JPH09266898A - Run set assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To twist off a cap to cover a piercing element without bending a needle by constituting so as to have a run set body being a column shape, a run set to prevent the piercing element from being exposed and a twisting cover. SOLUTION: A run set assembly 31 is constituted of a run set 33 and a twisting cover 35. The run set 33 is constituted by having a run set body 37 and a protective element 39, and is connected by a notch part 41. A piercing element is embedded in the run set body 37 and the protective element 39, and is exposed when the protective element 39 is moved forward and is separated from the run set body 37 by destroying the notch part 41. The run set body 37 has a columnar part 43 in its front part. The twisting cover 35 has an opening part to pass the protective element 39 and the columnar part 43 when the assembly is assembled.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lancet assembly having a piercing element for puncturing a user's skin and collecting a small amount of blood for use in blood sugar level and other tests. In particular, when the protective element surrounding the piercing element is twisted off, the piercing element has a structure that does not bend, and the lancet assembly is suitable for use or unused and for use. The present invention relates to a lancet assembly having a structure capable of surely visually recognizing an unsuitable state, and a lancet and a cover constituting them.

[0002]

2. Description of the Related Art The number of diabetic patients (insulin-dependent type and non-insulin-dependent type) is increasing more and more worldwide.
4 years). According to follow-up surveys of WHO and World Diabetes Association and related organizations, as a method to prevent the progress of diabetes treatment or complications, blood glucose level should be measured as frequently as possible, and insulin injection or oral drug should be taken as a result. It has been established that it is best to always keep blood sugar within a predetermined level by taking it, dieting, and exercising.

Approximately 10 years ago, Bayer, Johnson & Johnson (Johnson & Johnso)
n), Boehringer Mannhei
In order to capture this tendency, pharmaceutical manufacturers such as m) mainly use test strips for easily measuring blood glucose levels at home, blood glucose meters (portable type), lancets (blood sampling needles), lancet ejectors (blood sampling). Needle injection machine) has been marketed, and it has become easier for diabetic patients to manage themselves.

Recent advances in the performance of test strips and blood glucose meters have been significant, and until a few years ago, for a single blood glucose measurement,
Although a blood amount of about 20 to 25 microliters was required, it is now possible to accurately measure a blood glucose level with a blood amount of about 3 to 10 microliters. When using previous test strips or blood glucose meters that required approximately 20-25 microliters of blood, the lancet needle (or piercing element) used to obtain the required blood volume had a diameter of 0. 8 mm was required. With the progress of test strips and blood glucose meters, the required blood volume has decreased, and currently, lancets with a diameter of 0.65 mm and a diameter of 0.5 mm are commercially available, and these are the mainstream of lancets.

At present, a test strip and a blood glucose meter capable of measuring the blood glucose level with about 2 to 10 microliters of blood have been announced, and for the measurement using these, a diameter of about 0.3 to 0 is provided. There is a need for lancets with a diameter of 0.4 mm. On the other hand, from the perspective of diabetic patients, in order to control blood glucose levels accurately, in many cases, blood samples must be collected, for example, about 7 times a day (examples for insulin-dependent patients) and daily For patients who need to collect blood several times (for example, in non-insulin dependent patients), there are problems such as pain at the time of piercing due to the large diameter of the needle, internal bleeding, and small wounds that always remain on the fingertip. From a point of view, there was a growing demand for a lancet with a small needle diameter.

[0006] In addition, a lancet having a small needle diameter is also used by a mother of a juvenile diabetic patient (often insulin dependent type) found in infants or children to minimize the occurrence of fingertip pain and wounds during piercing. Market launch was desired.
In order to respond to such advances in test strips and blood glucose meters, as well as requests from the patient side, the trade names “Cleanlet 28G” (using a needle with a diameter of 0.4 mm) and “Cleanlet” have recently been used. 3OG "(diameter 0.3
Two lancets (using a 2 mm needle) are available from Genor Medical, Inc. (Gainor Medical, USA) and under the trade name "Ultra-Fine Lance".
t) ”(using a 0.36 mm diameter needle) is a Becton Dickins & Company (Becton Dickins)
on, USA).

These lancets have a conventional diameter of 0.8
mm, diameter 0.65 mm, diameter 0.5 mm, compared to needles with a much smaller diameter, so the patient who used it had a sharp decrease in pain during piercing and was used for a long time. However, they are generally welcomed as they rarely have internal bleeding or scars. However, lancets that use these small diameter needles have problems associated with the small diameter of the needle.

