JP4639300B2 - Lancet manufacturing method and lancet - Google Patents

Description

  The present invention relates to a method for manufacturing a lancet used for forming a puncture wound when collecting body fluid or the like from the skin, and in particular, a method for manufacturing a lancet including a puncture needle and a cap that covers the puncture needle, and The lancet thus manufactured is related.

  In recent years, with an increase in the number of diabetic patients, cases of diabetic patients themselves measuring blood glucose levels themselves at home or the like to self-manage fluctuations in blood glucose levels are increasing. In view of such a situation, when collecting blood for measuring blood glucose level, a lancet provided with a puncture needle that can easily damage a fingertip or the like and collect blood necessary for measurement. A device (puncture device) is provided.

  The lancet device has a puncture needle mounted on the tip portion, and the puncture needle is fired using a force of a spring or the like with the tip portion applied to a fingertip or the like. The puncture needle is protruded about several mm to 2.0 mm. Thereby, blood sugar level can be measured by incising a fingertip etc., collecting blood flowing out from the wound, and dropping the collected blood on a sensor portion of the blood glucose meter.

Such a lancet device includes a lancet having a puncture needle for forming a puncture wound, and a puncture body that is integrally formed with a resin together with a cap so as to cover the puncture needle. Some lancets have a resin cap attached to the tip of the puncture needle in order to ensure safety before use. Such a lancet with a cap may be attached later to a puncture body that holds the puncture needle (see Patent Document 1), or the holding portion of the cap and the puncture needle together with the puncture needle may be integrally molded with resin. is there.
JP-A-8-000597 (published January 9, 1996)

  However, both of the conventional lancets have the following problems.

  That is, the conventional lancet disclosed in the above publication requires a puncture needle, a puncture body, and a cap, and three parts are required, resulting in an increase in the number of parts and an increase in cost.

  On the other hand, the conventional lancet that integrally molds the cap part and the part that holds the puncture needle together with the puncture needle by resin is subjected to pressure on the puncture needle in the mold during the integral molding, causing problems such as deformation of the puncture needle Is likely to occur.

  The subject of this invention is providing the manufacturing method and lancet of a lancet which can reduce the load provided to the puncture needle at the time of shaping | molding, reducing a number of parts.

  The lancet manufacturing method according to the first invention is a lancet manufacturing method comprising: a puncture needle for forming a puncture wound; and a puncture body integrally formed with a cap for covering the tip of the puncture needle. Thus, the first to third steps are provided. In the first step, an opening leading to the inside of the cap is formed in the puncture body, and a puncture needle is inserted into this opening from the tip. In the second step, the puncture needle inserted into the opening is positioned in the insertion direction with respect to the puncture body. In the third step, the puncture needle is fixed to the puncture body.

  Here, after the puncture needle is inserted from the tip into the opening that leads from the opposite side of the puncture body formed integrally with the cap (hereinafter referred to as the rear end side) to the inside of the cap, positioning is performed. The puncture needle is fixed to the puncture body with an adhesive or the like.

  As a result, the puncture needle is not loaded during molding as compared with the case where the puncture needle is inserted into the molding die and integrally formed with the cap and the puncture body. Misalignment can be prevented. For this reason, for example, it becomes possible to use a thin needle having a diameter of 0.3 mm or less, and it is possible to reduce the pain of the blood collection subject when forming a puncture wound. Moreover, even when the puncture needle is inserted after the cap and the puncture body are integrally formed as in the present invention, a load is applied to the puncture needle by being inserted into the puncture body from the distal end side of the puncture needle. The puncture needle can be inserted into the cap from the puncture body.

  Furthermore, since the cap and the puncture body are integrally formed only with the resin, the conventional large-scale device required for the integral formation of the puncture needle, cap, and puncture body is unnecessary, and the cost of the product can be reduced. Compared to a lancet manufactured using three parts: a cap, puncture body, and puncture needle, it is manufactured from two parts, a puncture body and a puncture needle, thus reducing the number of parts and reducing costs. Can be planned.

