WO2019093351A1 - Corps d'emballage de dispositif médical et son procédé de production - Google Patents

Corps d'emballage de dispositif médical et son procédé de production Download PDF

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Publication number
WO2019093351A1
WO2019093351A1 PCT/JP2018/041276 JP2018041276W WO2019093351A1 WO 2019093351 A1 WO2019093351 A1 WO 2019093351A1 JP 2018041276 W JP2018041276 W JP 2018041276W WO 2019093351 A1 WO2019093351 A1 WO 2019093351A1
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WO
WIPO (PCT)
Prior art keywords
medical device
device package
sealing member
outer edge
application area
Prior art date
Application number
PCT/JP2018/041276
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English (en)
Japanese (ja)
Inventor
沖原等
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2019093351A1 publication Critical patent/WO2019093351A1/fr

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    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/10—Container closures formed after filling
    • B65D77/20—Container closures formed after filling by applying separate lids or covers, i.e. flexible membrane or foil-like covers
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants

Definitions

  • the present invention relates to a medical device package in which a medical device is accommodated in a storage space of a container body, and a method of manufacturing the same.
  • U.S. Pat. No. 7,431,157 discloses a medical device comprising a plurality of syringes (medical devices), a container body for housing medical devices, and a sheet-like sealing member provided on the container body.
  • a package is disclosed.
  • the container body has a bottom, a side projecting upward from the outer edge of the bottom, an opening formed at an upper end of the side, a storage space surrounded by the bottom, the side and the opening, and an opening And a flange portion provided to surround the
  • the medical device is stored in the storage space of the container body.
  • the sealing member is releasably adhered to the flange by an adhesive at the outer edge of the lower surface of the sealing member so that the opening of the container body is sealed.
  • the sealing member since the outer edge of the lower surface of the sealing member is bonded to the flange portion, the sealing member has no grip margin. Therefore, it is not easy for the user to open the sealing member.
  • the adhesive When a part of the sealing member is positioned outward of the flange portion in order to provide a gripping margin on the sealing member, the adhesive is applied to the gripping margin of the sealing member. Some parts of the product may be bent and bonded to the container body. In addition, when the sealing member is opened, the adhesive on the portion of the gripping margin of the sealing member may be transferred to the user's finger or the chuck of the unsealing device, which may cause contamination of the finger or the chuck or foreign matter.
  • the present invention has been made in consideration of such problems, and the sealing member can be easily opened, and stains on the user's fingers and the chuck of the opening device due to transfer of the adhesive at the time of opening. It is an object of the present invention to provide a medical device package capable of suppressing the occurrence of foreign matter adhesion and a method of manufacturing the same.
  • the medical device package according to the present invention comprises a bottom portion, a side portion projecting upward from an outer edge portion of the bottom portion, an opening portion formed in an upper end portion of the side portion, A container body having a storage space surrounded by the bottom, the side portion and the opening, and a flange portion provided so as to surround the opening and having a substantially rectangular outer shape, and the medical device stored in the storage space What is claimed is: 1.
  • a medical device package comprising: a device; and a substantially rectangular sealing member for sealing the opening of the container body, the medical device package comprising an upper surface and a lower surface, wherein the sealing member The lower surface is provided with an application area to which an adhesive is applied and an outer edge non-application area to which the adhesive is not applied, and the application area is releasably adhered to the flange part Said outer edge non-application area is less of said lower surface of said sealing member Also provided in one corner, at least a portion of the outer edge non-application area is characterized by exposed positioned outward from the flange portion.
  • the user holds a portion (hereinafter, referred to as “exposed portion”) located outside and exposed to the outer side than the flange portion in the outer edge non-application region with respect to the container body.
  • exposed portion a portion located outside and exposed to the outer side than the flange portion in the outer edge non-application region with respect to the container body.
  • the application area of the sealing member can be peeled off from the flange portion.
  • the sealing member can be easily opened.
