WO2011068130A1 - Pre-filled syringe - Google Patents

Abstract

A pre-filled syringe (1) is provided with: an outer tube (2); a medical liquid container (7) which is disposed within the outer tube (2); a pusher (3) which is provided in the outer tube (2) so as to be movable in the axial direction of the outer tube (2); an insertion needle (6); a needle support section (4) which supports the insertion needle (6); a contact section (5) which is provided at the front end of the outer tube (2) so as to surround the needle tip (61) at the front end of the insertion needle (6), and which can make contact with the surface of a living body; and a protective member (8). The medical liquid container (7) is provided with a container body (71) which is configured of a soft bag, and a medial liquid is previously contained within a liquid holding section (72) of the container body (71). A pair of openings (21) is formed, so as to face each other, in the side wall of the outer tube (2) at positions corresponding to the liquid holding section (72).

Description

Prefilled syringe

The present invention relates to a prefilled syringe containing a chemical solution.

Many vaccinations that administer vaccines to prevent infections such as influenza are performed by subcutaneous injection. In particular, children may move without stabbing, and because the skin is soft, the puncture needle of a syringe There is a possibility that puncture cannot be performed at the puncture depth targeted.

Therefore, in order to solve such problems, there has been proposed a puncture needle assembly in which a tubular body is provided on a puncture needle hub so as to surround the puncture needle (see, for example, Patent Document 1). According to this puncture needle assembly, when the tip of the cylindrical body abuts on the epidermis, the positional relationship between the puncture needle and the epidermis is regulated, and the puncture needle can be punctured to a target puncture depth.

However, with conventional syringes, it is necessary to make preparations such as sucking the vaccine into the syringe at the time of vaccination, and it takes time and effort to prepare. , Vaccines can be wasted.

It is expected that the dose of the vaccine is reduced by administering the vaccine to the upper skin layer where many immunocompetent cells are present, not subcutaneously. The upper skin layer refers to the epidermis and dermis (dermis layer) of the skin.

Also, as a dental syringe, there is known a type of syringe that is used by mounting a chemical cartridge containing a chemical (for example, see Patent Document 2). In use, this syringe is used with a chemical cartridge and a double-ended needle attached to the syringe body. In addition, the syringe body is repeatedly used a plurality of times by performing sterilization treatment, and the drug solution cartridge and the double-ended needle are used only once and are disposable.

Since the conventional dental syringe is a type that is used with a chemical liquid cartridge attached, the chemical liquid can be prevented from being wasted and can be easily prepared during use.

By the way, when using a prefilled syringe containing a chemical solution in which a precipitate is generated, it is necessary to agitate the chemical solution before administration of the chemical solution. In a prefilled syringe, generally, the inside is filled with a gas such as air together with a chemical solution, and by shaking the prefilled syringe so that its vertical direction is alternately reversed, the air inside moves, The chemical solution can be easily stirred.

However, for the purpose of improving ease of use, air is filled in the case of products that do not require air venting during use, or products that contain chemicals whose medicinal effects are reduced by contact with air. For this reason, there is a drawback that the chemical solution cannot be stirred even if a precipitate is formed in the chemical solution.

Also, for example, when the amount of stored chemical solution is small, as in the case of administering a vaccine as a drug solution, the drug solution cannot be stirred even if it is filled with air.

JP 2000-37456 A JP 2002-159575 A

The objective of this invention is providing the prefilled syringe which can stir a chemical | medical solution easily and reliably.
In order to achieve the above object, the present invention comprises an outer cylinder,
A chemical solution container provided with a container main body having a soft part that is installed in the outer cylinder and stores the chemical solution;
A prefilled syringe comprising a pusher that is movably installed with respect to the outer cylinder and that presses and deforms the soft portion by the movement.

In the prefilled syringe of the present invention, it is preferable that the prefilled syringe has an operation unit that performs an operation of deforming the soft portion from the outside of the outer cylinder and stirring the chemical solution.

In the prefilled syringe of the present invention, it is preferable that the operation portion has an opening formed in a side wall of the outer cylinder.

In the prefilled syringe of the present invention, it is preferable that the operation portion has a pair of openings formed on a side wall of the outer cylinder and arranged to face each other with the soft portion interposed therebetween.

In the prefilled syringe of the present invention, it is preferable that the soft part is a bag-like soft bag in which the chemical solution is stored.

In the prefilled syringe of the present invention, it is preferable that one end has a needle tip capable of puncturing a living body and the other end is provided with a puncture needle capable of communicating with the inside of the soft bag.

In the prefilled syringe of the present invention, the container main body removably adheres to the inner surfaces of the soft bag, and the inside of the container main body contains a first space in which the chemical solution is stored, and the first space. It has a weak seal part that partitions into a second space located on the tip side,
The proximal end side of the puncture needle communicates with the second space,
It is preferable that the base end side of the puncture needle communicates with the first space when the weak seal portion is peeled off.

