Patent Application
20220323681
The present invention relates to a grip for a syringe barrel to be attached to a syringe barrel, a barrel assembly including such a grip for a syringe barrel, and a syringe.
Some drug-filled syringes (prefilled syringes) use a plunger that is not coupled to a gasket to prevent medical malpractice. In such a prefilled syringe, a clip (backstop) for preventing the plunger from moving to a proximal end side and falling off from the barrel is attached (JP 2015-517860 A (US2015/105,734 A1)).
In addition, in order to facilitate gripping and operation of the syringe, it is also known to attach a clip (grip), having a finger hook portion protruding outward, to the proximal end portion of the barrel (WO2017/073658 (US2018/243,509 A1)).
These clips are fitted to an outer peripheral surface of the barrel at a fitting portion having a tubular shape and firmly attached to the syringe so as not to rattle or come off during operation of the syringe.
Patent Document 1: JP2015-517860 A (US2015-105734A1)
Patent Document 2: WO2017-073658 A (US2018-243509A1)
In recent years, in prefilled syringes for an ophthalmic application or the like, higher sterility of not only a drug to be administered and a part in a prefilled syringe in contact with the drug, but also whole of the prefilled syringe including a grip is required.
Therefore, the inventors have studied application of a surface sterilization method with a small heat load, such as the hydrogen peroxide sterilization, the ethylene oxide gas (EOG) sterilization, and the NO2 sterilization, to a prefilled syringe to which a grip is attached. These surface sterilization methods are sterilization with gas (sterilization gas), and in order to achieve higher sterility, it is preferable that the sterilization gas is brought into contact with a wider area of the surface of the prefilled syringe.
Therefore, the present invention provides a grip for a syringe barrel capable of achieving higher sterility in the state of being attached to a syringe barrel, a barrel assembly and a syringe including such a grip for a syringe barrel.
The above object is achieved by the following.
A grip for a syringe barrel to be attached to a syringe barrel that includes a tubular body, and a flange provided on the tubular body and projecting outward, the grip includes a flange receiving portion configured to receive the flange, and a side wall portion extending in a distal end direction from the flange receiving portion and configured to partially cover a proximal end portion of the tubular body adjacent to the flange, wherein the side wall portion includes a fitting portion configured to be fitted to the proximal end portion of the tubular body, and an airflow portion configured to allow sterilization gas to flow to an outer surface of the tubular body covered by the side wall portion.
In addition, the above object is achieved also by the following.
A barrel assembly including: a syringe barrel including a tubular body and a flange provided at a proximal end of the tubular body and projecting outward; and the above grip for a syringe barrel attached to the barrel.
In addition, the above object is achieved also by the following.
A syringe including: the barrel assembly; a gasket slidably received in the barrel; and a plunger configured to move the gasket.
A barrel assembly including a grip for a syringe barrel and a syringe according to the present invention will be described with reference to examples illustrated in the drawings.
In the present example, the description will be given assuming that the right side in
A syringe 1 of the present invention includes a barrel assembly 2 including the syringe barrel 20 (hereinafter also simply referred to as barrel 20) and the grip 30 for a syringe barrel (hereinafter also simply referred to as grip 30) attached to the barrel 20, a gasket 11 slidably received in the barrel 20, and a plunger 12 configured to move the gasket 11.
The barrel 20 includes the tubular body 21 and the flange 22 provided on the tubular body 21 and projecting outward (in a direction orthogonal to the axial direction of the barrel 20). A distal end opening portion (nozzle portion) 23 configured to discharge drug is provided at the distal end portion of the barrel 20. In addition, the barrel 20 includes a collar 24 that covers a proximal end side portion of the nozzle portion 23.
A barrel-side screwing portion (female screwing portion) is formed on an inner surface of the collar 24.
The nozzle portion 23 is sealed by a seal cap 13, so that a drug 50 stored in the barrel 20 is prevented from leaking out and the drug 50 aseptically filled is prevented from coming into contact with the outside air.
Examples of constituent materials of the barrel 20 include various resins, e.g., polyolefin such as polyethylene and polypropylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, cyclic polyolefin polymer, and cyclic olefin copolymer. Among the materials, resins such as polypropylene, cyclic polyolefin polymer, and cyclic olefin copolymer are preferable because these resins are easy to mold and have heat resistance. A cyclic olefin polymer or a cyclic olefin copolymer that has high transparency allowing the chemical solution filled inside to be visually confirmed from the outside and has heat resistance capable of withstanding high-pressure steam sterilization is particularly preferable as a material for forming the barrel 20.
