JP6031114B2 - Prefilled syringe outer cylinder, puncture tool for prefilled syringe, and prefilled syringe - Google Patents

Description

The present invention relates to an outer cylinder for a prefilled syringe, a puncture device for a prefilled syringe, and a prefilled syringe.

  The prefilled syringe is provided in a state filled with a medical liquid such as a drug solution or a drug solution. As a prefilled syringe, for example, there is a prefilled syringe whose tip is sealed with a cap to which a double-ended needle can be attached. In such a prefilled syringe, a puncture member having a double-ended needle is attached at the time of use. The Further, as a puncture member having a double-ended needle and its mounting form, there is also one as shown in Patent Document 1 (Japanese translations of PCT publication No. 2010-540122: WO2009 / 043000).

Japanese translation of PCT publication 2010-540122 (WO2009 / 043000)

The assembly 10 of Patent Document 1 includes a tubular body 16, a first stopper 18, a second stopper 20, a flexible insert 22, and a rigid retainer 24. The flexible insert 22 is formed from a material that can be pierced by a medical needle or other piercing device. The surface of the flexible insert 22 that is pierced by a medical needle or other piercing device is exposed. Thus, if bacteria adhere to the surface by the time of use, there is a risk that the bacteria will be mixed into the assembly 10 by the inserted medical needle or other piercing device. And there exists a danger that the microbe mixed in the assembly 10 will be administered with the chemical | medical agent in an assembly.
The object of the present invention is to keep the surface of the sealing member that seals the tip of the syringe outer cylinder from being contaminated until use, and to use the syringe outer cylinder with a simple operation. The present invention provides a prefilled syringe outer cylinder, a prefilled syringe puncture tool, and a prefilled syringe that can be put into a possible state, in other words, a state in which a puncture member having a double-ended needle can be attached.

What solves the above problems is as follows.
A prefilled syringe outer cylinder to which a puncture member comprising a hollow needle having needle portions at both ends and a puncture member body mounted with the hollow needle can be mounted, wherein the prefilled syringe outer cylinder has a tip having an opening An outer cylinder main body provided with a portion, an opening at the tip end portion, and a seal member through which the needle portion of the hollow needle can be inserted, and at the tip end portion of the outer cylinder main body An outer cylinder sealing member mounted, the outer cylinder sealing member including a puncture member mounting portion to which the puncture member can be mounted, and detachment of the outer cylinder sealing member mounted to the outer cylinder main body. The outer cylinder sealing member is formed between the puncture member mounting portion and the rupture operation portion, and the rupture operation portion protruding from the puncture member mounting portion. A breakable portion, and the breakable portion is By separating the breaking operation unit, the all SANYO that the puncture member to puncture member mounting portion is mountable, wherein the regulating portion for regulating the withdrawal and rotation of the outer cylinder sealing member, the outer tube A window provided on a side of the sealing member, wherein the outer cylinder main body includes a protrusion protruding from a side of the tip of the outer cylinder main body, and the protrusion engages with the window Thus, a prefilled syringe outer cylinder in which detachment and rotation of the outer cylinder sealing member attached to the outer cylinder main body are restricted .

Moreover, what solves the said problem is as follows.
The prefilled syringe outer cylinder, a gasket housed in the outer cylinder and capable of liquid-sliding in the outer cylinder, and a medicine housed in a space formed by the outer cylinder and the gasket; Prefilled syringe consisting of

Moreover, what solves the said problem is as follows.
An outer cylinder main body having a front end portion having an opening, and a seal member for sealing the opening of the front end portion are housed, and attached to the front end portion of the outer cylinder main body so as to be detached from the outer cylinder main body. A prefilled syringe puncture member to be attached to a prefilled syringe outer cylinder having an outer cylinder sealing member having a regulating portion for regulating, wherein the puncture member includes a hollow needle having a needle portion, A cylindrical puncture member main body equipped with a hollow needle, the puncture member main body comprising an opening provided on a side surface, and a puncture member side rib projecting inward from a base end portion of the opening A proximal-side cylindrical portion extending in the proximal direction from the opening, and when the puncture member is attached to the prefilled syringe outer cylinder, the puncture member-side rib is sealed with the outer cylinder. Engagement with the outer cylinder sealing member side engaging portion provided on the member By pre-filled syringe puncture member withdrawal is to regulate from the outer cylinder sealing member of the piercing member.

Moreover, what solves the said problem is as follows.
A puncture device comprising the puncture member for a prefilled syringe and a storage member for detachably storing the puncture member, wherein the storage member is sealed with the rib on the puncture member side of the puncture member and the outer cylinder After the outer cylinder sealing member side engaging portion of the member is engaged, it is detached from the puncture member by pulling in the distal direction, and the storage member is separated from the puncture member, A prefilled syringe puncture device that can be reattached to a puncture member.

FIG. 1 is a front view of a prefilled syringe and a puncture tool for a prefilled syringe according to the present invention. FIG. 2 is a right side view of the prefilled syringe shown in FIG. FIG. 3 is an enlarged cross-sectional view taken along line AA in FIG. FIG. 4 is an enlarged longitudinal sectional view of the prefilled syringe puncture device of the present invention. FIG. 5 is an enlarged cross-sectional view of the distal end portion of the prefilled syringe outer cylinder shown in FIG. 1. FIG. 6 is a front view of the prefilled syringe outer cylinder and the outer cylinder used in the prefilled syringe of the present invention. 7 is a right side view of the outer cylinder shown in FIG. FIG. 8 is an enlarged plan view of the outer cylinder shown in FIG. FIG. 9 is a perspective view of the outer cylinder shown in FIG. FIG. 10 is a front view of the outer cylinder sealing member used for the prefilled syringe outer cylinder and the prefilled syringe of the present invention. FIG. 11 is a right side view of the outer cylinder sealing member shown in FIG. 12 is a cross-sectional view taken along line BB in FIG. FIG. 13 is an enlarged front view of a puncture member used in the prefilled syringe puncture device of the present invention. FIG. 14 is a left side view of the puncture member shown in FIG. 15 is a cross-sectional view taken along the line CC of FIG. 16 is a cross-sectional view taken along the line DD of FIG. 17 is a perspective view of the puncture member shown in FIG. FIG. 18 is an enlarged front view of a storage member used for the prefilled syringe puncture device of the present invention. 19 is a cross-sectional view taken along line EE in FIG. FIG. 20 is an enlarged front view of a plunger used in the prefilled syringe of the present invention. FIG. 21 is a cross-sectional view of a gasket used in the prefilled syringe of the present invention. FIG. 22 is an explanatory diagram for explaining constituent members used for the prefilled syringe and the puncture member shown in FIG. 1. FIG. 23 is an explanatory diagram for explaining the operation of the prefilled syringe outer cylinder shown in FIG. 1. FIG. 24 is an explanatory diagram for explaining the action of the prefilled syringe outer cylinder shown in FIG. 1. FIG. 25 is an explanatory diagram for explaining the operation of the prefilled syringe outer cylinder and the puncture member shown in FIG. 1. FIG. 26 is an explanatory diagram for explaining the operation of the prefilled syringe outer cylinder and the puncture member shown in FIG. 1. FIG. 27 is an explanatory diagram for explaining a state in which the puncture member is attached to the prefilled syringe outer cylinder shown in FIG. 1. FIG. 28 is an explanatory diagram for explaining how the outer cylinder sealing member and the puncture member of the prefilled syringe outer cylinder shown in FIG. 1 are mounted. FIG. 29 is an enlarged cross-sectional view of the distal end portion of the prefilled syringe outer cylinder of another embodiment of the present invention. 30 is an enlarged longitudinal sectional view of a puncture device used in the prefilled syringe shown in FIG. FIG. 31 is an explanatory diagram for explaining constituent members of the prefilled syringe using the prefilled syringe outer cylinder shown in FIG. 29 and the puncture tool shown in FIG. 30. 32 is a longitudinal sectional view of the storage member shown in FIG. FIG. 33 is an explanatory diagram for explaining the operation of the prefilled syringe using the prefilled syringe outer cylinder shown in FIG. 29 and the puncture device shown in FIG. 30. FIG. 34 is a perspective view of the prefilled syringe outer cylinder package of the present invention. FIG. 35 is an explanatory diagram for describing an internal configuration of the prefilled syringe outer cylinder package illustrated in FIG. 34. 36 is a front view of the prefilled syringe outer cylinder package shown in FIG. 34. FIG. FIG. 37 is a plan view of the prefilled syringe outer cylinder package shown in FIG. 38 is an enlarged sectional view taken along line FF in FIG.