In the prefilled syringe of the present invention, when the pusher is moved in the distal direction, the soft bag is pressed and deformed, the weak seal portion is peeled off, and the proximal end side of the puncture needle communicates with the first space. And it is preferable that the said chemical | medical solution is discharged | emitted from the needle point of the said puncture needle.

In the prefilled syringe of the present invention, it is preferable to have a contact portion provided on the distal end side of the outer cylinder, spaced apart from the needle tip of the puncture needle in the radial direction of the puncture needle and capable of contacting the surface of the living body. .

In the prefilled syringe of the present invention, it is preferable that the prefilled syringe has a protective member for sealing the space inside the abutting portion, and the aseptic state of the space inside the abutting portion is held in an unused state. .

In the prefilled syringe of the present invention, it is preferable that the prefilled syringe includes a needle support portion having a convex portion that supports the puncture needle and can come into contact with the surface of the living body.

FIG. 1 is a partial longitudinal sectional view showing a first embodiment (a state in which a protective member is removed) of a prefilled syringe of the present invention. FIG. 2 is a partial longitudinal sectional view showing a state in which the protective member of the prefilled syringe shown in FIG. 1 is mounted. FIG. 3 is a view for explaining the procedure for assembling the prefilled syringe shown in FIG. 1. FIG. 4 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. FIG. 5 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. FIG. 6 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. FIG. 7 is a perspective view showing an outer cylinder in the second embodiment of the prefilled syringe of the present invention.

Hereinafter, the prefilled syringe of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

Although the present invention can be applied to a prefilled syringe that administers various chemicals to a living body, in the following embodiment, the present invention is typically applied to a prefilled syringe that administers a vaccine. Will be described.

<First Embodiment>
FIG. 1 is a partial longitudinal sectional view showing a first embodiment of the prefilled syringe of the present invention (a state in which a protective member is removed), and FIG. 2 is a partial longitudinal section showing a state in which the protective member of the prefilled syringe shown in FIG. FIG. 3 is a diagram for explaining a procedure for assembling the prefilled syringe shown in FIG. 1, and FIGS. 4 to 6 are partial longitudinal sectional views for explaining a method of using the prefilled syringe shown in FIG. FIG. FIG. 3F is a cross-sectional view taken along line AA in FIG.

In the following description, the upper side in FIGS. 1 to 6 is referred to as “base end”, the lower side as “tip”, the right side as “right”, and the left side as “left”. 5 and FIG. 6, illustration of the living body is omitted.

As shown in FIGS. 1 and 2, the prefilled syringe 1 includes an outer cylinder (syringe outer cylinder) 2, a chemical solution container 7 installed in the outer cylinder 2, and an axis of the outer cylinder 2 with respect to the outer cylinder 2. The pusher 3 movably installed along the direction (longitudinal direction), the puncture needle 6, the needle support portion 4 that supports the puncture needle 6, and the distal end side of the puncture needle 6 on the distal end side of the outer cylinder 2 A contact portion 5 provided so as to surround the needle tip 61 and capable of contacting the surface of the living body, and a protective member (cap) 8 are provided.

The outer cylinder 2 is a cylindrical member, which is a cylindrical member in the illustrated configuration. And in this embodiment, the chemical | medical solution container 7 is accommodated in this outer cylinder 2, and is being fixed to the front end side of the outer cylinder 2. FIG.

The constituent material of the outer cylinder 2 is not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene- Various resins such as styrene copolymers, polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be mentioned. Resin such as polypropylene, cyclic polyolefin, polyester, and poly- (4-methylpentene-1) is preferable because it is easy to mold. In addition, it is preferable that the constituent material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.

The chemical liquid container 7 has a container main body (main body of the chemical liquid container) 71, and the chemical liquid is stored in advance in the container main body 71 in a liquid-tight (air-tight) manner.

That is, the container main body 71 is constituted by a bag-like soft bag, and is formed by fixing the inner surfaces of the container main body 71 in a strip shape in the middle of the container main body 71 in the vertical direction in FIG. A weak seal portion 74 is formed. The inside of the container body 71 is partitioned by the weak seal portion 74 into a first space 76 on the proximal end side and a second space 77 on the distal end side. The weak seal portion 74 can be formed, for example, by fusing the inner surfaces of the container body 71 (thermal fusion, high frequency fusion, ultrasonic fusion, etc.).

A portion of the container body 71 on the tip side of the weak seal portion 74, that is, a portion that defines the first space 76 of the container body 71 is a liquid retaining portion 72 that is a soft portion (soft bag). In the space 76, a chemical solution is stored. The first space 76 is a hermetically sealed space that is kept sterile. In the configuration shown in the drawing, the external shape of the liquid retaining portion 72 is circular when viewed from a direction perpendicular to the paper surface in FIG. A polygon, an ellipse, etc. may be sufficient.