The seal cap 13 includes a body part 51 having a rear end side hollow portion receiving the nozzle portion 23 of the barrel 20, and a seal member 52 received in the body part 51 and disposed at an upper end portion of the rear end side hollow portion. In addition, on an outer surface of the rear end side hollow portion, a cap side screw portion (male screw portion) capable of being screwed with a barrel side screw portion (female screw portion) formed on an inner surface of the collar 24 is formed.
Examples of molding materials of the seal cap 13 include various resins, e.g., polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, and cyclic polyolefin. Among the materials, resins such as polypropylene and cyclic polyolefin are preferable because these resins are easy to mold and have heat resistance.
As molding materials of the seal member 52, elastic materials, e.g., natural rubber, isoprene rubber, butyl rubber, butadiene rubber, fluororubber, synthetic rubber such as silicone rubber, and thermoplastic elastomer such as olefinic elastomer and styrene elastomer are preferable.
The gasket 11 received in the barrel 20 is made of elastic rubber or synthetic resin. The gasket 11 includes a body having a substantially cylindrical shape extending with substantially the same outer diameter as that of the gasket 11 and a plurality of annular ribs provided on an outer surface of the body. An outer surface of the annular rib is able to be in liquid-tight contact with an inner surface of the barrel 20 and is slidable in a liquid-tight state.
As molding materials of the gasket 11, elastic rubber (e.g., butyl rubber, latex rubber, silicone rubber, and the like), and synthetic resin (e.g., styrene elastomer such as styrene-butadiene-styrene (SBS) elastomer and styrene-ethylene-butylene-styrene (SEBS) elastomer, olefin elastomer such as ethylene-α-olefin copolymer elastomer, and the like) are preferably used.
The plunger 12 is made of hard or semi-hard resin. In this example, the plunger 12 includes a gasket pressing portion 14 provided at a distal end and having a small disk shape, a pressing operation portion 15 provided at a proximal end and having a disk shape, and a shaft portion 16 having a cross shaped section and extending in the axial direction of the barrel 20 between the gasket pressing portion 14 and the pressing operation portion 15. The shaft portion 16 may be a columnar shaft. The columnar shaft may be a rod, a circular column, a polygonal column, a cylindrical tube, a square tube, and the like.
The plunger 12 is not connected to the gasket 11, is capable of contacting a proximal end portion of the gasket 11 at the gasket pressing portion 14, and can move the gasket 11 to the distal end side by the pressing after the abutment.
A distal end side portion (the gasket pressing portion 14 and a part in the distal end side of the shaft portion 16) of the plunger 12 is received in the barrel 20 (tubular body 21). The plunger 12 includes a stopper portion 17 that is provided at a part (shaft portion 16) to be received in the barrel 20, configured to abut on the grip 30 (stopper abutment portion 31) described in detail later, and configured to restrict the plunger 12 from being slipped from the barrel 20. More specifically, the stopper portion 17 has a disk shape having the outer shape (outer diameter) smaller than the inner shape (inner diameter) of the barrel 20 (tubular body 21) and larger than the outer shape (outer diameter) of the shaft portion 16 of the plunger 12.
Examples of constituent materials of the plunger 12 including a hard or semi-hard resin such as high-density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate may be preferably used.
In the syringe 1, a drug (medicinal solution) 50 is stored (filled) in the barrel 20 (or, in a space formed between the seal cap 13 and the gasket 11).
Although the drug 50 to be stored is not particularly limited, examples of the drug 50 include vitamins mainly as nutrients, sugars, electrolytes, organic acids, minerals, fat emulsions, amino acids, proteins, organ preparations, and the like. Furthermore, the examples of the drug 50 include general anesthetics mainly as therapeutic agents, drugs for central nervous system such as antipyretic analgesic antiphlogistic agents and general cold preparations, drugs for peripheral nervous system such as local anesthetics and muscle relaxants, drugs for sensory organ such as ophthalmologic agents, metabolic drugs such as circulatory drugs, respiratory drugs, digestive drugs, urogenital anal drugs, hormonal agents, antibiotics, and diabetes drugs, antitumor drugs, allergic drugs, biological preparations such as antibacterial agents and antiviral agents, and prescription drugs such as distilled water and physiological saline. In addition, the examples of the drug 50 include vaccines mainly as preventive agents, contrast agents mainly as diagnostic agents, and the like.
