WO2002064077A1 - Dispositif d'etancheite pour orifice d'injection/extraction de medicament liquide - Google Patents

Dispositif d'etancheite pour orifice d'injection/extraction de medicament liquide Download PDF

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Publication number
WO2002064077A1
WO2002064077A1 PCT/JP2001/005775 JP0105775W WO02064077A1 WO 2002064077 A1 WO2002064077 A1 WO 2002064077A1 JP 0105775 W JP0105775 W JP 0105775W WO 02064077 A1 WO02064077 A1 WO 02064077A1
Authority
WO
WIPO (PCT)
Prior art keywords
sealing device
hole
connector
syringe
tip
Prior art date
Application number
PCT/JP2001/005775
Other languages
English (en)
Japanese (ja)
Inventor
Akitoshi Fukai
Takeshi Ikegami
Yoshihito Okui
Original Assignee
Fukai Kogyo Kabushiki Kaisha
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fukai Kogyo Kabushiki Kaisha filed Critical Fukai Kogyo Kabushiki Kaisha
Publication of WO2002064077A1 publication Critical patent/WO2002064077A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A61M2039/0072—Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M2039/0202—Access sites for taking samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M2039/0205—Access sites for injecting media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes

Definitions

  • the present invention relates to a medical device and the like for extracting a medical solution from a medical solution bottle or a medical solution container (including a patch) or injecting a medical solution or the like into a co-infusion tube of an infusion circuit.
  • the present invention relates to a device for injecting and extracting a drug solution or the like capable of directly injecting and extracting a drug solution or the like from a tip of a syringe or a connector without using a syringe needle.
  • the apparatus of the present invention can be used to inject a liquid such as a drug solution bottle, a drug solution container, a co-infusion tube, etc.
  • a stopper body provided with a cut portion or a slit portion or a conical hole for inserting a tip of a syringe or a connector.
  • a tightening pressure is generated in the cut portion or slit portion or conical hole, and the cut portion, slit portion or conical hole is closed by this tightening pressure to seal the chemical solution or the like.
  • the stopper body is prevented from dropping from the injection port for injecting the chemical solution or the like. Injection and extraction of the drug solution is performed by inserting the tip of the syringe or connector into a cartridge, slit, or conical hole against the tightening pressure.
  • the outer diameter of the stopper body is made larger by a predetermined amount than the inner diameter of the injection port for chemicals and the like, and the stopper body is pressed into the injection port for the chemicals and the like without the need for other auxiliary members.
  • the term “connector” refers to a device or a device used for an infusion circuit or a nutrition circuit in the medical field, and a pipe used for supplying a drug solution or a liquid containing nutrients from a supply source. It refers to a connection device used when connecting to a class. As shown in Fig.
  • the bottle stopper of the conventional drug solution bottle is composed of a rubber stopper 22 press-fitted into the drug solution inlet 21 of the bottle body 20 and a bottle mouth flange formed by covering the rubber stopper 22. It consists of a cap 24 fixed to 23 and the center of the cap 24 when extracting the chemical. An exfoliation is provided, or an opening is provided in advance, and an injection needle 26 attached to the tip of the syringe 25 is pierced into the rubber stopper 22 from the opening to suck out the internal chemical solution.
  • the conventional co-injection tube is formed on the side of a T-shaped tube main body 30 as shown in FIG. 25; a rubber stopper 32 is airtightly fitted in a branch tube portion 31.
  • the tube main body 30 is inserted and connected in the middle of an infusion circuit (for example, a dialysis circuit of an artificial kidney, a drip circuit, etc.), and the rubber plug 3 of the branch pipe part 31 is connected.
  • An injection needle 26 attached to the tip of a syringe 25 is inserted into 2 to inject the drug solution in the main body of the syringe 25 into the infusion circuit.
  • the conventional sealing device used for the bottle stopper of the drug solution bottle and the drug solution injection / extraction port of the co-infusion tube needs to pierce the rubber stopper with the injection needle, and the cost is increased by using the injection needle.
  • the used needle needs to be carefully disposed of in order to prevent contamination of pathogenic bacteria due to blood adherence to the patient. There were also problems.
  • the present invention has been proposed in view of the above-mentioned conventional problems, and its object is to extract a drug solution from a drug solution bottle or the like using a syringe alone without using a syringe needle and to inject the drug solution into a co-infusion tube. It is an object of the present invention to provide a sealing device for an injection / extraction port for a drug solution or the like, which is capable of performing injection and extraction.
  • the device of the present invention is characterized in that the cut portion or the slit is formed by simply pressing a stopper body provided with a cut portion or a slit portion or a conical hole into an injection port of a drug solution or the like such as a drug solution bottle, a drug solution container, or a mixed injection tube.
  • a drug solution or the like such as a drug solution bottle, a drug solution container, or a mixed injection tube.
  • a tightening pressure is generated in the portion or the conical hole, and the force port portion, the slit portion or the conical hole is sealed by the tightening pressure to prevent leakage of a chemical solution and the like.
  • the tip of the syringe or connector is connected to the power section or the slit section.
  • the outer diameter of the stopper body is made larger by a predetermined amount than the inner diameter of the injection port for chemicals and the like, and the stopper body is pressed into the injection port for the chemicals and the like without the need for other auxiliary members.
  • a sealing device for an injection / extraction port for a drug solution or the like comprises a plug body substantially made of a cylindrical elastic body, wherein the plug body has a valve membrane portion at a central portion, Either a cut portion, a slit portion, or a conical hole is formed in the center of the valve membrane portion, and the valve body is fastened to the cut portion, the slit portion, or the conical hole by an external pressure applied to the plug body from outside in the radial direction. A pressing force is applied, and the cut portion, the slit portion, or the conical hole is maintained in a sealed state by the tightening pressure.
