JPS61255661A - Holder for syringe needle having metal electrode for living body inserted therein - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a syringe needle holder, and more specifically to a syringe needle holder for use in high-pressure steam sterilization of a syringe needle containing a microelectrode that is inserted directly into a living body for clinical testing. This invention relates to a syringe needle holder used for.

[Conventional technology]

We previously applied for Utility Application No. 54-153522 and Patent Application No. 56
-2865, etc., by coating the tip surface of a metal electrode with a porous membrane, oxygen can be continuously, stably, and accurately distributed even in living tissues or blood vessels without being affected by the movement of tissues or blood. A method to measure pressure was proposed. Furthermore, when inserting the electrode obtained by this method into living tissue or blood vessels, we
The method using a syringe needle proposed in No. 17401 can be used. However, in this case, it is necessary to sterilize the electrode and injection needle.

Conventionally, as a method for sterilizing the electrodes and injection needles mentioned above, the fifth method has been used.
As shown in the figure, after inserting the electrode (4) into the injection needle (5), it is attached to the injection needle holder (3), and the ion-exchanged water (
7) was placed in a filled vial (2), the screw cap (1) was not completely closed to allow steam to pass through, and the method was followed by high-pressure steam sterilization.

[Problem that the invention seeks to solve]

In the above-mentioned sterilization method, an abnormality was sometimes observed in the output behavior of the electrode after sterilization. According to the research of the present inventor, this is because the air near the injection needle holder is sometimes sterilized while being trapped in the porous membrane covering the electrode part. It was discovered that this was due to changes in the shape of the membrane, the diameter of the membrane pores, or the membrane being in a dry state.

The present invention solves these conventional problems and provides a syringe needle holder that enables a sterilization method that does not cause abnormalities in output behavior after sterilization.

[Means for solving problems]

The present invention is a syringe needle holder molded from a material capable of withstanding autoclaving conditions and having gas passage openings in at least the lower portion of the side surface and the upper portion proximate to the root of the syringe needle.

The present invention will be explained in more detail below.

The syringe needle holder of the present invention has an upper end opening having an inner diameter that is larger than the outer diameter of the thinnest part of the base of the syringe needle and smaller than the outer diameter of the thickest part.

This is for inserting and supporting the injection needle through its upper end opening.

Further, the injection needle holder of the present invention must be able to provide sufficient space between the cutting edge of the injection needle and the bottom of the holder when the injection needle is held therein. This is to prevent the tip of the biological metal electrode protruding from the cutting edge of the injection needle from hitting the bottom of the injection needle holder and being damaged. Note that among the electrodes,
The tip covered with a porous membrane must be sterilized with it exposed beyond the cutting edge of the needle. This is because air exists inside the injection needle, so if the electrode tip is sterilized without protruding from the injection needle, the air in the injection needle will be trapped inside the porous membrane, and the output behavior of the electrode after sterilization will change. This is because abnormalities may be observed in

The dimensions of the syringe needle holder of the present invention vary depending on the dimensions of the syringe needle to be stored.
When GX 3/4 (manufactured by Terumo Corporation) is used, it can be of a cylindrical shape with an inner diameter of about 5 mm and a length of about 40 cm.

Furthermore, the syringe needle holder of the present invention needs to have a gas passage opening at least in the lower part of its side surface and in the upper part close to the syringe needle root.

In the structure shown in Figure 4, where there is no gas passage opening on the side of the needle holder, that is, a part where gas can escape, the air inside the needle holder is taken into the porous membrane. Therefore, abnormalities may be observed in the output behavior of the electrode after sterilization.

Therefore, it is necessary to use a needle holder with gas passage openings on the side.

In addition, when high-pressure steam sterilization is performed with the porous membrane-covered electrode tip immersed in ion-exchanged water or distilled water to prevent degeneration of the porous membrane, bubbles may occur from the bottom of the holder. In order to prevent these air bubbles from accumulating near the tip of the porous membrane-coated electrode, it is not sufficient to provide gas passage openings only at the bottom of the side of the injection needle holder or only at the top of the side near the base of the injection needle. That's enough. In fact, when sterilization is performed using a needle holder with a gas passage opening only at the bottom of the side, or only at the top of the side near the base of the needle, the output behavior of the electrode after sterilization may be abnormal. It may be recognized.

