JP6982750B2 - Sterilization protective stopper and connector with sterilization protective stopper - Google Patents

Description

The present invention relates to a protective stopper for sterilization and a connector with a protective stopper for sterilization that can be suitably used for sterilization treatment.

Conventionally, medical instruments such as syringes are delivered to pharmaceutical companies, medical institutions, etc. after undergoing some kind of sterilization treatment such as steam sterilization. As the sterility treatment, for example, in addition to high-pressure steam sterility, γ-ray sterility, electron beam sterility, EOG (engineered chillene oxide gas) sterility and the like are known.

As for these γ-ray sterilization and EOG sterilization treatments, a method of sterilizing with a cap made of a rubber material containing ethylene propylene diene rubber attached to an male luer taper portion formed at the tip of a syringe such as a syringe is known. (For example, Patent Document 1).

Japanese Unexamined Patent Publication No. 2013-43957

However, when sterilizing with the cap attached, it is necessary to ensure that the gas has permeated to the inside of the syringe, but in the EOG sterilization process, the highly toxic EOG gas is surely sterilized. Must be removed.

However, for example, in order to confirm that EOG gas is removed from each surface of the fitted luer taper, it is necessary to remove the cap from the male luer taper portion, and on the contrary, the sterilized male luer taper portion is contaminated. There is the inconvenience of being exposed to the risk of being exposed.

In view of the above problems of the prior art, it is an object of the present invention to provide a protective stopper for sterilization which can be sterilized by gas in a mounted state and can surely remove gas.

In order to achieve such an object, the protective stopper for sterilization of the present invention is a protective stopper for sterilization that is screwed and locked while being fitted to the tip of a luer connector, and has a disk-shaped top plate and a disk-shaped top plate. An outer cylinder portion extending downward from the peripheral edge of the top plate portion, a female screw portion formed on the inner peripheral surface of the outer cylinder portion, and a tip surface of the luer connector extending downward from the lower side surface of the top plate portion. It is characterized by having a protrusion that comes into contact with a part of the above.

The protective stopper for sterilization of the present invention can be externally fitted to a luer connector formed at the tip of a syringe, a feeding kit or a feeding catheter. Then, it can be screwed into the luer connector by the female screw portion provided on the inner peripheral surface of the sterilization protective plug.

At this time, the protective stopper for sterilization of the present invention is provided with a protrusion extending downward from the lower side surface of the top plate portion and in contact with a part of the tip surface of the luer connector, so that the protective stopper for sterilization is provided. A gap can be created between the lower surface of the top plate of the stopper and the tip surface of the luer connector.

As a result, the fluid that has moved between the outer peripheral surface of the luer connector and the inner peripheral surface of the outer cylinder of the sterilization protective plug through the gap between the screwed threads is transferred by the protrusion to the sterilization protective plug. It can also pass between the lower side surface of the top plate and the tip surface of the luer connector.

Therefore, since the internal space and the external space of the lure connector can be ventilated even if the sterilization protective plug is screwed, according to the sterilization protective plug of the present invention, gas sterilization can be performed while the lure connector is attached, and gas can be sterilized. It can be reliably removed.

In the protective stopper for sterilization of the present invention, the top plate portion is provided with a guide portion that extends downward from the lower side surface of the top plate portion and is loosely fitted inside from the tip opening of the luer connector. preferable.

According to this, the guide portion extending downward from the lower side surface of the top plate portion is supported on the inner peripheral surface of the luer connector, so that the protective stopper for sterilization can be easily screwed straight to the luer connector. Can be done. Further, since the guide portion is loosely fitted, it does not come into close contact with the entire inner peripheral surface of the luer connector, so that the ventilation of the fluid is not hindered.

In the protective stopper for sterilization of the present invention, it is preferable that the guide portion is provided in the central portion of the lower side surface of the top plate portion, and the protrusion portion extends radially from the outer edge of the base end portion of the guide portion. ..

According to this, the flow line of the fluid can be made symmetrical with respect to the axial direction of the luer connector, so that the air permeability can be improved.

In the protective stopper for sterilization of the present invention, the inner peripheral surface of the outer cylinder portion has a convex shape from the inner peripheral surface toward the axial direction of the outer cylinder portion, and abuts the outer peripheral surface of the luer connector. It is preferable to have a locking portion for locking.

According to this, it is possible to prevent the screwed state from being loosened while allowing the sterilization protective stopper to be ventilated.