  • the external pressure can be generated by attaching the stopper main body to an injection port for a drug solution or the like.
  • the outer diameter of the stopper body should be larger than the inner diameter of the injection port for chemicals, etc., by the amount of the interference.
  • the plug body is pressed into the injection port of the chemical solution or the like to generate stress around the plug body, and the action of relieving this stress and the repulsive force exerts a force on the center of the plug body.
  • a tightening pressure can be generated in the gate portion or the slit portion to seal the cart portion or the slit portion.
  • the stopper body is pressed into the injection port of the drug bottle, the drug solution or the mixing tube, the drug solution, blood or other liquid in the drug bottle, the drug solution or the mixing tube is prevented from leaking to the outside. be able to.
  • the tip of the syringe or the connector is inserted toward the cut or slit at the time of injecting and extracting the drug solution + or the like, the elastic body around the power or slit portion elastically deforms and opens. Etc. can be extracted by injection. Therefore, according to the present invention, it is possible to perform injection and extraction of a liquid such as a drug solution from a mixed solution tube or the like without using a needle, thereby reducing the problems caused by the needle. Can be.
  • a projection may be formed on the outer periphery of the plug body in a direction perpendicular to the longitudinal direction of the force port portion or the slit portion of the plug body. Tightening pressure of cut or slit of plug body by convex Can be further increased to further improve the density.
  • the slit portion of the plug body may be formed as an elongated opening gap that penetrates in the vertical direction of the plug body when the plug body is formed.
  • the slit portion can be formed at the same time when the plug main body is molded, and the step for forming the cut portion can be omitted.
  • the elongated opening gap of the slit portion may be formed in parallel with the plug main body in the vertical direction. By doing so, substantially the same sealing function can be exerted against pressure from either the upper or lower direction of the slit portion.
  • the elongated opening gap of the slit portion may be formed in a V-shaped cross section or an inverted V-shaped cross section in which the gap gradually increases or decreases in the vertical direction of the plug body.
  • the sealing function of the slit increases as the pressure from below the stopper body, that is, from the inside of the chemical bottle increases, so that the slit is suitable for internal pressure resistance.
  • the sealing function of the slit portion increases as the pressure from the outside of the chemical liquid bottle or the like increases, so that the slit portion is suitable for withstanding external pressure.
  • the kart or slit of the stopper body is elastically deformed and opened by press-fitting the tip of the syringe or connector, and is elastically restored by removing the tip of the syringe or connector and sealed. There may be.
  • the elastic body around the cartridge or the small screw will be damaged. It is elastically deformed and opened, and injection and extraction of chemicals etc. become possible, and when the tip of the syringe or connector is pulled out, the elastic body around the power port or the slit resiliently recovers and the power port Alternatively, it is possible to prevent the liquid inside the chemical solution bottle or the like from leaking by sealing the slit portion.
  • the vertical thickness of the outer peripheral portion of the plug body may be greater than the vertical thickness of the central portion.
  • the tightening pressure of the cut portion or the slit portion can be increased.
  • a region having a uniform thickness in the vertical direction may be formed at the center of the plug body, and a region having a gradually increasing thickness in the vertical direction may be formed at the outer periphery.
  • the thickness in the vertical direction may be gradually increased from the center of the plug body toward the outer periphery. By doing so, the tightening pressure of the cut portion or the slit portion can be increased.
  • Both or one or both of the upper central part and the lower central part of the plug main body (the concave portion may be formed.
  • the vertical thickness of the outer peripheral part of the plug main body is made larger than the vertical thickness of the central part.
  • the concave portion at the lower central portion is larger in diameter than the concave portion at the upper central portion, and the concave portion at the lower central portion is increased.
  • a part of the corner between the inner peripheral surface and the ceiling surface of the concave portion may have an arc shape, so that the higher the internal pressure of the chemical liquid or the like, the higher the tightening pressure of the cartridge or slit portion. This improves the function of preventing the leakage of the filled liquid, and inserts the tip of the syringe or connector into the cut or slot, J, or G from the outside to cut the cut or slot.
  • the resilience of the elastic body when one tip is inserted into the cartridge or slit can be increased, and the sealing performance can be increased.
  • the inner surface of the recess at the center of the upper surface is larger than the outer diameter of the tip of the syringe or connector. By doing so, the tip of the syringe or connector is inserted into the recess at the center of the top surface of the stopper body, and further inserted into the cut or slit.
  • the concave portion at the center of the upper surface may have an annular convex portion having an inner diameter slightly smaller than the outer diameter of the distal end portion of the syringe or the connector on the inner surface. Even when doing so, when inserting the tip of the syringe or connector into the recess at the center of the upper surface of the stopper body, and inserting it into the cut or slit, the injection or extraction of the drug solution or the like is performed. In addition, it is possible to prevent the liquid medicine or the like from leaking from the concave portion, and to stably hold the syringe or the connector.
  • a conical hole is formed in the center of the stopper body, which penetrates in the vertical direction with the small diameter side on the lower surface side of the stopper body, and the stopper body to the injection port for chemical solution etc.
  • the conical hole can be sealed by a tightening pressure generated by press-fitting of the conical hole.
  • the elastic body around the conical hole is in close contact with the tip of the syringe or the connector over the entire circumference, it is possible to prevent the leakage of the drug solution or the like from the conical hole.
