JPH025428B2 - - Google Patents

Description

BACKGROUND OF THE INVENTION (Technical Field) The present invention relates to a tube that is inserted between a tube that connects a needle that punctures a blood donor's vein and a blood (collection) bag, and that collects blood into a blood bag. The present invention relates to an autoclaved blood bag having an inner needle assembly configured to permit the collection of a blood sample for testing after collection.

(Prior Art and its Problems) The donor's blood collected in a blood bag is sampled into a vacuum blood collection tube or the like for various tests. This is similar to drawing blood into a blood bag.
It must be done without contamination. For this reason, many so-called blood bags with inner needles have been developed, in which a needle for collecting blood for testing is incorporated into a tube connecting the blood bag and a venipuncture needle. Representative examples thereof include US Pat. No. 3,127,892, US Pat. No. 3,217,710, and US Pat. No. 3,342,179. In US Pat. No. 3,127,892, the joint is constructed of two rubber sleeves, which are connected to each other by a protruding ring and a fitting groove, and can be separated by pulling apart by hand. This has the following disadvantages: That is, since the rubber sleeve is fitted, the tensile strength is less than about 500 g, which means that the bonding force is weak, and therefore there is a risk that the two may come apart during manufacturing and use, resulting in liquid leakage and bacterial contamination. Also, since it is made of rubber, there is a risk of deterioration due to high-pressure steam sterilization.

U.S. Pat. No. 3,217,710 and U.S. Pat. No. 3,342,179 also disclose a hub assembly that incorporates a needle tube in two integrally molded parts, with a weakened or ruptured section between the two parts, and when necessary, both parts can be threaded. This is the format used when In this type, the tear strength of the thin-walled weakened portion formed between the two parts is not uniform and sometimes becomes too large, so wings for thread cutting are additionally provided.

Furthermore, when storing a needle tube with a sharp end for puncture into a protector during assembly, it is necessary to prevent the tip of the needle tube from coming into direct contact with the inner wall of the protector; however, there is no way to prevent this contact. It was extremely difficult. When the tip of the needle comes into contact with the inner wall of the protector, the tip of the needle scrapes away the constituent material of the protector, generating foreign matter. The foreign matter may mix into the collected test blood and affect test values or damage the blade surface of the needle tube.
Such situations should be avoided as much as possible, but
None of the prior art disclosed in the above-mentioned publications has proposed a technique for avoiding this problem. If I had to give an example, there is U.S. Patent No. 3540447,
This type of needle has a small diameter part with the required dimensions and angle to reduce the destruction of cell tissue that occurs when puncturing the spinal cord and to facilitate positioning. There have been no problems with damage to the inner surface of the protector or the needle tube.

Purpose of the Invention An object of the present invention is to provide an inner needle that has been sterilized using high-pressure steam so that the blade surface of the needle tube does not come into contact with the inner wall of the protector and scrape off the constituent material of the protector to generate foreign matter or damage the needle tube. The present invention aims to provide a blood bag with an assembly.

Another object of the present invention is to provide a high-pressure steam sterilized blood bag with an inner needle assembly that has excellent joint strength and airtightness at the joint and can be easily disassembled when necessary. .

Specific Structure of the Invention According to the present invention, there is provided a blood sampling puncture needle, a first tube having one end connected to the puncture needle, and a through hole A connected to the first tube and communicating with the inside of the first tube. a hub having a through hole, communicating with a through hole of the hub;
and a needle tube implanted with a pointed end protruding from the other end of the hub, one end connected to the blood bag via a second tube, and the other end having a through hole B into which the needle tube protruding from the hub can be inserted. a second tube connected to the one end of the through hole B of the protector, and a blood bag connected to the other end of the second tube, and a blood bag connected to the hub of the protector. has an annular protruding ring C, and has an annular protruding ring D having an outer diameter slightly smaller than the inner diameter of the protruding ring C of the protector on the end surface of the hub connected to the protector; There is a gap between the interface between the protruding ring C and the protruding ring D, and the tip of the needle tube is located inward in the axial direction or in the radial direction from the large diameter part of the needle tube. A blood bag with a characteristic autoclaved inner needle assembly is provided.

