WO1999027855A1

WO1999027855A1 - Lancet and method of production thereof

Info

Publication number: WO1999027855A1
Application number: PCT/JP1998/005433
Authority: WO
Inventors: Susumu Morita
Original assignee: Apls Co., Ltd.
Priority date: 1997-12-03
Filing date: 1998-12-02
Publication date: 1999-06-10

Abstract

A manual lancet (10) for providing a constant piercing depth, comprising a body (12) including a piercing element (16) and having an end face (20) having a protruding distal end portion (20), and a cap (14) for surrounding the distal end portion, wherein the cap has two first anchor members (24) and a cap end face (22) facing the end face of the body, the cap end face has a second anchor member (26) into which the distal end portion of the piercing member is fitted, the body has a first concave portion (30) having a shape corresponding to the distal end portion of the first anchor and a second concave portion (32) having a shape corresponding to the second anchor, and each of the first anchors is tightly disposed inside the first concave portion while the second anchor is tightly disposed inside the second concave portion, so that the end face of the body and the end face of the cap are brought into integral and close contact with each other lest any space is substantially formed between them.

Description

Specification

Lancet and manufacturing method

【Technical field】

The present invention relates to a device used for collecting blood when measuring a blood sugar level or the like, and more particularly, to a lancet for collecting blood.

[Background Art]

In recent years, the impact of increased treatment costs on diabetes and its complications on health financing, especially in advanced Western countries, has become increasingly serious.

In a recently published report, the American Diabetes Association (ADA) provided a guideline for the prevention of diabetes in which fasting plasma glucose (FPG) tests were performed every three years after reaching the age of 45. (Early morning fasting plasma glucose test) and the critical value for diabetes is revised from 14 OmgZd 1 established in 1979 to 126 mg / d 1 . Such movements are expected to occur soon in Japan and Europe.

It is also said that the number of diabetic patients has increased remarkably in regions other than the United States, Europe and Japan, especially in Southeast Asia, due to the remarkable economic development in recent years. According to the World Health Organization (WHO) estimates, an estimated 51.42 million patients in Asia alone (as of 1994, insulin dependen t diabete mellitus) and NI DDM (i nsulin) independent diabete mellitus, non-insulin-dependent diabetes mellitus), and this figure represents the global population of 11.36 million people with diabetes (as of 1994, the sum of IDDM and NI DDM patients). Indeed 4 7. This is equivalent to 4%.

In these developing countries as well, if healthcare systems are further improved and awareness and interest in diabetes are further increased, it is expected that screening of diabetic patients by measuring blood glucose levels will be conducted through mass screening. Therefore, the demand for blood glucose measurement is expected to grow even more, and simpler, cheaper and safer blood collection devices will be required. In particular, it must be safe against the transmission of blood-borne bacteria attached to the blood collection device (for example, a device that has been used once will not be accidentally reused for blood collection by another person), and the stimulation itself will be safe and Appropriateness (eg, the ability to achieve the appropriate depth of stimulation to collect a given amount of blood) is required.

Blood sampling devices currently on the market are roughly divided into those that use a stimulating element such as a needle to injure the blood collection site and those that use the resilience of an elastic body such as a panel and those that pierce manually. You.

The former type is basically a lancet in which the tip of the stimulus element is exposed, the injector that fires it, and the piercing element that stops the movement of the fired lancet and moves the piercing element to the target site. It has an end cap that can be pierced. In this type of device, the movement of the fired piercing element is stopped by the end cap, so that the length of the stimulating element protruding from the opening of the end cap becomes substantially constant. Since the blood collection site is pressed against the substantially flat opening of the end cap, there is an advantage that the penetration depth is constant. However, this device requires the use of an injector and an end cap in addition to the lancet, which complicates the procedure for using the device and increases the manufacturing cost of the device. Such devices are suitable when a particular individual routinely collects blood to measure blood glucose. W

For example, as the lancet used for the former type of device, a lancet composed of a lancet body with a penetrating element protruding and a cap element placed on the protruding end is commercially available (eg, Becton & Dickenson). Ultra-fine Lancet). In this device, the lancet body and the cap element are mutually independent members, and after these are separately formed, the lancet body can be covered with the cap element. Therefore, the sterilization property of the piercing element cannot be maintained with the cap element covered, and there is a problem that the piercing element needs to be stored in a sterilized bag in the covered state. In addition, the lancet simply covers the lancet body with the cap element. Therefore, since these can be separated freely, it is impossible to determine whether the stimulus element is maintained in a sterile state or whether the stimulus element is exposed once and is not maintained in a sterile state.

