JPS6148381B2 - - Google Patents

Description

[Detailed description of the invention]

[Technical Field] The present invention relates to a ventilation needle used for infusion bottles and the like. [Prior art and its problems] When administering an infusion using an infusion bottle, etc., it is necessary to supply air into the bottle as the amount of liquid decreases. It is used to pierce the rubber stopper of an infusion bottle, etc. to ensure smooth infusion. However, since the air that enters the bottle through the ventilation needle needs to be clean, the hub of the ventilation needle is filled with cotton to serve as a filter. The important requirements for this filter are that it does not get wet even if liquid leaks through the needles, and that it has the ability to purify the air. In order to avoid getting wet with liquid, it is best to use raw cotton that has not been degreased, but since raw cotton requires treatment to remove pyrogen and hemolytic toxic substances, absorbent cotton is generally used. When a ventilation needle using absorbent cotton as a filter is used in an infusion bottle or the like without a lead tube, the absorbent cotton becomes wet, resulting in a decrease in the amount of ventilation and a change in the drip rate. What is even more troubling is that there is an increased risk that the infusion solution or the like will be contaminated by bacteria via the wet cotton. [Object of the Invention] Therefore, the present invention provides a ventilation needle that does not use cotton as a filter for the ventilation needle, has no risk of bacterial contamination, and can stabilize the drip volume without changing the ventilation volume. The purpose is to provide. [Specific Structure of the Invention] According to the present invention, the ventilation hub portion includes a ventilation member made of a sintered body of plastic powder, and a piercing member such as a needle is implanted in this ventilation member, so that air can be It allows air to flow through the microporous mass of the sintered body, thereby preventing wetting of the air passages and acting as a mouthwash. In order to ensure a constant supply of air, a slit or hole is formed in the part of the piercing member where the hollow needle is embedded in the ventilation member, or an air pocket is formed inside the needle-embedded part of the ventilation member. It is preferable to leave it there. Further, the piercing member does not necessarily need to be a hollow needle, but may be a solid bar or a tip for the purpose of piercing, and air may be supplied into the bottle through the ventilation member. In any case, it is preferable to use a water-repellent plastic material. Next, a preferred embodiment of the ventilation needle used in the infusion bottle and the like of the present invention will be described in detail with reference to the accompanying drawings. FIG. 1 shows a ventilation needle 1 currently in use. This ventilation needle 1 includes a cannula 2 which is a hollow tube body, and a plastic hub 3 attached to the proximal end of this cannula.
The hub is filled with cotton 4 which acts as a filter. As stated at the beginning of the specification, ventilation needles with such a configuration have various problems, as will become clear from the test results described below. The ventilation needle 10 according to the present invention has the distal end of the puncture member 11 embedded in a ventilation member 12 made of plastic powder, which will be described in detail later, and is normally fitted with a protector 13 for safety and hygiene reasons. . Air is supplied into the infusion bottle or the like from the hollow part 14 of the puncture member 11 through the microporous mass of the sintered body. When air passes through the ventilation member 12 made of a microporous sintered body, not only dust but also bacteria in the air are removed by the sintered body. Therefore, the porosity and thickness of the sintered body should be such that the required amount of air is supplied to the infusion bottle, etc., and that bacteria in the air are sufficiently removed. It must be to the extent that By forming a ventilation member made of such a microporous sintered body, even if a liquid such as an infusion were to flow back from the hollow part 14 of the puncture member 11, the minute pores of the sintered body would The liquid will not leak out due to the resistance. Furthermore, it is preferable to use a water-repellent material as the plastic powder constituting the ventilation member made of a sintered body. This completely prevents the cotton from getting wet and over-effecting, resulting in unstable drips and bacterial infections, which is the case with current ventilation needles that use cotton filters (see below). (See Examples). There are various ways to ensure that sufficient air is supplied through the ventilation member 12. If the pore size of the ventilation member is too large, there is a risk of bacterial contamination, so the pore size of the ventilation member should be made small enough to prevent bacteria from passing through, so that air can pass through the microporous mass of the ventilation member to the puncture member. The path leading to point 11 (thickness of the sintered body) should also be made sufficient. and,
For example, a puncture member stop 15 is formed inside the ventilation member 12, and an air reservoir 16 is provided at the lower end of the hollow hole 14 of the puncture member 11. Alternatively, a slit 17 as shown in FIG. 3 or a side hole 18 as shown in FIG. 4 may be formed in the puncture member 11 itself so as to communicate with the hollow portion 14 of the cannula.
Thereby, the inner surface area of the ventilation member made of the sintered body reaching the hollow portion 14 of the puncture member 11 can be increased, and a required amount of air can be supplied through the puncture member 11. Furthermore, it goes without saying that the slit 17 or side hole 18 of the puncturing member 11 and the air reservoir 16 of the ventilation member 12 can be used together. The plastic powder material forming the ventilation member 12 is preferably an inexpensive material such as polyethylene or polypropylene, but other water-repellent plastic materials may also be used. The ventilation member 12 is made by appropriately selecting the type of plastic, the particle size of the plastic powder, the sintering conditions, the porosity of the sintered body, the length of the air passage leading to the puncture member 11 (thickness of the sintered body), etc. It is configured to perform the filter function as described above. The shape of the ventilation member may be a hub shape similar to the ventilation needle commonly used in the past, but is not limited to such a shape, and may be configured in a spherical shape, a circular shape, or other three-dimensional structures. Although the ventilation needle of the present invention has an air passage formed of a sintered body and a hollow piercing member, the invention is not necessarily limited thereto. That is, the sintered body can also be penetrated into the interior of an infusion bottle or the like so that air can be supplied through the microporous mass of the sintered body. In this case, the piercing member does not need to be a hollow tube, but can also be constructed of a solid metal rod or wire so that it only performs the piercing function. Alternatively, a piercing tip may be attached or molded to the tip of the sintered body. [Dust Collection Efficiency Test] In order to confirm the performance of the sintered body which is the ventilation member applied to the ventilation needle of the present invention, cotton was removed from the current ventilation needle as shown in Figure 1, and the average particle size was 110. ~120
A convex sintered filter 20 (R=3.6
mm, H = 7.2 mm, average pore size 50 μ) was fitted instead of cotton, and part take counter counter manufactured by Rion Co., Ltd.
1 atmosphere using the KC-01 model, the atmosphere is 50ec/
The dust collection efficiency of the sintered filter was tested by flowing the filter at a rate of 30 c.c./min. The results are shown in Table 1. As is clear from the table below, the ventilation member (filter) used in the ventilation needle of the present invention is 1
It was found that the μ removal rate was about 99% or more, and that 5μ was completely removed. Most of the bacteria that normally exist in the atmosphere are around 1μ in size, and the smallest bacteria is said to be around 0.5μ. Considering that cocci are around 1μ, rods are 2 to 4μ (long direction), 0.5 to 1.0μ (short direction), and fungi (mycelium, etc.) are 1μ or more, and the ability to remove 0.5μ particles is over 90%. , this sintered body can remove bacteria with considerable precision.