The prefilled syringe outer cylinder, the prefilled syringe puncture tool, the prefilled syringe, and the prefilled syringe outer cylinder package of the present invention will be described with reference to the embodiments shown in the drawings.
The prefilled syringe outer cylinder 2 of the present invention can be mounted with a puncture member 6 including a hollow needle 61 having needle portions 61a and 61b at both ends and a puncture member body 60 to which the hollow needle 61 is mounted. The prefilled syringe outer cylinder 2 is a seal that seals the outer cylinder body 4 having a tip 41 having an opening 48 and the opening 48 of the tip 41 and allows the needle 61b of the hollow needle 61 to be pierced. An outer cylinder sealing member 5 that houses the member 10 and is attached to the distal end portion 41 of the outer cylinder main body 4 is provided. The outer cylinder sealing member 5 includes a puncture member mounting portion 50 to which the puncture member 6 can be mounted, and a restricting portion that restricts detachment and rotation of the outer cylinder sealing member 5 mounted on the outer cylinder main body 4. Further, the outer cylinder sealing member 5 includes a breaking operation portion 56 protruding from the puncture member mounting portion 50, and a breakable portion 57 formed between the puncture member mounting portion 50 and the breaking operation portion 56, and the breakable portion The puncture member 6 can be attached to the puncture member attachment portion 50 by breaking 57 and separating the break operation portion 56.
For this reason, until the breaking operation part is separated, the sealing member 10 is covered with the breaking operation part, and the surface thereof is not exposed, so that the clean state is maintained until use. Moreover, in the state which does not isolate | separate a fracture operation part, the puncture member 6 cannot be mounted | worn.

The puncture member 6 of this embodiment has a puncture member side engagement portion 35 provided in the puncture member main body 60, and the prefilled syringe outer cylinder 2 (including the outer cylinder sealing member 5) is associated with the puncture member side engagement. The outer cylinder sealing member side engaging part 32 which engages with the joint part 35 and regulates the detachment of the puncture member 6 from the outer cylinder sealing member 5 after the engagement is provided. In this embodiment, the outer cylinder sealing member 5 is engaged with the puncture member side engaging portion 35 by pushing the prefilled syringe outer cylinder 2 into the puncture member 6 from the outer cylinder sealing member 5 side, It has the outer cylinder sealing member side engaging part 32 which controls the detachment | leave from the outer cylinder sealing member 5 of the puncture member 6 after engagement. In this embodiment, the puncture member 6 is mounted by pushing the outer cylinder sealing member 5 of the outer cylinder 2 from which the breaking operation portion 56 is separated into the outer cylinder. And easy.

The outer cylinder sealing member 5 includes a breaking operation portion 56 that protrudes from the puncture member mounting portion 50, and a breakable portion 57 formed between the puncture member mounting portion 50 and the breaking operation portion 56. The puncture member 6 can be attached to the puncture member attachment portion 50 by breaking 57 and separating the break operation portion 56.
Further, as shown in FIGS. 1 to 3, the prefilled syringe 1 of this embodiment includes a prefilled syringe outer cylinder 2 and a gasket 8 which is housed in the outer cylinder 2 and can slide in a liquid-tight manner in the outer cylinder. And the medicine 11 accommodated in the space formed by the outer cylinder 2 and the gasket 8. As shown in FIG. 1 and FIG. 2, the prefilled syringe outer cylinder 2 is formed on the outer cylinder main body 4 having a tip 41 having an opening 48 and the tip 41 of the outer cylinder main body 4. The outer cylinder sealing member 5 is provided.

As shown in FIGS. 1 to 3 and 5 to 9, the outer cylinder main body 4 includes a main body portion 40, a distal end portion 41, and a flange 46. The main body 40 is substantially cylindrical and has a liquid storage space inside.
The tip portion 41 protrudes from the shoulder portion of the main body portion 40 in the tip direction. The distal end portion 41 includes a distal end opening 48 for discharging a chemical solution or the like in the outer cylinder and cannot be connected to a medical device having a connection portion to a nozzle portion conforming to the ISO standard. That is, it is not a luer taper shape that the tip of a normal syringe has.

  In particular, in the outer cylinder main body 4 of this embodiment, the distal end portion 41 includes a diameter-expanded portion 44 formed at a boundary portion with the main-body portion 40, and a concave portion 47 (specifically, Two concavities facing each other) and near the tip of the intermediate portion 42 of the tip 41 (a portion having a smaller diameter than the enlarged diameter portion 44 and a diameter larger than the most distal portion) (in other words, near the central portion in the axial direction of the tip 41). The protruding portion 43 (specifically, two protruding portions facing each other) is provided. And the front-end | tip part 41 is equipped with the small diameter part at the front-end | tip, and the opening 48 is formed in the front-end | tip.

And in the outer cylinder main body 4 of this Example, the protrusion part 43 is extended predetermined length in the circumferential direction. The two recesses 47 extend a predetermined length in the axial direction. The two protrusions 43 and the two recesses 47 are provided so as not to overlap in the axial direction. In particular, in this outer cylinder, each recessed portion 47 and each protruding portion 43 are shifted from each other by approximately 90 degrees with respect to the central axis of the distal end portion 41.
And the protrusion part 43 of the front-end | tip part 41 of the outer cylinder main body 4 comprises the engaging part for outer cylinder sealing member detachment | limiting regulation on the outer cylinder side, and the recessed part 47 rotates the outer cylinder sealing member on the outer cylinder side. A restricting engaging portion is formed.
The flange 46 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder body 4. As shown in FIGS. 8 and 9, the flange 46 includes two grip portions facing each other.
The outer cylinder body 4 is a cylindrical body made of a transparent or translucent material, if necessary, made of a material having low oxygen permeability and water vapor permeability.

  Examples of the material for forming the outer cylinder body 4 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, and polyethylene. Various resins such as polyesters such as terephthalate and cyclic polyolefins may be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferred because they are easy to mold and have heat resistance.

Further, the distal end portion 41 of the outer cylinder main body 4 is sealed by the outer cylinder sealing member 5.
As shown in FIGS. 1 to 3, 5, 10 to 12, and 22 to 24, the outer cylinder sealing member 5 includes a hollow main body 51 having a puncture member mounting portion 50 and an operation portion 56. And a seal member 10 accommodated in the main body 51. A closed space 95 is formed between the inner surface of the outer cylinder sealing member 5 and the upper surface of the seal member 10. The outer cylinder sealing member 5 is closed at the tip by the breaking operation portion 56.

