TW542731B - Mouth member for mixed filling processing and infusion container using the mouth member - Google Patents

Abstract

A mouth member (20) for mixed filling processing fitted to the outside of a chemical container and dividing a mouth part for mixed filling processing and an infusion container using the mouth member; the mouth member comprising (i) a generally tubular plug (30) disposed toward the outside of the chemical container, (ii) a check valve (21) disposed in the infusion container on the inner side of the plug (30), stopping the flow of chemicals, and allowing the chemicals to flow when receiving a fluid pressure (P) from a plug (30) side, and (iii) a filter (41) disposed in the infusion container on the inner side of the check valve (21), whereby the possibility of entry of foreign matter and bacteria can be eliminated in a mixed filling processing for chemicals into the infusion container and, even after the mixed filling processing is performed, the sealability of the infusion container can be assured.

Description

542731

542731 V. Description of the invention (2) Sealability of infusion container. Disclosure of the Invention As a result of deliberate research to solve the above-mentioned problems, the present inventors have discovered the following novel facts and completed the present invention. As a member for forming an infusion opening for an infusion volume, it is a substantially cylindrical insertion port provided with an injection member for holding, locking, or screwing a syringe for infusion processing, and the like. A backflow prevention valve to prevent the medicine liquid from flowing out of the medicine liquid container in the inside, and a filter to prevent the inclusion of foreign substances from the outside of the medicine liquid container; when using this component, the medicine liquid is carried into the infusion container In the case of mixed injection processing, there is no concern about the inclusion of elastomer chips or film fragments, and the sealing performance of the infusion container can be ensured after the mixed injection processing. That is, the opening member for co-injection processing of the present invention for solving the above-mentioned problems is an opening member installed on a medicinal solution container to separate the opening portion for co-injection processing, and is characterized in that: (i ) A substantially cylindrical insertion v disposed toward the outer side of the medicinal solution container, (ii) An infusion container disposed on the inner side of the infusion container to close the circulation of the medicinal solution, and if received from the above-mentioned insertion port side, Fluid pressure, the backflow prevention valve that allows the liquid to flow, and (iii) the filter. The above-mentioned opening member for coinjection processing according to the present invention can be subjected to coinjection processing without the need to pierce the elastomer or pierce the film. Therefore, chipping of the elastomer or chipping of the film does not occur during the infusion process.

91113614.ptd Page 5 542731 V. Description of the invention (3) Therefore, there will be no mixing with reflow. In addition, the infusion capacity of the backflow prevention and the like can also be expected to prevent the above-mentioned valve system applicable to the present invention from being provided with a valve constituted by the above-mentioned valve body, flowing from above with the above-mentioned valve seat through the above-mentioned liquid container. It is preferable that the direction of the above-mentioned valve body of the fluid pressure of the fluid pressure in the valve seat above the valve seat is the same as above. There is a concern that such debris may be erroneously mixed. In addition, the stop valve and filter can prevent the opening of the valve for mixing processing from foreign debris or bacteria, not only during the manufacturing of the mixing processing device, but also for preventing leakage of the chemical solution. The reason is that the opening member for mixing opening and mixing processing of the infusion container for injecting the infusion container according to the present invention communicates with the insert 1 of the above (i): body, which is connected from the insertion port side, and is arranged on the insertion port side of the cylinder A person who moves on the inner side of the infusion container of the infusion container for injecting the medicinal fluid between the fluid pressures; is provided with a medicinal fluid circulation hole; a through hole is opened when the valve body can not be closed by the valve body With the gap and the valve seat, the chemical liquid flowing member in the gap portion is provided with the above-mentioned, and during the sterilization process, and when the liquid container is transported, the physical opening member is an extremely mouthful member. By. (Ii) The backflow prevention cylinder of (ii) above is connected to the valve seat of the valve body by an elastomer; the inside of the valve body is used to close the medicinal solution, and it is easy to compress and deform into the gap, and the valve body The fixed part can restrict the medicine from coming from the above-mentioned insertion port side, and the valve body is communicated with the upper part; the pressure direction of the valve body is arranged to intersect with each other.