In these examples, many kinds of drugs are mainly composed of synthetic compounds of low molecular weight, synthetic compounds of middle molecular weight, biopharmaceuticals such as polypeptide preparations and protein preparations, and biologically derived pharmaceuticals such as blood preparations, but these substances can be used as drugs regardless of the use described above. In addition, substances that correspond to a molecular targeted drug such as an antibody can also be used as a drug. From the viewpoint of usability, the preferable dosage form of these drugs is a liquid preparation even in a drug having a dosage form of a solid preparation such as a powder preparation or a granule in addition to a liquid preparation.
In addition, as the drug 50, ophthalmic agents capable of being administered by puncture can be used. Specific target diseases for which such ophthalmic agents are used include choroidal neovascularization, age-related macular degeneration (both wet and dry), macular edema secondary to retinal vein occlusion (RVO) (including both branch retinal vein occlusion (bRVO) and central retinal vein occlusion (cRVO)), choroidal neovascularization secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, and proliferative retinopathy. Examples of the drug to be used for these target diseases include anti-VEGF antibodies used for the treatment of age-related macular degeneration, e.g., ranibizumab [trade name: LUCENTIS (registered trademark)], bevacizumab [trade name: AVASTIN (registered trademark)], and aflibercept [trade name: EYLEA (registered trademark)], and Conbercept known as VEGF-TrapEye (aflibercept intravitreal injection drug).
The structure of the grip 30 for a syringe barrel of the present invention will be described with reference to an example illustrated in
The grip 30 for a syringe barrel of this example includes a flange receiving portion 33 configured to receive the flange 22, and the side wall portion 32 extending in a distal end direction from the flange receiving portion 33 and configured to partially cover a proximal end portion of the tubular body 21 adjacent to the flange 22. The side wall portion 32 includes a fitting portion 34 configured to be fitted to the proximal end portion of the tubular body 21, and an airflow (ventilation) portion (openings 35) configured to allow a sterilization gas to flow to an outer surface of the tubular body 21 covered by the side wall portion 32.
In the example, the side wall portion 32 is cylindrical and has an insertion opening for insertion the proximal end portion of the tubular body 21 on a side thereof. In other words, the side wall portion 32 is a tubular portion (short substantially semi-cylindrical portion) having an insertion opening for the proximal end portion of the tubular body 21.
Specifically, the flange receiving portion 33 of the grip 30 constitutes a proximal end side portion of the grip 30. On the flange receiving portion 33, a pair of finger hook portions 36 and 36 is formed projecting outward (in the direction orthogonal to the axial direction of the barrel 20). The finger hook portions 36 and 36, being a couple, project in opposite directions from each other along the direction orthogonal to the axial direction of the barrel 20. The pair of finger hook portions 36 and 36 extends outward further than the flange 22 of the barrel 20. An operator can use the pair of finger hook portions 36 and 36 to hook fingers when operating the syringe 1.
The flange receiving portion 33 includes an upper plate portion 37 and a lower plate portion 38 that sandwich the flange 22. As illustrated in
As illustrated in
As illustrated in
The grip 30 includes the side wall portion 32 extending in the distal direction, specifically, toward the axial distal end side from the flange receiving portion 33. The side wall portion 32 is integrated (connected) with the inner edge portion of the slit 40 in the lower plate portion 38 of the flange receiving portion 33 at the proximal end. The side wall portion 32 is formed with an attachment opening (attachment slit) 41 (insertion opening for the proximal end portion of the tubular body 21) extending over the entire length in the axial direction, and the proximal end portion of the barrel 20 (tubular body 21) is partially covered in a part other than the opening 41. The side wall portion 32 excluding the opening 41 extends in the circumferential direction. In other words, the side wall portion 32 is obtained by cutting out a part of the cylindrical member in the circumferential direction as the attachment slit 41, and is formed such that a cross section by a plane orthogonal to the axial direction has a C shape. In the example, the side wall portion 32 is a tubular portion (short substantially semi-cylindrical portion) having an insertion opening for the proximal end portion of the tubular body 21.
