Patent Description:
Some drug-filled syringes (prefilled syringes) each use a plunger that is not coupled to a gasket in order to prevent medical errors. To such a prefilled syringe, a clip (backstop) for preventing a plunger from moving to a proximal end side and falling off from a barrel is attached (Patent Literature <NUM>).

In addition, in order to facilitate gripping and operation of a syringe, it is also known to attach a clip (grip) including a finger hook portion protruding outward to a proximal end portion of a barrel (Patent Literature <NUM>).

These clips are each fitted to an outer peripheral surface of a barrel at a cylindrical fitting portion and firmly attached to a syringe so as not to rattle or come off during operation of the syringe.

In recent years, in ophthalmic use and the like, higher sterility of not only a drug to be administered and a portion in contact with the drug but also the entire prefilled syringe including a grip is required. Therefore, the present inventors have studied an application of a surface sterilization method with a small heat load, such as hydrogen peroxide sterilization, EOG sterilization, or NO<NUM> sterilization, to a prefilled syringe to which a grip is attached. These surface sterilization methods perform sterilization with a gas (sterilization gas), and in order to achieve higher sterility, the sterilization gas preferably comes into contact with a wider area of a surface of the prefilled syringe.

Therefore, the present invention provides a syringe barrel grip having good operability and capable of achieving higher sterility in a state of being attached to a syringe barrel, and a barrel assembly and a syringe each including such a syringe barrel grip.

The above object is achieved by the following.

A syringe barrel grip attached to a syringe barrel including a cylindrical body and a flange disposed in the cylindrical body, protruding outward, and including a pair of flange straight portions facing each other in parallel,.

The above object is also achieved by the following.

A barrel assembly including: a syringe barrel including a cylindrical body and a flange disposed at a proximal end of the cylindrical body, protruding outward, and including a pair of flange straight portions facing each other in parallel; and the syringe barrel grip attached to the barrel.

A syringe including: the barrel assembly; a gasket slidably housed in the barrel; and a plunger for moving the gasket.

A syringe barrel grip of the present invention, and a barrel assembly and a syringe each including such a syringe barrel grip will be described with reference to an embodiment illustrated in the drawings.

Note that the present embodiment will be described by defining an upper side in <FIG> (the side on which a flange <NUM> of a syringe barrel <NUM> is formed) as a proximal end side or an upper side, defining a lower side in <FIG> (the side on which a nozzle portion <NUM> of the syringe barrel <NUM> is disposed) as a distal end side or a lower side, and defining the vertical direction in <FIG> as an axial direction (the axial direction of the syringe barrel <NUM> or a cylindrical body <NUM>).

As illustrated in <FIG>, a syringe <NUM> of the present invention includes: a barrel assembly <NUM> including a syringe barrel <NUM> (hereinafter, also simply referred to as a barrel <NUM>) and a syringe barrel grip <NUM> (hereinafter, also simply referred to as a grip <NUM>) attached to the barrel <NUM>; a gasket <NUM> slidably housed in the barrel <NUM>; and a plunger <NUM> for moving the gasket <NUM>.

The barrel <NUM> includes a cylindrical body <NUM> and a flange <NUM> (thickness t) disposed in the cylindrical body <NUM>, protruding outward (in a direction orthogonal to the axial direction of the barrel <NUM>), and including a pair of flange straight portions <NUM> and <NUM> (width w) facing each other in parallel. In the present embodiment, the cylindrical body <NUM> of the barrel <NUM> has a circular (annular) outer shape and a circular (annular) inner shape in a cross section taken along a plane orthogonal to the axial direction thereof as a whole. A distal end opening portion (nozzle portion) <NUM> for discharging a drug is disposed at a distal end portion of the barrel <NUM>.

In addition, the barrel <NUM> includes a collar <NUM> covering a proximal end side portion of the nozzle portion <NUM>. A barrel side screwing portion (female screwing portion) is formed on an inner surface of the collar <NUM>.

The nozzle portion <NUM> is sealed by a seal cap <NUM> to prevent leakage of a drug <NUM> stored in the barrel <NUM> and to prevent the aseptically filled drug <NUM> from coming into contact with outside air.

Examples of a constituent material of the barrel <NUM> include various resins such as a polyolefin including polyethylene and polypropylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly-(<NUM>-methylpentene-<NUM>), an acrylic resin, an acrylonitrile-butadiene-styrene copolymer, a polyester including polyethylene terephthalate, a cyclic polyolefin polymer, and a cyclic olefin copolymer. Among these resins, resins such as polypropylene, a cyclic polyolefin polymer, and a cyclic olefin copolymer are preferable because the resins are easily molded and have heat resistance. Note that a cyclic olefin polymer or a cyclic olefin copolymer having high transparency such that a drug solution filled inside can be visually confirmed from the outside and having heat resistance capable of withstanding high-pressure steam sterilization is particularly preferable as a material for forming the barrel <NUM>.