The size of the gas passage opening is preferably larger as long as the protective function of the injection needle holder is not impaired.

Although various forms of such gas passage openings are possible, holders having typical openings are shown in FIGS. 1, 2, and 3. The holder shown in Figure 1 has a large number of holes on the side that allow air to freely enter, while the holder shown in Figure 2 has only the side part that can protect the membrane and the other side parts. It is cut from
The holder shown in FIG. 3 has a side surface formed into a mesh-like structure. It should be noted that the holder is not limited to the structure described above, but may be of any type as long as it can protect the membrane and allow air to escape easily.

As the material for the syringe needle holder of the present invention, any material can be used as long as it can maintain its shape even when exposed to high-pressure steam sterilization. For example, various materials such as polypropylene, Teflon, and high-density polyethylene can be used. can be mentioned. Furthermore, products that emit eluates during sterilization should be avoided, as these eluates are known to adhere to the electrode surface and cause abnormal output behavior. High-pressure steam sterilization processing conditions generally involve a temperature of approximately 115 to 125 degrees.
C1 pressure 0.7~1.6 kg/ca! and time 20~
A 30 minute condition is used.

The injection needle holder of the present invention is used, for example, as follows. A biomedical metal electrode whose tip is covered with a porous membrane is inserted into the injection needle so that the electrode tip comes out beyond the cutting edge of the injection needle, and this is inserted into the injection needle holder of the present invention. and hold it.

The needle holder is then placed in a container made of a material capable of withstanding high-pressure steam sterilization conditions, has a sealable lid, and is filled with ion-exchanged water. Sterilization is performed in a state where steam can pass through without completely closing the lid, and after sterilization, the lid is closed and sealed. In this state, it can be held or moved while maintaining complete sterilization.

Preferably, the container is transparent so that the inside can be observed. Examples of the material for the container include polymethyl methacrylate, polystyrene, polycarbonate, polypropylene, glass, and the like. As for the form, a vial can be preferably used.

〔Example〕

Diameter 100μ, with polyurethane insulating coating,
Length 20C! The tip of the platinum wire No. 11 was cut at right angles in the length direction with a sharp knife to expose a new platinum cross section, and the exposed portion was covered with a polyurethane porous film. Approximately 3C11 of the insulating corrugated RI layer at the end not covered with the porous film was peeled off, and this portion was used as a connection portion. The thus obtained electrode was used together with a silver-silver chloride electrode as an indifferent electrode, using an oxygen partial pressure measuring device PO-2080 (manufactured by Mitsubishi Rayon Co., Ltd.).
connected to.

Twist determination was carried out in physiological saline, which had been stirred to such an extent that the electrolytic current value was not affected by the liquid flow, and which had been saturated at 37° C. with an oxygen partial pressure of 149+nHg.

After the measurement, high-pressure steam sterilization (121° C. x 20 minutes) was performed in the form shown in FIG. 5 using the polypropylene injection needle holder shown in FIGS. 2 and 4. When measurements were taken after sterilization, the output behavior of the electrode using the injection needle holder shown in FIG. 2 was almost the same as before sterilization, and the stabilization time was about 20 to 30 minutes. On the other hand, the electrode using the conventional holder shown in Figure 4 has a stabilization time of 40 hours after sterilization.
It took ~60 minutes.

〔Effect of the invention〕

When the syringe needle holder of the present invention configured as described above is used, sterilization can be performed in a state where the porous membrane of the electrode part does not take in air, so it has a special effect that no abnormality occurs in the output behavior after sterilization. It is something.

[Brief explanation of drawings]

1, 2, and 3 are side views showing various aspects of the injection needle holder according to the present invention, FIG. 4 is a side view of a conventional injection needle holder, and FIG. 5 is a side view of a conventional injection needle holder. FIG. 3 is a side view of the sterilization device with the injection needle holder attached. In FIG. 5, 1 is a screw cap, 2 is a vial, 3 is a syringe needle holder, 4 is an electrode, 5 is a syringe needle, 6 is a base portion of the syringe needle, and 7 is ion-exchanged water.

Claims (1)

[Claims] A syringe needle holder molded from a material capable of withstanding autoclaving conditions and having gas passage openings in at least a lower portion of the side and an upper portion proximate to the root of the syringe needle.