The attachment slit 41 in a natural state where the side wall portion 32 is not elastically deformed has an opening width smaller than the outer diameter of the tubular body 21 of the barrel 20. In the process of attaching the grip 30 to the barrel 20, the attachment slit 41 is elastically deformed by the barrel 20 to be widened. When the grip 30 has been attached to the barrel 20, the width of the attachment slit 41 returns to the original opening width by the elastic restoring force. As a result, the grip 30 is firmly attached to the barrel 20.
In the side wall portion 32, a part to be in direct contact with the outer surface of the tubular body 21 of the barrel 20 forms the fitting portion 34. In other words, the fitting portion 34 refers to an inner surface of the side wall portion 32 to be in direct contact with the outer surface of the tubular body 21 and a part of the side wall portion 32 corresponding to such an inner surface. In the present example, a part in the side wall portion 32 where the openings 35 (described in detail later) are not formed and an inner surface of the part form the fitting portion 34.
The plurality of openings 35 are formed in the side wall portion 32. These openings 35 constitute an airflow portion. In the grip 30, the airflow portion is formed by the openings 35 formed on the side wall portion 32. In the present example, the six openings 35 like rectangular holes (windows) are formed in the side wall portion 32. Each opening 35 penetrates the side wall portion 32 in the radial direction (direction orthogonal to the axial direction). Through the part where the openings 35 are formed, the outer surface of the tubular body 21 of the barrel 20 is exposed to the outside.
A contact area between the side wall portion 32 of the grip 30 for a syringe barrel and the proximal end portion of the tubular body 21 when the grip 30 is attached to the syringe barrel 20 is preferably 40% or less of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 32. The airflow portion is formed by a non-contact area between the side wall portion 32 of the grip 30 for a syringe barrel and the proximal end portion of the tubular body 21 when the grip 30 is attached to the syringe barrel 20. With this configuration, sterilization is ensured.
In the present example, as illustrated in
In the side wall portion 32, 5 to 10 openings 35 like rectangular holes are preferably formed. In addition, the area of the part (fitting portion 34) where the inner surface of the side wall portion 32 and the outer surface of the tubular body 21 are in contact with each other is preferably 10 to 50%, and particularly preferably 10 to 40%, as compared with the case where the openings 35 are not formed (the area of the inner surface of the entire side wall portion 32). In addition, the length of the side wall portion 32 in the axial direction is preferably 0.17 to 3.4 mm, and particularly preferably 0.34 to 1.7 mm.
It is desirable that none of the openings 35 be opened at the distal end portion (end surface) of the side wall portion 32. As a result, the strength of the distal end portion of the side wall portion 32 is maintained, the grip 30 can be firmly attached to the barrel 20 while reducing the area of the fitting portion 34, and rattling or the like of the grip 30 can be suppressed.
As a constituent material of the grip 30, a hard or semi-hard resin, e.g., polyolefin such as polyethylene and polypropylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, cyclic polyolefin polymer, and cyclic olefin copolymer is preferably used.
As the constituent material of the grip 30, a material having a thermal expansion coefficient (linear thermal expansion coefficient) larger than that of the barrel 20 may be used. As a result, when the syringe 1 is heated in a surface sterilization (gas sterilization) step described later, the inner surface (inner diameter) of the grip 30 expands more greatly than the outer surface (outer diameter) of the barrel 20 (tubular body 21), a slight gap is formed between a part of the inner surface (fitting portion 34) of the grip 30 and the outer surface of the tubular body 21, and the sterilization gas enters the gap, whereby the sterilizability of the syringe 1 can be improved.
A manufacturing method (manufacturing process) of such a syringe 1 will be described.
First, the barrel 20 attached to the seal cap 13 in the nozzle portion 23 of the barrel 20 is sterilized. The sterilization method adopted here is not particularly limited, and for example, an autoclave sterilization method using an autoclave (high temperature steam sterilization method), a surface sterilization method using a sterilization gas such as hydrogen peroxide or EOG (gas sterilization method), a radiation sterilization method by radiation irradiation such as γ ray or electron radiation, and the like can be used. Here, as an example, autoclave sterilization is performed.