For the latter type, a lancet consisting of only a blade-shaped stainless steel plate as a stimulating element is used. The lancet is stored and sold in a sterile whole bag. For blood collection, the sterile bag is broken, the lancet is removed, and the stimulating element is pressed vertically against the blood collection site and manually stimulated. Since there is no need to use an end cap and an injector, the structure is simple, and the procedure for use is simple. Therefore, efficiency in terms of workability of blood collection and production cost is high. Therefore, it is appropriate to use such a lancet when collecting blood from a large number of people, such as mass screening. However, when this lancet is used manually, the penetration depth varies greatly depending on the amount of force applied, and the amount of blood obtained varies. Maximum penetration depth reaches 3 mm, maximum wound width reaches 0.9 mm There is. Also, such lancets have extremely sharp edges exposed in the sterilization bag. In such a packaging configuration, the sharp edge can very easily create a pinhole in the sterilization bag due to some external mechanical action, ensuring that the sterile condition is maintained. There is a problem in

Against this background, it is desirable to provide a lancet that satisfies at least one of the following:

1. Considering the efficiency and economy of blood collection work, blood can be collected manually without using an injector, and when used manually, the penetration depth is substantially the same as when using an injector. And have a structure that is always constant.

2. The lancet must have a structure that does not need to be packed in a sterilization bag in order to improve workability and efficiency of blood collection.

3. The lancet must have a structure that can maintain the sterilization state of the tip of the stimulating element effectively and effectively for a long period of time (for example, at least 5 years).

4. Have a structure that makes it easy to judge instantly that a lancet is not being used.

5. The number of test items that can be analyzed by blood analysis is increasing year by year, so that needles with various diameters, blades with various angles or shapes can be used to cope with blood collection of 2 to 200n. A structure that can support various lengths of the stimulus element or the stimulus element protruding from the end face of the lancet body.

DISCLOSURE OF THE INVENTION

Therefore, the problem to be solved by the present invention is that the piercing depth is as constant as possible, can be manufactured safely and inexpensively, and the sterilization state can be ensured without being stored in a sterilization bag. The objective is to provide a lancet that can be used manually for blood collection, and that is particularly suitable for unspecified large numbers of blood collections.

The present invention

A lancet body including a stimulating element and having a protruding end surface, and

Cap element surrounding the tip of the projecting piercing element

A lancet comprising

The cap element has at least two first anchor members and a cap element end face facing the end face of the lancet body, the cap element end face having a second anchor member into which the tip portion of the stimulating element is inserted. ,

The lancet body has a first recess having a shape substantially complementary to a distal end portion of the first anchor member and a second recess having a shape substantially complementary to the second anchor member. The member is closely located in each first recess and the second anchor member is closely located in the second recess.

The end face of the lancet body and the end face of the cap element are so closely joined together that substantially no air gap is formed between them.

I will provide a.

[Brief description of the drawings]

FIG. 1 is a schematic perspective view of a lancet according to the present invention before use. FIG. 2 shows the state of FIG. 1 with the upper half removed.

FIG. 3 is a schematic perspective view of the lancet of the present invention in a state where a cap element is separated from a lancet body.

FIG. 4 shows the state of FIG. 3 with the upper half removed.

FIG. 5 shows a schematic view of a lancet according to the invention having a piercing element in the form of a blade. W /

It is a top view.

FIG. 6 is a schematic plan view of the lancet of FIG. 5 in which a cap element is separated from a lancet body.

FIG. 7 is a schematic plan view of a lancet of the present invention having a penetrating element in another blade form.

FIG. 8 is a schematic plan view of the lancet of FIG. 7 with the cap element separated from the lancet body.

FIG. 9 is a schematic plan view of a lancet of the present invention having still another piercing element in the form of a blade.

FIG. 10 is a schematic plan view of the lancet of FIG. 9 in which the cap element is separated from the lancet body.

FIG. 11 is a schematic perspective view of a cap element obtained by a first-stage molding process in the lancet manufacturing method of the present invention.

FIG. 12 schematically shows a state in which the cap element obtained in the first-stage molding step is arranged in a mold used in the second-stage molding step in the lancet manufacturing method of the present invention. FIG.

In the drawings, the reference numerals represent the following elements:

1 0 'lancet, 1 2 ... lancet body, 1 4 ... cap element, 1 6' stimulating element, 1 8 ... tip, 2 0 ... end face of lancet body, 2 2 'end face of cap element, 2 4 ... The first anchor member,

2 6 'Second anchor member, 28 ... tip portion of first anchor member,

3 0 • 1st concave, 3 2… second concave, 3 4… concave for tip

3 6 'Central part of end face, 38 ... Base part of end face, 40 ... Flat blade,

4 2 'bevel blade, 4 4 ... round blade, 50 ... mold,

5 2 • Stopper pin, 5 4… Gate, 5 6… Cavity, 5 8… Square pillar stage (part of cap element), 60… Pinning element holding pin.

DETAILED DESCRIPTION OF THE INVENTION

In the lancet of the present invention, portions other than the stimulating element may be substantially formed of a plastic material that can be used for injection molding. The cap element and the lancet body may be formed from the same or different plastic materials. Suitable plastic materials include LLDPE (linear low density polyethylene), LDPE (low density polyethylene), HDPE (high density polyethylene), PP (polypropylene, especially gamma resistant linear grade) and PS (polystyrene) Examples thereof include polymer alloys of any combination of these polymers, and copolymers of any combination of monomers of these polymers.

