WO2017080521A1 - 单针混药器、硬双接口及输液软袋 - Google Patents

单针混药器、硬双接口及输液软袋 Download PDF

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Publication number
WO2017080521A1
WO2017080521A1 PCT/CN2016/105563 CN2016105563W WO2017080521A1 WO 2017080521 A1 WO2017080521 A1 WO 2017080521A1 CN 2016105563 W CN2016105563 W CN 2016105563W WO 2017080521 A1 WO2017080521 A1 WO 2017080521A1
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WO
WIPO (PCT)
Prior art keywords
cup
mixing
mixing device
soft bag
needle
Prior art date
Application number
PCT/CN2016/105563
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English (en)
French (fr)
Inventor
邱宇
李科
张云
Original Assignee
重庆莱美药业股份有限公司
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 重庆莱美药业股份有限公司 filed Critical 重庆莱美药业股份有限公司
Priority to EP16863697.5A priority Critical patent/EP3375426B1/en
Priority to JP2018544392A priority patent/JP2018533457A/ja
Priority to CA3004960A priority patent/CA3004960C/en
Priority to US15/776,072 priority patent/US20200253826A1/en
Priority to KR1020187014832A priority patent/KR102119989B1/ko
Publication of WO2017080521A1 publication Critical patent/WO2017080521A1/zh

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    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • 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
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    • A61J1/1406—Septums, pierceable membranes
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    • 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
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • 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
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    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
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    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/07—Flat, e.g. panels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/30—Extrusion nozzles or dies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/30—Extrusion nozzles or dies
    • B29C48/304—Extrusion nozzles or dies specially adapted for bringing together components, e.g. melts within the die
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10—Homopolymers or copolymers of propene
    • C08L23/12—Polypropene
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
    • B29K2027/06—PVC, i.e. polyvinylchloride
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/712—Containers; Packaging elements or accessories, Packages

Definitions

  • the invention relates to a medicine mixer, in particular to a single needle mixing device with a mixing cup, a hard double interface and an infusion soft bag.
  • the syrup or water for injection in the infusion soft bag needs to be pumped out into the vial via a syringe, and the above work is repeated until there is enough liquid in the vial. Then, shake the vial repeatedly until the medicine in the bottle is evenly mixed, and then use the syringe to pump the liquid in the vial into the infusion soft bag, and repeat until the liquid in the bottle is exhausted.
  • the above-mentioned mixed drug operation process is relatively time consuming, laborious, and consumables such as a syringe. More seriously, in the above mixed drug process, it is very easy to inject the outside air into the vial and the infusion soft bag under normal conditions. There are a lot of dust and germs in the air, and they will enter the human body after being mixed with the injection liquid, which will bring about a very serious medical accident.
  • the traditional method of liquid dispensing is to first re-inject the medicine, and then pump the medicine in the vial to the infusion soft bag, and then bring the infusion soft bag with the medicine to the patient to infusion. After the medicine is finished, the vacant vials are placed on one side, and the patient protection medical staff is completely unaware of what medicine is contained in the infusion soft bag and is not traceable. Once the medical staff pays little attention to the mistakes during the dosing, the mismatching of the liquid is wrong, and the consequences will be unimaginable.
  • the drug mixture is welded on the infusion soft bag.
  • the high temperature sterilization environment is generally a high temperature of 115-121 degrees Celsius, and the sterilization time is 30- The sterilization pressure was 0.15 MPa for 15 minutes.
  • the material used in the blender and the infusion soft bag can withstand temperatures of 120 degrees Celsius, it will inevitably soften, plus a high pressure of 0.15 MPa, which is equivalent to a pressure of 150 N per square centimeter - this is In the case of a sealed mixed cup, it is fatal.
  • the mechanical strength of the mixing cup and the sealing film will decrease at 120 °C.
  • the pressure of 150 N per square centimeter will directly cause the cup of the mixing cup to deform, the sealing film to be stretched, and wrinkles appear. The seal is broken, causing the mixed cup structure to be completely damaged and unusable.
  • the terminal sterilizing of the mixed drug cup structure was an insurmountable obstacle; and the mixed cup was not sealed, and it was not guaranteed to meet the sterility requirements at the time of use, whether from policies and regulations. From the perspective of practical safety, terminal sterilization of infusion soft bags is necessary and necessary.
  • the object of the present invention is to provide an infusion soft bag which is convenient and reliable and has no safety hazard, and a mixer and an interface therewith.
  • a single-needle mixing device comprising an integrally formed base, a mixing channel, and a mixing cup, the mixing cup being composed of a cup wall and a cup bottom, and a puncture needle.
  • a lower end of the mixed drug passage passes through the base, and an upper end passes through the bottom of the cup; at an upper end of the mixed drug passage, a puncture needle having a hollow passage is provided, and a lower end of the puncture needle and the mixed drug passage The upper end is sealingly connected and the hollow passage is in communication with the mixing passage; the mixer further includes a sealing film welded to the cup mouth of the mixing cup by pressure welding, for the mixing The medicine cup forms a seal; the sealing film is an easy-to-tear film which can maintain a substantially flat shape after the wet heat method is terminally sterilized.
  • the needle of the puncture needle is provided with a hole communicating with the hollow passage, and the puncture needle does not extend out of the cup mouth of the mixing cup;
  • sealing film is a gas permeable and easily tearable film.
  • the air permeability of the sealing film is 5% to 35%.
  • the upper surface of the sealing film is plated with a metal film layer.
  • a cover plate is further included; the cover plate is located at an inner edge of the cup mouth and is covered by the sealing film.
  • the cover plate has a polygonal shape, and a through hole is disposed at a center thereof, and a needle portion of the puncture needle is located in the through hole but does not pass through the hole; an inner diameter of the through hole is smaller than an outer diameter of the puncture needle The diameter of the needle is larger than the tip of the needle so that the needle tip can extend into the through hole but cannot pass through the through hole to form a support for the cover plate; the cover plate is provided with a reinforcing rib.
  • the mixed cup is preloaded with a certain amount of liquid before being sealed by the sealing film.
  • the liquid is a liquid that can be rapidly vaporized in a high temperature sterilization environment.
  • the pre-installed amount of the liquid vaporizes the formed gas in a high-temperature sterilization environment, so that the gas pressure inside and outside of the mixed medicine cup is substantially balanced.
  • a limiting protrusion is disposed on an inner wall of the cup wall, and the limiting protrusion defines the needle plate at the limiting protrusion and the bottom of the cup after the cross pin is installed into the mixing cup Can not be taken out.
  • the limiting protrusion is an elastic claw, the upper end of the elastic claw is evenly arranged and fixed along a circumference of the inner wall of the cup wall, the lower end of the elastic claw is a free end, and the elastic claw is fixed
  • the upper end to the free lower end is inclined toward the center of the mixing cup; the distance from the free end of the elastic claw to the bottom of the cup is substantially the same as or slightly larger than the thickness of the vial cap
  • the thickness of the vial cap is such that after the vial is assembled to the blender, the cap of the vial is caught between the free end and the cup bottom by the elastic jaw.
