JP4288016B2 - Prefilled syringe - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a prefilled syringe filled with a drug solution in advance.
[0002]
[Prior art]
As a container for a radiopharmaceutical, a syringe filled with a liquid medicine (prefilled syringe) filled with a radiopharmaceutical in advance is generally used. When administering a radiopharmaceutical, it is usual to house a prefilled syringe in the radiation shielding member in order to reduce the exposure of the user and the recipient. This radiation shielding member is a tube made of a high specific gravity material having a radiation shielding effect, such as lead or tungsten alloy, provided with an observation window made of lead glass, and is generally called an administration shield.
[0003]
FIG. 8 is a sectional view showing the prefilled syringe described above. The prefilled syringe 100 has a main tube 102 and a thin tube 104 connected to the tip of the main tube 102, a transparent glass injection tube 108 filled with a radiopharmaceutical (injection solution) 106 therein, and a hollow portion of the thin tube 104 A rubber stopper (closing member) 110 that allows the injection needle to pass through when used, a rubber gasket 112 inserted into the rear end portion of the syringe barrel 108, and a cylindrical fitting portion 114. The fitting portion 114 is attached to the syringe barrel 108 with the thin tube 104 fitted therein, and the distal end side is provided with a luer tip 116 fitted into a needle base (described later) of the injection needle. The injection solution 106 is filled in between. A plunger mounting hole (not shown) into which the tip of a plunger (not shown) is screwed is formed on the upper surface of the gasket 112.
[0004]
The double-edged needle 120 mounted on the prefilled syringe 100 described above is attached with a needle base 124 to which the distal end side of the luer tip 116 is fitted in an intermediate portion of a metal injection needle 122 that is sharply cut at both ends. It is what was done. When the double-edged needle 120 is attached to the prefilled syringe 100, as shown in FIG. 9, the proximal end 126 of the injection needle 122 is inserted through the rubber stopper 110 and inserted into the syringe barrel 108, and the concave groove of the needle base 124 is inserted. The luer tip 116 is fitted into the shaped luer part 128.
[0005]
The above-mentioned method of administering an injection solution using a prefilled syringe and a double-edged needle is widely used in the field of radiopharmaceuticals because it does not require a transfer operation of the radioactive drug solution and can reduce the radiation exposure of the operator.
[0006]
[Problems to be solved by the invention]
However, after attaching the injection needle to the prefilled syringe as described above, after a while, a small amount of the injection solution may leak from the tip of the injection needle before the injection solution is administered to the recipient. Such leakage of the injection solution has been a problem in terms of exposure, particularly with radiopharmaceuticals.
[0007]
The present invention has been made in view of the above-described circumstances, and an object of the present invention is to provide a technique capable of effectively preventing the injection liquid from leaking from the injection needle after the injection needle is mounted on the prefilled syringe. .
[0008]
[Means for Solving the Problems]
As a result of various studies, the present inventor attached a ring-shaped member covering a part or all of the outer peripheral surface of the thin tube in the axial direction to the thin tube at the tip of the syringe tube, and the outer surface of the thin tube and the tube of the luer tip. When the ring-shaped member is interposed between the outer peripheral surface of the thin tube and the inner peripheral surface of the cylindrical fitting portion of the luer tip in a state where the inner peripheral surface of the cylindrical fitting portion is in pressure contact with the ring-shaped member, respectively. The inventors have found that the above-described object can be effectively achieved.
[0009]
This invention is made | formed based on the above-mentioned knowledge, and provides the prefilled syringe shown to following (1).
(1) have a main and main tip provided continuously tubules of the capillary and the syringe barrel made of a large outer diameter distal portion from the proximal portion and the proximal portion, the hollow portion of said capillary And a cylindrical fitting part having a main part and a base end part having an inner diameter and an outer diameter larger than that of the main part. in prefilled syringe and a luer tip attached to the barrel in a state in which the thin tube is inserted, has a cylindrical main portion, said cylindrical main portion is covered with the outer peripheral surface of the proximal portion of said capillary And a cylindrical main portion of the ring-shaped member has an inner diameter substantially equal to an outer diameter of a proximal end portion of the thin tube, and the outer diameter is a cylindrical fitting portion of the luer tip. fitting of larger than the inner diameter of the proximal end portion, a cylindrical outer peripheral surface and luer tip of the proximal portion of the capillary In a state where the inner circumferential surface of the proximal end portion of the section is pressed against the cylindrical main portion of the ring-shaped member, of the proximal end of the tubular fitting portion of the outer peripheral surface and luer tip of the proximal portion of the capillary A prefilled syringe, characterized in that a cylindrical main portion of the ring-shaped member is interposed between a peripheral surface and a peripheral surface.
