JPH0243365Y2 - - Google Patents

Description

[Detailed explanation of the idea]

[Industrial Application Field] The present invention relates to a blood collection needle used for collecting blood from a human body. [Prior Art] Conventionally, a vacuum blood sampling device shown in FIGS. 7 and 8 has been used to collect blood for, for example, clinical tests and biochemical tests. FIG. 7 is a cross-sectional view showing a conventional reduced-pressure blood sampling device before use, and FIG. 8 is a cross-sectional view showing the same state during use. As shown in FIG. 7, this reduced pressure blood collection device 10 is composed of a blood collection holder 13 comprising a reduced pressure blood collection tube 11 and a blood collection needle 12. The reduced pressure blood collection tube 11 is
A plug body 15 is attached to the upper opening of a tube body 14 made of glass material, transparent resin material, etc.
The inside of 4 is in a reduced pressure state. That is, the plug body 15 is required to maintain a reduced pressure state inside the tube body 14 and to be able to be punctured with a hollow needle as described later. Further, the plug body 15 is required to close the needle hole and maintain a liquid-tight state after the punctured hollow needle is removed. In this respect, it has conventionally been preferable to use a rubber material or the like for the plug body 15. On the other hand, the blood collection holder 13 has a cylindrical holder main body 17 with an open lower end, and a blood collection needle 12 is attached to the upper tip thereof. The blood collection needle 12 includes a blood vessel puncture portion 19 at one end of a hollow needle body 18, and a stopper 15 of the reduced pressure blood collection tube 11 at the other end.
A plug puncturing section 20 is provided. A hub 21 is provided at the intermediate portion of the needle body 18, and the hub 21 is formed with a male threaded portion 22. Blood collection needle 1
2 is attached to the holder body 17 by a female threaded portion 23 formed at the upper tip of the holder body 17.
This is done by screwing the male threaded portion 22 onto the male threaded portion 22. Furthermore, the plug piercing part 20 of the blood collection needle 12 attached to the holder body 17 is connected to a sheath-like covering cover 2.
4. That is, this cover 2
4 is made of a material that can be expanded and contracted, such as a soft rubber material, and can cover the plug puncture section 20 in an unused state as shown in FIG. When blood is collected using the reduced pressure blood collection device 10 having such a configuration, first, the blood collection holder 1 is
The blood vessel puncture part 19 of the blood collection needle 12 provided in 3.
Puncture the human body, etc. Next, the reduced pressure blood collection tube 11 is pushed into the holder main body 17 as shown by arrow A in FIG. At this time, the plug puncturing part 20 of the blood collection needle 12
As shown in FIG. 8, the covering cover 24 and the stopper 15 are punctured, and the inside of the tube body 14, which is brought into a reduced pressure state, is penetrated. At this time, the covering cover 24 is
It will be folded into a bellows shape between the plug body 15 and the holder body 17. In this way, the other end side of the hollow needle body 18 is connected to the tube body 1 as shown in FIG.
When the needle body 18 is penetrated into the inside of the tube body 14, due to the reduced pressure inside the tube body 14, the blood vessel puncture part 1 of the hollow needle body 18
Blood can be introduced from 9 to the plug puncture section 20 side. As a result, blood flows into the tube body 14 and blood is collected. Once a predetermined amount of blood has been collected inside the tubular body 14, the reduced pressure blood collection tube 11 is removed from the blood collection holder 13. In the removed state, the covering cover 24, which had been folded up to that point, is restored to its original state as shown in FIG. If a larger amount of blood is to be collected, an unused vacuum blood collection tube 11 may be pushed into the holder main body 17 as shown by arrow A, as shown in FIG. When blood collection is completed, the blood vessel puncture section 19 is removed from the human body. [Problems to be solved by the invention] By the way, in the reduced pressure blood sampling device 10 having the above-described configuration, after the end of blood collection, the plug puncturing part 20 is removed from the plug 15. Blood leaked to the outside from the needle hole opened by the needle hole, and the leaked blood sometimes remained on the surface of the plug body 15 as a blood pool. For this reason, it has been desired to develop a blood sampling needle that can be provided in the blood sampling holder 13 and which does not cause the above-mentioned blood leakage. [Purpose of the invention] The present invention quickly and reliably closes the needle hole formed in the stopper when the stopper puncture part is removed from the stopper of a vacuum blood collection tube, thereby preventing problems such as blood leakage and blood pooling. The purpose is to eliminate it. [Means for Solving the Problems] In order to achieve the above object, the present invention has a hub in the middle of a hollow needle body, a blood vessel puncture part on one end, and a vacuum on the other end. A blood collection needle comprising a stopper puncture part for puncturing a stopper of a blood collection tube, and the entire stopper puncture part is covered with a sheath-shaped elastic cover extending from the hub and having elasticity that can be expanded and contracted. , the hardness of the above cover is 33 to 50 (JIS-A