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V. Description of the invention (4) According to the above-mentioned preferred t, the opening of the injection opening is provided with the second and second, that is, the infusion container of the present invention is simple to mix and can be manufactured with mt; do! The structure of the backflow prevention chamber itself has better sealing performance. Excellent in the production of the infusion container after the infusion treatment is performed. 2 The infusion container is filled with the infusion volume and f ΐ ΐ. The good body can describe the elastic body of the valve body, which is used to form the upper two birds, and then shrink permanently to = to = °, preferably through the above-mentioned thermoplastic elasticity ..., plastic elastic body. Compression deformability and recovery make a good valve-it can make the backflow prevention valve in the opening member for mixing processing of the present invention: into the outer peripheral surface with a protrusion or two; approximately cylindrical 1 internal thread It is preferable that the outer tube part and the inner part provided with the inserting part are screwable with the lure 10 injector. . The suction-locking outer peripheral surface is provided with a protrusion or a screw thread. The injection member at the insertion port is provided with a so-called suction-locking type syringe and the injection member is screwed with the insertion port. Available. ^ 'S situation can be made. In addition, Ma Geyi maintains and stops the pore diameter of the opening member for the mixed injection processing of the present invention should be 0.1 ~ 10 " m, so that the above-mentioned filter can reach A smoothly, and can be prevented from the outside. Miscellaneous? Under the mixed injection throughput, it is better t. The aperture of the above-mentioned transitional device is 1111 ~ 0 ~ 25. In this case, not only the inclusion of debris in the target range can be prevented, but also the debris of the self-falling body can be reliably prevented. 1 ° 卩 Bacteria mixture 542731 V. Description of the invention (5) Entry ° The task of the mouth component of the present invention is achieved according to this section. However, such crushing prevention valves and medicine liquid containers do not occur when mixing injection processing or piercing the film, so this valve is not only used to manufacture the container to prevent the contents of the liquid from the above and after the treatment to achieve security. The above-mentioned infusion chamber can be mixed by the present inventors. Because the fat is mixed into one of the internal infusion volume and the liquid container, and the elastic opening and the like are broken by the mixed opening, the ming is lost during mixing, or the reason for the leakage, the contents are all put into the container, multiple supply. The condition of the infusion fat emulsion is the contents, and the mixing place is filled with processing parts to separate the workable debris, which can be mixed in accidentally, so it can prevent the liquid container from being stored and discharged after processing. The leakage of the drug of the present invention is opaque through the infusion container provided with the infusion isolation container, and is formed by preparing the opening for discharge of the mixed injection treatment of the present invention. The treatment and discharge processes can be performed at different openings. Since the present invention is passed through the present invention, it is not necessary to pierce the elastomer to perform the injection process. Therefore, there is no concern at the mixing place or the broken film. In addition, it is possible to use an infusion container to prevent confusion when it is equipped with a foreign substance or bacteria mixed from the outside to the above-mentioned backflow prevention and when the infusion container is transported during the sterilization process. From time to time, there is no concern about contamination, making it a very suitable container. It is difficult to confirm that there is a partition wall which can be opened, and the partition wall is opened when necessary. For example, a person who contains a fat emulsion and a piece of debris such as an elastomer are extremely difficult to confirm. Whereas, ilill

m

\\ 326 \ 2d- \ 91-09 \ 91113614.ptd Page 8 of 542731 V. Description of the invention (6) In the infusion container of the present invention, since a filter is provided in the opening member for mixing processing, there will be no Concerns about the inclusion of debris from the mixing injection opening during and after the mixing injection treatment. For this reason, the infusion container of the present invention is suitable for the purpose of containing a fat emulsion. Examples of the infusion container separated by the partition wall that can be opened include two compartments separated by the partition wall. One compartment contains an infusion solution containing sugar and a fat emulsion, and the other compartment is housed in the other compartment. There are infusions containing amino acids and electrolytes. Best Mode for Carrying Out the Invention Next, the opening member for co-injection processing of the present invention and an infusion container using the same will be described in detail with reference to the drawings. The infusion container 10 using the opening member for infusion processing according to the present invention is, for example, as shown in FIG. 1, provided with an opening portion 11 for discharging treatment with an internal solution, and the opening member 2 with infusion processing according to the present invention. One of the two openings of the injection processing openings 12. The infusion container 10 may be a so-called single-chambered infusion container having only one accommodating chamber, or a so-called multiple-chambered infusion container having two or more accommodating chambers. In the case shown in Fig. 1, the accommodating chamber 14 is composed of two chambers (the upper accommodating chamber 14a and the lower accommodating chamber 14b) separated by a partition wall 13 which can be opened. The form of the partition wall is not particularly limited, and various known arrangements can be adopted. In particular, a peelable hot-melt blender by compression bonding has been used in a commercially available 2-chamber infusion solution, and is preferred. In the above-mentioned two-chamber container, for example, one chamber contains an infusion solution containing a sugar and fat emulsion, and the other chamber contains an amino acid and an electrolyte.