  • the adhesive since the adhesive is not applied to the exposed portion, it is possible to suppress the occurrence of the contamination of the user's fingers or the chuck of the unsealing apparatus and the adhesion of foreign matter due to the transfer of the adhesive at the time of opening.
  • the lower surface of the sealing member may have the outer edge non-application area provided at at least two corners adjacent to each other.
  • the sealing member in the application region can be peeled from the flange portion from the both ends toward the center from the both ends, the sealing member can be opened more easily. it can.
  • the flange portion of the container body is formed in a substantially rectangular shape having a long side and a short side, and the sealing member is long so as to correspond to the shape of the flange portion.
  • the lower surface of the sealing member is formed in a substantially rectangular shape having a side and a short side, and the lower surface of the sealing member has the outer edge non-coated area provided at two corners located at both ends of the short side. It is also good.
  • the sealing member in the application region can be easily peeled from the flange portion from the both ends toward the center, the sealing member can be opened more easily. can do.
  • the flange portion of the container body is formed in a substantially rectangular shape having a long side and a short side, and the sealing member is long so as to correspond to the shape of the flange portion.
  • the lower surface of the sealing member may be formed into a substantially rectangular shape having a side and a short side, and the lower surface of the sealing member may have the outer edge non-application area provided at two diagonally opposite corners.
  • the outer edge non-application area which becomes a grip margin at the time of opening only by positioning the medical device package with one of the long side and the short side of the sealing member as a guide To be opened easily.
  • the lower surface of the sealing member may have the outer edge non-application area provided at all four corners.
  • the sealing member can be opened from any of the four corners. Further, the sealing member can be unsealed by arbitrarily selecting two corners adjacent to each other from the four corners.
  • the lower surface of the sealing member may have the outer edge non-application region provided around the outer edge of the sealing member so as to include four corners. .
  • the outer side portion of the sealing member can be restrained from bending and adhering to the lower surface of the flange portion .
  • a chamfered corner may be formed at the corner of at least one of the flanges.
  • At least a part of the outer edge non-application region can be positioned outward from the flange portion with a simple configuration.
  • the sealing member has a substantially rectangular sheet main body to which the adhesive is applied, and the outer edge non-application area is a portion where the lower surface of the sheet main body is exposed. Good.
  • the outer edge non-application region can be easily formed.
  • the lower surface of the sealing member may have a central non-application area provided at a central portion of the lower surface located above the medical device.
  • the sealing member has a substantially rectangular sheet main body and a central sheet provided at a central portion of the sheet main body, and the central non-application area is the central sheet. It may consist of the lower surface.
  • the sealing member having the central non-application region can be easily manufactured.
  • the central sheet may be a screen sheet that absorbs or reflects an electron beam or radiation.
  • the medical device package is accommodated inside the container body by the electron beam or radiation. It can reduce the influence of medical devices.
  • the medical device package may be subjected to a sterilization process involving a heat load.
  • the medical device includes a drug solution container having a hollow body portion capable of being filled with a drug solution and a drug solution filling port provided at an end portion of the body portion.
  • the drug solution filling port may be stored in the storage space so as to point upward.
  • the drug solution can be efficiently filled from the drug solution filling port into the body.
  • a method of manufacturing a medical device package according to the present invention comprises a sealing member having a medical device, a container body, an application region on the lower surface of which an adhesive is applied, and an outer edge non-application region on which the adhesive is not applied. , Preparing the medical device in the storage space of the container body, and after the storage step, the coating area is releasable around the flange portion of the container body. And a sealing step of sealing the opening of the container body by bonding, wherein the outer edge non-application region is at least one of the lower surface of the sealing member. It is provided at a corner, and in the sealing step, the application area is adhered to the flange so that at least a part of the outer edge non-application area is exposed outward from the flange. It is characterized by
  • a sterilization step may be performed in which the medical device package is sterilized with a heat load.
  • the medical device includes a drug solution container having a hollow body portion which can be filled with a drug solution and a drug solution filling port provided at an end portion of the body portion. It may be stored in the storage space with the mouth directed upward.