The seal cap <NUM> includes a body portion <NUM> having a proximal end side hollow portion that houses the nozzle portion <NUM> of the barrel <NUM>, and a seal member <NUM> housed in the body portion <NUM> and disposed at a distal end portion of the proximal end side hollow portion. In addition, on an outer surface of the proximal end side hollow portion, a cap side screwing portion (male screwing portion) capable of being screwed with the barrel side screwing portion (female screwing portion) formed on an inner surface of the collar <NUM> is formed.

Examples of a material for forming the seal cap include various resins such as polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly-(<NUM>-methylpentene-<NUM>), an acrylic resin, an acrylonitrile-butadiene-styrene copolymer, a polyester including polyethylene terephthalate, and a cyclic polyolefin. Among these resins, resins such as polypropylene and a cyclic polyolefin are preferable because the resins are easily molded and have heat resistance.

As a material for forming the seal member <NUM>, an elastic material such as a natural rubber, a synthetic rubber including an isoprene rubber, a butyl rubber, a butadiene rubber, a fluororubber, and a silicone rubber, or a thermoplastic elastomer including an olefin-based elastomer and a styrene-based elastomer is preferable.

The gasket <NUM> housed in the barrel <NUM> is made of an elastic rubber or a synthetic resin. The gasket <NUM> includes a substantially cylindrical body portion extending with substantially the same outer diameter and a plurality of annular ribs disposed on an outer surface of the body portion. Outer surfaces of the annular ribs are in liquid-tight contact with an inner surface of the barrel <NUM> and are slidable in a liquid-tight state.

As a material for forming the gasket <NUM>, it is preferable to use an elastic rubber (for example, a butyl rubber, a latex rubber, or a silicone rubber), a synthetic resin (for example, a styrene-based elastomer such as an SBS elastomer or an SEBS elastomer, or an olefin-based elastomer such as an ethylene-α olefin copolymer elastomer), or the like.

The plunger <NUM> is made of a hard or semi-hard resin. In this embodiment, the plunger <NUM> includes a small disk-shaped gasket pressing portion <NUM> disposed at a distal end thereof, a disk-shaped pressing operation portion <NUM> disposed at a proximal end thereof, and a shaft portion <NUM> having a cross-shaped cross section and extending in the axial direction of the barrel <NUM> between the gasket pressing portion <NUM> and the pressing operation portion <NUM>. Note that the shaft portion <NUM> may be a columnar shaft. The columnar shaft may have a rod shape, a circular columnar shape, a polygonal columnar shape, a circular cylindrical shape, a polygonal cylindrical shape, or the like.

In this embodiment, the plunger <NUM> is not connected to the gasket <NUM>, and can abut on a proximal end portion of the gasket <NUM> at the gasket pressing portion <NUM>. The gasket <NUM> can be moved to a distal end side by pressing after abutment.

A distal end side portion (the gasket pressing portion <NUM> and a part of a distal end side of the shaft portion <NUM>) of the plunger <NUM> is housed in the barrel <NUM> (cylindrical body <NUM>). The plunger <NUM> includes a stopper portion <NUM> that is disposed in a portion (shaft portion <NUM>) housed in the barrel <NUM>, abuts on the grip <NUM> (stopper abutment portion <NUM>) described in detail later, and restricts detachment of the plunger <NUM> from the barrel <NUM>. More specifically, the stopper portion <NUM> has a disk shape having an outer shape (outer diameter) smaller than the inner shape (inner diameter) of the barrel <NUM> (cylindrical body <NUM>) and larger than the outer shape (maximum diameter portion) of the shaft portion <NUM> of the plunger <NUM>.

As a constituent material of the plunger <NUM>, a hard or semi-hard resin such as high-density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate is preferably used.

In the syringe <NUM>, the drug (drug solution) <NUM> is stored (filled) in the barrel <NUM> (in a space formed between the seal cap <NUM> and the gasket <NUM>).

The drug <NUM> to be stored is not particularly limited, and examples thereof include a vitamin, a sugar, an electrolyte, an organic acid, a mineral, a fat emulsion, an amino acid, a protein, and an organ preparation mainly as nutrients. Examples thereof further include a drug for a central nervous system, such as a general anesthetic, an antipyretic analgesic, or a general cold preparation, a drug for a peripheral nervous system, such as a local anesthetic or a muscle relaxant, a drug for a sensory organ, such as an ophthalmic agent, a metabolic drug such as a circulatory drug, a respiratory drug, a digestive drug, an urogenital anal drug, a hormonal agent, an antibiotic, or a diabetes drug, a biological preparation such as an antitumor drug, an allergic drug, an antibacterial agent, or an antiviral agent, and a prescription drug such as distilled water or physiological saline mainly as therapeutic agents. Examples thereof further include a vaccine mainly as a preventive agent and a contrast agent mainly as a diagnostic agent.

