JP4449401B2 - Prefilled syringe - Google Patents

Description

  The present invention relates to a prefilled syringe. More specifically, the present invention relates to a prefilled syringe provided with an extendable plunger.

  A so-called prefilled syringe in which a medicine is filled in advance is generally provided in the form shown in FIG. However, such a prefilled syringe has a problem that a space becomes large at the time of storage because of its long overall length.

  In order to solve this problem, an invention has been made in which a rod is separated from a prefilled syringe body, the separated rod is provided in a packaging state in close contact with the side surface of the syringe body, and the two are combined during use. (See Patent Document 1). Thereby, the package body of a prefilled syringe can be put together in a more compact state than before.

  Ordinary prefilled syringes are packaged after undergoing a sterilization process such as high-pressure steam sterilization. Therefore, since the proximal end side of the gasket in the barrel shown by S in FIG. 12 is exposed to the outside air after sterilization, sterility cannot be completely guaranteed. Therefore, when a so-called flashback operation is performed by pulling the plunger to confirm that the puncture needle has been punctured into the blood vessel, or when another drug is sucked into the barrel, the internal drug is caused by bacteria. There was a risk of contamination.

  In order to solve this problem, an invention that prevents sterilization after packaging a prefilled syringe or prevents the invasion of microorganisms into a syringe during storage by closing the rear end opening of the syringe with a stopper. (See Patent Document 2).

JP-A-8-173533 (paragraph number 0034 and FIG. 15) Japanese Patent No. 3219845 (5th column, lines 25 to 28 and FIG. 2)

  However, in the invention described in Patent Document 1, although the length of the prefilled syringe during storage is shortened, the lateral width is increased. Furthermore, after use, the rod must be separated from the syringe body and then bonded to the gasket, which may impair the quickness that is an advantage of the prefilled syringe. In addition, no means for preventing bacteria from entering the base end side of the gasket in the barrel is provided.

  Also, the invention described in Patent Document 2 is similar to the invention described in Patent Document 1, and the rod must be coupled to the gasket during use, which may impair the speed. Further, in the invention described in Patent Document 2, there is no means for storing the rod and the syringe body in an integrated manner as in the invention described in Patent Document 1, and the rod may be lost.

  That is, the problem to be solved by the present invention is to reduce the space during storage as much as possible without impairing the quick use that is an advantage of the prefilled syringe, and to guarantee the sterility on the proximal side of the gasket in the barrel. It is.

Thus, the present inventors have intensively studied to solve the above-mentioned problems, and have arrived at the present invention. That is, the present invention
(1) a barrel having a distal end provided with an injection needle connection sealed with a cap and an open proximal end;
A plunger having a rod and a gasket coupled to the tip of the rod;
The plunger is slidably inserted into the barrel and extends in the axial direction from a shortened state to an extended state;
(2) The prefilled syringe according to (1), wherein the rod is formed by nesting a plurality of hollow members having at least one end opened on the same axis;
(3) The plunger further comprises an expansion / contraction prevention means,
The prefilled syringe according to (1) or (2), wherein the expansion / contraction preventing means prevents the plunger from expanding and contracting in the axial direction in the extended state;
(4) Stretch prevention means
An inner flange formed at one end of the first hollow member;
An outer flange formed on one end of a second hollow member inserted or packaged in the first hollow member, and abutting against the inner flange;
Comprising a locking claw formed on a side surface of the first hollow member or the second hollow member;
The pre-filled syringe according to (3), wherein the locking claw, when extended, holds the other flange in cooperation with one flange;
(5) The plunger further comprises anti-rotation means,
The prefilled syringe according to any one of (1) to (4), wherein the rotation preventing means prevents the hollow members from relatively rotating in the extended state;
(6) The rotation prevention means
A plurality of protrusions formed on the axial end surface of the inner flange;
A plurality of protrusions formed on the end surface of the outer flange in contact with the end surface in the axial direction;
The prefilled syringe according to (5), wherein the protrusions mesh with each other in the extended state;
(7) The plunger further comprises a sealing means,
The prefilled syringe according to any one of (1) to (6), wherein the sealing means seals the space on the proximal end side with respect to the gasket in the barrel in a shortened state;
(8) The sealing means is composed of a bottomed cylindrical part surrounding the rod, and the bottomed cylindrical part is provided in the hollow member located on the most proximal side in the extended state and is fitted into the barrel in the shortened state. The prefilled syringe according to (7);
(9) The prefilled syringe according to any one of the above (1) to (8), which is formed by inserting a plunger prevention means from the base end side of the barrel;
(10) The plunger according to any one of (1) to (8);