The connector with a protective stopper for sterilization of the present invention includes the protective stopper for sterilization and the luer connector, and a plurality of ribs screwed with the female thread portion are spaced apart from each other on the outer peripheral surface of the luer connector. It is characterized by being provided in existence.

According to this, since the fluid can pass between the surface of the outer peripheral surface of the luer connector where the rib is not provided and the inner peripheral surface of the outer cylinder portion of the cap, the air permeability can be improved.

It is explanatory drawing which shows the connector with the protective plug for sterilization of this invention, and is the partial sectional view in the state which the protective plug for sterilization is removed. Side view of the syringe shown in FIG. The bottom view of the protective stopper for sterilization shown in FIG. It is explanatory drawing which shows the connector with the protective plug for sterilization of this invention, and is the partial sectional view in the state which the protective plug for sterilization is attached. It is a figure which shows the modification of the protective plug for sterilization of this invention, A is a partial sectional view seen from the front, B is a bottom view.

Next, embodiments of the present invention will be described in more detail with reference to the accompanying drawings.

As shown in FIG. 1, the syringe 1 with a protective stopper for sterilization according to the present embodiment includes a syringe 10 having a substantially cylindrical shape and a protective stopper 20 for sterilization attached to the tip of the syringe 10.

In the present embodiment, the syringe 1 will be described as an example as having a luer connector, but the present invention is not limited to this, and the present invention is not limited to this, and the present invention is not limited to this. , Nutrition bag, nutrition / oral / administration syringe, etc. may be used.

After sterilization described later, the syringe 1 with a protective stopper for sterilization is sealed with a gasket (not shown) provided at the tip of the plunger rod in a state where the inside of the syringe 10 is filled with a chemical solution, and the protective stopper for sterilization 20 is sealed. By pressing the plunger rod after removing the sterilizer, the chemical solution can be freely poured out.

Next, the configuration of the syringe 10 will be described with reference to FIGS. 1 and 2.

The syringe 10 is molded from a synthetic resin such as polyethylene or polypropylene.

As shown in FIG. 1, the syringe 10 has a cylindrical body portion 11 having an internal space filled with a chemical solution.

A substantially cylindrical neck portion 12 having a reduced diameter is integrally formed at the tip of the body portion 11. The inner peripheral surface of the neck portion 12 is a female luer taper 13 that communicates with the internal space of the body portion 11 and fits with an male luer taper (not shown) provided in a mixed injection port or a feeding bag.

As shown in FIG. 2, a pair of ribs 14 and 14 are provided on the outer peripheral surface of the neck portion 12 on the tip end side. The ribs 14 and 14 each have a spirally inclined shape, and are formed point-symmetrically at positions displaced by 180 degrees with respect to the axis of the syringe 10.

The neck portion 12 having the above configuration corresponds to the luer connector of the present invention.

In the present embodiment, each rib 14 is formed along the outer peripheral surface of the neck portion 12 in a plan view to be one-fourth the length of the outer peripheral surface. On the contrary, in the outer peripheral surface of the neck portion 12, the region where the rib 14 is not provided from the base end to the tip end (hereinafter referred to as a flat surface 14') is also 2 with a length of 1/4 of the outer peripheral surface in a plan view. Is formed.

Since the ribs of the present invention may be provided at intervals of each, the ribs are not limited to the shape of the present embodiment, and the number may be three or more, and the lengths and shapes are the same. It may not be necessary, and the spiral strip forming the male screw may be provided with a notch that divides the strip.

Further, as shown in FIG. 1, a pair of finger hook portions 15 are integrally formed on the peripheral edge of the rear end of the body portion 11.

Next, the configuration of the sterilization protective stopper 20 will be described with reference to FIGS. 1 and 3.

The sterilization protective stopper 20 is formed of a synthetic resin such as polyethylene or polypropylene.

As shown in FIG. 1, the sterilization protective plug 20 has a disk-shaped top plate portion 21 and an outer cylinder portion 22 extending downward from the peripheral edge of the top plate portion 21.

A plurality of outer ribs 23 projecting in a direction away from the axial direction of the sterilization protective plug 20 are provided on the outer peripheral surface of the outer cylinder portion 22 at predetermined intervals. The outer ribs 23 are provided in parallel along the axial direction of the sterilization protective stopper 20, respectively.