  • the sealing member can be easily opened, and transfer of the adhesive at the time of opening is performed. It is possible to suppress the occurrence of the contamination of the user's fingers and the chuck of the unsealing device and the adhesion of foreign matter due to the above.
  • FIG. 6A is a first explanatory view showing a state in which the sealing member is unsealed
  • FIG. 6B is a second explanatory view showing a state in which the sealing member is unsealed.
  • FIG. 7A is a first explanatory view showing another example of the opening method of the sealing member, and FIG.
  • FIG. 7B is a second explanatory view showing another example of the opening method of the sealing member.
  • 8A is a plan view of the sealing member according to the first modification viewed from the lower surface side
  • FIG. 8B is a plan view of the sealing member according to the second modification viewed from the lower surface side
  • FIG. 8D is a plan view of a sealing member according to a third modification viewed from the lower surface side
  • FIG. 8D is a plan view of the sealing member according to the fourth variation viewed from the lower surface. It is the top view which looked at the sealing member concerning the 5th modification from the undersurface side.
  • the medical device package 10 includes a medical device 12 and a package body 14 for packing the medical device 12, and is subjected to a sterilization process involving a thermal load.
  • the medical device 12 includes a plurality of syringes 16.
  • the syringe 16 is a drug solution container, and has a syringe outer cylinder 18 capable of being filled with a drug solution, and a cap 20 attached to the tip of the syringe outer cylinder 18.
  • the syringe outer cylinder 18 has a cylindrical barrel 22 extending in the axial direction, a nozzle 24 projecting in the distal direction from the distal end of the barrel 22, and a base end provided at the base end of the barrel 22. And a flange portion 26.
  • the body portion 22, the nozzle portion 24 and the proximal end flange portion 26 are integrally formed.
  • a drug solution filling port 28 for filling the drug solution into the lumen 18a (see FIG. 3) of the syringe outer cylinder 18 is provided.
  • the constituent material of the syringe barrel 18 is not particularly limited, and examples thereof include polypropylene, polyurethane, polyethylene, cyclic olefin polymer, cyclic olefin copolymer, polyolefin such as polymethylpentene 1, polyester, nylon, polycarbonate, polymethylmethacrylate (PMMA) ), Resinous materials such as polyetherimide (PEI), polyethersulfone, polyetheretherketone (PEEK), fluorocarbon resin, polyphenylene sulfide (PPS), polyacetal resin (POM), etc., metallic materials such as stainless steel, It may be formed of glass or the like.
  • PEI polyetherimide
  • PEEK polyethersulfone
  • PES polyetheretherketone
  • PPS polyphenylene sulfide
  • POM polyacetal resin
  • metallic materials such as stainless steel, It may be formed of glass or the like.
  • the packaging body 14 is used when transporting and storing the medical device 12, and includes a container body 30, a support member 32, an inner sheet 34, and a sheet-like sealing member 36.
  • the container body 30 has a bottom portion 38, a side portion 40 projecting from the outer edge of the bottom portion 38, and a flange portion 42 projecting on the outer surface side of the side portion 40 from an upper end portion of the side portion 40 opposite to the bottom portion 38.
  • the bottom 38, the side 40 and the flange 42 are integrally formed.
  • the bottom portion 38 and the side portion 40 constitute a storage space S for storing the medical device 12.
  • the bottom portion 38 is a plate-like portion formed in a substantially rectangular shape in plan view.
  • the side portion 40 is formed in a square ring shape. That is, the upper end portion of the side portion 40 constitutes a substantially rectangular opening 44.
  • the side portion 40 has a first side wall 46 projecting from the outer edge of the bottom 38, an overhang 48 projecting from the projecting end of the first side wall 46 to the outer surface of the first sidewall 46, and an overhang And a second side wall portion 50 that protrudes from the protruding end portion (outer edge portion) 48 of the base plate 48 to the opposite side (upward) from the bottom portion 38.
  • the height dimension of the first side wall 46 is larger than the height dimension of the second side wall 50.
  • the overhanging portion 48 has a flat upper surface 48a (see FIG. 3).