In the lancet of the present invention, the stimulating element is an element that causes a tip to penetrate a blood sampling site (for example, a fingertip, an earlobe, or the like) to damage the site and cause bleeding. The piercing element is not particularly limited as long as it is used in a conventional lancet-type blood collection device, and may be, for example, in the form of a needle or a blade. In the case of the blade form, the leading edge of the blade may be a so-called round blade, flat blade, or oblique blade. Such a piercing element is usually made of a metal such as stainless steel, and is usually in an elongated form, most of which is buried in the lancet body, with only the lancet body penetrating the blood collection site. Protruding from the end face.

Also, the cap element extends toward the end face of the lancet body, the tip of which extends into at least two of the first anchor members and the end face of the lancet body that are tightly inserted into a portion of the end face of the lancet body, usually a peripheral portion of the end face. It has opposing cap element end faces. Cap element and lancet The body is in close contact with both ends via both end faces. In this case, the shapes of the two end faces are substantially complementary to each other at least at a portion where they face and are opposed to each other, so that there is substantially no gap between the two end faces. Such a complementary end face can be achieved by, for example, a two-stage molding method described later.

In the lancet of the present invention, when the end faces of the cap element and the lancet body are substantially complementary, an embodiment in which both end faces are substantially flat is preferable, but in another embodiment, one end is convex. At least partially, and the other at least partially has a corresponding concave surface. Also, a combination of these aspects may be used.

The end face of the cap element has a second anchor member which extends partly into the end face of the lancet body, usually the central portion, and the tip of the stimulating element projecting from the end face of the lancet body, Before the use of the second anchor member, it has been tightly inserted into the second anchor member.

Therefore, in the lancet of the present invention, the lancet body tightly receives the first anchor member and the first concave portion and the second anchor member corresponding to the number of the first anchor members. A second concave portion to be received is provided at the end face portion. Also, the cap element, especially the second anchor member, has a recess for tightly receiving the distal end of the stimulating element.

In the present invention, the anchor member is fitted tightly into a concave portion formed in a portion (at the end face of the lancet body in the present invention) at least the tip of which extends, so that the lancet can be used before use. Lancet A member that forms and retains the engagement (or connection) state between the body and the cap element (forms a so-called anchor state).

At least the tip of the anchor member is fitted. The second anchor member is substantially entirely fitted in only the distal end portion.) The concave portion has a shape substantially complementary to the distal end portion. Preferably, no gap is substantially formed between the portion and the recess. Such a state can be obtained by a two-stage molding method described later. The number of the first anchor members is not particularly limited, but usually two is sufficient, and in some cases, may be more. The number of the second anchor members is one. Such a complementary shape can be achieved by a two-stage molding method described later.

With such an anchor member, close contact between the cap element and the lancet body is ensured. Here, the close state is a state in which both are in contact with each other to the extent that can be achieved by the two-stage molding method described below, and both forms another solid phase (like melting). Are not in a single phase) but are in substantial physical contact. Also, the tight fitting of the anchor member into the corresponding recess is similarly formed by the two-stage molding method described later, and the cap element is separated from the lancet body by the force applied manually. It is enough to release the close contact of the end face by operation.

Before the use of the lancet, the form of the anchor member is not particularly limited as long as the end faces of the lancet body and the cap element are kept in close contact. For example, in one preferred embodiment, the anchor member has a conical or frusto-conical shape in which the portion that fits into the end face portion of the lancet body (narrows forward), and has a rounded tip. Good.

When using the lancet, these anchor members can be easily pulled from the end face of the lancet body by grasping the cap element with a finger and pulling it away from the lancet body. Can be pulled out. At this time, at least the second anchor member comes out of the second recess without substantially breaking. Preferably, not only the second anchor member but also the first anchor member comes out of the first recess without substantially breaking. The form of the portion (of the first anchor member) that does not fit into the end face portion is not particularly limited, but may be, for example, substantially cylindrical or prismatic.

The shapes of the cap element and the lancet body are not particularly limited, and may be any suitable shapes. The arrangement of the anchor member and the corresponding recess is not particularly limited, but the stimulating element is usually embedded in the center of the lancet body. When three or more are arranged so that the second concave portion is located, the second concave portion is provided at the center (a portion corresponding to the center of gravity) of the triangle or polygon formed by the first concave portion. A first anchor member and a second anchor member are provided. Usually, the first anchor member and the first recess are arranged at symmetrical positions with respect to the second anchor member and the second recess.