  • the limiting protrusion is an elastic card holder
  • the elastic card holder includes a snap ring
  • the lower side of the snap ring is provided with an elastic claw
  • the upper end of the elastic claw is evenly arranged and fixed along the snap ring.
  • the lower end of the elastic claw is a free end, and the elastic claw is from the fixed upper end to the free one
  • the lower end is inclined toward the center of the mixing cup; the distance between the free end of the elastic claw and the bottom of the cup is substantially the same as the thickness of the Xilin cap or slightly larger than the thickness of the Xilin cap, so that Xilin After the bottle is assembled to the mixer, the cap of the vial is caught between the free end and the cup bottom by the elastic claw; a limited structure is arranged on the inner wall of the cup wall.
  • the elastic card holder is installed in the mixing cup and is limited by the limiting structure.
  • the elastic card holder has an integrally formed bottom plate, a support column, the snap ring and the elastic claw, and the outer periphery of the bottom plate is provided with a support column to form and support the buckle ring; the bottom plate is provided with a center a hole through which the puncture needle cooperates.
  • the lower end of the mixed drug channel is provided with a frangible handle, and the lower end of the mixed drug channel is sealed by the easy folding handle.
  • a mixing device having a reinforcing structure, comprising any of the mixing devices; a wall of the mixing cup provided with a reinforcing rib structure to reinforce the cup The compressive strength of the wall.
  • the reinforcing ribs are disposed integrally inside the cup wall in an up-down direction and/or a horizontal direction.
  • a hard dual interface with a drug mixture comprising any one of the mixers, on the base of the mixer, with respect to the mixing channel On one side, there is an infusion channel.
  • an infusion soft bag with a hard dual interface is also provided, the hard dual interface being the aforementioned hard dual interface.
  • an infusion soft bag with a drug mixture the drug mixture being any type of drug mixture; the drug mixture being coupled to the soft bag through the base Together.
  • an infusion interface is provided, the infusion interface being disposed on the infusion soft bag on the same side as the drug mixture, or on the infusion soft bag on the other side opposite to the drug mixture.
  • the infusion soft bag is a non-PVC multi-layer co-extruded film;
  • the integrally formed base and the mixed cup and the diaphragm are made of medical polypropylene material, preferably polypropylene R530C material;
  • the limiting protrusion is a polypropylene material, preferably a polypropylene P17 material.
  • Figure 1 is a schematic view of a single needle mixing device
  • Figure 2 is a partial detail view of a single needle
  • Figure 3 is a partial detail view of a single needle
  • Figure 4 is a partial detail view of the mixing cup
  • Figure 5 is a schematic view of an elastic card holder
  • Figure 6 is a schematic view of the cover
  • Figure 7 is a schematic view of an infusion soft bag with a single needle mixing device
  • Figure 8 is a schematic view of a single needle mixing device infusion soft bag in use state
  • Figure 9 is a schematic diagram of a single-needle mixing device infusion soft bag for infusion and mixed drug
  • Fig. 10 is a schematic view showing the infusion soft bag of the single-needle mixing device in the infusion state and the mixed drug in the use state.
  • the base 2, the mixing cup 3, the limiting protrusion 4, the puncture needle 5, the mixing passage 7, and the easy folding handle 6, the above-mentioned base 2, the mixing cup 3, and the mixing passage 7 Constituent body structure It is formed in one piece.
  • the easy-to-fold handle 6 forms a closed end to the lower end of the mixed medicine channel 7, and in the state of use as shown in FIG. 8, the easy-to-fold handle 6 is cut off, so that the mixed medicine passage 7 communicates with the vial 10 via the puncture needle 5, thereby completing the mixing. medicine.
  • the mixing device shown in FIG. 1 can be integrally formed with the infusion channel 11 in addition to the mixed drug channel, and is arranged side by side on the base 2 in combination with the mixed drug channel 7.
  • the upper end of the infusion channel 11 is provided with an easy-folding cover, including an inner cover 12, a rubber plug 13 and an easy-folding cover 14.
  • a cover 8 and a sealing film 9 are provided to form a complete seal to the mixing cup.
  • an elastic claw is preferable; more preferably, the elastic claw as the stopper projection 4 is integrally formed with the mixing cup 3.
  • the upper end of the elastic claw 4 is evenly arranged and fixed along the circumference of the inner wall of the cup wall 3-1, the lower end of the elastic claw is a free end, and the elastic claw 4 is from the fixed upper end to the free side
  • the lower end is inclined toward the center of the mixing cup, as shown in FIG.
  • the vial 10 is pushed into the mixing cup 3, and the cap is pierced by the puncture needle 5 and then freed by the elastic claw 4. The end is stuck and cannot be pulled out.
  • the thickness of the cap of the vial 10 should be substantially the same as the distance between the free end of the elastic jaw 4 and the bottom 3 - 2 of the mixing cup, so that the vial 10 is just stuck in the elastic jaw through the cap.
  • the free end of 4 is between the bottom of the cup and the bottom of the cup, and cannot move up and down.
  • the puncture needle 5 it is disposed at the upper end of the mixed drug channel, and can be connected with the detachable seal of the mixed drug channel, preferably integrally formed with the body structure of the drug mixture.
  • the needle structure of the puncture needle 5 it is preferable to adopt the structure of the needle tip 5-2 and the side hole 5-1 as described in FIG. 2, so as to avoid the puncture needle 5 when puncture the rubber stopper or the stopper.
  • the edge of the outlet creates a direct cut of the plug and produces a large amount of debris.
  • the outer surface of the puncture needle 5 may be covered with a layer.
  • Flexible receipt The shrink film 5-3, after the puncture, the elastic shrink film 5-3 is compressed and accumulated around the puncture hole, so that the liquid medicine can be effectively prevented from leaking along the gap of the puncture hole.
  • an alternative solution is to use a separate elastic card holder 4 as shown in FIG. 5 to fit into the mixing cup 3 to limit the vial. effect.
  • the elastic card holder 4 includes a snap ring 4-2, and the lower side of the snap ring 4 ⁇ 2 is provided with an elastic claw 4 ⁇ 1.
  • the upper end of the elastic card 4 ⁇ 1 is evenly arranged and fixed along the snap ring 4 ⁇ 2, the lower end of the elastic claw 4 ⁇ 1 is a free end, and the elastic claw is free from the upper end of the fixed
  • the lower end is inclined toward the center of the mixing cup.
  • the elastic card holder has an integrally formed bottom plate 4-5, a support column 4 ⁇ 4, a snap ring 4 ⁇ 2 and an elastic claw 4 ⁇ 1, and the bottom plate 4 ⁇ 5 is provided with a support column 4 ⁇ 4 on the outer circumference.