  The puncture member mounting portion 50 includes a cylindrical small diameter portion provided at the distal end, a flange portion 55 provided at the proximal end, and a window portion 53 provided on the side portion (specifically, two window portions facing each other). ), A puncture member side engagement portion (annular rib) 32 provided on the outer surface on the distal end side from the window portion 53, and a rib 59 (plurality) formed on the distal end side from the flange portion 55 and on the proximal end side from the window portion 53. And a projecting portion 58 (specifically, two projecting portions facing each other) extending in the axial direction provided on the inner surface of the base end portion of the main body 51.

  In the outer cylinder sealing member 5 of this embodiment, the window 53 is for accommodating and engaging the protruding portion 43 of the outer cylinder main body 4, and extends a predetermined length in the circumferential direction. . The protrusion 43 of the outer cylinder main body 4 enters the window 53 of the outer cylinder sealing member 5 and engages to prevent the outer cylinder sealing member from being detached from the outer cylinder main body 4 and rotate. It also regulates. Therefore, in the prefilled syringe 1 of this embodiment, the outer cylinder sealing member 5 cannot be detached from the outer cylinder main body 4.

When the outer cylinder sealing member 5 is mounted on the outer cylinder main body 4, the protrusion 58 provided on the inner surface of the base end portion of the outer cylinder sealing member 5 enters the concave portion 47 of the outer cylinder main body 4. And are engaged. For this reason, the outer cylinder sealing member 5 cannot rotate with respect to the outer cylinder main body 4. Therefore, by rotating the outer cylinder main body 4, the outer cylinder sealing member 5 follows and rotates.
Therefore, the window portion 53 of the outer cylinder sealing member 5 constitutes an outer cylinder sealing member detachment restricting engagement portion on the cylindrical body side, and the projecting portion 58 is an outer cylinder sealing member rotation restriction on the cylindrical body side. The engagement part is constituted.

And the outer cylinder sealing member side engaging part 32 is provided in the outer surface of the front end side part of the puncture member mounting part 50. As shown in FIG. In this embodiment, the outer cylinder sealing member side engaging portion 32 is formed by an annular rib. Moreover, the front-end | tip part of the cyclic | annular rib 32 becomes the cyclic | annular inclined surface 32a diameter-reduced toward a front-end | tip direction. Further, the rear end surface of the annular rib 32 is an upstanding surface orthogonal to the central axis of the puncture member. The outer cylinder sealing member side engaging portion 32 engages with a puncture member side engaging portion 35 of the puncture member 6 described later as shown in FIG.
Moreover, in the outer cylinder sealing member 5 of this embodiment, two flat portions 54 facing each other are provided on the side of the base end portion side, so that the outer cylinder sealing member 5 can be easily held.

The outer cylinder sealing member 5 includes a breaking operation portion 56 that projects forward from the puncture member mounting portion 50, and a breakable portion 57 that is formed between the puncture member mounting portion 50 and the breaking operation portion 56. The puncture member 6 can be attached to the puncture member attachment portion 50 by breaking the possible portion 57 and separating the break operation portion 56.
The breakable portion 57 is a portion where a wedge-shaped annular recess is formed, and is thinner than other portions. For this reason, the breakable portion 57 is weaker than other portions, and by pushing the break operation portion 56 as shown in FIG. 23, the breakable portion 57 breaks at the breakable portion 57 portion as shown in FIG. And the fracture | rupture operation part 56 can isolate | separate from an outer cylinder sealing member, and can mount | wear with the puncture member 6. FIG. In this embodiment, the breaking operation portion has a flat plate shape and has a certain surface area. For this reason, the visual recognition of the breaking operation part is easy, and the pressing operation of the breaking operation part is also easy. The maximum width of the breaking operation portion is preferably smaller than the outer diameter of the main body portion 40 of the outer cylinder main body 4. Moreover, it is preferable to provide a non-slip | skid part in the flat surface of a fracture | rupture operation part, as shown in a figure. As the forming material of the outer cylinder sealing member, those described above are preferably used.

  The seal member 10 is housed in the distal end portion of the puncture member mounting portion 50, and when the outer cylinder sealing member 5 is mounted on the distal end portion 41 of the outer cylinder main body 4 as shown in FIGS. The tip opening 48 of the cylinder body 4 is sealed in a liquid-tight manner. The seal member 10 is formed of an elastic member that can seal the tip opening of the tip portion 41 of the outer cylinder main body 4 in a liquid-tight manner and that can be pierced with a seal member piercing needle portion 61b of the puncture member 6 described later. Further, the seal member 10 may include a protruding portion that enters the outer cylinder main body 4. As the material for forming the seal member, the above-described materials are preferably used.

  The prefilled syringe outer cylinder 2 of the illustrated embodiment has a closed space 95 formed between the inner surface of the outer cylinder sealing member 5 and the upper surface of the seal member 10, and the closed space 95 can be broken. Opening occurs when the portion 57 is broken. And it is preferable that the closed space 95 retains moisture for sterilization. The amount of sterilization water may be very small because the volume of the closed space is small. As water, aseptic water such as distilled water is suitable.

  As shown in FIGS. 1 to 3, the prefilled syringe 1 of this embodiment includes the prefilled syringe outer cylinder 2 to which the outer cylinder sealing member 5 described above is attached, the outer cylinder 2 accommodated in the outer cylinder 2, and the outer cylinder 2 The gasket 8 is slidable in a liquid-tight manner in the cylinder, and the medicine 11 is stored in the space formed by the outer cylinder 2 and the gasket 8. Further, the prefilled syringe 1 of this embodiment includes a plunger 9 attached to a gasket.

As shown in FIGS. 3 and 21, the gasket 8 includes a main body portion 81 whose front end is closed and extends with substantially the same outer diameter, and a plurality of annular ribs 82 and 83 provided on the main body portion. The rib comes into liquid-tight contact with the inner surface of the main body portion 40 of the outer cylinder main body 4.
As a material for forming the gasket 8, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber, isoprene rubber, etc.), thermoplastic elastomer (for example, SBS elastomer, SEBS elastomer, SEPS elastomer, styrene, etc.) It is preferable to use olefin-based elastomers, olefin-based elastomers such as ethylene-α-olefin copolymer elastomers, and the like.

  The gasket 8 is provided with a recess extending inward from the rear end thereof, and this recess serves as a plunger mounting portion 84. Specifically, the plunger mounting portion 84 has a female screw shape, and can be screwed with a male screw portion 93 formed on the outer surface of the gasket mounting portion 92 formed at the distal end portion of the plunger 9. The plunger 9 is mounted on the gasket 8 by screwing them together.

  As shown in FIG. 1 to FIG. 3 and FIG. 20, the plunger 9 is provided at a gasket mounting portion 92 provided at the tip portion, a main body portion 91 extending in a cross-shaped axial direction, and a tip portion of the main body portion. A flat plate portion 95, a pressing portion 94 provided at the rear end portion of the main body portion 91, and reinforcing ribs 96 and 98 provided in the middle of the main body portion 91 are provided. In the plunger of this embodiment, a male screw portion 93 that is screwed with the plunger mounting portion 84 is formed on the outer surface of the gasket mounting portion 92. The plunger 9 is connected to the gasket 8 when the plunger mounting portion 84 and the male threaded portion 93 of the gasket mounting portion 92 are screwed together. The plunger 9 may be of a type that is not attached to the gasket and is attached at the time of use.