[0010]
The reason why the injection solution leaks from the injection needle after the injection needle is attached to the prefilled syringe and the reason why it can be prevented by the present invention are not necessarily clear, but are considered as follows. That is, when the prefilled syringe is used, when the injection needle is inserted into the rubber plug (occlusion member), the injection needle is inserted into the rubber plug while pushing the rubber plug, so that the rubber plug moves slightly extending in the injection needle traveling direction. In this case, if the rubber stopper is firmly and firmly attached to the thin tube, the movement amount of the rubber stopper (the extension amount of the rubber stopper) is not so large, and the pressure in the prefilled syringe is not so high. However, when the rubber plug is not firmly and firmly attached to the thin tube, the amount of movement of the rubber plug increases and the pressure in the prefilled syringe increases, and it is estimated that the injection solution leaks due to this pressure. On the other hand, in the present invention, the above-mentioned ring-shaped member is interposed between the outer peripheral surface of the thin tube and the inner peripheral surface of the cylindrical fitting portion of the luer tip. Is firmly attached to the narrow tube. As a result, in the prefilled syringe of the present invention, the amount of movement of the rubber plug when the injection needle is inserted into the rubber plug is small, and the pressure in the prefilled syringe does not increase so much, so that the injection solution does not leak from the injection needle. Conceivable.
[0011]
In addition, as a result of further investigation, the inventor has provided a concave portion or a convex portion on the outer peripheral surface of the tip side wall portion of the luer tip, or provided a notch in the wall portion, and the tip side of the luer tip is based on the needle base. When fitted, a gap is formed between the needle base and the luer tip by the concave portion, the convex portion, and the notch, and the inside and outside of the connecting portion between the needle base and the luer tip are interposed through the gap. Is an injection needle having a needle base, and when the tip side portion of the luer tip is fitted to the needle base, a hole, groove or notch that allows the inside and outside of the needle base to communicate with each other It has been found that when the injection needle formed on the basis is used, the above-mentioned object is achieved more effectively.
[0012]
Therefore, this invention provides the prefilled syringe shown to following (2)-(5).
(2) When the concave portion is formed on the outer peripheral surface of the luer tip that contacts the inner peripheral surface of the needle base of the injection needle and the tip side portion of the luer tip is fitted to the needle base, the inner peripheral surface of the needle base and the luer tip The prefilled syringe according to (1), wherein a gap is formed by the concave portion between the outer peripheral surface and the inside and outside of the connecting portion between the needle base and the luer tip communicate with each other through the gap.
[0013]
(3) A convex portion is formed on the outer peripheral surface of the luer tip that contacts the inner peripheral surface of the needle base of the injection needle, and when the tip side portion of the luer tip is fitted to the needle base, the needle base inner peripheral surface and the lure The prefilled syringe according to (1), wherein a gap is formed by the convex portion between the outer peripheral surface of the tip and the inside and outside of the connecting portion between the needle base and the luer tip communicate with each other through the gap.
[0014]
(4) When a notch is formed in the wall portion of the luer tip that contacts the inner peripheral surface of the needle base of the injection needle, and the tip side portion of the luer tip is fitted into the needle base, the inner peripheral surface of the needle base and the luer tip The prefilled syringe according to (1), wherein a gap is formed between the wall portion by the cut and the inside and outside of the connecting portion between the needle base and the luer tip communicate with each other through the gap.
[0015]
(5) An injection needle having a needle base, in which a hole, a groove, or a cut is formed in the needle base to communicate the inside and outside of the needle base when the tip side portion of the luer tip is fitted to the needle base. The prefilled syringe according to any one of (1) to (4), further comprising a needle.
