JPS58183172A - Blood sampling or syringe needle and production thereof - 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 (I) Background of the Invention Technical Field The present invention relates to a vacuum blood collection tube or syringe for medical use, which is connected to a syringe and can confirm that a needle has punctured a vein when blood collection or injection is performed. This invention relates to a needle and a method for manufacturing the same.

The configuration of the reduced pressure blood collection device is shown in Figure 1. A is a blood collection needle (hereinafter referred to as a medical needle as it may be used as a syringe needle as described later), and when blood is collected into multiple vacuum blood collection tubes with a single puncture using the needle tube 1 and hub 2, it is inserted into the holder. It consists of a rubber sheath 3 that prevents blood from flowing out. B is a cylindrical holder made of substantially transparent plastic or the like that can hold the medical needle A via the hub 2. Reference numeral C denotes a vacuum blood collection tube, which consists of a glass tube 4 with a bottom and a rubber stopper 5 that seals the glass tube 4 and can be inserted through the needle tube 1. It is depressurized.

To collect blood, screw holder B and medical needle A together, then insert vacuum blood collection tube C into holder B from the rear end of π, so that the end surface of rubber stopper 5 of vacuum blood collection tube C becomes the mark of holder B. Push it in until it lines up with the line 6, and pierce the rubber stopper 5 to the extent that it does not penetrate the connection side needle tube portion 1a. Then, holding the holder B, puncture the puncture side needle tube portion 1a into a blood vessel at a desired site such as the arm of the blood sample recipient, and while illustrating the relative fixation of the arm and the holder, push the reduced pressure blood collection tube C further into the connection side needle tube portion. 1
Blood flows into the reduced pressure blood collection tube C by passing the rubber stopper 5 through the tube a. Another method is to insert a vacuum blood collection tube into the holder after puncturing.

However, in the vacuum blood sampler with the above configuration, the needle tube 1 is replaced by the rubber stopper 5.
It cannot be confirmed that the needle tube 1 has punctured the vein until the needle tube 1 is penetrated into the reduced pressure blood collection tube C to see whether blood has flowed into the tube C.

If no blood flows into the vacuum blood collection tube C, puncturing must be attempted again, and one vacuum blood collection tube C is wasted.
This will unnecessarily increase the need for puncturing the blood sample recipient.

FIG. 2 shows a medical needle proposed to solve the above problem. On one side of the rubber sheath fitting locking portion 2b, there is an air escape passage 7 that communicates the inside and outside of the rubber sheath 3. When this medical needle A punctures the blood vessel with the needle tube 1, the hub 2 has an air escape passage 7, so the air inside the rubber sheath 3 and the needle tube 1 escapes through the passage 7, and the blood is released under the pressure inside the blood vessel. The rubber sheath 3 passes through the passage in the needle tube 1.
The puncture can be confirmed because it flows inside. After that, if you stick the connecting side needle tube part 1a into the rubber stopper until it penetrates,
A predetermined amount of blood corresponding to a predetermined degree of vacuum is drawn into the vacuum blood collection tube without coming into contact with the outside air, and at the same time, since the rubber sheath 3 is thick and strong, it is pushed by the rubber stopper 5 and moves slightly in the axial direction. and is compressed in the axial direction with the air escape passage 7 closed. However, if there is a delay in connecting the needle tube 1 and the vacuum blood collection tube after confirming puncture, blood not only flows out through the passage in the needle tube 1 into the rubber sheath 3, but also flows out into the holder through the air escape passage 7. There are many things to put away. In other words, the drawback of the medical needle A shown in FIG. 1, which is that puncturing cannot be confirmed, can be improved by allowing air to escape from the air escape passage 7 and causing blood to flow into the rubber sheath. However, prevention of blood flowing out into the holder can only be achieved by quickly connecting the vacuum blood collection tube to the medical needle A before blood flows out, and only after the doctor confirms the puncture. There is no leeway in the operation.