A cleanlet 28G having a needle diameter of 0.4 mm is shown in FIG. This lancet 11
The lancet body 13 and the protective cap 15 are integrally connected by the notch portion, and the tip of the piercing element can be surely held until just before use. The state (status) of whether or not the lancet has been used is visually and lancet body. It is a disposable lancet that can be surely judged by the relative twisting of the protective cap 15 and the protective cap 15, and that the tip of the piercing element of the used lancet can be reliably separated and safely discarded. Meets the minimum required requirements.

When such a lancet is used, when the protective cap 15 is twisted off for use,
It cannot be said that the cap is twisted by the rotational movement around the piercing element as an axis. Indeed, it can be said that the opposing end faces of the lancet body and the protective cap are substantially flat, so that the rotation of the piercing element about its axis is relatively easy to ensure.

However, since many users perform the operation of pulling out the protective cap simultaneously with the rotation about the piercing element, the flat surface of the cap and the flat end surface of the lancet body are separated from each other. In the latter half of the twist-off operation, the separating direction (arrows A and B) does not always match the longitudinal direction of the piercing element (arrow C), and as a result, the protruding piercing element bends, especially the lancet body. It cannot be denied that the piercing element may bend at the end face 17 of the. This bending is more likely to occur as the diameter of the piercing element decreases. Such bending of the piercing element is particularly likely to occur at the end face of the lancet body from which the piercing element projects.

Even if such bending of the lancet occurs, it does not substantially affect the function of the lancet except for the extremely extreme bending, but the piercing element directly invades the puncture opening. Since the wound is the smallest and the pain is reduced, it is of course desirable that the piercing element is not bent when the lancet is used. For details of such a lancet, please refer to Japanese Utility Model Application No. 4-60676 (Actual Kaihei No. 6-2350).
5) and corresponding US Pat. No. 5,385,5
71, the disclosures of which are incorporated by reference.

FIG. 2 shows an ultra-fine lancet 21 with a piercing element diameter of 0.36 mm. As can be seen from the figure, this lancet assembly has a needle 23
Is inserted into a small hole in the center of the end face of the molded holder 25 and fixed by an adhesive. Therefore, the piercing element 23 is always exposed from the holder 25. In order to cover the exposed needle tip, a separately molded protective cap 27 is press-fitted to the holder tip portion 29 including the piercing element. Because of this structure,
Since the protective cap does not contact the exposed piercing element at all, it is less likely to bend the needle tip when removing the protective cap 27. Further, after the blood collection needle is used, the tip of the holder is covered with a protective cap by press fitting again so that the blood collection needle can be safely discarded.

However, the problem with the lancet assembly shown in FIG. 2 is that the status (whether unused or used) of the lancet assembly cannot be reliably determined from the appearance. After using this lancet assembly for blood collection, if the end of the lancet body is covered with a protective cap for safe disposal, the state is exactly the same as before use. Even if the protective cap is twisted, it is twisted with the same twist torque as before use, and even if the protective cap is pulled (in the longitudinal direction of the piercing element with respect to the holder 25), the pulling force is virtually the same as before use. Indicates. This is shown by the following actual measurement data (average of 5 measured values): Twist torque 1) Extraction force 2) Unused 144g 340g After use 150g 350g 1) Using torque meter 2) Using tensile tester

As described above, the status of the lancet after blood collection is exactly the same as that before use, and the fact that the status cannot be discriminated means that the possibility of accidentally reusing the lancet cannot be denied. means. Body fluid-borne infectious diseases such as AIDS, hepatitis B, and hepatitis C are taken up as major social problems,
Now that the prevention of these infectious diseases is required, there is a problem with the mechanism that if the product is re-capped after use for safe disposal, it cannot be distinguished from the unused one.

In this respect, the lancet body including the cleanlet 28G and the cleanlet 30G as shown in FIG. 1 and the needle tip protection cap are integrally molded, and the protection cap is twisted and removed immediately before use. Even if the lancet is re-capped with the piercing element after use, the torque is practically not felt when the protection cap is twisted for use. You can recognize that it was done.

Further, as shown in FIG. 2, the holder for holding the needle and the needle tip protection cap are separate pieces, and in the case of the lancet which is not integrally molded, these elements are simply joined by press fit. , After assembly,
In the process of automatic weighing, packaging, sterilization and further transport, the protective cap may come loose or come off, in that sense maintaining the sterile condition of the protruding tip of the piercing element, That guarantee is inferior.