There are various structures in which the diameter near the tip of the needle tube is reduced, and some representative ones are shown below. A small diameter part is formed following the large diameter part of the needle tube, and a tip is provided at the tip of this small diameter part. Alternatively, a tapered portion may be formed following the large diameter portion of the needle tube, and a tip may be provided at the tip of the tapered portion. It is preferable that the tip of the needle tube be positioned inward in the perpendicular direction or inward in the radial direction with respect to the axial direction by about one-tenth of the diameter of the large diameter portion.

Although the connecting end surfaces of the hub and the protector can have various configurations, the inner needle assembly portion of the blood bag of the present invention has an annular protruding ring C on the connecting end surface of the protector with the hub,
The end surface of the hub to be joined to the protector has an annular protruding ring D having an outer diameter slightly smaller than the inner diameter of the protruding ring C of the protector, thereby achieving a tight joint. In addition, the protector and the hub are connected between the interface between the protruding ring D and the protruding ring C of both the hub and the protector, so that the bonding force does not become excessively large due to mutual blocking (natural adhesion caused by high-pressure steam sterilization). Provide an appropriate gap.

The shape of the hub and protector is not particularly limited and may be round or square; however, in the present invention, both are rectangular parallelepipeds, and the part on which the finger is placed when trying to separate the protector and hub is Preferably, the central portion is concave so as to be approximately complementary to the shape, and a rib is provided in the central concave portion to prevent slipping during dissection. In addition, the joint between the hub and protector is
As mentioned above, the needle tube inserted into the through hole B of the protector is precisely formed so that there is no wobbling, but the inner diameter of the through hole B of the protector is set to Preferably, the protector has the same size or a slightly smaller diameter, and after heating and expanding the protector, the needle tube is inserted and the protector and hub are joined to prevent the needle tube from wobbling.
At this time, since the tip of the needle tube is positioned inward in the axial direction or in the radial direction from the large diameter portion of the needle tube, no problem arises in such operation.

Next, a blood bag with an inner needle assembly according to the present invention will be described in detail with reference to preferred embodiments shown in the accompanying drawings.

As shown in FIG. 1, blood is collected by puncturing the donor's vein with a blood collection needle 1, passing through a first tube 2, an inner needle assembly 3, and a second tube 4, and collecting the blood in a blood bag 5. be done. Once a sufficient amount of blood has been collected in the blood bag 5, the knot 6 of the second tube 4 is tied tightly to stop the blood flow, the inner needle assembly 3 is dissociated, and the needle tube 8 implanted in its hub 7 is removed. is extracted from the protector 9,
As shown in FIG. 2, a needle tube 8 is inserted into a sampling tube 10 such as a vacuum tube to collect sampled blood. In this way, the inner needle assembly 3 performs two functions: it ensures a contamination-free blood passage when drawing blood into the blood bag 5, and it is easily dissociated and used when sampling blood is drawn. Must do. As mentioned above, conventional devices have not been able to perform this function satisfactorily.

Next, the structure of the blood bag with an inner needle assembly according to the present invention will be explained with reference to FIGS. 3 to 6.

As shown in FIG. 3, the three parts of the inner needle assembly of the blood bag of the present invention include a hub 7 whose one end is connected to the first tube 2, and a protector 9 whose one end is connected to the second tube 2. They are joined at the joining part 11. FIG. 4 shows a cross section taken along the line .about. in FIG. 3. The hub 7 and the protector 9 each have a through hole A and a through hole B (12 and 13 in the figure) that serve as blood passages.
The needle tube 8 is properly positioned in the through hole 12 of the
is inserted and fixed to the hub 7 with adhesive 15. The through hole 13 of the protector 9 is for inserting and storing the needle tube 8, and is designed to prevent the needle tube 8 from shaking inside the through hole 13.

At the assembly joint of the hub 7 and protector 9,
The sharp end of the needle tube 8 implanted in the hub 7
Careful operation is performed so as not to directly contact the inner circumferential wall of the protector 9 and scrape off the constituent material of the protector to generate foreign matter or damage the blade surface of the needle tube 8. However, the inner surface of the protector 9 is not necessarily completely smooth with respect to the cylindrical body of the needle tube 8, and the above-mentioned danger still remains.