\\ 326 \ 2cl- \ 91-09 \ 91113614.ptd Page 9 542731 V. Description of the invention (7) Infusion. Thereby, it is possible to avoid the Mailer reaction (M a 1 1 a r d r e a c t i ο η) via sugar and amino acid and the aggregation of the fat emulsion due to the electrolyte. (Backflow prevention valve) As described above, the backflow prevention valve 21 of the opening member 20 for infusion processing of the present invention is disposed on the inner side of the insertion port 3o of the infusion container 10. This backflow prevention valve 2 1 ′ is a circulator for closing the chemical liquid of the opening processing member 20 for mixing processing, and allows the liquid to circulate when the fluid pressure ρ is received from the insertion port 30 side. The cross-sectional structure of the opening member 20 for mixed injection processing of the present invention is shown in FIG. 2. FIG. 2 shows a state in which the fluid pressure ρ from the insertion port 30 side is not applied to the valve body 23 of the backflow prevention valve 21, and the backflow prevention valve 2 is shown to close the flow of the chemical solution of the opening member 2 for mixing processing. Of the state. A cross-sectional structure of a state in which the liquid pressure ρ from the insertion port 30 side is applied to the backflow prevention valve 21 so that the medicinal liquid of the mixing processing opening member 20 can be circulated (that is, used) is shown in FIG. 3 (a ), (B). 2 and 3 are cross-sectional views taken along line a-A of FIGS. 4 (a) and (b) described later. The backflow prevention valve 21 shown in Figs. 2 and 3 includes a cylindrical body 22 communicating with the insertion port 30 and a valve body 23 made of an elastic body.体 体 M 'It will be placed inside the cylindrical body 22 to close the flow of the medicinal solution. When the fluid pressure ρ from the insertion port 30 side is received, compression deformation is likely to occur.' The medicinal solution flows into the valve seat 24 Used gap section 2 6. This valve body 23 'is connected via the inner side of the wheel fluid container. A stopper 2 7 'connected to the valve body 23 can restrict the movement of the medicinal solution toward the inner side. The spacer 24 'is connected to the valve body 23 from the insertion port 30 side. Valve seat 24

Page 542731

There is a medicinal fluid flow hole 25, and the medicinal fluid flow hole 25 has a valve body 23 that is closed by the valve body 23 when the fluid pressure p from the side of the insertion port 30 is not. The fluid pressure p on the port 30 side is in a state of ^ and communicates with the above-mentioned void portion 26. … The sweat valve body 23 and the valve seat 24 are such that the direction in which the fluid pressure p is applied to the valve body 23 intersects the flow direction of the medicinal liquid in the gap portion 26 (the direction indicated by the arrow in FIG. 3 (b)). Way to configure.

The valve body 23 is in a state shown in Figs. 3 (a) and 3 (b) due to compression deformation. That is, through the compression deformation of the valve body 23 due to the load due to the fluid pressure p from the side of the insertion port 30, a gap portion 26 is formed between the valve body 23 and the valve seat 24, and passes through the medicinal fluid flow hole 2 5 and the void portion 2 6 enable the inflow of the mixed liquid and the like. When the load on the fluid pressure p of the valve body 23 is terminated, the valve body 23 will return to the original state (that is, the state shown in FIG. 2), and at the same time when the gap portion 26 and / or are lost, the liquid medicine will circulate. The hole 25 is closed via the valve body 23. The direction of the fluid pressure p in the valve body 23 is the same as the movement direction of the valve body 23 during compression deformation, and is on the same axis (axis direction X) as the movement direction of the valve body 23 when it returns. On the other hand, the direction y in which the medicinal solution flows into the void portion 26 generated by the compression deformation is not the direction in which the fluid pressure P is applied to the valve body 23.