  The drug 11 to be filled in the prefilled syringe 1 is not particularly limited, but vitamin agents (total vitamin agents), various amino acids, antithrombotic agents such as heparin, insulin, antibiotics, antitumor agents, Analgesic, cardiotonic, intravenous anesthetic, antiparkinsonian, ulcer treatment, corticosteroid, arrhythmia, hormone preparation, interferon preparation, human immunoglobulin preparation, blood coagulation factor preparation, vaccine preparation, etc. Is mentioned.

Next, the prefilled syringe puncture device 3 of the present invention will be described with reference to FIGS. 4 and 13 to 17.
The prefilled syringe puncture device 3 of the present invention is used by being mounted on the prefilled syringe outer cylinder 2 or the outer cylinder sealing member 5 of the prefilled syringe 1 described above. The puncture device 3 is equipped with a hollow needle 61 having needle portions at both ends (specifically, a puncture needle portion 61a at one end and a sealing member piercing needle portion 61b at the other end), and a hollow needle 61, and an outer cylinder A puncture member 6 that can be attached to the sealing member 5 and includes a puncture member main body 60 having a puncture member side engaging portion 35 and a storage member 7 that removably accommodates the puncture member 6 are provided. The storage member 7 is pulled by pulling in the distal direction after the puncture member 6 is mounted on the outer cylinder sealing member 5 and the puncture member side engaging part 35 and the outer cylinder sealing member side engaging part 32 are engaged. It is separated from the puncture member 6.
And in the thing of this Example, the outer cylinder sealing member side engaging part is comprised by the annular rib 32 formed in the outer surface of the outer cylinder sealing member 5, and the puncture member side engaging part is a puncture member main body. The rib 35 is formed on the inner surface of the rib 60 and can be moved over the annular rib 32 when the outer cylinder sealing member 5 is pushed into the puncture member 6.

The puncture device 3 includes a storage member 7 and a puncture member 6 stored in the storage member 7.
The storage member 7 has a cap shape with one end closed as shown in FIGS. 4, 18 and 19. The storage member 7 includes a cylindrical main body portion 71, a closing portion 75 formed at the front end portion thereof, a small diameter portion 73 formed at the front end side portion of the main body portion 71, and a flange 72 formed at the rear end portion. I have. The storage member 7 stores the entire puncture member 6. In particular, the storage member stores the puncture member so that the blade surface of the hollow needle of the puncture member is not exposed.

As shown in FIGS. 4, 13 to 17, and 28, the puncture member 6 includes a puncture member main body 60 and a hollow needle 61 fixed to the puncture member main body 60.
The puncture member main body 60 is a cylindrical body having a hollow needle fixing portion having a small diameter at the distal end portion and an outer cylinder sealing member accommodating portion at the proximal end side portion. The outer cylinder sealing member housing portion includes an outer cylinder sealing member mounting portion to which the outer cylinder sealing member 5 of the outer cylinder 2 can be mounted.
Specifically, the outer cylinder sealing member mounting portion includes a puncture member side engaging portion 35 that engages with the outer cylinder sealing member side engaging portion 32 provided on the outer surface of the outer cylinder sealing member 5. Yes.

  In this embodiment, the puncture member 6 has an opening 64 (specifically, two openings facing each other), and the puncture member side engagement is performed by a rib 35 protruding inward from the bottom of the opening 64. The part is formed. The rib 35 extends in a predetermined circumferential direction. The puncture member side engaging portion is not limited to the short rib as described above, and may be an annular rib, or may be constituted by a plurality of annularly arranged ribs. Also good. Further, the lower surface of the rib 35 is an inclined surface 35a directed toward the inner surface, and the annular inclined surface of the annular rib 32 of the outer cylinder sealing member 5 when the puncture member 6 is attached to the outer cylinder sealing member 5. 32a is in contact with both surfaces and is inclined, so that the rib 35 is guided over the annular rib 32. After both of them get over, the rear end surface of the annular rib 32 that is an upright surface and the front end surface of the rib 35 that is an upright surface come into contact with each other to prevent separation.

In addition, the puncture member 6 of this embodiment includes an annular recess 87 provided on the inner surface near the base end. When the puncture member 6 is mounted on the outer cylinder sealing member 5, the ribs 59 (a plurality of circumferential ribs) of the outer cylinder sealing member 5 enter the annular recess 87, so that both are engaged. The puncture member 6 is prevented from being detached from the outer cylinder main body 4.
Therefore, the outer cylinder sealing member 5 of this embodiment has the first outer cylinder sealing member side engaging portion 32 and the first outer cylinder sealing member side engaging portion 32 of the outer cylinder sealing member 5. A second outer cylinder sealing member side engaging portion (arc-shaped rib) 59 is provided on the proximal end side, and the puncture member 6 is engaged with the first outer cylinder sealing member side engaging portion 32. 1 puncture member side engagement portion 35 and a second puncture member side engagement portion (annular) which is located on the proximal end side of puncture member 6 and engages with second outer cylinder sealing member side engagement portion 59 (Concave part) 87 is provided. Moreover, the outer surface of the axial center part of the puncture member main body 60 is provided with a recess 67 (specifically, two recesses facing each other).

The hollow needle 61 is fixed to the hollow needle fixing portion 63 of the puncture member main body 60 with an adhesive 68, and has needle portions at both ends. Specifically, the hollow needle 61 has one end projecting toward the distal end side from the fixing portion 63, and a puncture needle portion 61 a for living body is provided at the distal end, and the other end side of the hollow needle 61 is inserted into the puncture member from the fixing portion 63. 6 is protruded inward, and a sealing member piercing needle portion 61b capable of piercing the sealing member of the outer cylinder sealing member 5 is provided at an end thereof. The hollow needle 61 extends substantially parallel to the central axis of the puncture member body 60.
In the prefilled syringe and the prefilled syringe injector of this embodiment, the puncture member 6 attached to the outer cylinder sealing member 5 of the outer cylinder 2 is substantially unremovable.

Further, in the prefilled syringe outer cylinder 2 and the puncture device 3 of this embodiment, the outer cylinder sealing member side engagement portion 32 and the puncture member side engagement portion 35 are formed by the seal member insertion needle portion 61b of the hollow needle 61. After the seal member 10 is pierced, the outer cylinder sealing member side engaging portion 32 and the puncture member side engaging portion 35 are arranged to engage with each other.
The prefilled syringe outer cylinder 2 of this embodiment is preferably a prefilled syringe outer cylinder for autoclave sterilization. In particular, the prefilled syringe outer cylinder 2 may be autoclaved. Similarly, the prefilled syringe 1 of this embodiment may be autoclaved.

Next, the effect | action of the prefilled syringe 1 of this Example is demonstrated using FIG. 1 thru | or FIG. 3, FIG.
As shown in FIGS. 1 to 3, in the prefilled syringe 1, the outer cylinder 2 is sealed by an outer cylinder sealing member 5 attached to the tip, and the puncture device 3 is placed in the storage member 7. Is stored and the outer tube 2 and the puncture device 3 are not mounted. Further, as shown in FIGS. 3 and 5, the outer cylinder sealing member 5 is attached to the distal end portion 41 of the outer cylinder main body 4 so that it cannot rotate and cannot be detached. The puncture member 6 is housed in the housing member 7. As shown in FIG. 22, the distal end portion of the prefilled syringe outer cylinder 2 includes a distal end portion 41 of the outer cylinder main body 4, an outer cylinder sealing member 5, a puncture member 6, and a storage member 7.

