JPH0131391B2 - - Google Patents

Description

Detailed Description of the Invention () Background Technical Field of the Invention The present invention provides a medical needle and a syringe for blood collection or syringe that can confirm that the needle tube has punctured a vein when blood collection or injection is performed by connecting a vacuum blood collection tube or syringe. It relates to its manufacturing method.

Prior art and its problems The configuration of a reduced pressure blood collection device is shown in FIG. 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 connects the medical needle A to hub 2.
It is a cylindrical holder made of transparent plastic or the like that can be held through a holder. Reference numeral C denotes a reduced pressure blood collection tube, which consists of a bottomed glass tube 4 and a rubber stopper 5 that seals the glass tube 4 and can be pierced and penetrated by the needle tube 1. ing.

To collect blood, holder B and medical needle A are screwed together, and then vacuum blood collection tube C is inserted into holder B from the rear end so that the end surface of rubber stopper 5 of vacuum blood collection tube C is the mark of holder B. Push it in until it lines up with the line 6, and pierce the connecting side needle tube portion 1a into the rubber stopper 5 to the extent that it does not flow through. Then, holding the holder B, puncture the blood vessel at a desired site such as the arm of the blood sample with the puncture side needle tube portion 1b, and further push in the reduced pressure blood collection tube C while attempting to relatively fix the arm and the holder, and connect the needle tube portion 1a on the connection side. By penetrating the rubber stopper 5, blood flows into the reduced pressure blood collection tube C. Another method is to insert a vacuum blood collection tube into the holder after puncturing. However, with the vacuum blood collection device configured as described above, it cannot be confirmed that the needle tube 1 has punctured a vein until the needle tube 1 is passed through the rubber stopper 5 and the presence or absence of blood flowing into the vacuum blood collection tube C is checked. 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, resulting in an unnecessary increase in puncturing the blood sample recipient.

FIG. 2 shows a medical needle proposed to solve the above problem. Rubber sheath fitting locking part 2
On one side of b, 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 the connecting needle tube portion 1a is inserted until it penetrates the rubber stopper, a predetermined amount of blood corresponding to the predetermined degree of vacuum will be drawn into the vacuum blood collection tube without coming into contact with the outside air, and at the same time, the rubber sheath 3 will be removed. Since it is thick and strong, it is pushed by the rubber stopper, moves slightly in the axial direction, and is compressed in the axial direction while blocking the air escape passage 7.
However, if there is a delay in connecting the needle tube 1 and the vacuum blood collection tube after confirming the 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. It will end up being put away. In other words, the drawback of the medical needle A shown in FIG. 1, which is that puncture 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. , the prevention of blood from flowing 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 the operation after the doctor confirms the puncture. There was a risk of infection from blood leaking into the holder.

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. Connect the syringe D, then pull the pusher 9 to collect blood, or push the pusher 9 to inject the liquid such as medicine stored in the tube body 8, and after the blood collection or injection is finished, fix the holder B. Hold syringe D
The procedure is to pull out the syringe D and reconnect the next new syringe D, but in this case as well, the second
The conventional medical needle shown in the figure has a problem in that the needle tube 1 and the syringe D must be connected quickly after confirmation of puncture and before blood flows out of the rubber sheath.

Other medical needles have been proposed that have an extremely small valve mechanism in the hub part that provides liquid-tight ventilation.
The problem is that it is extremely difficult and expensive to manufacture, making it unsuitable for mass production.

() 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 by a needle tube by the blood flowing out into the rubber sheath through the passage in the needle tube, but also allows the puncture of a vein by reducing the pressure. A medical needle for a blood collection or syringe that is improved so as to automatically prevent the blood that has flowed into the rubber sheath from flowing out without any operation of connecting 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 medical needle.

The purpose of this is to provide 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 rubber sheath fitting locking part at one end, and a hub on the side of the rubber sheath fitting locking part of the hub. A blood collection or syringe medical needle comprising a transparent or translucent rubber sheath that encloses an extended needle tube portion and is fitted and locked in the rubber sheath fitting locking portion, wherein the hub is fitted with a rubber sheath fitting. This is achieved by a medical needle for blood collection or a syringe, characterized in that the locking part is equipped with a liquid-tight breathable member containing a water-swellable substance that allows air permeability between the inside and outside of the rubber sheath. Ru.

