Technical Field
The present disclosure relates to a medical device package that stores medical devices, such as syringes and connectors.
Background Art
Conventionally, for conveyance or storage of syringes before being filled with a drug solution or the like, syringe storage containers capable of holding and storing a plurality of syringes in an upright state are widely used. Such syringe storage containers are provided with a box-shaped container main body having an upper surface opening, a holder that holds the plurality of syringes in an upright state, and a sealing member that seals the opening of the container main body.
A shelf-like portion that supports the holder is provided inside the container main body. The holder is formed into a plate shape having a plurality of through-holes. The syringe is inserted into the through-hole of the holder, and a flange portion provided at an end portion of the syringe is hooked on a peripheral edge of the through-hole, so that the syringe is held in the holder. When such a syringe storage container is used, a plurality of syringes can be held in an upright state such that filling openings for the drug solution face upward.
Typically, manufacturing of the syringes is performed in a place different from a place where the drug solution is filled. At the place where the syringes are manufactured, manufactured syringes are stored in the syringe storage container, the opening of the syringe storage container is sealed with the sealing member, and the medical device package is assembled. Following that, sterilization processing is applied to the syringe storage container by causing a high-temperature vapor or gas to permeate the sealing member, such as high-pressure vapor sterilization (autoclave) or ethylene oxide gas (EOG) sterilization.
The syringe storage container to which the sterilization processing has been applied is conveyed to the place where the drug solution is filled. At the place where the drug solution is filled, the sealing of the syringe storage container with the sealing member is released, and the holder in which the plurality of syringes is held is taken out from the container main body, and is set to a filling device for filling the drug solution. Following that, the drug solution is filled in the syringes.
A container that stores medical devices is described in JP 2009-183768 Av, for example. The medical container described in JP 2009-183768 A includes a tray that supports a syringe body, a vessel into which the tray is fit in, a protection sheet that covers the tray and the syringe body, and a cover sheet that seals the vessel. The cover sheet is a gas permeable material such as nonwoven polyolefin, and is glued to a flange of the vessel in a peelable manner. An adhesive to be applied on the cover sheet is applied on one surface at a side facing the flange of the vessel. The protection sheet is arranged inside the vessel, and is used to prevent bacteria, dust, and the like from entering the syringes after the cover sheet is peeled from the vessel.
However, in the medical container described in Patent Literature 1, when the sterilization processing is applied to the vessel using a high-temperature vapor or gas, the cover sheet is pressed by the vapor or the gas and is deformed to be dented into the vessel. Therefore, the surface of the cover sheet, on which the adhesive is applied, comes in contact with the protection sheet, and the protection sheet is glued by the cover sheet.
If the protection sheet is glued by the cover sheet, the protection sheet is removed together with the cover sheet when the cover sheet is peeled from the vessel. Therefore, when the cover sheet is peeled from the vessel, the syringe is exposed, and bacteria, dust, and the like may enter the syringe.
When the cover sheet is peeled from the vessel in an environment where there are no bacteria, dust, and the like, the protection sheet may not be used. However, in this case, when the sterilization processing is applied to the vessel using a high-temperature vapor or gas, the surface of the cover sheet, on which the adhesive is applied, comes in contact with the syringe. As a result, the syringe may be glued by the cover sheet, or the adhesive may be transferred to the syringe and attached as a foreign substance. This is not favorable.
USPTO Backgrounds
USPTO Backgrounds