Next, under a sterile environment, the barrel 20 having been sterilized is aseptically filled with the drug 50 that has already been subjected to sterilization treatment (for example, filtration sterilization or the like). In this example, the drug 50 for ophthalmic use, which is relatively sensitive to heat, is filled in the barrel 20. After the barrel 20 is filled with the drug 50, the gasket 11 is inserted into the barrel 20. Insertion of the gasket 11 (plugging) can be performed in a depressurized state.
Next, a part in the distal end side of the plunger 12 is received in the barrel 20, and the grip 30 is attached to the barrel 20. This operation can also be performed in a place under an unsterilized environment.
Next, the syringe 1 with the grip 30 attached to the barrel 20 is sterilized. In the present example, since the drug 50 stored in the barrel 20 is a drug for ophthalmic use that is relatively sensitive to heat, surface sterilization using a sterilization gas (here, NO2 (nitrogen dioxide)) is performed (NO2 sterilization).
As described above, the syringe 1 can be aseptically manufactured.
The grip 30 (side wall portion 32) of the present example has the plurality (here, six) of the openings 35. Through each opening 35, the sterilization gas is brought into contact with the outer surface of the proximal end portion of the barrel 20 (tubular body 21) partially covered by the side wall portion 32. As a result, the syringe 1 including the barrel 20 to which the grip 30 has been attached (barrel assembly 2) is more reliably sterilized.
In the present example, in the side wall portion 32, the side wall portion 32 (fitting portion 34) where the openings 35 are not formed is formed to be thinner toward the inside in the cross section on a plane orthogonal to the axial direction. As a result, the sterilization gas can be brought into contact with a wider area of the outer surface of the barrel 20 (tubular body 21) and the inner surface of the grip 30, while the strength of the fitting portion 34 is maintained. The shape of the fitting portion 34 in the side wall portion 32 is appropriately set based on molding conditions or the like.
In addition, the sterilization gas can enter a gap inevitably formed between the inner surface of the fitting portion 34 and the outer surface of the tubular body 21 from a peripheral portion of the fitting portion 34 in the side wall portion 32. In the grip 30 of the present example, since the openings 35 are formed in the side wall portion 32, the sterilization gas can enter between the inner surface of the fitting portion 34 and the outer surface of the tubular body 21 also from the peripheral portions of the openings 35. As a result, the sterilization gas can be brought into contact with a wider area of the outer surface of the barrel 20 (the tubular body 21) and the inner surface of the grip 30, so that sterilization can be performed more reliably. When focusing on such an effect, forming a large number of relatively small openings in order to increase the peripheral edge length of the openings (the total length of the peripheral edge portions of the openings) with respect to the opening area (the total area of the openings) is also effective. Specifically, it is conceivable that a large number of through holes are formed as relatively small openings.
The shape of the opening formed as the airflow portion in the side wall portion is not limited to the rectangular hole described above, and may be, for example, a circular, triangular, or other polygonal hole (window). In a grip 30a illustrated in
When the opening formed in the side wall portion is formed by the openings 35a like triangular holes providing the side wall portion 32a with the truss structure, six to 20 openings 35a are preferably formed. The contact area between the side wall portion 32a of the grip 30a for a syringe barrel and the proximal end portion of the tubular body 21 is preferably 10 to 40% of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 32a. In other words, the contact area between the side wall portion 32a of the grip for a syringe barrel and the proximal end portion of the tubular body 21 when the grip is attached to the syringe barrel (the area of the part where the inner surface of the side wall portion 32a and the outer surface of the tubular body 21 are in contact with each other) is preferably 10 to 40% of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 32a (the area of the inner surface of the entire side wall portion 32a when the openings are not formed). The airflow portion is formed by a non-contact area between the side wall portion 32a of the grip 30a for a syringe barrel and the proximal end portion of the tubular body 21 when the grip 30a is attached to the syringe barrel 20.
In addition, as in a grip 30b illustrated in
In the syringes and the barrel assemblies of the present invention illustrated in
In a syringe 7 and a barrel assembly 8 of the present invention illustrated in
Specifically, on the inner surface of the side wall portion 62 of the grip 60, a plurality (here, 10) of recesses 65 that have a substantially rectangular cross section on a plane orthogonal to the axial direction and extend in the axial direction are formed. Each recess 65 is formed over the entire length in the axial direction of the side wall portion 62. In other words, each recess 65 is open at both axial end portions of the side wall portion 62. The inner surface of the side wall portion 62 and the outer surface of the tubular body 21 are not in contact with each other at the part where the recesses 65 are formed.