  • the elastic body around the conical hole is elastically restored and seals the conical hole.
  • the tightening pressure acting on the above conical hole increases from the upper surface to the lower surface of the stopper body, facilitating insertion of the tip of the syringe or connector, and conversely, leakage of chemicals, etc.
  • the check valve the tightening pressure increases, and the dense fiber performance increases.
  • An air replacement tube may be installed in a part of the plug body so as to penetrate in the vertical direction of the plug body. By doing so, when extracting or injecting a liquid such as a drug solution from a drug solution bottle or a drug solution container, or by injecting or draining air into the inside through an air replacement pipe, the injection of the drug solution, etc. Extraction can be facilitated.
  • a pipe material filled with a water-repellent substance that allows gas to pass but does not allow liquid to pass can be used. By doing so, it is possible to prevent the inflow and outflow of liquid through the air replacement pipe, and to allow only the replacement inflow and outflow of air. Bactericidal properties can also be imparted to the substance.
  • a vertical through-hole is formed in a part of the plug body, and an air replacement tube having a short through hole is inserted into the through-hole while being biased toward the upper surface of the plug body.
  • a sealing device for an injection port for a liquid medicine or the like is provided with a plug body made of an elastic body formed by vertically penetrating a linear force-port portion or a slit portion in a center portion.
  • An annular concave groove is provided around the upper surface, and an annular convex portion having a larger volume than the rectangular concave groove fitted into the annular concave groove is formed on an inner surface of a cap for fixing the stopper body to an injection port for a chemical solution or the like.
  • an annular retaining projection is provided at the tip of the syringe or connector, and when the syringe or connector is inserted into the cut or slit or conical hole of the stopper body, the tip of the syringe or connector is inserted.
  • the insertion connection state of the tip of the syringe or the connector can be maintained for a long time and stably.
  • the sealing device for an injection port for a medical solution or the like is press-fitted to the injection port for a chemical solution with a predetermined interference, and is pulled out of the injection port for a drug solution by a cap.
  • a stopper body to be stopped and fixed wherein the upper surface of the stopper body is a flat surface, a concave portion is formed on a lower surface side, and a force member, a slit, or a conical hole is formed at the center. Is formed, and On the flat surface on the upper surface of the main body, an annular convex portion that fits into the center hole of the cap is formed around the central cut, slit, or conical hole.
  • the inner surface of the center hole of the cap is a tapered surface of an inverted conical hole, and the flat surface inside the tapered surface of the taper surface and the upper surface of the plug body.
  • a chemical solution or the like accompanying the injection or extraction of a chemical solution or the like by the injector or the connector is collected on the upper surface of the stopper body, it is caused by absorbent cotton, gauze, or the like. It can be easily disinfected with absorbent cotton or gauze impregnated with a disinfecting solution such as alcohol, etc.
  • the inside of the ⁇ -shaped protrusion on the upper surface of the plug body is a flat surface higher than the outside, or a convex arc-shaped surface.
  • the concave portion on the lower surface side of the plug main body may have a part of a corner between the inner peripheral surface and the ceiling surface formed as a substantially arcuate or tapered inclined surface.
  • an injection hole at the tip of the syringe or the connector is vertically penetrated, and an annular groove is formed in the middle of the insertion hole.
  • the two discs can be combined into a single disc shape, and the joint between the cut and slit portions can be airtightly fitted and held by the valve membrane member. In this case, the formation of the cut portion or the slit portion can be omitted, and two half disks can be used instead.
  • An insertion hole is formed at the center of the upper surface of the stopper main body at the tip of the syringe or connector, and a female screw groove is formed on the inner surface of the plastic inner cylinder fitted and mounted in the insertion hole or the insertion hole.
  • the female screw groove and a male screw ridge formed at the tip of the syringe or the connector can be screwed together to prevent the female screw from coming off. By doing so, it is possible to prevent the leakage of the drug solution from the injection hole or the inner cylinder while extracting or injecting the drug solution by inserting the tip of the syringe or the connector into the injection hole or the inner cylinder.
  • the insertion position of the tip of the syringe or connector into the insertion hole or the inner cylinder can be stopped at an arbitrary position, and the connected state can be maintained at that position.
  • An insertion hole at the tip of the syringe or connector is formed in the center of the upper surface of the stopper main body, and one or more hollow members are formed on the inner surface of the plastic inner cylinder fitted and mounted in the insertion hole or the insertion hole.
  • a stopper may be formed so that the annular locking portion and the annular locking portion formed at the distal end portion of the syringe or the connector can be locked and released.
  • FIG. 1A is a plan view of a plug body according to a first embodiment
  • Figure 1B is a longitudinal sectional view
  • FIG. 1C is a longitudinal sectional view of a main part in which a plug body is pressed into a co-infusion tube and fixed with a cap;
  • FIG. 2A is a plan view of a plug body of a modification of the first embodiment;
  • Figure 2B is a longitudinal sectional view
  • Fig. 2C is a vertical sectional view of the main part where the plug body is pressed into the co-injection tube and fixed with the cap;
  • Figs. 3A and 3B are patterns that increase the tightening pressure by changing the external pressure receiving area of the plug body. Schematic explanatory diagram of;
  • 4A, 4B, and 4C are schematic diagrams showing examples of the shape of a slit formed on the plug body
  • FIGS. 5A, 5B and 5C are a plan view and a longitudinal sectional view, respectively, of a plug body according to another modification of the first embodiment;
  • FIGS. 5C and 5D show tightening in the modification of FIGS. 5A and 5B.