  First, as shown in FIG. 23, the rupturing operation portion 56 of the outer cylinder sealing member 5 is pushed with a finger in the direction of the arrow, and the outer cylinder sealing member 5 is broken at the breakable portion 57 portion, as shown in FIG. As shown, the breaking operation portion 56 is separated from the outer cylinder sealing member. As a result, the outer cylinder sealing member 5 is formed with the breakable portion break end 57a and the opening 38, and the puncture member 6 can be mounted.

  Then, as shown in FIG. 25, the distal end portion of the outer cylinder 2 in which the opening 38 is formed is pushed into the puncture device 3, whereby the sealing member piercing needle portion 61b of the hollow needle 61 of the puncture member 6 is The sealing member 10 of the sealing member 5 is pierced. Thereafter, the inclined surface 32a of the outer cylinder sealing member side engaging portion 32 and the inclined surface 35a of the puncture member side engaging portion 35 come into contact with each other, and by further pushing, the inclined surface 35a of the puncture member side engaging portion 35 becomes The inclined surface 32a of the outer cylinder sealing member side engaging part 32 advances.

  And the puncture member side engaging part 35 gets over the outer cylinder sealing member side engaging part 32, and the outer cylinder sealing member side engaging part 32 and the puncture member side engaging part 35 engage. In the engaged state, the upright surface of the outer cylinder sealing member side engaging portion 32 and the upright surface of the puncture member side engaging portion 35 come into contact with each other, and the puncture member 6 from the outer cylinder sealing member 5 (outer cylinder 2). Regulate the withdrawal of. In addition, since there is a certain amount of resistance during the above engagement, the operator recognizes the end of the mounting operation. Further, in the prefilled syringe 1 of this embodiment, the outer cylinder sealing member 5 is inserted into the annular recess 87 provided on the inner surface near the proximal end portion of the puncture member 6 at the same time or slightly before the above engagement. Ribs 59 (a plurality of circumferential ribs) enter and engage, and there is some resistance even during this engagement. Therefore, since the two engagement mechanisms are provided, the operator can recognize the end of the mounting operation more reliably.

When the attachment of the puncture device 3 to the outer cylinder 2 is completed, the state shown in FIG. 26 is obtained. In this state, the storage member 7 is detached by pulling the storage member 7, and the puncture member 6 is removed as shown in FIG. And the needle part 61a for puncture is exposed and preparation for administration is completed. And in this prefilled syringe 1, since the puncture member is mounted | worn in the state engaged with the syringe main body (outer cylinder for prefilled syringes), unintentional looseness does not arise. Then, after the administration operation is completed, the storage member 7 is attached to the syringe body (the puncture member attached to the syringe body) and then discarded.

In the prefilled syringe of the present invention, the mounting mechanism between the outer cylinder sealing member and the puncture member is not limited to the above-described embodiment. For example, the type shown in FIGS. 29 to 33 may be used.
The difference between the prefilled syringe 1a, the prefilled syringe outer cylinder and the puncture tool 3a of this embodiment, and the above-described prefilled syringe 1, the prefilled syringe outer cylinder 2 and the puncture tool 3 is that the outer cylinder sealing member 5a and the puncture member 6a are different. Only the difference in the mounting mechanism, and the other is the same. The same parts are denoted by the same reference numerals, and the above description is referred to.

In the prefilled syringe 1a of this embodiment, the puncture member 6a has a puncture member side engaging portion 86 provided in the puncture member main body 60a, and the prefilled syringe outer cylinder 2 is engaged with the puncture member side engaging portion 86. And an outer cylinder sealing member-side engaging portion 53 that regulates the detachment of the puncture member 6a from the outer cylinder sealing member 5a after the engagement. Furthermore, in the prefilled syringe 1a of this embodiment, the puncture member 3a has a puncture member side screwing portion 85, and the outer cylinder sealing member 5a is an outer cylinder seal that can be screwed with the puncture member side screwing portion 85. The piercing member side engaging portion 86 and the outer cylinder sealing member side engaging portion 53 are composed of an outer cylinder sealing member side screwing portion 52 and a puncturing member side screwing portion 85. It engages after screwing and regulates the backward movement of the screwing.
As shown in FIGS. 29 and 31, the outer cylinder sealing member 5 a includes a hollow main body 51 having a puncture member mounting portion 50 a and an operation portion 56, and a seal member 10 accommodated in the main body 51. Prepare. A closed space 95 is formed between the inner surface of the outer cylinder sealing member 5 a and the upper surface of the seal member 10. The outer cylinder sealing member 5 a is closed at the tip by the breaking operation portion 56.

  The puncture member mounting portion 50a has a cylindrical shape, a small diameter portion provided at the distal end, a flange portion 55 provided at the proximal end, and a window portion 53 (specifically, two facing each other). Two window portions), an outer cylinder sealing member side screwing portion 52 provided on the outer surface on the distal end side from the window portion 53, and a rib 59 formed on the distal end side from the flange portion 55 and on the proximal end side from the window portion 53. (A plurality of circumferential ribs), an excessive rotation restricting rib 88 (specifically, two ribs facing each other) provided on the side of the small diameter portion, and an inner surface of the base end portion of the main body 51. A protruding portion 58 (specifically, two protruding portions facing each other) extending in the axial direction is provided.

And as shown in FIG. 31, the outer cylinder sealing member side screwing part 52 is provided in the outer surface of the front end side part of the puncture member mounting part 50a. In this embodiment, the outer cylinder sealing member side screwing portion 52 is formed by two spiral ribs. Further, a bulging portion 52a is formed at the central portion of the spiral rib, and a bulging portion 52b is also formed at the terminal portion of the spiral rib. An excessive rotation restricting rib 88 (specifically, two ribs facing each other) is provided on the distal end surface of the outer cylinder sealing member 5a. The outer cylinder sealing member side screwing portion 52 is screwed with a puncture member side screwing portion 85 described later.
In addition, the outer cylinder sealing member 5a of this embodiment is provided with two flat portions 54 facing each other on the side of the base end portion, so that the outer cylinder sealing member 5a can be easily held.

  And the outer cylinder sealing member 5a is provided with the fracture | rupture operation part 56 which protrudes ahead from the puncture member mounting part 50a, and the fracture | rupture possible part 57 formed between the puncture member mounting part 50a and the fracture | rupture operation part 56, and is fractured | ruptured. By breaking the possible portion 57 and separating the breaking operation portion 56, the puncture member 6a can be attached to the puncture member attachment portion 50a.

  The prefilled syringe puncture tool 3a of this embodiment is attached to and detached from the puncture member mounting portion 50a of the prefilled syringe outer cylinder 2 after the breaking operation portion 56 is separated, as shown in FIGS. Is possible. The puncture device 3a includes a puncture member 6a and a storage member 7a for storing it. The puncture member 6a is equipped with a hollow needle 61 having needle portions at both ends (specifically, a puncture needle portion 61a at one end and a seal member piercing needle portion 61b at the other end), and the hollow needle 61, and the puncture member A puncture member main body 60a that is detachable from the mounting portion 50a and has a puncture member side screwing portion 85 and a puncture member side engaging portion 86 is provided. The storage member 7a stores the puncture member 6a in a detachable manner. Further, the storage member 7a includes a rotational force transmitting portion 74 that transmits the rotational force applied to the storage member 7a to the puncture member 6a, and the storage member 7a is mounted on the outer cylinder sealing member 5a. After being done, it is detached from the puncture member 6a by pulling in the distal direction.