Further, the central portion of the base end portion of the mounting portion 73 that is the base end side portion of the weak seal portion 74 of the container body 71 is fixed to the convex portion 43 of the needle support portion 4 to be described later. The inner surfaces of the remaining portions of the base end portion are fixed to each other, whereby a strong seal portion 75 is formed at the base end portion of the mounting portion 73 (see FIG. 3F). The strong seal portion 75 can be formed by, for example, fusing the inner surface of the container main body 71 and the outer surface of the convex portion 43, and fusing the inner surfaces of the container main body 71 together.

In this way, the second space 77 is defined, and the proximal end side of the puncture needle 6 communicates with the second space 77. The second space 77 is a hermetically sealed space except for a proximal end opening 62 of the puncture needle 6 which will be described later, and the aseptic state is maintained in a state where the protective member 8 is attached to the contact portion. ing. In addition, the dimension of the attachment part 73 is set smaller than the liquid retaining part 72.

Here, the weak seal portion 74 is peeled off by, for example, pressing (pressing) the liquid retaining portion 72 of the container body 71 with the pusher 3 and increasing the internal pressure of the first space 76 to a predetermined threshold value or more. Is configured to do. The threshold value is set to a value higher than the internal pressure of the first space 76 when the liquid retaining part 72 is deformed and the chemical liquid in the liquid retaining part 72 is stirred. Thereby, it is possible to prevent the weak seal portion 74 from being peeled when the liquid retaining portion 72 is deformed and the chemical liquid in the liquid retaining portion 72 is stirred.

In addition, you may comprise so that the weak seal part 74 may peel by raising the internal pressure of the 2nd space 77 (not shown).

Further, the weak seal portion 74 is not limited to the case where the weak seal portion 74 is formed entirely from the right end portion to the left end portion in FIG. 1 of the container body 71, but the right end portion in FIG. To the left end portion.

The constituent material of the container main body 71 (particularly, the liquid retaining part 72) is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, olefin elastomer, styrene elastomer, etc. And various combinations of these (e.g., blend resins, polymer alloys, laminates). These resin materials are preferable in that they are rich in flexibility and transparency, and have heat resistance and water resistance that can withstand high-pressure steam sterilization (autoclave sterilization). In addition, it is preferable that the constituent material of the container main body 71 is substantially transparent in order to ensure internal visibility.

Particularly preferred as the constituent material of the container body 71 are polyethylene, polypropylene, styrene elastomer such as styrene-butadiene copolymer and styrene-ethylene-butylene-styrene block copolymer, ethylene-butene copolymer, A soft resin obtained by blending an elastomer such as an olefin-based elastomer such as an ethylene-propylene copolymer and softening can be given. This material is preferable in that it has high strength and flexibility, heat resistance (particularly heat resistance during sterilization) and water resistance, and is particularly excellent in workability and can reduce manufacturing costs. Furthermore, since two or more kinds of materials having different melting points (softening points) are used, setting of seal conditions between the strong seal portion 75 and the weak seal portion 74 and stabilization of the seal strength of the weak seal portion 74 are performed. Can be carried out easily and satisfactorily.

The thickness of the sheet material constituting the container main body 71 is not particularly limited, and varies depending on other conditions such as the material, but is usually about 0.01 to 0.30 mm, preferably 0.05 to More preferably, it is about 0.15 mm.

Moreover, as a chemical | medical solution accommodated in the 1st space 76 of the chemical | medical solution container 7, in this embodiment, although various vaccines which prevent various infections, such as influenza, are mentioned, in this invention, a vaccine is mentioned. Is not limited. In addition to vaccines, for example, glucose injection solutions such as glucose, electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, antibiotic injection solutions, contrast agents, steroid agents, proteolytic enzyme inhibitors, fat Emulsions, anticancer agents, anesthetics, stimulants, narcotics, heparin calcium, antibody drugs and the like can be mentioned.

Further, the amount of the chemical solution stored in the first space 76 (volume of the first space 76) is not particularly limited, but is preferably about 0.02 to 2.0 mL, for example, 0.05 to 0.8 mL. The degree is more preferable. That is, the prefilled syringe 1 is particularly suitable when such a small amount of drug solution is administered.

In addition, the first space 76 may be filled with a gas such as air together with the chemical solution, or may not be filled. The filling and non-filling of air can be appropriately selected as necessary.

Here, in the prefilled syringe 1, a pair of openings 21 are formed on the side wall of the outer cylinder 2 as an operation part that performs an operation of deforming the liquid retaining part 72 from the outside of the outer cylinder 2 and stirring the chemical liquid. Yes. The pair of openings 21 is formed at a position corresponding to the liquid retaining part 72 on the side wall of the outer cylinder 2, that is, in the vicinity of the liquid retaining part 72. Further, the pair of openings 21 are disposed so as to face each other with the liquid retaining portion 72 interposed therebetween. A finger can be inserted into the outer cylinder 2 from the opening 21 and the liquid retaining portion 72 can be deformed by the finger or the like to stir the drug solution.

The shape of the opening 21 is circular in the illustrated configuration, but is not limited to this, and may be, for example, a polygon such as a quadrangle, an ellipse, or the like.