[0016]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited to the following examples.
[0017]
(First embodiment)
FIG. 1 is a cross-sectional view showing a first embodiment of a prefilled syringe according to the present invention. This example is an example of the prefilled syringe of (1). The prefilled syringe 2 includes a syringe barrel 4, a rubber stopper (blocking member) 6, a rubber gasket (not shown) inserted into the rear end of the syringe barrel 4, a luer tip 8, and a ring-shaped member 10. And.
[0018]
The syringe barrel 4 has a main tube 12 and a thin tube 14 connected to the tip of the main tube 12, and is made of transparent glass filled with a radiopharmaceutical (not shown). The thin tube 14 includes a proximal end portion 16 and a distal end portion 18 having an outer diameter larger than that of the proximal end portion 16.
[0019]
The rubber stopper (closing member) 6 closes the hollow portion of the thin tube 14 and allows the injection needle to pass through during use. As shown in FIG. 2, the rubber stopper 6 includes a substantially bottomed cylindrical insertion portion 20 that is inserted into the narrow tube 14, and a flange portion 22 that is disposed between the distal end surface of the narrow tube 14 and the luer tip 8. The injection needle is inserted through the bottom 24 of the insertion portion 20. Further, on the outer peripheral surface of the insertion portion 20, a belt-like bulging portion 26 that is in pressure contact with the inner peripheral surface of the thin tube 14 is formed along the circumferential direction.
[0020]
The luer tip 8 is made of plastic, and has a cylindrical fitting portion 28 into which the thin tube 14 is fitted, and a tip side portion 30 fitted into the luer portion of the needle base of the double-edged needle. The outer peripheral surface of the distal end side portion 30 is slightly tapered. The tubular fitting portion 28 has a main portion 32 and a base end portion 34 having an inner diameter and an outer diameter larger than the main portion 32.
[0021]
The ring-shaped member 10 is made of plastic having flexibility, and has a cylindrical main portion 36 and a flange portion 38 as shown in FIG. 3, and the cylindrical main portion 36 is the proximal end of the thin tube 14. The side tube 16 is attached to the thin tube 14 so as to cover the outer peripheral surface of the side portion 16. In addition, four cuts 40 for facilitating deformation of the cylindrical main portion 36 are formed in the cylindrical main portion 36 along the axial direction. The outer peripheral surface of the thin tube 14 is in a state where the outer peripheral surface of the proximal end portion 16 of the thin tube 14 and the inner peripheral surface of the proximal end portion 34 of the tubular fitting portion 28 of the luer tip 8 are pressed against the ring-shaped member 10. And the ring-shaped member 10 is interposed between the inner peripheral surface of the cylindrical fitting portion 28 of the luer tip 8. This is because the inner diameter of the cylindrical main portion 36 of the ring-shaped member 10 is substantially equal to the outer diameter of the proximal end portion 16 of the thin tube 14, and the outer diameter of the cylindrical main portion 36 of the ring-shaped member 10 is the tube of the luer tip 8. This is because the inner diameter of the base end portion 34 of the shape fitting portion 28 is larger.
[0022]
(Second Embodiment)
FIG. 4 shows a second embodiment of the prefilled syringe according to the present invention, in which (a) is a cross-sectional view showing a state in which a double-edged needle is attached to the prefilled syringe, and (b) is a line bb in FIG. It is an end view of the lure tip in. This example is an example of the prefilled syringe of (2). 4 that are the same as those in FIG. 1 are given the same reference numerals, and descriptions thereof are omitted.
[0023]
In the prefilled syringe 42 of this example, a shallow groove-like shape is formed on the outer peripheral surface of the distal end portion 30 of the luer tip 8 that contacts the inner peripheral surface of the needle base 124 of the double-edged needle 120 along the axial direction of the distal end portion 30. A recess 44 is formed. When the distal end side portion 30 is fitted to the needle base 124, a gap is formed by the recess 44 between the inner peripheral surface of the needle base 124 and the outer peripheral surface of the distal end side portion 30, and this gap is The inside 48 and the outside 50 of the connecting portion 46 between the needle base 124 and the luer tip 8 communicate with each other.