(For example, the first anchor member and the second anchor member are located on one straight line, and the first recess and the second recess are located on one straight line). As described above, when the anchor member is anchored to the end face of the lancet body, various forces expected to be received before the lancet is used (for example, packaging, vibration during transportation, stress, etc.). Even if the lancet acts on the lancet, the cap element does not substantially separate from the lancet body, and the two are kept in close contact with each other. The sterilization of the lancet (especially the piercing element) is preferably performed using radiation, and may be performed at any suitable time during the process of manufacturing the lancet. Usually, after the lancet of the present invention is formed, a plurality of the lancets are placed in a packaging case (or a plurality of the cases are individually separated). It can be sterilized using radiation, usually with radiation. The sterilized state is maintained for the piercing element until the second anchor member is pulled out.

When collecting blood, the cap element is removed from the lancet body and the cap element which are in close contact as described above, so that the stimulating element is exposed from the end face of the lancet body. This is accomplished by rotating (eg, twisting) the cap element relative to each other about the longitudinal axis of the stimulating element relative to the lancet body, depending on the configuration of the stimulating element used. The cap element is moved relative to the lancet body about an axis perpendicular to the longitudinal axis of the stimulating element by pulling the elements relative to each other along the longitudinal axis of the stimulating element relative to the lancet body. The rotation can be performed by rotating the shafts relatively in opposite directions, or by combining them.

In the lancet of the present invention, when removing the cap element, the first anchor member and the second anchor member are pulled out from the first concave portion and the second concave portion, and the anchoring state is released. As a result, the portion where the piercing element protrudes from the end face of the lancet body is in a state where burrs are not generated by pulling out (that is, the plastic material constituting the second anchor member is not broken at least partially). However, the second anchor member is pulled out of the second recess. As a result, at the time of blood collection, after the tip of the piercing element penetrates the blood collection site, the tip of the stimulating element is pushed in until the blood collection site hits the end face of the lancet body. There is no possibility of interruption or interruption during the penetration), so that a substantially constant stimulation depth is ensured.

Therefore, when the second anchor member is pulled out, if the above-mentioned burrs do not occur, There is no problem even if the shape of the second anchor member and the shape of the “or second concave portion are slightly changed. However, preferably, the shape of the second anchor member and the shape of Z or the second concave portion are substantially the same. More preferably, the distal end portion of the first anchor member and the second anchor member are pulled out of the concave portions while maintaining the original shape. At a distance from the element, even if the first anchor is removed when the cap element is removed, burrs on the end face of the lancet body do not substantially affect the penetration depth In most cases O

As mentioned above, the anchor member and the corresponding lancet body, depending on the plastic material used, can allow the anchor member to be pulled out of the corresponding recess while retaining its original shape. The prototype of the concave portion can be variously changed, and an appropriate anchor member and the corresponding concave portion can be selected by trial and error. For example, in one embodiment, PP or LDPE is used for the cap member, LDPE or LLDPE is used for the lancet body, and the shape of the tip of the first anchor member is conical (height 2.4 to 3. O mm, bottom diameter 0.5-0.6 mm) and the shape of the second anchor member is conical (height 0.9-1.0 mm, bottom diameter 0.8-1.0 mm) Then, a lancet in which the anchor member is fitted into the recess with an appropriate bonding strength can be obtained.

In order for the anchor member to be able to be pulled out of the recess in the substantially original shape, it is generally necessary to use an anchor member having strength (particularly tensile strength), and a thick member when the anchor member is columnar. Is preferred. That is, if the member is weak (thin), the anchor member may be completely broken or partially broken at the time of withdrawal, and burrs may be generated. Departure In a light lancet, at least the second anchor member is withdrawn in its original form, so it is generally preferred that the second anchor member be thicker than the first anchor member. Therefore, in this sense, the first anchor member may be thinner than the second anchor member (in the embodiment of the lance of the present invention shown in the attached drawings, the first anchor member is thinner in each case). However, basically, it is more preferable that all anchors be pulled out in their original form, so taking into account the balance between the strength of the anchor and the force required for pulling out, the form and shape of the anchor are determined by trial and error. It is preferable to select an appropriate strength by changing the material used or the material used.

If such an anchor member is not in its intended anchoring state, the lancet has already been used, or the cap member has been separated for use and the tip of the stimulating element has been exposed at least once. Therefore, the anchor member functions as an indicator for indicating whether or not the lancet can be used. That is, when the anchor member is not in the anchored state, it means that the sterilization state is not maintained because the tip of the piercing element is exposed, and that Z or lancet has been used. This means that a lancet that is not anchored must not be used for blood collection.

In a preferred embodiment, the end surface of the lancet body from which the stimulating element protrudes is a step-shaped end surface, the central portion of the end surface protrudes from the surrounding base portion to form a platform, and the blood collection site is After the stimulating element has penetrated, it is pressed against the central part. In this embodiment, the distal end portion of the first anchor partial member is embedded in the base portion, and the distal end portion of the second anchor is embedded in the central portion. In this case, even when the cap element is separated, burrs are generated on the end face of the lancet body when the first anchor member is pulled out. However, if a step higher than the height of the burr that can occur is provided in advance, it is possible to prevent the penetration depth from being changed due to the presence of the burr.