  • the flange portion 42 extends in a substantially square ring shape.
  • the flange portion 42 is formed in a substantially rectangular shape having a long side and a short side.
  • the flange portion 42 has a flange main body 52 protruding from the upper end of the second side wall portion 50 to the outer surface side of the second side wall portion 50 and a protruding portion 54 provided on the upper surface of the flange main body 52.
  • the flange main body 52 is provided around the opening 44 at the upper end of the second side wall 50.
  • the outer shape of the flange main body 52 is formed in a substantially rectangular shape.
  • the flange body 52 has four corners (corners). At each corner of the flange body 52, an R-shaped chamfered corner 56 is provided.
  • the upper surface of the flange main body 52 is formed flat throughout.
  • the protruding portion 54 extends in a square ring shape and is provided around the opening 44 in the flange main body 52.
  • the protruding portion 54 extends over the entire circumference of the flange main body 52.
  • the sealing member 36 is adhered to the protrusion 54.
  • the width dimension of the protruding portion 54 is smaller than the width dimension of the flange main body 52.
  • the outer edge portion of the protruding portion 54 is located inside the outer edge portion of the flange main body 52.
  • the inner edge of the protrusion 54 is located outside the outer edge of the upper end of the second side wall 50.
  • the protrusion 54 has four corners. At each corner of the projecting portion 54, a projection 58 is provided which protrudes toward the outermost portion of the chamfered corner 56 of the flange main body 52. As shown in FIG. The protrusions 58 are formed in a narrow triangular shape in the projecting direction. In this case, when the sealing member 36 is peeled from the container main body 30, stress can be concentrated on the portion of the sealing member 36 adhered to the projection 58.
  • the support member 32 is for supporting the syringe 16 with respect to the container main body 30 in a state where the drug solution filling port 28 is directed upward.
  • the support member 32 has a rectangular base plate 60 and a plurality of cylindrical portions 62 provided on the base plate 60.
  • the outer peripheral portion of the lower surface of the base plate 60 is placed on the upper surface 48 a of the overhang portion 48 of the container body 30.
  • two notches 64 for inserting the user's fingers when the support member 32 is removed from the container body 30 are formed. These notches 64 may be provided on each long side of the base plate 60.
  • each cylindrical portion 62 extends through the base plate 60.
  • the barrel 22 of the syringe 16 is inserted into the lumen 62 a of the barrel 62. Therefore, the inner diameter (pore diameter) of the cylindrical portion 62 is larger than the outer diameter of the syringe outer cylinder 18.
  • the plurality of cylindrical portions 62 are arranged on the upper surface of the base plate 60 in a staggered manner. The upper end of the cylindrical portion 62 contacts the proximal flange portion 26 of the syringe 16.
  • the container body 30 and the support member 32 are preferably not denatured by sterilization using high temperature steam or gas such as high pressure steam sterilization (autoclave) or EOG (ethylene oxide gas) sterilization.
  • high temperature steam or gas such as high pressure steam sterilization (autoclave) or EOG (ethylene oxide gas) sterilization.
  • a resin excellent in durability such as polypropylene, polystyrene, polyethylene, polycarbonate, ABS resin, and PET, is used.
  • the container main body 30 and the supporting member 32 be substantially transparent or translucent. In this case, among the above-mentioned resins, polypropylene, polycarbonate, polystyrene and PET are used.
  • the inner sheet 34 is formed in a rectangular shape, and the proximal end of each syringe 16 held by the support member 32 so as to cover the drug solution filling port 28 of each syringe 16 from above. It is placed on the flange portion 26.
  • the sealing member 36 is formed in a substantially rectangular shape having a short side and a long side so as to correspond to the shape of the flange portion 42.
  • the sealing member 36 is for sealing the opening 44 of the container main body 30 and has a sheet main body 63.
  • the outer shape of the sheet main body 63 is larger than the outer shape of the flange portion 42.
  • the sheet body 63 is preferably permeable to a gas for sterilization and impermeable to particles such as bacteria and viruses.