The present invention provides an embodiment in which the liquid-tight breathable member is sandwiched between the rubber sheath and the rubber sheath fitting locking portion of the hub, or at least the rubber sheath fitting locking portion of the hub by the liquid-tight breathable member. Embodiments of the present invention include embodiments in which the

() Detailed Description of the Present Invention Detailed Structure of the Present Invention The medical needle for blood collection or syringe of the present invention is shown in FIG. The medical needle A includes a needle tube 1 having blade surfaces at both ends, a hub 2 that supports the middle of the needle tube 1, and a transparent or translucent rubber sheath 3 that fits into the needle tube portion 1a on the side of the extraction tube in a bag shape. It consists of. The needle tube 1 is made of a stainless steel tube or the like, the hub 2 is made of plastic or the like, and the rubber sheath 3 is made of soft rubber with sufficient flexibility and resilience and is shaped like a thin bag with only one end open. It will be done. The hub 2 has a locking part 2 fitted with a rubber sheath at one end of the male screw part 2a that can be screwed into the holder and connected to a vacuum blood collection tube, etc.
There is b. Further, the rubber sheath 3 is slightly longer than the needle tube portion 1a extending 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 1a in a bag-like manner. It is fitted and locked to the rubber sheath fitting and locking part 2b. The above configuration is no different from the conventional medical needle shown in FIG. Particularly, in this embodiment of the present invention, a swelling substance is included between the rubber sheath 3 and the rubber sheath fitting locking portion 2b of the hub 2 so as to provide only air permeability between the inside and the outside of the rubber sheath 3. A liquid-tight breathable member 10 is provided as a separate member. To explain the liquid-tight breathable member 10 in detail, the fine pores of the filter base are made by sintering a granular or granular thermoplastic aggregate, that is, a sintered filter constituent material, into a cylindrical shape having fine pores. This structure contains a water-swellable substance in a dry state so as not to block the water. As the thermoplastic aggregate, thermoplastic polymers such as polypropylene, polyethylene, and polyacrylonitrile are preferably used from the viewpoint of ease of molding. The filter base material has micropores with an average pore diameter of 1 to 20 μm, preferably 5 to 10 μm, and a porosity of 15 to 60 μm when containing the water-swellable substance in a dry state.
%, preferably 20-40%. In addition, water-swelling substances are substances that absorb 100 to 1000 times their own weight in water and swell within 10 minutes after coming into contact with blood at room temperature or body temperature. Specific examples include starch-acrylonitrile, starch-acrylic acid,
Acrylate-based starch grout compounds containing hydrolysates such as starch-acrylamide and starch-sodium acrylate; for example, partially saponified polyvinyl alcohol; acrylic polymers such as polyacrylates and acrylic acid-vinyl alcohol; polyethylene oxide; Preferably, a cellulose polymer is used. The content of the water-swellable substance in the liquid-tight breathable member is preferably 10 to 60% by weight, preferably 10 to 40% by weight. Note that in order to make the liquid-tight breathable member 10, granular or granular thermoplastic aggregate (=
A uniformly dispersed mixture of the sintered filter constituent material) and the water-swellable material is placed in a mold and heated and pressurized to shape it.

() Modification of the present invention As shown in FIG.
It may also be a medical needle held between the rubber sheath and the fitting locking part 2b.

Further, as shown in FIG. 6, the hub 2 is constructed by sintering a sintered filter constituent material into a microporous hub base and containing a water-swellable substance in the micropores in a dry state. It is also possible to use a medical needle in which the rubber sheath fitting locking portion 2b is used as a liquid-tight and breathable member. In addition, only the part to which the rubber sheath is fitted is formed by sintering the sintered filter constituent material into a microporous state and containing a water-swellable substance in the micropores, and then sintering this into a non-porous material made of polypropylene, polyethylene, etc. It is also possible to provide a medical needle that is integrally bonded to the hub body and has the rubber sheath fitting and locking portion as a liquid-tight breathable member.

As shown in FIG. 7, a bellows-shaped rubber sheath 3 is fitted over the needle tube portion 1a, and is easily folded in the axial direction by being pressed against the rubber stopper of the vacuum blood collection tube during blood collection. It can also be used as a needle.