  The puncture member main body 60a includes a puncture device side screwing portion 85 that is screwed with the outer tube sealing member side screwing portion 52 provided on the outer surface of the outer tube sealing member 5a. The puncture member 6a includes an opening 64 (specifically, two openings facing each other), and is punctured by a rib 85 protruding obliquely (short spiral) protruding inward from the bottom of the opening 64. A tool-side threaded portion is formed. The puncture member 6a includes a protrusion 86 (specifically, two protrusions facing each other) provided on the inner surface in the vicinity of the axially central portion (slightly from the base end). The protrusion 86 extends a predetermined length in the circumferential direction. When the puncture member 6a is attached to the outer cylinder sealing member 5a, the protrusion 86 enters and engages with the window 53 of the outer cylinder sealing member 5a. As a result, the mounting state of the puncture member 6a to the outer cylinder main body 4 becomes stable, the rotation of the puncture member in the direction in which the screwing is retracted is restricted, and the puncture member is loosened and detached from the outer cylinder. To prevent.

Further, in the puncture member 6a of this embodiment, the distal end portion of the main body 60a has a small diameter portion 62, and the bulging portion 65 (specifically, faces the outer surface of the small diameter portion 62 extending in the axial direction). 2 bulges). The bulging portion 65 enters and engages between a plurality of bulging portions 74 (rotational force transmitting portions) formed on the inner surface of the axially central portion of the storage member 7a described above. As a result, the puncture member 6a is restricted from idling in the state of being stored in the storage member 7a, and rotates following the rotation of the storage member 7a.
Furthermore, as shown in FIG. 30, the puncture member 6a includes a protruding portion 89 (specifically, two bulging portions facing each other) provided on the inner surface of the distal end of the small diameter portion 62. The protruding portion 89 includes an excessive rotation regulating rib 88 provided on the distal end surface of the outer cylinder sealing member 5a after the outer cylinder sealing member side screwing portion 52 and the puncture member side screwing portion 85 are screwed together. It abuts and prevents excessive rotation of the puncture member.

  And the prefilled syringe 1a of this Example pushes the fracture | rupture operation part 56 of the outer cylinder sealing member 5a with a finger | toe in the arrow direction similarly to the prefilled syringe 1 of the Example mentioned above, and is in the breakable part 57 part. The outer cylinder sealing member 5a is broken, and the breaking operation portion 56 is separated from the outer cylinder sealing member and opened. Then, as shown in FIG. 33, by pushing the puncture tool 3a into the outer cylinder 2, the sealing member piercing needle portion 61b of the hollow needle 61 of the puncture member 6a causes the seal member 10 of the outer cylinder sealing member 5a to move. Pierce. Thereafter, as shown in FIG. 33, by rotating the puncture tool 3a (the outer cylinder 2 may be rotated), the outer cylinder sealing member side screwing portion (spiral rib) 52 and the puncture member side screwing are performed. Screwing with the part 85 is started. By proceeding with the screwing, the puncture member side engagement portion 86 of the puncture member 6a enters the outer tube sealing member side engagement portion (window portion) 53 of the outer tube sealing member 5a and engages therewith. To do. Then, the preparation for administration is completed by removing the storage member 7a.

Next, a packaging body in which a plurality of prefilled syringe outer cylinders according to the present invention are housed will be described with reference to FIGS.
The package 100 in which a plurality of prefilled syringe outer cylinders of the present invention are housed is one that can be autoclaved or autoclaved.
The packaging body 100 includes a container body 102 having an open top surface and shape retention, an outer cylinder holding member 104 capable of holding a plurality of prefilled syringe outer cylinders 2, and a plurality of outer cylinder holding members 104. The prefilled syringe outer cylinder 2 and a sheet-like lid member 103 that hermetically seals the upper surface opening of the container body 102 and can be peeled off are provided. Furthermore, the package 100 includes a ventilation portion provided in the container body 102 or the lid member 103 and having a bacteria-impermeable and water vapor flow property.

  As shown in FIGS. 34 to 38, the prefilled syringe outer cylinder package 100 of the present invention includes a container body 102, an outer cylinder holding member 104 capable of holding a plurality of prefilled syringe outer cylinders 2, and an outer cylinder holding body. It consists of a plurality of prefilled syringe outer cylinders 2 held by a member 104, and a sheet-like lid member 103 which seals the upper surface opening of the container body 102 in an airtight manner and is peelable.

  As shown in FIGS. 34 to 38, the container body 102 has a tray-like shape having a predetermined depth with a certain degree of strength and shape retention, and has a main body 121 and an upper portion of the main body 121. An outer cylinder holding member holding part 126 for holding the peripheral part of the outer cylinder holding member 104 holding the formed prefilled syringe outer cylinder, and an annular flange 124 provided in the upper surface opening are provided.

  The container body 102 in this embodiment is a bottomed container having a rectangular shape, as shown in FIGS. 34 and 35, and a thin plate-like annular shape formed in the upper end opening so as to extend annularly and outward. A flange 124 is provided. Further, an annular heat seal convex portion 125 for fixing to the sheet-like lid member 103 is provided on the upper surface of the annular flange 124. The annular heat-sealing convex portion 125 is provided so that the entirety is inside the outer edge of the annular flange portion. Further, the annular heat seal convex portion 125 is provided so as to be entirely outside the inner edge of the annular flange portion. Furthermore, a protrusion 125 a extending in the direction of the corner of the annular flange 124 is formed at the corner of the annular heat-sealing convex portion 125.

  An outer cylinder holding member holding portion 126 is formed at a position that is a predetermined long bottom side from the flange 124. In the container body 102 of this embodiment, the outer cylinder holding member holding portion 126 is an annular stepped portion, and the peripheral portion of the outer cylinder holding member 104 holding the prefilled syringe outer cylinder can be placed thereon. Yes. The outer cylinder holding member holding portion is not continuous in an annular shape, and may be discontinuous.

  The container body 102 preferably has a certain degree of shape retention and rigidity. In order to cope with autoclave sterilization, it is desirable to use a thermoplastic material having heat resistance (120 ° C. or higher). Examples of materials having a certain degree of shape retention, a certain degree of rigidity, heat resistance and thermoplasticity include polyolefins such as polypropylene and polyethylene, vinyl chloride resins, polystyrene / polypropylene resins, polyethylene / ionomers (eg, ethylene-based, styrene). Type, fluorine type) / polyethylene, polyester resin (for example, polyethylene terephthalate, polybutylene terephthalate, amorphous-polyethylene terephthalate), PP / EVOH / PP (laminate), and the like. In this case, the thickness of the container body 102 is preferably about 0.05 to 4.00 mm, and more preferably 1.00 to 2.00 mm.

  As shown in FIGS. 35 and 38, the outer cylinder holding member 104 capable of holding the plurality of prefilled syringe outer cylinders 2 includes a substrate portion 141 and a plurality of cylindrical portions 142 protruding upward from the substrate portion 141. I have. An opening 143 is formed at the upper end of the cylindrical portion 142, and a gripping notch portion 144 is formed at the side portion of the substrate portion 141. The inner diameters of the cylindrical portion 142 and the opening 143 are larger than the maximum outer diameter portion of the prefilled syringe outer cylinder 2 to be held, and the flange portion of the prefilled syringe outer cylinder 2 to be held is The passage is impossible. For this reason, as shown in FIG. 38, the outer cylinder main body 4 and the outer cylinder sealing member 5 of the prefilled syringe outer cylinder 2 penetrate the cylindrical portion 142, and the flange 46 cannot pass through the cylindrical portion 142. The flange of the outer cylinder is suspended from the opening 143 of the cylindrical portion 142. As shown in FIG. 38, the lower end of the prefilled syringe outer cylinder 2 held by the outer cylinder holding member 104 (the tip of the outer cylinder sealing member) is not in contact with the bottom surface of the container body 102. . It is desirable that the material for forming the outer cylinder holding member 104 also has heat resistance (120 ° C. or higher) in order to cope with autoclave sterilization.