  • the snap ring 4-6 forms a support and is fixed.
  • the bottom plate 4-5 is provided with a central hole 4-3 through which the puncture needle 5 passes.
  • the independent elastic card holder 4 cooperates with a limiting structure (not shown) on the inner wall of the cup wall 3-1, and the elastic card holder 4 is installed in the mixing cup and is The limit structure is limited such that the elastic card holder 4 does not slide out of the mixing cup after being placed.
  • the elastic card holder 4 is completely restricted by the stopper structure to the bottom of the cup and cannot be withdrawn.
  • the infusion can be traced back, because the vial 10 is fixed to the mixing cup 3, and after being caught by the elastic claw 4/4 ⁇ 1, the vial 10 cannot be removed non-destructively. That is to say, from the dispensing, to the completion of the infusion, to the recycling process, it can be traced back to what kind of medicine is added and injected.
  • the above-mentioned mixed medicine device for a type of medicine that needs special preservation, for example, needs to be ready to be placed, or can be taken from the pharmacy to take out the medicine contained in the vial 10, and then assembled into the mixed medicine cup of the infusion soft bag 1 Bring it to the ward, and then break the easy-to-fold handle 6 to complete the mixed drug, so that it can be used immediately.
  • the infusion soft bag with the drug mixture shown in FIG. 7
  • the pedestal welding site damages the infusion soft bag
  • the pedestal is designed as a dumbbell or a boat, as shown in the pedestal 2 in Fig. 1, and the mixing channel 7 and the infusion channel 11
  • the lower end is flush with the lower end of the base 2.
  • the welding pattern is uniformly distributed on the side walls of the base 2, which can ensure that the base 2 can be welded and welded to the soft bag 2 even at a lower temperature during the welding process of the infusion soft bag. .
  • the boat-shaped or dumbbell-shaped pedestal has a good streamlined shape, which improves the mechanical properties of the welding, and has no sharp angle, so that the combination of the hard double interface and the infusion soft bag 2 is smoother and the soft bag is not easily damaged.
  • the infusion soft bag uses the commonly used non-PVC multi-layer co-extruded film, including three-layer and five-layer multi-layer co-extruded film.
  • the drug mixture is made of medical polypropylene material which is compatible with the non-PVC material of the infusion soft bag.
  • the base, the mixing cup and the cover plate are preferably polypropylene R530C material; and the puncture needle and the elastic card
  • the seat and limit structure, in view of its puncture and mechanical properties, are preferably P17 materials in the pp material system.
  • the terminal is sterilized after the seal is welded to the soft bag.
  • all pharmaceutical packaging must be terminally sterilized before injection, or an injection sterility assurance process.
  • Terminal sterilization process On the basis of controlling the amount of microbial contamination, after the drug is potted, it is sterilized by moist heat sterilization. In general, the method is low in cost and high in sterility assurance, and is suitable for sterilization of large-volume injections and small-volume injections.
  • Aseptic production process In the aseptic system environment, through the sterilization filtration method or the aseptic operation method, in order to prevent pollution, various possibilities of pollution are eliminated to ensure the sterility level. In general, the sterility assurance level is lower than the terminal sterilization process due to the high requirements of the method for the environmental system and the factors affecting the aseptic operation.
  • the aseptic production process is generally suitable for powder injections, and can also be suitable for small-volume injections that are clinically necessary but cannot be terminally sterilized. Thus, the terminal sterilization process and the aseptic production process have different system requirements, different sterilization methods and different sterility assurance results.
  • the mixing device and the infusion soft bag are all selected polypropylene materials capable of withstanding high temperatures of 120 degrees Celsius, the mechanical properties of the drug mixture in the sealed state at such high temperatures are reduced, and it is very easy to be 0.15 MPa.
  • the deformation under pressure; the sealing film will also deform, wrinkle at this temperature and pressure, and lose the sealing effect.
  • a reinforcing rib 3-3 is provided in the lower half of the cup.
  • the ribs are placed against the cup wall of the mixing cup, preferably in the lower half of the cup wall.
  • the ribs may be vertical strips integrally formed with the mixing cups disposed on the inside and/or outside of the cup wall, or horizontal strips, or crisscrossed web structures. Preference is given to a vertical strip-like structure uniformly distributed along the lower half of the inner side of the cup wall; more preferably the raised vertical strip extends from the lower inner side of the cup wall to the bottom of the cup, most preferably the thickness of the vertical strip projections from top to bottom The gradual smoothing continues to increase continuously.
  • the mixing cup with the ribs is provided to improve the mechanical pressure resistance of the cup to a considerable extent. Comparing the experiments, there is no mixing cup with ribs. After the wet heat sterilization process, the round mixing cup cup is compressed into a square shape and cannot be used at all.
  • the round mixture cup After the ribs are set, after the wet heat sterilization process, the round mixture cup has a slight compression, which basically does not affect the normal use function.
  • the sealing film 9 it is only a very thin and easy-to-peel film, which serves to seal the mixed cup 3 and is easy to tear when used.
  • the sealing film 9 is weaker than the cup of the mixing cup 3 because the sealing film 9 itself is only a film of a micron order thickness and cannot withstand a pressure of 0.15 MPa in the wet heat sterilization process.
  • a cover plate 8 as shown in FIG. 6 was attached under the sealing film 9, and the sealing film 9 covered the cover plate 8, so that the cover plate 8 formed an effective support for the sealing film 9.
  • the sealing film 9 is prevented from being compressed and deformed upon sterilization.
  • the cover plate 8 rests on the step of the mixing cup cup
  • the inner edge is such that the upper surface of the cover plate disposed at the cup opening is flush with or slightly lower than the cup opening, and the cover plate 8 is disposed such that the sealing film 9 is pressure welded to the upper end of the cup wall.
  • the surface sealing process does not affect it.
  • the preferred cover plate 8 is polygonal in cross section, such as a pentagon, a hexagon, an octagon, and a twelve deformation.
  • the advantage of the polygonal cover 8 on the one hand is that it is easier to remove when used; and another unexpected effect of the cover 8 being polygonal is mentioned below.
  • the cover plate 8 is disposed coaxially with the puncture needle, and the needle tip 5-2 faces the center of the cover plate and supports the cover plate. More preferably, the center of the cover 8 is provided with a through hole 8 -1.
  • the inner diameter of the through hole 8 - 1 is smaller than the outer diameter of the puncture needle 5 , and the portion of the needle tip 5 - 2 is located in the through hole but cannot pass through the through hole. That is, the needle tip 5-2 is inserted into the through hole 8.1 of the cover 8 so that the support effect of the puncture needle 5 on the cover 8 is more remarkable.
  • the cover plate 8 is also reinforced, as shown in FIG.