In order to facilitate the operation of assembling and joining the hub 7 and protector 9 and to prevent the above-mentioned problems from occurring, in the present invention, as shown in FIG. 4, the tip 8a of the needle tube 8 is , is configured to be located inward in the direction perpendicular to the axial direction or inward in the radial direction from the large diameter portion 8b of the needle tube. An example of the configuration of the needle tube 8 is shown in FIGS. 5 and 6. In the example shown in FIG. 5, the pointed end 8a of the needle tube 8 is formed at the tip of a slightly smaller diameter portion 8c with a diameter d that follows the large diameter portion 8b with a diameter D, and in the example shown in FIG. A pointed end 8a is formed at the tip of a tapered portion 8d following a large diameter portion 8b having a diameter D so as to have a diameter d. Although the configuration is not limited to this example, in any case, the tip 8a of the needle tube 8 may be located inward in the axial direction or in the radial direction from the large diameter portion 8b of the needle tube 8. It is essential. In this way, the point 8a is positioned so that it does not come into contact with the inner circumferential wall of the protector when the needle tube 8 is inserted into the protector, preferably by one-tenth of the diameter of the large diameter portion of the needle tube 8. located inward in a perpendicular direction or radially inward with respect to the axial direction. In this case, the large diameter portion 8b, small diameter portion 8c, and tapered portion 8d of the needle tube 8 are preferably made concentric.

As a method for forming the needle tube 8 having such a configuration, a swaging process in which the needle tube 8 is formed by rotating it at high speed and putting it into a mold is suitable and well known. Note that the gap S (see FIG. 4) that inevitably occurs between the small diameter portion 8c or tapered portion 8d formed by the swaging process and the inner surface of the protector 9 may cause undue turbulence in the blood flow. Of course, it is necessary to prevent an inappropriate amount of blood from accumulating. Further, the needle tube 8 is not necessarily limited to a cylindrical body, but may be a prismatic body.

The hub 7 and the protector 9 are connected to each other by an annular protruding ring C (16 in FIG. 4) that protrudes in the axial direction from the end surface of the protector 9 connected to the hub 7. The inner diameter of the protruding ring 16 is slightly smaller than An annular protruding ring D (17 in the figure) that has an outer diameter and protrudes in the axial direction from the joint end surface of the hub 7 with the protector 9.
made by.

The protruding rings 16 and 17 are provided concentrically with the through holes 13 and 12, and are configured to be aligned and tightly joined.

Furthermore, the through hole 13 of the protector 9 into which the needle tube 8 is inserted is made to have the same size or a slightly smaller diameter than the large diameter portion 8b of the needle tube 8, so that the needle tube 8 is inserted after the protector is heated and expanded so that the two are tightly fitted. By doing so, wobbling can be further prevented. The looseness of the joint must be avoided as much as possible since it impairs the airtightness of the joint 11 and induces bacterial contamination.

Further, in the present invention, the interface between the protruding rings 17 and 16 of the hub 7 and the protector 9, especially between the inner circumferential surface 19 of the protruding ring 16 and the outer circumferential surface 20 of the protruding ring 17, is blocked by high-pressure steam sterilization, In order to prevent the hub 7 and protector 9 from being coupled with excessively large coupling force, the fourth
As shown in the figure, there is a gap 2 between the inner circumferential surface 19 of the protruding ring 16 and the outer circumferential surface 20 of the protruding ring 17.
1 is provided. This makes it difficult for the aforementioned blocking to occur, making it possible to provide a blood bag with an inner needle assembly that has been sterilized using high-pressure steam and is of uniform quality.

The shape of the hub 7 and protector 9 is preferably such that it is easy to hold and easy to thread.
In the present invention, as shown in FIGS. 3 and 4, the hub 7 and the protector 9 are preferably formed of a rectangular parallelepiped molded plastic material.
Particularly, it is preferable that at least the portions of the opposing surfaces on which the fingers are placed have a concave central portion 22 and adapted to the shape of the fingers. Also, when holding the hub 7 and protector 9 with your fingers and twisting them to separate them, make sure that your fingers do not slip.
Preferably, ribs 23 or grooves (not shown) are provided.

Specific Effects of the Invention As is clear from the above explanation, the high-pressure steam sterilized blood bag with inner needle assembly of the present invention provides many advantages as follows.

(1) Since the tip of the needle is configured to be located inward in the axial direction or radially inward from the main body of the needle, the tip of the needle will touch the inner circumferential wall of the protector during assembly, etc. There is no longer any risk of foreign matter being generated by scraping the needle, which may enter the collected test blood and affect test values, or conversely damage the blade surface at the tip of the needle tube. .