In another preferred embodiment, the end face of the lancet body comprises a central portion where the piercing element is exposed and a tapered portion (ie, a slope portion) extending from the central portion toward the side of the lancet body. The portion and the tapered portion define a tapered configuration toward the tip of the lancet body, and the blood collection site is pressed against the central portion after the penetration element has penetrated. In this embodiment, the distal end of the first anchor member is embedded in the tapered portion, and the distal end of the second anchor is embedded in the central portion. In this case as well, as in the above-described embodiment, even if burrs are formed on the end face of the lancet body when the first anchor member is pulled out when the cap element is separated, the burrs are located at a position higher than the height of the burrs that can be generated. The center part and the tapered part are positioned with respect to the body of the lancet body so that the burr does not protrude forward (in the protruding direction of the stimulating element) beyond the level of the center part. Therefore, it is possible to prevent the penetration depth from being different due to the presence of the burr. In this embodiment, in certain cases, the end portion of the lancet body is frusto-conical, the central portion corresponds to the narrow base (or end surface) of the frusto-conical shape, and the tapered portion defines the frusto-conical side. Stipulate.

In the lancet of the present invention as described above, the tip portion of the piercing element is inserted into the cap element, and a piece having the remaining portion of the piercing element exposed is formed by the first injection molding of a plastic material. And then forming a lancet body located around the exposed stimulating element by a second injection molding. That is, the tip of the piercing element is tightly inserted into the second anchor member, and the cap element having the first anchor member and the second anchor member is formed first. After that, the molten resin is poured around the distal end portion of the first anchor member, the second anchor member, and the remaining portion of the exposed piercing element, so that the end face of the cap element is formed. And a lancet body in which the anchor member is tightly fitted.

In the method of the present invention, in the second step of forming the lancet body, the injected molten resin comes into contact with the tip portion of the first anchor member, the second anchor member and the end face of the cap element. However, the injected resin must not melt the contact portion of the cap member and fuse with the injected resin. Therefore, in order to prevent such fusion, the resin used for the cap element and the lancet body (these resins may be the same or different), the cooling temperature after molding the cap element and / or the lancet body It is necessary to appropriately select the melting heating temperature of the resin.

Therefore, in order to prevent such fusion, for example, the plastic material of the cap element has higher heat resistance (for example, heat distortion temperature (for example, AS Select the material; if the cap element and the lancet body are the same material, wait for the resin temperature to drop sufficiently after molding the cap element before using it for the lancet body. The molten resin is injected to form a lancet body; or, at the time of molding, the molten resin temperature for the lancet body may be set lower than the molten resin temperature for the cap element.

In polyolefin-based resin molding, the mold temperature is usually 30 to 40 ° C, and the surface temperature of the anchor member of the cap element and the end face of the cap element, which are molded earlier, is determined by the fact that the molten plastic material is When the lancet body is injected, it drops rapidly, and in the subsequent molding of the lancet body, these parts are melted and fused by injection of the molten resin for the lancet body. It is considered that this is not the case (see examples described later).

These cooling and melting temperatures may be those used in normal injection molding as long as fusion does not occur (usually cooling to room temperature).

. Particularly preferred resin combinations are combinations using PP or propylene copolymer for the cap element, LLDPE for the lancet body; combinations using PP or propylene copolymer for the cap element, and LDPE or HDPE for the lancet body; Examples include L 0 £ or 110? £, and combinations using LLDPE for the lancet body. When using PP, it is preferable to select a grade that can withstand radiation sterilization.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Hereinafter, the lancet of the present invention will be described with reference to the accompanying drawings with reference to the accompanying drawings. FIG. 1 is a perspective view showing a state before using the lancet of the present invention for blood collection, and the upper half is cut off. FIG. 2 schematically shows a perspective view of the case where the stimulating element 16 is shown (however, the stimulating element 16 shows the whole). The lancet 10 includes a lancet body 12 and a cap element 14. The lancet body 12 includes a piercing element 16, the tip 18 of which protrudes from an end face 20 of the lancet body.

As is clear from FIG. 2, the tip 18 is inserted into the cap element 14 before the lancet 10 is used. The cap element 14 has a cap element end face 22 that is in close contact with the lance body end face 20. As shown, these end faces (20 and 22) have shapes that are complementary to each other (eg, a substantially flat shape), so that there is substantially no air gap between them. Does not exist. The cap element 14 has two first anchor members 24 and a second anchor member 26.

The lancet body 12 has a first concave portion 30 and a second concave portion 32 corresponding to the distal end portion 28 of the first anchor member 24 and the entire second anchor member 26. Furthermore, the second anchor member 26 has a recess 34 into which the tip 18 of the stimulating element is tightly inserted. As shown in the figure, the distal end portion 28 of the first anchor member 24 and the entirety of the second anchor member 26 are embedded in the end face 20 of the lancet body.

