JPH06237922A - Blood collecting device - Google Patents

Abstract

PURPOSE:To safely abandon a run set by collecting blood while fitting an end cap after the run set is mounted, and keeping the state of housing the main body of the run set inside the end cap only by opening the main body of the run set after the blood is collected. CONSTITUTION:This blood collecting device is provided with a run set 101 composed of a main body 102 of the run set equipped with a plane blade tip part 105 and a plane blade tip protecting part 103, and the respective parts 102 and 103 can be separated at a notched part 104. The main body 101 of the run set can be fitted to a pricking device by a fitting means 106 and provided with a first lock means 107 to be cooperated with the calling part of a first means 122 to be locked of an end cap 121 at the time of mounting the end cap 121 to the pricking device. Further, the main body 102 of the run set is provided with an arm means 113 to be cooperated with a second means to be locked and after blood is collected, the main body 102 of the run set can be saved into the end cap 121 by cooperating these means.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood sampling device, and more particularly to a pricking blood sampling device characterized by the cooperation of a lancet and an end cap, and more particularly to a flat blade tip that pierces a blood sampling site. The present invention relates to a pricking blood collection device that uses a lancet having a portion (hereinafter, also referred to as a flat blade lancet).

[0002]

2. Description of the Related Art In recent years, the number of diabetic patients has been increasing all over the world, and the governments of various countries and various institutions are focusing on early detection of diabetes. Early detection requires tests to measure blood glucose levels in the blood. Due to the rapid progress of electronic technology in recent years, blood test devices and reagents (to obtain information on various diseases such as diabetes) have become more compact, simpler, and cheaper, and blood glucose levels have become Has become easier to implement. In this case, it is necessary to collect the blood to be tested, but if this is done alone,
It is very difficult to collect blood from the ear lobe, and blood is generally collected from the fingertip.

When collecting blood from fingertips, finger-pricking devices are widely used in hospitals and general households. When using this finger-pricking device, it is necessary to use a disposable lancet having a needle tip portion that pierces the fingertip (though this need not be the case, but it may be other portion). Various types have been proposed so far.

By the way, when the amount of blood to be collected is large, a large wound is not formed even if the lancet having the needle as described above is used. Therefore, in order to form a larger wound, a lancet having a flat blade is used instead of the needle. In particular, to collect blood samples used for blood tests of premature babies, newborns and infants,
This flat blade lancet is used. Further, even in the case of an adult or a child, a larger amount of blood may be required depending on the type of examination, and in this case, of course, the flat blade lancet is used.

Conventionally, two types of blood collecting devices using a flat blade lancet have been used. One type is an automatic incision devic that uses a spring mechanism to eject a flat blade lancet.
e), and the other type is a jig that manually extrudes a flat blade lancet to damage the skin.

The former device is Becton & Dickinson (USA)
Commercially available from Microtainer (Microtai
ner) is representative. The latter device is commercially available from International Technidyne Corporation (USA) under the trade name tenderfoot (tendfoot).
erfoot) and tenderlett.

Devices using such flat-blade lancets are required to meet the following requirements: First, the required blood volume must be readily available. When the required amount of blood cannot be collected by one puncture, it is necessary to repeat the puncture, which causes unnecessary pain to the blood sample. Secondly, it is necessary that the time required for blood collection be short. If it takes time to collect blood, the efficiency in the hospital or lab will decrease,
In addition, there is a possibility that necessary inspection cannot be performed when necessary.

[0008] Third, a blood collector (ph) who handles the lancet
It is necessary to be able to obtain a uniform blood sample regardless of who does it, regardless of the personal skill of the nurse or nurse. Fourth, the quality of the blood sample taken must be constant. Inadequate blood collection may cause hemolysis of the blood, which may affect the accuracy and reliability of the test, such as potassium levels. For example, hemolysis may occur depending on the width and depth of the wound due to piercing and the time of blood collection. Finally, it is necessary to have less pain when piercing.

[0009] The experimental results comparing the automatic piercing tool and the manual piercing tool (both of which have flat blades) are described in a report by Maureen Andrew and Ron Muller. (Neonatal Intensive Car)
e), July / August issue (1992), pp. 18-21). According to this report, the best blood sampling method is
This is a method in which the flat blade lancet pierces a blood sampling site by injecting the flat blade lancet using an automatic piercing tool. This method reduces the time required for blood collection to approximately 57% compared to the method of manually piercing the lancet, and
It is said that the amount of blood collected will be about 2.4 times. Furthermore, the number of hemolyzed samples is also greatly reduced. As a result, of the 20 blood samples collected by the automatic piercing device, 19 were suitable for analysis, whereas in the case of manual piercing, 14 samples were suitable for analysis. It was stated that it was only there.

As can be easily understood from this report, there is no individual difference in the piercing with the automatic piercing tool, and the lancet is ejected using the spring, so the speed of piercing the skin is much higher. It is characterized by a rapid blade retreat from the wound. On the contrary, in the case of manual piercing, there are individual differences, the piercing speed is slow, and the blade retreats slowly from the wound,
Blood samples will take longer for pain, and the depth of the wound will also vary.

[0011]

As described above, the automatic piercing device is far more useful than the manual piercing, but the automatic blood collecting device using a commercially available flat-blade lancet is as follows. There are insufficient points. First, the lancet is incorporated into the retainer, but the cutting edge of the flat blade lancet is unsealed. The blade part of the lancet needs to be sealed in a sterile state until it is about to be used, but in the case of a commercially available lancet, only the blade part is not sealed and it is difficult to hold the lancet. The entire device needs to be packaged in a blister pack-like form and sterilized. With this, the cost of the blister pack becomes necessary, and it becomes bulky,
Therefore, distribution costs such as packaging costs, transportation costs, and storage costs increase.

Further, unlike the case of a lancet using a needle, a large amount of blood is collected by a single puncture, so there is a high possibility that blood will adhere to the vicinity of the ejection opening of the blade of the tool. Therefore, if the same automatic piercing device is used repeatedly, contamination of the device with blood becomes a problem. Therefore, it is desirable to change the device after each puncture, but this increases the cost of blood collection.