The dimensions of the opening 21 are not particularly limited, and are appropriately determined according to various conditions such as the dimensions of the outer cylinder 2 and the liquid retaining part 72.

Specifically, the diameter of the opening 21 is preferably a minimum size that allows a finger to reach the chemical liquid container 7 and deform the liquid retaining portion 72. That is, the diameter of the opening 21 is preferably about 10 to 20 mm, and more preferably about 13 to 17 mm.

The opening 21 may be covered with a soft sheet (not shown). Further, as this sheet, for example, a filter for sterilization that allows air to pass but does not allow bacteria to pass may be used. Also in this case, the chemical solution can be stirred by deforming the liquid retaining portion 72 through the sheet.

The pusher 3 is an operation member that pushes and deforms the liquid retaining portion 72 of the chemical liquid container 7 by moving the pusher 3 in the distal direction along the axial direction with respect to the outer cylinder 2.

The pusher 3 has a bar-shaped main body 31 whose cross section is circular, for example. The front end of the main body 31 is a part that comes into contact with the liquid retaining part 72 and is rounded. Thereby, the front-end | tip part of the main-body part 31 can press and deform the liquid holding part 72 reliably, without damaging the liquid holding part 72. FIG.
A disc-shaped flange 32 is formed at the base end of the main body 31.

The constituent material of the pusher 3 is not particularly limited, but for example, the same constituent material as that of the outer cylinder 2 can be used.

In addition, the main body 31 of the pusher 3 and the outer cylinder 2 may be provided with a detachment prevention means (not shown) that prevents the pusher 3 from detaching from the outer cylinder 2.

The puncture needle 6 has a sharp needle tip 61 that can puncture a living body on the distal end side, and a base that can communicate with the inside of the liquid retaining portion 72 of the drug solution container 7, that is, the first space 76, on the proximal end side. An end opening 62 is provided. When the weak seal portion 74 of the drug solution container 7 is peeled off, the proximal end opening 62 of the puncture needle 6 communicates with the first space 76 via the second space 77.

As the puncture needle 6, a needle having a size of 26 to 33 G (outer diameter: 0.2 to 0.45 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)) is used. It is preferable to use one having a size of 30 to 33G.

A cutting edge having a blade surface is formed on the distal end side of the puncture needle 6, and the axial length (hereinafter referred to as “bevel length”) B of the puncture needle 6 on the blade surface is the maximum of the upper layer portion of the skin. The thickness is preferably 1.4 mm (adult) or less, which is a thin thickness, and is preferably about 0.5 mm or more which is the bevel length when a short bevel is formed on a 33G puncture needle. That is, the bevel length B is preferably set within a range of 0.5 to 1.4 mm.

Furthermore, the bevel length B is more preferably 0.9 mm (child) or less, which is the thinnest thickness of the upper skin layer. That is, the bevel length B is more preferably set within a range of 0.5 to 0.9 mm.

Further, the depth (puncture depth) of the puncture needle 6 to be punctured on the upper skin portion is the length of the portion of the puncture needle 6 that protrudes from the distal end surface of the convex portion 42 described later (hereinafter referred to as “projection length”). Say) determined by L.

The thickness of the upper skin layer portion corresponds to the depth from the surface of the skin to the dermis layer, and is generally 0.5 to 3.0 mm. Therefore, the protruding length L of the puncture needle 6 is 0.5 to 3.0 mm. It is preferable to set within the range.

By the way, the administration site of influenza vaccine is generally the deltoid muscle. The thickness of the upper skin layer in the pediatric deltoid muscle is 0.9 to 1.6 mm, and the upper skin thickness in the adult deltoid muscle is 1.4 to 2.6 mm in the distal portion. The central portion is 1.4 to 2.5 mm, and the proximal portion is 1.5 to 2.5 mm. Considering these, when the prefilled syringe 1 is used when administering a vaccine to the deltoid muscle, the protruding length L of the puncture needle 6 can be set within a range of 0.9 to 1.4 mm.

The constituent material of the puncture needle 6 is not particularly limited. For example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, superelastic alloy such as Ni-Ti alloy, and various hard materials such as polyphenylene sulfide. Resin material etc. are mentioned.

The needle support portion 4 includes a base portion 40, a convex portion 42 fixed to the central portion of the distal end surface of the base portion 40, and a convex portion 43 fixed to the central portion of the base end surface of the base portion 40. It is fixed to the tip (tip part). In the illustrated configuration, the base portion 40 has a disk shape, and the convex portions 42 and 43 each have a columnar shape. The tip surface of the convex portion 42 is a part that comes into contact with the surface (skin) of a living body when a drug solution is administered (when the puncture needle 6 is punctured), and the shape of the tip surface is relative to the axis of the puncture needle 6. Vertical plane. In addition, the base 40 and any one or both of the convex part 42 and the convex part 43 may be formed integrally. Further, the needle support portion 4 may be formed integrally with the outer cylinder 2.