[Table] Next, we compared the ventilation needle of the present invention with a puncturing member embedded in the ventilation member (see Figure 6) and the current ventilation needle with cotton filled inside the ventilation member (see Figure 7) as shown below. If the convex sintered body shown in Figure 5 is installed, the current ventilation needle with a cotton plug is applied to a girdle bottle, and each The relationship between the amount of outflow from the ventilation needle and time was measured. In FIGS. 6 and 7, the dimensions are as follows. Note that x is the length of the air reservoir 16, and the hole diameter of the puncture member is 0.5 mm. a=4mm, b=6mm, c=7mm, d=10mm, e
=6mm, f=4mm, g=8mm, a'=4.3mm, b'=
5.7 mm, c' = 6 mm, d' = 14 mm, f' = 4.3 mm, g' = 7 mm. Examples of pore sizes of the sintered body 12, which is a ventilation member, are 25 and 50μ. The test results are shown in Table 2. It can be seen that by using the sintered body ventilation member as in the present invention, the amount of outflow per unit time can be stabilized compared to the current ventilation needle with a cotton plug. It has also been found that the size of the air pocket provided inside the ventilation member is best selected from the test results shown in the table below. All of these tests were performed with the vents not getting wet, but in reality they may get wet, so it is necessary to check the water resistance of the vents.

【table】

[Water resistance test]

Using a glass tube with an open upper end and a rubber plug attached to the lower end, insert the ventilation needle according to the present invention (see Figure 6) and the ventilation needle (with cotton plug and The convex sintered body shown in Fig. 5 was pierced, water was injected from the top of the glass tube, and the height H of the water column when liquid leaked from the ventilation needle was determined. The results are shown in Table 3.

[Elimination effect test]

Next, a microbial permeability (sterilization effect) test was conducted using the system shown in FIG. 8 for the ventilation needle of the present invention and the current ventilation needle. In the system shown in Fig. 8, 21 is a test tube containing a culture medium, 22 is a conduit, 23 is a flow meter, 24 is a water bottle, 25 is a drainage conduit with a flow rate regulator, 26 is a conduit, and a vinyl chloride tube is attached to the top of the conduit 26. 27 can be added and a sample ventilation needle 28 can be attached to this. (Test Method) Air was introduced through the test vent needle 28 by draining water through the drain pipe 25. The air introduced into the test ventilation needle 28 contains approximately 4 microorganisms per unit (measured using a pinhole sampler in the cleaning room), and at a flow rate of 130 to 150 ml/mm, each sample contains 4.5 microorganisms.
Introduced. Normal broth was used as the medium, and after the test, the culture was observed at 37°C for 7 days and judgments were made. Each sample was sterilized with ethylene oxide gas, and test tubes, conduits, etc. were sterilized in an autoclave. (Results) The culture results are shown in Table 4 below.