In the present example, parts in the side wall portion 62 where the recesses 65 are not formed and the inner surface of the side wall portion 62 form fitting portions 64 configured to be fitted to the proximal end portion of the tubular body 21. The fitting portions 64 each have a substantially rectangular cross section on a plane orthogonal to the axial direction.
On the grip 60 (side wall portion 62) of the present example, the plurality (here, 10) of recesses 65 are formed. The sterilization gas is brought into contact with the inner surface of the side wall portion 62 and the outer surface of the proximal end portion of the barrel 20 (tubular body 21) partially covered by the side wall portion 62, through each recess 65. As a result, the syringe 7 including the barrel 20 to which the grip 60 has been attached (barrel assembly 8) is more reliably sterilized. The number of recesses 65 (fitting portions 64) is preferably 3 to 30, and particularly preferably 10 to 20.
In addition, in the present example, the recesses 65 formed on the grip 60 (side wall portion 62) are open at both axial end portions of the side wall portion 62, so that the sterilization gas easily flows (enters or passes) through the recesses 65. In addition, in this example, the width (circumferential dimension) of each recess 65 formed on the grip 60 (side wall portion 62) is wide at the distal end of the side wall portion 62 (the lower end of the side wall portion 62 in
In the side wall portion 62, three to 10 recesses 65 are preferably formed on the inner surface of the side wall portion 62. In addition, the contact area between the side wall portion 62 of the grip 60 for a syringe barrel and the proximal end portion of the tubular body 21 is preferably 0.1 to 40% of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 62. In other words, the contact area between the side wall portion 62 of the grip for a syringe barrel and the proximal end portion of the tubular body 21 when the grip is attached to the syringe barrel (the area of the part where the inner surface of the side wall portion 62 and the outer surface of the tubular body 21 are in contact with each other) is preferably 0.1 to 40% of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 62 (the area of the inner surface of the entire side wall portion 62 when the recesses are not formed). The airflow portion is formed by a non-contact portion (non-contact area) between the side wall portion 62 (inner surface of the side wall portion 62) of the grip 60 for a syringe barrel and the proximal end portion of the tubular body 21 (outer surface of the tubular body 21) when the grip 60 is attached to the syringe barrel.
In addition, a grip 60g illustrated in
In addition, also in the grip 60g of the example illustrated in
The cross-sectional shape on a plane orthogonal to the axial direction of each recess formed on the side wall portion as the airflow portion is not limited to a substantially rectangle as described above, and may be various shapes such as a triangular shape, a trapezoidal shape, another polygonal shape, and a crescent shape. It is desirable that the recesses be formed so as to have a trapezoidal or triangular cross section on a plane orthogonal to the axial direction such that the contact area between the inner surface of the side wall portion (fitting portion) and the outer surface of the tubular body is reduced (or, such that the shape of the fitting portion is narrowed radially inward in the cross section on a plane orthogonal to the axial direction). In addition, the recesses forming the airflow portion preferably extend parallel to the axial direction, but may extend obliquely or extend spirally with respect to the axis.
In a grip 60a of a syringe 7a and a barrel assembly 8a of the present example, a side wall portion 62a has a plurality of protrusions 66 formed on an inner surface of the side wall portion 62a, and an airflow portion is formed by a space between a plurality of protrusions 66. In other words, an airflow portion is formed by a part (inter-protrusion portion 67) between a plurality of protrusions 66 formed on an inner surface of a side wall portion 62a.
Specifically, the plurality (here, 11) of protrusions 66 protruding radially inward are formed on the inner surface of the side wall portion 62a of the grip 60a. The protrusions 66 each have a substantially semicircular shape as viewed from the radially inner side of the side wall portion 62a (as viewed in the radial direction), and are formed on the inner surface of the proximal end portion (upper end portion) of the side wall portion 62a, the protrusions 66 being arranged on the same circle. Upper surfaces of the protrusions 66 are substantially flush with an upper surface of the lower plate portion 38. In the present example, surfaces of the protrusions 66 directed radially inward (inner surfaces of the protrusions 66) and a part of the side wall portion 62a where the protrusions 66 are formed are fitting portions 64a configured to be fitted to the proximal end portion of the tubular body 21. An inner surface of a part (inter-protrusion portion 67) of the side wall portion 62a where the protrusions 66 are not formed is not in contact with the outer surface of the tubular body 21. In the grip 60 a, as the airflow portion, the inter-protrusion portion 67 which is a part not in contact with the outer surface of the tubular body 21 is formed on the inner surface of the side wall portion 62a.