The puncture needle 6 is fixed to the center portion of the needle support portion 4 and supported by the base portion 40 and the convex portions 42 and 43, and the needle tip 61 on the distal end side is located on the distal end side with respect to the needle support portion 4. is doing. Further, in the configuration shown in the figure, the proximal end opening 62 of the puncture needle 6 is located on the proximal end side with respect to the convex portion 43, but if the proximal end opening 62 communicates with the second space 77, Not limited to this, the proximal end opening 62 may coincide with the proximal end surface of the convex portion 43, or may be located on the distal end side with respect to the proximal end surface of the convex portion 43.

Since the needle support part 4 has the convex part 42, when the puncture needle 6 is punctured into a predetermined part of the living body, the convex part 42 comes into contact with the epidermis, whereby the epidermis is brought into contact with the axis of the puncture needle 6. The needle tip 61 of the puncture needle 6 can be punctured so as to be perpendicular to the epidermis.

The distance S from the outer peripheral edge (outer peripheral surface) of the convex portion 42 to the outer peripheral surface of the puncture needle 6 is preferably set to 1.4 mm or less, and is set within a range of 0.3 to 1.4 mm. Is more preferable. This distance S is set in consideration of the pressure applied to the blisters formed by administering the drug solution to the upper skin layer. That is, the distance S is set so that the size of the tip surface of the convex portion 42 is sufficiently smaller than the blisters formed on the upper skin layer and does not hinder the formation of the blisters. Thereby, it can prevent that the chemical | medical solution administered when the convex part 42 pressed the epidermis around the puncture needle 6 leaks.

Further, the base 40 of the needle support portion 4 has a portion that comes into contact with the epidermis when the puncture needle 6 is punctured. When the puncture needle 6 is punctured, the abutment portion 5 and the puncture needle 6 press the epidermis by pressing the abutment portion 5 against the epidermis until the portion of the base 40 that abuts against the epidermis abuts the epidermis. Can be secured above a predetermined value. Thereby, the site | part (part corresponding to the protrusion length L) which protrudes from the front end surface of the convex part 42 of the puncture needle 6 is punctured reliably in skin.

The distance Y from the distal end surface (lower end surface) of the base portion 40 to the distal end surface of the contact portion 5 is such that when the puncture needle 6 is punctured, the contact portion 5 and the puncture needle 6 press the epidermis with an appropriate pressing force. The puncture needle 6 is set so as to be punctured reliably. This distance Y is appropriately determined based on the inner diameter d of the contact portion 5 and the distance X from the outer wall surface (outer peripheral surface) of the base portion 40 to the outer wall surface (outer peripheral surface) of the contact portion 5. For example, when the inner diameter d is 11 mm and the distance X is 0.5 mm, the distance Y is preferably set within a range of 0.75 to 2.6 mm. As a result, the pressing force with which the abutment portion 5 and the puncture needle 6 press the epidermis is reliably transmitted (guided) to the epidermis by the base portion 40, and the needle tip 61 of the puncture needle 6 is reliably positioned on the upper skin portion. be able to.

Although it does not specifically limit as a constituent material of the needle support part 4, For example, the thing similar to the constituent material of the said outer cylinder 2 can be used.

The abutting portion 5 has a cylindrical shape, a cylindrical shape in the illustrated configuration, and is fixed to the tip surface (tip portion) of the base portion 40 of the needle support portion 4. In this case, the contact portion 5 is provided away from the needle tip 61 on the distal end side of the puncture needle 6 in the radial direction of the puncture needle 6.

The distal end surface of the abutment portion 5 is located on the proximal end side with respect to the distal end side of the puncture needle 6 and on the proximal end side with respect to the distal end surface of the convex portion 42. When puncturing the puncture needle 6, first, the tip surface of the convex portion 42 contacts the epidermis, and then the tip surface of the contact portion 5 contacts the epidermis. Thus, when the front end surface of the contact part 5 contacts the epidermis, the prefilled syringe 1 is stabilized, and the puncture needle 6 can be maintained in a posture perpendicular to the epidermis.

The tip surface of the contact portion 5 may be located at the same position as the tip surface of the convex portion 42 (on the same plane as the tip surface of the convex portion 42) in the axial direction of the puncture needle 6, You may be located in the front end side rather than the front end surface of the convex part 42. FIG. In these cases as well, the puncture needle 6 can be maintained in a posture perpendicular to the epidermis.

Further, in consideration of the swelling of the epidermis when the abutment portion 5 is pressed against the epidermis, the distance r between the distal end surface of the abutment portion 5 and the distal end surface of the convex portion 42 in the axial direction of the puncture needle 6 is 1.3 mm. It is preferable to set as follows.

The distance T from the inner wall surface (inner circumferential surface) of the contact portion 5 to the outer peripheral edge of the convex portion 42 is preferably set to 4 mm or more, and there is no particular upper limit. However, since the outer diameter of the contact portion 5 increases corresponding to the distance T, if the distance T is too large, when the puncture needle 6 is inserted into a thin arm such as a child, the contact portion 5 It becomes difficult to bring the entire tip surface into contact with the epidermis. Therefore, the distance T is preferably set to 15 mm or less in consideration of the thinness of the child's arm and the like. That is, the distance T is preferably set within a range of 4 to 15 mm.

