JP3294047B2 - Medical device and method of manufacturing medical device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device constructed by connecting a needle cap and a needle base. The medical device maintains airtightness and does not allow foreign substances or the like to adhere to the needle tip when opening the medical device. It relates to a manufacturing method. Hereinafter, an example of the blood collection needle will be described.

[0002]

2. Description of the Related Art At present, a blood collection needle has a hermetic seal by applying silicone or paste resin dissolved in a solvent between a needle cap and a needle base and solidifying them. I was holding. However, as shown in FIG. 4, when the needle cap is opened from the needle base 33, the solidified silicon 37 or the like breaks into an irregular shape, and a very small portion of these pieces are peeled off from the needle base 33 to form the needle tube 34. May adhere to the surface. Thus, the present invention has conducted intensive studies in order to solve the above problems, and as a result, has arrived at the following invention.

[0003]

Means for Solving the Problems [1] The present invention is constituted by connecting a needle cap (2, 12, 22) made of polypropylene and a needle base (3, 13, 23) made of polyvinyl chloride. The needle coated with di-octyl phthalate
Steps (5, 15, 25, 6, 1) of the groups (3, 13, 23)
6, 26) and the needle cap (2, 12, 22)
And a medical device (1, 11, 21) in which the inner wall surface of the large diameter portion (8, 18, 28) of the needle cap is fitted. [2] The present invention provides a medical device (1, 1) comprising the following steps:
1, 21). (1) a step of applying di-octyl phthalate to the outer periphery of the step (5, 15, 25, 6, 16, 26) of the needle base (3, 13, 23) made of polyvinyl chloride; (2) The steps (5, 15,...) Of the needle bases (3, 13, 23)
25,6,16,26) The outer periphery of polypropylene needle
A step of fitting the cap (2, 12, 22) and the inner wall surface of the large diameter portion (8, 18, 28) of the needle cap , (3) phthalic acid-di-octyl is added to the needle base (3, 13, 2, 2).
3) to penetrate the step (5, 15, 25, 6, 16, 26) to swell the step (5, 15, 25, 6, 16, 26) and to remove the needle cap (2, 12, 22) and needle cap
And pressure on the inner wall surface of the flop large-diameter portion (8, 18, 28) from the inside, the stepped portion of the needle hub (3,13,23) (5, 15, 25,
6, 16, 26) and needle caps (2, 12, 22) and
A step of fitting to the inner wall surface of the large diameter portion (8, 18, 28) of the needle cap ; [3] The present invention provides a needle cap (2,
12, 22) and a needle base (3, 13, 2) made of polyvinyl chloride.
After fitting the 3), subjected to high pressure steam sterilization, a needle calibration
Shape and secondary molding of-up (2,12,22), a needle cap
Flop (2,12,22) and needle hub (3,13,23) engaged firmly fitted [2], wherein the medical device (1, 11, 21)
And a method for producing the same. [Detailed description of the invention]

[0004]

FIG. 1 is a schematic view of a blood collection needle 1 according to the present invention. The blood collection needle 1 comprises a polypropylene needle cap 2 and a polyvinyl chloride needle base 3 having a needle tube 4 implanted therein. DOP (di-octyl phthalate) such as 2-ethylhexyl phthalate is applied to the outer periphery of the first step portion 5 and the second step portion 6, and the outer periphery of the first step portion 5 and the second step portion 6 Are fitted on the inner wall surfaces of the needle cap 2 and the large diameter portion 8 of the needle cap.

When assembling the blood collection needle 1, a DOP is applied to the first step portion 5 and the second step portion 6 of the needle base 3, and the outer periphery of the DOP is applied to the inner wall surface of the needle cap 2 and the large diameter portion 8 of the needle cap. Fit. The DOP coating surface of each step 5, 6 of the needle base 3 is DO
P swells by penetrating into the step portions 5 and 6 of the needle base 3 made of polyvinyl chloride, and presses the inner wall surfaces of the needle cap 2 and the large diameter portion 8 of the needle cap from inside and tightly fits them. Thereby, the first step portion 5 and the second step portion 6 of the needle base 3 can be tightly fitted to the inner wall surfaces of the needle cap 2 and the large diameter portion 8 of the needle cap, and the airtightness can be improved. (The area indicated by 7 in FIG. 1 is an airtight portion.) Further, after the needle cap 2 and the needle base 3 are fitted as described above, high-pressure steam sterilization is performed to secondary-shape the shape of the needle cap 2. Thus, the needle cap 2 and the needle base 3 can be firmly fitted.