Similar problems arise with medical needles when blood is collected or injected using a syringe instead of the vacuum blood collection tube described above. That is, as shown in FIG. 3, the needle tube 1 is punctured into a vein, and after confirming the puncture, the syringe D is pushed into the holder B until the needle tube 1 is inserted into the tip opening of the tube body 8. After connecting the syringe D, pull the pusher 9 to collect blood, or push the pusher 9 to inject the liquid such as medicine or infusion stored in the tube body 8. When the blood collection or injection is finished, the holder B The conventional method is to pull out the syringe D while holding it fixedly, and then reconnect the next new syringe D. In this case, too, with the conventional medical needle shown in Figure 2, blood does not drain out after confirming the puncture. There is a problem in that the needle tube 1 and the syringe D must be connected quickly before it flows out of the rubber sheath.

Other medical needles have been proposed that have a microscopic valve mechanism in the hub portion that provides liquid-tight ventilation, but these have the problems of being extremely difficult to manufacture and expensive, making them unsuitable for measurement.

Oi) Purpose of the Invention The present invention has been devised in view of the above-mentioned points, and it not only makes it possible to confirm the puncture of a vein with a needle tube by the blood flowing out into the rubber sheath through a passage in the needle tube, but also allows the pressure to be reduced. A medical needle for a blood collection or syringe that is improved so as to prevent the blood that has leaked into the rubber sheath from flowing out to the outside without the need for an operation to connect the blood collection tube or syringe to the needle tube, and the above-mentioned improved medical needle. To provide a method for manufacturing a medical needle for blood collection or a syringe, which can be easily manufactured in mass production without increasing cost while maintaining reliable and uniform quality of the needle.

However, according to the present invention, a medical needle for blood collection or a syringe, which is one of the purposes of a lever, has a needle tube having blade surfaces at both ends, a needle tube that supports the outer surface midway of the needle tube, and has a rubber sheath fitted and locked at one end. a hub having a section, and a hub that is slightly longer than the connecting side needle tube portion extending toward the rubber sheath fitting and locking portion side of the rubber sheath, and being placed over the needle tube portion in a bag shape and engaging the rubber sheath fitting and locking portion. In a blood collection or syringe medical needle consisting of a transparent or translucent rubber sheath that is stopped, the hub is provided with a liquid-tight breathable member at least at one location on the circumference of the rubber sheath fitting locking part,
Blood collection characterized in that a rubber sheath is fitted on the outside of the liquid-tight breathable member so that air permeability between the inside and the outside of the rubber sheath can be achieved only through the liquid-tight breathable member. Accomplished by a medical needle of a syringe.

Further, the present invention provides an embodiment in which the liquid-tight breathable member is a hydrophobic filter material, an embodiment in which the liquid-tight breathable member is paper that has breathability, and an embodiment in which the liquid-tight breathable member has breathability and is a blood coagulant. Each embodiment includes an embodiment in which the paper is impregnated with It is preferable that the flexible member is in the shape of a disk having a needle tube insertion hole substantially in the center thereof, and is provided so as to fit in the fitting locking portion of the rubber sheath.

According to the present invention, a method for manufacturing a medical needle for blood collection or a syringe, which is another one of the above objects, has a needle tube insertion hole inside and is coated with a rubber sheath at one end of the outer surface in a direction along the needle tube insertion hole. A knob with a fitting and locking part is inserted through the needle tube insertion hole into the middle of the outer surface of the needle tube, which has blade surfaces at both ends, and fixed, and a disc-shaped liquid-tight breathable member is inserted into the needle tube. pierce the connecting side needle tube part that extends toward the rubber sheath fitting and locking part side of the rubber sheath to fit it to the fitting and locking part, then one longitudinal end is open and the other end is bag-shaped. Yes, a transparent or translucent rubber sheath that is slightly longer than the connecting side needle tube portion is placed over the needle tube portion in a bag-like manner, and the liquid-tight breathable member whose open end is aligned with the rubber sheath fitting locking portion is inserted from the outside. This is achieved by a method of manufacturing a medical needle for blood collection or a syringe, which is characterized by being fitted in a restraining manner.