  The lancet manufacturing method according to the second invention is the lancet manufacturing method according to the first invention, wherein the puncture needle positioned in the second step is placed inside the cap integrally formed with the puncture body. A space is formed in which the tip portion is not in contact with the cap.

  Here, a space is formed inside the cap so that the tip of the puncture needle inserted along the opening of the puncture body does not contact the inside of the cap.

  Thereby, even when the cap is removed by twisting or the like when using the lancet, it is possible to reduce the load applied to the tip of the puncture needle and avoid the occurrence of problems such as deformation of the tip of the puncture needle. As a result, since the deformation of the puncture needle can be avoided even if a thin puncture needle is used, it is possible to relieve the pain of the blood sampled person at the time of puncture wound formation using the thin needle.

  The lancet manufacturing method according to the third invention is the lancet manufacturing method according to the first or second invention, and in the second step, a jig for positioning the puncture body in the insertion direction of the puncture needle is provided. Used.

  Here, when the puncture needle is inserted into the opening of the holder, the second step is performed using a jig for positioning the puncture needle in the insertion direction.

  Thereby, a highly accurate lancet can be manufactured in a state where the length of the puncture needle protruding from the puncture body is constant.

The lancet manufacturing method according to the fourth invention is a lancet manufacturing method according to any one of the first to third inventions, wherein in the third step, the puncture needle is an ultraviolet curable adhesive or It is fixed to the puncture body using at least one of anaerobic adhesive.

  Here, the puncture needle inserted into the opening formed in the puncture body is fixed to the puncture body using an ultraviolet curable adhesive or an anaerobic adhesive.

  Thereby, even when the puncture needle is inserted into the opening of the puncture body from the tip, the puncture body and the puncture needle can be fixed without contaminating the tip of the puncture needle.

  The lancet manufacturing method according to the fifth invention is the lancet manufacturing method according to the fourth invention, wherein the puncture body is formed of a transparent resin.

  Here, for example, even when the puncture needle and the holder are fixed using an ultraviolet curable adhesive, since the puncture body is transparent, the ultraviolet rays reach the inside of the puncture body and completely cure the adhesive. be able to.

  The lancet manufacturing method according to the sixth invention is the lancet manufacturing method according to the fourth or fifth invention, wherein in the third step, the lancet is formed on a side surface of the holder parallel to the insertion direction of the puncture needle. The adhesive is injected from the opening where the cage puncture needle is exposed.

  Here, the adhesive is injected from the side surface side of the puncture needle and the puncture body, and the puncture needle and the puncture body are fixed.

  Thereby, for example, even when a puncture needle is inserted from behind the puncture body using a jig, the puncture body and the puncture needle can be easily fixed using an adhesive. Further, since the adhesive is injected from the side surface of the puncture body, for example, even when an ultraviolet curable adhesive is used, the adhesive can be easily cured by irradiating ultraviolet rays from the side surface of the puncture body.

  The lancet according to the seventh invention is formed by the lancet manufacturing method according to any one of the first to sixth inventions.

  Here, a lancet manufactured by the above manufacturing method can be obtained.

  For this reason, it is possible to reduce the load applied to the puncture needle when molding or removing the cap. Accordingly, it is possible to provide a lancet that can reduce pain of a blood sampled person when forming a puncture wound by adopting a puncture needle that is thin and easily deformed, has a small number of parts, and has a reduced manufacturing cost. it can.

  According to the lancet manufacturing method according to the first aspect of the invention, it is possible to prevent the tip of the puncture needle from being bent and the puncture needle from being displaced at the time of molding, so that a thin needle can be used and a puncture wound is formed. At the same time, the pain of the blood sample can be reduced, and a large-scale device and cap required for integral molding with the puncture body are not required, so that the cost can be reduced.