As shown in FIG. 8, puncture the medical needle A, confirm the puncture, push the syringe D from the rear end of the holder B to connect it to the needle tube 1, and pull the pusher 9 to collect blood. Push in the connector 9 further and remove the tube body 8.
It can also be used as a medical needle for blood collection or syringes for injecting medical solutions.

() Specific effects and effects of the present invention As explained above, the medical needle for blood collection or syringe of the present invention has a transparent or translucent rubber sheath covering the needle tube portion in the form of a bag, and the rubber sheath of the hub is fitted into the needle. In the part that is fitted and locked to the locking part, the part that is fitted and locked by the rubber sheath is made of a liquid-tight breathable material containing a water-swellable substance to ensure ventilation between the inside and outside of the rubber sheath. It is the composition.

Therefore, when the blood sampling or syringe medical needle of the present invention punctures a blood vessel with the needle tube, the air inside the rubber sheath and the needle tube escapes to the outside through the liquid-tight breathable member due to the pressure inside the blood vessel. Blood is discharged from the blood vessel through the passage in the needle tube and flows into the rubber sheath, making it possible to confirm from the outside that the needle has penetrated into the blood vessel. And the blood inside the rubber sheath does not leak out to the outside of the rubber sheath. This is because when the blood that has flowed out into the rubber sheath reaches the liquid-tight breathable member and penetrates, the water-swellable substance contained in the dry state in the micropores of the liquid-tight breathable member absorbs the blood and swells into fine particles. By closing the holes, the liquid-tight breathable member becomes substantially liquid-tight, and blood will not leak out of the rubber sheath. For this reason, when the blood sampling or syringe medical needle of the present invention is punctured, blood flows into the rubber sheath and the color of the rubber sheath changes to confirm whether the vein has been secured, so there is no need to worry about blood sampling errors. Not only can blood be removed, but the medical needle itself has been improved to prevent blood from leaking outside the rubber sheath, so there is no need for quick connection operations and blood can be collected safely. can. Specifically, the medical needle for blood collection or syringe of the present invention is provided with a separate cylindrical or rod-shaped liquid-tight breathable member between the rubber sheath and the rubber sheath fitting locking portion of the hub. The present invention includes an embodiment and an embodiment in which at least the rubber sheath fitting portion of the hub is formed of a liquid-tight breathable member, and each medical needle has the above effects.

[Brief explanation of drawings]

FIG. 1 is a longitudinal sectional front view of a conventional medical needle used in a vacuum blood sampling device, etc., and FIG. 2 a is a longitudinal sectional front view of a conventional medical needle improved from the above medical needle. Figure 2b is _b − _b in Figure 2a
3 is a longitudinal sectional front view of a conventional medical needle in use with a syringe; FIG. 4 is a partially sectional front view of a medical needle for blood collection or a syringe according to an embodiment of the present invention; 5 to 7 are sectional views of main parts of medical needles according to modified examples of the present invention, respectively;
FIG. 8 is a partially sectional front view showing a state in which a medical needle for blood collection or a syringe is used as a syringe according to another modification of the present invention. A... Medical needle for blood collection or syringe, 1... Needle tube, 1a... Needle tube part, 1b... Puncture side needle tube part, 2... Hub, 2b... Rubber sheath fitted locking part (depending on the embodiment, liquid (also serves as a gas-tight member), 3...
...Rubber sheath, 10...Liquid-tight breathable member.

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 rubber sheath fitting locking portion at one end, and a locking portion for fitting the rubber sheath of the hub. A blood collection or syringe medical needle comprising a transparent or translucent rubber sheath that encloses a needle tube portion extending toward the body and is fitted and locked in the rubber sheath fitting and locking part, wherein the hub is made of rubber. A medical needle for blood collection or a syringe, characterized in that a sheath-fitting locking part is provided with a liquid-tight breathable member containing a water-swellable substance that allows ventilation between the inside and outside of the rubber sheath. 2. The medical needle for blood collection or syringe according to claim 1, wherein the liquid-tight breathable member is provided as a separate member between the rubber sheath and the rubber sheath fitting locking portion of the hub. 3. The medical needle for blood collection or syringe according to claim 1, wherein at least the rubber sheath fitting locking portion of the hub is formed of a liquid-tight breathable member.