[0017]

Therefore, the lancet,
Particularly in a lancet with a small diameter piercing element, FIG.
And it is desired to provide a lancet that combines the desirable features of the lancet of FIG. That is, for such a lancet, 1) the cap covering the piercing element can be twisted off without bending the needle; 2) through processes such as molding, sterilization, assembly, weighing, packaging and transportation, Being able to ensure that the piercing element remains sterile until it is used for blood collection; 3) Lancet status (unused or used or not used, but unsuitable for use) Whether it is in a state or not) can be judged visually, or by twisting the needle tip protection cap, for example; 4) After using it for blood collection, make sure the needle tip is isolated and can be safely discarded. It is desirable to combine the above.

[0018]

According to the first aspect of the present invention, there is provided (1) (i) a cross section of a portion where a piercing element such as a needle projects from one end (with respect to the longitudinal direction of the piercing element). And (ii) surrounding the protruding piercing element to prevent exposure of the piercing element prior to use of the lancet assembly. A lancet having a protection element having a cross section (a cross section perpendicular to the longitudinal direction of the piercing element) having a substantially non-circular portion, and (2) a protection element of the lancet and a circle of a lancet body A space (eg, cylindrical space) and protection that receives at least a portion of the columnar portion and allows rotation of the piercing element about its longitudinal section (columnar portion) about the longitudinal direction of the piercing element. Providing a lancet assembly comprising a kinking cover having an interior space comprising a space to preclude rotation of the longitudinal direction of the piercing element and the axis around the elements.

In the lancet assembly of the present invention, the twisting cover can cover substantially all and at least a portion, preferably substantially all, of the cylindrical portion of the protective element, in which condition the longitudinal length of the piercing element. When the twisting cover and the lancet are rotated in opposite directions about a directional axis (hereinafter, also simply referred to as “longitudinal axis”), both are about to rotate around a cylindrical portion. However, it tries to resist rotation around the protective element. Therefore, when the rotational force exceeds a certain level, the twisting cover and the lancet can rotate in opposite directions due to the resistance.

During such rotation, the cylindrical portion of the lancet body has a certain length (corresponding to the height of the cylinder) along the longitudinal axis, as can be understood from the name. Further, the outer surface of the columnar portion and the inner surface defining the columnar space of the twisting cover have a clearance such that they can rotate on substantially the same axis in opposite directions. For example, it slides substantially easily.

In this way, in the lancet assembly of the present invention, the cylindrical portion of the lancet body and the internal space of the twisting cover that receives the columnar portion are coaxially rotated in opposite directions between the twisting cover and the lancet body. (Provided that there is a piercing element in the center of the cylindrical portion, and thus the shaft is substantially a piercing element), and the cylindrical portion has a certain length, The coaxial rotation can be maintained even if one or both of them move relative to each other along the longitudinal axis during the coaxial rotation.
This is because when the user of the lancet assembly performs a twist-off operation to expose the piercing element, the piercing element, especially the lancet body, may be rotated and pulled out at the same time. It means that unreasonably large bending force is not applied to the end faces.

In a preferred embodiment of the present invention, the lancet assembly, in which all the elements except the piercing element are made of a plastic material, has a notch having a strength capable of being manually twisted off between the cylindrical portion and the protection element. These are integrally molded so that they are connected by the part having the (notch). Suitable plastic materials for the lancet assembly of the present invention include, for example, polyethylene polypropylene for the lancet,
For the twist cover, for example, polyethylene polypropylene can be exemplified, but the twist cover is not limited thereto. When polyethylene is used, it is convenient because γ-ray sterilization can be performed. As an example of a particularly preferable combination, polyethylene is used for the lancet and polypropylene is used for the twist cover.

By using the above-mentioned plastic material, there is an advantage that it can be mass-produced at low cost, and the notch can be easily formed. In the present invention, the notch means a portion of which the cross section is partially reduced, and the function of intentionally weakening the strength of the portion so that the protection element and the lancet body are separated from each other by twisting off at the notch portion. And the notch itself is a matter known to those skilled in the art of plastic molding.

When the twisting cover and the lancet are coaxially rotated in opposite directions, the protective element and the twisting cover cannot be rotated, but the twisting cover and the circle are integrally formed of the plastic material. Since the columnar part can rotate, if the breaking strength of the notch part is larger than the rotating force, the twisting cover and the lancet cannot rotate, and if the rotating force becomes larger than the breaking strength of the notch part,
The notch part breaks and the relative rotation between the twisting cover and the lancet becomes possible, and at the time of further rotation after breaking, rotate both with a rotating force much smaller than the rotating force required for breaking. You can Therefore, by feeling the force required to rotate both of them, the user has noticed that the notch portion has already been destroyed (because it has been used or due to some trouble) (hence not using such a lancet). You can easily determine if it is not) or if it has not been destroyed (thus you may use such a lancet from now on).