[0013]

[Means for Solving the Problems] The above-mentioned problems are solved by attaching a lancet body having a protruding flat blade tip portion, a lancet having a flat blade tip protecting portion into which the protruding flat blade tip portion is inserted, and protecting the lancet body, and collecting blood. In order to accommodate the pricking device that ejects toward the site and pierces the flat blade tip part into the blood sampling site, as well as the lancet body attached to the pricking device during blood sampling,
A blood sampling device having an end cap that can be attached to a pricking device at one end, and that has an opening at the other end that has an opening through which the flat cutting edge portion of the lancet body passes during ejection of the lancet body. The lancet body further comprises first locking means and arm means, and the end cap has a first inner side.
It further comprises a first locked means cooperating with the locking means and a second locked means cooperating with the arm means, and at the time of blood collection, after attaching the lancet body to the pricking device, the end cap is preplated. When mounted on the king device, the lancet body is housed in the end cap with the first locking means of the lancet body riding over the first locked means of the end cap, and when the lancet body is ejected, the arm means is The elastic deformation does not hinder the flat blade edge portion of the lancet body from piercing the blood sampling site, and after blood collection, the arm means elastically recovers the original shape before the deformation and the second object By contacting with the locking means, the flat blade tip portion is not exposed to the outside from the opening of the other end of the end cap, and the first locking means and the first locked means cooperate with each other. The lancet body has been found to be solved by blood collection device housed within the end cap so as to prevent from falling off the one end of the end cap by.

That is, the blood collecting device of the present invention comprises a lancet, a pricking device and an end cap, which will be described below. The lancet of the blood collection device of the present invention comprises a lancet body and a flat blade edge protection portion. The lancet body is embedded with a flat blade (blade crossing of 1.2 to 2.3 mm) that pierces the blood sampling site, and the flat blade tip portion projects with an appropriate length according to the blood sampling. Normally, it projects about 3.1 to 3.3 mm from the lancet body. In the lancet of the present invention, the flat blade to be used is to form a wound for bleeding the blood to be collected by piercing the blood sampling site of the blood sampling subject. A flat blade similar to that conventionally used for a commonly used flat blade lancet is sufficient. The lancet body is a member that holds at least the tip portion of such a flat blade in a protruding state.

Further, the lancet body is adapted to be attached to the pricking device. It is sufficient that the pricking device is substantially similar to the commonly used pricking device that ejects a lancet with a needle. The lancet body has attachment means for attaching to the pricking device, preferably at or near the end opposite to the end on which the cutting edge projects. Generally, the pricking device has an ejection means for mounting the lancet body and ejecting the lancet body. Therefore, the ejection means has a lancet body holding portion that cooperates with the mounting means of the lancet body, and the lancet body can be mounted. You can do it. Generally, in a commercially available finger-pricking device, since the lancet body can be attached by press-fitting the lancet body holding portion of the ejection means, the lancet body can be attached to the ejection means of the pricking device. As long as it can be fitted into the lancet body holding part,
There is no need to supply any special means. It is usually sufficient that the dimensional relationship between the end of the lancet body (and hence the mounting means located there) and the lancet body holding part of the lancet injection means of the finger-pricking device be press fit. Is.

In the device of the present invention, the lancet body has a first locking means that cooperates with a first locking means and an arm means that cooperates with a second locking means inside the end cap, which will be described later. Further, it will be described later. In the device of the present invention, the lancet has a cutting edge protection portion, which protects the cutting edge portion protruding from the lancet body and shields the cutting edge portion from the outside (seal) until the lancet body is mounted on the pricking device. ) Has a function of preventing the blade edge portion from being contaminated.

Therefore, the cutting edge protection portion protects the cutting edge portion protruding from the lancet body, and before the lancet is used, the cutting edge portion is located in the cutting edge protection portion (for example, inserted state, embedded state). It includes the state of being intrusive and intrusive). In terms of protecting and cutting off the entire cutting edge part, it is particularly preferable that the cutting edge protection part is integral with the lancet body, and by using a suitable plastic material such as polyethylene or polypropylene, the lancet body and cutting edge protection The parts can be integrally molded.

In the lancet of the present invention, when collecting blood,
In order to easily separate the blade tip protection part from the lancet body (for example, by pulling it by hand), notches (cuts) are formed on the upper and lower surfaces of the flat blade at the part where the lancet body and the blade tip protection part are adjacent to each other. The formed plastic material is extremely thin (for example, about 0.1 to 0.15 mm). Specifically, at the time of molding, the thickness of the plastic material on the upper and lower surfaces of the blade of the adjacent portion is set to about 0.6 to 0.7 mm, and the adjacent portion is vertically adjusted after molding by an appropriate jig (for example, a press machine). The incision is formed by compression. By providing the notch portion in this way, after the lancet is mounted on the pricking device, the flat blade can be exposed by pulling the lancet body and the blade edge protection portion in opposite directions to break the plastic material of the notch portion. it can.

In a preferred aspect of the present invention, the cutting edge protection portion has, as a part thereof, a protruding portion that fits into the opening of the end cap through which the cutting edge portion passes during blood collection. It is particularly preferable that the protruding portion is a protruding portion having a shape and dimensions that snap fit into the opening through which the cutting edge portion of the end cap passes. This protruding part
It may be provided between the lancet body and the blade tip protecting portion, adjacent to the blade tip protecting portion. (Thus, strictly speaking, the notch portion and the protruding portion of the cutting edge protection portion are adjacent to each other.) However, in a particularly preferred embodiment, the protruding portion is provided in the middle of the largest surface of the cutting edge protection portion as described later. In this case, the snap fit to the opening of the end cap can be performed most safely and easily.

The pricking device used in the blood collecting device of the present invention may be a commercially available so-called finger-pricking device (for a lancet having a needle). This pricking device has a structure in which a lancet body is attached and the lancet body can be ejected toward a blood sampling site. That is, the pricking device includes an injection means having a lancet body holding part to which the lancet body can be attached, preferably an injection means having a lancet body holding part to which the lancet body, especially its end can be fitted by press fitting. Have.