  • the annular rib 8-2 provides enhanced mechanical strength of the cover 8.
  • the pressure-welding and sealing film 9 at the upper end of the cup mouth is tightly applied to the upper surface of the cover plate 9, so that the sealing film 9 does not need to be subjected to high pressure substantially, and the phenomenon of deformation and wrinkles of the sealing film 9 is greatly alleviated.
  • a thin metal film such as an aluminum-plated sealing film, is applied on the upper surface of the sealing film 9, which can effectively alleviate the problem of wrinkles of the sealing film.
  • the sealed drug mixture thus set can basically be used normally even after being subjected to the high temperature and high pressure of the moist heat sterilization process, however, the shape of the product is still difficult to maintain in a good state, from the viewpoint of the infusion product. , still a product that is not qualified.
  • the function can only be guaranteed.
  • the terminal sterilization problem of the sealed mixer it is also necessary to solve the problem from the root - the sealed mixed cup is sterilized by damp heat The internal and external air pressure balance.
  • the sealed mixing cup containing the liquid is rapidly vaporized at a high temperature when the terminal is sterilized with the infusion soft bag, so that the pressure inside and outside the cup can be quickly balanced.
  • the prefilled liquid a liquid having a small heat capacity and a high saturated vapor pressure is preferred.
  • a liquid having a small heat capacity and a high saturated vapor pressure is preferred.
  • the prefilled liquid is water.
  • PV nRT, where P is the internal and external pressure difference during wet heat sterilization, V is the volume of the mixed cup, n is the number of moles of prefilled liquid/water, R is the gas constant, and T is the absolute temperature during wet heat sterilization. .
  • V 0 n * M / ⁇ , where M is the molar mass of liquid / water and ⁇ is the density of liquid / water.
  • the internal and external air pressure of the sealed mixture at the time of terminal sterilization can be well balanced.
  • a more preferred solution is that we have specially studied a sealing membrane with a certain gas permeability based on the pp material system, which ensures sufficient gas exchange through the gas permeable sealing membrane and the outside after the liquid is vaporized. Thus, after the sterilization is completed, there is no residual liquid in the mixing cup.
  • the gas permeability of the gas permeable sealing film is most preferred after a long period of repeated experiments with a 5% to 35% air permeability.
  • the mixed cup has no slight deformation, and the sealing film is smooth as before, and no wrinkles appear.
  • an improved solution is to seal the drug mixture directly with a gas-permeable sealing film with suitable air permeability without pre-filling the liquid.
  • the gas permeability is selected at 25%. Between 3 and 55%, preferably about 30% of the sealing film, basically guarantees the integrity of the structure of the mixer after sterilization.
  • the shape of the cover plate is preferably designed—a polygonal structure with a hole in the middle.