As the prefilled syringe outer cylinder 2, any of the above-described ones can be used.
The sheet-like lid member 103 encapsulates and seals the upper end opening of the container body 102 and can be peeled off from the container body 102. In the packaging body 100, the sheet-like lid member 103 is fixed to the upper surface opening of the container body 102 by an annular heat seal portion 131 so as to be peelable. The sheet-like lid member 103 is substantially impermeable to bacteria and water vapor, and can be detachably sealed with respect to the container body 102.

The sheet-like lid 103 is preferably a member that cannot permeate microparticles such as bacteria and viruses and has water vapor flowability for autoclave sterilization. Further, it is preferable that the container body 102 can be heat sealed. For example, a synthetic resin nonwoven fabric, specifically, a nonwoven fabric made of a synthetic resin material such as polyolefin known as Tyvek (registered trademark), a synthetic resin porous membrane, and the like can be suitably used.

The sheet-like lid member 103 is heat-sealed so that the peripheral portion thereof can be peeled off by a heat-sealing convex portion 125 provided on the annular flange 124 of the container body 102. In this embodiment, the outer edge of the sheet-like lid member is not heat-sealed to the annular flange 124 of the container body 102, and is easy to peel off. Moreover, the protrusion part 125a provided in the corner | angular part of the convex part 125 for heat seal functions as a peeling start part. The sheet-like lid member 103 preferably has a thickness of about 0.05 to 1.00 mm, and more preferably about 0.10 to 0.50 mm.
In the above-described embodiment, the ventilation portion is provided in the lid member, but is not limited thereto, and may be provided in the container body 102.

The prefilled syringe outer cylinder of the present invention is as follows.
(1) A prefilled syringe outer cylinder to which a puncture member including a hollow needle having needle portions at both ends and a puncture member main body to which the hollow needle is mounted can be mounted, wherein the prefilled syringe outer cylinder has an opening An outer cylinder main body having a distal end portion, a seal member that seals the opening of the distal end portion, and through which the needle portion of the hollow needle can be pierced, and the outer cylinder main body An outer cylinder sealing member mounted on a distal end portion, the outer cylinder sealing member including a puncture member mounting portion on which the puncture member can be mounted, and the outer cylinder sealing member mounted on the outer cylinder main body. The outer cylinder sealing member further includes a breaking operation portion protruding from the puncture member mounting portion, and between the puncture member mounting portion and the breaking operation portion. A breakable portion formed, and the breakable portion is broken And by separating the breaking operation unit, the all SANYO that the puncture member to puncture member mounting portion is mountable, wherein the regulating portion for regulating the withdrawal and rotation of the outer cylinder sealing member, A window provided on a side of the outer cylinder sealing member, the outer cylinder main body including a protrusion protruding from a side of the tip of the outer cylinder main body, and the protrusion is the window A prefilled syringe outer cylinder in which disengagement and rotation of the outer cylinder sealing member attached to the outer cylinder main body are regulated by engaging with the outer cylinder main body .
In the prefilled syringe outer cylinder, the surface of the seal member that seals the tip of the prefilled syringe outer cylinder can be kept in a state that is not contaminated until use, and can be used for a syringe by a simple operation. The outer cylinder can be used, in other words, the puncture member having a double-ended needle can be mounted.

And as an embodiment of the above-mentioned prefilled syringe outer cylinder, the following may be sufficient.
(2) The prefilled syringe outer cylinder has a closed space formed between the inner surface of the outer cylinder sealing member and the upper surface of the seal member, and the closed space is opened by the break of the breakable portion. The outer cylinder for prefilled syringes according to (1) above.
(3) The said closed space is an outer cylinder for prefilled syringes as described in said (2) which has the water | moisture content for sterilization.
(4) The outer cylinder main body has a recess on an outer surface of the tip portion of the outer cylinder main body, and the outer cylinder sealing member is an outer cylinder sealing member side protruding portion on an inner surface of the outer cylinder sealing member. (1) The rotation of the outer cylinder sealing member mounted on the outer cylinder main body is restricted by the engagement of the recess and the outer cylinder sealing member side protrusion. Thru | or the outer cylinder for prefilled syringes in any one of (3).

(5) The outer cylinder sealing member engages with a puncture member side engaging portion provided in the puncture member main body, and regulates the detachment of the puncture member from the outer cylinder sealing member after the engagement. The prefilled syringe outer cylinder according to any one of (1) to (4), wherein the outer cylinder sealing member side engaging portion is provided.
By having such a configuration, the puncture member is attached by pushing the outer cylinder sealing member of the outer cylinder from which the breaking operation portion is separated into the outer cylinder, so that the installation operation is easy to understand and easy. It is.
(6) After the separation of the breaking operation portion, the outer cylinder sealing member pushes the prefilled syringe outer cylinder into the puncture member from the outer cylinder sealing member side, thereby allowing the puncture member side engagement. The prefilled syringe outer according to the above (5), which has an engaging portion on the outer cylinder sealing member side that engages with a joint portion and regulates detachment of the puncture member from the outer cylinder sealing member after engagement. Tube.
(7) The outer cylinder sealing member has an outer cylinder sealing member side screwing portion that can be screwed with a puncture member side screwing portion provided in the puncture member, and the outer cylinder sealing member side engagement. The joint portion engages with the puncture member side engaging portion after the outer tube sealing member side screwing portion and the puncture member side screwing portion are screwed together , whereby the outer cylinder sealing member side screwing is performed. The prefilled syringe outer cylinder according to the above (5) or (6) , which regulates the backward movement of the screwing between the joint portion and the puncture member side screwing portion .
(8) The outer cylinder sealing member has an outer cylinder sealing member-side rib provided on an outer surface of the outer cylinder sealing member, and the outer cylinder sealing member-side rib is formed by the puncture member having the outer rim. The prefilled syringe outer cylinder according to any one of the above ( 5 ) to ( 7 ), which enters and engages in an annular recess provided on an inner surface of the puncture member when mounted on a cylinder sealing member .
(9) The prefilled syringe outer cylinder according to any one of (1) to (8), wherein the prefilled syringe outer cylinder is autoclaved.

The prefilled syringe of the present invention is as follows.
(10) The prefilled syringe outer cylinder according to any one of the above (1) to ( 9 ), a gasket that is housed in the outer cylinder and is capable of liquid-tight sliding in the outer cylinder, and the outer The prefilled syringe which consists of a chemical | medical agent accommodated in the space formed with the pipe | tube and the said gasket.
In the prefilled syringe described above, the surface of the seal member that seals the tip of the prefilled syringe outer cylinder can be kept in a state that is not contaminated until use, and the syringe outer cylinder can be easily operated. A usable state, in other words, a state where a puncture member having a double-ended needle can be mounted can be obtained.