In the illustrated embodiment, the end face 20 of the lancet body is formed in a step shape, and the end face 20 is constituted by a central portion 36 as a platform from which the stimulating element projects and a base portion 38 around the platform. ing.

In order to expose the distal end portion 18 of the stimulating element during blood collection, in the lancet shown in FIG. 1, the lancet body 12 and the cap element 14 are moved away from each other (for example, in the direction of the piercing element). Twisting by pulling (along the longitudinal direction) or rotating the lancet body 12 and the cap element 14 in relatively opposite directions (eg, about the longitudinal axis of the piercing element) As a result, the lancet body 12 and the cap element 14 can be easily separated (see the arrow in FIG. 1).

FIG. 3 is a perspective view schematically showing a state in which the distal end portion 18 is exposed in this manner, and FIG. 4 is a perspective view showing a state in which the upper half is cut off. As is evident from the illustrated embodiment, the anchoring members 24 and 26 are pulled out of the recesses 30 and 32 with the original shape, without forming burrs-like fracture pieces, and the stimulating element 1 The tip 18 of 6 is exposed from the end face 20 (or 36).

In the above embodiment, the piercing element is in the form of a needle, but in the form of a blade, Is also good. Examples are shown in FIG.

FIGS. 5 and 6 show a lancet 10 of the present invention in which the piercing element is in the form of a flat blade 40 blade. FIG. 5 is a schematic plan view showing a state where the cap element 14 and the lancet body 12 are in close contact with each other, and FIG. 6 is a schematic plan view showing a state where the cap element is separated from the lancet body. is there. 7 and 8 show a lancet 10 of the present invention in which the stimulating element is in the form of a blade having an oblique blade 42. FIG. FIG. 7 is a schematic plan view showing a state in which the cap element 14 and the lancet body 12 are in close contact with each other, and FIG. 8 is a schematic view showing a state in which the cap element 14 is separated from the lancet body 12. FIG.

FIGS. 9 and 10 show the lancet 10 of the present invention in which the stimulating element is in the form of a round blade 44. FIG. 9 is a schematic plan view showing a state in which the cap element 14 and the lancet body 12 are in close contact with the body, and FIG. 10 is a view in which the cap element 14 is separated from the lancet body 12. It is a schematic plan view of a state.

When the piercing element is in the form of a blade, it is not easy to twist the cap element 14 and the lancet body 12 relatively in opposite directions. What is necessary is just to pull away from each other in the longitudinal direction of the passing element. Alternatively, the cap element 14 can be separated by rotating the cap element 14 relative to the lancet body 12 in the direction of the arrows shown in FIGS. In the lancet having a stimulating element in the form of a blade, the second anchor member 26 has a substantially truncated conical shape in order to facilitate separation by rotation. On the other hand, when the piercing element is in the form of a needle, the second anchor member 26 may have a substantially right conical shape as shown in the figure (for example, see FIG. 4). In order to collect blood using the lancet of the present invention, the tip 18 of the stimulating element is exposed by any of the methods described above, and then is applied to the stimulus target site (for example, a fingertip skin It). The stimulus element is pressed so that the axis of the stimulus element is substantially perpendicular to the stimulus element, and then the stimulus element is pressed against the stimulus target in the axial direction by applying force. If the distal end 18 penetrates into the stimulus target area and the end face 20 (or 36) of the lancet body comes into contact with the target area, the puncture is stopped, and then the piercing element is pulled out. Good. The used lancet can then be safely disposed of (eg discarded).

The lancet of the present invention can be manufactured, for example, by the following method. First, after the stimulating element 16 is inserted into the mold having the cavity corresponding to the cap element 14, the cap element 14 having the stimulating element 16 as shown in FIG. 11 is formed by ordinary injection molding. 'To form Next, in addition to the cavity portion for disposing the cap element 14 ′ as shown in FIG. 12, another mold 50 (shown only on the lower side) having a cavity portion 56 corresponding to the lancet body is prepared. I do. The cap element 14 ′ is arranged in the mold 50 as shown in FIG. 12, and the lancet body 12 is formed by injection molding. At this time, the end face 22 of the cap element, the distal end portion 28 of the first anchor member 24 and the second anchor member 26 (and the portion of the exposed stimulating element) together with the mold 50, Specifies the cavity 56 for the lancet body. In this case, the resin forming the cap element 14 and the resin forming the lancet body may be the same or different.

In this way, the injection molding is divided into two stages to form the lancet (ie, a two-stage molding method), so that the cap element 14 is fused to the lancet body 12 even when the same resin is used. And the end face of the cap element 14 is in close contact with the end face of the lancet body 12. The lancet can be formed in a state where the lancet is in a closed state. The main reason is that when the resin is injected into the mold to form the lancet body, the molten resin for the lancet body is already in the mold because the cap element is already sufficiently cooled and solidified. Even if injected, the lancet body becomes another phase because it is cooled and solidified by the cap element. From such a viewpoint, it is preferable that the melting temperature and the heat deformation temperature of the resin forming the cap element 14 are the same as or higher than the melting temperature of the resin forming the lancet body.