Many of the exemplified drugs each contain, as a main component, a synthetic low molecular weight compound, a synthetic middle molecular weight compound, a biopharmaceutical such as a polypeptide preparation or a protein preparation, or a biologically derived pharmaceutical such as a blood preparation, but these substances can be used as drugs regardless of the applications described above. In addition, a substance corresponding to a molecular target drug such as an antibody can also be used as a drug. A dosage form of each of these drugs is preferably a liquid even in a drug having a solid dosage form such as a powder or a granule in addition to a liquid from a viewpoint of usability.

In addition, as the drug <NUM>, an ophthalmic drug that can be administered by puncture can be used. Examples of a specific target disease for which such an ophthalmic drug is used include choroidal neovascularization, age-related macular degeneration (both exudative and atrophic), 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 include ranibizumab [trade name: LUCENTIS (registered trademark)], bevacizumab [trade name: AVASTIN (registered trademark)], and aflibercept [trade name: EYLEA (registered trademark)], which are anti-VEGF antibodies used as therapeutic agents for age-related macular degeneration, and conbercept known as VEGF-TrapEye (aflibercept intravitreal injection solution).

The structure of the syringe barrel grip <NUM> of the present invention will be described with reference to the embodiment illustrated in <FIG>.

The syringe barrel grip <NUM> of this embodiment includes a flange housing portion <NUM> that houses the flange <NUM>. As illustrated in <FIG>, the flange housing portion <NUM> includes: a side surface opening <NUM> formed on a side surface of the grip <NUM>; a flange insertion portion <NUM> extending in an internal direction of the grip <NUM> from the side surface opening <NUM>; and a flange rotation restricting portion <NUM> that communicates with the flange insertion portion <NUM>, extends into the grip <NUM>, and restricts relative rotation between the grip <NUM> and the flange <NUM> that has entered the flange rotation restricting portion <NUM> by rotating the barrel <NUM> by a predetermined angle in a state where the flange <NUM> is housed in the flange insertion portion <NUM>. The flange insertion portion <NUM> includes a first pair of grip straight portions <NUM> and <NUM> having a slightly wider width W1 than the pair of flange straight portions <NUM> and <NUM> (width w), and the flange rotation restricting portion <NUM> includes a second pair of grip straight portions <NUM> and <NUM> having a slightly wider width W2 than the pair of flange straight portions <NUM> and <NUM> (width w) and is inclined with respect to the first pair of grip straight portions <NUM> and <NUM>.

In the present embodiment, as illustrated in <FIG>, <FIG>, and <FIG>, at an end portion of the flange insertion portion <NUM> on the flange rotation restricting portion <NUM> side, a protrusion <NUM> that abuts on the flange <NUM> (flange straight portion <NUM>) when the barrel <NUM> is rotated and the flange <NUM> is caused to enter the flange rotation restricting portion <NUM> is formed. As illustrated in <FIG>, in the grip <NUM>, at an end portion of the left first grip straight portion <NUM> (in <FIG>) of the flange insertion portion <NUM> on the flange rotation restricting portion <NUM> side (a connecting portion between the left first grip straight portion <NUM> and the left second grip straight portion <NUM>), the protrusion <NUM> is formed. In addition, as illustrated in <FIG>, between the right first grip straight portion <NUM> (in <FIG>) and the right second grip straight portion <NUM>, a stepped portion <NUM> which is continuous to the first grip straight portion <NUM> at a right angle and connects the first grip straight portion <NUM> and the second grip straight portion <NUM> to each other is formed.

As illustrated in <FIG> and <FIG>, in the grip <NUM>, in a state where the flange <NUM> is housed in the flange rotation restricting portion <NUM>, front sides of the pair of flange straight portions <NUM> and <NUM> are located in the second pair of grip straight portions <NUM> and <NUM> (between the second pair of grip straight portions <NUM> and <NUM>), and rear sides of the pair of flange straight portions <NUM> and <NUM> are located in the first pair of grip straight portions <NUM> and <NUM> (between the first pair of grip straight portions <NUM> and <NUM>).

Furthermore, in this embodiment, one rear end portion of the pair of flange straight portions <NUM> and <NUM> (an end portion of the flange <NUM> on a rear side in an insertion direction into the grip <NUM>) abuts on or approaches one of the first pair of grip straight portions <NUM> and <NUM>. That is, as illustrated in <FIG> and <FIG>, in <FIG> and <FIG>, a rear end portion of the right flange straight portion <NUM> abuts on or approaches the right first grip straight portion <NUM>. As a result, the flange <NUM> housed in the flange rotation restricting portion <NUM> is prevented from moving (rattling) along the second pair of grip straight portions <NUM> and <NUM> and being detached from the flange rotation restricting portion <NUM>.