(III) Detailed description of the present invention Specific configuration of the present invention A medical needle for blood collection or a syringe according to the present invention is shown in FIG.

The medical needle A of the present invention includes a needle tube 1 having blade surfaces at both ends, a tube 2 that supports the middle of the needle tube 1, and a transparent or translucent tube that fits into the blood collection tube side needle tube portion 1a like a bag. It consists of 3 rubber sheaths. The needle tube 1 is made of a stainless steel tube or the like, the needle tube 2 is made of molded plastic or the like, and the rubber sheath 3 is made of soft rubber with sufficient flexibility and resilience and is thin and shaped like a bag with only one end open. It is formed into.

The hub 2 has a rubber sheath fitting locking part 2b at one end of the hub 2 on the side connected to a vacuum blood collection tube or the like, rather than the male threaded part 2a which can be screwed into the holder B shown in FIG. Further, the rubber sheath 3 is slightly longer than the connecting side needle tube portion 1a which extends from the hub 2 of the needle tube 1 to the side where it is punctured and connected to the rubber stopper of the vacuum blood collection tube, and covers the needle tube portion laK in a bag shape. The rubber sheath is fitted and locked to the fitting and locking portion 2b. The above configuration is no different from the conventional medical needle shown in FIG. Particularly, in this embodiment of the present invention, a liquid-tight breathable member 10 is provided around the entire circumference of the rubber sheath fitting and locking portion 2b, and the interior of the rubber sheath 3 is only accessed through the liquid-tight breathable member 1(). The rubber sheath 3 is bag-shaped so as to improve air permeability between the rubber sheath and the outside, and is fitted so as to suppress the liquid-tight breathable member 10 from the outside. The surface is continuous with the end surface so that the cross section along the IK has a rounded corner shape, and furthermore, the liquid-tight breathable member 10 has air permeability formed by pressing and compacting multiple pieces of paper or the like and cutting out a disk shape. It is characterized by being made of paper or paper that is breathable and impregnated with a blood coagulant, and is provided in the shape of a collar on the needle tube 1.

Next, a specific method for manufacturing the medical needle having the above structure will be described.

As shown in FIG. 5(a)K, a hub 2 having a needle tube insertion hole inside and a rubber sheath fitting locking portion 2b at one end of the outer surface in the direction along the insertion hole is inserted into the needle tube insertion hole. The needle tube 1, which has blade surfaces at both ends, is inserted through the needle tube 1 at a required point halfway through the outer surface thereof and fixed with adhesive.Then, as shown in FIG. The hub 2 of
The connecting side needle tube portion 1a extending toward the side to be connected to a reduced pressure blood collection tube etc. is pierced in a brim shape so as to fit into the fitting locking portion of the rubber sheath, and then one longitudinal end is open and the other end is bag-shaped. Yes, the transparent or translucent rubber sheath 3, which is slightly longer than the connecting side needle tube portion 1a, is placed over the needle tube portion 1a in a bag-like manner, and its open end is aligned with the rubber sheath fitting locking portion of the liquid-tight breathable member. 10 from the outside.

(IV) Modifications of the Invention The liquid-tight breathable member may be a hydrophobic filter material.

Further, as shown in FIG. 6, a liquid-tight breathable member 10 formed by compressing tissue paper or the like into a cylindrical or annular shape having a flange is fitted into the rubber sheath fitting locking portion 2bK of the hub 2. It can also be used as a needle.

Further, as shown in FIG. 7, a rubber sheath fitting locking portion 2b is formed into a cylindrical shape using a liquid-tight, air-permeable filter material 10K, and this is fixed to the hub body with an adhesive.
It may also be a medical needle in which a rubber sheath 3 is fitted on a part of the outer surface of the needle. Especially in such cases, it is better to form the entire hub from a liquid-tight breathable filter material. That is, in the present invention, the liquid-tight air-permeable member does not need to be a separate member from the knob. In addition, as shown in FIG.
One side of the outer periphery of b ((liquid-tight breathable member) good.