As described above, when manufacturing the lancet of the present invention, when molding the cap element 14 ′, the molten resin is completely filled around the tip 18 of the stimulating element in the cavity, and thereafter, Since the second anchor member 26 is formed of the resin that has been cooled and solidified, the second anchor member 26 tightly holds the distal end portion 18 of the piercing element. In addition, when molding the lancet body 12, molten resin is completely injected around the already formed second anchor member 26, which cools and solidifies and contracts inward. Therefore, the second concave portion 32 of the lancet body presses the second anchor member 26 further inward. As a result, the force with which the cap element 14 tightens and holds the tip 18 of the stimulation element further increases. This means that the sterilization state is stably maintained by the second anchor member 26 by shaping the tip portion 18 after sterilization in advance.

【Example】

A lancet 10 as shown in FIG. 1 was manufactured. The piercing element 16 is in the form of a needle (SUS304, diameter 0.4 mm), and the length of the protruding needle (cap element 14 The distance from the end face 36 of the lancet body after removal to the tip of the piercing element) was 1. Omm.

The length X width X thickness of the lancet body 12 was 26.5 mm x 6.5 mm x 1.5 mm (the portion 3.5 mm from the tip was 2.4 mm thick). The outer diameter X thickness of the disk-shaped cap element 14 was 6.5 mm x 2.9 mm in diameter. The total length of the cap element 14 and the lancet body 12 was 35 mm.

As can be seen from FIG. 2, two first anchor members 24 for connecting the cap element 14 and the lancet body 12 are provided from the side of the cap element 14 facing the lancet body 12.

The side surface side of the cap element between the first anchor members is a prismatic stage 58 facing the lancet body 12, and the end face 22 thereof is in close contact with the end face 36 of the lancet body 12. A second anchor member 26 is provided at the center of the stage 58 to hold the tip of the stimulating element and to provide a strong connection between the cap element 14 and the lancet body 12. .

The diameter of the tip portion of the first anchor member was 0.5 mm, and the second anchor member was conical with a bottom surface diameter of 0.8 mm and a height of 0.9 mm. The conical shape further ensures that the second anchor member is detached from the lancet body 12 in substantially its original configuration when the cap element 14 is twisted relative to the lancet body 12.

The molding machine needs to insert a needle as a stimulating element, so the vertical clamping and side injection 30 ton molding machine of Nissei Resin Kogyo Co., Ltd. (It is used for molding a normal type lancet. ) Was used. Two molds are used: one for the cap element 14 '(one piece) and one for the lancet body (one piece) did. Both dies have a top and bottom holding pin 60 for holding the stainless steel needle in the center of the lancet body, and a stopper pin 52 for regulating the front and rear positions. The gate was attached to the tip of the disk for the cap element and intended to press the piercing element against the pin. The lancet body has a gate 54 at the rear end.

The materials used were LLDPE and gamma-resistant PP (both manufactured by Showa Denko KK) for the cap element, and the same LLDPE for the lancet body. The color of the lancet body is natural and the color of the cap element is yellow (LLDPE) and dark blue so that the connection between the cap element and the lancet body can be easily observed.

(Gamma-resistant single-line grade PP).

First, attach the mold for the cap element to the molding machine, insert the needle, close the mold, and heat and melt the polymer. (Heat melting temperature: LLDP E 210 ° C, gamma resistant linear grade PP At 220. C), it was supplied into the mold cavity and molded. After cooling down to about 35 ° C using a mold, cap elements 14 'as shown in Fig. 11 were obtained (50 LLDPE, 50 PPX grades with gamma resistance). This molding could be performed without any problem.

Next, the mold 50 for the lancet body is attached to the molding machine, the cap element 14 'is inserted into the cavity, the mold is closed, and the polymer heated and melted at 200 ° C is injected. The lancet 10 of the invention was obtained. This molding could be performed without any problem.

Since the color of the material on the cap element side and the color of the material on the lancet body side of the finished product thus obtained were different, the state of connection between the two could be observed well. Careful observation has shown that the end face 22 of the cap element and the end face 20 of the lancet body are close to each other for both lancets. And could not find the gap with the naked eye. In addition, the anchor members were all closely inserted into the end face of the lancet body in the intended state.

Next, when the cap element 14 is swung with respect to the lancet body 12, it is necessary to twist and remove the cap of a normal type lancet (a type using an injector) that is currently used. With the required amount of force (ie, manually), the cap element was separated from the lancet body, exposing the needle tip (see data below). Also, after removing the cap element, no burrs were formed on any of the concave portions on the end face of the lancet body, and no deformation occurred in the body shape. Further, the shape of the distal end portion of the first anchor member and the shape of the second anchor member were also substantially unchanged.