  • Tyvek registered trademark
  • DuPont As a constituent material of the sheet main body 63, for example, Tyvek (registered trademark) which is a high density polyethylene non-woven fabric of DuPont is used.
  • the lower surface 37 of the sealing member 36 (the lower surface of the sheet main body 63) is provided with an application region 66 to which the adhesive 65 is applied and a non-application region 68 to which the adhesive 65 is not applied.
  • the adhesive 65 is a thermoplastic hot melt adhesive.
  • the application area 66 is formed in a rectangular shape at the central portion of the lower surface 37. The application area 66 is releasably adhered (fused) to the ridge portion 54 of the flange portion 42 through the adhesive 65.
  • the non-application region 68 is a portion where the lower surface of the sheet main body 63 is exposed.
  • the non-application area 68 has an outer non-application area 70 provided along the outer edge of the sealing member 36 so as to include four corners. A portion of each of the outer edge non-application region 70 that constitutes each corner of the lower surface 37 is exposed outside the corner (chamfered corner 56) of the flange main body 52.
  • the exposed portion (exposed portion 72) has a size that can be manually grasped (picked).
  • the medical device package 10 according to the present embodiment is basically configured as described above, and next, a method of manufacturing the same will be described.
  • the medical device 12 When manufacturing the medical device package 10, as shown in FIG. 5, the medical device 12, the container main body 30, the support member 32, the inner sheet 34, and the sealing member 36 are prepared in the preparation process of step S1. At this time, an application region 66 and a non-application region 68 are formed on the lower surface 37 of the sealing member 36 by applying the adhesive 65 to a predetermined portion.
  • the plurality of syringes 16 as the medical device 12 are stored in the storage space S of the container main body 30. Specifically, the base plate 60 of the support member 32 is placed on the upper surface 48 a of the overhang portion 48. Then, the body portion 22 of the syringe 16 is inserted from above into the lumen 62 a of the cylindrical portion 62 of the support member 32. Then, the proximal end flange portion 26 of the syringe 16 contacts the upper end surface of the cylindrical portion 62.
  • the plurality of syringes 16 are supported on the container body 30 via the support member 32. That is, the plurality of syringes 16 are stored in the storage space S of the container body 30. At this time, the drug solution filling port 28 of each syringe 16 points upward. Also, the tip (cap 20) of the syringe 16 is spaced apart from the bottom 38. Thereafter, the inner sheet 34 is placed on the proximal end surface of the syringe 16 so as to cover the drug solution filling port 28.
  • the application region 66 of the sealing member 36 is projected so that each corner of the sealing member 36 is exposed outside of the corner of the flange main body 52. It peelably adheres to the part 54.
  • the application area 66 of the sealing member 36 is placed on the ridge 54 of the flange 42.
  • a receiving jig (not shown) is brought into contact with the lower surface of the flange portion 42, and the application region 66 is pressed against the projecting portion 54 by a heated mold (not shown).
  • a heated mold not shown
  • the medical device package 10 is subjected to a sterilization process involving a heat load. Specifically, the medical device package 10 is packaged in a sterilization packaging bag having an opening, and the opening of the packaging bag is sealed. Next, the medical device package 10 is subjected to sterilization treatment using high-temperature steam or gas such as high-pressure steam sterilization (autoclave) or EOG (ethylene oxide gas) sterilization.
  • high-temperature steam or gas such as high-pressure steam sterilization (autoclave) or EOG (ethylene oxide gas) sterilization.
  • a part of the packaging bag for sterilization is made of a material which is permeable to a gas for sterilization and is not permeable to microparticles such as bacteria and viruses. Therefore, high-temperature steam or gas, which is a gas for sterilization, can permeate into the packaging bag and into the medical device package 10. As a result, the container main body 30, the support member 32, and the syringe 16 which is the medical device 12 can be sterilized. After completion of the sterilization process, the medical device package 10 is manufactured.