Further, as shown in FIG. 9, a liquid-tight breathable member 10 formed in an annular shape is fitted into the rubber sheath fitting locking portion 2b, and a bellows-shaped rubber sheath 3 is attached to the connecting side needle tube portion 1aK. It may also be a medical needle that is covered and can be compressed in the axial direction by being pressed against a rubber stopper of a vacuum blood collection tube during blood collection.

Furthermore, as shown in FIG. 10, connect the medical needle A to the ring D, pull the pusher 9 to collect blood, or push the pusher 9 to inject the medicinal solution or infusion in the tube body 8 intravenously. It can also be used as a medical needle for blood collection or syringes.

(V) Specific effects and effects of the present invention As explained above, the medical needle of the blood sampling or syringe of the present invention has a transparent or translucent material that covers the connection side needle tube portion in a bag-like manner. For those in which the comb sheath fits into the hub, the entire circumference or one place of the rubber sheath fitting part of the knob is impregnated with hydrophobic filter material, breathable paper, or breathable blood coagulant. The rubber sheath is provided with a liquid-tight breathable member made of paper or the like, and the rubber sheath is connected to the nozzle from the outside of the liquid-tight breathable member so that air permeability between the inside and the outside of the rubber sheath can be achieved only through the member. It has a fitted configuration.

Therefore, the medical needle for blood collection or syringe of the present invention is
When a blood vessel is punctured, the air inside the rubber sheath and the needle tube is discharged to the outside through the liquid-tight breathable member due to the pressure of the blood, and the blood flows from the blood vessel into the rubber sheath through the passage inside the needle tube and is released from the outside. You can confirm that the needle has penetrated into the blood vessel. The blood inside the rubber sheath does not leak out of the rubber sheath. This means that when blood that has flowed into the rubber sheath comes into contact with the liquid-tight breathable part, if the liquid-tight breathable member is made of a breathable hydrophobic filter material, capillary action due to the hydrophobicity of the filter material is prevented. If the paper is made of paper that is impermeable to blood but still has air permeability, the blood that passes through the capillary tubes will coagulate quickly and substantially, and the swelling properties of the paper fibers will further increase the ability of the paper to be air permeable and a blood coagulant. In the case of paper impregnated with a liquid, blood does not pass through the capillary tubes of the liquid-tight breathable member, or even if it does, it permeates through the capillaries of the liquid-tight breathable member, by adding the coagulation-promoting action of the blood coagulant to the above-mentioned action. This is because it solidifies at a stage and becomes substantially liquid-tight. For this reason, when the blood collection or syringe medical needle of the present invention is punctured, blood flows out into the rubber sheath and the puncture can be confirmed by seeing the color of the rubber sheath change. The medical attachment itself has been improved to prevent blood from leaking to the outside, so there is more time to connect the needle tube and vacuum blood collection tube or syringe after confirming the puncture. This reduces the burden on doctors, who would otherwise have to perform quick connection operations.

Further, in an embodiment of the present invention, the cross section of the rubber sheath fitting and locking part along the needle tube has a rounded corner shape, and the liquid-tight and breathable member has a disk shape having a needle tube insertion hole approximately in the center, and the rubber sheath fitting and locking part has a rounded corner shape. When the rubber sheath is fitted to the locking part and the rubber sheath is fitted from the outside, it is easy to manufacture and install the liquid-tight ventilation member to achieve the above-mentioned initial effects. As a medical needle that can confirm puncture while automatically preventing blood outflow, it has the advantage of consistent quality, high cost, and mass production. In addition, when the entire hub is made of a liquid-tight breathable material as an embodiment of the present invention, the number of parts is reduced and the number of assembly steps is reduced compared to when the hub is made of a separate material. You don't have to pay attention to it.

In addition, in another method of manufacturing a medical needle for blood collection or a syringe according to the present invention, a hub is fixed in the middle of the needle tube, and a disc-shaped liquid-tight breathable member is passed through the needle tube in a brim shape. The rubber sheath is fitted onto the fitting and locking part, the rubber sheath is placed over the connection side needle tube part, and the rubber sheath is fitted and locked onto the fitting and locking part from above the liquid-tight air-permeable member.