  According to the present invention, it is possible to provide a prefilled syringe that can be used quickly as in the case of a conventional prefilled syringe, requires only a small storage space, and maintains the proximal end side in a sterile state with respect to the gasket in the barrel until just before use. .

Next, embodiments of the present invention will be described with reference to the drawings.
1-3 is a figure which shows Example 1 of this invention. 1 is a front view, and FIGS. 2 and 3 are longitudinal sectional views. 1 and 2 is in the extended state, and the rod in FIG. 3 is in the shortened state. (A) of FIG. 2 is the elements on larger scale of the expansion-contraction prevention means.
4 to 6 are assembly diagrams of the plunger of the prefilled syringe of the first embodiment. 4 shows a one-side sectional assembly view, FIG. 5 shows a side assembly view, and FIG. 6 shows a partial sectional perspective assembly view.
FIG. 7 is a one-side sectional assembly view of a plunger of the prefilled syringe of Example 2 (the prefilled syringe is not shown).
8 and 9 are partial longitudinal sectional views showing the prefilled syringe of Example 3. FIG. The rod in FIG. 8 is in an extended state, and the rod in FIG. 9 is in a shortened state. FIG. 8A is a partially enlarged view.
FIG. 10 is a one-side cross-sectional assembly view of the plunger of the prefilled syringe of Example 3.
FIG. 11 is an enlarged one-side sectional view showing another method of joining the plunger rod and gasket of the third embodiment.
FIG. 12 shows a conventional prefilled syringe.
In the present specification, the distal end side or distal end direction indicates the direction of arrow A, and the proximal end side or proximal end direction indicates the direction of arrow B. In each of the first to third embodiments of the present invention, the plunger can be extended by making the rod extendable.

  A first embodiment of the present invention will be described with reference to FIGS. As shown in FIGS. 1 to 3, the prefilled syringe 1 according to the first embodiment includes a barrel 10 in which the injection needle connecting portion 11 is sealed with a cap 30 and a plunger 20 inserted into the barrel 10. The rod 50 of the plunger 20 can be extended from the shortened state to the extended state. The rod 50 is stored in a shortened state and is extended when in use. In the shortened state, the sealing means 60 provided on the rod 50 seals the proximal end opening 12 of the barrel 10.

  As shown in FIGS. 1 to 3, a syringe needle connecting portion 11 sealed with a cap 30 is formed at the distal end of the barrel 10, and a finger hook flange 13 is formed at the proximal end. Although the medicine D is accommodated in the barrel 10, the medicine D may be a liquid agent or a solid agent. The barrel 10 is preferably formed of polyethylene, polypropylene, a mixture of polyethylene and polypropylene, or polyolefin resin such as cyclic polyolefin, but has been used as a medical material such as polycarbonate, methacrylic resin, or polymethylpentene. Any resin that does not interact with the drug D contained in the container and has no fear of elution to the drug D can be suitably used.

  If the cap 30 can seal the injection needle connection part 11, the structure will not be specifically limited. The material is not particularly limited as long as it has a track record of use as a packaging material for chemicals. For example, elastic materials such as butyl rubber, silicone rubber, thermoplastic elastomer, silicone elastomer, polyethylene, polypropylene, a mixture of polyethylene and polypropylene, cyclic polyolefin, etc. The polyolefin resin is mentioned. Further, the cap and the injection needle connecting portion may be integrally formed and can be broken at the time of use.