  • the user When opening the sealing member 36 of the medical device package 10, as shown in FIG. 6A, the user holds, for example, one of the four exposed portions 72 of the sealing member 36, and the exposed portion 72 thereof. Is pulled up along the diagonal of the sealing member 36 with respect to the container body 30. Then, the force input to the exposed portion 72 is concentrated on the portion of the application area 66 to be adhered to the protrusion 58 of the ridge 54, so the corner of the application area 66 is peeled off from the ridge 54.
  • the user further pulls up the gripping exposed portion 72 along the diagonal.
  • the peeled area of the application area 66 of the sealing member 36 with respect to the ridge portion 54 is expanded.
  • the entire application region 66 of the sealing member 36 is peeled off from the ridge portion 54, whereby the sealing member 36 is unsealed.
  • the user may unseal the sealing member 36 as shown in FIGS. 7A and 7B. That is, as shown in FIG. 7A, the user holds, for example, one of the four exposed portions 72 of the sealing member 36, and applies a diagonal of the sealing member 36 to the container body 30 with respect to the exposed portion 72.
  • the corners of the application area 66 are peeled off from the ridges 54 by pulling up along the direction.
  • the user holds the exposed portion 72 with respect to the container main body 30, for example, with the exposed portion 72 positioned in the direction of the short side with respect to the corner of the sealing member 36 peeled from the container main body 30. Pull up along the diagonal of the sealing member 36. Then, as shown in FIG. 7B, the portion of the application region 66 along the short side of the sealing member 36 is peeled off from the ridge 54. Thereafter, the user pulls up the sealing member 36 along the longitudinal direction, so that the entire application region 66 of the sealing member 36 is peeled off from the projection 54, and the sealing member 36 is unsealed.
  • the medical device package 10 according to the present embodiment has the following effects.
  • the lower surface 37 of the sealing member 36 is provided with an application area 66 to which the adhesive 65 is applied and a non-application area 68 to which the adhesive 65 is not applied.
  • the application area 66 is releasably adhered to the flange 42 (protrusion 54) of the container body 30 in a peelable manner.
  • the non-application area 68 has an outer edge non-application area 70 provided to include the four corners of the lower surface 37, and at least a portion of the outer edge non-application area 70 is more outward than the corners of the flange portion 42. It is exposed and located.
  • the user can peel off the application area 66 of the sealing member 36 from the flange portion 42 by holding the exposed portion 72 of the sealing member 36 and pulling up the container body 30. Therefore, the sealing member 36 can be easily opened. Further, since the adhesive 65 is not applied to the exposed portion 72, adhesion of the exposed portion 72 to the outer surface of the container main body 30 can be prevented. Furthermore, when the sealing member 36 is opened, transfer of the adhesive to the user's finger or the chuck of the opening device can be suppressed.
  • the outer edge non-application area 70 is provided at two corners adjacent to each other. Thereby, the portion along the side of the sealing member 36 in the application region 66 can be easily peeled from the flange portion 42 from the both ends toward the center from the both ends, so the sealing member 36 can be opened more easily. Can.
  • the flange portion 42 is formed in a substantially rectangular shape having a long side and a short side
  • the sealing member 36 is formed in a substantially rectangular shape having a long side and a short side so as to correspond to the shape of the flange portion 42
  • the outer edge non-application areas 70 are provided at two corners located at both ends of the short side of the sealing member 36.
  • the outer edge non-application area 70 is provided at all four corners. This allows the sealing member 36 to be opened from any of the four corners. In addition, two corners adjacent to each other can be arbitrarily selected from the four corners to unseal the sealing member 36.
  • the outer edge non-application area 70 is provided along the outer edge of the sealing member 36 so as to include four corners. Thus, even when the outer side of the sealing member 36 protrudes outward beyond the flange 42, the outer side of the sealing member 36 can be restrained from bending and adhering to the lower surface of the flange 42. .
  • a chamfered corner portion 56 whose corner is chamfered is formed.
  • at least a part of the outer edge non-application area 70 can be positioned outward of the corner of the flange portion 42 with a simple configuration.
  • the outer edge non-application area 70 is a portion where the lower surface of the sheet main body 63 is exposed, so that the outer edge non-application area 70 can be easily formed.