The ejection means is generally combined with spring means to attach the lancet body and then eject the lancet body. Before injection, the spring means is fixed (locked) in a compressed state, and by releasing this fixed state, the lancet body moves toward the blood sampling site in conjunction with the action of the spring means returning to the original state. It is supposed to do. After being pierced, the ejection means is slightly reversed to allow the blade tip to come off the blood sampling site. Commercially available finger-pricking devices of the lancet-mounted type allow press-fit mounting of most types of lancets that are commercially available separately. Such finger-pricking devices can also be used in the device of the present invention. Of course, it is also possible to manufacture a special pricking device.

In the device of the present invention, after attaching the lancet to the lancet body holding portion (so-called holder) of the injection means of the pricking device, the cutting edge protection portion is removed from the lancet, and the end cap is engaged with the pricking device. Let The end cap can be engaged with the pricking device by any suitable method, for example, snap fit, press fit, or the like. By attaching the end cap to the pricking device, the lancet body attached to the ejection means is completely accommodated in the end cap before blood collection.

Further, the end cap has a substantially rectangular cross section, particularly a rectangular cross section, in a plane perpendicular to the injection direction of the lancet, and the opening portion through which the cutting edge portion penetrating the blood sampling site passes is attached to the pricking device. At or near the end opposite to the mating side. Only the cutting edge portion projected from the lancet body ejected by the pricking device passes through this opening, and the blood sampling site is positioned with respect to this opening. The opening may have any suitable size and shape as long as only the cutting edge portion can pass through it, but it is preferable that it has a cross-sectional shape slightly larger than that corresponding to the cross-sectional shape of the cutting edge portion. . Specifically, for example, the width of the blade is 2.0 mm and the thickness of the root portion of the blade (the root of the blade protruding from the lancet body) is 0.0 mm.
When using a 15 mm flat blade, it is appropriate to make a rectangular opening of about 5 × 3 mm. The opening may be at the end of the end cap (ie, the end surface of the end cap includes the opening), but in another aspect, slightly from the end,
For example, in consideration of the wall thickness of the end surface, the surface existing at a position retracted inward by about 2 mm to 3 mm has an opening.

In the device of the present invention, the lancet body has a first locking means, and the end cap has a first locked means inside which cooperates with the first locking means. First
The positional relationship and shape of the locking means and the first locked means are such that when the lancet body is attached to the pricking device to separate the blade edge protection portion before blood collection, the lancet is attached to the lancet. The first locking means of the main body overcomes the first locked means provided inside the end cap (toward the opening of the end cap) so that the lancet body is located inside the end cap. In this state, the blood collection standby state is set. In addition, after blood collection, the first locking means of the lancet body cannot get over the first locked means of the end cap (in the direction of the engaging portion with the pricking device). Therefore, once the end cap is once mounted on the pricking device by the first locking means and the first locked means, the lancet body is on the side opposite to the opening, that is, the side to be mounted on the pricking device. It will not fall out.

As a concrete mode of the first locking means and the first locked means having such a function, the diameter becomes smaller toward the opening of the end cap, and the deformability (for example, flexibility) is increased. Or so called "invitation" with elasticity
A taper portion called an appropriate width along the lengthwise direction of the end caps on at least a part of each of the inner surfaces of at least one pair of opposing end caps to form the first locked means, and The distance (corresponding to the length of the side of the virtual circumscribing rectangle of the cross section perpendicular to the axial direction of the lancet body) is the minimum distance of the tapered portion of the end cap (corresponding to the distance between the opposing first locked means portions). ) Is slightly larger than the lancet body, and more preferably has a “call-in” on the side toward the opening of the end cap (the opposite side has substantially no “call-in”) and is perpendicular to the axial direction outside the lancet body. At least one set of means provided so as to extend in opposite directions may be used as the first locking means.

As for "invitation", as in the above-described preferred embodiment, both the first locked means and the first locked means have, or only one of them (for example, in the above-mentioned first embodiment). In addition, only the first locked means) may have.
On the contrary, the first locking means has "invitation", and the first locked means is simply a portion where the cross section of the end cap is small (a flange-shaped portion protruding inward from the inner surface of the end cap). May be only Which is selected depends on the deformability (for example, flexibility or elasticity) of the material to be used and the difference between the distance between the tips of the first locking means of the lancet body and the distance of the first locked means of the end cap. It is appropriate to decide by For example, when the difference between the length between the tips of the first locking means and the distance between the first locked means is small or when a material having large flexibility is used, both of them are generally “invited”.
Need not have.

With this arrangement, when the end cap is attached to the pricking device, the distance between the tips of the first locking means of the lancet body is larger than the distance between the tapered portions of the first locked means. Also, at least one of the first locking means and the first locked means is slightly deformed by the force when the end cap is attached (for example, the force that pushes the cap and fits it in the pricking device), so that the lancet body The first locking means can pass over the first locked means and pass therethrough. This is because the material forming the first locking means and / or the first locked means is made of a deformable material. However,
Even if an attempt is made to pull out the lancet body in the direction opposite to the opening after blood collection, the portion of the first locking means that is not substantially engaged hits the first locked means. You can't get over the end cap by getting over it.

On the contrary, even when the first locking means has a call on the engagement side with the pricking device, if the first locked means does not have a call on the opening side, The first locking means cannot get over the first locked means toward the engagement side, and has the same effect as the above case. Of course, the same applies when both parties do not have a call. Therefore, when trying to remove the end cap from the pricking device, the end cap is removed from the pricking device while the lancet body is located inside the end cap (that is, the lancet body and the lancet body holding means of the lancet body injection means are held). Since the engaging force between the lancet body and the portion is much smaller than the force required to get over the first locked means, the lancet body can be removed from the lancet body holding portion). The lancet body does not fall off the end cap when it is removed from the king device.