  According to the lancet manufacturing method according to the second aspect of the invention, since a fine puncture needle can be used, it is possible to relieve the pain of the blood sampled person at the time of puncture wound formation.

  According to the lancet manufacturing method of the third invention, a highly accurate lancet can be manufactured with the length of the puncture needle protruding from the puncture body being constant.

  According to the lancet manufacturing method of the fourth invention, the puncture body and the puncture needle can be fixed without making the tip of the puncture needle dirty.

  According to the lancet manufacturing method of the fifth aspect of the invention, since the puncture body is transparent, the ultraviolet rays reach the inside of the puncture body and the ultraviolet curable adhesive can be completely cured.

  According to the lancet manufacturing method of the sixth aspect of the present invention, even when the puncture needle is inserted from behind the puncture body using a jig, the puncture body and the puncture needle can be easily fixed using an adhesive. it can.

  According to the lancet according to the seventh aspect of the present invention, the load applied to the puncture needle at the time of molding or removing the cap is reduced, and a blood sample is collected when a puncture wound is formed by adopting a puncture needle that is thin and easily deformed. Thus, it is possible to provide a lancet with a reduced number of parts and reduced manufacturing costs.

  A lancet according to an embodiment of the present invention will be described below with reference to FIGS. 1 (a) to 3 (d).

  The “front end side” used below refers to the direction in which the front end of the puncture needle faces (front side in the puncture direction), and “rear end side” refers to the opposite end.

[Lancet configuration]
A lancet 10 according to an embodiment of the present invention is a member attached to the tip of a puncture device (lancet device) used for collecting a body fluid when a diabetic patient performs blood glucose measurement or the like. A puncture wound is formed by the puncture needle 11 (see FIG. 2) projecting from an opening formed at the distal end portion in a state in which the skin is in contact with the skin.

  The lancet 10 includes a puncture needle 11, a main body (puncture body) 12, and a cap 13, as shown in FIGS. 1 (a) to 1 (c) and FIG.

  The puncture needle 11 is a member for forming a puncture wound on the skin from which a body fluid is collected. As shown in FIG. 2, the puncture needle 11 is integrally formed with a body portion 12 and a cap 13 integrally formed of resin from the tip end side of the needle. It is held by the main body 12 in the inserted state. For this reason, the lancet 10 is substantially constituted by two parts, that is, a main body portion 12 with a cap 13 formed of resin and a puncture body 11. In this embodiment, in particular, a thin puncture needle of 30 G (gauge) or more is used in order to reduce as much as possible the pain that can be applied to the blood sample when forming a puncture wound.

  As shown in FIG. 2, the main body 12 has a cylindrical portion 12a, a columnar portion 12b, an insertion hole 12c, and a connecting portion 12d. The cylindrical portion 12a is a substantially cylindrical member having a hollow inside, and is connected to the cap 13 via a connecting portion 12d on the distal end side. The columnar part 12b is a substantially columnar member disposed in a hollow part in the cylindrical part 12a, and is connected to the cylindrical part 12a and the cap 13 on the distal end side. The insertion hole 12c is formed so as to communicate from the rear end side of the cylindrical portion of the cylindrical portion 12b to the inside of the cap 13, and the puncture needle 11 is inserted from the distal end portion of the needle. In addition, as shown in FIG. 2, the insertion hole 12 c has a large diameter so that a space can be formed between the cylindrical portion and the outer peripheral surface of the puncture needle 11 from near the middle to the rear end side. A UV curable adhesive, which will be described later, is injected into the space between the outer periphery of the puncture needle 11 having a large diameter. The connecting portion 12d is a portion formed of a thin resin for connecting the main body portion 12 and the cap 13, and when the puncture needle 11 is exposed, it can be easily broken by pulling while rotating the cap 13. To do.