(2) Processing to reduce the diameter of the tip of the needle to prevent the needle from scraping the inner wall of the protector is as follows:
This can be easily done by swaging or the like.

(3) Shakiness at the joint is completely prevented by the joint structure of the hub and protector, and also by the tight fitting structure of the needle tube and the through hole of the protector.

(4) Even after high-pressure steam sterilization, the bonding force between the hub and protector is moderately strong due to the avoidance of blocking, there is no rattling at the joints, and the airtightness is excellent. Excellent leak resistance.

(5) Handling can be made easier if the hub and protector holding portions are shaped to fit the shape of the finger and provided with ribs, etc.

[Brief explanation of drawings]

FIG. 1 is a diagram showing a first mode of use of a blood bag with an inner needle assembly that has been sterilized by autoclaving according to the present invention, and FIG. FIG. 3 is a side view of the inner needle assembly portion of the high-pressure steam sterilized blood bag with an inner needle assembly of the present invention, and FIG.
A sectional view taken along the - line in the figure, and FIGS. 5 and 6 are longitudinal sectional views showing an example of the configuration of the needle tube portion. Explanation of symbols, 1...Blood collection needle, 3...Inner needle assembly, 5...Blood bag, 7...Hub,
8...Needle tube, 8a...Point, 8b...Large diameter part, 8
c...Small diameter part, 8d...Tapered part, 9...Protector, 10...Reduced pressure blood collection tube, 11...Joint part, 12, 13...Through hole, 15...Adhesive, 1
6, 17...Protruding ring, 21...Gap, 22...
...Central recess, 23...rib.

Claims (1)

[Scope of Claims] 1. A puncture needle for blood collection, a first tube having one end connected to the puncture needle, and a first tube connected to the first tube,
a hub having a through hole A that communicates with the inside of the first tube; a needle tube that communicates with the through hole of the hub and is implanted with a pointed end protruding from the other end of the hub; a protector connected to the blood bag and having a through hole B at the other end into which a needle tube protruding from the hub can be inserted; and a second protector connected to the one end of the through hole B of the protector.
a tube, and a blood bag connected to the other end of the second tube, an annular protruding ring C on an end surface of the protector connected to the hub, and an annular protruding ring C on an end surface of the hub connected to the protector. has an annular protrusion ring D having an outer diameter slightly smaller than the inner diameter of the protrusion ring C of the protector, and therefore has a gap between the interface between the protrusion ring C and the protrusion ring D, and A high-pressure steam sterilized blood bag with an inner needle assembly, characterized in that the tip of the needle tube is located inward in the axial direction or in the radial direction from the large diameter portion of the needle tube. 2. The high-pressure steam sterilized blood bag with an inner needle assembly according to claim 1, wherein the pointed end of the needle tube is formed at the tip of a small diameter section that follows a large diameter section of the needle tube. 3. The high-pressure steam sterilized blood bag with an inner needle assembly according to claim 1, wherein the pointed end of the needle tube is formed at the tip of a tapered portion that continues to the large diameter portion of the needle tube. 4. Claim 1, characterized in that the pointed end of the needle tube is located inward in the perpendicular direction or radially inward with respect to the axial direction by one-tenth of the diameter of the large diameter portion of the needle tube. 4. A blood bag with an inner needle assembly that has been sterilized using high-pressure steam according to any one of items 1 to 3. 5. Any one of claims 1 to 4, characterized in that the hub and the protector are formed of a rectangular parallelepiped, and the central part thereof is lowered so that the part on which the finger is placed has a substantially complementary shape to the shape of the finger. A blood bag with an inner needle assembly that has been sterilized using high-pressure steam as described in the above. 6. The high-pressure steam sterilized blood bag with inner needle assembly according to claim 5, characterized in that ribs are formed in the lower central portions of the hub and the protector where the fingers rest. 7 The inner diameter of the through hole B of the protector is the same as or slightly smaller than the outer diameter of the large diameter part of the needle tube, and after heating and expanding the protector, the needle tube is inserted to join the protector and the hub, and the protector and the hub are joined together. A blood bag with an inner needle assembly sterilized by high-pressure steam according to any one of claims 1 to 6, characterized in that rattling of the needle tube inserted into the through hole B of the protector is prevented. .