In this case, the first locking means may come into contact with at least a part of the first locked means. For example, the first locked means may be present along the entire circumference inside the end cap, in which case the first locked means is circumferentially shaped to abut the entire circumference of the first locked means. It is not always necessary, for example, when considering a plane perpendicular to the injection direction of the lancet body, two points (for example, every 180 °, that is, opposite side) or four points (for example, 90 degrees) facing each other of the first locked means. It suffices if the first locking means comes into contact only every (°). Also, the reverse aspect of the above aspect is possible. That is, the first locking means of the lancet body may be present over the entire circumference on the opposite side surface side, and the first locked means of the end cap may be partially present.
In either case, the first locking means and the first locked means at least partially contact each other.

Because of the functioning of the first locking means and the first locked means as described above, in the present invention the lancet and the end cap are made of a plastic material such as polyethylene or polypropylene, especially each of them. It is preferably manufactured by integral molding. Such a material is also preferable from the viewpoint of ease of molding. Further, the distance between the tips of the first locking means (corresponding to L ₁ in "FIG. 2") and the slightly smaller minimum distance between the first locked means (corresponding to L ₂ in "FIG. 3"). Difference (L ₁ −L ₂ )
Is usually preferably about 0.3 to 0.4 mm.

In the device of the present invention, the lancet body has arm means, and the end cap has second locked means inside which cooperates with the arm means. The arm means is elastically deformable and recoverable. By forming the arm means integrally with the lancet body by using the same material as the lancet body, this elastic deformation and recovery function can be imparted. The positional relationship and shape of the arm means and the second locked means are such that the lancet body can move in the axial direction of the end cap within a certain range within the end cap when the lancet body is released from the lancet body holding portion after blood collection. However, since the arm means and the second locked means cooperate with each other, the blade tip portion of the lancet body does not protrude from the opening of the end cap. The arm means and the second locked means are preferably formed integrally with the lancet body and the end cap, respectively.

The arm means is generally a protrusion protruding laterally from the lancet body, and may be in the form of a rod, a column or a wall. Further, the arm means may have a curved surface portion at its tip portion, whereby friction between the arm means and the second locked means at the time of ejecting the lancet body is reduced. Specifically, a cylindrical portion at the tip of the arm means (which does not necessarily mean a perfect cylinder, but at least a part may be cylindrical,
For example, it may include a semi-cylindrical shape, and may optionally be curved corresponding to the inner surface of the end cap. ) (See the attached drawings) or a spherical portion (not necessarily a perfect sphere, at least a part of which may be spherical, including, for example, a hemispherical portion) may be provided.

As a concrete mode of the arm means and the second locked means having such a function, a tapered portion whose diameter becomes smaller toward the opening of the end cap,
A cross section having a taper portion of the end cap (the end cap shaft) is provided as a second locked means provided circumferentially inside the end cap with an appropriate width in the longitudinal direction of the end cap. At least one set of protrusions, which are equal to the distance between the opposite sides in the cross section perpendicular to the direction), are provided as arm means on the lateral side of the lancet body. As in the case of the first locking means and the first locked means, as long as the engagement between the arm means and the second locked means can be ensured between at least a part of each, either It may be provided around the circumference or in parts.

In this aspect, when the arm means and the second locked means are in contact with each other in the cross section, unless a large force such as the force at the time of ejection of the pricking device is externally applied to the lancet body. The second locked means is not deformed, and therefore, even if the lancet body is released in the end cap, the movement of the lancet body in the direction toward the opening in the end cap does not cause the arm means and the second locked body to move. It is designed to be restricted by the locking action of the cooperation of the means (this state is referred to as "rest state" for convenience.
Called). However, when a large force is applied, such as when the lancet body is ejected, the arm means comes into contact with the second locked means, but since the applied force is large, the arm means is elastically deformed and the lancet. The body moves more toward the opening side than in the stationary state described above, and the blade tip portion of the lancet body can protrude from the opening (that is, when the blood sampling site is located with respect to the opening). , That part can be pierced). After the piercing, the lancet body returns by the mechanism of the pricking device, so that the shape of the arm means is elastically restored to the original state before the deformation.

In order for the arm means and the second locked means to cooperate to perform such a function, the relative positional relationship between the arm means and the second locked means, the taper angle and the arm. The degree of protrusion of the means may be adjusted appropriately with respect to each other, taking into account the elastic deformation and recovery properties of the arm means, which adjustment is based on the above-mentioned function of the arm means and the second locked means. It is easy for those skilled in the art. As mentioned above, the length of the tapered portion of the end cap and the angle of the taper are interrelated and also depend on the material properties (particularly elasticity) and the degree of protrusion of the arm means of the lancet body. Generally, the length of the tapered portion is about 8 to 11 mm as the axial length of the end cap, and the angle of the tapered portion is about 8 to 11 ° as the inclination from the axial direction of the end cap. The range is not particularly limited. Further, the degree of protrusion of the arm means depends on the shape of the arm means and the properties of the material used for the arm means, but in general, the distance from the lancet body to the tip of the arm means is 1.7 to 2.0 mm. However, it is not particularly limited to these ranges.

As described above, the projecting portion as the arm means projects laterally from the lancet body to come into contact with the second locked means, and elastically deforms when the lancet body is ejected during blood collection. The movement of the lancet body in the direction towards the opening (and hence the blood sampling site) must not be obstructed. Therefore, the protrusion is made of a material (for example, polyethylene, polypropylene, etc.) that can be elastically deformed when the lancet body is ejected. Further, the arm means has a certain angle with respect to the axial direction of the lancet body, for example, 70
Preference is given to protrusions projecting at an angle of ˜90 °, particularly preferably 90 °. In this case, the angle is used to mean an angle formed by the arm means and the axial direction of the lancet body, which is on the side opposite to the cutting edge portion.