  • this preferred design can quickly balance the air pressure inside and outside the mixing cup, thereby being hot and humid. In the sterilization process, the performance is even better - the sealing film is flat as before, and the mixing cup is not deformed. This is because the polygonal and intermediate cover plate can increase the gas exchange speed under the cover plate and the area above the cover plate, which can balance the air pressure in the mixing cup more quickly and balance the inside and outside of the mixing cup. .
  • the mixing cup 3 is disposed separately from the infusion channel 11, and is located on the upper and lower sides of the infusion soft bag.
  • the mixing device and the infusion channel can be disposed separately on the same side of the infusion soft bag.
  • the mixing device, the infusion channel and the interface in this embodiment are exactly the same as those in the embodiment 1, except that the drug mixture and the infusion channel 11 and the inner cover 12 and the easy-folding cover are used in this embodiment. 14.
  • the interfaces formed by the rubber plugs are set separately.
  • Figure 10 is an infusion soft bag with a drug mixture in a use state, the vial 10 is assembled and pushed into the mixing cup 3, the cap is pierced by the puncture needle 5, and the vial 10 is simultaneously elasticized by the claw 4 The bottleneck under the bottle cap can not be undone.

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Abstract

一种单针混药器、硬双接口和输液软袋（1），该混药器包括基座（2）、混药通道（7）、混药杯（3）和穿刺针（5），基座（2）、混药通道（7）和混药杯（3）一体成型，混药杯（3）由杯壁（3-1）和杯底（3-2）构成，混药通道（7）下端穿过基座（2），上端穿过杯底（3-2）；在混药通道（7）的上端，设置有具备中空通道的穿刺针（5），穿刺针（5）的下端与混药通道（7）上端密封连接且中空通道与混药通道（7）连通；混药器还包括密封膜（9），密封膜（9）以压焊的方式焊接在混药杯（3）的杯口，对混药杯（3）形成密封；密封膜（9）是湿热法终端灭菌后依然能保持基本平整的易撕膜。该混药器使用便捷且无安全隐患。

Description

单针混药器、硬双接口及输液软袋 技术领域
本发明涉及一种混药器，特别涉及一种带混药杯的单针混药器、硬双接口和输液软袋。
背景技术
在使用西林瓶盛装的粉针剂、冻干粉针剂或水针剂时，需要通过注射器将输液软袋中的药水或注射用水抽出注入西林瓶内，重复上述工作，直到西林瓶内有足够的药液；然后再将西林瓶反复摇动直到瓶内的药剂混合均匀，再用注射器将西林瓶内药液抽出注入输液软袋中，如此反复，直到瓶内的药液被抽完为止。
首先，上述的混药操作过程比较费时、费力、费耗材如注射器，更为严重的是，在上述混药过程中，非常容易将外面的空气注入到西林瓶以及输液软袋中，一般条件下空气中存在非常多的各种尘埃、病菌，混入注射药液后再进入人体，会带来非常严重的医疗事故。
其次，传统的配液方式，是先配药再注射，事先将西林瓶中的药抽吸至输液软袋中，再将配好药的输液软袋带至病房给患者输液。在配完药后，空置的西林瓶被放置一边，患者保护医护人员完全不知道输液软袋中所配的是什么药，不具备可追溯性。一旦医护人员在配液时稍不注意出现差错，将药液配错用错，后果将不堪设想。
再次，对于一些特殊的药物，譬如需要即配即用的药物，传统的配药方式非常不便，而且在本专利之前披露的各种混药器结构，并未能很好的解决该问题。
最后，在本发明之前披露的各种混药器结构，一直未能解决混药之后药液渗漏的问题。出于对更高的医疗服务水平的需要，迫切需要一种使用便捷、安全、可靠、无安全隐患的输液产品。
另外，混药器焊接在输液软袋上，在输液软袋灌装完毕后，需要对输液软袋整体进行高温灭菌，高温灭菌环境一般是115-121摄氏度的高温，灭菌时间30-15分钟，灭菌压力是0.15MPa。虽然混药器以及输液软袋所用的材料聚丙烯能够经受住120摄氏度的温度，但是不可避免的会软化，再加上0.15MPa的高压，相当于每平方厘米承受了150N的压力——这对于处于密封状态的混药杯而言，是致命的。首选，混药杯和密封膜在120摄氏度的温度下，机械强度会有所降低；其次，每平方厘米150N的压力，会直接导致混药杯的杯体变形、密封膜被拉伸，出现褶皱，密封性被破坏，导致混药杯结构完全被损坏而无法使用。
在本发明之前，密封混药杯结构的混药器，其终端灭菌，是个难以克服的障碍；而混药杯不密封，又不能保证满足使用时的无菌要求，不论是从政策法规还是从实际安全角度考虑，输液软袋的终端灭菌，都是必须而且是十分必要的。
发明内容
本发明的目的是提出一种使用便捷可靠且无安全隐患的输液软袋及与之相关的混药器、接口。
根据本发明实施例的一个方面，提供一种单针混药器，包括一体成型的基座、混药通道、混药杯，所述混药杯由杯壁和杯底构成，穿刺针，所述混药通道下端穿过所述基座，上端穿过所述杯底；在所述混药通道的上端，设置有具备中空通道的穿刺针，所述穿刺针的下端与所述混药通道上端密封连接且所述中空通道与所述混药通道连通；所述混药器还包括密封膜，所述密封膜以压焊的方式焊接在所述混药杯的杯口，对所述混药杯形成密封；所述密封膜是湿热法终端灭菌后依然能保持基本平整的易撕膜。
进一步，穿刺针的针头上开有与所述中空通道连通的孔，穿刺针没有延伸出混药杯的杯口；
进一步，所述密封膜是透气性易撕膜。
进一步，所述密封膜的透气率是5％到35％。
进一步，所述密封膜上表面镀有金属膜层。
进一步，还包括一盖板；所述盖板位于所述杯口内沿，且被所述密封膜覆盖。