Further, the inner diameter d of the contact portion 5 is preferably set to a value equal to or larger than the diameter of the blister formed in the upper skin layer. In addition, if the distance S from the outer periphery of the convex part 42 to the outer peripheral surface of the puncture needle 6 is 0.3 mm or more, the convex part 42 does not enter the skin. Therefore, considering the preferable value (4 mm or more) of the distance T from the inner wall surface of the contact part 5 to the outer peripheral edge of the convex part 42 and the preferable value (0.3 mm or more) of the distance S, the contact part 5 The inner diameter d is preferably set to 9 mm or more.

When administering the drug solution, as shown in FIGS. 4 (a) and 4 (b), the front end surface of the contact portion 5 and the front end surface of the convex portion 42 are brought into contact with the epidermis in the target region of the living body, Press with strength. As a result, the epidermis of the part that is not in contact with the distal end surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the distal end surface of the convex part 42 is puncture needle 6. The needle tip 61 on the distal end side of the puncture needle 6 is punctured into the living body. The puncture depth of the puncture needle 6 is such that the positional relationship between the puncture needle 6 and the epidermis is regulated by the front end surface of the contact portion 5 and the front end surface of the convex portion 42 being in contact with the epidermis. Become deep.

Although it does not specifically limit as a constituent material of the contact part 5, For example, the thing similar to the constituent material of the said outer cylinder 2 can be used.

As shown in FIG. 2, the protection member 8 is a member that seals the space 52 inside the contact portion 5, and is detachably attached to the contact portion 5 in an unused state.

The protection member 8 has a bottomed cylindrical shape having a bottom portion on the front end side, or a bottomed cylindrical shape in the illustrated configuration. When the protection member 8 is attached to the contact portion 5, the contact portion 5 is configured such that the inner space 52 is hermetically sealed.

In the unused state, the space 52 inside the contact portion 5 is hermetically sealed by the protective member 8, thereby sealing the space 52 and holding the sterile body of the space 52.

Further, when the prefilled syringe 1 is used, the protective member 8 is removed from the contact portion 5 as shown in FIG. Thereby, sealing of the space 52 inside the contact part 5 is cancelled | released.

Although it does not specifically limit as a constituent material of the protection member 8, For example, it is using elastic materials, such as various rubber materials, various thermoplastic elastomers, or those mixtures, and the same material as the constituent material of the said outer cylinder 2. FIG. it can.

In the prefilled syringe 1, the necessary members are sterilized, and then the protective member 8 is attached to the contact portion 5, whereby the space 52 inside the contact portion 5, the puncture needle 6, and the drug solution container 7. The aseptic condition of the second space 77 is maintained.

Next, an example of the procedure for assembling the prefilled syringe 1 will be described.
First, as shown in FIG. 3 (a), a container main body 71, which is a bag-like soft bag molded into a predetermined shape, is prepared. As shown in FIG. Fill the amount of chemical solution. Thereby, the chemical | medical solution container 7 with which the chemical | medical solution was accommodated in the 1st space 76 is obtained.

Next, as shown in FIG. 3C, the inner surfaces of the boundary portion between the liquid retaining portion 72 and the mounting portion 73 of the container main body 71 are fused so as to be peelable by, for example, heat fusion, and the weak seal portion. 74 is formed.

Next, as shown in FIG. 3D, a needle support portion 4 to which the contact portion 5 and the puncture needle 6 are fixed is prepared, and a protective member 8 is attached to the contact portion 5.

Next, as shown in FIGS. 3 (e) and 3 (f), the chemical solution container 7 is installed so that the attachment portion 73 covers the convex portion 43 of the needle support portion 4, and the proximal end portion of the attachment portion 73 is installed. The inner surface of the central portion, the convex portion 43, and the inner surfaces of the remaining portions of the base end portion of the attachment portion 73 are firmly fused together by, for example, heat fusion to form the strong seal portion 75. Thereby, the attachment portion 73 is fixed to the convex portion 43, and the second space 77 of the drug solution container 7, the lumen of the puncture needle 6, and the space 52 inside the contact portion 5 are integrally and airtight. Sealed.

Next, as shown in FIG. 2, the outer cylinder 2 is put on the chemical container 7, the chemical container 7 is accommodated in the outer cylinder 2, and the proximal end surface of the base 40 of the needle support portion 4 and the distal end of the outer cylinder 2 are attached. For example, fusion is performed by ultrasonic heat fusion or the like. Then, the pusher 3 is inserted into the outer cylinder 2. This completes the assembly of the prefilled syringe 1.

The pusher 3 may be inserted into the outer cylinder 2 when the prefilled syringe 1 is used.

Next, an example of how to use the prefilled syringe 1 will be described.
[1] When using the prefilled syringe 1, first, as shown in FIG. 1, the protective member 8 is removed from the contact portion 5 of the prepared prefilled syringe 1.