  • FIG. 6A and 6B are a plan view and a longitudinal sectional view of a plug body according to still another modified example;
  • FIG. 6C is an enlarged longitudinal sectional view of a conical hole portion in a state at the time of molding;
  • FIG. 6D is a longitudinal sectional view of the conical hole portion in a contracted state after annealing
  • FIG. 6E is an enlarged longitudinal sectional view of the conical hole portion when tightening pressure is applied
  • Fig. 7A, Fig. 7B, Fig. 7C are explanatory views of the opening operation of the conical hole portion in the modified example of Fig. 6A, Fig. 6B by the tip of the syringe or connector;
  • Figures 7D, 7E and 7F are bottom views in each case
  • FIGS. 8A and 8B show a modified example of FIGS. 6A and 6B in which the tip of a syringe or connector provided with an annular retaining projection at the end is inserted into the conical hole of the stopper body. Operation explanatory diagram showing before and after states;
  • FIG. 9A is a longitudinal sectional view of a plug body according to another modification of the first embodiment before a tightening pressure is generated;
  • FIG. 9B is a longitudinal sectional view of the stopper body in a state where the tightening pressure is applied;
  • FIG. 9C is a longitudinal sectional view of a modification in which an air displacement pipe is installed in the plug body of FIG. 9A;
  • FIGS. 10A and 10B show the fitting of the cap and the plug body in the second embodiment of the present invention. Longitudinal sectional view showing the state before and after;
  • FIG. 11A is a vertical sectional side view of the assembled state of the stopper main body to the mixed injection tube according to the third embodiment of the present invention.
  • Fig. 11B is a longitudinal side view of the stopper body alone
  • FIG. 12A is a longitudinal sectional side view of a modification of the third embodiment in which the plug body is attached to the co-infusion tube;
  • Figure 12B is a longitudinal side view of the stopper body alone
  • FIG. 13A is a longitudinal sectional side view of the assembled state of the stopper main body to the co-infusion tube in another modified example of the third embodiment
  • Figure 13B is a vertical side view of the stopper body alone
  • FIG. 14 is a longitudinal sectional view of a main part of a modification of the first embodiment
  • FIG. 15A is a bottom view of the stopper body of the modification of FIG. 14;
  • Fig. 15B is a cross-sectional plan view of the injection port for chemicals, etc .;
  • FIG. 16A is a longitudinal sectional view of a main part of a modification of the first embodiment
  • Fig. 16B is an enlarged view of the power section
  • FIG. 17A to FIG. 17E are longitudinal cross-sectional views of main parts of different modifications of the first embodiment
  • FIG. 18A, FIG. 18B, and FIG. FIG. 19 is a vertical sectional view of an essential part of another modification of the first embodiment
  • FIG. 20A and FIG. 20B are longitudinal cross-sectional views of a main part showing states before and after the opening operation of the valve leaflet according to another modification of the first embodiment
  • FIG. 21 is a longitudinal sectional view of a main part of still another modification of the first embodiment
  • FIG. 22 is a longitudinal sectional view of a main part of still another modification of the first embodiment
  • FIG. 23A is a vertical sectional view of a main part of still another modification of the first embodiment
  • Fig. 23B is a longitudinal sectional view of the main part in the state when the valve is opened;
  • Figure 23C shows decomposition of the valve leaflet 13 ⁇ 4
  • Fig. 24 is a cross section for explaining the bottle stopper of a conventional chemical bottle! !;
  • FIG. 25 is an explanatory sectional view of a conventional co-infusion tube.
  • the first embodiment as shown in FIGS. 1A, 1B and 1C, comprises a plug body 1 made of a substantially cylindrical elastic body.
  • FIG. 2A, FIG. 2B, and FIG. 2C are modifications of the first embodiment, in which a projection 1b is provided on the outer periphery of the plug body in a direction orthogonal to the longitudinal direction of the card portion 1a of the plug body 1.
  • the clamping pressure of the cut portion 1a is further increased.
  • the plug body 1 has a cylindrical outer peripheral surface, and has concave portions lc and Id at the center of the upper surface and the center of the lower surface.
  • the inner diameter of the recess l.c on the upper surface is slightly smaller than the outer diameter of the tip of the syringe or connector.
  • a round guide portion 1e is formed at the entrance of the recess 1c.
  • the depth of the recess 1c on the upper surface side is shorter than the length of the tip of the syringe or connector.
  • the bottom surface of the concave portion 1c on the upper surface side is a flat surface.
  • the recess 1d on the bottom side has the same inner diameter as the recess 1c on the top side in Figs.1B and 1C. ing. In Fig. 2B and Fig.
  • the recess Id on the lower surface is larger in diameter than the recess lc on the upper surface, and the corner between the inner peripheral surface of the recess 1d on the lower surface and the ceiling surface of the recess 1d.
  • the recess Id on the lower surface is originally formed to facilitate elastic deformation of the elastic body around the central force port 1a when the tip of the syringe or connector is inserted.
  • the shape is preferably as shown in FIG. 2 in order to increase the sealing performance without unnecessarily opening the power outlet 1a. That is, by making the shape of FIG. 2 as compared with the shape of FIG.
  • the elastic body of the arcuate portion at the corner increases the repulsive support force (compression repulsive force) against external pressure, and the sealing property of the cut portion 1a.
  • the resistance to pulling up increases, and as the internal pressure increases, the rigid bodies on both sides of the cut 1a tighten the force socket 1a.
  • the sealing performance of the cut portion 1a can be improved.
  • the plug body 1 is formed into the above shape using a mold. Then, the cut portion la is cut using an appropriate tool after molding the plug body 1. In this case, the length of the cut portion 1a is substantially the same as the inner diameter of the concave portion 1c on the upper surface side.