  As shown in FIGS. 1 to 3, the plunger 20 is slidably inserted into the barrel 10 and includes a gasket 40 and a rod 50 capable of coupling the gasket 40 to the tip. Examples of the method for connecting the gasket 40 and the rod 50 include screwing and press fitting (not shown) shown in FIGS. 2 to 4, but the gasket and the rod are easily separated when the plunger is pulled. Otherwise, the bonding method is not particularly limited. As a material for forming the rod 50, polyethylene resin, polypropylene, a mixture of polyethylene and polypropylene, and polyolefin resin such as cyclic polyolefin are most preferable, but polycarbonate, methacrylic resin, polymethylpentene, ABS resin, etc. have been used as medical materials. If it is a thing, it will not specifically limit.

  As a material for forming the gasket 40, an elastic material such as butyl rubber, silicon rubber, thermoplastic elastomer, or silicon elastomer can be suitably used.

  The rod 50 has a structure in which at least one hollow member having an open end (a cylindrical member is employed as a hollow member in the first embodiment) is arranged on the same axis and nested. As shown in FIGS. 2 and 3, the rod 50 according to the first embodiment includes a hollow member 52 in which a top surface member 51 provided with a male screw 511 is crowned, a hollow member 53 inserted in the hollow member 52, and a hollow member 53, and a hollow member 55 having a bottom surface 551 inserted in the hollow member 54, and can extend in the axial direction from the shortened state shown in FIG. 2 to the extended state shown in FIG. It has become. The storage space is reduced by shortening the rod 50 during storage.

  Further, the rod 50 is provided with expansion / contraction preventing means 80 for preventing the rod 50 in the extended state from expanding and contracting in the axial direction. By providing the expansion / contraction prevention means 80, when the rod 50 is extended, it is possible to prevent the rod 50 from being disassembled due to the hollow member inserted therein dropping out from the outer hollow member. Further, when the medicine D is discharged by pushing the plunger 20, it is possible to prevent the possibility of preventing the medicine D from being discharged by returning the rod 50 to the shortened state. The expansion / contraction preventing means 80 shown in FIG. 2A includes an inner flange 81 formed at the proximal end of the hollow member 53, and an outer flange 82 formed at the distal end of the hollow member 54 inserted into the hollow member 53. The locking claw 83 includes a locking claw 83 formed on the side surface of the hollow member 54, and the locking claw 83 holds the inner flange 81 in cooperation with the outer flange 82. That is, when a force for extending the rod 20 is applied, the outer flange 82 comes into contact with the inner flange 81 and the extension is stopped. When a force for shortening the rod 50 is applied to the extended rod 50, the inner flange 81 is applied. Shortening is prevented by contact of the locking claw 83 with 81. As shown in FIG. 6, a plurality of locking claws 83 are formed in a virtual plane shape perpendicular to the axial direction of the side surface of the hollow member 54 and can swing in the radial direction. As shown in FIG. 2A, the distal end side of the locking claw 83 has a surface 83a perpendicular to the axial direction, and the proximal end side is connected to the side surface of the hollow member 54 via a gentle slope 83b. When the inclined surface 83b of the locking claw 83 comes into contact with the distal end side of the inner flange 81 when the rod 50 is extended, the locking claw 83 swings radially inward, so that the rod 50 can continue to extend thereafter. . If one of the inner flange 81 and the outer flange 82 can prevent the hollow member 54 from falling off, it is shaped like a gear tooth with a part cut away as in Example 2 described later. It may be.