  The cap 13 is a member that is formed on the distal end side of the main body portion 12 and is integrally formed with the main body portion 12, and is provided so as to cover the distal end of the puncture needle 11. Further, the cap 13 has a non-contact space 13 a formed on the connection side with the main body 12 so that the tip portion of the puncture needle 11 does not contact the inside of the cap 13. Then, as described above, the cap 13 is pulled while being rotated, whereby the thin connecting portion 12d is broken to expose the puncture needle 11. At this time, since the non-contact space 13a is formed inside the cap 13, it is possible to avoid applying a load to the tip of the puncture needle 11 when the connecting portion 12d is twisted while the cap 13 is rotated.

  In the lancet 10 of the present embodiment, the main body 12 with the cap 13 is formed of a transparent resin such as PE (polyethylene), PP (polypropylene), or nylon.

[Lancet manufacturing method]
The lancet 10 configured as described above is manufactured by the following procedure.

  That is, in the lancet 10 of this embodiment, the main body 12 and the cap 13 are integrally formed. For this reason, in the lancet 10, first, as shown in FIG. 3A, the body portion 12 with the cap 13 integrally formed is placed on the side of the needle tip of the puncture needle 11 held by the positioning jig 20. (Step S1). At this time, the puncture needle 11 is held in a state protruding by a predetermined length by a positioning jig 20 used together with the plate 21 for positioning in the insertion direction of the puncture needle 11. The puncture needle 11 is inserted into the insertion hole 12c of the cylindrical portion 12b formed inside the main body portion 12 while being held by the positioning jig 20. The puncture needle 11 has a depth at which the distal end portion of the puncture needle 11 does not come into contact with the wall forming the non-contact space formed inside the cap 13 and protrudes from the distal end of the main body portion 12 by a predetermined length. It is inserted to the depth to do. This insertion depth is adjusted by the holding position of the puncture needle 11 by the positioning jig 20 for positioning the puncture needle 11 in the insertion direction and the thickness of the plate 21.

  Next, as shown in FIG. 3B, the puncture needle 11 is inserted until the positioning jig 20 comes into contact with the end portion on the rear end side of the main body portion 12 (cylindrical portion 12a) via the plate 21. (Step S2), the UV curable adhesive A is applied from the adhesive injection nozzle 20a formed in the positioning jig 20 to the puncture needle of the insertion hole 12c formed in the main body 12 (cylindrical portion 12b). 11 is injected into the space with the outer peripheral portion.

  Next, after injecting the adhesive A, as shown in FIG. 3C, UV (ultraviolet light) is irradiated from the side surface to the portion into which the adhesive A has been injected. At this time, as described above, since the main body 12 is formed of a transparent resin, UV can be transmitted to the inside of the main body 12. Therefore, even when UV is irradiated from the side surface of the cylindrical portion 12b, the adhesive A can be sufficiently cured. As a result, the puncture needle 11 is fixed at a predetermined position with respect to the main body 12 in the insertion direction (step S3).

  Finally, after the adhesive is cured by UV irradiation, the positioning jig 20 and the plate 21 are removed as shown in FIG.

[Features of the manufacturing method of this lancet]
(1)
As shown in FIG. 3A, the lancet 10 of the present embodiment is a lancet having a main body 12 integrally formed with the cap 13 and communicates from the rear end side of the main body 12 to the inside of the cap 13. An insertion hole 12c is formed. Then, the puncture needle 11 is inserted into the insertion hole 12c from the distal end portion (step S1). Next, as shown in FIG. 3B, after the puncture needle 11 inserted into the insertion hole 12c is positioned in the insertion direction (step S2), as shown in FIG. Is fixed to the main body 12 by the adhesive A (step S3).

  In this way, the main body portion 12 with the cap 13 is inserted from the needle tip side of the puncture needle 11, in other words, the puncture needle 11 is inserted into the main body portion 12 with the cap 13 from the needle tip and fixed. Compared to a conventional manufacturing method in which a puncture needle is integrally formed with a cap and a main body, the load applied to the puncture needle 11 during manufacturing can be reduced. For this reason, the lancet 10 can be manufactured without bending the needle tip even when a puncture needle that is thinner and easier to bend than before is used. As a result, it is possible to provide the lancet 10 capable of reducing the pain given to the blood sample by using the thin puncture needle 11 while reducing the number of parts as compared with the prior art. Furthermore, compared with the case where insert molding with the conventional puncture needle 11 inserted is performed, a large-scale device required for insert molding is not required, so that the cost can be reduced.