A female screw portion 24 is formed on the inner peripheral surface of the outer cylinder portion 22. _{The inner diameter r 1} (distance between the inwardly convex portions of the female screw portion 24) of the outer cylinder portion 22 shown in FIG. 3 is _{larger than the outer diameter r 2} of the neck portion 12 of the syringe 10 shown in FIG. 2, and the rib 14 It is designed smaller than the distance r ₃ between 14 outer surface.

A pair of inner ribs 25, 25 (corresponding to the "locking portion" of the present invention) are located along the axis of the sterility protective stopper 20 in the vicinity of the top plate of the spiral groove formed by the female screw portion 24. It is provided in parallel. The inner ribs 25, 25 are formed in a convex shape toward the axis of the sterilization protective plug 20, and are symmetrical positions on the inner peripheral surface of the sterilization protective plug 20 with the axis of the sterilization protective plug 20 interposed therebetween. It is provided in.

A cylindrical guide portion 26 extending downward from the center is provided on the lower side surface of the top plate portion 21. As shown in FIG. 3, the guide portion 26 is arranged concentrically with the top plate portion 21 in the bottom view. Further, since the outer diameter of the guide portion 26 is formed to be smaller than the inner diameter of the neck portion 12, the guide portion 26 is loosely fitted to the neck portion 12 when the sterilization protective plug 20 is attached to the syringe 10. Since the guide portion 26 of the present invention is sufficient as long as it is loosely fitted to the neck portion 12, the shape is not limited to a cylindrical shape, and may be a square cylinder or a columnar shape.

As shown in FIG. 1, a convex protrusion 27 is formed on the lower side surface of the top plate 21. As shown in FIG. 3, four protrusions 27 of the present embodiment are formed at equal intervals and extend radially from the outer edge of the base end of the guide portion 26, respectively. The protrusion 27 of the present invention is shaped so that the lower side surface of the top plate 21 is formed so as to be in contact with a part of the tip of the neck 12 so as not to seal the tip of the neck 12. Is not limited to a square columnar shape, but may be a hemispherical shape, and the number may be 1 or more.

The sterilization protective stopper 20 described above can be attached to the syringe 10. Specifically, first, the sterilization protective plug 20 is screwed into the neck portion 12 of the syringe 10 while rotating it clockwise. At this time, since the guide portion 26 is supported by the inner peripheral surface of the neck portion 12, the sterilization protective plug 20 can be attached straight to the neck portion 12.

When further screwed in, as shown in FIG. 4, the ribs 14 and 14 of the syringe 10 ride on the inner rib 25 of the sterilization protective stopper 20 and are locked, and the sterilization protective stopper 20 is screwed and fixed to the syringe 10. Will be done.

At this time, since the outer peripheral surface of the neck portion 12 has flat surfaces 14', 14', which are regions where the ribs 14 are not formed, the flat surfaces 14', 14'and the outer cylinder portion 22 of the sterilization protective plug 20 By creating a gap between the inner peripheral surface and the inner peripheral surface, a first fluid passage 30 that communicates the internal space and the external space of the syringe 10 is formed.

Further, the tip surface of the neck portion 12 is in contact with the protrusion portion 27 provided on the top plate portion 21 of the sterilization protective plug 20. As a result, a gap is created between the lower side surface of the top plate portion 21 and the tip end surface of the neck portion 12, so that the second fluid passage 31 that communicates the internal space and the external space of the syringe 10 (the "fluid" of the present invention). A passage "corresponds to.) Is formed.

Next, with reference to FIG. 4, the flow of gas when the syringe 1 with a protective stopper for sterilization of the present embodiment is sterilized with gas (EOG) will be described. Note that FIG. 4 describes how the gas flows from the internal space of the syringe 10 to the external space, but this is an example, and the flow direction may be opposite. Further, the sterilization is not limited to EOG gas sterilization, and may be hydrogen peroxide low temperature gas plasma sterilization, hydrogen peroxide gas low temperature sterilization, low temperature steam formaldehyde sterilization, or the like.

As shown in FIG. 4, the sterilizing gas flows into the internal space from the proximal end side of the body 11 of the syringe 10 and reaches the distal end side of the neck 12. Then, it passes through the second fluid passage 31 generated between the lower side surface of the top plate portion 21 and the tip surface of the neck portion 12, and then the outer peripheral surface of the neck portion 12 and the inside of the outer cylinder portion 22 of the sterility protective plug 20. It passes through the first fluid passage 30 generated between the peripheral surface and the peripheral surface, and flows out to the external space of the body portion 11.