In another aspect of the invention, the second locked means may be a step portion formed in the end cap. This stepped portion is substantially the same as when the angle of the tapered portion is increased to 90 °. Even in this case, the arm means at the time of injection,
The arm means is in contact with the second locked means, but is elastically deformed by the momentum of the lancet body at the time of ejection to project the blade edge portion of the lancet body from the opening. However, after blood collection, the arm means has the original shape. In the state where the lancet body is recovered, the movement of the lancet body is restricted by coming into contact with the arm means (because no external force is applied). Instead of the step portion, the weir portion is provided around the entire inner circumference of the end cap, or partially
You may provide as a locked means. Also in the case of the second engaged means of another aspect, the second engaged means does not necessarily have to be provided over the entire inner circumference of the end cap as long as the contact with the arm means is secured.

Further, in a preferred aspect of the present invention, as described above, the opening portion of the end cap can be fitted with the protruding portion of the blade edge protecting portion. That is, the opening and the projection have a complementary relationship in shape and dimension. As mentioned above, after blood collection, the lancet body
When it comes off from the pricking device, it does not fall off from the pricking device side of the end cap due to the cooperative action of the first locking means and the first locked means, but it can move within the end cap, and the blade tip portion of the lancet body Although it does not protrude from the opening, it may approach the opening. Therefore, in order to completely isolate the inside of the end cap from the outside thereof, in the preferred embodiment of the present invention, the opening can be completely closed by fitting the opening into the protruding portion. As a result, after blood collection,
The lancet body does not fall off the end cap, and the tip portion of the blade is blocked at the opening, so that the lancet body together with the end cap can be disposed of more safely as compared with the conventional lancet. In another aspect, the invention provides a lancet and an end cap for use in addition to the device described above.

Next, the device of the present invention will be described with reference to the drawings. The lancet 101 of the present invention is schematically shown in a side view in FIG. 1 and a plan view in FIG. The lancet 101 of the present invention comprises a lancet body 102 and a cutting edge protection portion 103. In the illustrated embodiment, the lancet body 102 and the cutting edge protection portion 1
03 is integrally molded, for example, by molding a plastic material, and the two are connected by a notch portion 104 in a state where they can be separated by applying a force so as to pull them away from each other (in FIG. 2, the plastic material is surrounded by a flat blade). Shows a state where is thin). The lancet body 102 has a cutting edge portion 105 protruding from its end.
When the blade edge protection portion 103 is removed, the blade edge portion 105 is exposed from the lancet body 102 in a protruding state. The lancet body 102 has an attachment means 106 so that the lancet body can be attached to the lancet body holding portion 13 (see “FIG. 10”) of the pricking device 11. Mounting means 106
Is sized and shaped to be press-fitted to the lancet body holding portion 13 of the pricking device 11.

Further, the lancet body 102 has a first locking means 107. The first locking means 107 has a tapered portion 108 and a non-tapered portion 109, which are so-called “pull-in”. Taper part 1
The diameter of 08 is smaller toward the cutting edge portion 105. The non-tapered portion 109 may actually have a taper that abuts the first locked means so that the first locking means 107 does not fall off the end cap. That is, it may have a taper as long as it is a taper that forms a "pull-in" such that the lancet body can be easily pulled out from the end portion of the end cap by hand. In this specification, such a state is referred to as having substantially no "invocation". In the illustrated mode, the first locking means 107 is provided as a pair on opposite sides of the lancet.
One pair may be provided on each of the two sides.

When the end cap is attached to the pricking device, the first locking means 107 functions as the invoking portion 108 of the first locking means, and preferably the first engaged member provided on the end cap described later. By cooperating with the invoking portion 124 of the stopping means, it is possible to easily get over the first locked means 122 provided on the end cap and proceed toward the blood collection site, and a blood collection standby state can be achieved. However, when the lancet body tries to retreat after blood collection, the non-tapered portion 109 having no "invocation" hits the first locked means of the end cap, so that the lancet body does not easily fall off the end cap. Therefore, by removing the end cap from the pricking device, the lancet body can be automatically removed from the lancet body holding portion of the pricking device while being held by the end cap.

Further, the lancet body 102 has arm means 113. In the illustrated embodiment, the arm means 113 is a pillar that projects from the lateral side of the lancet body 102 in a substantially vertical direction, but as described above, it does not have to be the case, and The angle (angle α in FIG. 2) on the side opposite to the cutting edge portion among the angles formed by the axial direction and the arm means may be, for example, about 70 to 90 °, or may slightly exceed 90 °. , Generally 90 °. Also, the thickness of the arm means (the axial length of the lancet body), the circumferential length and the protruding length (the length from the lancet body surface to the apex of the arm means) are combined with the material properties of the arm means. This makes it possible to easily adjust the elastic deformation and recovery characteristics of the arm means.

In the case of the lancet of the illustrated embodiment used in commonly used finger-pricking devices, the arm means generally have a thickness (t) of between 0.6 and 0.
8 mm, the circumferential length (l) is 1.3 to 1.6 mm, and the protruding length (h) is 1.7 to 2.0 mm. Further, in the illustrated mode, a columnar portion is provided at the tip of the arm means 113. In the illustrated embodiment, the arm means 113 is provided at two locations around the lancet body at every 180 ° (sides facing each other), but the blade edge portion of the lancet body pierces the blood collection site at the time of blood collection. May be provided at, for example, more places than the cutting edge portion as long as the cutting edge portion is not exposed from the encap due to the cooperative action of the arm means and the second locked means. In a particularly preferred embodiment, at least two locations spaced apart at appropriate intervals in the circumferential direction of the lancet body, for example, four locations at 90 ° intervals about the axis of the lancet body in a cross section perpendicular to the longitudinal direction of the lancet body as shown in the figure, or Providing about two places every 180 °. In selecting this number, it is necessary to take into consideration the deformation characteristics of the arm means and the fact that the release from the mold during molding is not hindered.