The hardness of at least the piercing portion of the plug is smaller than the hardness of the covering cover. Further, in the present invention, the material of the cover is isoprene rubber. [Specific Description of the Invention] The blood sampling needle of the invention will be described below with reference to the drawings. Fig. 1 is a front view showing a blood sampling needle according to an embodiment of the present invention, Fig. 2 is a cross-sectional view showing a vacuum blood sampling device formed using the blood sampling needle before use, and Fig. 3 is a sectional view showing the state before use. 4A to 4D are cross-sectional views showing the process of puncturing and removing the plug puncturing part from the plug, respectively. FIG. 2 is a perspective view showing a state in which blood is collected from a human arm using the device. A reduced pressure blood collection device 31 formed using the blood collection needle 30 shown in FIG. 1 is composed of a reduced pressure blood collection tube 32 and a blood collection holder 33, as shown in FIG. The reduced pressure blood collection tube 32 includes a tube body 34 made of a transparent material and a stopper 35 attached to the upper opening of the tube body 34 to maintain a reduced pressure inside the tube body 34 . As the material for the tube body 34, resin materials such as polyvinyl chloride and polyethylene can be used in addition to glass materials. On the other hand, plug body 3
5 is required to maintain a reduced pressure state inside the tube body 34 and to be able to puncture a hollow needle as described later. Further, the plug body 35 is required to close the needle hole and maintain a liquid-tight state after the punctured hollow needle is removed. For this reason, the plug body 35 is made of a rubber material or the like. Furthermore, a sealing member 36 made of styrene elastomer or the like is integrally molded at the puncture portion of the hollow needle of the plug body 35 . The hardness of the sealing member 36 is about 10 to 50, preferably about 15 to 40, and more preferably about 20 to 30 using a spring hardness tester type A described in JIS Handbook K6301. The blood collection holder 33 has a cylindrical holder body 37 with an open bottom end, and a blood collection needle 30 shown in FIG. 1 is attached to the upper tip of the holder body 37. The blood collection needle 30 is provided with a blood vessel puncture part 39 at one end of a hollow needle body 38, and a plug puncture part 40 which is inserted into the plug 35 of the reduced pressure blood collection tube 32 at the other end. A hub 41 is provided at the intermediate portion of the needle body 38, and the hub 41 has a male threaded portion 4.
2 is formed. Holder body 37 of blood sampling needle 30
Attachment to the holder body 37 is carried out by screwing the male threaded portion 42 into a female threaded portion 43 formed at the upper tip of the holder body 37. Furthermore, the plug puncture portion 4 of the blood collection needle 30 attached to the holder body 37
0 is covered with a sheath-like covering cover 44. The covering cover 44 is made of an elastic material that can be expanded and contracted, and isoprene rubber or natural rubber is preferably used as the material for the covering cover 44. Further, the hardness of the covering cover 44 is set to be about 33 to 50, preferably about 35 to 45, and more preferably about 37 to 45 using a spring hardness tester type A described in JIS Handbook K6301. When blood is collected using the reduced-pressure blood sampling device 31 having such a configuration, first, as shown in FIG. 5, the blood vessel puncture portion 39 of the blood sampling needle 30 provided in the blood sampling holder 33 is punctured into the arm 45 of a human body. Next, the reduced pressure blood collection tube 32 is pushed into the holder main body 37 as shown by arrow B in FIGS. 2 and 5. In this state, first, as shown in FIG. 4A, the plug puncture section 40 is
The tip of the covering cover 44 that covers the plug body 35
abuts against a partial surface of the sealing member 36. At this time, the contact area of the covering cover 44 with the sealing member 36 is approximately 1 to 2 mm ² . In this state, when the vacuum blood collection tube 32 is further pushed in the direction of arrow B, the cover 44 compresses the sealing member 36 in the direction of arrow C, as shown in FIG. 4B. That is, the hardness (JIS-A30 to 50) of the covering cover 44 is
Since the hardness is greater than the hardness (JIS-A10 to 15) of the seal member 36, the tip of the covering cover 44 that comes into contact with the seal member 36 is recessed into the interior of the seal member 36. As a result, the portion of the sealing member 36 that abuts the covering cover 44 is pushed out in the radial direction (direction of arrow D) as shown in FIG. 4B. When the vacuum blood collection tube 32 is further pushed in in the direction of arrow B in this state, the covering cover 44 is folded into a bellows shape as shown in FIG. 4C. At the same time, the plug piercing portion 40 is punctured into the surface portion of the sealing member 36 that has been expanded by the tip portion of the covering cover 44, as shown in FIG. 4C. In this way, the stopper puncture part 40 that has been inserted into the stopper 35 is penetrated into the inside of the tube body 34 which is brought into a reduced pressure state by further pushing the reduced pressure blood collection tube 32 in the direction of arrow B. . In this way, as shown in FIG. 3, when the other end of the hollow needle body 38 is penetrated into the inside of the tube body 34, the hollow needle body 38 is opened due to the reduced pressure inside the tube body 34. Blood can be introduced from the blood vessel puncture section 39 to the plug puncture section 40 side. As a result, blood flows into the tube body 34 and blood is collected. Once a predetermined amount of blood has been collected inside the tubular body 34, the vacuum blood collection tube 32 is removed from the blood collection holder 33. At the same time, the sealing member 36 was compressed and expanded due to the contact with the covering cover 44.