As illustrated in <FIG>, in the grip <NUM>, in a state where the flange <NUM> of the barrel <NUM> is housed in the flange rotation restricting portion <NUM> of the grip <NUM>, a lower inner peripheral surface of the grip <NUM> is not in contact with the barrel <NUM>, and there is a gap <NUM> for allowing a sterilization gas to flow between the lower inner peripheral surface of the grip <NUM> and the barrel <NUM>.

More specifically, as illustrated in <FIG>, the flange housing portion <NUM> includes an upper plate portion <NUM> covering a proximal end side surface of the flange <NUM> and a lower plate portion <NUM> covering a distal end side surface of the flange <NUM>. As illustrated in <FIG> and <FIG>, a distance T between the upper plate portion <NUM> and the lower plate portion <NUM> of the flange housing portion <NUM> is larger than the thickness t of the flange <NUM>. As a result, a gap for allowing a sterilization gas to flow is formed between the upper plate portion <NUM> and the proximal end side surface of the flange <NUM> and/or between the lower plate portion <NUM> and the distal end side surface of the flange <NUM>.

As illustrated in <FIG>, an upper slit (opening) <NUM> is formed in the upper plate portion <NUM> of the flange housing portion <NUM>. The upper slit <NUM> communicates with the side surface opening <NUM>, the flange insertion portion <NUM>, and the flange rotation restricting portion <NUM> of the flange housing portion <NUM>, and is formed such that the shaft portion <NUM> of the plunger <NUM> can enter the upper slit <NUM>. A part of an inner edge portion of the upper slit <NUM> is a stopper abutment portion <NUM> that protrudes inward and abuts on the stopper portion <NUM> of the plunger <NUM>.

As a result, the upper slit <NUM> allows the shaft portion <NUM> of the plunger <NUM> to pass therethrough, and abuts on the stopper portion <NUM> of the plunger <NUM> at the stopper abutment portion <NUM>. Therefore, as illustrated in <FIG>, the plunger <NUM> housed in the barrel <NUM> abuts on the stopper abutment portion <NUM> of the grip <NUM> at the stopper portion <NUM>, whereby detachment of the plunger <NUM> from the barrel <NUM> is restricted.

As illustrated in <FIG> and <FIG>, a lower slit (opening) <NUM> is formed in the lower plate portion <NUM> of the flange housing portion <NUM>. The lower slit <NUM> communicates with the side surface opening <NUM>, the flange insertion portion <NUM>, and the flange rotation restricting portion <NUM> of the flange housing portion <NUM>, and is formed such that the cylindrical body <NUM> of barrel <NUM> can enter the lower slit <NUM>. More specifically, the lower plate portion <NUM> (lower slit <NUM>) includes a barrel insertion portion <NUM> including a pair of lower straight portions <NUM> and <NUM> that has a width W3 larger (wider) than the outer shape (outer diameter) of the barrel <NUM> (cylindrical body <NUM>) portion that enters the lower slit <NUM> and narrower than the width w of the pair of flange straight portions <NUM> and <NUM>, and are substantially parallel to the first pair of grip straight portions <NUM> and <NUM>, respectively.

As illustrated in <FIG>, the lower plate portion <NUM> (lower slit <NUM>) includes a barrel housing portion <NUM> that communicates with the barrel insertion portion <NUM>, and partially surrounds the barrel <NUM> (cylindrical body <NUM>) (houses the barrel <NUM>) in a state where the flange <NUM> is housed in the flange rotation restricting portion <NUM>. The barrel housing portion <NUM> has an inner shape (inner diameter, radius R illustrated in <FIG>) larger than the outer shape (outer diameter, radius r illustrated in <FIG>) of the barrel <NUM> (cylindrical body <NUM>) housed therein. As a result, as illustrated in <FIG>, in a state where the flange <NUM> is housed in the flange rotation restricting portion <NUM> of the grip <NUM>, an inner peripheral surface of the barrel housing portion <NUM> is not in contact with the barrel <NUM>, and the gap <NUM> for allowing a sterilization gas to flow between the inner peripheral surface of the barrel housing portion <NUM> and the barrel <NUM> is formed. That is, in the grip <NUM>, on an inner peripheral surface of the lower plate portion <NUM> of the flange housing portion <NUM> (the barrel housing portion <NUM> of the lower slit <NUM>), at least a part of a lower inner peripheral surface of the grip <NUM> is formed.

Note that, as illustrated in <FIG> and <FIG>, a recess <NUM> is formed in an upper inner edge portion of the lower plate portion <NUM>. As a result, a sterilization gas can be brought into contact with a wider area of a distal end side surface of the flange <NUM> facing the lower plate portion <NUM>.

In the flange housing portion <NUM> of the grip <NUM>, a pair of finger hook portions <NUM> and <NUM> is formed so as to constitute a proximal end side portion of the grip <NUM> and to protrude outward (in a direction orthogonal to the axial direction of the barrel <NUM>). The pair of finger hook portions <NUM> and <NUM> protrude in directions opposite to each other and orthogonal to the axial direction of the barrel <NUM>. The pair of finger hook portions <NUM> and <NUM> extends outward from the flange <NUM> of the barrel <NUM>. The pair of finger hook portions <NUM> and <NUM> can be used by an operator to hook a finger when the operator operates the syringe <NUM>.

As illustrated in <FIG> and <FIG>, the grip <NUM> of the present embodiment includes a side wall portion <NUM> extending to an axial distal end side from the flange housing portion <NUM>. The side wall portion <NUM> is integrated with (connected to) an inner edge portion of the lower slit <NUM> of the lower plate portion <NUM> of the flange housing portion <NUM> at a proximal end thereof. As illustrated in <FIG>, the outer shape of the side wall portion <NUM> increases toward a proximal end side (flange housing portion <NUM> side), and is smoothly connected to the finger hook portions <NUM> and <NUM> of the flange housing portion <NUM>. As a result, the side wall portion <NUM> contributes to improvement in operability of the syringe <NUM>.

An inner peripheral surface of the side wall portion <NUM> is formed by extending an inner peripheral surface of the lower slit <NUM> in the axial direction over the entire length in the axial direction, and has a semi-cylindrical shape with a substantially U-shaped cross section as a whole. In the side wall portion <NUM>, an opening for insertion extending over the entire length in the axial direction (for insertion of a proximal end portion of the cylindrical body <NUM>) (insertion slit) <NUM> is formed. In a state where the flange <NUM> of the barrel <NUM> is housed in the flange rotation restricting portion <NUM> of the grip <NUM>, an inner peripheral surface of the side wall portion <NUM> is not in contact with the barrel <NUM>, and a gap for allowing a sterilization gas to flow between the inner peripheral surface of the side wall portion <NUM> and the barrel <NUM> (the gap <NUM> and a gap continuous with the gap <NUM>) is formed. In other words, the side wall portion <NUM> partially covers a proximal end portion of the cylindrical body <NUM> adjacent to the flange <NUM>, and at least a part of the inner peripheral surface constitutes a lower inner peripheral surface of the grip <NUM> that forms a gap for allowing a sterilization gas to flow between the inner peripheral surface and the barrel <NUM>.

Preferable examples of a constituent material of the grip <NUM> include a hard or semi-hard resin such as a polyolefin including polyethylene and polypropylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly-(<NUM>-methylpentene-<NUM>), an acrylic resin, an acrylonitrile-butadiene-styrene copolymer, a polyester including polyethylene terephthalate, a cyclic polyolefin polymer, or a cyclic olefin copolymer.

Note that, as a constituent material of the grip <NUM>, a material having a thermal expansion coefficient (linear thermal expansion coefficient) larger than that of the barrel <NUM> may be used. As a result, when the syringe <NUM> is heated in a surface sterilization (gas sterilization) step described later, an inner surface (inner diameter) of the grip <NUM> expands more than an outer surface (outer diameter) of the barrel <NUM> (cylindrical body <NUM>), a gap is formed or expanded between the inner surface of the grip <NUM> and the outer surface of the cylindrical body <NUM>, and a sterilization gas enters the gap, whereby sterilizability of the syringe <NUM> can be improved.

A method (process) for manufacturing such a syringe <NUM> will be described.

First, the barrel <NUM> is sterilized with the seal cap <NUM> attached to the nozzle portion <NUM> of the barrel <NUM>. Note that a sterilization method adopted at this time 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), or a radiation sterilization method by radiation irradiation using a γ ray, an electron radiation, or the like can be used. Here, as an example, autoclave sterilization is performed.

Subsequently, under a sterile environment, the drug <NUM> that has been previously subjected to sterilization treatment (for example, filtration sterilization) is aseptically filled in the sterilized barrel <NUM>. In the present embodiment, the drug <NUM> for ophthalmic use, which is relatively vulnerable to heat, is filled. After the drug <NUM> is filled, the gasket <NUM> is inserted into the barrel <NUM>. The gasket <NUM> can be inserted (capped) in a depressurized state.

Subsequently, a distal end side portion of the plunger <NUM> is housed in the barrel <NUM>, and the grip <NUM> is attached to the barrel <NUM>. Note that this operation can also be performed under an environment other than a sterile environment.

A step of attaching the grip <NUM> to the barrel <NUM> will be described in detail with reference to <FIG>.

First, as illustrated in <FIG>, in a state where the pair of flange straight portions <NUM> and <NUM> of the barrel <NUM> and the first pair of grip straight portions <NUM> and <NUM> of the grip <NUM> are substantially parallel to each other, the flange <NUM> of the barrel <NUM> is inserted into the grip <NUM> from the side surface opening <NUM>, and the flange <NUM> is housed in the flange insertion portion <NUM>.