进一步，所述盖板呈多边形，且中心设有通孔，所述穿刺针的针头部分位于所述通孔内但不穿过所述孔；所述通孔的内径小于所述穿刺针的外径但大于所述针头的针尖，使得所述针尖能伸入所述通孔中但不能穿过所述通孔，以对所述盖板形成支撑；所述盖板上设置有加强筋。
进一步，所述混药杯在被所述密封膜密封之前，预装一定量的液体。
进一步，所述液体是能在高温灭菌环境下迅速汽化的液体。
进一步，预装的所述一定量液体在高温灭菌环境下汽化所形成的气体，能让所述混药杯内、外气压基本平衡。
进一步，所述杯壁的内壁上设置有限位突起，所述十字针安装进所述混药杯后，所述限位突起将所述针板限定在所述限位突起和所述杯底之间而不能被取出。
进一步，所述限位突起为弹性卡爪，所述弹性卡爪上端沿所述杯壁的内壁周沿均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构；所述弹性卡爪的自由端到所述杯底之间的距离与西林瓶盖的厚度基本一致或略大于所述西林瓶盖的厚度，使得西林瓶装配到所述混药器上之后，所述西林瓶的瓶盖被所述弹性卡爪卡在所述自由端与所述杯底之间。
进一步，所述限位突起为弹性卡座，所述弹性卡座包括一卡环，所述卡环下侧设置有弹性卡爪，所述弹性卡爪上端沿所述卡环均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述 下端呈向所述混药杯中心倾斜结构；所述弹性卡爪的自由端到所述杯底之间的距离与西林瓶盖的厚度基本一致或略大于所述西林瓶盖的厚度，使得西林瓶装配到所述混药器上之后，所述西林瓶的瓶盖被所述弹性卡爪卡在所述自由端与所述杯底之间；所述杯壁的内壁上设置有限位结构，所述弹性卡座安装于所述混药杯内而被所述限位结构限制。
进一步，所述弹性卡座具有一体成型的底板、支撑柱、所述卡环和所述弹性卡爪，所述底板外周设置有支撑柱对所述卡环形成支撑固定；所述底板设有中心孔，所述穿刺针相配合的穿过所述中心孔。
进一步，所述混药通道下端，设置有易折柄，并通过所述易折柄对所述混药通道的下端进行密封。
根据本发明的另一个方面，还提供一种具有加强结构的混药器，包括任一种混药器；所述混药杯的所述杯壁上，设置有加强筋结构以增强所述杯壁的抗压强度。
进一步，所述加强筋设置在所述杯壁内侧沿上下方向和/或水平方向一体布置。
根据本发明的另一个方面，还提供一种带混药器的硬双接口，包括任一种混药器，在所述混药器的所述基座上相对于所述混药通道的另一侧，设有一输液通道。
根据本发明的另一个方面，还提供一种带硬双接口的输液软袋，所述硬双接口是前述的硬双接口。
根据本发明的另一个方面，还提供一种带混药器的输液软袋，所述混药器是任一种混药器；所述混药器通过所述基座与所述软袋接合在一起。
进一步，还包括一输液接口，所述输液接口设置在与所述混药器同侧的输液软袋上，或者设置在与所述混药器相对的另一侧的输液软袋上。
进一步，所述输液软袋采用的是非PVC多层共挤膜；所述一体成型的基座及混药杯、隔膜采用的是医用聚丙烯材料，优选的是聚丙烯R530C材料；所述十字针、所述限位突起为聚丙烯材料，优选的是聚丙烯P17材料。
附图说明
图1为单针混药器示意图；
图2为单针针头局部细节图；
图3为单针局部细节图；
图4为混药杯局部细节图；
图5为弹性卡座示意图；
图6为盖板示意图；
图7为带单针混药器的输液软袋示意图；
图8为使用状态下的单针混药器输液软袋示意图；
图9为输液与混药分立的单针混药器输液软袋示意图；
图10为使用状态下的输液与混药分立的单针混药器输液软袋示意图。
附图标记：
1、输液软袋，2、基座，3、混药杯，3-1、杯壁，3-2、杯底，3-3、加强筋，4、限位突起/弹性卡座，4-1、弹性卡爪，4-2、卡环，4-3、中心孔，4-4、支撑柱，4-5、底板，5、穿刺针，5-1、侧孔，5-2、针尖，5-3、弹性收缩膜，6、易折柄，7、混药通道，8、盖板，9、密封膜，10、西林瓶，11、输液通道，12、易折内盖，13、胶塞，14、易折外盖。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明了，下面结合具体实施方式并参照附图，对本发明进一步详细说明。应该理解，这些描述只是示例性的，而并非要限制本发明的范围。此外，在以下说明中，省略了对公知结构和技术的描述，以避免不必要地混淆本发明的概念。
下面，结合说明书附图，对本发明进行进一步的说明。
第一实施例
如图1所示，包括基座2，混药杯3，限位突起4、穿刺针5、混药通道7、易折柄6，上述由基座2、混药杯3、混药通道7构成的混药器本体结构 以一体成型的方式形成。易折柄6对混药通道7的下端形成封闭，在如图8所示的使用状态下，掰断易折柄6，使得混药通道7经穿刺针5与西林瓶10连通，从而完成混药。
如图1所示的混药器，除了混药通道外，还可以一体成型的设置输液通道11，与混药通道7评选的并排设置在基座2上。输液通道11上端设置有易折盖，包括内盖12、胶塞13及易折盖14。
在混药杯上端的开口部位，设置有盖板8以及密封膜9，对混药杯形成完全的密封。
至于限位突起4，优选的是弹性卡爪；更为优选的是，作为限位突起4的弹性卡爪与所述混药杯3一体成型。
弹性卡爪4上端沿所述杯壁3‐1的内壁周沿均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪4从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构，如图1所示。
在如图8所示的使用状态下的混药器，在装入西林瓶10之后，西林瓶10被推入混药杯3，其瓶盖被穿刺针5穿刺而后被弹性卡爪4的自由端卡住而不能拔出。可以理解的是，西林瓶10的瓶盖厚度应该与弹性卡爪4的自由端到混药杯杯底3‐2之间的距离基本一致，使得西林瓶10刚好通过瓶盖卡在弹性卡爪4的自由端与杯底3‐2之间，且不能上下移动。
对于穿刺针5，设置在混药通道的上端，可以和混药通道可拆卸的密封连接，优选的是与混药器本体结构一体成型。对于穿刺针5的针头结构，比较优选的是采用如图2所述的针尖5‐2加侧孔5‐1的结构，如此设置，是为了避免在穿刺胶塞、瓶塞时，穿刺针5出口的边缘对塞子形成直接切割而产生大量的碎屑。通过将出口设置在针头的侧壁上形成如图2所示的侧孔5‐1，针尖5‐2可以直接刺入胶塞中，不会形成直接切割作用，降低碎屑的产生。
另外，对于穿刺针5刺穿瓶盖后，为了防止药液沿穿刺针5与西林瓶瓶盖之间的缝隙渗漏，可以如图3所示，在穿刺针5的外表面包覆一层弹性收 缩膜5‐3，在穿刺后弹性收缩膜5‐3受到压缩，堆积在穿刺孔周围，从而可以有效防止药液沿穿刺孔的缝隙渗漏出来。
对于混药杯3中的限位突起4，一个可替代的方案是，采用如图5所示的独立的弹性卡座4，装配入混药杯3内，以起到对西林瓶的限位作用。
对于弹性卡座4的结构，一个可以具体的设计是：如图5所示，弹性卡座4，包括一卡环4‐2，所述卡环4‐2下侧设置有弹性卡爪4‐1，所述弹性卡4‐1上端沿所述卡环4‐2均匀布置且固定，所述弹性卡爪4‐1下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构。所述弹性卡座具有一体成型的底板4‐5、支撑柱4‐4、卡环4‐2和弹性卡爪4‐1，所述底板4‐5外周设置有支撑柱4‐4对所述卡环4‐6形成支撑固定。
所述底板4‐5设有中心孔4‐3，所述穿刺针5穿过所述中心孔。
与之独立的弹性卡座4相配合的是，在所述杯壁3‐1的内壁上设置有限位结构(未示出)，所述弹性卡座4安装于所述混药杯内而被所述限位结构限制，使得弹性卡座4在安放好之后不会滑出混药杯。尤其是，在如图8所示的使用状态下的混药器，西林瓶10被推入穿刺后，弹性卡座4完全被限位结构所限制至杯底而不能退出。