  • the medical device package 10 Since the medical device package 10 is subjected to sterilization processing involving heat load, the medical device package 10 subjected to sterilization processing can be obtained.
  • the medical device 12 includes a plurality of syringes 16 (chemical solution containers) each having a hollow body 22 which can be filled with a drug solution and a drug solution filling port 28 provided at the base end of the body 22.
  • syringes 16 chemical solution containers
  • Each syringe 16 is stored in the storage space S such that the drug solution filling port 28 points upward.
  • the sealing member 36 is unsealed, the drug solution can be efficiently filled into the body 22 from the drug solution filling port 28.
  • the medical device package 10 according to the present invention is not limited to the above-described configuration.
  • the medical device package 10 may include sealing members 36a to 36e shown in FIGS. 8A to 9 instead of the sealing member 36.
  • the lower surface 37 of the sealing member 36a is provided with an application area 66a to which the adhesive 65 is applied and a non-application area 68a to which the adhesive 65 is not applied.
  • the application area 66a is provided in all parts except the four corners of the lower surface 37 of the sealing member 36a.
  • the non-application area 68a has an outer non-application area 70a provided at each of the four corners of the lower surface 37 of the sealing member 36a.
  • the outer edge non-application region 70a is a portion where the lower surface of the sheet main body 63 is exposed.
  • Each outer edge non-application area 70 a is formed in a triangular shape, and is located outward from the flange portion 42.
  • Such a sealing member 36a exhibits the same effect as the sealing member 36 described above.
  • the lower surface 37 of the sealing member 36b is provided with an application region 66b to which the adhesive 65 is applied and a non-application region 68b to which the adhesive 65 is not applied.
  • the application area 66b is provided in all parts except for one corner of the lower surface 37 of the sealing member 36b.
  • the non-application area 68b has an outer edge non-application area 70a provided only at one corner of the lower surface 37 of the sealing member 36b.
  • the lower surface 37 of the sealing member 36c is provided with an application area 66c to which the adhesive 65 is applied and a non-application area 68c to which the adhesive 65 is not applied.
  • the application area 66c is provided in all parts of the lower surface 37 of the sealing member 36c except two adjacent corners.
  • the non-application area 68c has an outer edge non-application area 70a provided only at two corners located on both sides of one short side of the lower surface 37 of the sealing member 36c.
  • the outer edge non-application region 70a may be provided only at each of the corners located at both ends of one long side of the lower surface 37. That is, the outer edge non-application area 70 a may be provided only at each of the two corners of the lower surface 37.
  • Such a sealing member 36c exhibits the same effect as the sealing member 36 described above.
  • the lower surface 37 of the sealing member 36d is provided with an application region 66d to which the adhesive 65 is applied and a non-application region 68d to which the adhesive 65 is not applied.
  • the application area 66d is provided in all parts except for two corners located diagonally of the lower surface 37 of the sealing member 36d.
  • the non-application area 68d has an outer edge non-application area 70a provided only at two corners located diagonally of the lower surface 37 of the sealing member 36d. According to such a sealing member 36d, the outer edge non-application area 70a which becomes a grip margin at the time of opening is disposed at the same position every time only by guiding either the long side or the short side of the sealing member 36d. Because it is easy to open.
  • the lower surface 37 of the sealing member 36e is provided with an application area 66e to which the adhesive 65 is applied and a non-application area 68e to which the adhesive 65 is not applied.
  • the application area 66e is formed in a square ring shape at the central portion of the lower surface 37 of the sealing member 36e.
  • the non-application area 68e is provided in an outer edge non-application area 70 provided along the outer edge of the sealing member 36e so as to include the four corners of the lower surface 37 of the sealing member 36e.
  • a central non-application area 74 is constituted by a central sheet 76 adhered to the central portion of the lower surface of the sheet main body 63 by an adhesive or the like.
  • the central non-application area 74 is located above the medical device 12 (plural syringes 16).
  • the central sheet 76 is a screen sheet that absorbs or reflects electron beams or radiation.