Subsequently, in a state where the flange <NUM> is housed in the flange insertion portion <NUM>, the barrel <NUM> is biased in a rotational direction (here, counterclockwise) and rotated. During the rotation of the barrel <NUM>, as illustrated in <FIG>, one (here, the left flange straight portion <NUM> in <FIG>) of the pair of flange straight portions <NUM> and <NUM> abuts on the protrusion <NUM>, and a rear end portion of the other (here, the right flange straight portion <NUM> in <FIG>) or a portion in the vicinity thereof abuts on the right first grip straight portion <NUM> in <FIG> [the grip <NUM> (flange housing portion <NUM>) and barrel <NUM> (flange <NUM>) are temporarily engaged with each other (first engagement state)].

When the barrel <NUM> is further biased in the rotational direction from the state where the grip <NUM> and the barrel <NUM> are engaged with each other, the upper slit <NUM>, the lower slit <NUM>, and the insertion slit <NUM> are formed in the grip <NUM> (the flange housing portion <NUM> and the side wall portion <NUM>), and therefore the flange housing portion <NUM> of the grip <NUM> is elastically deformed and pushed out. As a result, the rotation of the barrel <NUM> is allowed, the engagement state between the barrel <NUM> (flange <NUM>) and the grip <NUM> (flange housing portion <NUM>) is released, and the flange <NUM> enters the flange rotation restricting portion <NUM>. That is, the grip <NUM> is temporarily engaged with the barrel <NUM> when the flange <NUM> is caused to enter the flange rotation restricting portion <NUM> by rotating the barrel <NUM> by a predetermined angle in a state where the flange <NUM> is housed in the flange insertion portion <NUM>.

As illustrated in <FIG>, when the flange <NUM> is housed in the flange rotation restricting portion <NUM> (the grip <NUM> is attached to the barrel <NUM>), the grip <NUM> returns to the original state by an elastic restoring force. By causing the flange <NUM> to enter the flange rotation restricting portion <NUM>, the attachment of the grip <NUM> to the barrel <NUM> is completed. In a state where the flange <NUM> is housed in the flange rotation restricting portion <NUM>, the pair of flange straight portions <NUM> and <NUM> face the second pair of grip straight portions <NUM> and <NUM>, respectively, whereby relative rotation between the barrel <NUM> and the grip <NUM> is restricted.

Note that, although not illustrated, when the barrel <NUM> is biased in a rotational direction (here, clockwise) opposite to the rotational direction when the flange <NUM> is caused to enter the flange rotation restricting portion <NUM> in a state where the grip <NUM> is attached, one (here, the left flange straight portion <NUM> in <FIG>) of the pair of flange straight portions <NUM> and <NUM> abuts on the protrusion <NUM>, and a front end portion of the other (here, the right flange straight portion <NUM> in <FIG>) or a portion in the vicinity thereof abuts on the right second grip straight portion <NUM> in <FIG> [the grip <NUM> (flange housing portion <NUM>) and barrel <NUM> (flange <NUM>) are temporarily engaged with each other (second engagement state)]. Therefore, it is possible to prevent the grip <NUM> attached to the barrel <NUM> from unintentionally falling off. In other words, since the grip <NUM> is temporarily engaged with the barrel <NUM> (the first engagement state exists) when the flange <NUM> is caused to enter the flange rotation restricting portion <NUM> by rotating the barrel <NUM> by a predetermined angle in a state where the flange <NUM> is housed in the flange insertion portion <NUM>, the second engagement state occurs in the flange <NUM> once housed in the flange pivoting restriction portion <NUM>, and detachment of the grip <NUM> from the barrel <NUM> after attachment can be prevented.

Subsequently, the syringe <NUM> with the grip <NUM> attached to the barrel <NUM> is sterilized. In the present embodiment, since the drug <NUM> stored in the barrel <NUM> is a drug for ophthalmic use, which is relatively vulnerable to heat, surface sterilization (NO<NUM> sterilization) using a sterilization gas (here, NO<NUM> (nitrogen dioxide)) is performed.

As described above, the syringe <NUM> can be aseptically manufactured.

The grip <NUM> (flange housing portion <NUM>) of the present embodiment includes the flange rotation restricting portion <NUM> including the second pair of grip straight portions <NUM> and <NUM> that is inclined with respect to the first pair of grip straight portions <NUM> and <NUM> disposed in the flange insertion portion <NUM>, and in a state where the flange <NUM> is stored in the flange rotation restricting portion <NUM>, a part of the pair of flange straight portions <NUM> and <NUM> is located in the second pair of grip straight portions <NUM> and <NUM>. Therefore, relative rotation between the flange <NUM> (barrel <NUM>) and the grip <NUM> is restricted in a state where the grip <NUM> is attached to the syringe barrel <NUM>, and therefore operability is good.