Once the notch portion breaks, the protective element can be separated from the lancet by only moving them relative to each other along the longitudinal axis, with only a small force required for this movement. Although not required, strictly along the longitudinal axis is not easy. However,
In the assembly of the present invention, the cylindrical portion guides the movement along this longitudinal axis, so that the problem of bending of the piercing element upon removal of the protective element is substantially eliminated.

In another preferred embodiment of the invention, the inner space of the twisting cover comprises a groove in which the protective element is movable along the longitudinal axis, and its movement is visible. The twisting cover has a window portion (opening) that can be observed. As explained above, the twisting cover has an internal space in which the protective element can be received, in which the protective element allows movement along the longitudinal axis. This movement is achieved by moving the twisting cover axially with respect to the lancet in the state where the protective element and the lancet body are integrally connected (that is, before twist-off), and at least the protective element and the columnar portion. Allows a part to be covered. Also, after the twist-off, only the protective element remains in the twisting cover and can be restrictedly moved therein.

To that end, the protective element comprises a projecting portion as a stop on its outer surface, the edge defining the window portion of the protective element mentioned above cooperating with the stopper in the longitudinal axis of the protective element. Limit movement along. This window portion locks the stopper to prevent further movement of the protective element towards the opening of the twisting cover. Furthermore, the window portion allows confirmation of the movement of the protective element therein,
After using the lancet, when the lancet end with the protruding piercing element is re-inserted into the twisting cover and the cover is put over the lancet, the piercing element pushes the protective element inside the cover. Make it possible to see how it is being held.

When the lancet is inserted into the twisting cover after the use of the lancet, the piercing element pushes the protective element held in the cover forward and there is a space in the cover in which the protective element can move. The pushed protective element moves forward and none of the exposed piercing element penetrates into the protective element. Therefore, at least a part of the exposed piercing element and a part of the protective element pushed thereby can be visually confirmed from the window portion. Therefore, even if the lancet is set in the twisting cover, by checking the inside from the window, it is a used lancet (the piercing element can be seen) or a lancet before use. It is possible to easily confirm whether or not (the piercing element cannot be seen).

In a more preferable state, the internal space of the twisting cover is smaller than that in the above description, and when the used lancet is inserted into the twisting cover, the piercing element pushes the protective element forward, but to some extent. It is preferably adapted to stop its movement when pushed and to allow the tip of the piercing element to penetrate the protective element upon further insertion of the lancet. This is advantageous because the tip of the piercing element, to which a small amount of body fluid has adhered, is enclosed in the protective element.

Further, in another preferred aspect of the present invention, the cylindrical portion of the lancet body has engaging means, which cooperates with engaged means provided on the inner surface of the twisting cover. This prevents the lancet and the twisting cover from being separated from each other very easily and promotes the coaxial rotation of the twisting cover with respect to the lancet body at the time of twisting off. That is, after use of the lancet of the present invention, the twisting cover is put on the lancet and discarded, but there is an engagement means for maintaining the covered state. As a specific example, the engaging means is a circumferential groove provided around the cylindrical portion,
The engaged means is a protrusion provided on the inner surface of the twisting cover, and may have a snap-fit relationship such that the protrusion fits in the groove.

In the lancet assembly of the present invention, when the internal space of the protective element has a non-circular cross section, it means that a part of the internal space has a cross section other than circular, and the shape of such cross section. Is not particularly limited, and may have any shape as long as the protective element does not rotate with respect to the twisting cover. For example, square (for example, square and rectangular), pentagonal, and hexagonal cross sections can be exemplified, and these may be chamfered. Also,
The cross section of the portion of the twisting cover that receives the protective element does not necessarily correspond to the cross section of the protective element, or it may correspond. Regarding the circular cross section, the cross section of the part where the twisting cover receives the part is
It may be circumscribed on a portion having a substantially circular cross section within such a degree that both can rotate relative to each other. In a second aspect, the present invention provides
There is provided a lancet and a twisting cover that constitute the lancet assembly as described above. These features
The description has been made in connection with the lancet assembly of the first aspect.

[0032]

BEST MODE FOR CARRYING OUT THE INVENTION Next, preferred embodiments of the present invention will be described with reference to the drawings. 3 to 6 show the assembly of the present invention in an exploded perspective view. 3 is a state of the lancet assembly before assembly, FIG. 4 is a perspective view of the lancet 33, FIG. 5 is a partially cutaway perspective view of the twisting cover 35, and FIG.
FIG. 6 schematically shows a partially cutaway perspective view of a state after being assembled and before being twisted off.