[0024]
(Third embodiment)
5A and 5B show a third embodiment of a luer tip according to the present invention, wherein FIG. 5A is a cross-sectional view showing a state in which a double-edged needle is attached to a prefilled syringe, and FIG. 5B is a side view showing the tip side of the luer tip. is there. This example is an example of the prefilled syringe of (3). The prefilled syringe of this example is the same as the luer tip in FIG. 4 except that the concave portion of the luer tip is replaced with a convex portion. The description is omitted.
[0025]
In the prefilled syringe 52 of this example, a large number of small disk-shaped convex portions 54 are formed on the outer peripheral surface of the distal end portion 30 of the luer tip 8 in contact with the inner peripheral surface of the needle base 124 of the double-edged needle 120. When the distal end portion 30 is fitted to the needle base 124, a gap is formed by the convex portion 54 between the inner peripheral surface of the needle base 124 and the outer peripheral surface of the distal end portion 30, and this gap The inner portion 48 and the outer portion 50 of the connecting portion 46 between the needle base 124 and the luer tip 8 are communicated with each other.
[0026]
Note that the convex portion may be further minute, or one or more convex portions having a low ridge shape may be formed along the axial direction of the distal end side portion 30, and the shape, size, There is no limitation on the number.
[0027]
(Fourth embodiment)
6A and 6B show a fourth embodiment of a luer tip according to the present invention, wherein FIG. 6A is a sectional view showing a state in which a double-edged needle is attached to a prefilled syringe, and FIG. 6B is a line bb in FIG. It is an end view of the lure tip in. This example is an example of the prefilled syringe of (4). Since the prefilled syringe of this example is the same as the luer tip of FIG. 4 except that the recess of the luer tip is replaced with a notch, the same reference numerals are used in FIG. A description thereof will be omitted.
[0028]
In the prefilled syringe 62 of this example, the wall portion penetrates the wall portion of the tip side portion 30 of the luer tip 8 in contact with the inner peripheral surface of the needle base 124 of the double-edged needle 120 along the axial direction of the tip side portion 30. An incision 64 is formed. When the distal end side portion 30 is fitted to the needle base 124, a gap is formed by the notch 64 between the inner peripheral surface of the needle base 124 and the wall portion of the distal end side portion 30. The inside 48 and the outside 50 of the connecting portion 46 between the needle base 124 and the luer tip 8 communicate with each other.
[0029]
(Fifth embodiment)
FIG. 7 is a cross-sectional view showing a fifth embodiment of the luer tip according to the present invention. This example is an example of the prefilled syringe of (5). Since the prefilled syringe of this example is the same as the prefilled syringe of FIG. 1 except that it further includes a specific injection needle, the same reference numerals are given to the same components in FIG. Therefore, the description is omitted.
[0030]
The prefilled syringe 72 of this example is a double-edged needle 120 having a needle base 124, and a hole 74 that communicates the inside and outside of the needle base 124 when the distal end side portion 30 of the luer tip 8 is fitted to the needle base 124. Is further provided with a double-edged needle 120 formed on the needle base 124. The hole 74 may be replaced with a groove or a notch.
[0031]
When the test was conducted by attaching a double-edged needle to the prefilled syringes of the first to fifth embodiments, these prefilled syringes can effectively prevent the injection solution from leaking from the injection needle after the injection needle is attached. confirmed.
[0032]
【The invention's effect】
As described above, according to the prefilled syringe of the present invention, it is possible to prevent the injection solution from leaking from the injection needle after the injection needle is attached.
[Brief description of the drawings]
FIG. 1 is a cross-sectional view showing a first embodiment of a luer tip according to the present invention.
FIG. 2 is a partial cross-sectional view showing a rubber plug.
3A and 3B show a ring-shaped member, where FIG. 3A is a plan view and FIG. 3B is a cross-sectional view.
4A and 4B show a second embodiment of the prefilled syringe according to the present invention, in which FIG. 4A is a cross-sectional view showing a state in which a double-edged needle is attached to the prefilled syringe, and FIG. 4B is a cross-sectional view taken along line bb in FIG. It is an end view of the lure tip in a line.