Further, after separation, the first anchor member could not be inserted into the lancet body even if the cap element was to be put on the lancet body again. This is considered to be because the corresponding concave portion remaining in the lancet body contracted after the distal end portion of the first anchor member and the second anchor member were pulled out. As a result, when the first anchor member comes out of the body, it means that the cap element has already been separated for some reason, and the anchor member is in an inappropriate state for use. It has been confirmed that it functions as an indicator to indicate. Of course, when the second anchor member comes out of the body, it also functions as an indicator ^

Thereafter, a needle with a protruding length of 1.5 mm at the tip of the needle and a needle with a length of 0.5 mm were similarly molded to obtain a lancet of the present invention. Both remove the cap element and withdraw while the anchor member is substantially in its original configuration. There was no problem at all.

Hereinafter, the necessary force (for pulling out the penetrating element in the longitudinal direction) and twisting force (for twisting around the axis of the piercing element) required to separate and remove the cap element of the obtained lancet are described. The measured data is shown in Tables 1 and 2 below:

(table 1)

Cap removal force (average of 10 pieces when pulling out cap element without twisting) Measured by push-pull gauge

Projection length 0.5mm 1.0mm 1.5mm Cap material PP (kgf) 2.0 1.25 1.01 Cap material PE (kgf) 2.2 1.65 1.05

(Table 2)

Cap twist torque (average of 10 pieces) Measured by torque gauge Protrusion length 0.5mm 1.0mm 1.5mm Cap material PP (gf'cm) 200 190 200 Cap material PE (gf'cm) 190 180 190 Judge from these results Thus, it can be seen that the lancet according to the present invention has a sufficient structural strength against various forces received in processes such as packaging and transportation.

In addition, the second anchor member of the cap element holding the needle is taken into the central portion of the end surface of the lancet body, the polymer is injected into the body portion, and the polymer of the lancet body is in the process of contracting. Needle from around W

It is considered effective for maintaining the sterile state of the needle tip because it is compressed toward.

After twisting the cap element, the lancet was manually stimulated with a finger. The penetration depth was regulated by the end face of the lancet body contacting the finger as a stopper.

By squeezing the finger and pushing out the blood from the wound, about 3 to 41 blood was obtained. The obtained blood was measured for blood glucose using Bayer's test paper and a blood glucose meter DexterZ to obtain a blood glucose level.

These blood sampling operations were much simpler than the blood sampling operations using the injector and end cap, confirming their practicality.

In addition, blood sampling using a lancet together with an injector and an end cap requires at least 8 to 9 steps as described below.

1. Remove the end cap from the injector.

2. Set the lancet on the holder of the injector.

3. Remove the lancet cap to expose the needle tip.

4. Put the end cap on the injector.

5. Compress the elastic element of the injector and lock it.

6. Release the lock and fire the lancet to penetrate the target site.

7. Remove the end cap.

8. Remove the lancet and discard.

9. Cover the end cap or disinfect the end cap to protect the mechanism of the injector.

Blood sampling using the lancet of the present invention requires only three steps as follows. 1. Twist the cap element to expose the tip of the stimulating element.

2. Be stimulating.

3. Discard the lancet.

As can be seen, the use of the lancet of the present invention makes it very easy to perform a blood collection operation.

Claims

The scope of the claims

1. A lancet body including a stimulating element and having a protruding end surface, and

Cap element surrounding the tip of the protruding stimulation element

A lancet comprising

The cap element has at least two first anchor members and a cap element end surface facing the end surface of the lancet body, wherein the cap element end surface has a second anchor member into which the tip of the stimulating element is inserted. Have

The lancet body has a first recess having a shape corresponding to the distal end portion of the first anchor member and a second recess having a shape corresponding to the second anchor member, and each first anchor member has a first recess. And the second anchor member is tightly disposed within the second recess,

A lancet in which the end face of the lancet body and the end face of the cap element are integrally intimate so that no air gap is formed between them.

2. The end face of the lancet body is composed of a central part where the piercing element is exposed and a base part around the central part, the central part of the lancet body forming a platform rising from the base part. The lancet according to claim 1, wherein the end face is stepped.

3. The end face of the lancet body is composed of a central portion where the stimulating element is exposed and a tapered portion extending from the central portion toward the side of the lancet body, and the central portion and the tapered portion are provided at the tip of the lancet body. 2. The lancet according to claim 1, wherein the lancet defines a tapered configuration.

4. The lancet according to any one of claims 1 to 3, wherein the stimulating element is in the form of a needle.

5. The piercing element is in the form of a blade according to any one of claims 1 to 3. Lancet.

6. A method for producing a lancet according to any one of claims 1 to 5, wherein

First, the tip portion of the stimulating element is inserted into the cap element to form a piece with the remaining portion of the stimulating element exposed by injection molding of a plastic material; and

Next, a step of forming a lancet body located around the exposed stimulating element by injection molding.

A method comprising: