part 10 in the soft bag 2. Furthermore, by proceeding with the breaking operation, the state shown in FIGS. 20 and 21 is obtained, and the entire breakable portion 33 is broken. Before reaching the state shown in FIGS. 20 and 21, the break end 33 c formed by the break of the breakable portion 33 is located in the tubular portion 6 and is not exposed from the tubular portion. For this reason, the breaking end 33c does not come into contact with the soft bag 2 during the breaking operation, and the soft bag 2 is not damaged. Moreover, the operation part 34 in the medicine container main body part 5 has a notch part 34 c, and as shown in FIGS. 20 and 21, the distal end part of the cylindrical part 6 is located on the distal side from the breakable part 33. However, it does not hinder the breaking operation.

FIG. 1 is a front view of an infusion container according to an embodiment of the present invention. FIG. 2 is a front view of a drug container used for the infusion container of FIG. FIG. 3 is a side view of the medicine container of FIG. 4 is a cross-sectional view of the drug container of FIG. 2 along the line AA. FIG. 5 is an enlarged cross-sectional view of the drug container of FIG. 2 along the line BB. FIG. 6 is an enlarged cross-sectional view of the drug container of FIG. FIG. 7 is a front view of a drug container main body used in the drug container of FIG. FIG. 8 is a side view of the drug container body of FIG. FIG. 9 is a cross-sectional view taken along the line DD of the drug container main body of FIG. FIG. 10 is an enlarged view of the vicinity of the breakable portion of the drug container body of FIG. FIG. 11 is an enlarged bottom view of the drug container body of FIG. FIG. 12 is a plan view of a lid portion constituting the drug container main body portion of FIG. 13 is a bottom view of the lid portion of FIG. FIG. 14 is a side view of the lid of FIG. 15 is a cross-sectional view of the lid portion of FIG. FIG. 16 is a front view of a cylindrical portion used in the medicine container of FIG. 17 is a cross-sectional view of the cylindrical portion of FIG. FIG. 18 is a cross-sectional view (before breakage) for explaining a method of using the infusion container according to the embodiment of the present invention. FIG. 19 is a sectional view (during breakage) for explaining a method of using the infusion container according to the embodiment of the present invention. FIG. 20 is a cross-sectional view (during breakage) for explaining a method of using the infusion container according to the embodiment of the present invention. FIG. 21 is an explanatory diagram for explaining a usage state of the infusion container according to the embodiment of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Infusion container 2 Soft bag 3 Drug container 4 Chemical solution discharge port 5 Drug container main-body part 6 Cylindrical part 10 Chemical solution storage part 11 Drug 20 Infusion container 21 Drug container 30 Drug storage part 33 Breakable part 34 Operation part

Claims (14)

An infusion container comprising a soft bag containing a drug solution and a hard drug container attached to the soft bag and containing a drug for mixing with the drug solution, wherein the drug container stores the drug A hollow medicine storage portion formed on the front end side of the medicine storage portion, a breakable portion capable of discharging the medicine inside the medicine storage portion by breakage, and a breakable portion provided on the front end side from the breakable portion A drug container body portion having an operation portion for performing a breaking operation of the portion, and encircling the breakable portion coaxially at the distal end portion without contacting the breakable portion, and a proximal end from the distal end portion A cylindrical portion fixed to the drug container main body portion and / or the soft bag on the side, and the distal end of the cylindrical portion is located on the operation portion side by a predetermined length from the breakable portion, and Before the operation unit Fluid vessel, characterized in that it is intended to prevent exposure from the tubular portion of the fracture site of 該破 cross possible unit at break operation breakable portion. An infusion container comprising a soft bag containing a drug solution and a hard drug container attached to the soft bag and containing a drug for mixing with the drug solution, wherein the drug container stores the drug A hollow medicine storage portion formed on the front end side of the medicine storage portion, a breakable portion capable of discharging the medicine inside the medicine storage portion by breakage, and a breakable portion provided on the front end side from the breakable portion A drug container body portion having an operation portion for performing a breaking operation of the portion, and encircling the breakable portion coaxially at the distal end portion without contacting the breakable portion, and a proximal end from the distal end portion A cylindrical portion fixed to the drug container main body part and / or the soft bag on the side, and the smallest diameter that passes through the outer diameter of the breakable part or the central axis of the drug container main body part in the breakable part Outside diameter In the case where the diameter is Amm, the tip of the tubular portion, from the breakable portion, the container Infusion, characterized in that located 0.4Amm~Amm the operation unit side. The infusion container according to claim 1 or 2, wherein a tip of the cylindrical part is located 4 to 10 mm closer to the operation part than the breakable part. The infusion container according to claim 1 or 2, wherein a tip of the cylindrical portion is located 5 to 8 mm closer to the operation portion than the breakable portion. The ruptureable portion is a rupture operation that starts from a portion facing the fulcrum with a point of the ruptureable portion as a fulcrum by the rupture operation of the operation portion, and the breakage of the breakable portion proceeds, 5. The operation portion is separated from the drug container main body portion at the breakable portion by a break operation progressing with a contact point between the operation portion and the cylindrical portion serving as a second fulcrum. An infusion container according to any one of the above. 6. The infusion solution according to claim 1, wherein the operation portion near the breakable portion where the breakage is started is not substantially in contact with the tubular portion during the breaking operation of the operation portion. container. The operation portion includes a concave portion or a notch portion for avoiding contact of the distal end portion of the tubular portion with the operation portion when the operation portion is operated to break the breakable portion. 7. The infusion container according to any one of 6. The groove | channel extended in the inner surface of the said cylindrical part from the said front-end | tip of this cylindrical part to the position exceeding the said fracture | ruptureable part of the said chemical | medical agent container main-body part is formed in any one of Claim 1 thru | or 7. Infusion container. The infusion container according to any one of claims 1 to 8, wherein the breakable part is a fragile part provided at a boundary part between the medicine storage part or the medicine storage part and the operation part. The infusion container according to claim 9, wherein the fragile portion is an annular groove forming portion formed on an outer surface of the medicine storage portion. The infusion container according to claim 10, wherein the edge portion on the operation portion side of the annular groove forming portion is chamfered. The infusion container according to any one of claims 1 to 11, wherein the infusion container includes a discharge port for discharging the drug solution in the soft bag or a mixed solution of the drug solution and the drug. The infusion container according to any one of claims 1 to 11, wherein the drug container is a discharge port for discharging the drug solution in the soft bag or a mixed solution of the drug solution and the drug. The infusion container according to any one of claims 1 to 13, wherein the drug container is attached to the soft bag via the cylindrical portion.

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