  • the stopper body 1 pushes while elastically deforming the elastic body around the cassette 1a downward on both sides with the tip. Open to open the cut section 1a, which enables liquid injection and extraction, where the outer peripheral surface of the tip of the syringe or connector is in close contact with the power outlet 1a and the cut section 1a.
  • the liquid in the liquid medicine bottle and the like is prevented from leaking to the outside by penetrating into the inside and being in close contact with the inner peripheral surface of the concave portion lc.
  • the tightening pressure Pi can be increased by increasing the external pressure P or the stress coefficient E.
  • FIG. 3A and FIG. 3B are schematic explanatory diagrams of a pattern in which the clamping pressure is increased by changing the external pressure receiving area of the plug body 1.
  • the external pressure P and the stress coefficient E can be increased by increasing the vertical thickness of the outer peripheral portion more than the vertical thickness of the central portion to increase the tightening pressure P. That is, in FIG. 3A, a uniform region having a ⁇ downward thickness is formed at the center of the valve membrane portion 1 o of the plug main body 1, and a gradually increasing region having a vertical thickness is formed at the outer peripheral portion.
  • FIG. 3A a uniform region having a ⁇ downward thickness is formed at the center of the valve membrane portion 1 o of the plug main body 1, and a gradually increasing region having a vertical thickness is formed at the outer peripheral portion.
  • FIG. 3B shows a case where the thickness in the vertical direction is gradually increased from the center of the valve membrane 1 o of the plug body 1 toward the outer periphery. As for these relations, the tightening pressure can be increased in FIG. 3B than in FIG. 3A.
  • the valve membrane part lo of the plug body 1 may have other shapes.
  • FIG. 4A, FIG. 4B, and FIG. 4C are schematic views showing examples of the shape pattern of the slit portion If formed in the valve membrane portion 1 o of the plug body 1, and the cut portion la is shown in FIG. B, As shown in FIG. 4C, the slit portion If may be used instead.
  • FIG. 4A, FIG. 4B, and FIG. 4C are schematic views showing examples of the shape pattern of the slit portion If formed in the valve membrane portion 1 o of the plug body 1, and the cut portion la is shown in FIG. B, As shown in FIG. 4C, the slit portion If may be used instead.
  • FIGS. 5A and 5B show another modification of the first embodiment. In this modification, a slit portion If of an opening gap having a V-shaped cross section is formed in the valve membrane portion 1 o of the plug body 1. ing. FIGS. 5C and 5D are partially enlarged explanatory views of the slit portion 1f.
  • the slit portion Before the external pressure is generated, the slit portion If has elasticity around the slit portion If as shown in FIG. 5C.
  • the outside diameter of the body D 'what was found when I connection external pressure is generated to press-fitting the plug body 1 to the injection spout of the chemical solution the outer diameter D 2 as shown in FIG. 5 D' fused to The slits 1 f are sealed by the diameter.
  • the above and E> 2 are proportional to the outer diameter of the entire plug body 1! ⁇ and!) 2 .
  • the parallel slits shown in Fig. 4A 1 : F and the inverted V-shaped slit portion I f ⁇ shown in FIG. 4B also have the same sealing characteristics as in FIGS. 5C and 5D.
  • FIGS. 6A and 6B show still another modified example of the first embodiment.
  • the plug body 1 is replaced with the power port portion 1a or the slit portion 1f.
  • FIGS. 6C, 6D, and 6E are partially enlarged explanatory views of the conical hole 1 g.
  • the conical hole lg is formed slightly larger when the stopper body 1 is formed. Then, it is annealed and contracted so that the small diameter side of the conical hole 1 g is closed as shown in Fig. 6D.
  • the conical hole lg has the outer diameter of the elastic body in the peripheral part before the external pressure is generated (see Fig.
  • FIG. 7A shows the modified examples of Figures 6A and 6B, until the tip 3 of the syringe or connector is inserted into and removed from the conical hole 1 g of the stopper body 1.
  • 7D, FIG. 7E, and FIG. 7F show the states as viewed from the bottom. That is, in FIG. 7A, the stopper main body 1 receives the tightening pressure from the outer periphery toward the center by being pressed into the injection / extraction port of the chemical bottle, and the conical hole by receiving the internal pressure of the chemical bottle. 1 g shows a sealed state.
  • FIGS. 8A and 8B show a modified example of FIGS. 6A and 6B, in which an annular retaining projection 3 ′ is formed at the distal end of the distal end 3 of the syringe or connector 1 to form a cone of the plug body 1. This shows the state before and after inserting the tip 3 of the syringe or connector into the hole 1 g.In particular, as shown in Figure 8B, the retaining projection 3 'is projected to the back of the conical hole 1g. Note This is to stabilize the holding of the distal end 3 of the injector or connector 1 and to keep it locked.
  • FIG. 9A shows another modification of the first embodiment.
  • the air displacement pipe 4 is installed in a part of the plug body 1 so as to penetrate in the vertical direction.
  • the air displacement pipe 4 is formed by filling a pipe material 4a with a water-repellent substance 4b that allows gas to pass therethrough but does not allow liquid to pass.
  • This substance 4b is made of an appropriate fibrous material having a filter function, and is provided with water repellency and antibacterial properties.
  • a through hole lh is formed in a part of the plug body 1, and the air replacement pipe 4, which is shorter than the through hole lh 3 ⁇ 4 Unbalanced Insert it in a biased position.