通过上述设置，可以安全、方便、快捷的配药、加药，完全解决了在配药环节的二次污染问题。同时也能保证输液可追溯，因为从西林瓶10对接固定到混药杯3上，被弹性卡爪4/4‐1卡住后，西林瓶10就不能非破坏性的取出。也就是说，从配药，到输液完成，直至回收环节，都能追溯到所加、所注射的是何种药物。
而且上述混药器，对于一类需要特殊保存的药物，譬如说需要即配即注型的，也可以从药房取出西林瓶10所装的药物后，装配到输液软袋1的混药杯3上带到病房，再掰断易折柄6后完成混药，实现即配即用。
关于基座2的形状及结构，为了避免混药器、输液通道或者带混药器及输液通道的硬双接口焊接在软袋上之后，如图7所示的带混药器的输液软袋 在储存、运输以及使用过程中，基座焊接部位对输液软袋造成的损坏，基座设计为哑铃形或船形，如图1中的基座2所示，且混药通道7、输液通道11的下端与基座2的下端平齐。基座2的四周侧壁上均布焊接纹路，这样能很好的保证在于输液软袋的焊接过程中，即使是在较低的温度下基座2也能和软袋2很好的熔合焊接。而且，船形或哑铃形的基座，流线型好，不尽改善了焊接的力学性能，而且没有锋锐的角度，可以使硬双接口与输液软袋2的结合更平滑，不易损坏软袋。
对于混药器以及输液软袋材料的选择，输液软袋采用的是目前普遍使用的非PVC多层共挤膜，包括三层、五层的多层共挤膜。
而混药器，则采用的是和输液软袋非PVC材料相容性很好的医用聚丙烯材料，基座、混药杯、盖板优选的是聚丙烯R530C材料；而穿刺针、弹性卡座、限位结构，考虑到其穿刺性以及机械特性，优选的是pp材料系中的P17材料。
最后，在密封结构的混药器关键的一点——密封混药器在焊接到软袋上之后的终端灭菌。目前从政策法规以及实际注射安全的角度考虑，所有的药品包装，在灌装出厂之前，必须进行终端灭菌，或者是采用注射剂无菌保证工艺。
目前，注射剂的无菌保证工艺主要有两种：
1.终端灭菌工艺：在控制微生物污染量的基础上，在药品灌封后，通过湿热灭菌方式除菌。一般来说，本方法成本低，无菌保证水平高，适宜于大容量注射剂和小容量注射剂的灭菌。
2.无菌生产工艺：在无菌系统环境下，通过除菌过滤法或无菌操作法，以防止污染为目的，消除导致污染的各种可能性来保证无菌水平。一般来说，由于本方法对环境系统的要求高，且影响无菌操作的因素多而使得无菌保证水平比终端灭菌工艺低。无菌生产工艺一般适宜于粉针剂，亦可适宜于临床需要但不能进行终端灭菌的小容量注射剂。由此，终端灭菌工艺和无菌生产工艺具有不同的系统要求、不同的除菌方法和不同的无菌保证结果
对于大输液而言，是成本极度敏感性的，故而，大输液中的终端灭菌，只可能采用低成本且高效的湿热灭菌工艺——灭菌条件一般是在115‐121摄氏度的高温、0.15MPa压力的蒸汽下，保持30‐15分钟。
虽然混药器以及输液软袋，都是选用的能耐120摄氏度高温的聚丙烯材料，然而，密封状态下的混药器，在如此高的温度下，其机械性能会降低，非常容易在0.15MPa的压强下变形；而密封膜也会在这个温度和压强下出现变形、褶皱，失去密封效果。
我们从2011年到2014年进行了长达四年上百次的实验，解决了密封状态下的混药器及输液软袋终端灭菌问题。
首先，对于混药杯的结构，如图4所示，在杯体的下半部设置了加强筋3‐3。加强筋的设置是对混药杯的杯壁，优先的是在杯壁下半部来进行。
加强筋可以是设置在杯壁内侧和/或外侧的均匀分布的突起的与混药杯一体成型的竖条，或者横条，或者纵横交错的网状结构。优选的是沿杯壁内侧下半部均匀分布的竖条状结构；更优选的是突起的竖条从杯壁内侧下半部延伸至杯底，最优选的是竖条突起的厚度从上到下逐渐平滑的连续增加。
设置了加强筋的混药杯，在相当的程度上提高了杯体的机械抗压性。实验比较，没有设置加强筋的混药杯，在采用湿热法灭菌工艺之后，圆形的混药杯杯体，被压缩成了方形，完全不能使用。
在设置了加强筋之后，经过湿热法灭菌工艺之后，圆形的混药杯杯体，有轻微的压缩，基本上不影响正常的使用功能。
其次，对于密封膜9，本身只是一个很薄的易撕膜，起到对混药杯3的密封和使用时便于撕开的效果。密封膜9比混药杯3的杯体更为薄弱，因为密封膜9本身只是一层微米量级厚度的薄膜，承受不了湿热法灭菌工艺中0.15MPa的压强。
对此，经过了大量的实验，发现，在密封膜9之下加装一个如图6所示的盖板8，密封膜9覆盖盖板8，使得盖板8对密封膜9形成有效的支撑，防止密封膜9在灭菌时被压缩变形。而盖板8则搁置在所述混药杯杯口台阶状 内沿上，使得设置在杯口处的盖板的上表面与杯口平齐或略低于所述杯口，而盖板8的如此设置，对密封膜9压焊在所述杯壁上端表面的密封工艺不会造成影响。
对于盖板的形状，和混药杯杯口的形状基本匹配的圆形，优选的盖板8的形状是横截面呈多边形，譬如五边形、六边形、八边形、十二变形。多边形的盖板8一方面的好处是使用时比较方便的取出；而盖板8设置为多边形的另外的一个意想不到的作用在下面会提到。
此外，为了增强盖板的抗压强度，优选的是盖板8与穿刺针同轴设置，针尖5‐2正对盖板中心并对盖板形成支撑。更有优选的是，盖板8中心设有一通孔8‐1，通孔8‐1内径小于穿刺针5的外径，针尖5‐2部分位于通孔内但不能穿过所述通孔，即针尖5‐2嵌入盖板8的通孔8‐1中，从而使得穿刺针5对盖板8的支撑效果更为显著。
与此同时，考虑到盖板8所承受的巨大的向下压力，除了设计穿刺针5对盖板8形成支撑外，还对盖板8进行了加强设置，如图6所示的呈放射状和环状设置的加强筋8‐2，增强了盖板8的机械强度。
压焊与杯口上端的密封膜9，紧紧的贴敷于盖板9上表面，使得密封膜9基本上不需要承受高的压力，极大的缓解了密封膜9变形褶皱的现象。
而对于褶皱，由于密封膜9太薄，稍有压力就会导致褶皱的出现，严重影响产品的视觉效果。
经过多次的对比实验，在密封膜9上表面镀一层薄的金属膜，譬如镀铝的密封膜，可以有效的缓解密封膜褶皱的问题。
如此设置的密封混药器，虽然经受住湿热法灭菌工艺的高温和高压后还基本上能正常使用，然而，作为产品的外形依然难以保持在很好的状态，从输液产品的角度来考虑，仍然是不合格的产品。
在结构上对混药器进行了上述设计之后，只能保证使用功能，为了彻底解决密封混药器的终端灭菌问题，还需要从根部上解决——密封的混药杯在湿热法灭菌时的内外气压平衡。
在混药杯组装完成之后，加装盖板8和密封膜9对其密封之前，向杯体内预装一定量的液体，然后再加装盖板，密封。
内装液体的密封混药杯，在随输液软袋一起进行终端灭菌时，高温下液体快速汽化，从而可以很快的让杯体内外的气压达到一个平衡。
对于预装液体，优选的是热容量较小，饱和蒸汽压较高的液体。我们研究了各种液体在120摄氏度，0.15MPa下的状态，包括水、乙醇等常用的无害液体，均能满足我们的需求。考虑到成本以及安全性，优选的是预装液体是水。
至于至关重要的预装水量V0，可以通过以下方程来确认：
PV＝nRT，其中P为湿热法灭菌时的内外压力差，V为混药杯容积，n为预装液体/水的摩尔数，R为气体常数，T为湿热法灭菌时的绝对温度。
V0＝n*M/ρ，其中M即为液体/水的摩尔质量，ρ为液体/水的密度。
根据上述方程可以很好的平衡密封混药器在终端灭菌时的内外气压。
以预装液体的方式来平衡内外气压，是一个比较优选的解决方案。
然而，上述方法能够解决气压平衡的问题，然后在实际使用中，依然存在一定的问题，最为典型的是，灭菌完了的成品输液软袋，冷却后在混药杯内存在水滴或液体，非常的影响观感，而且这样的产品通常也不太会被医院和患者所接受。
在此基础上，一个更为优选的方案是，我们特别研究了基于pp材料系的具有一定透气性的密封膜，保证在液体汽化后，能通过透气性密封膜和外面进行充分的气体交换，这样在灭菌完成之后，混药杯内不会存在残留的液体。