Furthermore, in the grip <NUM> of the present embodiment, in a state where the flange <NUM> of the barrel <NUM> is housed in the flange rotation restricting portion <NUM> of the grip <NUM>, a lower inner peripheral surface of the grip <NUM> (an inner peripheral surface of the lower slit <NUM> of the lower plate portion <NUM> and/or an inner peripheral surface of the side wall portion <NUM>) is not in contact with the barrel <NUM>, and there is a gap <NUM> for allowing a sterilization gas to flow between the lower inner peripheral surface of the grip <NUM> and the barrel <NUM>. Therefore, the sterilization gas can be brought into contact with a wider area of surfaces of the grip <NUM> and the barrel <NUM>, and the syringe barrel grip <NUM> and the syringe barrel <NUM> to which such a grip <NUM> is attached are more reliably sterilized.

Note that, in the present embodiment, the cylindrical body <NUM> of the barrel <NUM> has a circular cylindrical shape in which the cross sections of the outer shape and the inner shape are substantially circular, but the present invention is not limited thereto. It is possible to appropriately use those having various cylindrical shapes in which the cross sections are elliptical, polygonal, and the like, those having different cross-sectional shapes between the outer shape and the inner shape, and the like, and the shape of the grip <NUM> (flange housing portion <NUM>) can also be appropriately changed accordingly.

In addition, as in a grip 30a illustrated in <FIG>, the side wall portion (<NUM>) does not have to be disposed. In the grip 30a, a lower plate portion 42a of a flange housing portion 32a constitutes a most distal end portion (lowest portion) of the grip 30a. As a result, the grip 30a can be further reduced in size and weight.

In a grip 30b illustrated in <FIG>, a lower plate portion 42b of a flange housing portion 32b is thicker than the grip 30a (lower plate portion 42a) described above. As a result, the strength of the grip 30b can be increased. In the grip 30b, as illustrated in <FIG>, an inner peripheral surface (inner shape) of the lower plate portion 42b (a barrel housing portion 47b of a lower slit 44b) expands downward. As a result, a flow of a sterilization gas between the grip 30b and the barrel <NUM> is further promoted while the strength of the grip 30b is increased by thickening the lower plate portion 42b, and the sterilization is more reliably performed.

In addition, as in a grip 30c illustrated in <FIG>, a right first grip straight portion 36c and a right second grip straight portion 37c in <FIG> in a flange housing portion 32c may be connected to each other as they are without forming the stepped portion (<NUM>).

In addition, as in a grip 30d illustrated in <FIG>, a right first grip straight portion 36d and a right second grip straight portion 37d in <FIG> in a flange housing portion 32d may be connected to each other at a gentle angle with an inclined stepped portion 39d.

In addition, although not illustrated, the protrusion <NUM> formed in the flange housing portion <NUM> is not limited to the exemplified one. For example, the protrusion <NUM> may be formed so as to protrude from the first grip straight portion <NUM> toward the inside of the flange housing portion <NUM>, and as for a formation portion thereof, the protrusion <NUM> may be formed at a middle portion of the first grip straight portion <NUM> instead of the end portion of the first grip straight portion <NUM> on the flange rotation restricting portion <NUM> side.

The syringe barrel grip of the present invention is attached to a syringe barrel including a cylindrical body and a flange disposed in the cylindrical body, protruding outward, and including a pair of flange straight portions facing each other in parallel. The grip of the present invention includes a flange housing portion that houses a flange, and the flange housing portion includes: a side surface opening formed on a side surface of the grip; a flange insertion portion extending in an internal direction of the grip from the side surface opening; and a flange rotation restricting portion that communicates with the flange insertion portion, extends into the grip, and restricts relative rotation between the grip and the flange that has entered the flange rotation restricting portion by rotating the barrel by a predetermined angle in a state where the flange is housed in the flange insertion portion.

Furthermore, the flange insertion portion of the grip of the present invention includes a first pair of grip straight portions having a slightly wider width than the pair of flange straight portions, the flange rotation restricting portion includes a second pair of grip straight portions having a slightly wider width than the pair of flange straight portions and is inclined with respect to the first pair of grip straight portions, and in a state where the flange is housed in the flange rotation restricting portion, front sides of the pair of flange straight portions are located in the second pair of grip straight portions, and rear sides of the pair of flange straight portions are located in the first pair of grip straight portions.

Therefore, in the syringe barrel grip, the barrel assembly, and the syringe of the present invention, relative rotation between the flange and the grip is restricted in a state where the grip is attached to the syringe barrel, and therefore operability is good.

Furthermore, in the grip of the present invention, in a state where the flange of the barrel is housed in the flange rotation restricting portion of the grip, a lower inner peripheral surface of the grip is not in contact with the barrel, and there is a gap for allowing a sterilization gas to flow between the lower inner peripheral surface of the grip and the barrel.