  • the air replacement pipe 4 which is shorter than the through hole lh 3 ⁇ 4 Unbalanced Insert it in a biased position.
  • the elastic body around the through hole 1 h below the lower end of the air displacement pipe 4 is tightened in a rip-like manner, and becomes a check valve 5 against outflow of a chemical solution or the like.
  • a bottomed hole 1j having a bottom 1i is provided, and a cutout 1k vertically penetrating the bottom 1i of the hole 1j is appropriately provided. It forms in the evening. Insert the air displacement pipe 4 into the hole 1 j, press the plug body 1 into the injection port of a chemical bottle or the like.When the plug body 1 is pressed into the extraction port, the tightening pressure generated in the plug body 1 and the repulsive force and stress relaxation to this tightening pressure By this action, the cut portion lk is sealed, so that leakage of a chemical solution or the like can be prevented.
  • a small hole may be made with a needle-shaped piercing tool.
  • FIGS. 10A and 10B show a second embodiment of the present invention, in which an annular concave groove 1 n having a V-shaped cross section is provided around the upper surface of the plug body 1, and a cap 6 corresponding to this is provided.
  • annular convex portions 6a having a circular cross section on the inner surface and press-fitting them as shown in FIG. 10B, a tightening pressure is generated in the plug body 1 to seal the slit portion 1f.
  • the ⁇ -shaped concave groove 1 n is formed on the outer diameter side of the slit portion 1 f of the plug body 1.
  • the ⁇ -shaped convex portion 6 a is configured to generate a tightening pressure by increasing the width of the annular concave groove In.
  • the shape of the groove of the annular groove In and the shape of the annular convex portion 6a may be other shapes than those shown in FIGS. 10A and 1OB. In this modified example, it is not an essential requirement that the outer diameter of the stopper body 1 be larger than the inner diameter of the injection port for the injection of a drug solution or the like.
  • FIGS. 11A and 1IB show a third embodiment of the present invention. In this embodiment, as shown in FIG.
  • a stopper body 1 is provided at a chemical solution injection / extraction port 2 a of a co-infusion tube 2.
  • the fitting is press-fitted with a tight margin, and the cap 6 prevents the cap from being pulled out and fixed to the chemical liquid inlet 2a.
  • the stopper body 1 has a flat surface lv on the upper surface, a concave portion Id on the lower surface, and a slit portion 1a or a slit portion 1f at the center.
  • one of the conical holes 1 g is formed.
  • a flat surface 1 V on the upper surface of the plug body 1 has a rectangular shape that fits into the central hole 6 b of the cap 6 around the central portion 1 a or the slit portion 1 f or the conical hole 1 g.
  • a convex part lu is formed, and the inside of this annular convex part lu is set as a flat surface lv, so that it is flush with the outside.
  • the inner peripheral surface of the center hole 6b of the cap 6 is an inverted conical hole-shaped tapered surface 6b '.
  • the tapered surface 6b and the flat surface 1V 'inside the annular convex portion 1u on the upper surface of the plug body 1 are formed so as to be smoothly continuous.
  • the inside of u ′ is a flat surface lv ”that is higher than the outer flat surface lv.
  • the central flat surface lv can be raised upward in a convex arc shape. This further facilitates wiping with absorbent cotton or gauze when a chemical solution or the like accumulates on the upper surface of the plug main body 1 and disinfection with absorbent cotton or gauze impregnated with an antiseptic solution such as alcohol.
  • 13A and 13B show another modified example of the third embodiment.
  • the plug body 1 in this modified example has substantially the same configuration as the embodiment of FIGS.
  • the top surface of the plug body 1 is a flat surface 1 V, and an annular step luu ′ is used instead of the ⁇ -shaped convex lu (FIG. 11A, 1 IB).
  • the inside of 1 u ' is a convex arc-shaped surface 1.
  • the concave portion 1 d on the lower surface side of the stopper main body 1 originally has a central cut portion 1 a, a slit portion 1 f or a slit portion when the tip of the syringe or the connector is inserted. It is formed to facilitate elastic deformation of the elastic body around the conical hole 1 g downward, but in order to improve the sealing performance without unnecessarily during normal times other than injection and extraction of chemicals etc.
  • the corner between the inner peripheral surface and the ceiling surface of the concave portion 1 d on the lower surface side is formed in an arc shape to increase the compression repulsion force against pushing and the external pressure of the tip of the syringe or connector, and pulling by the internal pressure
  • the resistance is increased to prevent rolling up, and as the internal pressure increases, the sealing performance of the cut portion 1a, the slit portion If, or the conical hole 1g can be enhanced.
  • the embodiments and modified examples shown in FIGS. 11 to 13 can be applied not only to a mixed injection tube but also to a chemical bottle and other ⁇ !.
  • Fig. 14 shows another modified example of the first embodiment, in which the stopper body 1 is tightly fitted to the injection port 2a for injecting a chemical solution or the like, and the upper flange portion 1b is fitted to the flange projection 2b with the cap 6. m is locked and fixed, and the whole is made of an elastic body such as rubber. The recess at the center of the upper surface is deepened to form the insertion hole 1c 'at the tip 3 of the syringe or connector.
  • the valve membrane 10 is formed between the inlet 1c and the recess 1d at the center of the lower surface, and the cassette 1a is formed at the center of the valve membrane 1o. As shown in FIG.
  • protrusions lb, lb are formed on the outer peripheral surface of the plug body 1 at a right angle to the longitudinal direction of the cut portion la, corresponding to the formation position of the valve membrane portion 10.
  • the protrusion further increases the tightening pressure of the cut 1a.