Orientation is on the same axis and cross each other (preferably perpendicular intersection) (refer to Figure 3b). ‘So the reason’ can solve the significant problem in the conventional backflow prevention valve for the backflow of fluids such as medicinal liquid and the like generated when the valve body returns to its original shape (position). In addition, as long as there is no load of the fluid pressure from the opening portion 12 for mixing processing, the circulation of the chemical liquid in the opening portion 2 is closed.

91113614.ptd Page 11 542731 V. Description of the invention (9) Closed, therefore, leakage of the medicinal solution during and after the infusion treatment can be prevented. (Valve Body) As an elastic body for forming the valve body 23 of the backflow prevention valve 21, it is required that the elastic body can be easily deformed at the fluid pressure P of the mixed liquid generated by, for example, pressing of a piston of a syringe. It is generally soft, and it must be able to maintain its shape (for example, a person showing a colloidal property) in a state where the fluid pressure P is not loaded. Specific examples of this elastomer include rubbers such as natural rubber, silicone rubber, and isoprene rubber; plastics such as polyethylene and polypropylene; various thermoplastic elastomers; and hardness in elastomer members such as Those who are sufficiently low and sufficiently show the properties as colloids. Among them, a thermoplastic elastomer is particularly preferable. Specific examples of the thermoplastic elastomer include styrene-ethylene / butene-styrene segmented copolymer (SEBS) and styrene-butadiene-styrene block copolymer (SBS). ), Styrene-isoprene-styrene block copolymer (SIS), modified SEBS such as cis-butenedioic acid, styrene-ethylene / propylene-styrene block copolymer (SEPS), Styrene-silicon elastomers such as styrene-ethylene / butene block copolymers (SEB), styrene-ethylene / propylene block copolymers (SEP); olefin-based elastomers such as ethylene-propylene block copolymers; Polyurethane-based elastomers and the like; and mixtures of these. The size of the valve body 23 is not particularly limited, and is appropriately set depending on the inner diameter of the cylindrical body 22 and the like. Also, if the valve body 2 3 is too large, the bulging during compression will be too large.

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542731

Silicon-polyurethane j (Chem i tech is a specific example of such a material, and a commercially available acetic acid-based colloid with a trade name of rChemitch ^ el) may be appropriately added. (Opening member) The opening member 20 for co-injection processing of the present invention can be made of various plastics described below. It is, for example, polyolefins such as polyethylene, polypropylene, poly 4-fluorenyl pentene [eg, Mitsui = academic (stock) trade name "TPX"], etc .; ethylene-tetracyclododecene copolymer [Mitsui Polycyclic olefins such as chemical (stock) under the trade name "APL ·"]; propylene <nitrile> —butadiene-styrene copolymer (ABS); poly

Polyesters such as ethylene (naphthalene) SI (PEN) (poly ethylene naphthalate), polyethylene terephthalate (PET), polyallyl ester, etc .; benzene series such as polydiphenylsulfide (PPS) Polymer, etc. The opening member 20 for coinjection processing can be manufactured by the following method. For example, the base portion 40 for placing the filter 41 is formed by injection molding or extrusion molding, and the base portion 40 is formed by injection molding or extrusion molding in advance. The formed components including the cylindrical body 22 and the insertion opening 30 are combined, and the two sides are fixed and bonded by a method such as thermal connection, ultrasonic connection, aspiration, assembly, and the like.

After the valve body 23 is disposed on the pre-formed base portion 40, a member including the cylindrical body 22 and the insertion port 30 may be combined. (Insertion port) The insertion port 30 having a substantially cylindrical shape is a part to be inserted and fixed by an injection device or the like for injecting a liquid medicine for mixing. There are no special restrictions on the outer peripheral surface of the insertion port 30 to provide protrusions.