Moreover, the puncture member for prefilled syringes of the present invention is as follows.
(11) An outer cylinder main body having a front end portion having an opening and a seal member that seals the opening of the front end portion are housed, and attached to the front end portion of the outer cylinder main body, from the outer cylinder main body A puncture member for a prefilled syringe to be attached to a prefilled syringe outer cylinder having an outer cylinder sealing member having a restriction portion for restricting detachment of the hollow tube, wherein the puncture member is a hollow needle having a needle portion And a cylindrical puncture member main body to which the hollow needle is attached, the puncture member main body including an opening provided on a side surface and a puncture member protruding inward from a base end portion of the opening And a proximal end tubular portion extending in the proximal direction from the opening. When the puncture member is attached to the outer cylinder for a prefilled syringe, the puncture member side rib is Outer cylinder sealing member side engagement provided on the cylinder sealing member A pre-filled syringe puncture member that regulates detachment of the puncture member from the outer cylinder sealing member by engaging with a joint.
And as an embodiment of the said puncture member for prefilled syringes, the following may be sufficient.
(12) The puncture member for a prefilled syringe has an annular recess provided on the inner surface of the proximal-end cylindrical portion of the puncture member, and the annular recess has the puncture member serving as the outer cylinder sealing member. The prefilled syringe puncture member according to the above (11), which is engaged with an outer tube sealing member side rib provided on an outer surface of the outer tube sealing member when mounted.

Moreover, the prefilled syringe puncture device of the present invention is as follows.
(1 3 ) A puncture device comprising the puncture member for a prefilled syringe according to the above (11) or (12) and a storage member for detachably storing the puncture member, wherein the storage member is the puncture device After the puncture member side rib of the member and the outer cylinder sealing member side engaging portion of the outer cylinder sealing member are engaged, by pulling in the distal direction, it is detached from the puncture member, and The prefilled syringe puncture device, wherein the storage member can be reattached to the puncture member after being detached from the puncture member.
The prefilled syringe puncture tool can be easily mounted on the prefilled syringe outer cylinder and the prefilled syringe described above.

Claims (13)

A prefilled syringe outer cylinder to which a puncture member comprising a hollow needle having needle portions at both ends and a puncture member main body equipped with the hollow needle can be attached,
The outer cylinder for a prefilled syringe contains an outer cylinder body having a tip portion having an opening, and a seal member that seals the opening of the tip portion and allows the needle portion of the hollow needle to be pierced. And an outer cylinder sealing member attached to the distal end portion of the outer cylinder main body, the outer cylinder sealing member being attached to the puncture member mounting portion to which the puncture member can be attached, and the outer cylinder main body. A restricting portion for restricting detachment and rotation of the mounted outer cylinder sealing member, and the outer cylinder sealing member includes a breaking operation portion protruding from the puncture member mounting portion, and the puncture member The puncture member is attached to the puncture member attachment portion by providing a breakable portion formed between the attachment portion and the break operation portion, and breaking the breakable portion and separating the break operation portion. all SANYO made possible,
The restricting portion that restricts the detachment and rotation of the outer cylinder sealing member includes a window provided in a side portion of the outer cylinder sealing member, and the outer cylinder main body is the tip of the outer cylinder main body. The protrusion part protruded from the side part of the part, and the detachment and rotation of the outer cylinder sealing member mounted on the outer cylinder main body are regulated by the protrusion part engaging with the window part. A prefilled syringe outer cylinder characterized by the above. The prefilled syringe outer cylinder has a closed space formed between the inner surface of the outer cylinder sealing member and the upper surface of the seal member, and the closed space opens when the breakable portion is broken. The prefilled syringe outer cylinder according to claim 1. The prefilled syringe outer cylinder according to claim 2, wherein the closed space holds moisture for sterilization. The outer cylinder main body has a recess on the outer surface of the tip portion of the outer cylinder main body, and the outer cylinder sealing member has an outer cylinder sealing member side protrusion on the inner surface of the outer cylinder sealing member. The rotation of the outer cylinder sealing member mounted on the outer cylinder main body is restricted by the engagement of the recess and the protruding portion on the outer cylinder sealing member side. The outer cylinder for prefilled syringes according to crab. The outer cylinder sealing member engages with a puncture member side engaging portion provided in the puncture member main body, and controls the detachment of the puncture member from the outer cylinder sealing member after engagement. The prefilled syringe outer cylinder according to any one of claims 1 to 4, further comprising a stop member side engaging portion. The outer cylinder sealing member is configured to push the prefilled syringe outer cylinder into the puncture member from the outer cylinder sealing member side after separation of the breaking operation section, thereby The pre-filled syringe outer cylinder according to claim 5, wherein the outer cylinder sealing member-side engaging portion engages and regulates the detachment of the puncture member from the outer cylinder sealing member after engagement. The outer cylinder sealing member has an outer cylinder sealing member side screwing portion that can be screwed with a puncture member side screwing portion provided in the puncture member, and the outer cylinder sealing member side engagement portion is The outer cylinder sealing member side screwing portion and the puncture member side screwing portion are engaged with the puncture member side engaging portion, and then the outer cylinder sealing member side screwing portion is engaged with the outer cylinder sealing member side screwing portion. The prefilled syringe outer cylinder according to claim 5 or 6 , wherein retraction of the screwing with the puncture member side screwing part is restricted. The outer cylinder sealing member has an outer cylinder sealing member side rib provided on an outer surface of the outer cylinder sealing member,
  8. The outer cylinder sealing member-side rib enters and engages in an annular recess provided on the inner surface of the puncture member when the puncture member is attached to the outer cylinder sealing member. The prefilled syringe outer cylinder according to any one of the above. The prefilled syringe outer cylinder for the prefilled syringe outer cylinder for according to any one of claims 1 to 8 is already autoclaved. A prefilled syringe outer cylinder according to any one of claims 1 to 9, a gasket housed in the outer cylinder and slidable liquid-tightly in the outer cylinder, and formed by the outer cylinder and the gasket A prefilled syringe comprising a medicine stored in a sealed space. An outer cylinder main body having a front end portion having an opening, and a seal member for sealing the opening of the front end portion are housed, and attached to the front end portion of the outer cylinder main body so as to be detached from the outer cylinder main body. A prefilled syringe puncture member to be attached to a prefilled syringe outer cylinder having an outer cylinder sealing member having a regulating part for regulating,
  The puncture member comprises a hollow needle having a needle portion, and a cylindrical puncture member body equipped with the hollow needle,
  The puncture member main body has an opening provided on a side surface, a puncture member side rib projecting inward from the base end of the opening, and a proximal-side cylindrical shape extending in the proximal direction from the opening With
  When the puncture member is mounted on the prefilled syringe outer cylinder, the puncture member side rib is engaged with an outer cylinder sealing member side engaging portion provided on the outer cylinder sealing member. A puncture member for a prefilled syringe, which restricts the puncture member from being detached from the outer cylinder sealing member. The puncture member for a prefilled syringe has an annular recess provided on the inner surface of the proximal end tubular portion of the puncture member, and the puncture member is attached to the outer cylinder sealing member in the annular recess The puncture member for a prefilled syringe according to claim 11, wherein the puncture member is engaged with an outer cylinder sealing member side rib provided on an outer surface of the outer cylinder sealing member. A puncture device for a prefilled syringe comprising the puncture member for a prefilled syringe according to claim 11 or 12, and a storage member for detachably storing the puncture member,
  The housing member is detached from the puncture member by pulling in the distal direction after the puncture member side rib of the puncture member and the outer cylinder sealing member side engaging portion of the outer cylinder sealing member are engaged. Is what
  The prefilled syringe puncture device, wherein the storage member is removable from the puncture member after being detached from the puncture member.

Images