On the grip 60a (side wall portion 62a) of the present example, the plurality (here, 11) of protrusions 66 are formed. The sterilization gas is brought into contact with the inner surface of the side wall portion 62a and the outer surface of the proximal end portion of the barrel 20 (tubular body 21) partially covered by the side wall portion 62a, through the inter-protrusion portion 67 that is formed between the protrusions 66 not in contact with the outer surface of the tubular body 21. As a result, sterilizability of the syringe 7a including the barrel 20 to which the grip 60a has been attached (barrel assembly 8a) can be further improved.
In addition, the inter-protrusion portion 67 formed on the grip 60a (side wall portion 62a) is open to the outside at both axial end portions and both circumferential ends of the side wall portion 62a, so that the sterilization gas easily flows (enters or passes) through the inter-protrusion portion 67.
In the side wall portion 62a, 3 to 20 protrusions 66 are preferably formed on the inner surface of the side wall portion 62a. In addition, the contact area between the side wall portion 62a of the grip 60a for a syringe barrel and the proximal end portion of the tubular body 21 is preferably 0.1 to 40% of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 62a. In other words, the area of a part (fitting portion 64a) where the inner surface of the side wall portion 62a (surfaces of the protrusions 66 directed radially inward) and the outer surface of the tubular body 21 are in contact with each other is preferably 0.1 to 40% of the area of the part where the inner surface of the side wall portion 62a and the outer surface of the tubular body 21 are in contact with each other when the protrusions are not formed. In this example, the contact area between the side wall portion 62a of the grip 60a for a syringe barrel and the proximal end portion of the tubular body 21 is 14% of the area of the proximal end portion of the tubular body 21 covered by the side wall portion 62a.
The shape of each protrusion (as viewed in the radial direction) formed on the side wall portion is not limited to the exemplified semicircular shape, and may be, for example, a rectangular shape or another polygonal shape. In addition, the shape may be a conical shape, a triangular pyramid shape, another polygonal pyramid shape, a truncated cone shape, a triangular frustum shape, and another polygonal frustum shape that have a cross-sectional area gradually decreasing radially inward.
In addition, the protrusions formed on the grip (side wall portion) may have the form illustrated in
In addition, the protrusions formed on the grip (side wall portion) may have the form illustrated in
The protrusions are not limited to those provided on the same circle as exemplified, and may be provided at arbitrary positions. In addition, for example, the protrusions may be provided over two or more rows on circles having different axial positions, or may be provided in two rows in an alternate (staggered) manner. A grip 60d illustrated in
In a grip 60e of a syringe 7b and a barrel assembly 8b of the present example, a side wall portion 62b has a rough surface portion 68 formed on an inner surface of the side wall portion 62b, and an airflow portion is formed by a gap formed in the rough surface portion 68. In other words, an airflow portion is formed by a rough surface portion 68 formed on an inner surface of a side wall portion 62b.
Specifically, the rough surface portion 68 is formed on the entire inner surface of the side wall portion 62b of the grip 60e (indicated by dot hatching in
The rough surface portion 68 formed on the inner surface of the side wall portion 62b is preferably formed such that the sterilization gas can enter the rough surface portion 68 in a state where the grip 60e is attached to the barrel 20 (tubular body 21).
As the degree of surface roughness of the rough surface portion 68, an embossed portion in which a plurality of recessed portions intersecting each other and having a thin grooved shape with a depth of about 5 to 1000 μm are formed is preferable.
As a result, a non-contact portion between the inner surface of the side wall portion 62b and the outer surface of the tubular body 21 is formed at a part where the rough surface portion 68 is formed.
On the grip 60e (side wall portion 62b) of the present example, the rough surface portion 68 is formed. The sterilization gas is brought into contact with the inner surface of the side wall portion 62b and the outer surface of the proximal end portion of the barrel 20 (tubular body 21) partially covered by the side wall portion 62b, through the rough surface portion 68. As a result, the syringe 7b including the barrel 20 (barrel assembly 8b) to which the grip 60e has been attached is more reliably sterilized.