In a preferred embodiment, the cutting edge protection portion 103 of the lancet of the present invention comprises a convex portion 110, which is a protruding portion that fits into the opening of the end cap. In the embodiment shown in FIGS. 1 and 2, the protruding portion is slightly larger in cross section (111) so that it can be snap-fitted into the opening. Once the convex part fits into the opening, it is preferable that it does not come off easily. Therefore, although the snap-fit connection is particularly preferable,
A mode in which they are connected by press fit is also possible. In a particularly preferred embodiment of the present invention, the protruding portion 110 is present on the widest surface of the cutting edge protection portion. This aspect is shown in FIGS. 9 and 10. As is apparent from the figure, the case of fitting from the direction of arrow A is easier than the case of fitting from the direction of arrow B. Therefore, after blood collection, the protruding portion can be easily and safely fitted into the opening of the end cap in the direction indicated by the arrow C in FIG.

The end cap 121 of the present invention is shown in FIG.
Is schematically shown in a longitudinal sectional view. The end cap 121 has a first locked means 122 and an opening 123 therein. The first locked means 122,
By mounting the end cap on the pricking device with the lancet body 102 attached, the first locking means 107 of the lancet body gets over the first locked means 122 of the end cap and the lancet body 102.
Is placed in such a position that the
Moreover, it has such a shape. That is, the first locked means 122 is the tapered portion 10 of the lancet body 102.
"Call" to the side that hits 8 like the lancet body
It is preferable that the first locked means 122 has a non-tapered portion 109 of the first locking means 107 when the end cap is attached.
At least adjacent to or away from the non-tapered portion 109.

Thus, tapered portions (108 and 124) are provided on both the lancet body and the end cap.
By providing the end cap to the pricking device, the first locking means 107 of the lancet body 102 can easily get over the first locked means 122 and proceed toward the opening 123. The angle of the locked portion tapered portion 124 of the end cap (that is, the inclination of the slope of the taper portion) depends on the angle of the tapered portion 108 of the locking portion of the lancet body, and the end cap and the lancet body, especially the first portion. 1. The end cap is attached to the pricking device according to the material of the first locked means and the first locking means, and the difference between the maximum outer diameter of the first locked means and the minimum inner diameter of the first locked means. In this case, the first locking means of the lancet body rides over the first locked means of the end cap, but it can be changed appropriately so that it cannot be easily overcome after blood collection. Generally, the angle of the tapered portion of the first locking means (β in FIG. 2) is about 20 to 35 °, and the angle of the tapered portion of the first locked means (γ in FIG. 3) is 45 to 45 °. The angle of the tapered portion 108 of the first locking means is 30 °, and the tapered portion 12 of the first locked means 12 is about 50 °.
The angle of 4 is 45 °.

Non-tapered portion 10 of first locking means 107
On the side (125) of the first locked means with which 9 abuts, it is preferable that the tapered portion is not provided from the viewpoint of securing the falling of the lancet body, but in the manufacturing process of integrally molding the end cap. From a viewpoint, it may be preferable to provide a tapered portion having a certain angle (for example, about 45 to 50 °). The characteristics of such a non-tapered portion are the same for the non-tapered portion 109 of the lancet body.

The first aspect of providing the tapered portion
There is a mode in which a taper portion is provided on one side of both means and a mode in which a taper portion is provided on one side of either one of the means so that the locking means can get over the first locked means. . On the other hand, in order to ensure that the lancet body does not slip out of the end cap after blood collection, the first locking means cannot cross over the first locked means, so that the other side of both means does not A mode in which a tapered portion is provided and a mode in which a non-tapered portion is provided on the other side of either one of the means can be considered. As described above, any one of the modes is appropriately selected depending on the difference in diameter, the material used for the means, the taper angle, etc. so as to achieve the object.

The end cap 121 has a mounting means 126 for a pricking device at an end portion opposite to the opening 123. In the mode shown in FIG. 3,
The attachment means 126 comprises a snap-fit portion complementary to the pricking device, but may have other forms, such as a press fit to attach the end cap to the pricking device. Further, in the device of the present invention, the end cap has the second locked means 141. In the embodiment shown in FIG.
The second locked means is the tapered portion 141 existing at the end portion of the end cap. This tapered portion 141 has an appropriate angle (ω in FIG. 3) with respect to the axial direction of the end cap.
Is done. This angle can be appropriately determined in consideration of the arm means 113, but is generally 8 to 11 °.
It is a degree. The arm means 113 abuts on any part of the second locked means in the axial direction of the lancet body.

That is, since the inner cross section of the end cap becomes smaller toward the opening, the arm means comes into contact with the inner side surface of the end cap at any position, and no force is applied to the lancet body. Alternatively, when the force is small and the arm means 113 is not deformed, the movement of the lancet body is restricted at that position, and when a force is applied to the lancet body, the end cap is adjusted according to the magnitude of the force. The arm means 113 is deformed by the contact between the inner surface of the arm means and the arm means, and the abutting portion moves to the right in FIG. Tapered part 141
Instead of the step portion 142 or the dam portion 143
The second locked means may be supplied by forming (indicated by broken lines) inside the end cap. Figure 3
In the above, in the end portion of the end cap, the upper half and the lower half show the second locked means in different modes, but in reality, they are vertically symmetrical.

The end cap has an opening 123 at the end opposite to the mounting means 126. In a preferred mode, the opening 123 has a size that allows the blade tip portion to pass through when the lancet body is ejected, but after blood collection, the convex portion 110 of the blade tip protection portion of the lancet fits to close the opening portion. Have a shape. This is because when the lancet body is released from the lancet body holding portion of the pricking device after blood collection, the lancet body of the present invention has a cutting edge portion exposed from the opening due to the cooperative action of the arm means and the second locked means. Although it is not possible to touch the cutting edge portion, it is considered that it is better to close the opening in the unlikely event that the opening is not in a closed state. Therefore,
When the opening is closed by the protrusion after blood collection, the lancet body is completely held in the ent cap, which further enhances safety. The surface 127 including the opening 123 may, but need not necessarily, be located at the end of the end cap as shown in FIG. 3, and the surface 127 including the opening 123 may be located at the end of the end cap. A peripheral bank portion may be formed at the end of the end cap, which is located at a portion slightly retracted, for example, about 2 to 3 mm.