Therefore, in the syringe barrel grip, the barrel assembly, and the syringe of the present invention, the sterilization gas can be brought into contact with a wider area of surfaces of the grip and the barrel, and the syringe barrel grip and a syringe barrel to which such a grip is attached are more reliably sterilized.

Furthermore, the flange insertion portion of the grip includes a first pair of grip straight portions having a slightly wider width than the pair of flange straight portions, the flange rotation restricting portion includes a second pair of grip straight portions having a slightly wider width than the pair of flange straight portions and is inclined with respect to the first pair of grip straight portions, and in a state where the flange is housed in the flange rotation restricting portion, front sides of the pair of flange straight portions are located in the second pair of grip straight portions, and rear sides of the pair of flange straight portions are located in the first pair of grip straight portions.

Therefore, in the barrel assembly of the present invention, relative rotation between the flange and the grip is restricted in a state where the grip is attached to the syringe barrel, and therefore operability is good.

Furthermore, in the barrel assembly of the present invention, in a state where the flange of the barrel is housed in the flange rotation restricting portion of the grip, a lower inner peripheral surface of the grip is not in contact with the barrel, and there is a gap for allowing a sterilization gas to flow between the lower inner peripheral surface of the grip and the barrel.

Therefore, in the barrel assembly of the present invention, the sterilization gas can be brought into contact with a wider area of surfaces of the grip and the barrel, and the syringe barrel grip and a syringe barrel to which such a grip is attached are more reliably sterilized.

The syringe of the present invention includes a syringe barrel grip attached to a syringe barrel including a cylindrical body and a flange disposed in the cylindrical body, protruding outward, and including a pair of flange straight portions facing each other in parallel. The grip includes a flange housing portion that houses a flange, and the flange housing portion includes: a side surface opening formed on a side surface of the grip; a flange insertion portion extending in an internal direction of the grip from the side surface opening; and a flange rotation restricting portion that communicates with the flange insertion portion, extends into the grip, and restricts relative rotation between the grip and the flange that has entered the flange rotation restricting portion by rotating the barrel by a predetermined angle in a state where the flange is housed in the flange insertion portion.

Therefore, in the syringe of the present invention, relative rotation between the flange and the grip is restricted in a state where the grip is attached to the syringe barrel, and therefore operability is good.

Furthermore, in the syringe of the present invention, in a state where the flange of the barrel is housed in the flange rotation restricting portion of the grip, a lower inner peripheral surface of the grip is not in contact with the barrel, and there is a gap for allowing a sterilization gas to flow between the lower inner peripheral surface of the grip and the barrel.

Claim 1:
A syringe barrel grip (<NUM>) attached to a syringe barrel (<NUM>) including a cylindrical body and (<NUM>) a flange (<NUM>) disposed in the cylindrical body (<NUM>), protruding outward, and including a pair of flange straight portions (<NUM>; <NUM>) facing each other in parallel,
the grip (<NUM>; 30a; 30b; 30c; 30d) comprising a flange housing portion (<NUM>; 32a; 32b; 32c; 32d) that houses the flange (<NUM>), wherein
the flange housing portion (<NUM>; 32a; 32b; 32c; 32d) includes: a side surface opening (<NUM>) formed on a side surface of the grip (<NUM>); a flange insertion portion (<NUM>) extending in an internal direction of the grip (<NUM>) from the side surface opening (<NUM>); and a flange rotation restricting portion (<NUM>) that communicates with the flange insertion portion (<NUM>), extends into the grip (<NUM>), and restricts relative rotation between the grip (<NUM>) and the flange (<NUM>) that has entered the flange rotation restricting portion (<NUM>) by rotating the barrel (<NUM>) by a predetermined angle in a state where the flange (<NUM>) is housed in the flange insertion portion (<NUM>),
the flange insertion portion (<NUM>) includes a first pair of grip straight portions (<NUM>; <NUM>) having a wider width than the pair of flange straight portions (<NUM>; <NUM>), and the flange rotation restricting portion (<NUM>) includes a second pair of grip straight portions (<NUM>; <NUM>) having a wider width than the pair of flange straight portions (<NUM>; <NUM>) and is inclined with respect to the first pair of grip straight portions (<NUM>; <NUM>),
in a state where the flange (<NUM>) is housed in the flange rotation restricting portion (<NUM>), front sides of the pair of flange straight portions (<NUM>; <NUM>) are located in the second pair of grip straight portions (<NUM>; <NUM>), and rear sides of the pair of flange straight portions (<NUM>; <NUM>) are located in the first pair of grip straight portions (<NUM>; <NUM>), and
in a state where the flange (<NUM>) of the barrel (<NUM>) is housed in the flange rotation restricting portion (<NUM>) of the grip (<NUM>), a lower inner peripheral surface of the grip (<NUM>) is not in contact with the barrel (<NUM>), and there is a gap (<NUM>) for allowing a sterilization gas to flow between the lower inner peripheral surface of the grip (<NUM>) and the barrel (<NUM>).