  Further, the rod 50 is provided with an anti-rotation means 90 for preventing the hollow members from relatively rotating in the extended state. As shown in FIGS. 4 to 6, the rotation preventing means 90 is formed on a plurality of protrusions 91 formed on the end surface in the distal direction of the inner flange 81 and an end surface in the proximal direction of the outer flange 82 that contacts the inner flange 81. The protrusions 91 and 92 are engaged with each other in the extended state to prevent relative rotation of the hollow members in the circumferential direction. Note that the width of one protrusion is preferably substantially the same as the distance between the other protrusions. If the distance between all the protrusions provided on one flange is equal to the width of the other protrusion, the minimum number of the other protrusions is sufficient to prevent rotation. For example, as shown in FIG. 4, the distances between the protrusions 91 are all equal to the width of the protrusion 92, so the number of protrusions 92 is smaller than the number of protrusions 91. Moreover, although the top part of the protrusion 92 and the protrusion 91 is an arc and the protrusions can be easily engaged with each other, a taper (not shown) may be used.

  Further, the base end of the hollow member 55 located on the most proximal side of the rod 50 in the extended state has a flange-shaped bottom surface 551. The bottom surface 551 is gripped to extend the rod 50, and the bottom surface 551 is pushed to discharge the medicine D. As shown in FIG. 4, the outer flange 552 at the tip of the hollow member 55 has a tooth-like shape, and each element has a substantially L-shaped hook shape having radially outward teeth. Further, the outer flange 552 can swing radially inward, and the outer side in the oblique tip direction is a slope 552a. The hollow member 55 can be inserted from the proximal end side of the hollow member 54 by making the outer flange at the distal end have such a shape. A protrusion 92 is formed on the base end side of each hook 552.

  The rod is provided with a sealing means 60 for sealing the space S closer to the base end than the gasket 40 in the barrel 10. By providing the sealing means 60, the aseptic condition of the space S on the proximal end side with respect to the gasket 40 in the barrel 10 can be ensured until just before use. As shown in FIGS. 1 to 6, the sealing means 60 includes a cylindrical portion 61 that surrounds the rod 50, and an O-shaped bottom surface 62 that connects the base end of the cylindrical portion 61 and the rod 50. While being provided in the hollow member 55 located at the most proximal end of the rod 50, the tubular portion 61 is fitted into the proximal end of the barrel 10 in a shortened state. In FIG. 3, the tubular portion 61 is fitted in a drop prevention means 70 described later. In addition, if the cylindrical part 61 of the sealing means 60 is extended to the bottom face 551 as the pressing part described above, the O-shaped bottom face 62 is not necessary.

  Further, a means for preventing the plunger 20 from coming off may be inserted into the base end of the barrel 10. By inserting the removal preventing means 70, it is possible to prevent the plunger 20 from falling off when the rod 50 is extended or when the chemical solution D is sucked. As shown in FIG. 3, the disconnection preventing means 70 is a substantially cylindrical member including a cylindrical portion 71 fitted into the proximal end of the barrel 10 and a flange portion 72 formed at the proximal end of the tubular portion 71. The distal end of the cylindrical portion 71 has a ridge 73 fitted in the groove 14 provided in the inner wall of the base end portion of the barrel 10 in the circumferential direction. When the rod 50 is extended or when the chemical solution D is sucked, the proximal end periphery of the hollow member 52 comes into contact with the distal end periphery of the disconnection preventing means 70, so that the plunger 20 can be prevented from coming off. As a forming material of the prevention means 70, polyethylene, polypropylene, a mixture of polyethylene and polypropylene, and a polyolefin resin such as a cyclic polyolefin are preferable. Polycarbonate, methacrylic resin, polymethylpentene, ABS resin, etc. have been used as medical materials. There is no particular limitation as long as it is. In addition, elastic materials such as butyl rubber, silicon rubber, thermoplastic elastomer, and silicon elastomer can also be suitably used.

  Subsequently, an example of the manufacturing method of the prefilled syringe 1 of Example 1 is demonstrated. After the injection needle connecting portion 11 of the barrel 10 is sealed with the cap 30, the drug D is filled into the barrel 10. Further, the gasket 40 is inserted, and the means for preventing the gasket 40 from being detached is inserted. Here, the rod 50 in a shortened state assembled in advance is coupled to the gasket 40, and the sealing means 60 of the rod 50 is fitted into the removal preventing means 70 integrated with the barrel 10. Thereafter, the prefilled syringe 1 is sterilized by high-pressure steam sterilization, hot water shower sterilization or the like, and packaged by blister packaging, shrink packaging or the like. The package may be sterilized before sterilization and sterilized as a whole.