And, for example, when the components of the chemical solution are settled, the chemical solution is agitated as necessary. When stirring the chemical solution, a finger is inserted into the outer cylinder 2 from the pair of openings 21, and the liquid retaining portion 72 of the chemical solution container 7 is squeezed and deformed by the finger a predetermined number of times. Thereby, a chemical | medical solution is stirred and a sediment dissolves. The preparation for administering the drug solution is thus completed.

In this prefilled syringe 1, the liquid medicine 72 can be deformed as described above, whereby the chemical liquid can be stirred easily and reliably. In this case, for example, even when the first space 76 is not filled with a gas such as air or when the amount of the stored chemical solution is small, the liquid holding unit 72 is deformed to reliably stir the chemical solution. Can do.

Thus, with this prefilled syringe 1, preparations for administration of a drug solution can be made easily and quickly.

[2] Next, as shown in FIGS. 4 (a) and 4 (b), the front end surface of the contact portion 5 and the front end surface of the convex portion 42 are applied to the epidermis at a site where a chemical solution such as an arm is administered. Touch and press with a predetermined strength. As a result, the epidermis of the part that is not in contact with the distal end surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the distal end surface of the convex part 42 is puncture needle 6. The needle tip 61 on the distal end side of the puncture needle 6 is punctured into the living body. At this time, the needle tip 61 reaches the dermis by restricting the positional relationship between the puncture needle 6 and the epidermis by the contact portion 5 and the convex portion 42. Thus, with this prefilled syringe 1, the needle tip 61 of the puncture needle 6 can be punctured into the dermis easily and reliably.

[3] Next, a finger is applied to the flange 32 of the pusher 3, and the pusher 3 is pressed in the distal direction, that is, moved. As a result, as shown in FIG. 5, the liquid retaining part 72 of the chemical liquid container 7 is pressed at the tip of the pusher 3, the liquid retaining part 72 is deformed, and the internal pressure of the first space 76 is changed to the predetermined value described above. When the threshold is reached, the weak seal 74 is peeled off. As a result, the proximal end opening 62 of the puncture needle 6 communicates with the first space 76 via the second space 77 of the drug solution container 7.

When the pusher 3 is further pressed in the distal direction, as shown in FIG. 5, the liquid retaining portion 72 is further pressed and deformed by the distal end portion of the pusher 3 and is stored in the first space 76. Passes through the puncture needle 6, is discharged from the needle tip 61, and is administered to the target site.

As described above, according to the prefilled syringe 1, the chemical liquid container 7 in which a necessary amount of the chemical liquid is stored is provided, so that waste of the chemical liquid can be prevented and it is economical.

In addition, the drug solution container 7 and the puncture needle 6 are installed in advance, and in a unused state, the space 52 inside the contact portion 5 in which the puncture needle 6 is disposed and the second space 77 of the drug solution container 7. Therefore, preparation for administration of the drug solution can be easily and quickly performed by simply removing the protective member 8.

In particular, when preparing to administer the chemical solution, the chemical solution can be easily and reliably agitated by deforming the liquid retaining portion 72 of the chemical solution container 7.

In addition, when the drug solution is administered, the positional relationship between the puncture needle 6 and the epidermis is regulated by the front end surface of the abutment portion 5 and the front end surface of the convex portion 42 coming into contact with the epidermis. Furthermore, the puncture needle 6 can be punctured to a target puncture depth.

Further, since the liquid medicine 72 is pressed and deformed to discharge the liquid medicine from the needle tip 61 of the puncture needle 6, there is no need to provide a sliding part such as a gasket on the pusher 3, Thereby, the pusher 3 can be easily moved and operated with a relatively weak force, and a drug solution can be administered.

Further, when it is not desired to fill the first space 76 of the chemical solution container 7 with air, when the chemical solution is stored in the first space 76, the liquid retaining portion 72 is deformed to easily prevent air from entering. be able to.

In the present embodiment, the number of openings 21 is two. However, in the present invention, the number of openings 21 is not limited to this, and may be one, or may be three or more. .

In the present invention, a vent hole (venting means) (not shown) penetrating the needle support portion 4 may be formed in the needle support portion 4. For example, the air holes are formed at positions where the convex portions 42 and 43 of the base portion 40 are absent. By this vent hole, the space in the outer cylinder 2 on the proximal side relative to the needle support portion 4, that is, the space surrounded by the outer cylinder 2, the needle support portion 4 and the pusher 3, and the inner side of the contact portion 5. The space 52 communicates. The number of the air holes may be one or plural.

Further, in the present invention, a vent hole (not shown) penetrating the contact portion 5 may be formed in the contact portion 5. For example, the vent hole is formed as a side hole in the side wall of the contact portion 5. With this air hole, the space 52 inside the contact portion 5 communicates with the outside in a contact state in which the tip surface of the contact portion 5 is in contact with the surface of the living body. On the other hand, when the protective member 8 is attached to the contact portion 5, the vent hole is closed. The number of the air holes may be one or plural.