The lancet assembly 31 of the present invention comprises
It is composed of a lancet 33 and a twisting cover 35. The lancet 33 comprises a lancet body 37 and a protective element 39, which in the preferred embodiment are integrally molded and are connected by a notch portion 41. Although not shown, the piercing element is embedded in the lancet body 33 and the protective element 39, and the notch portion 41 is broken to move the protective element 39 forward (in the direction of the arrow) to thereby move the lancet body 37. When separated from, it is exposed. The lancet body 33 has a cylindrical portion 43 having a certain length at its front portion.

The twisting cover 35 has an opening 45 through which the protective element 39 and at least a portion of the cylindrical portion 39 pass when the assembly is assembled. The inner space of the twisting cover 35 includes a groove-shaped (or rectangular cross-section) space portion 47 and a cylindrical (or circular cross-section) space portion 4.
Comprising 9. The space portion 47 can receive the protective element 39 in a non-rotatable manner, and the space portion 49 can receive at least a part of the cylindrical portion 39 in a non-rotatable manner. The twisting cover 35 further comprises a window part 51 in a rectangular cross section, through which the state of the protective element 39 can be seen. There may be one or more window portions 51 on both sides or one side of the twisting cover as shown.

The cylindrical portion 43 of the lancet body has a groove portion 44 as an engaging means on the periphery thereof. This groove portion engages with the engaged means 53 provided inside the cover 35 to limit the movement of the lancet along the longitudinal axis within the cover, and also to promote the coaxial reverse rotation of the cover and the lancet body. To do. The illustrated embodiment is adapted to engage with a snap fit. Instead of the grooves, serrations (for example, a plurality of grooves having a small width) may be provided on the inner surface of the twisting cover. In this case, the columnar portion of the lancet body is engaged with the serrations in cooperation with the serrations. Unevenness is provided.

The protective element 39 has a projection 5 as shown.
5 which serves as a stopper locked by the edge 57 of the window portion 51. To assemble the assembly of the present invention for sale or use, when the lancets 33 are brought close together in the direction of the arrow to cover the twisting cover 35 (arrow D in FIG. 3), the protrusions extend rearward. Since it has a tapered shape and the parts other than the piercing element are made of a plastic material, even if the clearance between the protective element and the twisting cover is small, the lancet 33 is pushed into the cover 35 and the protruding portion is formed. 55 may be located in the window portion 51. However, once the protrusion 55 enters the window portion 51,
Due to the tapered shape of the protrusion 55, the protrusion 55 cannot move backward (in the direction opposite to the arrow) out of the window portion 51. That is, once the projecting portion 55 enters the window portion 51, the movement of the protective element 39 is restricted, and the protective element 39 is not substantially detached from the twisting cover 35.

From the state shown in FIG. 6, when the lancet 33 and the twisting cover 35 are rotated about the piercing element as a shaft 63 and force is applied in opposite directions, and the force becomes larger than the breaking strength of the notch portion 41, Breakage occurs at that portion, and the connection between the protection element 39 and the lancet body 37 disappears. Since the piercing element is coaxial with the cylindrical portion (that is, the axis of the cylinder is the piercing element), during this rotation, the cylindrical portion 43 of the lancet guides the rotation of the twisting cover around it. The rotation of the cover (and thus the protective element located therein) about the piercing element is ensured. Also, since the cylindrical portion has a certain length,
Even if a pulling force deviated from the axial direction is simultaneously applied during this rotation, the columnar portion resists that force, and therefore the pulling force does not bend the piercing element.

After the notch portion is broken by the rotation, a force is applied to the lancet assembly to separate the lancet 33 and the twisting cover 35 in opposite directions along the piercing element. Since it is not possible to get out of the lancet 33, the lancet 33, in which the piercing element 61 is projected from the end with the protective element 39 left behind in the cover 35, comes out of the cover. This state is schematically shown in a perspective view in FIG. 7 (directions opposite to each other are indicated by arrows E and F). The lancet 33 with the piercing element 61 exposed is attached to a commercially available finger-pricking device in that state and used for blood collection.