By forming the bank portion in this manner, there are the following advantages: When blood is collected using a pricking device, blood droplets are formed at the blood sampling site after being pierced at the blood sampling site. , A surface 12 of which a portion includes an opening
May adhere to 7. Therefore, when the surface 127 is exposed at the end portion of the end cap, for example, a nurse may accidentally touch the blood adhered to the surface 127 in the operation after blood collection. However, when the surface 127 is located receding from the end surface of the end cap as in the present invention, there is an advantage that the probability of contacting the adhered blood is greatly reduced. Further, as described above, before the convex portion of the blade tip protection portion is fitted into the opening, the blade tip portion may pop out, but the presence of the bank portion causes the tip of the flat blade to come out from the end surface of the end cap. Since it can be prevented from coming out, there is also an advantage that the possibility of accidentally touching the blade with blood attached thereto is greatly reduced.

Further, by appropriately adjusting the degree to which the blood sampling site is pressed against the bank portion, the degree of compression of the blood sampling site can be increased to increase the degree of hyperemia of the blood sampling site and vice versa. It is possible. Also, by changing the degree of compression, the depth of the blood sampling site that is pushed from the end surface of the end cap into the end cap changes, which allows the penetration depth to be changed and it is also possible to collect different amounts of blood. Becomes

1 and 2, the pair of the first locking means 107 and the arm means 113 are respectively present on opposite sides of the lancet body, but the lancet body of the present invention is shown. In the above, the first locking means and the arm means do not necessarily have to be a pair, but may be, for example, two pairs, and their positions are in a direction perpendicular to the plane of FIG. Either or one may be present. The end cap shown in FIG. 3 shows a cross section of the end cap when viewed from the same direction as FIG. 2 which is a plan view of the lancet body. That is,
The illustrated end cap has a rectangular shape with a relatively flat cross section (see FIGS. 5 to 8), and is a cross-sectional view when cut vertically to the short side of the rectangle. However, the cross section of the end cap does not necessarily have to be a flat rectangle, and for example, when the first locking means and the arm means are not on the same side,
The cross-sectional shape will approach a square. Next, an example of a method of using the lancet of the present invention will be described with reference to FIGS.

When collecting blood, the lancet 101 is supplied, for example, in the state shown in the perspective view of FIG. This lancet is attached as it is by pushing the lancet body attaching means 106 into the lancet body holding portion (corresponding to 13 in FIG. 10) of the cooperating pricking device. Next, with the lancet attached, the blade tip protection portion 103 is removed by pulling it by hand, and the blade tip portion 105 is projected. Next, "Fig. 5"
As shown in FIG. 10, by attaching the end cap 121 to the pricking device 11 (only the end cap is shown, the pricking device is not shown) by, for example, a snap fit (see FIG. 10) as shown, ( FIG. 5 "shows a cross-sectional perspective view of the end cap and a perspective view of the lancet body.) The first locking means 107 of the lancet body is the first locked means 1 of the end cap.
It has passed over 22, and is in a blood collection standby state. In the illustrated mode, the first locking means 107 and the first locked means 122 are adjacent to each other, but it is sufficient that the first locking means 107 is located on the right side of the first locked means 122, and both are You may be separated.

Next, after a blood sampling site (not shown) is positioned on the end surface of the end cap, the lock is released and the lancet body is ejected. FIG. 6 shows the state at the moment when the lancet body 102 is ejected and penetrates the blood sampling site. As is apparent from FIG. 6, the arm means 113 is in contact with the tapered portion 141 of the end cap, but is elastically deformed rearward with respect to the injection direction (thus reducing the angle α). Therefore, the cutting edge portion 105 of the lancet body is exposed from the opening 123, and therefore, there is no problem in piercing the blood sampling site. Immediately after the puncture shown in "Fig. 6", the lancet body retracts backward by the function of the pricking device and moves away from the blood sampling site, and the arm means recovers its original shape.

Next, the end cap 121 is removed from the pricking device 11. In this case, when the snap fit between the end cap and the pricking device is released and then a force is applied to separate the end cap 121 and the pricking device 11, the non-tapered portion 109 of the first locking means 107 and the first taper portion 109 are separated. 1 locked means 122
The non-tapered portion 125 of the lancet comes into contact with the lancet body as shown in FIG. 5, and at least one of the first locking means and the first locked means (both in the illustrated case).
The first locking means 107 of the lancet body 102 has a first end of the end cap since there is substantially no
The locked means 122 cannot be overcome. Nevertheless, when the end cap 121 and the pricking device 11 are tried to be separated from each other, the lancet body 102 is automatically removed from the lancet body holding portion 13 that is coupled by the snap fit.

As is apparent from FIG. 5, since the first locking means 107 and the first locked means 122 are in contact with each other, the lancet body 102 does not fall off the end cap 121. Further, as can be seen from FIG. 5, the arm means 113 has returned to its original shape. Therefore, when the lancet body moves to the right, the position at which the arm means contacts the second locked means 141 is on the left side of the position at which the arm means contacts in "FIG. 6". This state is shown in "Fig. 7". This is the case when the second locked means is a tapered portion. In the aspect in which the second locked means is the step-like portion and the aspect in the dam-like portion, the abutting position does not change (instead, the angle α changes). As is apparent from FIG. 7, the cutting edge portion 105 of the lancet body does not protrude from the opening 123 of the end cap, and the possibility of accidentally touching the cutting edge portion can be greatly reduced.