The punctured part is as shown by arrow E in Fig. 4D.
Shrunk back to its original state. As a result, the plug puncture section 2
Needle hole 46 formed in plug body 35 by puncturing 0
is closed by contraction of the stopper 35 including the seal member 36 in the direction of arrow E. When the vacuum blood collection tube 32 is removed, the covering cover 44, which has been folded up to that point, is restored to its original state as shown in FIG. 4D. If a larger amount of blood is to be collected, an unused vacuum blood collection tube 32 may be pushed into the holder main body 37 as shown by arrow B, as shown in FIGS. 2 and 5. When blood collection is completed, the blood collection holder 33 is removed from the human body. According to the reduced pressure blood collection tube 31 formed using the blood collection needle 30 described above, when the plug body puncture portion 40 punctures the plug body 35, the sealing member 36 integrally molded with the plug body 35 is punctured. The portion is compressed in advance by the covering cover 44 having high hardness and is sufficiently expanded in the radial direction, and in this state the needle is inserted. Further, when blood collection is completed and the plug puncture part 40 is removed from the plug 35, the plug material around the needle hole 46 formed in the plug 35 immediately contracts, and the needle hole 46 is quickly and reliably removed. This will result in a blockage. This ease of occlusion is achieved more quickly and reliably than in the conventional case where the punctured part of the stopper is not sufficiently expanded and the needle is punctured. As a result, it is possible to prevent blood from leaking to the outside from the needle hole 46 and to prevent blood from pooling in the stopper body 35 as in the conventional case. [Example 1] A cover 44 having the composition shown in Table 1 was made by press molding. The hardness was 35 (JIS-A). Further, the plug body 35 was injection molded with the composition shown in Table 2, and the seal member 36 was insert injection molded with the composition shown in Table 3 to obtain the plug body. The hardness of the seal member 36 is 25 (JIS-
A) It was. Using these, blood was actually collected and experiments were conducted to determine whether blood pooling occurred. The results are shown in Table 4. [Example 2] An experiment was conducted in the same manner as in Example 1 except that the hardness of the cover was set to 41 (JIS-A). The results are shown in Table 4. [Example 3] An experiment similar to Example 1 was conducted except that the hardness of the cover was set to 46 (JIS-A). The results are shown in Table 4. [Comparative Example] An experiment similar to Example 1 was conducted using a commercially available blood collection needle manufactured by Terumo Corporation. The hardness of the cover is 31 (JIS
-A). The results are shown in Table 4. Next, FIG. 6 shows the results of an experiment conducted to compare the blood sampling needle 30 according to the first embodiment and the conventional blood sampling needle. In this experiment, the blood collection needle 30 according to the conventional product and the present invention was
The penetration resistance was compared. In the experiment,
A state in which the plug 35 is compressed by the covering cover 44 [state P shown in FIG. 4B] and a state in which the covering cover is folded and the plug piercing part 40 punctures the plug 35 [in FIG. 4 C] As a result of comparing the states of Q shown in FIG. It can be seen that the compressive load W of the stopper 35 due to the covering cover 44 is approximately 170 to 180 g larger in the product of the present invention than in the conventional product. This indicates that because the cover of the present invention is made of a material with high hardness, extra compressive force can be applied to the stopper. [Effects of the invention] As described above, the invention has a hub in the middle part of the hollow needle body, a blood vessel puncture part on one end,
The other end side is provided with a stopper puncture part that is inserted into the stopper of the vacuum blood collection tube, and the entire stopper puncture part is covered with a sheath-shaped elastic cover that extends from the hub and is expandable and contractible. In the blood collection needle, the hardness of the covering cover is 33 to 50 (value measured with a JIS-A type tester), and the hardness of at least the piercing portion of the plug body is smaller than the hardness of the covering cover. When the puncture part of the cap is removed from the cap of the vacuum blood collection tube, the needle hole formed in the cap is quickly and reliably closed to prevent blood leakage, blood pooling, etc. It becomes possible to eliminate the problem. In addition, in the present invention, since the material of the covering cover is isoprene rubber, when the puncture part of the plug body is punctured, the part through which the needle hole of the plug body passes is reliably pushed out, and the puncture part of the plug body is removed. At this time, the needle hole portion of the stopper is reliably contracted.

【table】

【table】

【table】

【table】

【table】

【table】

Claims (1)

[Claims for Utility Model Registration] (1) A plug that has a hub in the middle of a hollow needle body, a blood vessel puncture part on one end, and a plug that is inserted into the plug of a vacuum blood collection tube on the other end. A blood collection needle including a puncturing part and covering the entire stopper puncturing part with a sheath-shaped elastic cover extending from the hub and having a hardness of 33 to 50 ( 2. A blood collection needle, characterized in that the needle has a hardness of at least the piercing portion of the plug (as measured by a JIS-A type tester) and is smaller in hardness than the covering cover. (2) The blood collection needle according to claim 1, wherein the cover is made of isoprene rubber.