After blood collection, the piercing element 61 and the columnar portion 43 are inserted into the twisting cover with or without removing the lancet 33 from the finger-pricking device (arrow D in FIG. 3). Same direction).
In this case, the protective element 39 exists in the cover in a state as shown in FIG. 7, for example, but by inserting the lancet 33, the protective element is pushed by the piercing element 61 to move forward, and The state shown in FIG. If the inner space of the twisting cover is made smaller so that the distance that the protective element can move forward (arrow G) becomes smaller, the tip of the piercing element is sharp and can penetrate into the protective element.

FIG. 9 is a top view of the state shown in FIG. 8. As can be easily understood from this, a part of the piercing element 61 and the protective element 39 exposed from the window portion can be confirmed,
It is immediately known that it has been used. In this state, the used lancet assembly can be safely discarded. FIG.
Fig. 0 schematically shows a partial perspective view of another preferable embodiment of the twisting cover of the present invention. In the embodiment shown, the twisting cover 35 comprises a self-supporting element 65 at the end opposite the opening 45. The shape of this self-supporting is not particularly limited, and is an element that makes it difficult for the twisting cover to tip over when the twisting cover is self-supporting with the opening 45 facing upward, and is the bottom of the twisting cover. Any element can be used as long as the area is substantially larger than the cross-sectional area of the twisting cover.

When the twisting cover has such a self-supporting element, it is easy to cover the used lancet through the opening while the twisting cover is made to stand on a desk, for example (therefore, the opening faces upward). , And at this time, it is not necessary to hold the cover with fingers.
Therefore, the piercing element 61 does not erroneously puncture the finger holding the cover 35, so that safety in use is ensured. The shape of the self-supporting element 65 may be, for example, circular or polygonal (triangular, quadrangular, hexagonal) or a combination thereof as in FIG. Since the self-supporting element 65 is larger than the cross-sectional area of the twisting cover 35, there is another effect that a force required for twisting is smaller than that in the case where the self-supporting element is not provided.

Further, the window portion 35 of the cover of the embodiment shown in FIG.
Is 9 in the circumferential direction of the shaft from the state shown in FIG.
It is placed in a state rotated by 0 °. In such an embodiment, the distance between the window portion and the shaft 63 of the twisting cover, and thus the piercing element 61, if present, will be greater than in the case of FIG. This is because even if the user pinches the twisting cover with the lancet 33 inserted in the twisting cover 35 after using the lancet assembly, the finger may touch the piercing element 61 (on which body fluid has adhered). Is substantially eliminated. Further, in the illustrated embodiment,
The width of the window portion (that is, the length in the direction perpendicular to the axial direction) is smaller. This too has the advantage of virtually eliminating the possibility of a finger touching the piercing element 61.

In the case of the shape shown in FIG. 10, the window portion 51
It is possible that the visibility of the inside of the twisting cover is lacking because the width is too small. In that case, the twisting cover may be made of a transparent material (for example, transparent grade resin such as polypropylene, polyethylene, polystyrene (and a copolymer thereof), and AS, MMA (polymethylmethacrylate), PC (polycarbonate), PCT (polyester). Cyclohexylene terephthalate), PET (polyethylene terephthalate) resin, which is originally transparent resin, makes the state of the needle tip (whether the needle tip is exposed, that is, whether it is already used) transparent. The advantage is that it can be easily confirmed through a simple twisting cover. Of course, a transparent material may be used in the embodiment of FIG.

[0044]

The lancet assembly of the present invention has the following effects in particular: (1) The protective element is not directly twisted and pulled, but is twisted using the front cylindrical portion of the lancet body and the groove provided therein as a guide. Since the protection cover is twisted with respect to the lancet and the twisting cover is pulled by using the cylindrical portion as a guide to indirectly remove the protective element and pull out the lancet, the piercing element is not bent.

(2) The lancet, in which the protective element and the lancet body are integrated, is firmly connected by integral molding, which has been proven to be reliable in maintaining its sterilized state, and thus the lancet assembly of the present invention. Also uses such a lancet. Therefore, in the process of sterilization, assembly, weighing, packaging, transportation, etc., the protective element does not fall off or come off.
The effect of sterilization can be reliably maintained until just before use.

(3) The status of the lancet assembly (whether unused, used, or not used but in an unsuitable state for use) when the twisting cover is twisted It is possible to make a reliable judgment based on the torque and whether or not the position of the protective element and the piercing element can be visually observed from the twisting cover. (4) It can be safely discarded if the twisting cover is put on the lancet again after being used for blood collection.