  • the sealing member 36e may be pressed by the high temperature steam or gas and deformed so as to be recessed inside the container main body 30.
  • the sealing member 36e since the central non-application region 74 is provided at the central portion of the lower surface 37, the sealing member 36e adheres to the inner sheet 34 (a member provided in the storage space S of the container main body 30). Can be suppressed. Therefore, at the time of opening the medical device package 10, removal of the inner sheet 34 together with the sealing member 36e can be suppressed, and the state where the chemical solution filling ports 28 of the plurality of syringes 16 are covered by the inner sheet 34 can be maintained. it can.
  • the sealing member 36e having the central non-application area 74 can be easily manufactured. Furthermore, since the central sheet 76 is a screen sheet that absorbs or reflects an electron beam or radiation, even when the medical device package 10 is irradiated with the electron beam or radiation to sterilize or decontaminate the container body 30. The influence of the electron beam or the radiation on the medical device 12 housed inside the container body 30 can be suppressed.
  • the central non-application area 74 may be formed by exposing the central portion of the lower surface of the sheet main body 63.
  • the flange portion 42 of the container main body 30 may not be provided with the protruding portion 54.
  • the application areas 66, 66a to 66e of the sealing members 36, 36a to 36e are adhered to the upper surface of the flange main body 52.
  • the medical device package and the method of manufacturing the same according to the present invention are, of course, not limited to the above-described embodiments, and various configurations can be adopted without departing from the scope of the present invention.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Food Science & Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)

Abstract

La présente invention se rapporte à un corps d'emballage de dispositif médical (10) et son procédé de production. Le corps d'emballage de dispositif médical (10) comprend : un dispositif médical (12) qui est stocké dans un espace de stockage (S) d'un corps de récipient (30); et un élément d'étanchéité (36) qui scelle une partie d'ouverture (44) du corps de récipient (30). Une région revêtue (66) de la surface inférieure (37) de l'élément d'étanchéité (36) est fixée de façon détachable à une partie de bride (42) par l'intermédiaire d'un adhésif (65). Une région non revêtue de bord externe (70) de l'élément d'étanchéité (36) est disposée au niveau d'au moins un coin de la surface inférieure (37). Au moins une partie de la région non revêtue de bord externe (70) est positionnée à l'extérieur de la partie de bride (42), et est exposée à partir de celle-ci.
PCT/JP2018/041276 2017-11-10 2018-11-07 Corps d'emballage de dispositif médical et son procédé de production WO2019093351A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017217433 2017-11-10
JP2017-217433 2017-11-10

Publications (1)

Publication Number Publication Date
WO2019093351A1 true WO2019093351A1 (fr) 2019-05-16

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Application Number Title Priority Date Filing Date
PCT/JP2018/041276 WO2019093351A1 (fr) 2017-11-10 2018-11-07 Corps d'emballage de dispositif médical et son procédé de production

Country Status (1)

Country Link
WO (1) WO2019093351A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010515634A (ja) * 2007-01-09 2010-05-13 ベクトン・ディキンソン・アンド・カンパニー 放射線により汚染除去される製品用のパッケージ
WO2013125443A1 (fr) * 2012-02-20 2013-08-29 テルモ株式会社 Corps de conditionnement pour dispositif médical
WO2016039111A1 (fr) * 2014-09-11 2016-03-17 テルモ株式会社 Ensemble seringue, emballage pour ensemble seringue, bouchon d'étanchéité de cylindre extérieur et seringue préremplie

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010515634A (ja) * 2007-01-09 2010-05-13 ベクトン・ディキンソン・アンド・カンパニー 放射線により汚染除去される製品用のパッケージ
WO2013125443A1 (fr) * 2012-02-20 2013-08-29 テルモ株式会社 Corps de conditionnement pour dispositif médical
WO2016039111A1 (fr) * 2014-09-11 2016-03-17 テルモ株式会社 Ensemble seringue, emballage pour ensemble seringue, bouchon d'étanchéité de cylindre extérieur et seringue préremplie

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