[Specific effects of the invention]

As is clear from the results of the airflow rate, water resistance, and sterilization tests described above, the ventilation needle having the ventilation member made of the sintered body of the present invention has the following characteristics compared to the cotton-filled ventilation needle currently in use: It brings many benefits as mentioned in. (1) The cotton-filled ventilation needles currently in use have poor water resistance and a high possibility of leakage, resulting in unstable infusion volume; however, the ventilation needle of the present invention uses a sintered body as a ventilation member. As a result, it became possible to avoid such situations. (2) The sintered ventilation member has a large dust removal and sterilization effect, and has excellent cleanliness. (3) Some conventional ventilation needles have a lead tube attached to the infusion bottle, etc. to prevent fluid leakage.
Using the ventilation needle of the present invention eliminates this need. (4) If the puncture member is made of a metal tube and air is allowed to flow through the ventilation member and the tube, the tube is hard and can be easily punctured, and even if external pressure is applied, the puncture will not occur. It is useful because the member does not break or bend. (5) Furthermore, if a slit or side hole communicating with the hollow part of the puncturing member is formed in the puncturing member at the part where the puncturing member is embedded in the ventilation member, the inner surface area of the ventilation member leading to the hollow part of the puncturing member is increased; The required amount of air can be supplied via the perforation. (6) Furthermore, if an air reservoir communicating with the hollow part of the puncturing member is provided inside the ventilation member at the end portion of the puncturing member embedded in the ventilation member, sufficient air can be supplied through the ventilation member. (7) The puncture member and the ventilation member are made of a sintered body,
When a puncturing tip is formed at the tip of the puncturing member,
Since the sintered body enters the inside of the infusion bottle or the like, more sufficient air can be supplied through the microporous mass of the sintered body. (8) In addition, if the ventilation member is made of water-repellent plastic material, as with the current ventilation needles that use cotton filters, the cotton gets wet and over-effect decreases, leading to unstable dripping and the risk of bacterial infection. This is completely prevented.

[Brief explanation of the drawing]

FIG. 1 is a partial cross-sectional side view of a current ventilation needle, FIG. 2 is a partial cross-sectional side view of a ventilation needle having a sintered hub of the present invention, and FIGS. 3 and 4 are views of other cannulas used in the ventilation needle of the present invention. Side view and sectional view of configuration example, fifth
The figures are a side view and a plan view of a filter made of a sintered body used in the ventilation needle of the present invention, Figures 6 and 7 are side sectional views showing the dimensions of the ventilation needle of the present invention and the current ventilation needle used in the test, Figure 8 is a diagram of the sterilization test device. Explanation of symbols 1...Current ventilation needle, 2...Cannula,
3... Hub, 4... Cotton, 10... Ventilation needle of the present invention, 11... Puncture member, 12... Ventilation member, 13
... protector, 14 ... hollow part, 15 ... puncture member stopper, 16 ... air reservoir, 17 ... slit,
18... side hole, 20... sintered filter, 21...
Test tube containing medium, 23...flow meter, 24...water bottle, 28...test aeration needle.

Claims (1)

[Scope of Claims] 1. A ventilation needle comprising a ventilation member made of a sintered body of plastic powder, and a puncture member partially embedded in the ventilation member. 2. The venting needle according to claim 1, wherein the puncturing member is made of a metal tubular body, and is configured to allow air to flow through the venting member and the tubular body. 3. The venting needle according to claim 2, wherein the puncturing member is provided with a slit that communicates with the hollow portion of the puncturing member at a portion where the puncturing member is embedded in the venting member. 4. The ventilation needle according to claim 2, wherein the puncture member is provided with a side hole that communicates with the hollow portion of the puncture member at a portion where the puncture member is embedded in the ventilation member. 5. Claims 2 to 4, characterized in that an air pocket communicating with a hollow portion of the puncture member is formed inside the ventilation member at an end portion of the puncture member embedded in the ventilation member. Venting needle. 6. The ventilation needle according to claim 1, wherein the puncture member and the ventilation member are made of a sintered body, and a puncture tip is formed at the tip of the puncture member. 7. The ventilation needle according to any one of claims 1 to 7, wherein the ventilation member is made of a water-repellent plastic material.