[0047]

【Example】

[Lancet] The lancet of FIG. 3 (where the protective element and the lancet body are integrally molded and have a notch portion)
In order to mold the above, a single mold was prepared. The material of the piercing element to be inserted was stainless steel 304, and there were two kinds of diameters of 0.3 mm and 0.4 mm, and the needle tip was ground by an NC needle grinder. The mold was set on a 30-ton vertical molding machine. The needle was molded by inserting it into the mold with tweezers. As the plastic material used for the lancet, LLDPE (low density polyethylene) of Japan Polyolefin Co., Ltd. was used. The molding could be performed without any problems, and 25 lancets were obtained.

The main dimensions of the molded lancet were as follows: (protective element-substantially quadrangular) width: 3.8 mm, thickness: 2.5 mm (excluding protrusions), length: 5 9.9 mm (cylindrical part of lancet body) Diameter: 4.65 mm,
Length: Diameter 5.6mm (groove on the side of the cylinder) width 0.4mm, depth 0.25
Grooves all around mm (projection on the protection element) Height: 0.6 mm (distance between peaks of projections on both sides: 3.7 mm)

[Twisting Cover] In order to mold the twisting cover shown in FIG. 3, a single mold was prepared. In order to mold the window portion of the twisting cover, the mold has a split mold and a slide structure. A mold was attached to a 40-ton horizontal molding machine to mold. The plastic material used for the cover was a high rigidity type LDPE manufactured by Nippon Polyolefin Co., Ltd. The molding could be performed without any problems.

The main dimensions of the molded twisting cover were as follows: (corresponding to the cylindrical portion receiving portion and the cylindrical portion of the lancet) outer diameter: 6.5 mm, inner diameter: 4.75 mm, length: 6 .5m
m (inner surface protrusion of the cylindrical portion receiving portion, engaged with the groove of the lancet) 4 places (90 degree interval), height: 0.22 mm,
Width: 0.8 mm (Protective element receiving part, inner dimension of rectangular cross section) Width: 4.8 m
m, length: 8.5 mm, height 2.8 mm (window portion) width: 2.8 mm, length: 4.5 mm

[Assembly] The twisting cover was set on the table so that the cylindrical portion receiving portion faces upward (hence, the opening of the cover faces upward). After the rectangular cross section of the protective element and the rectangular cross section inside the twisting cover were aligned, the protective element of the lancet was pushed into the twisting cover. Pushing was stopped when the projection on the protective element got over the square cross section inside the twist cover and entered the window portion. At that time, at the same time, the four protrusions in the twist cover also entered into the grooves formed in the cylindrical portion of the lancet, and the assembly was completed.

When this assembly was completed, the twisting cover was pulled out along the longitudinal axis so as to be separated from the lancet, but the projection on the needle tip protection cap was formed on the window portion of the twisting cover. It couldn't be pulled out easily because it was locked on the edge. The above-mentioned assembly could be carried out without any problems for 25 assemblies each.

[Simulation of Usage State] With the lancet held by the right hand, the twisting cover was twisted clockwise by the left hand. The twisting cover was twisted smoothly around the longitudinal axis (piercing element) by being guided by the cylindrical portion of the lancet and the groove provided therein. The protective element cannot rotate in the twisting cover, which means that the protective element is rotating integrally with the twisting cover through the window part of the twisting cover (thus the twisting cover is around the protective element). It cannot be rotated). When the twisting cover was pulled about the longitudinal axis, the pulling operation was guided by the column part of the lancet.
I was able to pull it straight out. Since the protective element is connected to the edge of the window portion of the twisting cover by the protrusion,
When the twisting cover was removed from the lancet, it left the lancet and remained in the cover.

In this way, the protruding piercing elements (each 25 pieces) of the lancet from which the protective element was removed through the twisting cover were visually inspected, but it was found that the protruding piercing elements were bent. There was no When the torque required to twist the twisting cover was measured with a torque meter,
Average value for 5 assemblies is 480g-c
m. This was at almost the same level as in the case of a normal lancet (a lancet in which the piercing element protection cap and the lancet body are integrally molded, for example, cleanlet). There was no significant difference between the 0.4 mm diameter needle and the 0.3 mm diameter needle.

Next, in order to confirm the adaptability to a commercially available pricking device (Indiector), Penlet (manufactured by Johnson & Johnson) and Glucolet (manufactured by Bayer) are selected from among them, and I set the device with the piercing element exposed in this way and ejected it.
m, diameter 0.65 mm, diameter 0.5 mm, no difference was found between the conventional type lancet and needle. Furthermore, the test was conducted assuming that the blood collection was completed. The twist cover was reattached to the lancet with the exposed needle tip. The twisting cover was guided by the columnar portion of the lancet body and could be smoothly reattached.