In the grip 60f of the syringe 7c and the barrel assembly 8c of this example, a side wall portion 62c has a tapered portion formed on an inner surface of the side wall portion 62c, and an airflow portion 70 is formed between an inner surface of the tapered portion and the outer surface of the tubular body 21 covered by the side wall portion 62c. In other words, an airflow portion 70 is formed by a tapered portion formed on an inner surface of a side wall portion 62c. In addition, a fitting portion 64c is formed of a small diameter portion (a part having a small inner diameter) at a base end of the tapered portion. The side wall portion 62c is a tapered portion in which the inner diameter increases toward the distal end, and the entire outer diameter is substantially the same. The side wall portion 62c therefore becomes thinner toward the distal end. In a part excluding the fitting portion 64c, the proximal end portion of the barrel 20 (tubular body 21) partially covered by the side wall portion 62c is not in contact with the side wall portion 62c. In this part, therefore, the outer surface of the barrel 20 and the tapered portion (airflow portion 70) of the side wall portion 62c come into contact with the sterilization gas. As a result, sterilizability of the syringe 7c including the barrel 20 to which the grip 60f has been attached (barrel assembly 8c) can be further improved.
In the present example, in order to further reduce the area of the fitting portion 64c and improve the sterilizability, as illustrated in
The inner surface of the side wall portion as the tapered portion is not limited to the inclined surface linearly separated from the outer surface of the tubular body 21 as in the present example, and may be, for example, a convex inward, curved surface or a concave outward, curved surface. In addition, the tapered portion may be provided from the axial center portion of the side wall portion toward the distal end side.
In the grip for a syringe barrel, and the barrel assembly and the syringe including such a grip for a syringe barrel of the present invention, the airflow portion of the grip is not limited to one that forms only one of the above-described opening and non-contact portion (recesses, inter-protrusion portion, rough surface portion, and tapered portion), and the airflow portion may be formed by appropriately combining these configurations.
A grip for a syringe barrel of the present invention is as follows.
the grip including a flange receiving portion configured to receive the flange, and a side wall portion extending in a distal end direction from the flange receiving portion and configured to partially cover a proximal end portion of the tubular body adjacent to the flange, in which
the side wall portion includes a fitting portion configured to be fitted to the proximal end portion of the tubular body, and an airflow portion configured to allow a sterilization gas to flow to an outer surface of the tubular body covered by the side wall portion.
With the grip for a syringe barrel described above, the sterilization gas can be brought into contact with a wider range of the outer surface of the syringe barrel, and the syringe barrel attached to the syringe barrel grip is more reliably sterilized.
In addition, the above-described aspect may be as follows.
A grip for a syringe barrel of the present invention is as follows.
a flange receiving portion configured to receive the flange; and a side wall portion extending in a distal end direction from the flange receiving portion and configured to partially cover a proximal end portion of the tubular body adjacent to the flange, wherein
the side wall portion includes a fitting portion configured to be fitted to the proximal end portion of the tubular body, and an airflow portion configured to allow sterilization gas to flow to an outer surface of the tubular body covered by the side wall portion, and
the side wall portion is cylindrical and has an insertion opening for insertion the proximal end portion of the tubular body on a side thereof, and
the airflow portion is provided on an inner surface of the side wall portion, and the airflow portion is formed by a non-contact portion between the inner surface of the side wall portion and the outer surface of the tubular body.
With the grip for a syringe barrel described above, the sterilization gas can be brought into contact with a wider range of the outer surface of the syringe barrel, and the syringe barrel attached to the syringe barrel grip is more reliably sterilized.
In addition, the above-described aspect may be as follows.
A barrel assembly of the present invention is as follows.
With the barrel assembly described above, the sterilization gas can be brought into contact with a wider range of the outer surface of the syringe barrel, and the barrel assembly is more reliably sterilized.
A syringe of the present invention is as follows.
With the syringe described above, the sterilization gas can be brought into contact with a wider range of the outer surface of the syringe barrel, and the syringe is more reliably sterilized.
In addition, the above-described aspect may be as follows.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2019-239094 | Dec 2019 | JP | national |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2020/047803 | Dec 2020 | US |
| Child | 17847772 | US |