542731 V. Description of the invention (12) γ or thread is preferred. In this case, a so-called suction-locking type injection tool (not shown) provided with an external cylindrical portion having an internal thread and an internal cylindrical portion for inserting can be fixed to the insertion port 30, for example. Those with good operability. (Filter) As the filter 41 of the opening member 20 for mixed injection processing of the present invention, a filter of the infusion line (that is, the same as the one assembled in the infusion set) can be used. As this filter Specific examples include a filter made of a resin such as polyethylene, polypropylene, polyester, polyamide (nylon), and a filter made of a non-woven fabric made of fibers of the resin. The pore diameter of the ten-membrane filter is taken to achieve the viewpoint of preventing debris and bacteria from passing through, and the erosion solution can flow in smoothly. It should be set to 〇1 and set to 0 · 1 ~ 0.3 / zm is better. The pore diameter, 二 2, 10, 旧 .25, is better, and 0.2 degree is more preferable. ^ In particular, the filter is used as long as it is in the opening member for mixing processing. Specially limited. Therefore, the two-position valve that can be placed in the infusion container can be placed on the inner side or on the outer side. I-M block (base part) is used for the infusion processing shown in Figure 2 and Figure 3. The opening is configured as a base on which the filter 41 is placed, and a writing base is used as the base. 40 (refer to FIG. 4 (b)). In addition, a bottom view of the base of the scoop fixing portion 27. FIG. 4 (b) is the base portion 40 of the opening member 20. Useful for communication

91113614.ptd Page 15 542731 V. Description of the invention (13) The medicinal solution passing through the filter 41 flows into the inflow container 42 in the infusion container (see FIG. 4 (b) and FIG. 5). FIG. 5 is a plan view showing only the base portion 40 among the opening members 20 for mixed injection processing shown in FIG. 2. The mixed liquid between the valve body 23 and the valve seat 24 (the gap portion 26) flows through the flow path 28 between the transition device 41 and the cylindrical body 22, passes through the filter 41, and then passes through the installation base. The flow path 42 of the portion 40 flows into the storage chamber 14 of the infusion container 10 (in the case of the infusion container 10 shown in FIG. 1, the lower storage chamber 14b). On the surface of the base portion 40, for example, it is preferable to form a plurality of convex portions 43 and groove portions 44 to form irregularities (see FIGS. 2, 3, and 5). With this, 〃U can pass through the filter 41 more easily, and the operability of the medicinal solution can be improved. (Cover) At the front end of the insertion port 30, and before the infusion container is used (previously treated with Kun injection), it is necessary to prevent the contamination of debris and bacteria. A removable sealing mechanism is required to seal it. Peelable sealing film is better for protection. I sub-35 or the sub-sequence as shown in Figures 1, 2 and 4 (a), because the technology 38 thread to go from the whistleblower I because it is tied to the inside with 31, and screwed to the plug The top view of the protrusion on the outer surface of the human U3G, and FIG. 4U) is the opening member for injection processing (the liquid valley is the main body and the opening for discharge processing) :: Infusion container of the invention] &quot; '作成The content of the body of the infusion container and the opening for discharge processing are not particularly limited, and may be used

542731 V. Description of the invention (14) Learners. In the above, the opening portion for co-injection processing and the infusion container using the same according to the present invention have been described in detail, but the present invention is not limited to the above (especially those described in FIGS. 1 to 5), and will not be changed. Appropriate design changes and implementation within the scope of the spirit of the present invention are possible, and all belong to the scope of the present invention. INDUSTRIAL APPLICABILITY The opening member 20 for infusion processing of the present invention and the infusion container using the same are free from contamination of foreign matter and bacteria during the infusion treatment of a medicinal solution into the infusion container. And after the co-injection treatment, since the tightness of the infusion container can be ensured, it can be advantageously used in medical applications. Description of Part Numbers 10 Sheep liquid container 11 Opening section for discharge processing 12 Opening section for mixing processing 13 Partition wall 14 Storage chamber 14a Upper storage chamber 14b Lower storage chamber 20 Opening chamber for mixing processing Member 21 Backflow prevention valve 22 Cylinder Body 23 valve body 24 valve seat