As the twisting cover was reattached to the lancet, the piercing element came into contact with the protective element remaining in the twisting cover, but the piercing element was replaced by the original needle hole (from the protective element to the piercing element). Does not enter the hole formed by the
Pushed forward (there is a gap between the protective element and the groove in the twisting cover due to the difference in width and thickness of the two, so the protective element separated from the lancet is restrained in the groove. As a result, the original needle hole is displaced from the needle tip). Then, at the time when the reattachment of the twisting cover was completed, the protective element and the exposed piercing element pushed forward by the piercing element from the window portion were clearly visible. In other words, the status of the lancet used was clearly visible.

Although the tip portion of the piercing element was visible, the fact that the window portion is deeply formed (that is, the edge of the window portion is high) makes it practically impossible to touch the piercing element with a finger. could not. Further, when the twisting cover was reattached, the four protrusions in the twisting cover were fitted in the grooves of the cylindrical portion of the lancet, so the twisting cover was firmly held by the lancet. . In this state, when the lancet was held and the twisting cover was rotated, virtually no torque was felt, and from this point as well, the status of the lancet that was already used could be confirmed.

From the results as described above, it was confirmed that the present invention has the same practicality as the lancet of the type that has been commercially available so far. Regarding the mass productivity of the lancet assembly of the present invention, judging from these examples, the blood sampling needle was a combination of a vertical molding machine and an automatic needle inserter, and the twisting cover was a horizontal molding machine. Therefore, it is considered that the assembly can be mass-produced easily and inexpensively by an automatic assembly machine.

[Brief description of drawings]

FIG. 1 is a schematic perspective view of a conventional lancet.

FIG. 2 is a schematic perspective view of another prior art lancet.

FIG. 3 is an exploded perspective view schematically showing a state of the lancet assembly before assembly.

FIG. 4 is a schematic perspective view of the lancet 33. ,

5 is a schematic partial cutaway perspective view of a twisting cover 35. FIG.

FIG. 6 is a schematic partial cutaway perspective view showing a state after assembly and before twisting off.

FIG. 7 is a schematic partial cutaway perspective view showing a state in which the lancet is pulled out from the lancet assembly.

FIG. 8 is a schematic partially cutaway perspective view showing a state in which the lancet assembly is fitted into the twisting cover after use.

FIG. 9 is a schematic top view of the state of FIG.

FIG. 10 is a schematic perspective view of a twisting cover.

[Explanation of symbols]

11 ... Lancet, 13 ... Lancet body, 15 ... Protective cap, 17 ... End face, 21 ... Lancet assembly, 23 ... Needle, 25 ... Holder, 27 ... Protective cap,
29 ..., 31 ... Lancet assembly, 33 ... Lancet, 35 ... Twist cover, 37 ... Lancet body,
39 ... Protective element, 41 ... Notch part, 43 ... Cylindrical part, 44 ... Groove, 45 ... Opening part, 47 ... Groove space, 49 ...
Cylindrical space, 51 ... Window portion, 53 ... Projection portion, 55 ... Projection portion, 57 ... Edge portion, 61 ... Penetration element, 63 ... Shaft, 65
… Independence element.

Claims (6)

[Claims] 1. A lancet assembly used for blood collection, comprising: (1) (i) a lancet body having a circular cross section at a portion where the piercing element projects from one end, and (ii) surrounding the projecting piercing element. A lancet having a protective element having a substantially non-circular cross section to prevent the piercing element from being exposed prior to use of the lancet assembly; and (2) a protective element for the lancet. And a lancet body that receives at least a part of the circular section and that allows the lancet body to rotate about the longitudinal section of the lancet body about the longitudinal axis of the piercing element and around the protective element. A lancet assembly having a twisting cover having an internal space having a space that prevents rotation of the through element about the longitudinal direction. 2. Except for the piercing element, the lancet body is formed of a plastic material so that the connection between the circular section of the lancet body and the protective element is provided by a portion having a notch portion having a strength capable of being manually twisted off. The lancet assembly according to claim 1, wherein these are integrally molded. 3. The inner space of the twisting cover has a groove for allowing the protective element to move in the axial direction of the piercing element and a window portion for visually observing the movement thereof. Lancet assembly described. 4. The protective element comprises a stopper, which once inside the window part limits the movement of the protective element along the groove, once the twisting cover has been put over the protective element. The lancet assembly of claim 3, which functions as follows. 5. A lancet used in the lancet assembly according to claim 1. 6. A twisting cover used in the lancet assembly according to any one of claims 1 to 4.