After the above sterilization process is completed, the gas is removed by similarly inflowing air from the base end side of the body portion 11 of the syringe 10 into the internal space.

As described above, according to the syringe 1 with a protective stopper for sterilization according to the present embodiment of the present embodiment, the syringe 10 can be reliably gas-sterilized with the protective stopper 20 for sterilization attached, and the gas can be reliably reliably supplied. Can be removed.

(Modification example)
The sterilization protective stopper 20'according to the modified example will be described with reference to FIGS. 5A and 5B. Since the sterilization protective stopper 20'is the same as the sterilization protective stopper 20 except for the configuration described below, the same configuration as the sterilization protective stopper 20 is designated by the same reference numerals and the description thereof will be omitted.

The sterilization protective plug 20'further has a notch 28 that divides a part of a spiral strip portion that is convex in the axial direction of the sterilization protective plug 20'forming the female threaded portion 24. Each notch 28 is formed in parallel along the axial direction of the sterilization protective stopper 20'.

In this modification, as shown in FIG. 5B, the notches 28 are provided at six locations on the inner peripheral surface of the outer cylinder portion 22 at equal intervals in the bottom view. Further, although the number increases or decreases depending on the arrangement of the spiral strips, in FIG. 5A, notches 28 are formed at two positions, and both notches 28 are arranged in parallel in the vertical direction.

As a result, a gap is created between the outer peripheral surface of the neck portion 12 and the inner peripheral surface of the outer cylinder portion 22 of the sterilization protective plug 20, so that a third fluid passage that communicates the internal space and the external space of the syringe 10 is provided. (Not shown) is formed.

Further, the notches 28 and 28 are formed at positions where the inner ribs 25 are arranged above the third fluid passage.

According to the sterilization protective plug 20'according to the modification described above, the third fluid passage further ventilates between the outer peripheral surface of the neck portion 12 and the inner peripheral surface of the outer cylinder portion 22 of the sterilization protective plug 20. It can be made free. Further, since the rib 14 is locked to the inner rib 25, the fluid moves along the outer periphery of the rib 14 in order for the fluid to flow into the third fluid passage arranged below the inner rib 25. It will be. As a result, the rib 14 can be reliably gas-sterilized and the gas can be reliably removed.

1 ... Syringe with protective plug for sterilization (connector with protective plug for sterilization), 10 ... Syringe, 12 ... Neck (luer connector), 14 ... Rib, 20 ... Protective plug for sterilization, 21 ... Top plate, 22 ... Outer cylinder Part, 24 ... Female screw part, 25 ... Locking part (inner rib), 26 ... Guide part, 27 ... Protrusion part.

Claims (3)

A sterilization protective plug that is screwed and locked while being fitted to the tip of the luer connector.
A disk-shaped top plate portion, an outer cylinder portion extending downward from the peripheral edge of the top plate portion, a female screw portion formed on the inner peripheral surface of the outer cylinder portion, and a lower side surface of the top plate portion downward. It has a protrusion that extends and contacts a part of the tip surface of the luer connector.
On the inner peripheral surface of the outer cylinder portion, a part of a spiral strip portion having a convex shape from the inner peripheral surface forming the female screw portion toward the axial direction of the outer cylinder portion is partially formed in the axial direction. A notch that divides parallel to the lower end of the spiral strip is formed along the line.
The inner peripheral surface of the outer cylinder portion has a locking portion that has a convex shape from the inner peripheral surface toward the axial direction of the outer cylinder portion and abuts and locks the outer peripheral surface of the lure connector. death,
The notch is engaged so as to form a gap at a position adjacent to the locking portion in the downward direction and at each end of the spiral strips that are divided by the notch and face each other in the bottom view. A protective stopper for sterilization, characterized in that the width in the circumferential direction is larger than that of the stop. In the connector with a sterilizing protective stopper provided with the sterilizing protective stopper according to claim 1 and the luer connector.
A connector with a protective stopper for sterilization, characterized in that a plurality of ribs to be screwed with the female threaded portion are provided on the outer peripheral surface of the luer connector at predetermined intervals. In the connector with a protective stopper for sterilization according to claim 2.
The outer peripheral surface of the lure connector is not provided with a pair of ribs on the tip end side of the lure connector and protruding in a direction away from the axis of the lure connector and the ribs from the base end to the tip end of the lure connector. There is an area and
The area is a connector with a protective stopper for sterilization, which is characterized by having a flat surface.

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