  • Outer diameter of plug body 1 The inner diameter of the injection / extraction port 2a for the drug solution shown in 15B is also made larger by the amount of the interference.
  • FIG. 16A shows still another modification of the first embodiment. In this modification, the shape of the power port 1a is increased in order to increase the contact area of the cut portion 1a at the time of sealing.
  • the valvular part is 1 dog in the thickness direction and has a mountain-shaped unevenness I dog.
  • FIGS. 17A to 17E show another modification of the first embodiment, in which the valve membrane portion of the plug body 1; L 0 is the modification shown in FIGS. 14 and 16A.
  • the flat type was replaced with a convex type (internal pressure resistant type) in Fig. 17A, a concave type (external pressure resistant type) in Fig.
  • FIG. 17B a bi-convex type (internal / external pressure resistant type) in Fig. 17C, and a figure. 17D shows an example of a flat outer / inward convex type (internal pressure resistant type), and FIG. 17E shows a case of an inner flat type with an outer convex type (external pressure resistant type).
  • the sealing effect of the cut portion la increases as the internal pressure increases
  • the sealing effect of the cut portion 1a increases as the external pressure increases.
  • the shape of the valve membrane portion 1 o may be an appropriate shape depending on the use to which the plug body 1 is applied.
  • FIG. 18C are views for explaining the opening operation of the valve membrane 1o shown in FIG. 17A.
  • the tip 3 When the tip 3 is inserted, the internal pressure in the insertion hole 1 increases and the cut 1a starts to open as shown in Fig. 18B, and the tip 3 of the syringe or connector is further inserted.
  • the valve leaflet 1 o As shown in 18 C, the valve leaflet 1 o is pushed by the distal end portion 3, and the power outlet portion 1 a is completely exposed. In this state, injection or extraction of the chemical is performed. Thereafter, when the distal end portion 3 of the syringe or the connector is pulled out, the cut portion 1a is sealed by the elastic restoring force of the valve membrane portion 1o and the negative pressure generated in the inlet 1c '.
  • FIG. 19 shows still another modification of the first embodiment, in which the mating surface of the cut portion 1a is shown. Lip portions 1 are formed on both the inner and outer surfaces to increase the sealing force of the cassette 1a in the valve leaflets 1-0.
  • FIGS. 20A and 20B are views for explaining the opening operation of the valve membrane portion 1 o of another modification of the first embodiment. In this modification, the inner surface of the insertion hole 1 c of the plug body 1 is shown. One or more annular locking portions lp are formed on each of the two (Fig.
  • FIG. 21 shows another modification of the first embodiment, and in this modification, the plastic body is formed on the inner surface of the insertion hole 1c 'of the plug body 1.
  • the inner cylinder 7 is fitted and mounted to improve the smoothness and abrasion resistance of the insertion hole 1 c ′ into which the distal end portion 3 of the syringe or the connector is inserted.
  • a female screw groove 7a is formed on the inner surface of a plastic inner cylinder 7 fitted and mounted in the insertion hole 1c of the plug body 1, and corresponding to this.
  • a male screw ridge 3b is formed on the distal end 3 of the syringe or connector 1 and screwed together to enable the self-holding of the connected state between the distal end 3 of the syringe or connector 1 and the plug body 1.
  • the female screw groove 7a is formed directly on the inner surface of the insertion hole 1c of the plug body 1 when the plastic inner cylinder 7 is omitted.
  • 23A, 23B, and 23C show another modification of the first embodiment, in which the insertion hole 1c 'of the plug body 1 is a through hole. And a ring at the back of the inlet hole 1 c.
  • W-groove 1q is formed, and annular disk 1q. Is combined with two semi-disc 8a made of rubber or other elastic material to form a single disc shape. and in c this modification is obtained by the seam of the two half-discs 8 a Te cowpea to the Katsuhito portion 1 a, omit the step for forming the cut portion 1 a to the plug body 1 can do.
  • the plastic inner cylinder 7 may or may not be provided.
  • the stopper body of each embodiment and the modified example is used by being pressed into an injection port of a liquid medicine such as a liquid medicine bottle, a liquid medicine container, a co-infusion tube, etc. , May be used without a cap.
  • a liquid medicine such as a liquid medicine bottle, a liquid medicine container, a co-infusion tube, etc.
  • the inner surface of the concave portion 1c or the insertion hole 1c 'at the center of the upper surface of the stopper main body 1 has a tapered surface shape adapted to the distal end portion 3 of the syringe or the connector, or An annular convex portion is formed in a headband shape on the inner surface to enhance the sealing property between the distal end portion 3 of the syringe or the connector and the inner surface to increase the function of preventing leakage of the drug solution during injection / extraction of the drug solution. You may. Further, the present invention can be applied to liquids other than chemicals. At this time, liquid injection and extraction may be performed by using an adapter having a connection port similar to that of the syringe tip 3.

Abstract

Dans un dispositif d'étanchéité pour orifice d'injection/extraction de médicament liquide ou analogue, le diamètre extérieur (D1) du corps de bouchon (1) [fait dans un matériau élastique et présentant une zone de coupe linéaire (1a) ou une partie fendue (1f) verticale au niveau de la partie centrale] est plus important pour cause de tolérance de montage serré que le diamètre intérieur (D2) de l'orifice d'injection/extraction. Ainsi, cet orifice (2a) est obturé par le montage serré du corps de bouchon (1), ce qui crée une pression de montage dans la zone de coupe (1a) ou la partie fendue (1f). Cette zone de coupe ou partie fendue (1f) du corps de bouchon (1) est déformée élastiquement et ouverte par le montage serré de la partie menante (3) d'un injecteur ou d'un raccord, pour ensuite reprendre élastiquement sa forme et rétablir l'étanchéité au moment où la partie menante (3) de l'injecteur ou du raccord est retirée.