透气性密封膜的透气率，经过长时间的多次实验，5％‐35％透气率，是最为优选的。
对于采用我们研究的透气性密封膜来密封的混药器，经过湿热法高温灭菌后，混药杯没有丝毫的变形，密封膜也光滑如初，没有褶皱出现。
当然，一个改进型方案是，在不预装液体，直接采用具有合适透气率的透气性密封膜来密封混药器，经过我们的多次实验，选择透气性在25％ ‐35％之间，优选的是30％左右的密封膜，基本能保证灭菌之后混药器结构的完整性。
而优选设计的盖板形状——多边形且中间带孔的结构，实验表明，在采用了气压平衡手段后，这种优选设计，能更快的让混药杯内外的气压达到平衡，从而在湿热法灭菌工艺中，表现更为出色——密封膜平整如初，混药杯没有丝毫变形。这是因为多边形且中间带孔的盖板，能加大盖板之下和盖板之上区域的气体交换速度，能更快的让混药杯内的气压均衡，让混药杯内外其他平衡。
第二实施例
如图9所示，混药杯3与输液通道11分开设置，且位于输液软袋上下两侧。当然，可以理解的是，混药器与输液通道可以分离的设置在输液软袋同侧。此实施例中的混药器、输液通道及接口与实施例1中的混药器完全一样，所不同的是该实施例中混药器与输液通道11及由内盖12、易折外盖14、胶塞构成的接口分开设置。
图10是使用状态下的带混药器的输液软袋，西林瓶10装配并被推入混药杯3中，其瓶盖被穿刺针5穿刺，而西林瓶10则同时被弹性卡爪4卡住瓶盖下的瓶颈部位，不能非破坏性的退出。
应当理解的是，本发明的上述具体实施方式仅仅用于示例性说明或解释本发明的原理，而不构成对本发明的限制。因此，在不偏离本发明的精神和范围的情况下所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。此外，本发明所附权利要求旨在涵盖落入所附权利要求范围和边界、或者这种范围和边界的等同形式内的全部变化和修改例。

Claims (23)

  1. 一种单针混药器，包括基座、混药通道、混药杯和穿刺针，所述基座、混药通道和混药杯一体成型，所述混药杯由杯壁和杯底构成，其特征在于：
    所述混药通道下端穿过所述基座，上端穿过所述杯底；
    在所述混药通道的上端，设置有具备中空通道的穿刺针，所述穿刺针的下端与所述混药通道上端密封连接且所述中空通道与所述混药通道连通；
    所述混药器还包括密封膜，所述密封膜以压焊的方式焊接在所述混药杯的杯口，对所述混药杯形成密封；
    所述密封膜是湿热法终端灭菌后依然能保持基本平整的易撕膜。
  2. 如权利要求1所述的混药器，其特征在于：
    所述密封膜是透气性易撕膜。
  3. 如权利要求1所述的混药器，其特征在于：
    所述密封膜的透气率是5％到35％。
  4. 如权利要求1所述的混药器，其特征在于：
    所述密封膜上表面镀有金属膜层。
  5. 如权利要求1-4所述的混药器，其特征在于：
    还包括一盖板；
    所述盖板位于所述杯口内沿，且被所述密封膜覆盖。
  6. 如权利要求1所述的混药器，其特征在于：
    所述盖板呈多边形，且中心设有通孔，所述穿刺针的针头部分位于所述通孔内但不穿过所述孔；
    所述通孔的内径小于所述穿刺针的外径但大于所述针头的针尖，使得所述针尖能伸入所述通孔中但不能穿过所述通孔，以对所述盖板形成支撑；
    所述盖板上设置有加强筋。
  7. 如权利要求1-6任一项所述的混药器，其特征在于：
    所述混药杯在被所述密封膜密封之前，预装一定量的液体。
  8. 如权利要求7所述的混药器，其特征在于：
    所述液体是能在高温灭菌环境下迅速汽化的液体。
  9. 如权利要求8所述的混药器，其特征在于：
    预装的所述一定量液体在高温灭菌环境下汽化所形成的气体，能让所述混药杯内、外气压基本平衡。
  10. 如权利要求1-9任一项所述的混药器，其特征在于：
    所述杯壁的内壁上设置有限位突起，所述十字针安装进所述混药杯后，所述限位突起将所述针板限定在所述限位突起和所述杯底之间而不能被取出。
  11. 如权利要求10所述的混药器，其特征在于：
    所述限位突起为弹性卡爪，所述弹性卡爪上端沿所述杯壁的内壁周沿均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构；
    所述弹性卡爪的自由端到所述杯底之间的距离与西林瓶盖的厚度基本一致或略大于所述西林瓶盖的厚度，使得西林瓶装配到所述混药器上之后，所述西林瓶的瓶盖被所述弹性卡爪卡在所述自由端与所述杯底之间。
  12. 如权利要求10所述的混药器，其特征在于：
    所述限位突起为弹性卡座，所述弹性卡座包括一卡环，所述卡环下侧设置有弹性卡爪，所述弹性卡爪上端沿所述卡环均匀布置且固定，所述弹性卡爪下端为自由端，且所述弹性卡爪从固定的所述上端到自由的所述下端呈向所述混药杯中心倾斜结构；
    所述弹性卡爪的自由端到所述杯底之间的距离与西林瓶盖的厚度基本一致或略大于所述西林瓶盖的厚度，使得西林瓶装配到所述混药器上之后，所述西林瓶的瓶盖被所述弹性卡爪卡在所述自由端与所述杯底之间；
    所述杯壁的内壁上设置有限位结构，所述弹性卡座安装于所述混药杯 内而被所述限位结构限制。
  13. 如权利要求10所述的混药器，其特征在于：所述限位突起为弹性卡座，
    所述弹性卡座具有一体成型的底板、支撑柱、卡环和弹性卡爪，所述底板外周设置有支撑柱对所述卡环形成支撑固定；
    所述底板设有中心孔，所述穿刺针相配合的穿过所述中心孔。
  14. 如权利要求1-13任一所述的混药器，其特征在于：
    所述混药通道下端，设置有易折柄，并通过所述易折柄对所述混药通道的下端进行密封。
  15. 一种具有加强结构的混药器，其特征在于：包括如权利要求1-14任一所述的混药器；
    所述混药杯的所述杯壁上，设置有加强筋结构以增强所述杯壁的抗压强度。
  16. 如权利要求15所述的混药器，其特征在于：
    所述加强筋设置在所述杯壁内侧沿上下方向和/或水平方向一体布置。
  17. 一种带混药器的硬双接口，包括如权利要求1-16任一项所述的混药器，其特征在于：
    在所述混药器的所述基座上相对于所述混药通道的另一侧，设有一输液通道。
  18. 一种带硬双接口的输液软袋，其特征在于：
    所述硬双接口是如权利要求17所述的硬双接口。
  19. 一种带混药器的输液软袋，其特征在于：包括混药器和输液软袋，所述混药器是如权利要求1-16任一项所述的混药器；
    所述混药器通过所述基座与所述输液软袋接合在一起。
  20. 如权利要求19所述的输液软袋，其特征在于：
    还包括一输液接口，所述输液接口设置在与所述混药器同侧的输液软 袋上，或者设置在与所述混药器相对的另一侧的输液软袋上。
  21. 如权利要求19或20所述的输液软袋，其特征在于：
    所述输液软袋采用的是非PVC多层共挤膜。
  22. 如权利要求19或20所述的输液软袋，其特征在于：
    所述一体成型的基座及混药杯、隔膜采用的是医用聚丙烯材料，优选的是聚丙烯R530C材料。
  23. 如权利要求19或20所述的输液软袋，其特征在于：
    所述十字针、所述限位突起为聚丙烯材料，优选的是聚丙烯P17材料。
PCT/CN2016/105563 2015-11-13 2016-11-13 单针混药器、硬双接口及输液软袋 WO2017080521A1 (zh)

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