Furthermore, in the blood collecting device of the present invention,
As shown in the cross-sectional perspective view of the end cap 121 in FIG. 8, the protruding portion 110 of the blade edge protection portion 103 is fitted into the opening 123 of the end cap by, for example, press fitting as shown in the figure, and is plugged. The lancet shown in FIG. 9 is fitted in the direction of arrow C in FIG.
As shown in FIG. 10, the capping operation is performed with the lancet body and the end cap still attached to the pricking device. Therefore, immediately after the piercing, the end cap 121 is removed from the pricking device. It is particularly preferred to carry out before. In other words, it is safer to plug the lancet body immediately after blood collection so that the cutting edge of the lancet body will never be seen through the opening after blood collection. In the aspect of "Fig. 7", there is no possibility of touching the blade tip portion, but by adopting "Fig. 8", there is no possibility of touching the blade tip portion, and the lancet body is housed in the end cap. It can be safely disposed of. Further, as is apparent from FIG. 8, in order to reduce the possibility of contacting blood attached to the end portion of the end cap to the maximum, when the protruding portion 110 is fitted in the opening 123, It is particularly preferable that the end surface 127 of the blade is completely covered with the cutting edge protection portion. That is, the cross section of the cutting edge protection portion is at least equal in size to the cross section of the end portion of the end cap.

[0060]

【The invention's effect】

(1) Similar to the case of using a finger pricking device using a conventional lancet, after attaching the lancet, attaching an end cap to collect blood, and after collecting the blood, simply release the lancet body, and the lancet body is released. The lancet can be safely disposed because it can be retained inside the end cap and there is no possibility of contact with the blade portion of the lancet. (2) Since the structure of the end cap is very simple,
The manufacturing of the end cap is very easy and the manufacturing cost of the end cap is low. Therefore, there is no economic problem even if the end cap is discarded together with the lancet body. (3) The lancet and end cap of the present invention can be used with a finger pricking device that has been conventionally used.

(4) In a preferred embodiment, the lancet body is completely isolated within the end cap by fitting the protruding portion, which is a part of the blade tip protecting portion of the lancet, into the opening of the end cap, and further, the end cap is further separated. Blood that may have adhered to the end surface of the will not come into contact with other things, further increasing safety. Although the present invention has been described with reference to specific examples, the present invention is not limited to the above-described embodiments, and those skilled in the art can make various changes and modifications within the scope of the concept of the present invention. It will be understood that these are also included in the scope of the present invention.

[Brief description of drawings]

FIG. 1 is a schematic side view of a lancet of the present invention (a flat blade is indicated by a broken line).

FIG. 2 is a schematic plan view of a lancet of the present invention (a flat blade is indicated by a broken line).

FIG. 3 is a schematic cross-sectional view of an end cap of the present invention (around the opening, different modes are shown simultaneously).
Is.

FIG. 4 is a schematic perspective view of the lancet of the present invention.

FIG. 5 is a schematic partial cross-sectional perspective view showing a method of using the blood sampling device of the present invention, in which the lancet body (perspective view) attached to the pricking device (not shown) ends. The state which exists in a cap (perspective sectional view) is shown.

FIG. 6 is a schematic partial cross-sectional perspective view similar to “FIG. 5” showing a method of using the blood collection device of the present invention, in which a flat blade pierces a blood collection site (not shown). The state of passing through is shown.

FIG. 7 is a schematic partial cross-sectional perspective view similar to “FIG. 5” showing a method of using the blood collection device of the present invention, in which the lancet body is released from the pricking device after blood collection. Shows the state.

FIG. 8 is a schematic partial cross-sectional perspective view showing a preferable disposal state of the lancet of the present invention, and similarly to “FIG. 5”, an end cap is shown in a perspective cross-sectional view.

FIG. 9 is a schematic perspective view of another embodiment of the lancet of the present invention, showing a state in which the cutting edge protection portion and the lancet body are separated.

[Fig. 10] Fig. 10 schematically shows a state in which the lancet of Fig. 9 is attached to a pricking device and fitting of protrusions when discarding the lancet, and a cross section of the end cap and the blade edge protection part. It is shown in a perspective view.

[Explanation of symbols]

11 ... Finger-pricking device, 13 ... Lancet body holding part, 101 ... Lancet, 102 ... Lancet body, 103 ... Blade tip protection part, 104 ... Twist-off part, 105 ... Blade tip protection part, 106 ... Attachment means, 107 ... 1 locking means, 108 ... tapered portion, 1
09 ... Non-tapered portion, 110 ... Projection portion, 111 ... Enlarged portion, 112 ... End portion, 113 ... Arm means, 121 ...
End cap, 122 ... First locked means, 123 ... Opening portion, 124 ... Tapered portion, 125 ... Non-tapered portion, 126 ... Attachment means, 127 ... Surface, 141 ... Second
Locked means, 142 ... step-like portion, 143 ... weir-like portion.

Claims (4)

[Claims] 1. A lancet body having a protruding flat blade tip portion, and a lancet having a flat blade tip protecting portion to which the protruding flat blade tip portion is inserted to protect the lancet body. It can be attached to the pricking device at one end so as to accommodate the pricking device that pierces the portion into the blood collection site, as well as the lancet body attached to the pricking device during blood collection,
A blood sampling device having an end cap at the other end having an opening through which the flat blade edge portion of the lancet body passes when the lancet body is ejected, wherein the lancet body has a first locking means and an arm means. A second end cooperating with the first locked means and the arm means cooperating with the first locking means on the inside.
When the end cap is attached to the pricking device after attaching the lancet body to the pricking device during blood collection, the first locking means of the lancet body causes the first latch of the end cap to engage. When the lancet body is housed in the end cap in a state of overcoming the stop means, and the arm means elastically deforms when the lancet body is ejected, the flat blade edge portion of the lancet body is used when piercing the blood sampling site. After the blood collection, the arm means elastically recovers the original shape before the deformation and comes into contact with the second locked means, so that the flat blade tip portion has the opening portion at the other end portion of the end cap. Is not exposed to the outside from the outside, and the lancet body is housed in the end cap due to the cooperation of the first locking means and the first locked means. Blood collection device adapted to prevent from falling off the one end of the command cap. 2. The flat blade edge protecting portion further comprises a protruding portion, and the protruding portion is adapted to be fitted into the opening portion of the other end portion of the end cap. Blood collection device. 3. A lancet for use in a device as claimed in claim 1 or 2, comprising a lancet body having first locking means and arm means. 4. The end cap used in the device according to claim 1, which has a first locked means, a second locked means and an opening.