(2)
In the lancet 10 of the present embodiment, a non-contact space 13 a that extends around the distal end portion of the puncture needle 11 inserted from the rear end side of the main body portion 12 is formed inside the cap 13.

  Thus, even when the cap 13 is detached and the tip of the puncture needle 11 is exposed when the lancet 10 is used, the inside of the cap 13 is twisted while twisting the connecting portion 12d (see FIG. 2) while rotating the cap 13. However, it is possible to avoid applying a load to the tip of the puncture needle 11. For this reason, after the cap 13 is detached, it is possible to prevent the occurrence of a problem that the needle tip of the puncture needle 11 is bent. As a result, even when, for example, a 30G thin puncture needle 11 as used in the present embodiment is employed, the puncture needle 11 can be used without being bent. Further, even when the puncture needle 11 is inserted into the cap 13 from the tip side of the needle, it is possible to avoid a problem that the tip portion of the puncture needle 11 comes into contact with the cap 13 and bends.

(3)
In the lancet 10 of the present embodiment, the positioning jig 20 is used when the puncture needle 11 is inserted into the main body portion 12.

  Thereby, relative positioning of the puncture needle 11 with respect to the main-body part 12 in the insertion direction (puncture direction) of the puncture needle 11 can be performed correctly.

(4)
In the lancet 10 of the present embodiment, a UV curable adhesive A is used to fix the puncture needle 11 to the main body 12.

  Thereby, even when the adhesive is injected after the puncture needle 11 is inserted into the main body 12, the adhesive A can be easily cured.

(5)
In the lancet 10 of the present embodiment, a main body portion 12 into which the puncture needle 11 is inserted and a cap 13 integrally formed with the main body portion 12 are formed of a transparent resin.

  Thus, even when the puncture needle 11 is fixed using the UV curable adhesive A as described above, the UV penetrates through the transparent resin portion, so that the adhesive A can be easily cured.

[Other Embodiments]
As mentioned above, although one Embodiment of this invention was described, this invention is not limited to the said embodiment, A various change is possible in the range which does not deviate from the summary of invention.

(A)
In the above-described embodiment, an example in which the adhesive that fixes the puncture needle 11 to the main body portion 12 is injected from the insertion hole 12c formed to insert the puncture needle 11 has been described. However, the present invention is not limited to this.

  For example, a lancet 30 as shown in FIGS. 4A to 4C and 5 can be used. In this lancet 30, as shown in FIG. 4 (b), injection holes 32e reaching the columnar portion puncture needle 11 are formed in the side portions of the cylindrical portion 32a and the columnar portion 32b. For this reason, the lancet 30 is manufactured by a procedure as shown in FIGS. 6 (a) to 6 (e). Specifically, as in FIGS. 3A and 3B, as shown in FIGS. 6A and 6B, the puncture needle 11 fixed to the positioning jig 50 is used. The body portion 32 with the cap 13 is covered from the side of the needle tip, and inserted through the plate 21 until the positioning jig 50 comes into contact with the end portion on the rear end side of the body portion 32. Then, as shown in FIG. 6C, the injection nozzle 40 is applied to the injection hole 32e, and the UV curable adhesive A is injected from the injection nozzle 40 into the exposed portion of the puncture needle 11 in the cylindrical portion 32b. . Thereafter, similarly to FIG. 3C, UV is irradiated to the injection portion of the adhesive A from the side surface of the lancet 30 as shown in FIG. Finally, as shown in FIG. 6E, the plate 21 and the positioning jig 50 are removed, and the lancet 30 is manufactured.