5A and 5B show a third embodiment of a luer tip according to the present invention, wherein FIG. 5A is a cross-sectional view showing a state in which a double-bladed needle is attached to a prefilled syringe, and FIG. 5B is a side view showing the tip side of the luer tip It is.
6A and 6B show a fourth embodiment of a luer tip according to the present invention, wherein FIG. 6A is a cross-sectional view showing a state in which a double-edged needle is attached to a prefilled syringe, and FIG. It is an end view of the lure tip in a line.
FIG. 7 is a cross-sectional view showing a fifth embodiment of a luer tip according to the present invention.
FIG. 8 is a cross-sectional view showing a prefilled syringe of a radiopharmaceutical and a double-edged needle.
FIG. 9 is a cross-sectional view showing a state in which a double-edged needle is attached to a prefilled syringe.
[Explanation of symbols]
2 Prefilled syringe 4 Syringe 6 Rubber stopper (blocking member)
8 Luer tip 10 Ring-shaped member 12 Main tube 14 Narrow tube 28 Cylindrical fitting portion 42 Prefilled syringe 44 Recessed portion 54 Convex portion 62 Prefilled syringe 64 Notch 72 Prefilled syringe 74 Hole 124 Needle base 120 Double-edged needle

Claims (6)

Main and have a main tip to continuously provided by tubules, the thin tube is closed and the syringe barrel made of a large outer diameter distal portion from the proximal portion and the proximal portion, the hollow portion of said capillary And a cylindrical fitting portion having a closing member for inserting the injection needle in use and a base portion having a main portion and a base end portion having an inner diameter and an outer diameter larger than the main portion, and the thin tube is disposed in the cylindrical fitting portion. A prefilled syringe having a luer tip attached to a syringe barrel in a state of being inserted, and having a cylindrical main portion , and the cylindrical main portion covers the outer peripheral surface of the proximal end portion of the thin tube and forms a thin tube An inner diameter of the cylindrical main portion of the ring-shaped member is substantially equal to the outer diameter of the proximal end portion of the thin tube, and the outer diameter is the proximal end of the tubular fitting portion of the luer tip parts larger than the inner diameter of the proximal portion of the tubular outer peripheral surface and a tubular fitting portion of the luer tip In a state where the inner circumferential surface of the end portion is pressed against the cylindrical main portion of the ring-shaped member, the outer circumferential surface and the inner circumferential surface of the proximal end portion of the tubular fitting portion of the luer tip of the proximal portion of the capillary A prefilled syringe, characterized in that a cylindrical main portion of the ring-shaped member is interposed therebetween.   When the concave portion is formed on the outer peripheral surface of the luer tip that contacts the inner peripheral surface of the needle base of the injection needle, and the tip side portion of the luer tip is fitted to the needle base, the inner peripheral surface of the needle base and the outer peripheral surface of the luer tip The prefilled syringe according to claim 1, wherein a gap is formed by the concave portion between the inside and outside of the connecting portion between the needle base and the luer tip through the gap.   A convex portion is formed on the outer peripheral surface of the luer tip that contacts the inner peripheral surface of the needle base of the injection needle, and when the tip side portion of the luer tip is fitted to the needle base, the needle base inner peripheral surface and the luer tip outer peripheral surface 2. The prefilled syringe according to claim 1, wherein a gap is formed by the convex portion between the inside and the outside of the connecting portion between the needle base and the luer tip through the gap.   When a notch is formed in the wall portion of the luer tip that contacts the inner peripheral surface of the needle base of the injection needle, and the tip side portion of the luer tip is fitted to the needle base, the inner surface of the needle base and the luer tip wall portion The prefilled syringe according to claim 1, wherein a gap is formed by the notch between the inside and outside of the connecting portion between the needle base and the luer tip through the gap.   An injection needle having a needle base, further comprising a hole, groove or cut formed in the needle base for communicating the inside and outside of the needle base when the tip side portion of the luer tip is fitted to the needle base. The prefilled syringe according to any one of claims 1 to 4, wherein the prefilled syringe is provided.   The prefilled syringe according to any one of claims 1 to 5, wherein the prefilled syringe is filled with a radiopharmaceutical.

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