In the present invention, a medical needle 11 having a shape shown in FIG. 2 (a thread projection 19 is formed in the needle cap 12 and the outer wall surface of the second step 16 of the needle base and the large diameter portion 18 of the needle cap) is formed. It is also applicable to the medical needle 21 having the shape shown in FIG. 3 (the outer wall surface of the second step portion 26 of the needle base and the inner wall surface of the large diameter portion 28 of the needle cap are formed straight). it can.

In the present invention, the first step 5 of the needle base 3 is provided.
And the amount of DOP applied to the outer periphery of the second step 6 is 2 to 1
0 μl is preferred. If it is less than 2 μl, the fitting is loose and the airtightness is reduced, and if it exceeds 10 μl, it becomes sticky.

The blood collection needles (medical needles) 1, 11, and 21 assembled by the method described in the above [0005] were subjected to an airtightness test to confirm the presence or absence of a leak, but no leak was found. Needle cap 2 (12, 22)
No foreign matter was found when removing from the needle base 3 (13, 23).

[0009]

The DOP applied to the outer periphery of the first step portion 5 and the second step portion 6 of the needle base 3 penetrates into the respective step portions 5 and 6 and swells them. Each of the swollen steps 5,
6 can press the inner wall surfaces of the needle cap 2 and the needle cap large diameter portion 8 and tightly fit these inner wall surfaces. Further, after the needle cap 2 and the needle base 3 are fitted as described above, the shape of the needle cap 2 is secondarily formed by performing high-pressure steam sterilization, and the needle cap 2 and the needle base 3 are more firmly fitted. Can be combined. By the above-mentioned fitting, the airtightness between the needle cap 2 and the needle base 3 can be sufficiently maintained. Since the needle cap 2 and the needle base 3 are fitted as shown in the figure, when the needle cap 2 is removed from the needle base 3, there is no generation of foreign matter pieces unlike a conventional blood collection needle.

[Brief description of the drawings]

FIG. 1 is a schematic diagram of a blood collection needle of the present invention.

FIG. 2 is a schematic view showing another embodiment of the blood collection needle (medical needle) of the present invention.

FIG. 3 is a schematic view showing another embodiment of the blood collection needle (medical needle) of the present invention.

FIG. 4 is a schematic view showing an opened state of a conventional blood collection needle.

[Explanation of symbols]

1, 11, 21, 31 Blood collection needle ( medical needle, medical device) 2, 12, 22 Needle cap 3, 13, 23, 33 Needle base 4, 14, 24, 34 Needle tube 5, 15, 25, 35 Needle base First step part 6, 16, 26, 36 Second step part of needle base 7 Airtight part 8, 18, 28 Needle cap large diameter part 19 Screw protrusion

Claims (3)

(57) [Claims] 1. A needle cap (2, 1) made of polypropylene.
2, 22) and a needle base made of polyvinyl chloride (3, 13, 2)
3), the needle base (3, 1) coated with di-octyl phthalate.
3, 23) steps (5, 15, 25, 6, 16, 26)
Outer periphery of the needle cap (2, 12, 22) and the needle cap
Tsu fitted the inner wall surface of the flop large-diameter portion (8, 18, 28), a medical device, characterized in that (1, 11, 21). 2. A method for manufacturing a medical device (1, 11, 21) comprising the following steps. (1) a step of applying di-octyl phthalate to the outer periphery of the step (5, 15, 25, 6, 16, 26) of the needle base (3, 13, 23) made of polyvinyl chloride; (2) The steps (5, 15,...) Of the needle bases (3, 13, 23)
25,6,16,26) The outer periphery of polypropylene needle
A step of fitting the cap (2, 12, 22) and the inner wall surface of the large diameter portion (8, 18, 28) of the needle cap , (3) phthalic acid-di-octyl is added to the needle base (3, 13, 2, 2).
3) to penetrate the step (5, 15, 25, 6, 16, 26) to swell the step (5, 15, 25, 6, 16, 26) and to remove the needle cap (2, 12, 22) and needle cap
And pressure on the inner wall surface of the flop large-diameter portion (8, 18, 28) from the inside, the stepped portion of the needle hub (3,13,23) (5, 15, 25,
6, 16, 26) and needle caps (2, 12, 22) and
A step of fitting to the inner wall surface of the large diameter portion (8, 18, 28) of the needle cap ; 3. A needle cap (2, 1) made of polypropylene.
2, 22) and a needle base made of polyvinyl chloride (3, 13, 2)
After fitting the 3), subjected to high pressure steam sterilization, a needle calibration
Shape and secondary molding of-up (2,12,22), a needle cap
The method for producing a medical device (1, 11, 21) according to claim 2, characterized in that the needle (2, 12, 22) and the needle base (3, 13, 23) are firmly fitted.