  Thus, even when the injection hole 32e reaching the side surface of the puncture needle 11 is formed on the side surfaces of the cylindrical portion 32a and the column portion 32b, the same effect as described above can be obtained.

(B)
In the above embodiment, an example in which a UV curable adhesive is used as the means for fixing the puncture needle 11 to the main body 12 has been described. However, the present invention is not limited to this.

  For example, besides the UV curable adhesive, an anaerobic adhesive can be used, or an adhesive obtained by mixing the two can also be used. In addition, when using an anaerobic adhesive, it is not necessary to perform UV irradiation like the said embodiment, Therefore As a resin which shape | molds a main-body part and a cap, things other than a transparent thing can also be used.

(C)
In the said embodiment, the example which uses the puncture needle 11 whose thickness is 30G was given and demonstrated. However, the present invention is not limited to this.

  For example, a puncture needle thinner than 30G can be used by greatly reducing the load applied to the puncture needle when molding or removing the cap 13.

(D)
In the above embodiment, an example in which the plate 21 is used when positioning the puncture needle 11 with the positioning jig 20 has been described. However, the present invention is not limited to this.

  For example, it is not essential to use the plate 21, and the puncture needle 11 may be positioned by the positioning jig 20 without the plate 21.

  The manufacturing method of the lancet according to the present invention produces an effect that it is possible to use a puncture needle thinner than before by manufacturing without applying a load to the puncture needle. On the other hand, it is widely applicable.

(A) is the top view seen from the front end side which shows the external appearance structure of the lancet which concerns on one Embodiment of this invention. (B) is the side view. (C) is the top view seen from the rear end side. The AA arrow directional cross-sectional view in the lancet of FIG. (A)-(d) is a figure which shows the manufacturing process of the lancet of FIG. (A) is the top view seen from the front end side which shows the external appearance structure of the lancet which concerns on other embodiment of this invention. (B) is the side view. (C) is the top view seen from the rear end side. FIG. 5 is a cross-sectional view taken along line B-B in the lancet of FIG. 4. (A)-(e) is a figure which shows the manufacturing process of the lancet of FIG.

Explanation of symbols

10 lancet 11 puncture needle 12 body (puncture body)
12a Cylindrical part 12b Columnar part 12c Insertion hole 12d Connection part 13 Cap 20 Positioning jig 20a Adhesive injection nozzle 21 Plate 30 Lancet 32 Main body part (puncture body)
32a Cylindrical part 32b Columnar part 32c Insertion part 32e Injection hole

Claims (7)

A lancet manufacturing method comprising: a puncture needle for forming a puncture wound; and a puncture body integrally formed with a cap for covering the tip of the puncture needle,
The puncture body is formed with an opening leading to the inside of the cap, and a first step of inserting the puncture needle into the opening from the tip thereof, and insertion of the puncture needle inserted into the opening into the puncture body A second step of positioning in a direction;
A third step of fixing the puncture needle to the puncture body;
Of manufacturing a lancet. A space is formed in the cap integrally formed with the puncture body so that the tip portion of the puncture needle positioned in the second step is in a non-contact state with the cap.
The manufacturing method of the lancet of Claim 1. In the second step, a jig for positioning the puncture body in the insertion direction of the puncture needle is used.
The manufacturing method of the lancet of Claim 1 or 2. In the third step, the puncture needle is fixed to the puncture body using at least one of an ultraviolet curable adhesive or an anaerobic adhesive,
The manufacturing method of the lancet of any one of Claim 1 to 3.
The puncture body is formed of a transparent resin,
The manufacturing method of the lancet of Claim 4. In the third step, the adhesive is injected from an opening formed on a side surface of the holder parallel to the insertion direction of the puncture needle and exposing the puncture needle.
The method for producing a lancet according to claim 4 or 5. It was manufactured by the method for manufacturing a lancet according to any one of claims 1 to 6.
Lancet.

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