PCT/JP2001/005775 2001-02-09 2001-07-03 Dispositif d'etancheite pour orifice d'injection/extraction de medicament liquide WO2002064077A1 (fr)

Applications Claiming Priority (4)

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JP2001-34242 2001-02-09
JP2001034242 2001-02-09
JP2001132803A JP2002306610A (ja) 2001-02-09 2001-04-27 薬液等注入抽出口用シール弁
JP2001-132803 2001-04-27

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WO2002064077A1 true WO2002064077A1 (fr) 2002-08-22

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JP (1) JP2002306610A (fr)
CN (1) CN1420754A (fr)
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WO2004074162A1 (fr) * 2003-02-19 2004-09-02 The Coca-Cola Company Systeme et procede de remplissage aseptique d'emballages avec des produits liquides
EP1649932A1 (fr) * 2004-10-20 2006-04-26 Agilent Technologies Inc. a Delaware Corporation Dispositif d'étanchéité
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US8926583B2 (en) 2007-09-11 2015-01-06 Carmel Pharma Ab Piercing member protection device
US9039672B2 (en) 2002-07-09 2015-05-26 Carmel Pharma Ab Coupling component for transmitting medical substances
US9168203B2 (en) 2010-05-21 2015-10-27 Carmel Pharma Ab Connectors for fluid containers
US9309020B2 (en) 2007-06-13 2016-04-12 Carmel Pharma Ab Device for providing fluid to a receptacle
WO2017111584A1 (fr) 2015-12-22 2017-06-29 Scholle Ipn Ip B.V. Bouchon pour raccord de seringue sans aiguille et contenant
US9913971B2 (en) 2012-09-28 2018-03-13 Terumo Kabushiki Kaisha Connector
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US10123938B2 (en) 2002-03-26 2018-11-13 Carmel Pharma Ab Method and assembly for fluid transfer and drug containment in an infusion system
US10220199B2 (en) 2012-09-28 2019-03-05 Terumo Kabushiki Kaisha Valve body and connector including the same
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JP5888070B2 (ja) * 2012-03-31 2016-03-16 ニプロ株式会社 透析液の原液タンク
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US9597260B2 (en) * 2013-03-15 2017-03-21 Becton Dickinson and Company Ltd. System for closed transfer of fluids
JP6456067B2 (ja) * 2014-07-30 2019-01-23 株式会社藤井合金製作所 流路接続装置
JP6719198B2 (ja) * 2015-12-11 2020-07-08 株式会社Ｅｖｉジャパン 固定構造
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US10806668B2 (en) 2002-03-26 2020-10-20 Carmel Pharma Ab Method and assembly for fluid transfer and drug containment in an infusion system
WO2003086530A1 (fr) * 2002-04-17 2003-10-23 Carmel Pharma Ab Procede et systeme de transfert de fluide dans un systeme a perfusion
US9039672B2 (en) 2002-07-09 2015-05-26 Carmel Pharma Ab Coupling component for transmitting medical substances
WO2004074162A1 (fr) * 2003-02-19 2004-09-02 The Coca-Cola Company Systeme et procede de remplissage aseptique d'emballages avec des produits liquides
EP1649932A1 (fr) * 2004-10-20 2006-04-26 Agilent Technologies Inc. a Delaware Corporation Dispositif d'étanchéité
EP3964245A1 (fr) * 2006-11-06 2022-03-09 Becton, Dickinson and Company Ventilation du septum d'un dispositif d'accès vasculaire
EP2086851A1 (fr) * 2006-11-13 2009-08-12 Raymond John Baker Fermeture et système de distribution
EP2086851A4 (fr) * 2006-11-13 2010-11-24 Raymond John Baker Fermeture et système de distribution
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US9309020B2 (en) 2007-06-13 2016-04-12 Carmel Pharma Ab Device for providing fluid to a receptacle
US10398834B2 (en) 2007-08-30 2019-09-03 Carmel Pharma Ab Device, sealing member and fluid container
US11071818B2 (en) 2007-08-30 2021-07-27 Carmel Pharma Ab Device, sealing member and fluid container
US8926583B2 (en) 2007-09-11 2015-01-06 Carmel Pharma Ab Piercing member protection device
US9168203B2 (en) 2010-05-21 2015-10-27 Carmel Pharma Ab Connectors for fluid containers
US9913971B2 (en) 2012-09-28 2018-03-13 Terumo Kabushiki Kaisha Connector
US10220199B2 (en) 2012-09-28 2019-03-05 Terumo Kabushiki Kaisha Valve body and connector including the same
WO2017111584A1 (fr) 2015-12-22 2017-06-29 Scholle Ipn Ip B.V. Bouchon pour raccord de seringue sans aiguille et contenant
US10905631B2 (en) 2015-12-22 2021-02-02 Scholle Ipn Ip Bv Needleless syringe connector cap and container
GB2560693A (en) * 2017-02-01 2018-09-26 Nerudia Ltd Valve assembly
GB2560693B (en) * 2017-02-01 2019-11-20 Nerudia Ltd Valve assembly and dispenser
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US11400018B2 (en) 2017-03-23 2022-08-02 Kobayashi Pharmaceutical Co., Ltd. Liquid medicine supply device

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CN1420754A (zh) 2003-05-28
JP2002306610A (ja) 2002-10-22

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