  The assembly of the rod 50 is performed in the following procedure. First, after sequentially inserting the hollow member 53 and the hollow member 54 from the front end side of the hollow member 52, the top surface member 51 provided with a male screw at the front end opening of the hollow member 52 is crowned. Thereafter, a hollow member 55 having a bottom surface is inserted from the base end side of the hollow member 54. When the hollow member 55 is inserted into the hollow member 54, the locking claw 83 is swung radially inward.

  A plunger 120 of a prefilled syringe (a prefilled syringe is not shown) of Example 2 of the present invention will be described with reference to FIG. The plunger 120 according to the second embodiment has substantially the same configuration as the plunger 20 according to the first embodiment, but is different from the expansion / contraction preventing means. The outer flange 182 constituting the expansion / contraction preventing means of the second embodiment has a shape with a part cut away.

  As shown in FIG. 7, the outer flange 182 constituting the expansion / contraction preventing means has a shape with a part cut away, and each element has a substantially L-shaped hook shape having radially outward teeth. . Further, the outer flange 182 can swing inward in the radial direction, and the outer side in the oblique tip direction is a slope 182a. By forming the outer flange at the tip of each hollow member in such a shape, all the hollow members can be inserted from the base end side of the hollow members that are externally fitted to the hollow members, and are coupled to the gasket 140. The male screw 1511 as a means and the hollow member 152 can be integrally formed. In addition, the protrusion 192 is formed in the base end side of each outer flange, and it comprises the protrusion 191 and comprises the rotation prevention means.

  Subsequently, an example of the manufacturing method of the prefilled syringe of Example 2 is demonstrated. The manufacturing method of the prefilled syringe of Example 2 is substantially the same as that of the prefilled syringe 1 of Example 1. The difference is the assembly of the rod 150. The rod 150 is assembled by sequentially inserting the hollow member 153 into the hollow member 152 provided with the male screw 1511, the hollow member 154 into the hollow member 153, and the hollow member 155 having the sealing means 160 into the hollow member 154. When the other hollow member is inserted into one hollow member, the locking claw 183 is swung inward in the radial direction.

  A third embodiment of the present invention will be described with reference to FIGS. The prefilled syringe 3 of Example 3 has a configuration substantially similar to that of the prefilled syringe 1 shown in Example 1. The difference is the structure of the plunger 220.

  The rod 250 of the plunger 220 has a structure in which the rod 50 of the first embodiment is substantially reversed. As shown in FIGS. 8 to 10, the rod 250 includes a hollow member 252 provided with a male screw 2511, a hollow member 253 sheathed by the hollow member 252, a hollow member 254 sheathed by the hollow member 253, and a hollow member 254. It comprises an outer hollow member 255 and a sealing means 260 attached to the proximal end opening of the hollow member 255. 8A includes an outer flange 282 formed at the proximal end of the hollow member 254, an inner flange 281 formed at the distal end of the hollow member 255 sheathed by the hollow member 254, The engaging claw 283 is formed on the side surface of the member 254, and the engaging claw 283 cooperates with the outer flange 282 to sandwich the inner flange 281.

  Subsequently, an example of the manufacturing method of the prefilled syringe 3 of Example 3 is demonstrated. The manufacturing method of the prefilled syringe 3 of Example 3 is substantially the same as the prefilled syringe 1 of Example 1. The difference is the assembly of the rod 250. The rod 250 is assembled by sequentially inserting a hollow member 254 in the hollow member 255, a hollow member 253 in the hollow member 254, and a hollow member 252 having a male screw in the hollow member 253, and then sealing the sealing means 260. . When the other hollow member is inserted into one hollow member, the locking claw is swung inward in the radial direction.