91113614.ptd Page 17 542731 V. Description of the invention (15) 25 Chemical solution flow hole 26 Gap portion 27 Fastening portion 28 Flow path 30 Insertion port 31 Protrusion 35 Cover 38 Internal thread 40 Base part 41 Filter 42 Flow path 43 convex portion 44 groove portion P fluid pressure

91113614.ptd Page 18 542731 Brief description of the drawings Fig. 1 is a front view showing an embodiment of the infusion container of the present invention. Fig. 2 is a cross-sectional view showing an embodiment of the opening member for mixed injection processing of the present invention. Fig. 3 (a) is a sectional view showing a use state of the opening member 20 for coinjection processing shown in Fig. 2; (b) is a partially enlarged view of (a). Fig. 4 (a) is a front view '(b) of the mixed injection processing opening member 20 shown in Fig. 2 is a bottom view. FIG. 5 is a plan view of the base portion 40 of the opening member 20 for the mixed injection processing shown in FIG. 2.

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Claims (1)

542731 VI. The scope of application for patents is divided into two parts, which are installed on the medicinal liquid container and are provided with: an opening member for the inner opening; characterized in that the opening is directed toward the outer side of the medicinal liquid container The approximately cylindrical insert-Λ1 is placed on the reflux resistance of the liquid container on the inner side than the insertion port, which is circulated by the u liquid: the side of the insertion port can withstand repeated fluids, so that the drug (hi) can be filtered Device. 〃 2 · As described in the first patent application, the above-mentioned ππ = the opening member for the treatment of this item, where the backflow prevention valve system of (11) above has a cylinder connected to the two inlets. The valve made of elastomer is connected to the valve seat of the valve body; the valve body on the inlet side is inserted into the valve body, and A is disposed inside the cylinder and circulates, and the fluid pressure is received from the insertion port side. The gap between Le Ye and the valve seat for the infusion of the medicinal fluid J is contracted and deformed and is connected to the inner side of the infusion container via the infusion container, and the valve body fluid container is moved toward the inner side; ° 卩 It can be restricted that the valve seat is provided with a medicine liquid flow hole to the medicine; the medicine liquid flow hole can be closed through the valve body when the valve body does not withstand the fluid pressure of, and, the above-mentioned insertion When the fluid pressure on the mouth side is described, it is opened, and the escape valve body is in contact with the above-mentioned gap portion, and the valve body and the valve seat are connected with each other by 傕 bu, +, j; the pressure direction is the medicine in the above-mentioned gap portion Application of liquid flow to the valve body / claw direction With another way to pay 91113614.ptd Page 20 542731 Sixth, the scope of patent application. 0 MPa 、 3. The opening member for coinjection processing as described in the scope of patent application No. 2, wherein the elastomer used to form the valve body is a hardness (JISA) 0 ~ 2 0, tensile stress 0. 05 ~ 2. 0 MPa 、 A thermoplastic elastomer with a compression set of 30% or less. 4. The opening member for coinjection processing according to any one of claims 1 to 3, wherein the above-mentioned substantially cylindrical insertion opening has protrusions or threads on an outer peripheral surface thereof and is provided with an inner portion. The suction-locking type injection tool provided with the outer cylindrical portion of the screw and the inner cylindrical portion for insertion is screwable. 1〜1 0 // m。 5. The opening member for coinjection processing according to the scope of application for patent, wherein the aperture of the transition device is 0.1 to 1 0 // m. 6. The opening member for coinjection processing according to item 1 of the patent application, wherein the front end of the insertion port is sealed by a removable sealing mechanism. 7. An infusion container comprising: an opening member for co-injection processing according to item 1 of the patent application range; and an opening for discharging the content liquid. 8. If the infusion container of item 7 of the patent application scope is provided with a plurality of rooms separated by a partition wall that can be opened. 9. For an infusion container according to item 7 of the scope of patent application, it is a person who contains a fat emulsion. 10. The infusion container according to item 9 of the scope of the patent application, which has two chambers separated by an openable partition wall, and one of the chambers contains an infusion solution containing a sugar and a fat emulsion. 91113614.ptd Page 21