Second Embodiment
FIG. 7 is a perspective view showing an outer cylinder in the second embodiment of the prefilled syringe of the present invention. In the following description, the upper side in FIG. 7 is referred to as “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”.

Hereinafter, the second embodiment will be described with a focus on differences from the first embodiment described above, and description of similar matters will be omitted.

As shown in FIG. 7, in the prefilled syringe 1 of the second embodiment, the outer cylinder 2 is connected by a pair of support columns 22 at the distal end side of the outer cylinder 2, that is, at a position corresponding to the liquid retaining portion 72. Yes. Thereby, a pair of openings 21 is formed at a position corresponding to the liquid retaining portion 72 on the side wall of the outer cylinder 2.

Further, the pair of support columns 22 are arranged so as to face each other via the liquid retaining part 72, and thereby the pair of openings 21 are formed to face each other via the liquid retaining part 72. The

In addition, in this embodiment, the number of support | pillars 22 is two, However, In this invention, the number of support | pillars 22 is not limited to this, For example, three or more may be sufficient.

According to this prefilled syringe 1, the same effect as the first embodiment described above can be obtained.

As mentioned above, although the prefilled syringe of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is substituted by the thing of the arbitrary structures which have the same function. be able to. In addition, any other component may be added to the present invention.

Further, the present invention may be a combination of any two or more configurations of the above embodiments.

Moreover, in the said embodiment, although the container main body 71 whole of the chemical | medical solution container 7 is comprised with the soft bag, in this invention, if at least one part of the site | part in which the chemical | medical solution of the container main body 71 is accommodated is a soft part. For example, only the liquid retaining part 72 may be configured by a soft bag or the like.

Further, in the present invention, for example, without forming an opening in the outer cylinder 2 (without providing an operation portion), the soft part of the chemical liquid container 7 is deformed by a predetermined member such as the pusher 3 to stir the chemical liquid. May be.

In the present invention, for example, a double-ended needle may be used as the puncture needle 6.
Moreover, in the said embodiment, although the cap was used as the protection member 8 which seals the space 52 inside the contact part 5, in this invention, it is not limited to this, For example, a film etc. may be used. .

The use of the prefilled syringe of the present invention is not limited to vaccine administration, and can be applied to prefilled syringes for administering various chemical solutions.

According to the present invention, since the container body of the chemical solution container has a soft portion, the chemical solution can be easily and reliably agitated by deforming the soft portion. In particular, even when the container body is not filled with a gas such as air or when the amount of the stored chemical is small, the chemical can be reliably stirred.
In addition, by pressing and deforming the soft part, the drug solution can be discharged from the needle tip of the puncture needle, and therefore it is not necessary to provide a sliding part such as a gasket on the pusher, so a relatively weak force Thus, the pusher can be easily moved and the drug solution can be administered.
Also, if you do not want to fill the container body with air, the container body has a soft part, so when storing the chemical in the container body, the soft part is deformed to prevent air from entering. be able to. Therefore, it has industrial applicability.

Claims (9)

An outer cylinder,
A chemical solution container provided with a container main body having a soft part that is installed in the outer cylinder and stores the chemical solution;
A prefilled syringe comprising a pusher that is movably installed with respect to the outer cylinder, and that pushes and deforms the soft portion by the movement. The prefilled syringe according to claim 1, further comprising an operation unit that performs an operation of deforming the soft portion from the outside of the outer cylinder and stirring the chemical solution. The prefilled syringe according to claim 1 or 2, wherein the soft part is a bag-like soft bag in which the chemical solution is stored. The prefilled syringe according to claim 3, further comprising a puncture needle having one end having a needle tip capable of puncturing a living body and the other end communicating with the inside of the soft bag. The container body fixes the inner surfaces of the soft bag so as to be peelable from each other, and the container body has a first space in which the medicinal solution is stored and a second space located closer to the tip than the first space. Has a weak seal part that partitions into
The proximal end side of the puncture needle communicates with the second space,
5. The prefilled syringe according to claim 4, wherein the proximal end side of the puncture needle communicates with the first space when the weak seal portion is peeled off. When the pusher is moved in the distal direction, the soft bag is pressed and deformed, the weak seal portion is peeled off, the proximal end side of the puncture needle communicates with the first space, and the needle of the puncture needle The prefilled syringe according to claim 5, which is configured to discharge the chemical liquid from the front. 7. A contact portion according to claim 4, further comprising a contact portion that is provided on the distal end side of the outer cylinder and spaced from the needle tip of the puncture needle in the radial direction of the puncture needle so as to contact the surface of a living body. Prefilled syringe. The prefilled syringe according to claim 7, further comprising a protective member that seals a space inside the contact portion, wherein a sterile state of the space inside the contact portion is maintained in an unused state. The prefilled syringe according to any one of claims 4 to 8, further comprising a needle support portion that has a convex portion that supports the puncture needle and can contact the surface of a living body.

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