Therefore, according to the method for manufacturing a medical needle of the present invention, it is possible to manufacture a medical needle equipped with a flange-like liquid-tight breathable member according to an embodiment of the above-mentioned medical needles that can obtain the above-mentioned effects. Therefore, the liquid-tight air-permeable member can be manufactured and attached easily, and the quality of the liquid-tight air-permeable member when assembled can be maintained uniformly, and the cost is not high, making it suitable for mass production.

[Brief explanation of drawings]

Figure 1 is a vertical front view of a medical needle used in a conventional vacuum blood sampling device, etc., and Figure 2 (a) is a vertical front view of a conventional medical needle that has been improved from the above medical needle. 2(b) is a 11b-11b sectional view in FIG. 2(a),
FIG. 3 is a longitudinal sectional front view of a conventional medical needle in use with a syringe, FIG. figure(
a) and (b) are manufacturing process diagrams for explaining the manufacturing method of the medical needle shown in FIG. 4, and FIGS. 6 to 10 respectively show a part of a modified example of the medical needle for blood collection or syringe of the present invention. FIG. 2 is a cross-sectional front view, a main part front view, or a front view in a state of use. A... Medical needle for blood collection or syringe, 1... Needle tube,
1a...Connection side needle tube part, 1b...Puncture side needle tube part, 2...Hub, 2b...Rubber sheath fitted locking part, 3...Rubber sheath, 10...Liquid-tight breathability Element. Patent applicant Terumo Corporation

Claims (1)

[Scope of Claims] 1. A needle tube having blade surfaces at both ends, a hub that supports the middle of the outer surface of the needle tube and has a locking part to which a rubber sheath is fitted at one end, and a rubber sheath of the nozzle to which the rubber sheath is fitted. Blood collection or In the medical needle of the syringe, the hub is provided with a liquid-tight breathable member at least at one location around the rubber sheath fitting locking part, and the inside and outside of the rubber sheath are connected only through the liquid-tight breathable member. A medical needle for blood collection or a syringe, characterized in that a rubber sheath is fitted on the outside of the liquid-tight breathable member to ensure breathability. 2. The medical needle for blood collection or syringe according to claim 1, wherein the liquid-tight breathable member is a hydrophobic filter material. 3. The medical needle for blood collection or syringe according to claim 1, wherein the liquid-tight breathable member is made of breathable paper. 4. A medical needle for blood collection or a syringe according to claim 3, wherein the liquid-tight breathable member is impregnated with a blood coagulant. 56 The rubber sheath fitting locking part has a surface continuous with the end surface so that the cross section along the needle tube has a rounded corner shape, and the liquid-tight breathable member has a disk shape with a needle tube insertion hole approximately in the center. A medical needle for blood collection or a syringe according to claim 1, 2, 3, or 4, which is provided to fit in the rubber sheath fitting locking portion. 6. A medical needle for blood collection or a syringe according to claim 1, wherein the entire needle is a liquid-tight breathable member. 7. A hub that has a needle tube insertion hole inside and has a rubber sheath fitting locking part at one end of the outer surface in the direction along the needle tube insertion hole is passed through the needle tube insertion hole to the middle of the outer surface of the needle tube that has blade surfaces at both ends. A disc-shaped liquid-tight breathable member is inserted into the hub of the needle tube in the shape of a brim and extends into the connecting side needle tube portion that extends to the upper side of the rubber sheath to be fitted. Align with the stop,
Next, a transparent or translucent rubber sheath, which has one longitudinal end open and the other end shaped like a bag and is slightly longer than the connection side needle tube portion, is placed over the needle tube portion in a bag shape, and the open end is used to cover the rubber sheath. A method for manufacturing a medical needle for blood collection or a syringe, characterized in that the liquid-tight air-permeable member aligned with the fitting and locking portion is fitted so as to be suppressed from the outside.