  In addition, since the plunger 220 of Example 3 has a small contact area between the gasket 240 and the rod 250, when the rod 250 swings with the tip as a fulcrum when discharging the drug D, the peripheral surface of the gasket 240 and the barrel 210. There is also a possibility that a gap will be formed in the inner wall of the. Therefore, by making the male screw 2511 at the tip of the rod 250 into a sphere 3511 as shown in FIG. 11, the sphere 3511 rotates in the gasket 340 even if a force that swings the rod 352 with the tip as a fulcrum acts. There is no gap in the barrel inner wall (not shown) with which the peripheral surface of 340 is in contact.

It is a front view of Example 1 of the present invention. It is a longitudinal cross-sectional view of Example 1 of this invention. It is a longitudinal cross-sectional view of Example 1 of this invention. It is a one-side cross-section assembly drawing of the plunger of Example 1 of this invention. It is a side assembly figure of the plunger of Example 1 of this invention. It is a partial section perspective assembly view of the plunger of Example 1 of the present invention. It is a one-side cross-section assembly drawing of the plunger of Example 2 of this invention. It is a partial longitudinal cross-section assembly drawing of Example 3 of this invention. It is a fragmentary longitudinal cross-section of Example 3 of the present invention. It is a half sectional view of the plunger of Example 3 of the present invention. It is an expansion half side sectional view which shows other embodiment of the plunger of Example 3 of this invention. It is a figure which shows a prior art.

Explanation of symbols

1, 3 Prefilled syringe 10 Barrel 11 Injection needle connector 20, 120, 220 Plunger 30 Cap 40, 140, 240, 340 Gasket 50, 250 Rod 60, 160, 260 Sealing means 70 Removal prevention means 80, 280 Stretch prevention means 81, 281 Inner flange 82, 182, 282 Outer flange 83, 183, 283 Locking claw 90 Anti-rotation means 91, 92, 191, 192 Protrusion S Space

Claims (7)

A barrel having a distal end provided with a cap-sealed needle connection and an open proximal end;
A plunger having a rod and a gasket coupled to the tip of the rod;
The plunger is slidably inserted into the barrel and extends in the axial direction from a shortened state to an extended state.
The rod comprises a plurality of hollow members having at least one end opened on the same axis and in a nested manner,
The rod further comprises sealing means;
The sealing means includes a bottomed cylindrical portion surrounding the rod, and the bottomed cylindrical portion is provided in a hollow member positioned closest to the proximal end in the extended state and is fitted into the barrel in the shortened state. A prefilled syringe that seals the space on the proximal side of the gasket in the barrel . The plunger further comprises a means for preventing expansion and contraction,
The prefilled syringe according to claim 1 , wherein the expansion / contraction prevention means prevents the plunger from expanding and contracting in the axial direction in the extended state. Stretching prevention means
In the hollow member adjacent on the distal end side and the proximal end side when the rod is extended,
An inner flange formed at an end of a hollow member having a large size, on a side where the hollow member having a small size is located,
An outer flange formed at the end of the hollow member having a small size, on the side where the hollow member having a large size is located,
Comprising a locking claw formed on a side surface of the hollow member having a small size,
The prefilled syringe according to claim 2 , wherein the inner flange is sandwiched between the outer flange and the locking claw . The plunger further comprises anti-rotation means,
The prefilled syringe according to any one of claims 1 to 3 , wherein the rotation preventing means prevents the hollow members from relatively rotating in the extended state. Anti-rotation means
A plurality of protrusions formed on the axial end face of the inner flange;
A plurality of protrusions formed on the end face in the axial direction of the outer flange contacting the end face,
The prefilled syringe according to claim 4 , wherein the protrusions mesh with each other in the extended state. The prefilled syringe according to any one of claims 1 to 5, wherein a plunger removal preventing means is inserted from the base end side of the barrel. The plunger of Claims 1-5 .

Images